Pharmaceutical Schedule, April 2008 (text extract)

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Pharmaceutical Management Agency

April 2008

New Zealand Pharmaceutical Schedule

Introducing PHARMAC

April 2008

Volume 15 Number 1

Editors Linda Wellington & Kaye Wilson email: schedule@pharmac.govt.nz Telephone +64 4 460 4990 Facsimile +64 4 460 4995 Level 14, Cigna House 40 Mercer Street PO Box 10 254 Wellington Freephone Information Line 0800 66 00 50 (9am – 5pm weekdays) Circulation Published each April, August and December. Changes to the contents are published in monthly updates. Annual subscription includes three Pharmaceutical Schedule books, 12 updates and occasional information on rule changes and news items. The Schedule is distributed free of charge to over 9,000 professionals, and is also available on an annual subscription. Prices $22.22 One Schedule book $4.44 One Update $120.00 Annual subscription All prices include postage and exclude GST. Production Typeset automatically using XML and TEX. Source XML suitable for database import available on request. Programmers Peter Ericson & John Geering email: texschedule@pharmac.govt.nz http://www.pharmac.govt.nz ISSN 1172 - 9376 Copyright c 1994 Pharmaceutical Management Agency. No part may be reproduced in any form or by any process without written permission, nor be used in any form of advertising, sales, promotion or publicity. While care has been taken in compiling this Schedule, PHARMAC takes no responsibility for any errors or omissions, and shall not be liable for any consequences arising therefrom.

Section A Section B

General Rules 12 Alimentary Tract & Metabolism 24

Blood & Blood Forming Organs 38 Cardiovascular System 52 Dermatologicals 61 Genito Urinary System 70 Hormone Preparations – Systemic 75 Infections – Agents For Systemic Use 86 Musculo-Skeletal System 98 Nervous System 103 Oncology Agents & Immunosuppressants 125 Respiratory System & Allergies 144 Sensory Organs 151 Various 156

Section C Extemporaneous Compounds (ECPs) 157 Section D Section E

Special Foods 163 Supply Orders (PSO & WSO) 183 Rural Areas 187

Section F Section G

Dispensing Period Exemptions 188 Safety Cap Medicines 190 Index 193

Introducing PHARMAC

PHARMAC, the Pharmaceutical Management Agency, is a Crown entity established pursuant to the New Zealand Public Health and Disability Act 2000 (The Act). The primary objective of PHARMAC is to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided. The PHARMAC Board consists of up to six members appointed by the Minister of Health. All decisions relating to PHARMAC’s operation are made by or under the authority of the Board. In particular, Board members decide on the strategic direction of PHARMAC and may decide which community pharmaceuticals should be subsidised and at what levels, and determine national prices for some pharmaceuticals to be purchased by and used in DHB Hospitals, and whether or not special conditions are to be applied to such purchases. Members of the PHARMAC Board Richard Waddel Gregor Coster Kura Denness David Kerr David Moore Adrienne von Tunzelmann Decisions taken by the PHARMAC Board members, or made under the authority of the Board, incorporate a balanced view of the needs of prescribers and patients. The aim is to achieve long-term gains and efﬁcient ways of making pharmaceuticals available to the community and for DHB Hospitals to purchase them. Murray Georgel, CE MidCentral DHB, attends PHARMAC’s Board meetings as an observer. The functions of PHARMAC are to perform the following, within the amount of funding provided to it in the Pharmaceutical Budget or to DHBs from their own budgets for the use of pharmaceuticals in their hospitals, as applicable, and in accordance with its annual plan and any directions given by the Minister (Section 103 of the Crown Entities Act): a) to maintain and manage a pharmaceutical schedule that applies consistently throughout New Zealand, including determining eligibility and criteria for the provision of subsidies; b) to manage incidental matters arising out of (a), including in exceptional circumstances providing for subsidies for the supply of pharmaceuticals not on the pharmaceutical schedule; c) to engage as it sees ﬁt, but within its operational budget, in research to meet its objectives as set out in Section 47(a) of the Act; d) to promote the responsible use of pharmaceuticals; e) to manage the purchasing of any or all pharmaceuticals, whether used either in a hospital or outside it, on behalf of DHBs; f) any other functions given to PHARMAC by or under any enactment or authorised by the Minister. The policies and criteria set out in the Pharmaceutical Schedule and PHARMAC’s Operating Policies and Procedures arise out of, and are designed to help PHARMAC achieve and perform, PHARMAC’s objective and functions under the Act. However PHARMAC may, having regard to its public law obligations, depart from the strict application of those policies and criteria in certain exceptional cases where it considers this necessary or appropriate in the proper exercise of its statutory discretion and to give effect to its objective and functions, particularly with respect to: q Determining eligibility and criteria for the provision of subsidies; and q In exceptional circumstances providing for subsidies for the supply of pharmaceuticals not on the Pharmaceutical Schedule. Decision Criteria PHARMAC updates the Pharmaceutical Schedule at regular intervals to notify prescribers, pharmacists, hospital managers and patients of changes to Community Pharmaceutical subsidies and the prices for Hospital Pharmaceuticals. In making decisions about amendments to the Pharmaceutical Schedule, PHARMAC is guided by its Operating Policies and Procedures, as amended or supplemented from time to time. PHARMAC takes into account the following criteria when making decisions about Community Pharmaceuticals: q the health needs of all eligible people within New Zealand (eligible deﬁned by the Government’s then current rules of eligibility); q the particular health needs of M¯ ori and Paciﬁc peoples; a q the availability and suitability of existing medicines, therapeutic medical devices and related products and related things; q the clinical beneﬁts and risks of pharmaceuticals; q the cost-effectiveness of meeting health needs by funding pharmaceuticals rather than using other publicly funded health and disability support services; q the budgetary impact (in terms of the pharmaceutical budget and the Government’s overall health budget) of any changes to the Pharmaceutical Schedule; q the direct cost to health service users; q the Government’s priorities for health funding, as set out in any objectives notiﬁed by the Crown to PHARMAC, or in PHARMAC’s Funding Agreement, or elsewhere; and q such other criteria as PHARMAC thinks ﬁt. PHARMAC will carry out appropriate consultation when it intends to take any such “other criteria” into account.

The Operating Policies and Procedures, including any supplements, also describe the way in which PHARMAC determines the level of subsidy or purchase price payable for each Community Pharmaceutical or Hospital Pharmaceutical, respectively. The decision criteria for Hospital Pharmaceuticals are set out in the hospital supplement to the Operating Policies and Procedures and in the introductory part of Section H of the Pharmaceutical Schedule. Copies of PHARMAC’s Operating Policies and Procedures and of any applicable supplements are available on the PHARMAC website (www.pharmac.govt.nz), or on request.

PHARMAC and the Pharmaceutical Schedule:

PHARMAC manages the national Pharmaceutical Schedule, which lists: q Pharmaceuticals available in the community and subsidised by the Government with funding from the Pharmaceutical Budget; and q some Pharmaceuticals purchased by DHBs for use in their hospitals, and includes those Hospital Pharmaceuticals for which national prices have been negotiated by PHARMAC. In the community approximately 1848 Pharmaceuticals are subsidised by the Government. Most are available to all eligible people within New Zealand on prescription by a medical doctor. Some are listed with guidelines or conditions such as ‘only if prescribed for a dialysis patient’ or ‘Special Authority - Retail Pharmacy’, to ensure that Pharmaceuticals are used by those people who are most likely to beneﬁt from them. Pharmaceuticals provided to patients for use while in DHB hospitals are not covered by Sections A to G of the Pharmaceutical Schedule. Section H of the Pharmaceutical Schedule is not a comprehensive list of Pharmaceuticals that are used within the DHB Hospitals. Section H of the Pharmaceutical Schedule includes Pharmaceuticals that can be purchased at a national price by DHBs for use in their hospitals. These are referred to as National Contract Pharmaceuticals. Section H of the Pharmaceutical Schedule also identiﬁes new Pharmaceuticals used in hospitals, which have been or are being assessed by PHARMAC, the results of that analysis being available to DHB Hospitals via PHARMAC’s website. A list of Discretionary Community Supply Pharmaceuticals, in Section H of the Pharmaceutical Schedule, identiﬁes those products that currently are not subsidised from the Pharmaceutical Budget as Community Pharmaceuticals in Sections A to G of the Pharmaceutical Schedule but which DHBs can at their discretion fund for use in the community from their own budgets without speciﬁc Hospital Exceptional Circumstances approval. PHARMAC’s clinical advisors Pharmacology and Therapeutics Advisory Committee (PTAC) PHARMAC works closely with the Pharmacology and Therapeutics Advisory Committee (PTAC), an expert medical committee which provides independent advice to PHARMAC on health needs and the clinical beneﬁts of particular pharmaceuticals for use in the community and/or in DHB Hospitals. The committee members are all senior, practising clinicians. The chair of PTAC sits with the PHARMAC Board in an advisory capacity. PTAC helps decide which community pharmaceuticals are to be subsidised from public monies by making recommendations to PHARMAC. Part of the role of PTAC is to review whether Community Pharmaceuticals already listed on the Schedule should continue to receive Government funds. The resources freed up can be used to subsidise other community pharmaceuticals with a greater therapeutic worth. PHARMAC may obtain clinical advice from PTAC in relation to national purchasing strategies for Hospital Pharmaceuticals. There may be additional specialist hospital representatives on PTAC subcommittees, or additional PTAC subcommittees, where PHARMAC considers this necessary. PTAC members are: Carl Burgess Ian Hosford Sisira Jayathissa Peter Jones Jim Lello Peter Pillans Tom Thompson Paul Tomlinson Howard Wilson Contact PTAC C/MBChB, MD, MRCP (UK), FRACP, FRCP, physician/clinical pharmacologist, Chair MBChB, FRANZCP, psychiatrist MBBS, MD, MRCP, FAFPHM, FRCP, FRACP, physician BMedSci, MBChB, PhD, FRCP, FRACP, physician BHB, MBChB, DCH, FRNZCGP, general practitioner MBBCh, MD, FCP, FRACP, clinical pharmacologist MBChB, FRACP, physician MBChB, MD, MRCP, FRACP, BSc, paediatrician, Deputy Chair BSc, PhD, MB, BS, Dip Obst, FRNZCGP, general practitioner PTAC Secretary Pharmaceutical Management Agency PO Box 10 254, WELLINGTON PTAC@pharmac.govt.nz

The PHARMAC Team The PHARMAC team has a wide range of expertise in health, medicine, economics, commerce, critical analysis, and policy development and implementation. Matthew Brougham Acting Chief Executive Erin Murphy PTAC Secretary / Panel Jason Arnold Senior Analyst Co-ordinator Peter Alsop Manager, Corporate and Sanjoy Nand Therapeutic Group Manager External Relations Christina Newman Executive Assistant to Chief Karen Barris Senior Receptionist Executive / Ofﬁce Manager Mike Bignall Therapeutic Group Manager Deborah Nisbet Receptionist Stephen Boxall Creative Director Jessica Nisbet Funding and Procurement Hayley Bythell PA to Medical Director Assistant Christine Chapman Contract Manager Jan Quin Team Leader, Medical Team Yvonne Chen Tender Analyst Marama Parore Manager, Access & Optimal Mary Chesterﬁeld High Cost Medicines Use & M¯ ori Health a Co-ordinator Chris Peck Analyst Steffan Crausaz Manager, Funding and Melanie Pemberton Communications Advisor Procurement Fisher Andrew Davies Procurement Initiatives Matthew Perkins Procurement Initiatives Manager Manager Sean Dougherty Therapeutic Group Manager Matthew Poynton Analyst/Health Economist Kim Ellis Access & Optimal Use Rachel Pratt Hospital Exceptional Co-ordinator Circumstances Panel Simon England Communications Manager Co-ordinator Peter Ericson Analyst/Programmer Ginny Priest Health Economist Andy Erceg IT Support Dilky Rasiah Deputy Medical Director Jackie Evans Therapeutic Group Manager Kyle Reid High Cost Medicines Panel John Geering Systems Architect Co-ordinator Rachel Grocott Health Economist / Team Brian Roulston Analyst Leader Assessment Fiona Rutherford Senior Policy Analyst Cameron Hall Health Economist Rico Schoeler Acting Manager, Analysis and Karen Jacobs Access & Optimal Use Manager Assessment Elspeth Kay Access & Optimal Use Manager Liz Skelley Finance Manager Geoff Lawn Applications Developer Paula Smith Records Manager Geraldine MacGibbon Therapeutic Group Manager Maria Storey Therapeutic Group Manager Janet Mackay Access & Optimal Use Manager Karen Vercoe M¯ ori Health Manager a Rachel Mackay Manager, Schedule and Jayne Watkins Community Exceptional Contracts Circumstances Panel Trish Mahoney Contract Manager Co-ordinator Adam McRae Team Leader, Access & Optimal Linda Wellington Schedule Analyst Use Lisa Williams Legal Counsel Scott Metcalfe Chief Advisor Population Kaye Wilson Schedule Analyst Medicine / Public Health a Mary-Ann Wilson M¯ ori Health Analyst Physician Stephen Woodruffe Therapeutic Group Manager Peter Moodie Medical Director

Purpose of the Pharmaceutical Schedule

The purpose of the Schedule is to list: q the Community Pharmaceuticals that are subsidised by the Government and to show the amount of the subsidy paid to contractors, as well as the manufacturer’s price (if it differs from the Subsidy) and any access conditions that may apply; and q some Hospital Pharmaceuticals that are purchased and used by DHB Hospitals, including those for which national prices have been negotiated by PHARMAC. The purpose of the Schedule is not to show the ﬁnal cost to Government of subsidising each Community Pharmaceutical or to DHBs in purchasing each Hospital Pharmaceutical since that will depend on any rebate and other arrangements PHARMAC has with the supplier and, for some Hospital Pharmaceuticals, on any logistics arrangements put in place by individual DHB Hospitals.

Finding Information in the Pharmaceutical Schedule

Community Pharmaceuticals For Community Pharmaceuticals, the Schedule is organised in a way to help the reader ﬁnd Community Pharmaceuticals, which may be used to treat similar conditions. To do this, Community Pharmaceuticals are ﬁrst classiﬁed anatomically, originally based on the Anatomical Therapeutic Chemical (ATC) system, and then further classiﬁed under section headings structured for the New Zealand medical system. q Section A lists the General Rules in relation to Community Pharmaceuticals and related products. q Section B lists Community Pharmaceuticals and related products by anatomical classiﬁcation, which are further divided into one or more therapeutic headings. Community Pharmaceuticals used to treat similar conditions are grouped together. q Section C lists the rules in relation to Extemporaneously Compounded Products (ECPs) and Community Pharmaceuticals that will be subsidised when extemporaneously compounded. q Section D lists the rules in relation to Special Foods and the Special Foods that are subsidised. q Section E Part I lists the Community Pharmaceuticals that are subsidised on a Practitioner’s Supply Order (PSO) and Wholesale Supply Order (WSO). q Section E Part II lists rural areas for the purpose of PSOs. q Section F lists the Community Pharmaceuticals dispensing period exemptions. q Section G lists the Community Pharmaceuticals eligible for reimbursement of safety cap and related rules. The listings are displayed alphabetically (where practical) within each level of the classiﬁcation system. Each anatomical section contains a series of therapeutic headings, some of which may contain a further classiﬁcation level. Where a Community Pharmaceutical is used in more than one therapeutic area, they may be cross-referenced. The therapeutic headings in the Pharmaceutical Schedule do not necessarily correspond to the therapeutic groups and therapeutic subgroups, which PHARMAC establishes for the separate purpose of determining the level of subsidy to be paid for each Community Pharmaceutical. The index located at the back of the book in which Sections A-G of the Pharmaceutical Schedule are published can be used to ﬁnd page numbers for generic chemical entities, or product brand names.

Hospital Pharmaceuticals

Section H lists Pharmaceuticals that DHBs fund from their own budgets. The Hospital Pharmaceuticals are grouped into the following Parts in Section H: q Part I lists the rules in relation to Hospital Pharmaceuticals. q Part II lists Hospital Pharmaceuticals for which national contracts exist (National Contract Pharmaceuticals). These are listed alphabetically by generic chemical entity name and line item, the relevant Price negotiated by PHARMAC and, if applicable, an indication of whether it has Hospital Supply Status (HSS) and any associated Discretionary Variance (DV) Pharmaceuticals and DV Limit. q Part III lists Assessed Pharmaceuticals, which have been or are being assessed by PHARMAC and, where such assessment is available, PHARMAC’s opinion regarding the use of the Assessed Pharmaceuticals in hospitals. DHB Hospitals are not obliged to implement those recommendations. q Part IV lists Discretionary Community Supply Pharmaceuticals, which are not Community Pharmaceuticals, but which a DHB Hospital can, in its discretion, fund for use in the community from its own budget. The index located at the back of the Section H supplement can be used to ﬁnd page numbers for generic chemical entities, or product brand names, for Hospital Pharmaceuticals.

Explaining drug entries

The Pharmaceutical Schedule lists pharmaceuticals subsidised by the Government, the amount of that subsidy paid to contractors, the supplier’s price and the access conditions that may apply. Example

ANATOMICAL HEADING

Subsidy (Manufacturer’s Price) $ Per Fully Brand or Subsidised Generic Manufacturer

Three months supply may be dispensed at one time if endorsed “certiﬁed exemption” by the prescriber. Practitioner’s Supply Order (or WSO for Wholesale Supply Order) Safety cap reimbursed Conditions of and restrictions on prescribing (including Special Authority where it applies) Three months or six months, as applicable, dispensed all-at-once

THERAPEUTIC HEADING CHEMICAL v Presentation, form and strength .........................10.00

100

Brand A Brand B Brand C Brand D Brand or manufacturer’s name Sole subsidised supply product Fully subsidised product Original Pack Subsidy is rounded up to a multiple of whole packs

Presentation - Available on a PSO .....................15.00 ‡ Presentation - Retail pharmacy-specialist ..........18.00 a) Prescriptions must be written by a paediatrician or paediatric cardiologist; or b) on the recommnedation of a paediatrician or a paediatric cardiologist CHEMICAL p Presentation, form and strength .........................26 26.53 (35.27)

50 250 ml OP

100 Brand E

Quantity the Subsidy applies to Subsidy paid on a product before mark-ups and GST Manufacturer’s Price if different from Subsidy

Sole Supply Fully Subsidised

vThree months supply may be dispensed at one time if endorsed “certiﬁed exemption” by the presriber.

Glossary

Units of Measure gram ..................................................g kilogram...........................................kg international unit ...............................iu microgram........................................µg milligram .........................................mg millilitre.............................................ml millimole......................................mmol unit.....................................................u

Abbreviations Ampoule ...................................... Amp Granules ......................................Gran Suppository ................................ Supp Capsule ........................................ Cap Infusion............................................Inf Tablet .............................................Tab Cream...........................................Crm Injection ...........................................Inj Tincture.........................................Tinc Device........................................... Dev Linctus .......................................... Linc Trans Dermal Delivery Dispersible................................... Disp Liquid..............................................Liq System.................................. TDDS Effervescent.................................... Eff Long Acting..................................... LA Emulsion..................................... Emul Ointment....................................... Oint Enteric Coated................................EC Sachet ........................................ Sach Gelatinous ..................................... Gel Solution........................................ Soln BSO Bulk Supply Order. CBS Cost Brand Source. There is no set manufacturer’s price, and the Government subsidises the product at the price it is obtained by the pharmacy. CE Compounded Extemporaneously. CPD Cost Per Dose. The Funder (as deﬁned in Part I of the General Rules) cost of a standard dose, without mark-ups or fees and excluding GST. ECP Extemporaneously Compounded Preparation. HSS Hospital Supply Status, the status of being the brand of the relevant Hospital Pharmaceutical listed in Section H Part II as HSS, that DHBs are obliged to purchase subject to any DV Limit for that Hospital Pharmaceutical for the period of hospital supply, as awarded under an agreement between PHARMAC and the relevant pharmaceutical supplier. OP Original Pack – subsidy is rounded up to a multiple at whole packs. PSO Practitioner’s Supply Order. Sole Subsidised Supplier Only brand of this medicine subsidised. WSO Wholesale Supply Order. XPharm Pharmacies cannot claim subsidy because PHARMAC has made alternative distribution arrangements. v Three months supply may be dispensed at one time if the exempted medicine is endorsed ‘certiﬁed exemption’ by the practitioner. p Three months dispensed all-at-once or, in the case of oral contraceptives, six months dispensed all-at-once, unless medicine is endorsed “close control” or “cc” and the endorsement is initialled by the prescriber. ‡ Safety cap required and subsidised for oral liquid formulations, including extemporaneously compounded preparations. Fully subsidised brand of a given medicine. Brands without the tick are not fully subsidised and may cost the patient a manufacturer’s surcharge. S29 This medicine is an unapproved medication supplied under Section 29 of the Medicines Act 1981. Practitioners prescribing this medication should: a) be aware of and comply with their obligations under Section 29 of the Medicines Act 1981 and otherwise under that Act and the Medicines Regulations 1984; b) be aware of and comply with their obligations under the Health and disability Commissioner’s Code of Consumer Rights, including the requirement to obtain informed consent from the patient (PHARMAC recommends that Practitioners obtain written consent); and c) exercise their own skill, judgement, expertise and discretions, and make their own prescribing decisions with respect to the use of an unapproved Pharmaceutical or a Pharmaceutical for an indication for which it is not approved. Note: Where medicines supplied under Section 29 that are used for emergency situations, patient details required under Section 29 of the Medicines Act may be retrospectively provided to the supplier.

Abbrev. [HP1]

[HP3]

[HP4]

Deﬁnitions Pharmacy Services Agreement Subsidised when dispensed from pharmacies that have the Complex Medicines Variation of the Pharmacy Services Agreement Subsidised when dispensed from pharmacies that have the Pharmacy Services Agreement. A Special Food with [HP3] annotation is subsidised when dispensed by a pharmacy that has a Special Foods Service appended to their Pharmacy Services Agreement by their DHB. Subsidised when dispensed from pharmacies that have the Monitored Therapy Variation (for Clozapine Services)

All other Pharmacy Agreements Available from selected pharmacies that have an exclusive contract to dispense ‘Hospital Pharmacy’ [HP1] pharmaceuticals. Available from selected pharmacies that have an exclusive contract to dispense ‘Hospital Pharmacy’ [HP3] pharmaceuticals.

Avaliable from selected pharmacies that have an exclusive contract to dispense ‘Hospital Pharmacy’ [HP4] pharmaceuticals.

Patient costs

Community Pharmaceuitical costs met by the Government Most of the cost of a subsidised prescription Community Pharmaceutical is met by the Government through the Pharmaceutical Budget. The Government pays a subsidy for the Community Pharmaceutical to Contractors, and a fee covering distribution and pharmacy dispensing services. The subsidy paid to Contractors does not necessarily represent the ﬁnal cost to Government of subsidising a particular Community Pharmaceutical. The ﬁnal cost will depend on the nature of PHARMAC’s contractual arrangements with the supplier. Fully subsidised medicines are identiﬁed with a in the product’s Schedule listing. CARBAMAZEPINE Tab 200 mg..................................................................... 14.53 (19.14) Fully subsidised brand Higher priced brand

Community Pharmaceutical costs met by the patient Some Community Pharmaceutical costs are met by the patient. Generally a patient pays a prescription charge. In addition a patient will sometimes pay a manufacturer’s surcharge, after hours service fee and any special packaging fee. PRESCRIPTION CHARGE The prescription charge for a three month course of a fully subsidised Community Pharmaceutical ranges up to $15.00 and represents the patient’s contribution to the cost of the Community Pharmaceutical, and a pharmacy dispensing fee. Where the cost of the Community Pharmaceutical and dispensing fee exceed the prescription charge the Government pays the rest of the cost. Maximum prescription charges vary by patient status as set out below. More information about prescription charges is contained in the pamphlet, Community Services Card, available from Work and Income. Patient’s subsidy entitlements Not a PHO enrolee or No Card Adult Child 6 - 17 Child under 6 Contraceptives No other card No other card No other card No other card With HUHC only With CSC Low-cost PHO Maximum prescription charge $15 $10 $0 $3 $3 $3 $3 $2 $2 $0 $0

PHO enrolee or Care plus patient Community Services Card (CSC) High Use Health Card (HUHC) Prescription Subsidy Card

for familes after ﬁrst 20 prescriptions since previous February* * Except prescriptions with $0 charge

MANUFACTURER’S SURCHARGE Not all Community Pharmaceuticals are fully subsidised. Although PHARMAC endeavours to fully subsidise at least one Community Pharmaceutical in each therapeutic group, and has contracts with some suppliers to maintain the price of a particular product, manufacturers are able to set their own price to pharmacies. When these prices exceed the subsidy, the pharmacist may recoup the difference from the patient. To estimate the amount a patient will pay on top of the prescription charge, take the difference between the manufacturer’s price and the subsidy, and multiply this by 1.86. The 1.86 factor represents the pharmacy mark-up on the surcharge plus other costs such as GST. Pharmacies charge different mark-ups so this may vary. Manufacturer’s surchage to patient = (price − subsidy) × 1.86

For example, a Community Pharmaceutical with a supplier (ex-manufacturer) cost of $11.00 per pack with a $10.00 subsidy will cost the patient a surchage of $1.86 on top of the prescription charge. The most a patient should pay is therefore $16.86 - being $15.00 maximum prescription charge, plus $1.86. Hospital Pharmaceutical and Pharmaceutical Cancer Treatment Costs The cost of purchasing Hospital Pharmaceuticals and Pharmaceutical Cancer Treatments (for use in DHB hospitals and/or in association with Outpatient services provided in DHB hospitals) is met by the Funder (in particular, the relevant DHB) from its own budget. As required by section 23(7) of the Act, in performing any of their functions in relation to the supply of Pharmaceuticals including Pharmaceutical Cancer Treatments, DHBs must not act inconsistently with the Pharmaceutical Schedule. PHARMAC web site PHARMAC has set up an interactive Schedule on the Internet. It can be used to calculate the cost of a prescribed Community Pharmaceutical. This site at http://www.pharmac.govt.nz takes into account the quantity of Community Pharmaceutical prescibed as well as the patient’s age, whether the patient has a community services card, high use health card or prescription subsidy card, the fee for pharmacy services and prescription charges. Other information about PHARMAC is also available on our website. This includes copies of the Annual Review, Annual Report and Annual Plan, as well as information such as the Pharmaceutical Schedule, Pharmaceutical Schedule Updates, National Hospital Pharmaceutical Strategy, other publications and recent press releases.

Special Authority Applications

Special Authority is an application process in which a prescriber requests government subsidy on a Community Pharmaceutical for a particular person. Subsidy Once approved, the presciber and the patient are provided a Special Authority number which must appear on the prescription. Specialists who make an application must communicate the valid authority number to the prescriber who will be writing the prescriptions. The authority number can provide access to subsidy, increased subsidy, or waive certain restrictions otherwise present on the Community Pharmaceutical. Some approvals are dependent on the availability of funding from the Pharmaceutical Budget. Criteria The criteria for approval of Special Authority applications are included below each Community Pharmaceutical listing, and on the application forms available on PHARMAC’s website. For some Special Authority Community Pharmaceuticals, not all indications that have been approved by Medsafe are subsidised. Criteria for each Special Authority Community Pharmaceutical are updated regularly, based on the decision criteria of PHARMAC. The appropriateness of the listing of a Community Pharmaceutical in the Special Authority category will also be regularly reviewed. Applications for inclusion of further Community Pharmaceuticals in the Special Authority category will generally be made by a pharmaceutical supplier. Special Authority Applications Application forms can be found at www.pharmac.govt.nz. Requests for fax copies should be made to PHARMAC, phone 04 460 4990. Applications are processed by HealthPAC (Wanganui), and should be sent to: HealthPAC, Private Bag 3015, WANGANUI Fax: (06) 349 1983 of free fax 0800 100 131 For inquiries, phone the Call Centre, free phone 0800 CHEM NO (0800 243 666) Note: HealthPAC can only provide information on Special Authority applications to prescribers and pharmacists. Each application must: q Include the patients name, date of birth and NHI number (codes for AIDS patients’ applications) q Include the practitioner’s name, address and Medical Council registration number q Clearly indicate that the relevant criteria, have been met. q Be signed by the practitioner.

Exceptional Circumstances policies

The purpose of the Exceptional Circumstances policies are to provide: q funding from the Community Exceptional Circumstances budget for medication, to be used in the community, in circumstances where the provision of a funded community medication is appropriate, but funding from the Pharmaceutical Budget is not able to be provided through the Pharmaceutical Schedule (“Community Exceptional Circumstances”); or q an assessment process for the DHB Hospitals to determine whether they can fund medication, to be used in the community, in circumstances where the medication is neither a Community Pharmaceutical nor a Discretionary Community Supply Pharmaceutical and where the patient does not meet the criteria for Community Exceptional Circumstances (“Hospital Exceptional Circumstances”); or q an assessment process for DHB Hospitals to determine whether they can fund pharmaceuticals for the treatment of cancer in their DHB Hospital, or in association with Outpatient services provided in their DHB hospital, in circumstances where the pharmaceutical is not identiﬁed as a Pharmaceutical Cancer Treatment (“Cancer Exceptional Circumstances”) in Sections A-H of the Pharmaceutical Schedule. Upon receipt of an application for approval for Community Exceptional Circumstances or Hospital Exceptional Circumstances, the Exceptional Circumstances Panel ﬁrst decides whether an application will be assessed initially under the Community Exceptional Circumstances criteria or the Hospital Exceptional Circumstances criteria. Cancer Exceptional Circumstances is a separate process.

Hospital Exceptional Circumstances

If the application is ﬁrst assessed but not approved under the Community Exceptional Circumstances criteria, the Exceptional Circumstances Panel may recommend the funding of the pharmaceutical for use in the community by a speciﬁc patient from a DHB Hospital’s own budget under Hospital Exceptional Circumstances. If the application is ﬁrst assessed under the Hospital Exceptional Circumstances criteria, the Exceptional Circumstances Panel may: a) recommend against the funding of the pharmaceutical for use in the community by a speciﬁc patient from a DHB Hospital’s own budget, in which case a DHB Hospital must not fund the pharmaceutical from its own budget; b) recommend the funding of the pharmaceutical for use in the community by a speciﬁc patient from a DHB Hospital’s own budget under Hospital Exceptional Circumstances, in which case a DHB Hospital may, but is not obliged to, fund the pharmaceutical from its own budget; c) defer its decision until further assessment under the Community Exceptional Circumstances criteria can undertaken; or d) recommend interim funding of the pharmaceutical for use in the community by a speciﬁc patient from a DHB Hospital’s own budget under Hospital Exceptional Circumstances until further assessment under the Community Exceptional Circumstances criteria can be undertaken. Permission to fund a pharmaceutical for use in the community by a speciﬁc patient from a DHB Hospital’s own budget under Hospital Exceptional Circumstances will only be granted by PHARMAC where it has been demonstrated that such funding is cost-effective for the relevant DHB in the region in which the patient resides. If the patient being treated with a pharmaceutical under Hospital Exceptional Circumstances usually resides in a district other than that within the jurisdiction of the DHB initiating the treatment, then the DHB initiating the treatment must either agree to fund any on-going treatment required once the patient has returned to his/her usual DHB, or obtain written consent from the DHB or DHBs in which the patient will reside following the commencement of treatment. Applications for Hospital Exceptional Circumstances should be made on the standard application form available from the PHARMAC website www.pharmac.govt.nz or the address below: The Coordinator, Hospital Exceptional Circumstances Panel Phone: (04) 916 7521 PHARMAC, PO Box 10 254 or fax (09) 523 6870 Wellington Email: ecpanel@pharmac.govt.nz

Cancer Exceptional Circumstances

Permission to fund a pharmaceutical for the treatment of cancer from the Hospital’s own budget under Cancer Exceptional Circumstances will only be granted by PHARMAC where it has been demonstated that the proposed use meets the criteria. If the patient being treated with a pharmaceutical under Cancer Exceptional Circumstances usually resides in a district other than that within the jurisdiction of the DHB initiating the treatment, then the DHB initiating the treatment must either agree to fund any on-going treatment required once the patient has returned to his/her usual DHB, or obtain written consent from the DHB or DHBs in which the patient will reside following the commencement of treatment.

Community Exceptional Circumstances

In order to qualify for Community Exceptional Circumstances approval one of the following criteria must be met: a) the condition must be rare; or b) the reaction to alternative funded treatment must be unusual; or c) an unusual combination of circumstances applies. Rare and unusual are considered to be in the order of less than 10 people nationally. Where one of the above Community Exceptional Circumstances entry criteria is met, the application may then be further examined under supplementary criteria, assessing suitability of the pharmaceutical, clinical beneﬁt, the cost effectiveness of the treatment, and the patient’s ability to pay for the treatment. Where these documented criteria are met, a subsidy sufﬁcient to fully fund the pharmaceutical will be made available to the speciﬁc patient on whose behalf the application was made. Community Exceptional Circumstances funding is only available where the criteria are met and is not available for ﬁnancial reasons alone. Applications for Community Exceptional Circumstances, Hospital Exceptional Circumstances and Cancer Exceptional Circumstances should be made on the standard application form available from the PHARMAC website www.pharmac.govt.nz or the address below: The Coordinator, Community Exceptional Circumstances Panel Phone (04) 916 7553 or fax (09) 523 6870 PO Box 10 254 Email: ecpanel@pharmac.govt.nz Wellington

SECTION A: GENERAL RULES

INTRODUCTION

Section A contains the restrictions and other general rules that apply to Subsidies on Community Pharmaceuticals. The amounts payable by the Funder to Contractors are currently determined by: q the quantities, forms, and strengths, of subsidised Community Pharmaceuticals dispensed under valid prescription by each Contractor; q the amount of the Subsidy on the Manufacturer’s Price payable for each unit of the Community Pharmaceuticals dispensed by each Contractor and; q the contractual arrangements between the Contractor and the Funder for the payment of the Contractor’s dispensing services. The Pharmaceutical Schedule shows the level of subsidy payable in respect of each Community Pharmaceutical so that the amount payable by the Government to Contractors, for each Community Pharmaceutical, can be calculated. The Pharmaceutical Schedule also shows the standard price (exclusive of GST) at which a Community Pharmaceutical is supplied ex-manufacturer to wholesalers if it differs from the subsidy. The manufacturer’s surcharge to patients can be estimated using the subsidy and the standard manufacturer’s price as set out in this Schedule. The cost to Government of subsidising each Community Pharmaceutical and the manufacturer’s prices may vary, in that suppliers may provide rebates to other stakeholders in the primary health care sector, including dispensers, wholesalers, and the Government. Rebates are not speciﬁed in the Pharmaceutical Schedule. This Schedule is dated 1 April 2008 and is to be referred to as the Pharmaceutical Schedule Volume 15 Number 1, 2008. Distribution will be from 20 April 2008. This Schedule comes into force on 1 April 2008.

PART I INTERPRETATIONS AND DEFINITIONS

1.1 In this Schedule, unless the context otherwise requires: “90 Day Lot” means the quantity of a Community Pharmaceutical required for the number of days’ treatment covered by the Prescription, being up to 90 consecutive days’ treatment; “180 Day Lot” means the quantity of a Community Pharmaceutical required for the number of days’ treatment covered by the Prescription, being up to 180 consecutive days’ treatment; “Access Exemption Criteria” means the criteria under which patients may receive greater than one Month’s supply of a Community Pharmaceutical covered by Section F Part II (b) subsidised in one Lot. The speciﬁcs of these criteria are conveyed in the Ministry of Health guidelines, which are issued from time to time. The criteria the patient must meet are that they: a) have limited physical mobility; b) live and work more than 30 minutes from the nearest pharmacy by their normal form of transport; c) are relocating to another area; d) are travelling extensively and will be out of town when the repeat prescriptions are due. “Act” means the New Zealand Public Health and Disability Act 2000. “Advisory Committee” means the Pharmaceutical Services Advisory Committee convened by the Ministry of Health under the terms of the Advice Notice issued to Contractors pursuant to Section 88 of the Act. “Alternate Subsidy” means a higher level of subsidy that the Government will pay contractors for a particular community Pharmaceutical dispensed to a person who has either been granted a Special Authority for that pharmaceutical, or where the prescription is endorsed in accordance with the requirements of this Pharmaceutical Schedule. “Assessed Pharmaceuticals” means the list of Pharmaceuticals set out in Section H Part III of the Schedule, that have been or are being assessed by PHARMAC. “Bulk Supply Order” means a written order, on a form supplied by the Ministry of Health, or approved by HealthPAC, made by the licensee or manager of an institution certiﬁed to provide hospital care under the Health and Disability Services (Safety) Act 2001 for the supply of such Community Pharmaceuticals as are expected to be required for the treatment of persons who are under the medical or dental supervision of such a Private Hospital or institution. “Cancer Exceptional Circumstances” means the policies and criteria administered by PHARMAC relating to the ability to fund, from a DHB hospital’s own budget, pharmaceuticals for the treatment of cancer that are not identiﬁed as Pharmaceutical Cancer Treatments in Sections A-H of the Pharmaceutical Schedule. “Class B Controlled Drug” means a Class B controlled drug within the meaning of the Misuse of Drugs Act 1975. “Close Control” means the dispensing of a Community Pharmaceutical, in accordance with a Prescription, in quantities

SECTION A: GENERAL RULES

less than one 90 Day Lot or, in the case of oral contraceptives, less than one 180 Day Lot for a Community Pharmaceutical referred to in Section F Part I, or in quantities less than a Monthly Lot for any other Community Pharmaceutical, as applicable, where all of the following conditions are met: i) the Community Pharmaceutical is a tri-cyclic antidepressant, antipsychotic, benzodiazepine, a Class B Controlled Drug, or any other Community Pharmaceutical that has been prescribed for a patient who: A) is not a resident in a Penal Institution, Rest Home or Residential Disability Care Institution; and B) in the opinion of the prescribing Doctor, Midwife or Nurse Prescriber is: 1) frail; or 2) inﬁrm; or 3) unable to manage their medication without additional support; or 4) intellectually impaired; and C) requires that Community Pharmaceutical to be dispensed in a smaller quantity than that for which it is currently funded; and ii) the prescribing Doctor, Midwife or Nurse Prescriber has A) endorsed each Community Pharmaceutical on the Prescription clearly with the words “close control” or “CC”; and B) initialled the endorsement in the prescribers own handwriting; and C) speciﬁed the maximum quantity or period of supply to be dispensed at any one time. “Community Exceptional Circumstances” means the policies and criteria administered by the Exceptional Circumstances Panel relating to funding from the Community Exceptional Circumstances budget for medication, to be used in the community, in circumstances where the provision of a funded community medication is appropriate, but funding from the Pharmaceutical Budget is not able to be provided through the Pharmaceutical Schedule. “Community Pharmaceutical” means a Pharmaceutical listed in Sections A to G of the Pharmaceutical Schedule that is subsidised by the Funder from the Pharmaceutical Budget for use in the community. “Contractor” means a person who is entitled to receive a payment from the Crown or a DHB under a notice issued by the Crown or a DHB under Section 88 of the Act or under a contract with the Ministry of Health or a DHB for the supply of Community Pharmaceuticals. “Controlled Drug” means a controlled drug within the meaning of the Misuse of Drugs Act 1975 (other than a controlled drug speciﬁed in Part VI of the Third Schedule to that Act). “Cost, Brand, Source of Supply” means that the Community Pharmaceutical is eligible for Subsidy on the basis of the Contractor’s annotated purchase price, brand, and source of supply. “Dentist” means a person registered with the Dental Council, and who holds a current annual practising certiﬁcate, under the HPCA Act 2003. “DHB” means an organisation established as a District Health Board by or under Section 19 of the Act. “DHB Hospital” means a DHB, including its hospital or associated provider unit that the DHB purchases Hospital Pharmaceuticals for. “Discretionary Community Supply Pharmaceutical” means the list of Pharmaceuticals set out in Section H Part IV of the Schedule, which may be funded by a DHB Hospital from its own budget for use in the community. “Doctor” means a medical Practitioner registered with the Medical Council of New Zealand and, who holds a current annual practising certiﬁcate under the HPCA Act 2003. “DV Limit” means, for a particular Hospital Pharmaceutical with HSS, the National DV Limit or the Individual DV Limit. “DV Pharmaceutical” means a discretionary variance Pharmaceutical, that does not have HSS and which: a) is either listed in Section H Part II of the Schedule as being a DV Pharmaceutical in association with the relevant Hospital Pharmaceutical with HSS; or b) is the same chemical entity, at the same strength, and in the same or a similar presentation or form, as the relevant Hospital Pharmaceutical with HSS, but which is not yet listed as being a DV Pharmaceutical. “Endorsements” - unless otherwise speciﬁed, endorsements should be either handwritten or computer generated by the practitioner prescribing the medication. The endorsement can be written as “certiﬁed condition”, or state the condition of the patient, where that condition is speciﬁed for the Community Pharmaceutical in Section B of the Pharmaceutical Schedule. Where the practitioner writes “certiﬁed condition” as the endorsement, he/she is making a declaration that the patient meets the criteria as set out in Section B of the Pharmaceutical Schedule. “Exceptional Circumstances Panel” means the panel of clinicians, appointed by the PHARMAC Board, that is responsible for administering policies in relation to Community Exceptional Circumstances and Hospital Exceptional Circumstances. “Funder” means the body or bodies responsible, pursuant to the Act, for the funding of pharmaceuticals listed on the

SECTION A: GENERAL RULES

Schedule (which may be one or more DHBs and/or the Ministry of Health) and their successors. “GST” means goods and services tax under the Goods and Services Tax Act 1985. “Hospital Care Operator” means a person for the time being in charge of providing hospital care, in accordance with the Health and Disability Services (Safety) Act 2001. “Hospital Exceptional Circumstances” means the policies and criteria administered by the Exceptional Circumstances Panel relating to the ability to fund, from a DHB Hospital’s own budget, pharmaceuticals for use in the community by a speciﬁc patient where a subsidy is not available from the Pharmaceutical Budget or under Community Exceptional Circumstances. “Hospital Pharmaceuticals” means National Contract Pharmaceuticals, DV Pharmaceuticals, Discretionary Community Supply Pharmaceuticals and Assessed Pharmaceuticals. “Hospital Pharmacy” means that the Community Pharmaceutical is not eligible for Subsidy unless it is supplied by a hospital or pharmacy contracted to the Funder to dispense as a hospital pharmacy to an person on the Prescription of a Practitioner. “Hospital Pharmacy-Specialist” means that the Community Pharmaceutical is not eligible for Subsidy unless it is supplied by a hospital or pharmacy contracted to the Funder to dispense as a hospital pharmacy: a) to an Outpatient; and b) on a Prescription signed by a Specialist; or if the treatment of an Outpatient with the Community Pharmaceutical has been recommended by a Specialist, on the Prescription of a Practitioner endorsed with the words “recommended by [name of specialist and year of authorisation]” and signed by the Practitioner. “As recommended by a Specialist” to be interpreted as: a) follows a substantive consultation with an appropriate Specialist; b) the consultation to relate to the Patient for whom the Prescription is written; c) consultation to mean communication by referral, telephone, letter, facsimile or email; d) except in emergencies consultation to precede annotation of the Prescription; and e) both the specialist and the General Practitioner must keep a written record of the consultation. For the purposes of the deﬁnition it makes no difference whether or not the Specialist is employed by a hospital. “Hospital Pharmacy-Specialist Prescription” means that the Community Pharmaceutical is not eligible for Subsidy unless it is supplied by a hospital or pharmacy contracted to the Funder to dispense as a hospital pharmacy: a) to an Outpatient; and b) on a Prescription signed by a Specialist. For the purposes of this deﬁnition, a “specialist” means a doctor who holds a current annual practicing certiﬁcate and who satisﬁes the criteria set out in paragraphs (a) or (b) or (c) of the deﬁnitions of Specialist below. “HSS” means hospital supply status, the status of being the brand of the relevant Hospital Pharmaceutical listed in Section H Part II as HSS, that DHBs are obliged to purchase subject to any DV Limit for that Hospital Pharmaceutical for the period of hospital supply, as awarded under an agreement between PHARMAC and the relevant pharmaceutical supplier. “In Combination” means that the Community Pharmaceutical is only subsidised when prescribed in combination with another subsidised pharmaceutical as speciﬁed in Section B or C of the Pharmaceutical Schedule. “Individual DV Limit” means, for a particular Hospital Pharmaceutical with HSS and a particular DHB Hospital, the discretionary variance limit, being the speciﬁed percentage of that DHB Hospital’s Total Market Volume up to which that DHB Hospital may purchase DV Pharmaceuticals of that Hospital Pharmaceutical. “Licensed Hospital” means a place or institution that is certiﬁed to provide hospital care within the meaning of the Health and Disability Services (Safety) Act 2001. “Lot” means a quantity of a Community Pharmaceutical supplied in one dispensing. “Manufacturer’s Price” means the standard price at which a Community Pharmaceutical is supplied to wholesalers (excluding GST), as notiﬁed to PHARMAC by the supplier. “Maternity hospital” means that the Community Pharmaceutical is not eligible for Subsidy unless it is supplied pursuant to a Bulk Supply Order to a maternity hospital certiﬁed under the Health and Disability Services (Safety) Act 2001. “Midwife” means a person registered as a midwife with the Midwifery Council, and who holds a current annual practising certiﬁcate under the HPCA Act 2003. “Month” means a period of 30 consecutive days. “Month restriction” means that no Subsidy is available: a) unless the Community Pharmaceutical is dispensed on the Prescription of a Practitioner; and b) for any quantity of that Community Pharmaceutical dispensed on the Prescription (whether or not dispensed as a repeat) in excess of a Monthly Lot. “Monthly Lot” means the quantity of a Community Pharmaceutical required for the number of days’ treatment covered by

SECTION A: GENERAL RULES

the Prescription, being up to 30 consecutive days’ treatment; “National Contract Pharmaceutical” means a Hospital Pharmaceutical for which PHARMAC has negotiated a national contract and the Price. “National DV Limit” means, for a particular Hospital Pharmaceutical with HSS, the discretionary variance limit, being the speciﬁed percentage of the Total Market Volume up to which all DHB Hospitals may collectively purchase DV Pharmaceuticals of that Hospital Pharmaceutical. “Not In Combination” means that no Subsidy is available for any Prescription containing the Community Pharmaceutical in combination with other ingredients unless the particular combination of ingredients is separately speciﬁed in Section B or C of the Schedule, and then only to the extent speciﬁed. “Nurse Prescriber” means a nurse registered with the Nursing Council and who holds a current annual practicing certiﬁcate under the HPCA Act 2003 and who is approved by the Nursing Council, to prescribe speciﬁed prescription medicines relating to his/her scope of practice. “Optometrist” means a person registered as an optometrist with the Optometrists and Dispensing Opticians Board, who holds a current annual practising certiﬁcate under the HPCA Act 2003, and who is authorised by regulations under the Medicines Act 1981 and approved by the Optometrists and Dispensing Opticians Board to prescribe speciﬁed medicines. “Outpatient” , in relation to a Community Pharmaceutical, means a person who, as part of treatment at a hospital or other institution under the control of a DHB, is prescribed the Community Pharmaceutical for consumption or use in the person’s home. “PCT” means Pharmaceutical Cancer Treatment in respect of which DHB hospital pharmacies and other Contractors can claim Subsidies. “PCT only” means Pharmaceutical Cancer Treatment in respect of which only DHB hospital pharmacies can claim Subsidies. “Penal Institution” means a penal institution, as that term is deﬁned in The Penal Institutions Act 1954; “PHARMAC” means the Pharmaceutical Management Agency established by Section 46 of the Act (PHARMAC). “Pharmaceutical” means a medicine, therapeutic medical device, or related product or related thing listed in Sections B to H of the Schedule. “Pharmaceutical Beneﬁts” means the right of: a) a person; and b) any member under 16 years of age of that person’s family, to have made by the Government on his or her behalf, subject to any conditions for the time being speciﬁed in the Schedule, such payment in respect of any Community Pharmaceutical supplied to that person or family member under the order of a Practitioner in the course of his or her practice. “Pharmaceutical Budget” means the pharmaceutical budget set for PHARMAC by the Crown for the subsidised supply of Community Pharmaceuticals. “Pharmaceutical Cancer Treatment” means Pharmaceuticals for the treatment of cancer, listed in Sections A to G of the Schedule and identiﬁed therein as a “PCT” or “PCT only” Pharmaceutical that DHBs must fund, from their own budgets, for use in their hospitals, and/or in association with Outpatient services provided in their DHB Hospitals, in relation to the treatment of cancers. “Practitioner” means a Doctor, a Dentist, a Midwife, a Nurse Prescriber or an Optometrist as those terms are deﬁned in the Pharmaceutical Schedule. “Practitioner’s Supply Order” means a written order made by a Practitioner on a form supplied by the Ministry of Health, or approved by HealthPAC, for the supply of Community Pharmaceuticals to the Practitioner, which the Practitioner requires to ensure medical supplies are available for emergency use, teaching and demonstration purposes, and for provision to certain patient groups where individual prescription is not practicable. “Prescription” means a quantity of a Community Pharmaceutical prescribed for a named person on a document signed by a Practitioner. “Private Hospital” means a hospital certiﬁed under the Health and Disability Services (Safety) Act 2001 that is not owned or operated by a DHB. “Residential Disability Care Institution” means premises used to provide residential disability care in accordance with the Health and Disability Services (Safety) Act 2001. “Rest Home” means premises used to provide rest home care in accordance with the Health and Disability Services (Safety) Act 2001. “Retail Pharmacy-Specialist” means that the Community Pharmaceutical is only eligible for Subsidy if it is supplied on a Prescription or Practitioner’s Supply Order signed by a Specialist, or, in the case of treatment recommended by a Specialist,

SECTION A: GENERAL RULES

a Prescription or Practitioner’s Supply Order and endorsed with the words “recommended by [name of Specialist and year of authorisation]” and signed by the Practitioner. “As recommended by a Specialist” to be interpreted as: a) follows a substantive consultation with an appropriate Specialist; b) the consultation to relate to the Patient for whom the Prescription is written; c) consultation to mean communication by referral, telephone, letter, facsimile or email; d) except in emergencies consultation to precede annotation of the Prescription; and e) both the Specialist and the General Practitioner must keep a written record of consultation. “Retail Pharmacy-Specialist Prescription” means that the Community Pharmaceutical is only eligible for Subsidy if it is supplied on a Prescription, or Practitioner’s Supply Order, signed by a Specialist. For the purposes of this deﬁnition, a “specialist” means a doctor who holds a current annual practicing certiﬁcate and who satisﬁes the criteria set out in paragraphs (a) or (b) or (c) of the deﬁnitions of Specialist below. “Schedule” means this Pharmaceutical Schedule and all its sections and appendices. “Section B” of this Pharmaceutical Schedule means the list of Community Pharmaceuticals eligible for Subsidies included in the Schedule. “Section C” of this Pharmaceutical Schedule means the list of community extemporaneously compounded preparations and galenicals eligible for Subsidies included in the Schedule. “Section D” of this Pharmaceutical Schedule means the list of community special foods eligible for Subsidies included in the Schedule. “Section E Part I” of this Pharmaceutical Schedule means the list of Community Pharmaceuticals eligible for Subsidies and available on a Practitioner’s Supply Order or a Wholesale Supply Order included in the Schedule. “Section E Part II” of this Pharmaceutical Schedule means the list of rural areas for the purpose of community Practitioner’s Supply Orders included in the Schedule. “Section F Part I” of this Pharmaceutical Schedule means the part of Section F relating to the exemption from dispensing in Monthly Lots, and requirement to dispense in 90 Day Lots or 180 Day Lots, as applicable, in respect of the Community Pharmaceuticals referred to in this part of Section F; “Section F Part II” of this Pharmaceutical Schedule means the part of Section F relating to the exemption from dispensing in Monthly Lots in respect of the Community Pharmaceuticals referred to in this part of Section F; “Section G” of this Pharmaceutical Schedule means the list of Community Pharmaceuticals eligible for reimbursement of safety caps. “Section H” of this Pharmaceutical Schedule means the general rules for Hospital Pharmaceuticals and the lists of National Contract Pharmaceuticals and any associated DV Pharmaceuticals, of Discretionary Community Supply Pharmaceuticals and Assessed Pharmaceuticals included in Section H of the Schedule. “Section H Part I” of this Pharmaceutical Schedule means the general rules for Hospital Pharmaceuticals. “Section H Part II” of this Pharmaceutical Schedule means the list of National Contract Pharmaceuticals, the relevant Price, an indication of whether the Pharmaceutical has HSS and any associated DV Pharmaceuticals and DV Limit. “Section H Part III” of this Pharmaceutical Schedule means the list of Assessed Pharmaceuticals. “Section H Part IV” of this Pharmaceutical Schedule means the list of Discretionary Community Supply Pharmaceuticals. “Special Authority” means that the Community Pharmaceutical or Pharmaceutical Cancer Treatment is only eligible for Subsidy or additional Subsidy for a particular person if an application meeting the criteria speciﬁed in the Schedule has been approved, and the valid Special Authority number is present on the prescription. “Specialist”, in relation to a Prescription, a doctor who holds a current annual practising certiﬁcate and who satisﬁes the criteria set out in paragraphs (a) or (b) or (c) or (d) below: a) i) the doctor is vocationally registered in accordance with the criteria set out by the Medical Council of New Zealand and the HPCA Act 2003 and who has written the Prescription in the course of practising in that area of medicine; and ii) the doctor’s vocational scope of practice is one of those listed below: — anaesthetics, cardiothoracic surgery, dermatology, diagnostic radiology, emergency medicine, general surgery, internal medicine, neurosurgery, obstetrics and gynaecology, occupational medicine, ophthalmology, oral and maxillofacial surgery, otolaryngology head and neck surgery, orthopaedic surgery, paediatric surgery, paediatrics, pathology, plastic and reconstructive surgery, psychological medicine or psychiatry, public health medicine, radiation oncology, rehabilitation medicine, urology and venereology; b) the doctor is recognised by the Ministry of Health as a specialist for the purposes of this Schedule and receives

SECTION A: GENERAL RULES

remuneration from a DHB at a level which that DHB considers appropriate for specialists and who has written that Prescription in the course of practising in that area of medicine; c) the doctor is recognised by the Ministry of Health as a specialist in relation to a particular area of medicine for the purpose of writing Prescriptions and who has written the Prescription in the course of practising in that area of medicine; d) the doctor writes the Prescription on DHB stationery and is appropriately authorised by the relevant DHB to do so. “Subsidy” means the maximum amount that the Government will pay Contractors for a Community Pharmaceutical dispensed to a person eligible for Pharmaceutical Beneﬁts and is different from the cost to Government of subsidising that Community Pharmaceutical. For the purposes of a DHB hospital pharmacy claiming for Pharmaceutical Cancer Treatments, Subsidy refers to any payment made to the DHB hospital pharmacy or service provider to which that pharmacy serves, and does not relate to a speciﬁc payment that might be made on submission of a claim. “Supply Order” means a Bulk Supply Order, a Practitioner’s Supply Order or a Wholesale Supply Order. “Unapproved Indication” means, for a Pharmaceutical, an indication for which it is not approved under the Medicines Act 1981. “Wholesale Supply Order” means a written order by a Practitioner, on a form supplied by the Ministry of Health for the supply of certain Community Pharmaceuticals as listed in Section B and Section E Part I of the Schedule. 1.2 In addition to the above interpretations and deﬁnitions, unless the content requires otherwise, a reference in the Schedule to: a) the singular includes the plural; and b) any legislation includes a modiﬁcation and re-enactment of, legislation enacted in substitution for, and a regulation, Order in Council, and other instrument from time to time issued or made under that legislation, where that legislation, regulation, Order in Council or other instrument has an effect on the prescribing, dispensing or subsidising of Community Pharmaceuticals.

PART II COMMUNITY PHARMACEUTICALS SUBSIDY

2.1 Community Pharmaceuticals eligible for Subsidy include every medicine, therapeutic medical device or related product, or related thing listed in Sections B to G of the Schedule, and every preparation (having an inert base) of any of them, is hereby declared to be a Community Pharmaceutical for the purposes of the Schedule, subject to: 2.1.1 clauses 2.2 and 2.3 of the Schedule; and 2.1.2 clauses 3.1 to 4.4 of the Schedule; and 2.1.3 the conditions (if any) speciﬁed in Sections B to G of the Schedule; 2.2 The following medicines, therapeutic medical devices, or related products or related things are not eligible for Subsidy: 2.2.1 substances, or combinations of substances, ordered for any purpose other than: a) treatment of a patient’s medical or dental condition; or b) pregnancy tests; or c) the prevention of sexually transmitted disease; or d) contraception. 2.2.2 substances and combinations of substances packed under pressure in aerosol cans or other similar devices, unless it is speciﬁed in Sections B to G of the Schedule that they may be so packed; 2.2.3 electrode jellies; 2.2.4 eye drops packed in single-dose units, unless it is speciﬁed in Sections B to G of the Schedule that they may be so packed; 2.2.5 insect repellents and similar preparations; 2.2.6 oral preparations in long-acting form, unless it is speciﬁed in Sections B to G of the Schedule that they may be in such a form; 2.2.7 substances or combinations of substances in lozenge or similar form, unless it is speciﬁed in Sections B to G of the Schedule that they may be in such a form; 2.2.8 machine-spread plasters; 2.2.9 preparations prescribed as foods, unless they are speciﬁed in Section D of the Schedule; 2.2.10 substances, combinations of substances, or articles, in the form of proprietary medicines or proprietary articles,

SECTION A: GENERAL RULES

unless they are deemed or declared to be Pharmaceuticals elsewhere in the Schedule; 2.2.11 shampoos, other than extemporaneously prepared medicated shampoos, or shampoos speciﬁed in Sections B to G of the Schedule intended for the treatment of a patient’s medical condition; 2.2.12 toilet preparations; 2.2.13 tooth pastes and powders; 2.2.14 lubricating jellies and catheter lubricants; 2.2.15 sterile diluents for nebulising solutions; 2.2.16 substances in a form intended to enable delivery by transdermal diffusion or osmosis or by the insertion of any solid object or substance into the eye cavity, unless it is speciﬁed in Sections B to G of the Schedule that they may be in such a form; 2.2.17 substances in a form intended for intravenous delivery (other than by injection), unless it is speciﬁed in Sections B to G of the Schedule that they may be in such a form; 2.2.18 substances packed in pre-loaded syringes known as Min-I-Jets, unless it is speciﬁed in Sections B to G of the Schedule that they may be so packed; 2.2.19 Community Pharmaceuticals prescribed as cough mixtures, unless they are speciﬁed in Sections B to G of the Schedule otherwise than in combination with other ingredients; 2.2.20 vitamin preparations in capsule form, unless they are speciﬁed in Sections B to G of the Schedule; 2.2.21 substances prescribed for use as irrigating solutions, unless it is speciﬁed in Sections B to G of the Schedule that they may be prescribed for such use. 2.3 No claim by a Contractor for payment in respect of the supply of Community Pharmaceuticals will be allowed unless the Community Pharmaceuticals so supplied: 2.3.1 comply with the appropriate standards prescribed by regulations for the time being in force under the Medicines Act 1981; or 2.3.2 in the absence of any such standards, comply with the appropriate standards for the time being prescribed by the British Pharmacopoeia; or 2.3.3 in the absence of the standards prescribed in clauses 2.3.1 and 2.3.2, comply with the appropriate standards for the time being prescribed by the British Pharmaceutical Codex; or 2.3.4 in the absence of the standards prescribed in clauses 2.3.1, 2.3.2 and 2.3.3, are of a grade and quality not lower than those usually applicable to Community Pharmaceuticals intended to be used for medical purposes.

SECTION A: GENERAL RULES

PART III PERIOD AND QUANTITY OF SUPPLY

3.1 Doctors’, Midwives’, Nurse Prescribers’ and Optometrists’ Prescriptions (other than oral contraceptives) The following provisions apply to all Prescriptions, other than those for an oral contraceptive, written by a Doctor, Midwife, Nurse Prescriber or Optometrist: 3.1.1 For a Community Pharmaceutical other than a Class B Controlled Drug, only a quantity suffcient to provide treatment for a period not exceeding three Months will be subsidised. 3.1.2 For methylphenidate hydrochloride and dexamphetamine sulphate, only a quantity sufﬁcient to provide treatment for a period not exceeding one Month will be subsidised. 3.1.3 For a Class B Controlled Drug other than methylphenidate hydrochloride and dexamphetamine sulphate, only a quantity: a) sufﬁcient to provide treatment for a period not exceeding 10 days; and b) which has been dispensed pursuant to a Prescription sufﬁcient to provide treatment for a period not exceeding one Month, will be subsidised. 3.1.4 Subject to clauses 3.1.3 and 3.1.7, for a Doctor, Midwife or Nurse Prescriber and 3.1.7 for an Optometrist, where a practitioner has prescribed a quantity of a Community Pharmaceutical sufﬁcient to provide treatment for: a) one Month or less than one Month, but dispensed by the Contractor in quantities smaller than the quantity prescribed, the Community Pharmaceutical will only be subsidised as if that Community Pharmaceutical had been dispensed in a Monthly Lot; b) more than one Month, the Community Pharmaceutical will be subsidised only if it is dispensed: i) in a 90 Day Lot, where the Community Pharmaceutical is a Pharmaceutical covered by Section F Part I of the Pharmaceutical Schedule; or ii) if the Community Pharmaceutical is not a Pharmaceutical referred to in Section F Part I of the Pharmaceutical Schedule, in Monthly Lots, unless: A) the eligible person or his/her nominated representative endorses the back of the Prescription form with a statement identifying which Access Exemption Criterion (Criteria) applies and signs that statement to this effect; or B) both: 1) the Practitioner endorses the Community Pharmaceutical on the Prescription with the words “certiﬁed exemption” written in the Practitioner’s own handwriting, or signed or initialled by the Practitioner; and 2) every Community Pharmaceutical endorsed as “certiﬁed exemption” is covered by Section F Part II of the Pharmaceutical Schedule. 3.1.5 A Community Pharmaceutical is only eligible for Subsidy if the Prescription under which it has been dispensed was presented to the Contractor: a) for a Class B Controlled Drug, within eight days of the date on which the Prescription was written; or b) for any other Community Pharmaceutical, within three Months of the date on which the Prescription was written. 3.1.6 No subsidy will be paid for any Prescription, or part thereof, that is not fulﬁlled within: a) in the case of a Prescription for a total supply of from one to three Months, three Months from the date the Community Pharmaceutical was ﬁrst dispensed; or b) in any other case, one Month from the date the Community Pharmaceutical was ﬁrst dispensed. Only that part of any Prescription that is dispensed within the time frames speciﬁed above is eligible for Subsidy. 3.1.7 If a Community Pharmaceutical: a) is stable for a limited period only, and the Doctor, Midwife, Nurse Prescriber or Optometrist has endorsed the Prescription with the words “unstable medicine” and has speciﬁed the maximum quantity that may be dispensed at any one time; or b) is stable for a limited period only, and the Contractor has endorsed the Prescription with the words “unstable medicine” and has speciﬁed the maximum quantity that should be dispensed at any one time in all the circumstances of the particular case; or

SECTION A: GENERAL RULES

c) is Close Control, The actual quantity dispensed will be subsidised in accordance with any such speciﬁcation. 3.2 Oral Contraceptives The following provisions apply to all Prescriptions written by a Doctor, Midwife or Nurse Prescriber for an oral contraceptive: 3.2.1 The prescribing Doctor, Midwife or Nurse Prescriber must specify on the Prescription the period of treatment for which the Community Pharmaceutical is to be supplied. This period must not exceed: a) three Months if prescribed by a Midwife; or b) six Months if prescribed by a Doctor or Nurse Practitioner. 3.2.2 Where the period of treatment speciﬁed in the Prescription does not exceed six Months, the Community Pharmaceutical is to be dispensed: a) in Lots as speciﬁed in the Prescription if the Community Pharmaceutical is Close Control; or b) where no Lots are speciﬁed, in one Lot sufﬁcient to provide treatment for the period prescribed. 3.2.3 An oral contraceptive is only eligible for Subsidy if the Prescription under which it has been dispensed was presented to the Contractor within three Months of the date on which it was written. 3.2.4 An oral contraceptive prescribed by a Midwife is only eligible for Subsidy if the Prescription under which it has been dispensed has been written within the period of post natal care of the eligible person. 3.2.5 Where a Community Pharmaceutical in a Prescription is Close Control and a repeat on the Prescription remains unfulﬁlled after six Months from the date the Community Pharmaceutical was ﬁrst dispensed only the actual quantity supplied by the Contractor within this time limit will be eligible for Subsidy. 3.3 Dentists’ Prescriptions The following provisions apply to every Prescription written by a Dentist: 3.3.1 The maximum quantity of a Community Pharmaceutical that will be subsidised is as follows: a) where the Community Pharmaceutical is a Controlled Drug, only such quantity as is necessary to provide treatment for a period not exceeding ﬁve days; and b) in any other case, only such quantity as is necessary to provide treatment for a period not exceeding ﬁve days and, where the Prescription speciﬁes a repeat, one further period not exceeding ﬁve days. 3.3.2 Notwithstanding clause 3.3.1, if, in the opinion of the Dentist, an eligible person needs extended treatment with sodium ﬂuoride for up to three Months, the Community Pharmaceutical will be subsidised for that extended period. A Prescription for any such extended supply of sodium ﬂuoride will be subsidised only if it is dispensed in Monthly Lots, unless the eligible person or his/her nominated representative endorses the back of the Prescription form with a statement identifying which Access Exemption Criterion (Criteria) applies and signs that statement to this effect. 3.3.3 A Community Pharmaceutical is only eligible for Subsidy if the Prescription under which it has been dispensed has been presented to the Contractor: a) for a Class B Controlled Drug, within eight days of the date on which the Prescription was written; or b) for any other Community Pharmaceutical, within three Months of the date on which the Prescription was written. 3.3.4 No Subsidy will be paid for any Prescription, or part thereof, that is not fulﬁlled within: a) one Month from the date the Community Pharmaceutical was ﬁrst dispensed; or b) in the case of sodium ﬂuoride, three Months from the date the Community Pharmaceutical was ﬁrst dispensed. Only that part of any Prescription that is dispensed within the time frames speciﬁed above is eligible for Subsidy. 3.4 Original Packs, and Certain Antibiotics 3.4.1 Notwithstanding clauses 3.1 and 3.3 of the Schedule, if a Practitioner prescribes or orders a Community Pharmaceutical that is identiﬁed as an Original Pack (OP) on the Pharmaceutical Schedule and is packed in a container from which it is not practicable to dispense lesser amounts, every reference in those clauses to an amount or quantity eligible for Subsidy, is deemed to be a reference: a) where an amount by weight or volume of the Community Pharmaceutical is speciﬁed in the Prescription, to the smallest container of the Community Pharmaceutical, or the smallest number of containers of the Community Pharmaceutical, sufﬁcient to provide that amount; and b) in every other case, to the amount contained in the smallest container of the Community Pharmaceutical that is manufactured in, or imported into, New Zealand. 3.4.2 If a Community Pharmaceutical is the liquid oral form of an antibiotic to which a diluent must be added by the

SECTION A: GENERAL RULES

Contractor at the time of dispensing and it is prescribed or ordered by a Practitioner in an amount that does not coincide with the amount contained in one or more standard packs of that Community Pharmaceutical, Subsidy will only be made for the amount prescribed or ordered by the Practitioner in accordance with either clause 3.1 or clause 3.3 of the Schedule, unless the Contractor satisﬁes the Funder that he or she has not been able to dispense the balance of the pack or packs from which the Community Pharmaceutical has been dispensed. In such cases all of that pack or those packs is eligible for Subsidy.

PART IV MISCELLANEOUS PROVISIONS

4.1 Bulk Supply Orders The following provisions apply to the supply of Community Pharmaceuticals under Bulk Supply Orders: 4.1.1 No Community Pharmaceutical supplied under a Bulk Supply Order will be subsidised unless all the requirements in Section B, C or D of the Schedule applicable to that pharmaceutical are met. 4.1.2 The person who placed the Bulk Supply Order may be called upon by the Ministry of Health to justify the amount ordered. 4.1.3 Class B Controlled Drugs will be subsidised only if supplied under Bulk Supply Orders placed by an institution certiﬁed to provide hospital care under the Health and Disability Services (Safety) Act 2001. 4.1.4 Any order for a Class B Controlled Drug or for buprenorphine hydrochloride must be written on a Special Bulk Supply Order Controlled Drug Form supplied by the Ministry of Health. 4.1.5 Community Pharmaceuticals listed in Part I of the First Schedule to the Medicines Regulations 1984 will be subsidised only if supplied under a Bulk Supply Order placed by an institution certiﬁed to provide hospital care under the Health and Disability Services (Safety) Act 2001 and: a) that institution employs a registered general nurse, registered with the Nursing Council and who holds a current annual practicing certiﬁcate under the HPCA Act 2003; and b) the Bulk Supply Order is supported by a written requisition signed by a Hospital Care Operator. 4.1.6 No Subsidy will be paid for any quantity of a Community Pharmaceutical supplied under a Bulk Supply Order in excess of what is a reasonable monthly allocation for the particular institution, after taking into account stock on hand. 4.1.7 The Ministry of Health may, at any time, by public notiﬁcation, declare that any approved institution within its particular region, is not entitled to obtain supplies of Community Pharmaceuticals under Bulk Supply Orders with effect from the date speciﬁed in that declaration. Any such notice may in like manner be revoked by the Ministry of Health at any time. 4.2 Practitioner’s Supply Orders The following provisions apply to the supply of Community Pharmaceuticals to Practitioners under a Practitioner’s Supply Order: 4.2.1 Subject to clause 4.2.3, a Practitioner may only order under a Practitioner’s Supply Order those Community Pharmaceuticals listed in Section E Part I and only in such quantities as set out in Section E Part I that the Practitioner requires to ensure medical supplies are available for emergency use, teaching and demonstration purposes, and for provision to certain patient groups where individual prescription is not practicable. 4.2.2 Any order for a Class B Controlled Drug or for buprenorphine hydrochloride must be written on a Special Practitioner’s Supply Order Controlled Drug Form supplied by the Ministry of Health. 4.2.3 A Practitioner may order such Community Pharmaceuticals as he or she expects to be required for personal administration to patients under the Practitioner’s care if: a) the Practitioner’s normal practice is in the speciﬁed areas listed in Section E Part II of the Schedule, or if the Practitioner is a locum for a Practitioner whose normal practice is in such an area. b) the quantities ordered are reasonable for up to one Month’s supply under the conditions normally existing in the practice. (The Practitioner may be called on by the Ministry of Health to justify the amounts of Community Pharmaceuticals ordered.) 4.2.4 No Community Pharmaceutical ordered under a Practitioner’s Supply order will be eligible for Subsidy unless: a) the Practitioner’s Supply Order is made on a form supplied for that purpose by the Ministry of Health, or approved by HealthPAC’s and which: i) is personally signed and dated by the Practitioner; and ii) sets out the Practitioner’s address; and

SECTION A: GENERAL RULES

iii) sets out the Community Pharmaceuticals and quantities, and; b) all the requirements of Sections B and C of the Schedule applicable to that pharmaceutical are met. 4.2.5 The Ministry of Health may, at any time, on the recommendation of an Advisory Committee appointed by the Ministry of Health for that purpose, by public notiﬁcation, declare that a Practitioner speciﬁed in such a notice is not entitled to obtain supplies of Community Pharmaceuticals under Practitioner’s Supply Orders until such time as the Ministry of Health notiﬁes otherwise. 4.3 Wholesale Supply Orders The following provisions apply to the supply of Community Pharmaceuticals to Practitioners under Wholesale Supply Orders: 4.3.1 Notwithstanding anything contained in the Schedule, but subject nevertheless to subclause 4.3.3 of this clause, a Practitioner may obtain from a wholesaler or distributor, pursuant to a Wholesale Supply Order made on a form supplied by the Ministry of Health, any Community Pharmaceutical speciﬁed in Section B and Section E Part I of the Schedule as being available on a Wholesale Supply Order. 4.3.2 Subject to clause 4.3.3, Community Pharmaceuticals supplied to Practitioners under Wholesale Supply Orders will be subsidised at a rate not exceeding the Manufacturer’s Price for each such Community Pharmaceutical as set out in Section B and Section E Part I of the Schedule. 4.3.3 No subsidy will be paid for any quantity of a Community Pharmaceutical supplied to a Practitioner under a Wholesale Supply Order in excess of what is a reasonable monthly allocation for that particular Practitioner, after taking into account stock on hand. 4.3.4 The Ministry of Health may, at any time, on the recommendation of an Advisory Committee appointed by the Ministry of Health for that purpose, by public notiﬁcation, declare that a Practitioner speciﬁed in such a notice is not entitled to obtain supplies of Community Pharmaceuticals under Wholesale Supply Orders until such time as the Ministry of Health notiﬁes otherwise. 4.4 Retail Pharmacy and Hospital Pharmacy-Specialist Restriction The following provisions apply to Prescriptions for Community Pharmaceuticals eligible to be subsidised as “Retail Pharmacy-Specialist” and “Hospital Pharmacy-Specialist”: 4.4.1 Record Keeping It is expected that a record will be kept by both the General Practitioner and the Specialist of the fact of consultation and enough of the clinical details to justify the recommendation. This means referral by telephone will need to be followed up by written consultation. 4.4.2 Expiry The recommendation expires at the end of two years and can be renewed by a further consultation. 4.4.3 The circulation by Specialists of the circumstances under which they are prepared to recommend a particular Community Pharmaceutical is acceptable as a guide. It must however be followed up by the procedure in subclauses 4.4.1 and 4.4.2, for the individual Patient. 4.4.4 The use of preprinted forms and named lists of Specialists (as circulated by some pharmaceutical companies) is regarded as inappropriate. 4.4.5 The Rules for Retail Pharmacy-Specialist and Hospital Pharmacy-Specialist will be audited as part of HealthPAC’s routine auditing procedures. 4.5 Pharmaceutical Cancer Treatments 4.5.1 DHBs must provide access to Pharmaceutical Cancer Treatments by funding their use in the treatment of cancers in their DHB hospitals, and/or in association with Outpatient services provided in their DHB hospitals. 4.5.2 DHBs must only provide access to Pharmaceuticals for the treatment of cancer that are listed as Pharmaceutical Cancer Treatments in Sections A to G of the Schedule, provided that DHBs may provide access to an unlisted pharmaceutical for the treatment of cancer where that unlisted pharmaceutical: a) has Cancer Exceptional Circumstances approval; b) has Community Exceptional Circumstances or Hospital Exceptional Circumstances approval; c) is being used as part of a bona ﬁde clinical trial which has Ethics Committee approval; d) is being used and funded as part of a paediatric oncology service; or e) was being used to treat the patient in question prior to 1 July 2005. 4.5.3 A DHB hospital pharmacy that holds a claiming agreement for Pharmaceutical Cancer Treatements with the Funder may claim a Subsidy for a Pharmaceutical Cancer Treatment marked as “PCT” or “PCT only” in Sections A to G of this Schedule subject to that Pharmaceutical Cancer Treatment being dispensed in accordance with:

SECTION A: GENERAL RULES

a) Part 1; b) clauses 2.1 to 2.3; c) clauses 3.1 to 3.4; and d) clause 4.5, of Section A of the Schedule 4.5.4 A Contractor (other than a DHB hospital pharmacy) may only claim a Subsidy for a Pharmaceutical Cancer Treatment marked as “PCT” in Sections A to G of the Schedule subject to that Pharmaceutical Cancer Treatment being dispensed in accordance with the rules applying to Sections A to G of the Schedule. 4.5.5 Some indications for Pharmaceutical Cancer Treatments listed in the Schedule are Unapproved Indications. Some of these formed part of the October 2001 direction from the Minister of Health as to pharmaceuticals and indications for which DHBs must provide funding. As far as reasonably practicable, these Unapproved Indications are marked in the Schedule. However, PHARMAC makes no representation and gives no guarantee as to the accuracy of this information. Practitioners prescribing Pharmaceutical Cancer Treatments for such Unapproved Indications should: a) be aware of and comply with their obligations under sections 25 and 29 of the Medicines Act 1981, as applicable, and otherwise under the Medicines Act and the Medicines Regulations 1984; b) be aware of and comply with their obligations under the Health and Disability Comissioner’s Code of Consumer Rights, including the requirement to obtain informed consent from the patient (PHARMAC recommends that Practitioners obtain written consent); and c) exercise their own skill, judgement, expertise and discretion, and make their own prescribing decisions with respect to the use of an unapproved Pharmaceutical Cancer Treatment or a Pharmaceutical Cancer Treatment for an Unapproved Indication. 4.6 Practitioners prescribing unapproved Pharmaceuticals Practitioners should, where possible, prescribe Pharmaceuticals that are approved under the Medicines Act 1981. However, the access criteria under which a Pharmaceutical is listed on the Pharmaceutical Schedule may: a) in some case, explicitly permit Government funded access to a Pharmaceutical that is not approved under the Medicines Act 1981 or for an Unapproved Indication; or b) not explicitly preclude Government funded access to a Pharmaceutical when it is used for an Unapproved Indication; Accordingly, if Practitioners are planning on prescribing an unapproved Pharmaceutical or a Pharmaceutical for an Unapproved Indication, Practitioners should: a) be aware of and comply with their obligations under sections 25 and 29 of the Medicines Act 1981, as applicable, and otherwise under that Act and the Medicines Regulations 1984; b) be aware of and comply with their obligations under the Health and Disability Commissioner’s Code of Consumer Rights, including the requirement to obtain informed consent from the patient (PHARMAC recommends that Practitioners obtain written consent); and c) exercise their own skill, judgment, expertise and discretion, and make their own prescribing decisions with respect to the use of an unapproved Pharmaceutical or a Pharmaceutical for an Unapproved Indication. Practitioners should be aware that simply by listing a Pharmaceutical on the Pharmaceutical Schedule PHARMAC makes no representations about whether that Pharmaceutical has any form of approval or consent under, or whether the supply or use of the Pharmaceutical otherwise complies with, the Medicines Act 1981. Further, the Pharmaceutical Schedule does not constitute an advertisement, advertising material or a medical advertisement as deﬁned in the Medicines Act or otherwise. 4.7 Amendment of Schedule PHARMAC may amend the terms of the Schedule from time to time by notice in writing given in such manner as PHARMAC thinks ﬁt, and in accordance with such protocols as agreed with the Pharmacy Guild of New Zealand (Inc) from time to time. 4.8 Conﬂict in Provisions If any rules in Sections B-G of this Schedule conﬂict with the rules in Section A, the rules in Sections B-G apply.

SECTION B: ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

Antacids and Antiﬂatulants Antacids and Reﬂux Barrier Agents

ALGINIC ACID Sodium alginate 225 mg and magnesium alginate 87.5 mg per sachet .................................................................................... 4.50

Gaviscon Infant

CALCIUM CARBONATE WITH AMINOACETIC ACID p Tab 420 mg with aminoacetic acid 180 mg – Higher subsidy of $38.73 per 1000 with Endorsement........................................ 30.00 1,000 (38.73) Titralac Additional subsidy by endorsement is available for pregnant women. The prescription must be endorsed accordingly. SIMETHICONE p Oral liq aluminium hydroxide 200 mg with magnesium hydroxide 200 mg and activated simethicone 20 mg per 5 ml ............... 1.50 500 ml (4.05) Mylanta P SODIUM ALGINATE p Tab 500 mg with sodium bicarbonate 267 mg and calcium carbonate 160 mg - peppermint ﬂavour ....................................... 1.80 (7.97) p Oral liq 500 mg with sodium bicarbonate 267 mg and calcium carbonate 160 mg per 10 ml ........................................................ 1.50 (4.95) p Oral liq 500 mg with sodium bicarbonate 267 mg per 10 ml (aniseed) ...................................................................................... 1.50 (8.08)

60 Gaviscon Double Strength 500 ml Acidex 500 ml Gaviscon

Phosphate Binding Agents

ALUMINIUM HYDROXIDE Tab 600 mg .......................................................................................12.56 100 Alu-Tab

Antidiarrhoeals Agents Which Reduce Motility

DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULPHATE p Tab 2.5 mg with atropine sulphate 25 µg ............................................3.90 LOPERAMIDE HYDROCHLORIDE – Up to 30 tab available on a PSO p Tab 2 mg ...........................................................................................11.50 100 400 Diastop Nodia

Rectal and Colonic Anti-inﬂammatories

BUDESONIDE Cap 3 mg – Special Authority see SA0698 on the next page – Retail pharmacy ...................................................................166.50

Entocort CIR

fully subsidised [HP1], [HP3], [HP4] refer page 8

S29 Unapproved medicine supplied under Section 29 Sole Subsidised Supply

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

¾SA0698 Special Authority for Subsidy Initial application only from a gastroenterologist, general surgeon or general physician. Approvals valid for 3 months for applications meeting the following criteria: Both: 1 Mild to moderate ileal, ileocaecal or proximal Crohn’s disease; and 2 Any of the following: 2.1 Diabetes; or 2.2 Cushingoid habitus; or 2.3 Osteoporosis where there is signiﬁcant risk of fracture; or 2.4 Severe acne following treatment with conventional corticosteroid therapy. Renewal only from a gastroenterologist, general surgeon or general physician. Approvals valid for 3 months where the treatment remains appropriate and the patient is beneﬁting from treatment. The patient may not have had more than 1 prior approval in the last year. Note: Clinical trials for Entocort CIR use beyond three months demonstrated no improvement in relapse rate. HYDROCORTISONE ACETATE Colifoam Rectal foam 10 %, CFC-Free (14 applications) ................................21.10 21.1 g OP MESALAZINE Tab 400 mg – Retail pharmacy-Specialist ........................................49.50 Tab long-acting 500 mg – Retail pharmacy-Specialist .....................69.06 Enema 1 g per 100 ml – Retail pharmacy-Specialist .......................46.90 Suppos 500 mg ................................................................................25.20 Suppos 1 g .......................................................................................50.96 OLSALAZINE – Retail pharmacy-Specialist Tab 500 mg .......................................................................................59.86 Cap 250 mg ......................................................................................31.51 SODIUM CROMOGLYCATE Cap 100 mg – Hospital pharmacy [HP3]-Specialist .........................89.21 SULPHASALAZINE p Tab 500 mg .........................................................................................8.42 p Tab EC 500 mg ...................................................................................9.44 100 100 7 20 28 100 100 100 100 100 Asacol Pentasa Pentasa Asacol Pentasa Dipentum Dipentum Nalcrom Salazopyrin Salazopyrin EN

Antihaemorrhoidals Corticosteroids

FLUOCORTOLONE CAPROATE WITH FLUOCORTOLONE PIVALATE AND CINCHOCAINE Oint 950 µg, with ﬂuocortolone pivalate 920 µg, and cinchocaine hydrochloride 5 mg per g .............................................6.35 30 g OP Suppos 630 µg, with ﬂuocortolone pivalate 610 µg, and cinchocaine hydrochloride 1 mg .......................................................2.66 12

Ultraproct Ultraproct

Soothing Agents

ZINC OXIDE Oint zinc oxide with balsam peru ........................................................4.50 (6.50) Suppos zinc oxide with balsam peru ..................................................4.47 (6.35) 50 g OP Anusol 12 Anusol

‡ safety cap pThree months or six months, as applicable, dispensed all-at-once

vThree months supply may be dispensed at one time if endorsed “certiﬁed expemption” by the prescriber.

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

Antispasmodics and Other Agents Altering Gut Motility

ATROPINE SULPHATE p Inj 600 µg, 1 ml – Up to 5 inj available on a PSO .............................26.00 p Inj 1200 µg, 1 ml – Up to 5 inj available on a PSO ...........................32.00 HYOSCINE N-BUTYLBROMIDE p Tab 10 mg ...........................................................................................1.33 p Inj 20 mg, 1 ml – Up to 5 inj available on a PSO ................................7.15 MEBEVERINE HYDROCHLORIDE – Retail pharmacy-Specialist p Tab 135 mg .......................................................................................10.72 (25.73) 50 50 20 5 90 Colofac AstraZeneca AstraZeneca Gastrosoothe Buscopan

Antiulcerants Antisecretory and Cytoprotective

MISOPROSTOL – Retail pharmacy-Specialist p Tab 200 µg ........................................................................................52.70 120 Cytotec

Helicobacter Pylori Eradication

OMEPRAZOLE, AMOXYCILLIN AND CLARITHROMYCIN Omeprazole cap 20 mg × 14, amoxycillin cap 500 mg × 28 and clarithromycin tab 500 mg × 14 .......................................... 55.00

1 OP

Losec Hp7 OAC

H2 Antagonists

CIMETIDINE – Only on a prescription p Tab 200 mg .........................................................................................5.00 (7.50) p Tab 400 mg .......................................................................................10.00 (12.00) FAMOTIDINE – Only on a prescription p Tab 20 mg ...........................................................................................8.10 p Tab 40 mg .........................................................................................11.35 100 Apo-Cimetidine 100 Apo-Cimetidine 250 250 Famox Famox

RANITIDINE HYDROCHLORIDE – Only on a prescription p Tab 150 mg .........................................................................................7.99 250 Arrow-Ranitidine Arrow-Ranitidine p Tab 300 mg .......................................................................................10.94 250 Peptisoothe p Oral liq 150 mg per 10 ml – Subsidy by endorsement.........................7.95 300 ml Oral liquid is subsidised only for patients: 1) with oesophageal stricture, or 2) in terminal care, or 3) who are either too young or too old to swallow conventional tablets and the prescription is endorsed accordingly. Note: the cost of treatment with ranitidine oral liquid is more than 10 times higher than that of ranitidine tablets. Following the derestriction of access PHARMAC will be monitoring expenditure on ranitidine oral liquid more closely and may, subject to consultation and PHARMAC Board approval, restrict access again if the expenditure was to grow substantially. p Inj 25 mg per ml, 2 ml .........................................................................8.75 5 Zantac

Proton Pump Inhibitors

LANSOPRAZOLE p Cap 15 mg ..........................................................................................4.30 p Cap 30 mg ..........................................................................................8.59

fully subsidised [HP1], [HP3], [HP4] refer page 8

28 28

Solox Solox

S29 Unapproved medicine supplied under Section 29 Sole Subsidised Supply

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

OMEPRAZOLE For omeprazole suspension refer, page 160 p Cap 10 mg ..........................................................................................2.99 5.95 17.37 p Cap 20 mg ..........................................................................................4.27 5.95 24.81 p Cap 40 mg ..........................................................................................5.01 8.84 29.05 p Inj 40 mg ...........................................................................................12.50 PANTOPRAZOLE p Tab 20 mg ...........................................................................................2.24 2.40 (22.00) p Tab 40 mg ...........................................................................................3.36 3.60 (28.00) (Somac Tab 20 mg to be delisted 1 June 2008) (Somac Tab 40 mg to be delisted 1 June 2008)

28 30 28 30 28 30 1 28 30 28 30

Dr Reddy’s Omeprazole Omezol Losec Dr Reddy’s Omeprazole Omezol Losec Dr Reddy’s Omeprazole Omezol Losec Losec Dr Reddy’s Pantoprazole Somac Dr Reddy’s Pantoprazole Somac

Site Protective Agents

SUCRALFATE Tab 1 g ..............................................................................................35.50 (48.28) 120 Carafate

Diabetes Hyperglycaemic Agents

GLUCAGON HYDROCHLORIDE Inj 1 mg syringe kit – Up to 5 kit available on a PSO........................27.00 1 Glucagen Hypokit

Insulin - Short-acting Preparations

INSULIN NEUTRAL v Inj human 100 u per ml .....................................................................25.26 v Inj human 100 u per ml, 3 ml ............................................................42.66 10 ml OP 5 Actrapid Humulin R Actrapid Penﬁll Humulin R

‡ safety cap pThree months or six months, as applicable, dispensed all-at-once

vThree months supply may be dispensed at one time if endorsed “certiﬁed expemption” by the prescriber.

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

Insulin - Intermediate-acting Preparations

INSULIN ISOPHANE v Inj human 100 u per ml .....................................................................17.68 v Inj animal (pork) 100 u per ml ..........................................................25.26 v Inj human 100 u per ml, 3 ml ............................................................29.86 (Protaphane Inj animal (pork) 100 u per ml to be delisted 1 July 2008) INSULIN ISOPHANE WITH INSULIN NEUTRAL v Inj human with neutral insulin 100 u per ml ......................................25.26 v Inj human with neutral insulin 100 u per ml, 3 ml .............................42.66 10 ml OP 5 Humulin 30/70 Mixtard 30 Humulin 30/70 PenMix 30 PenMix 40 PenMix 50 10 ml OP 10 ml OP 5 Humulin NPH Protaphane Protaphane Humulin NPH Protaphane Penﬁll

Insulin - Long-acting Preparations

INSULIN GLARGINE – Special Authority see SA0834 below – Retail pharmacy v Inj 100 u per ml, 10 ml ......................................................................63.00 v Inj 100 u per ml, 3 ml ........................................................................94.50 1 5 Lantus Lantus

¾SA0834 Special Authority for Subsidy Initial application only from a relevant specialist. Approvals valid for 1 year for applications meeting the following criteria: Either: 1 Both: 1.1 Patient has type 1 diabetes and has received an intensive regimen (injections at least three times a day) of an intermediate acting insulin in combination with a rapid acting insulin analogue for at least three months; and 1.2 Either: 1.2.1 Patient has experienced more than one unexplained severe hypoglycaemic episode in the previous 12 months (severe deﬁned as requiring the assistance of another person); or 1.2.2 Patient has experienced unexplained symptomatic nocturnal hypoglycaemia, biochemically documented at <3.0 mmol/L, more than once a month despite optimal management; or 2 Patient has documented severe, or continuing, systemic or local allergic reaction to existing insulins. Note this does not include hypoglycaemic episodes. Renewal only from a relevant specialist or general practitioner. Approvals valid for 1 year for applications meeting the following criteria: Either: 1 Patient is continuing to derive beneﬁt due to reduced hypoglycaemic events whilst maintaining similar or better glycaemic control; or 2 Patient’s allergic reaction has signiﬁcantly decreased, or resolved, following the change to long-acting insulin and patient is continuing to beneﬁt from treatment.

Insulin - Rapid Acting Insulin Analogues

INSULIN ASPART v Inj 100 u per ml, 3 ml ........................................................................53.57 v Inj 100 u per ml, 10 ml ......................................................................31.43 INSULIN LISPRO v Inj 100 u per ml, 10 ml ......................................................................34.92 v Inj 100 u per ml, 3 ml ........................................................................59.52 5 1 10 ml OP 5 NovoRapid Penﬁll NovoRapid Humalog Humalog

fully subsidised [HP1], [HP3], [HP4] refer page 8

S29 Unapproved medicine supplied under Section 29 Sole Subsidised Supply

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

Alpha Glucosidase Inhibitors

ACARBOSE – Special Authority see SA0490 below – Retail pharmacy p Tab 50 mg .........................................................................................22.00 p Tab 100 mg .......................................................................................31.00 90 90 Glucobay Glucobay

¾SA0490 Special Authority for Subsidy Initial application only from a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria: Any of the following: 1 Requires but is not able to tolerate metformin therapy; or 2 Requires metformin but metformin is contraindicated; or 3 Has not responded to or tolerated the maximum appropriate dose of metformin. Renewal only from a relevant specialist. Approvals valid for 2 years where the treatment remains appropriate and the patient is beneﬁting from treatment.

Oral Hypoglycaemic Agents

GLIBENCLAMIDE p Tab 2.5 mg ..........................................................................................3.78 p Tab 5 mg .............................................................................................3.31 GLICLAZIDE p Tab 80 mg .........................................................................................36.46 GLIPIZIDE p Tab 5 mg .............................................................................................3.50 METFORMIN HYDROCHLORIDE p Tab 500 mg .........................................................................................9.75 p Tab 850 mg .........................................................................................8.00 PIOGLITAZONE – Special Authority see SA0859 below – Retail pharmacy Tab 15 mg .........................................................................................61.04 Tab 30 mg .........................................................................................93.90 Tab 45 mg .......................................................................................119.18 100 100 500 100 500 250 28 28 28 Gliben Gliben Apo-Gliclazide Minidiab Arrow-Metformin Arrow-Metformin Actos Actos Actos

¾SA0859 Special Authority for Subsidy Initial application — (Patients with type 2 diabetes) from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria: Any of the following: Monotherapy 1 All of the following: 1.1 To be used as monotherapy for patients who after six months of diet and lifestyle changes have inadequate glycaemic control (deﬁned as HbA1c > 7.0% in tests carried out at least two months apart); and 1.2 Metformin is contraindicated or not tolerated after a minimum of a four-week trial period; and 1.3 Sulphonylurea is contraindicated or not tolerated or the patient is obese; or In combination with sulphonylurea 2 Both: 2.1 For use in combination with a sulphonylurea for patients who after diet and lifestyle changes and a six-month trial of sulphonylurea have poor glycaemic control (deﬁned as HbA1c > 7.5% measured within the last month of the six-month period); and 2.2 Metformin is contraindicated or not tolerated after a minimum of a four-week trial period; or In combination with metformin 3 Both: continued. . .

‡ safety cap pThree months or six months, as applicable, dispensed all-at-once

vThree months supply may be dispensed at one time if endorsed “certiﬁed expemption” by the prescriber.

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

continued. . . 3.1 For use in combination with metformin for patients who after diet and lifestyle changes and a six-month trial of the maximum tolerated dose of metformin have poor glycaemic control (deﬁned as HbA1c > 7.5% measured within the last month of the six-month period); and 3.2 Sulphonylurea is contraindicated or not tolerated, or the patient is obese; or In combination with metformin after a trial of metformin and sulphonylurea 4 For use in combination with metformin for patients who after diet and lifestyle changes and a six-month trial of a combination of metformin and sulphonylurea at maximum tolerated doses have poor glycaemic control (deﬁned as HbA1c > 7.5% measured within the last month of the six month period); or In combination with Insulin 5 For use in combination with insulin in patients requiring more than 1.5 units per kilogram of insulin a day for at least 6 months in conjunction with metformin if tolerated. Renewal — (Patients with type 2 diabetes) from any relevant practitioner. Approvals valid for 1 year where patient is continuing to derive beneﬁt from treatment. Notes: Pioglitazone is not to be used in triple oral combination (deﬁned as a combination of metformin, sulphonylurea and pioglitazone). Pioglitazone should not be used in patients with heart failure. Liver function tests should be performed at baseline. Gastrointestinal side effects are relatively common when initiating metformin therapy. Upward titration of metformin dose over several weeks and taking metformin with food will help to minimize these side effects. Intolerance and contraindications for metformin include: serum creatinine ≥ 0.15 or creatinine clearance < 60 ml/min; signiﬁcant liver impairment; severe left ventricular dysfunction; and intolerable gastrointestinal side effects that persist beyond 4 weeks duration. Intolerance for sulphonylurea includes: nausea; diarrhoea; rash; blood disorders (thrombocytopenia, agranulocytosis, aplastic anaemia); erythema multiforme, exfoliative dermatitis, hepatitis; and syndrome of inappropriate antidiuretic hormone secretion (SIADH) with water retention and hyponatraemia. Maximum tolerated dose of metformin deﬁned as: A dose up to a maximum of 3 g daily. Maximum tolerated dose of sulphonylurea deﬁned as: A dose up to a maximum of glibenclamide 20 mg daily or glipizide 20 mg daily or gliclazide 320 mg daily. For the purposes of these criteria “obese” is deﬁned as body mass index (BMI) greater than 33 kg/m2 . However, as ethnic differences between patients may vary BMI scores, practitioners may use discretion as to whether the patient meets this criterion. It is considered that when applying, that the patient may have initiated “six months diet and lifestyle changes” from the date of diagnosis of type 2 diabetes. TOLBUTAMIDE p Tab 500 mg .......................................................................................12.00 100 Diatol

Diabetes Management Glucose/Urine Testing

COPPER p Tab, diagnostic – Not on a BSO .........................................................5.02 (30.25) GLUCOSE OXIDASE Urine diagnostic test – Not on a BSO.................................................4.11 (7.00) Urine diagnostic test with peroxidase – Not on a BSO.......................4.13 (6.05) 4.11 (6.05) 36 OP Clinitest 50 strip OP Diabur 5000 50 strip OP Clinistix Diastix

fully subsidised [HP1], [HP3], [HP4] refer page 8

S29 Unapproved medicine supplied under Section 29 Sole Subsidised Supply

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

Glucose &/or Ketones/Urine Testing

GLUCOSE OXIDASE Urine diagnostic test with peroxidase, sodium nitroprusside and aminoacetic acid – Not on a BSO.........................................4.53 (8.00) Urine diagnostic test with peroxidase, potassium iodide, sodium nitroprusside and aminoacetic acid – Not on a BSO..............................................................................................4.53 (7.50) SODIUM NITROPRUSSIDE p Urine diagnostic strips, buffered – Not on a BSO...............................3.39 (6.00) 3.40 (7.15)

50 stick OP Keto-Diabur 5000

50 strip OP Keto-Diastix 50 strip OP Ketur-Test Ketostix

Glucose/Blood Testing

GLUCOSE BLOOD DIAGNOSTIC TEST METER – Subsidy by endorsement a) Maximum of 1 meter per prescription b) A diagnostic blood glucose test meter is subsidised for patients who begin insulin or sulphonylurea therapy after 1 March 2005. Only one meter per patient. No further prescriptions will be subsidised. The prescription must be endorsed accordingly. Meter ..................................................................................................9.00 1 Optium Xceed 19.00 Accu-Chek Advantage Accu-Chek Performa (Accu-Chek Advantage Meter to be delisted 1 July 2008) GLUCOSE DEHYDROGENASE The number of test strips available on a prescription is restricted to 50 unless: 1) Prescribed with insulin or a sulphonylurea but are on a different prescription and the prescription is endorsed accordingly; or 2) Prescribed on the same prescription as insulin or a sulphonylurea in which case the prescription is deemed to be endorsed; or 3) Prescribed for a pregnant woman with diabetes and endorsed accordingly. Blood/glucose test strips .................................................................22.00 50 test OP Accu-Chek Advantage Accu-Chek Performa Optium (Accu-Chek Advantage Blood/glucose test strips to be delisted 1 July 2008)

Insulin Syringes and Needles

Subsidy is available for disposable insulin syringes, needles, and pen needles if prescribed on the same form as the one used for the supply of insulin or when prescribed for an insulin patient and the prescription is endorsed accordingly. INSULIN PEN NEEDLES – Maximum of 100 dev per prescription NovoFine pen needles 31 g × 6 mm are subsidised for children under 12 years of age. p 29 g × 12.7 mm ................................................................................13.09 100 B-D Micro-Fine p 31 g × 5 mm .....................................................................................13.09 100 B-D Micro-Fine p 31 g × 6 mm .....................................................................................26.00 100 NovoFine p 31 g × 8 mm .....................................................................................13.09 100 B-D Micro-Fine

‡ safety cap pThree months or six months, as applicable, dispensed all-at-once

vThree months supply may be dispensed at one time if endorsed “certiﬁed expemption” by the prescriber.

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

INSULIN SYRINGES, DISPOSABLE WITH ATTACHED NEEDLE – Maximum of 100 dev per prescription p Syringe 0.3 ml with 29 g × 12.7 mm needle ....................................15.92 100 B-D Ultra Fine p Syringe 0.3 ml with 31 g × 8 mm needle .........................................15.92 100 B-D Ultra Fine II p Syringe 0.5 ml with 29 g × 12.7 mm needle ....................................15.92 100 B-D Ultra Fine p Syringe 0.5 ml with 31 g × 8 mm needle .........................................15.92 100 B-D Ultra Fine II p Syringe 1 ml with 29 g × 12.7 mm needle .......................................15.92 100 B-D Ultra Fine p Syringe 1 ml with 31 g × 8 mm needle ............................................15.92 100 B-D Ultra Fine II

Digestives Including Enzymes

PANCREATIC ENZYME Tab EC 1,900 BP u lipase, 1,700 BP u amylase, 110 BP u protease ..................................................................................... 32.46 Tab EC 5,600 BP u lipase, 5,000 BP u amylase, 330 BP u protease ..................................................................................... 58.44 Cap 8,000 BP u lipase, 9,000 BP u amylase, 430 BP u protease .......................................................................................... 67.26 Cap 8,000 USP u lipase, 30,000 USP u amylase, 30,000 USP u protease – Retail pharmacy-Specialist .............. 85.00 Cap EC 10,000 BP u lipase, 9,000 BP u amylase and 210 BP u protease – Retail pharmacy-Specialist ...................... 34.93 Cap EC 25,000 BP u lipase, 18,000 BP u amylase, 1,000 BP u protease – Retail pharmacy-Specialist ................... 94.38 Cap EC 25,000 BP u lipase, 22,500 BP u amylase, 1,250 BP u protease – Retail pharmacy-Specialist ................... 94.40

300 300 300 250 100 100 100

Pancrex V Pancrex V Forte Pancrex V Cotazym ECS Creon 10000 Creon Forte Panzytrat Actigall

URSODEOXYCHOLIC ACID – Special Authority see SA0841 below – Retail pharmacy Cap 300 mg ....................................................................................269.98 100

¾SA0841 Special Authority for Subsidy Initial application only from a gastroenterologist or general physician. Approvals valid for 6 months for applications meeting the following criteria: Both: 1 Primary biliary cirrhosis conﬁrmed by antimitochondrial antibody titre (AMA) > 1:80, and raised cholestatic liver enzymes with or without raised serum IgM or, if AMA is negative, by liver biopsy; and 2 Patient not requiring a liver transplant (bilirubin > 170umol/l; decompensated cirrhosis). Note: Liver biopsy is not usually required for diagnosis but is helpful to stage the disease. Renewal only from a gastroenterologist or general physician. Approvals valid for 2 years where the treatment remains appropriate and the patient is beneﬁting from treatment. Note: Actigall is not an appropriate therapy for patients requiring a liver transplant (bilirubin > 170 micromol/l; decompensated cirrhosis). These patients should be referred to an appropriate transplant centre. Treatment failure – doubling of serum bilirubin levels, absence of a signiﬁcant decrease in ALP or ALT and AST, development of varices, ascites or encephalopathy, marked worsening of pruritus or fatigue, histological progression by two stages, or to cirrhosis, need for transplantation.

fully subsidised [HP1], [HP3], [HP4] refer page 8

S29 Unapproved medicine supplied under Section 29 Sole Subsidised Supply

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

Laxatives Bulk-forming Agents

MUCILAGINOUS LAXATIVES – Only on a prescription p Dry ......................................................................................................5.72 6.69 7.92 (12.71) 8.80 (15.27) p Dry-original ﬂavour, regular texture only .............................................5.91 (12.38) p Sugar Free ..........................................................................................4.84 (10.60) MUCILAGINOUS LAXATIVES WITH STIMULANTS p Dry ......................................................................................................3.52 (7.69) 8.80 (15.27) 4.40 (12.00) (Granocol Dry to be delisted 1 July 2008) 325 g OP 380 g OP 450 g OP 500 g OP Normacol 336 g OP Metamucil 275 g OP Mucilax 200 g OP Normacol Plus 500 g OP Normacol Plus 250 g OP Granocol Konsyl-D Mucilax Isogel

Faecal Softeners

DOCUSATE SODIUM – Only on a prescription p Tab 50 mg ...........................................................................................4.89 p Tab 120 mg .........................................................................................6.73 p Enema conc 18% ...............................................................................5.40 DOCUSATE SODIUM WITH SENNOSIDES p Tab 50 mg with total sennosides 8 mg ...............................................7.98 POLOXAMER – Only on a prescription p Oral drops 10% ...................................................................................3.93 100 100 100 ml OP 200 30 ml OP Coloxyl Coloxyl Coloxyl Laxsol Coloxyl

Osmotic Laxatives

GLYCEROL p Suppos 2.55 g – Only on a prescription .............................................3.12 p Suppos 3.6 g – Only on a prescription ...............................................5.00 LACTULOSE – Only on a prescription p Oral liq 10 g per 15 ml ........................................................................6.65 12 20 1,000 ml Fleet Glycerin Suppositories PSM Duphalac

MACROGOL 3350 – Special Authority see SA0891 on the next page – Retail pharmacy Powder 13.125 g, sachets – Maximum of 60 sach per prescription ...................................................................................... 18.14 30

Movicol

‡ safety cap pThree months or six months, as applicable, dispensed all-at-once

vThree months supply may be dispensed at one time if endorsed “certiﬁed expemption” by the prescriber.

ALIMENTARY TRACT AND METABOLISM

Subsidy (Manufacturer’s Price) $ Fully Subsidised Per Brand or Generic Manufacturer

¾SA0891 Special Authority for Subsidy Initial application from any relevant practitioner. Approvals valid for 6 months where the patient has problematic constipation requiring intervention with a per rectal preparation despite an adequate trial of other oral pharmacotherapies including lactulose where lactulose is not contraindicated. Renewal from any relevant