Pharmaceutical Schedule - effective 1 December 2002 (text extract)

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Contents

Introducing PHARMAC .......................................................................................................... 2

Members of the PHARMAC Board ................................................................................................... 2 Decision Criteria ............................................................................................................................. 2

PHARMAC and Section H of the Pharmaceutical Schedule: .................................................... 4

The PHARMAC Hospital Team ......................................................................................................... 4 PHARMAC’s clinical advisors ......................................................................................................... 4 Pharmacology and Therapeutics Advisory Committee (PTAC) ......................................................... 4 Hospital Pharmaceuticals Advisory Committee (HPAC) ................................................................... 5

Purpose of the Pharmaceutical Schedule ............................................................................... 5

Finding Information in the Pharmaceutical Schedule ........................................................................ 6 Hospital Pharmaceuticals ............................................................................................................... 6 Explaining hospital pharmaceutical entries ...................................................................................... 7 Hospital Pharmaceutical Costs ....................................................................................................... 7 PHARMAC web site ........................................................................................................................ 7 Exceptional Circumstances policies ................................................................................................ 8 Hospital Exceptional Circumstances ................................................................................................ 8 Community Exceptional Circumstances ........................................................................................... 8

Part I – General Rules for Hospital Pharmaceuticals .............................................................. 9 Introduction .......................................................................................................................... 9 Part 1– Interpretation and Definitions .................................................................................... 9 Part II - Pharmaceuticals Under National Contracts .............................................................. 15 Part III – New Hospital Pharmaceuticals Assessed by PHARMAC ........................................ 17 Part IV – Discretionary Community Supply Pharmaceuticals ................................................ 18 Part V – Pharmaceutical Cancer Treatments ........................................................................ 18

Introducing PHARMAC

PHARMAC, the Pharmaceutical Management Agency, is a Crown entity established pursuant to the New Zealand Public Health and Disability Act 2000. 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 Liz Coutts Helmut Modlik Karen Guilliland Gregor Coster David Moore

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. 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 65 of the 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.

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. Pursuant to the hospital supplement to the Operating Policies and Procedures, PHARMAC takes into account the following criteria when making decisions about Hospital Pharmaceuticals: • the health needs of all eligible people within New Zealand (eligible defined by the Government’s then current rules of eligibility); • the particular health needs of Maori and Pacific peoples; • the availability and suitability of existing medicines, therapeutic medical devices and related products and related things, having regard (without limitation) to: - other interventions (existing pharmaceuticals, medical interventions, therapeutic medical devices etc.) currently available to meet the health needs that would be met by the pharmaceutical; - other interventions that the pharmaceutical would be used in addition to or instead of; - any evidence that the pharmaceutical is more efficacious, more safe and/or clinically more acceptable to patients than the other interventions currently available to meet these health needs; - the clinical significance of any advantages identified above;

• the availability and suitability of the pharmaceutical for use in hospitals, having regard (without limitation) to: - the level of importance of having uninterrupted supply of the pharmaceutical; - the reliability of the supplier of the pharmaceutical in ensuring its availability; - other pharmaceuticals or other interventions that could be used in the event that the pharmaceutical was unavailable; - the suitability of the packaging and/or proposed pack size for the pharmaceutical; - the impact, if any, that the proposal would have on existing DHB supply contracts, to the extent that this can be ascertained by PHARMAC; • the clinical benefits and risks of pharmaceuticals; • the cost-effectiveness of meeting health needs by funding pharmaceuticals rather than using other publicly funded health and disability support services, having regard (without limitation) to: - the cost-effectiveness of the pharmaceutical; - the effect that the use of the pharmaceutical would have on: i) the total cost of pharmaceuticals used in hospitals and/or the community; ii) the total cost of non-pharmaceutical hospital acquisitions; iii) staff costs in hospitals; and iv) other costs to DHBs; • the budgetary impact (in terms of the pharmaceutical budget and the Government’s overall health budget) of any changes to the Pharmaceutical Schedule, having regard (without limitation) to: - the impact the proposal has on total expenditure on pharmaceuticals; - the direct cost to health service users; • 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 • 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. Copies of PHARMAC’s Operating Policies and Procedures and of any applicable supplements are available on the PHARMAC website, or on request. The decision criteria for Community Pharmaceuticals are set out in the Operating Policies and Procedures and in the community part of the Pharmaceutical Schedule.

PHARMAC and Section H of the Pharmaceutical Schedule:

PHARMAC manages the national Pharmaceutical Schedule, which lists: • Pharmaceuticals available in the community and subsidised by the Government with funding from the Pharmaceutical Budget; and • 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 3000 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 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 Pharmaceutical Cancer Treatments that DHBs have been directed to fund for use in their hospitals and/or in association with services provided in their hospitals, as well as 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, when published, will identify 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.

The PHARMAC Hospital Team

The PHARMAC Hospital Team is: Cristine Della Barca Rachel Grocott Matthew Perkins Manager, Hospital Pharmaceuticals Hospital Pharmaceuticals Analyst Hospital Projects Advisor

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: John Hedley Robin Briant Carl Burgess Bruce Foggo Jim Lello Coleen Lewis Peter Pillans Tom Thompson Paul Tomlinson MBChB, FRACP FACCP Member Thoracic, Cardiac and Gastroenterology , , Societies of Australia and New Zealand, Chairman MD, FRACP physician and pharmacologist , MD, MRCP (UK), FRACP pharmacologist , MBChB, Dip Obs, FRNZCGP general practitioner , BHB, MBChB, DCH, FRNZCGP general practitioner , MBChB, general practitioner MBChB, FCP FRACP pharmacologist , , MBChB, FRACP physician , MBChB, MD, MRCP FRACP BSc, paediatrician , ,

Contact PTAC C/- PTAC Secretary Pharmaceutical Management Agency PO Box 10 254, WELLINGTON

Hospital Pharmaceuticals Advisory Committee (HPAC)

The PHARMAC Board has established a Hospital Pharmaceuticals Advisory Committee (HPAC), which PHARMAC works closely with. This committee is made up of representatives of the DHBs, as nominated by the DHBs, and appointed by the PHARMAC Board. Its role includes advising PHARMAC in relation to national purchasing strategies for Hospital Pharmaceuticals. HPAC members are: Brian Ellis (Chair) Stephanie Chapman Marilyn Crawley Sarah Fitt Paul Green Bruce Hastie Andre Mutavidzic Elizabeth Plant Neville Winsley Ian Winwood Julie Yee Contact HPAC C/Clinical Practice Group Manager Purchasing Manager Manager, Pharmacy Services Pharmacy Manager Manager, Materials Management Pharmacy Services Manager Pharmacy Team Leader Chief Pharmacist and DHB Pharmaceutical Management Coordinator Pharmacy/Radiology Manager Clinical Coordinator Pharmacy Service Leader, Pharmacy Manager, Hospital Pharmaceuticals Pharmaceutical Management Agency PO Box 10 254, WELLINGTON Otago Canterbury Waitemata Auckland Auckland Counties-Manukau Waikato Taranaki Hawkes Bay Southland Capital & Coast

Purpose of the Pharmaceutical Schedule

The purpose of the Schedule is to list: • 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 and any access conditions that may apply; and • 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. • Section A lists the General Rules in relation to Community Pharmaceuticals and related products. • 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. • Section C lists the rules in relation to Extemporaneously Compounded Products (ECPs) and Community Pharmaceuticals that will be subsidised when extemporaneously compounded. • Section D lists the rules in relation to Special Foods and the Special Foods that are subsidised. • Section E Part I lists the Community Pharmaceuticals that are subsidised on a Practitioner’s Supply Order (PSO) and Wholesale Supply Order (WSO). • Section E Part II lists remote areas for the purpose of PSOs. • Section F lists the Community Pharmaceuticals that are exempt from monthly dispensing and related rules. • 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: - Part I lists the rules in relation to Hospital Pharmaceuticals. - 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. - 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. - 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. - Part V lists Pharmaceutical Cancer Treatments that DHBs have been directed to fund for use in their hospitals and/or in association with services provided in their hospitals. The index located at the back of Section H can be used to find page numbers for generic chemical entities, or product brand names, for Hospital Pharmaceuticals.

Explaining hospital pharmaceutical entries

Section H of the Pharmaceutical Schedule lists National Contract Pharmaceuticals, DV Pharmaceuticals, Assessed Pharmaceuticals, Discretionary Community Supply Pharmaceuticals and Pharmaceutical Cancer Treatments that are available to be purchased by DHBs. Where applicable, the listing of the Hospital Pharmaceutical may have an indication of whether it has HSS (if the brand name is in bold), its Price and any associated DV Pharmaceuticals and DV Limit.

Contracted Pharmaceutical Description Brand Price ($) (ex man. excl. GST) Per DV Limit DV Pharmaceuticals

CEFTRIAXONE Inj IV, 250 mg vial ..................................... Rocephin FLUMAZENIL Inj, 0.5 mg per 5 ml amp .......................... Anexate GANCYLOVIR Cap, 250 mg ............................................ Cymevene

20.00

Baxter

Novartis

170.00

Flumaze

Flunil

380.00

(B)

In the case of ceftriaxone, Rocephin Inj IV, 250 mg vial is the Pharmaceutical with HSS. The 5% DV Limit means that at least 95% of the total volume of all brands of ceftriaxone 250 mg injections purchased by DHB Hospitals must be Rocephin. Subject to the provisions of 4.2(c)(iii) of the General Rules for Hospital Pharmaceuticals, DHB Hospitals may only purchase up to 5% of other brands of ceftriaxone 250 mg injections. Those other brands of ceftriaxone 250 mg injections known to be available in New Zealand are listed as DV Pharmaceuticals but the 5% DV Limit also applies to any unlisted brands of ceftriaxone 250mg injection. The 0% DV Limit applying to flumazenil 0.5 mg per 5 ml injections effectively means that the supplier of Anexate Inj, 0.5 mg per 5 ml amp is entitled to the entire flumazenil 0.5 mg per 5 ml injection market. DHB Hospitals are prevented from purchasing Flumaze, Flunil or any other brands of flumazenil 0.5 mg per 5 ml injections yet to be made available in New Zealand (except as provided for under clause 4.2(c)(iii) of the General Rules for Hospital Pharmaceuticals). The 0% DV Limit applying to gancyclovir 250 mg capsules has the same effect as in the flumazenil example except that there are no other brands of gancyclovir 250 mg capsules available in New Zealand. The (B) noted under DV Pharmaceuticals indicates that DHB Hospitals are prevented from purchasing any brands of 250 mg strength gancyclovir in the same or similar form distributed in New Zealand.

Hospital Pharmaceutical Costs

The cost of purchasing Hospital Pharmaceuticals is met by the Funder (in particular, the relevant DHB) from its own budget.

PHARMAC web site

Information about PHARMAC is available on its website at http://www.pharmac.govt.nz. The website includes copies of the Annual Review, Annual Report and Annual Plan, as well as information such as the Pharmaceutical Schedule, Pharmaceutical Schedule Updates, other publications and recent press releases.

Exceptional Circumstances policies

The purposes of the Exceptional Circumstances policies are to provide: • 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 • an assessment process for 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”). 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.

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 be 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.

Community Exceptional Circumstances

In order to qualify for Community Exceptional Circumstances approval one of the following entry 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. 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. Applications for Community Exceptional Circumstances and Hospital Exceptional Circumstances, when it is implemented, should be made on the standard application form available from the address below: The Coordinator, Exceptional Circumstances Panel Ministry of Health, Private Bag 92 522, Wellesley Street, Auckland Phone (09) 580 9173 or (09) 580 9174 or fax (09) 580 9205 Email: ecpanel@ppc.govt.nz

# Implementation date to be advised

Part I – General Rules for Hospital Pharmaceuticals

Introduction

Section H contains general rules that apply, and other information relating, to Hospital Pharmaceuticals. The amounts payable by a DHB to the relevant pharmaceutical supplier are based on the contractual arrangements between PHARMAC and the relevant pharmaceutical supplier for a national price for that National Contract Pharmaceutical. The Pharmaceutical Schedule shows the national price at which the National Contract Pharmaceutical can be purchased by DHBs, providers of logistics services, wholesalers or other such distributors, or Contract Manufacturers directly from the pharmaceutical supplier. As required by section 23(7) of the Act, in performing any of its functions in relation to the supply of Pharmaceuticals, DHBs must not act inconsistently with the Schedule.

Part 1– Interpretation and Definitions

1.1 In this Schedule, unless the context otherwise requires: “Act” means the New Zealand Public Health and Disability Act 2000. “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. “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. “Contract Manufacturer” means a manufacturer or a supplier that is a party to a contract with the relevant DHB Hospital to compound Hospital Pharmaceuticals, on request from that DHB Hospital. “Designated Delivery Point” means at a DHB Hospital’s discretion: a) a delivery point agreed between a pharmaceutical supplier and the relevant DHB Hospital, to which delivery point that pharmaceutical supplier must supply the Pharmaceuticals directly in accordance with any applicable delivery terms and conditions as at the date of this Agreement, or that are subsequently agreed between that pharmaceutical supplier and that DHB Hospital; and/or (b) any delivery point designated by the relevant DHB Hospital or PHARMAC, such delivery point being within 30 km of the relevant pharmaceutical supplier’s national distribution centre. “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 Pharmaceuticals” 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. “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. “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. # Implementation date to be advised 9

“Funder” means the body or bodies responsible, pursuant to the Act, for the funding of Pharmaceuticals listed on the 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 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, Assessed Pharmaceuticals and Pharmaceutical Cancer Treatments. “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. “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. “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. “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 Pharmaceutical for consumption or use in the person’s home. “PHARMAC” means the Pharmaceutical Management Agency established by Section 46 of the Act (PHARMAC). “Pharmacode” means the six or seven digit identifier assigned to a Pharmaceutical and notified to a pharmaceutical supplier by the Pharmacy Guild. “Pharmaceutical” means a medicine, therapeutic medical device, or related product or related thing listed in Sections B to H of the Schedule. “Pharmaceutical Budget” means the pharmaceutical budget set for PHARMAC by the Crown for the subsidised supply of Community Pharmaceuticals. “Pharmaceutical Cancer Treatments” means Pharmaceuticals listed in Part V of Section H of the Pharmaceutical Schedule, and their associated indications, that the Minister of Health has directed DHBs to 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. “Price” means the standard national price, and, unless agreed otherwise between PHARMAC and the pharmaceutical supplier, includes any costs associated with the supply of a National Contract Pharmaceutical listed in Section H Part II of the Pharmaceutical Schedule to, at a DHB Hospital’s discretion, any Designated Delivery Point, or to a Contract Manufacturer (expressly for the purpose of compounding). “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 remote areas for the purpose of community Practitioner’s Supply Orders included in the Schedule. 10 # Implementation date to be advised

“Section F” of this Pharmaceutical Schedule means the list of Community Pharmaceuticals eligible for exemption from monthly dispensing included in this Schedule. “Section G” of this Pharmaceutical Schedule means the list of Community Pharmaceuticals eligible for reimbursement of safety Cap. “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, of Assessed Pharmaceuticals and of Pharmaceutical Cancer Treatments 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. “Section H Part V” of the Pharmaceutical Schedule means the list of Pharmaceutical Cancer Treatments. “Total Market Volume” means, for a particular Hospital Pharmaceutical with HSS in any given period, in accordance with the data available to PHARMAC, the sum of: a) the total number of Units of the relevant Hospital Pharmaceutical with HSS purchased by all DHB Hospitals, or by a particular DHB Hospital in the case of the Individual DV Limit; and b) the total number of Units of all the relevant DV Pharmaceuticals, listed in Section H Part II in association with that Pharmaceutical, purchased by all DHB Hospitals, or by a particular DHB Hospital in the case of the Individual DV Limit. “Unit” means an individual unit of a Pharmaceutical (e.g. tablet, 1 ml of an oral liquid, amp, syringe). 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 Pharmaceuticals.

2. Current Hospital Pharmaceutical Contracts

2.1 A DHB Hospital may enter into a contract for the purchase of any Pharmaceutical that is not a National Contract Pharmaceutical, provided that such contract: (a) does not oblige the relevant DHB Hospital to purchase a volume of that Pharmaceutical, if that Pharmaceutical is a DV Pharmaceutical, that is greater than the relevant DV Limit; (b) enables PHARMAC to access and use future price and volume data in respect of that Pharmaceutical; and (c) enables the relevant DHB Hospital to terminate the contract or relevant parts of the contract in order to give full effect to the national contract on 3 months’ written notice to the pharmaceutical supplier. 2.2 From the day after a DHB Hospital’s current supply contract for a chemical entity that is a National Contract Pharmaceutical expires, that DHB Hospital is to purchase the relevant National Contract Pharmaceutical listed in Section H Part II at the Price, and is to comply with the DV Limits for the National Contract Pharmaceutical where it has HSS. 2.3 Following written notification from PHARMAC that a Pharmaceutical is a National Contract Pharmaceutical, either through Section H updates or otherwise, DHB Hospitals are to take any steps available to them to terminate current contracts, and are not to enter into any new contracts or extend the period of any current contracts, for the supply of that National Contract Pharmaceutical listed in Section H Part II or the relevant chemical entity, unless PHARMAC expressly notifies otherwise.

3. National Contract Pharmaceutical Price

3.1 DHB Hospitals must take all necessary steps to enable any contracts between PHARMAC and a pharmaceutical supplier in relation to National Contract Pharmaceuticals to be given full effect. 3.2 National Contract Pharmaceuticals that can be purchased by DHBs at the relevant Price, as agreed between PHARMAC and the relevant pharmaceutical supplier, are hereby deemed to include every medicine, therapeutic medical device, or related product or related thing listed in Section H Part II of the Schedule except DV Pharmaceuticals. 3.3 A National Contract Pharmaceutical is to be made available by the relevant pharmaceutical supplier for purchase at the relevant Price by any or all of the following: a) DHB Hospitals at Designated Delivery Points; and/or b) Contract Manufacturers (expressly for the purpose of compounding).

4. Hospital Supply Status (HSS)

4.1 The DV Limit for any National Contract Pharmaceutical, which has HSS is set out beside the listing of the relevant National Contract Pharmaceutical in Section H Part II of the Schedule and may be amended from time to time. 4.2 If a National Contract Pharmaceutical is listed in Section H Part II as having HSS, DHB Hospitals: a) are expected to use up any existing stocks of DV Pharmaceuticals during the First Transition Period; b) must not purchase DV Pharmaceuticals in volumes exceeding their usual requirements, or in volumes exceeding those which they reasonably expect to use, within the First Transition Period; and c) must purchase the Hospital Pharmaceutical with HSS except: i) to the extent that the DHB Hospital may use its discretion to purchase a DV Pharmaceutical within the DV Limit, provided that (subject to subclause (iii) below) the DV Limit has not been exceeded nationally; ii) if the pharmaceutical supplier fails to supply that Hospital Pharmaceutical, in which case the relevant DHB Hospital does not have to comply with the DV Limit for that Hospital Pharmaceutical during that period of non-supply (and any such month(s) included in a period of non-supply will be excluded in any review of the DV Limit in accordance with clause 4.3 below); iii) that where the DV Limit has been exceeded nationally, the DHB Hospital may negotiate with the pharmaceutical supplier who supplies the National Contract Pharmaceutical with HSS for written permission to vary the application of that DHB Hospital’s Individual DV Limit for any patient whose exceptional needs require a DV Pharmaceutical. 4.3 PHARMAC may, in its discretion, for any period or part period: a) review usage by DHB Hospitals of the National Contract Pharmaceutical and DV Pharmaceuticals to determine whether the DV Limit has been exceeded; and b) audit compliance by DHB Hospitals with the DV Limits and related requirements. 4.4 PHARMAC may address the issue of non-compliance by any individual DHB Hospital with a DV Limit by: a) obtaining the relevant DHB Hospital’s assurance that it will comply with the DV Limit for that National Contract Pharmaceutical with HSS in the remainder of the applicable period and any subsequent periods; and/or b) requiring financial compensation from the relevant DHB Hospital, or withholding payment of rebates and/or indemnity payments received from suppliers, for an amount either: i) representing its contribution towards exceeding the DV Limit (where PHARMAC is able to quantify this based on the information available to it); or ii) the sum of $5,000, whichever is the greater, within the number of business days specified in PHARMAC’s notice requiring such payment to be made. 4.5 PHARMAC will forward any financial compensation paid by the relevant DHB Hospital in accordance with clause 4.4(b) above to the relevant pharmaceutical supplier whose National Contract Pharmaceutical has HSS and, following any failure of the relevant DHB Hospital to provide such payment within 60 business days, the relevant pharmaceutical supplier may address the issue of non-payment directly with the relevant DHB.

4.6 The relevant DV Pharmaceuticals for any National Contract Pharmaceutical with HSS are listed in Schedule H Part II of the Schedule alongside that National Contract Pharmaceutical with HSS and may be amended from time to time. For the purposes of assessing a DHB Hospital’s compliance with the DV Limit, if a Pharmaceutical has been added to be, or removed from being, a DV Pharmaceutical during the period that is being assessed PHARMAC is only to count the amount of those Pharmaceuticals that were purchased during the portion of the applicable period in which that Pharmaceutical was a DV Pharmaceutical.

5. Collection of rebates and payment of financial compensation

5.1 Following the receipt of any rebates from a pharmaceutical supplier in respect of a particular Hospital Pharmaceutical, PHARMAC will notify each relevant DHB and DHB Hospital of the amount of the rebate owing to it, being a portion of the total rebate determined by PHARMAC on the basis of that DHB Hospital’s usage of that Hospital Pharmaceutical, where this is able to be determined. Where data to determine individual DHB Hospitals’ usage is not available, PHARMAC will apportion rebates on the basis of an alternative method agreed between the relevant DHBs and PHARMAC. 5.2 PHARMAC will pay each DHB Hospital the rebate amounts (if any) owing to it, no less frequently than once each calendar quarter in respect of rebates received quarterly (or more often).

6. Price And Volume Data

6.1 DHB Hospitals are to provide to PHARMAC, on a monthly basis in accordance with PHARMAC’s requirements, any volume data and, unless it would result in a breach of an existing contract, price data held by those DHB Hospitals in respect of any Hospital Pharmaceuticals listed in Section H of the Schedule. 6.2 All price and volume data provided to PHARMAC under clause 6.1 above should identify the relevant Hospital Pharmaceutical by using a Pharmacode or some other unique numerical identifier, and the date (month and year) on which the DHB Hospital incurred a cost for the purchase of that Pharmaceutical. Volume is to be measured in units (that being the smallest possible whole unit – e.g. a capsule, a vial, a millilitre etc).

7. Assessed Pharmaceuticals

7.1 Assessed Pharmaceuticals are hereby deemed to include every medicine, therapeutic medical device, or related product or related thing listed in Section H Part III of the Schedule. 7.2 Any DHB Hospital or pharmaceutical supplier may apply to PHARMAC at any time to have a pharmaceutical assessed and to be placed on the Assessed Pharmaceutical list in Section H Part III of the Schedule.

8. Discretionary Community Supply Pharmaceuticals

8.1 Discretionary Community Supply Pharmaceuticals are deemed to include every medicine, therapeutic medical device, or related product or related thing listed in Section H Part IV of the Schedule. 8.2 PHARMAC may, in its discretion, list any pharmaceutical that is not a Community Pharmaceutical as a Discretionary Community Supply Pharmaceutical, including a pharmaceutical that PHARMAC is made aware of by HPAC, the Exceptional Circumstances Panel, a DHB Hospital or relevant clinicians. 8.3 A DHB Hospital may use its discretion to purchase Discretionary Community Supply Pharmaceuticals for use in the community, provided that, if the patient being treated with a Discretionary Community Supply Pharmaceutical 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. 8.4 The funding of a Discretionary Community Supply Pharmaceutical for use in the community will be sourced from the relevant DHB’s own budget. For the avoidance of doubt, the Discretionary Community Supply Pharmaceutical is not a Community Pharmaceutical and funding is not available for Discretionary Community Supply Pharmaceuticals from the Pharmaceutical Budget.

# Implementation date to be advised

9. Pharmaceutical Cancer Treatments

9.1 DHBs are obliged to fund Pharmaceutical Cancer Treatments in accordance with the October 2001 direction from the Minister of Health. 9.2 The list of Pharmaceutical Cancer Treatments may be amended from time to time. Additions and/or amendments to Part V of Section H of the Pharmaceutical Schedule require the approval of the PHARMAC Board. 9.3 Subject to the provisions of clause 9.4, DHBs must not fund Pharmaceuticals for the treatment of cancer or Pharmaceutical Cancer Treatments for indications related to the treatment of cancer, if they are not listed in Part V of Section H of the Pharmaceutical Schedule, unless they have specific Community Exceptional Circumstances approval or permission under Hospital Exceptional Circumstances. # 9.4 DHBs may fund Pharmaceuticals that are not listed in Part V of Section H of the Pharmaceutical Schedule, and/or Pharmaceutical Cancer Treatments for indications not listed in Part V of Section H of the Pharmaceutical Schedule, provided that: a) such use is first assessed via established review mechanisms within DHB Hospitals involving experienced clinicians; b) such use is reported to the Exceptional Circumstances Panel within 7 working days of initiating such treatment; and c) the pharmaceutical or indications approved via this mechanism do not include those that have been assessed by the Pharmacology and Therapeutics Advisory Committee or its cancer treatments subcommittee and were not recommended for inclusion in Part V of Section H of the Pharmaceutical Schedule. 9.5 Applications to add pharmaceuticals, and add or amend indications for Pharmaceutical Cancer Treatments, to Part V of Section H of the Pharmaceutical Schedule may be made in writing by pharmaceutical suppliers and/ or clinicians to PHARMAC. Applications should follow PHARMAC’s Guidelines for Submissions to PTAC for New Chemical Entity Pharmaceuticals and Recommended methods to derive clinical inputs for proposals to PHARMAC, copies of which are available from PHARMAC and on PHARMAC’s website. 9.6 Applications made under clause 9.5 must be assessed by HPAC, PTAC and/or relevant sub-committees of PTAC, and by PHARMAC.

# Implementation date to be advised

Part II - Pharmaceuticals Under National Contracts

Contracted Pharmaceutical Description Brand Price ($) (ex man. excl. GST) Per DV Limit DV Pharmaceuticals

BASILIXIMAB

Inj 20 mg .................................................. Simulect

CAPECITABINE

3,200.00 115.00 705.00 20.00 35.00 45.00 45.00 90.00

1 60 120 5 5 5 5 5 0% 0% 5% 5% 5% 5% 5% (B) (B) Baxter

Novartis

Tab 150 mg .............................................. Xeloda Tab 500 mg .............................................. Xeloda

CEFTRIAXONE

Inj IV 250 mg ............................................ Rocephin Inj IV 500 mg ............................................ Rocephin Inj IM 1 g .................................................. Rocephin Inj IV 1 g ................................................... Rocephin Inf 2 g ....................................................... Rocephin

AFT

Baxter Novartis

AFT

Baxter Novartis

AFT

Baxter Novartis

AFT

Baxter Novartis

CLOZAPINE

Tab 25 mg ................................................ Clozaril Tab 100 mg .............................................. Clozaril

CYCLOSPORIN

22.00 57.00 85.00 169.34 338.69 377.38 635.00 76.02 152.04 228.06 304.08 380.10 456.12 760.20 650.00 135.00 170.10 380.00 441.00 4,800.00

50 50 50 50 50 50 ml OP 1 6 6 6 6 6 6 6 5 1 5 84 5 120 15 0% 0% 0% 0% 0% (B) (B) (B) (B) (B) 0% (B)

Cap 25 mg ............................................... Neoral Cap 50 mg ............................................... Neoral Cap 100 mg ............................................. Neoral Oral liq 100 mg per ml .............................. Neoral

DACLIZUMAB

Inj 25 mg per 5 ml .................................... Zenapax

ERYTHROPOIETIN BETA

Inj 1,000 iu prefilled syringe ..................... Recormon Inj 2,000 iu prefilled syringe ..................... Recormon Inj 3,000 iu prefilled syringe ..................... Recormon Inj 4,000 iu prefilled syringe ..................... Recormon Inj 5,000 iu prefilled syringe ..................... Recormon Inj 6,000 iu prefilled syringe ..................... Recormon Inj 10,000 iu prefilled syringe ................... Recormon

FILGRASTIM

Inj 300 µg per 1 ml ................................... Neupogen Inj 300 µg per 0.5 ml prefilled syringe ...... Neupogen

FLUMAZENIL

Inj 0.5 mg per 5 ml ................................... Anexate

GANCYCLOVIR

Cap 250 mg ............................................. Cymevene Inj 500 mg ................................................ Cymevene

IMATINIB MESYLATE

Cap 100 mg…………………………….. Glivec Products with Hospital Supply Status (HSS) are in bold.

(B) – Subject only to part (b) of the definition of “DV Pharmaceutical”

Contracted Pharmaceutical Description

Brand

Price ($) (ex man. excl. GST)

Per

DV Limit

DV Pharmaceuticals

MIDAZOLAM

Inj 5 mg per ml, 3 ml ................................ Hypnovel Inj 1 mg per ml, 5 ml ................................ Hypnovel

MYCOPHENOLATE MOFETIL

14.00 12.65

5 10

5% 5%

Baxter

Pharmacia

Baxter

Pharmacia

Inj 500 mg ................................................ CellCept Tab 500 mg .............................................. CellCept Tab 250 mg .............................................. CellCept

OCTREOTIDE

133.33 206.66 206.66 39.15 72.90 359.10 1,772.50 2,358.75 2,951.25 4.94 6.18

4 50 100 1 1 1 1 1 1 5 5

0% 0% 0%

(B) (B) (B)

Inj 50 µg per ml, 1 ml ............................... Sandostatin Inj 100 µg per ml, 1 ml ............................. Sandostatin Inj 500 µg per ml, 1 ml ............................. Sandostatin Inj LAR, 10 mg ......................................... Sandostatin LAR Inj LAR, 20 mg ......................................... Sandostatin LAR Inj LAR, 30 mg ......................................... Sandostatin LAR

OXYTOCIN

Inj 5 iu per ml, 1 ml amp .......................... Syntocinon Inj 10 iu per ml, 1 ml amp ........................ Syntocinon

OXYTOCIN WITH ERGOTAMINE MALEATE

Inj 5 iu with ergotamine maleate 500 µg per ml, 1 ml ................ Syntometrine

RITUXIMAB

8.40 1,195.00 2,987.00 1,850.00 1,350.00 3,875.00 154.82 19.20 38.40 550.00

5 2 1 2 1 1 5 1 1 1 0% 0% 0% 0% 0% (B) (B) (B) (B) (B)

Inj 100 mg per 10 ml vial .......................... Mabthera Inj 500 mg per 50 ml vial .......................... Mabthera

RETEPLASE

Inj 10 iu vial .............................................. Rapilysin

TRASTUZUMAB

Inj 150 mg vial .......................................... Herceptin Inj 440 mg vial .......................................... Herceptin

TROPISETRON

Cap 5 mg……………………………….. Navoban Inj 2 mg amp……………….. ................. Navoban Inj 5 mg amp……………….. ................. Navoban

ZOLEDRONIC ACID

Inj 4 mg .................................................... Zometa

16 Products with Hospital Supply Status (HSS) are in bold.

(B) – Subject only to part (b) of the definition of “DV Pharmaceutical”

Part III – New Hospital Pharmaceuticals Assessed by PHARMAC

Pharmaceutical Brand Infliximab Indication(s) Assessed Comparator Pharmaceutical Status of Assessment Cost/QALY $53,152.34/QALY for single dose, $118,091.81/QALY for retreatment, $382,309.21/QALY for maintenance treatment on infliximab compared with usual care. To be advised Findings Poor cost effectiveness compared with usual care. Most cost-effective if used as a singledose in patients with severe first presentation of Chrohn’s disease, to enable them to be stabilised on routine treatment. Clear treatment guidelines and criteria recommended. To be advised

Remicade Moderate to severe Crohn’s disease for patients who are refractory to conventional treatment.

Usual care (combination Complete. Sent to of surgery, anti-inflammatory DHB hospitals agents, corticosteroids, antibiotics and immuno-modulators).

Linezolid

Zyvox

Methicillin-resistant staphylococcus aureus infections. Hypercalcemia of malignancy (HCM), bone metastases in patients with breast cancer, osteolytic lesions in patients with multiple myeloma, and osteoporosis. Severe sepsis.

Vancomycin

Consultation commencing in November 2002. Under review. Consultation likely to commence in December 2002.

Zoledronic Acid Zometa

Pamidronate in cases of HCM and cancer metastases, alendronate in patients with osteoporosis

To be advised

Drotrecogin alfa Xigris

Placebo

Under review. Consultation likely to commence in December 2002. Assessment in progress.

To be advised

Desflurane

Suprane

N/A

Sevoflurane and Isoflurane

To be advised

Part IV – Discretionary Community Supply Pharmaceuticals

List to be developed and consulted upon. Provisions for DSC set out in clause 8 of the General Rules relating to Section H do not apply until further notice.

Part V – Pharmaceutical Cancer Treatments

The following table shows all known brands, strengths and forms (but not pack sizes) of Pharmaceutical Cancer Treatments (PCTs) to which DHB Hospitals are expected to provide access. Some presentations may be missing or duplicated due to the quality of source information. Those PCTs against which “(s29)” is annotated can only be used under Section 29 of the Medicines Act, 1981.

Chemical and presentation 5-FLUOROURACIL Cream 5% Inj 2.5 g per 50 ml Inj 25 mg per ml, 10 ml Inj 25 mg per ml, 20 ml Inj 25 mg/ml, 100 ml Inj 50 mg per ml, 0.3 ml Inj 50 mg per ml 10 ml ACTINOMYCIN D Inj 0.5 mg with mannitol 20 mg per vial AMSACRINE Inj 50 mg per ml vial AZATHIOPRINE Tab (s29) 10 mg Tab 50 mg Brand Efudix Adrucil David Bull Delta West David Bull Delta West David Bull Delta West David Bull David Bull Adrucil Cosmegen Amsidyl Chemical and presentation CARBOPLATIN Inj 10 mg per ml, 5 ml Brand David Bull Delta West Carbosin David Bull Delta West Carbosin David Bull Delta West Carbosin Paraplatin Paraplatin BICNU Platinol Platosin Platosin Platosin Platinol David Bull Delta West Platamine David Bull Delta West Platamine David Bull Delta West Leustatin Leunase Cycloblastin Endoxan Cycloblastin Cycloblastin Cytoxan Cycloblastin Cytoxan Endoxan Endoxan

Inj 10 mg per ml, 15 ml

Inj 10 mg per ml, 45 ml Inj 10 mg per ml, 50 ml Inj 150 mg per 10 ml CARMUSTINE Inj 100 mg CISPLATINUM Inj 0.5 mg per ml, 20 ml Inj 0.5 mg per ml, 50 ml Inj 0.5 mg per ml, 100 ml Inj 1 mg per ml, 10 ml

ASPARAGINASE – see COLASPASE (L-ASPARAGINASE) Imuran Azamun Imuran Thioprine Blenoxane David Bull

BLEOMYCIN SULPHATE Inj 15 iu vial

Inj 1 mg per ml, 50 ml

CAPECITABINE Tab 150 mg Xeloda Tab 500 mg Xeloda Restricted indication 1. Metastatic colorectal cancer 2. Metastatic breast cancer – Post anthracycline and taxane relapse 3. Metastatic breast cancer – unsuitable anthracycline/ taxane therapy eg poor venous access, geographical isolation, intolerant of therapy 4. Substitute for single agent fluoropyrimidine when poor venus access/needle phobia exists

Inj 1 mg per ml, 100 ml CLADRIBINE Inj 1 mg per ml, 10 ml COLASPASE (L-ASPARAGINASE) Inj 10,000 iu vial CYCLOPHOSPHAMIDE Tab 50 mg Inj 200 mg Inj 500 mg Inj 1 g vial

Inj 2 g vial

Chemical and presentation CYTARABINE Inj 20 mg per ml, 5 ml Inj 20 mg per ml, 25 ml Inj 40 mg per ml, 50 ml Inj 50 mg per ml, 10 ml Inj 100 mg per ml, 1 ml Inj 100 mg per ml, 5 ml Inj 100 mg per ml, 10 ml Inj 100 mg per ml, 20 ml Inj 2 g, 20 ml DACARBAZINE Inj 100 mg Inj 200 mg DACTINOMYCIN – see ACTINOMYCIN D DAUNORUBICIN Inj 20 mg, 4 ml DAUNORUBICIN CITRATE LIPOSOME Inj 50 mg per 25 ml, 25 ml DEOXYCOFORMYCIN Inj (s29) 10 mg vial DISODIUM PAMIDRONATE Inf 3 mg per ml, 5 ml vial Inf 3 mg per ml, 10 ml vial Inf, 6 mg per ml, 10 ml vial Inf 9 mg per ml, 10 ml vial

Brand

Chemical and presentation DOXORUBICIN HYDROCHLORIDE Inj 2 mg per ml, 5 ml Inj 2 mg per ml, 10 ml Inj 2 mg per ml, 25 ml Inj 2 mg per ml, 50 ml Inj 10 mg Inj 50 mg EPIRUBICIN Inj 10 mg, 5 ml Inj 50 mg, 25 ml ERWINASE 10,000 iu ESTRAMUSTINE SODIUM PHOSPHATE Cap 140 mg

Brand Adriamycin Doxorubicin HCl Doxorubicin Adriamycin Doxorubicin HCl Doxorubicin HCl Doxorubin Doxorubicin Doxorubin Doxorubicin Pharmorubicin Pharmorubicin Crisantaspase Estracyt

Cytosar-U Delta West Delta West Cytosar-U Cytosar-U David Bull David Bull David Bull Delta West Delta West David Bull DTIC Dacarbazine DTIC

David Bull Cerubidine Daunoxome Nipent (Pentostatin) David Bull Aredia David Bull David Bull Aredia David Bull

ETOPOPHOS – see ETOPOSIDE PHOSPHATE ETOPOSIDE Cap 50 mg Cap 100 mg Inj 20 mg per ml, 5 ml Vepesid Vepesid David Bull Delta West Vepesid Etopophos Neupogen Neupogen Fludara oral Fludara IV Folinic acid

ETOPOSIDE PHOSPHATE Inj 113.6 mg FILGRASTRIM WITH SORBITOL Inj 300 µg, 0.5 ml prefilled syringe Inj 300 µg, 1 ml FLUDARABINE PHOSPHATE Tab 10 mg Inj 50 mg FOLINIC ACID Liq 5 mg per 5 ml

Restricted indication 1. Malignant hypercalcaemia 2. Metastatic breast cancer – predominant lytic bone metastases 3. Myeloma with lytic bone metastases 4. Pain – for control of pain due to lytic bone metastases in addition to standard care (analgesics + radiotherapy) – subsidy available in hospice DOCETAXEL Inf 20 mg per 0.5 ml vial Taxotere Inj formulation 3, 20 mg Taxotere Inf 40 mg per ml vial Taxotere Inj formulation 3, 80 mg Taxotere Restricted indication 1. Initial chemotherapy in ovarian, fallopian or primary peritoneal cancer 2. Subsequent chemotherapy in ovarian, fallopian tube or primary peritoneal cancer in patients not previously treated with taxanes 3. Metastatic breast cancer – post-anthracycline relapse 4. Metastatic breast cancer -anthracyclines contraindicated 5. Lung cancer – non-small cell: advanced disease or part of combined chemo-radiotherapy 6. Lung cancer – small cell: as second line therapy

GEMCITABINE HYDROCHLORIDE Inj (s29) 200 mg vial Gemzar Inj (s29) 1 g vial Gemzar Restricted indication 1. Advanced lung cancer (NSCLC and mesothelioma) 2. Advanced pancreatic cancer 3. Ovarian, fallopian tube or primary peritoneal cancer – post taxane therapy 4. Ovarian, fallopian tube or primary peritoneal cancer – initial therapy when taxane contraindicated IDARUBICIN Cap 5 mg Cap 10 mg Cap 25 mg Inj 1 mg per ml, 5 ml vial Inj 1 mg per ml, 10 ml vial IFOSFAMIDE Inj 0.1 g Inj 0.2 g Zavedos Zavedos Zavedos Zavedos Zavedos Haloxan Haloxan

Chemical and presentation INTERFERON 2A Inj 18 ml multidose cartridge Restricted indication 1. Carcinoid tumour 2. Metastatic malignant melanoma 3. Metastatic renal cell cancer INTERFERON ALPHA N1 Inj 3 million iu per ml Inj 10 million iu per ml Restricted indication 1. Carcinoid tumour 2. Metastatic malignant melanoma 3. Metastatic renal cell cancer INTERFERON ALPHA-2A Inj 3 million iu Inj 3 million iu prefilled syringe Inj 6 million iu Inj 6 million iu prefilled syringe Inj 4.5 million iu Inj 4.5 million iu prefilled syringe Inj 9 million iu Inj 9 million iu prefilled syringe Restricted indication 1. Carcinoid tumour 2. Metastatic malignant melanoma 3. Metastatic renal cell cancer INTERFERON ALPHA-2B Inj 18 million iu per 1.2 ml multidose pen Inj 30 million iu per 1.2 ml multidose pen Inj 60 million iu per 1.2 ml multidose pen Restricted indication 1. Carcinoid tumour 2. Metastatic malignant melanoma 3. Metastatic renal cell cancer

Brand Roferon A

Chemical and presentation METHOTREXATE Tab 2.5 mg

Brand

Tab 10 mg Inj 2.5 mg per ml, 2 ml Wellferon Wellferon Inj 2.5 mg per ml, 8 ml Inj (s29) 10 mg per ml, 2 ml prefilled syringe Inj 10 mg per ml, 2 ml Inj 25 mg per ml, 2 ml

Baxter David Bull Ledertrexate Methoblastin Methoblastin David Bull Emthexate Ledertrexate Methoblastin Methoblastin Baxter David Bull David Bull David Bull Delta West Emthexate Ledertrexate Methoblastin Ledertrexate David Bull David Bull Delta West Emthexate Ledertrexate Ledertrexate Baxter Baxter Baxter David Bull Delta West Ledertrexate Emthexate David Bull Mitomycin-C Mitomycin-C Mitomycin-C Novantrone Novantrone

Roferon A Roferon A Roferon A Roferon A Roferon A Roferon A Roferon A Roferon A

Inj 25 mg per ml, 4 ml Inj 25 mg per ml, 20 ml

Intron A Intron A Intron A

Inj 25 mg per ml, 200 ml Inj 100 mg per ml, 0.7 ml Inj 100 mg per ml, 0.8 ml Inj 100 mg per ml, 0.9 ml Inj 100 mg per ml, 10 ml

IRINOTECAN HYDROCHLORIDE Inj 20 mg per ml, 2 ml Camptosar Inj 20 mg per ml, 5 ml Camptosar 1. Metastatic colorectal cancer – initial chemotherapy in combination 2. Metastatic colorectal cancer – post fluoropyrimidine relapse as single agent LENOGRASTIM Inj 13.4 million iu vial Inj 33.6 million iu vial LOMUSTINE Cap 10 mg Cap 40 mg MERCAPTOPURINE Tab 10 mg Tab 50 mg MESNA – see UROMITEXAN Granocyte 13 Granocyte 34 Ceenu Ceenu Purinethol Purinethol

Inj 100 mg per ml, 50 ml MITOMYCIN-C Inj 0.5 mg per ml, 5 ml Inj (s29) 2 mg Inj (s29) 10 mg MITOZANTRONE Inj 20 mg, 10 ml Inj 25 mg, 12.5 ml

MUSTINE – see ESTRAMUSTINE SODIUM PHOSPHATE PACLITAXEL Inj 6 mg per ml, 5 ml Taxol Inj 100 mg Taxol 1. Initial chemotherapy in ovarian, fallopian or primary peritoneal cancer 2. Subsequent chemotherapy in ovarian, fallopian tube or primary peritoneal cancer in patients not previously treated with taxanes 3. Metastatic breast cancer – post-anthracycline relapse 4. Metastatic breast cancer – anthracyclines contraindicated 5. Lung cancer – non-small cell: advanced disease or part of combined chemo-radiotherapy 6. Lung cancer – small cell: as second line therapy

Chemical and presentation PENTOSTATIN - see DEOXYCOFORMYCIN

Brand

Chemical and presentation UROMITEXAN Tab 400 mg Tab 600 mg Inj 400 mg, 10 ml Inj 1 g, 10 ml VINBLASTINE SULPHATE Inj 1 mg per ml, 10 ml

Brand Uromitexan Uromitexan Uromitexan Mesna Uromitexan Velbe David Bull David Bull David Bull David Bull Delta West David Bull Delta West David Bull Delta West David Bull David Bull David Bull Oncovin Eldisine

OXALIPLATIN Inj (s29) 50 mg Eloxatin Inj (s29) 100 mg Eloxatin 1. Metastatic colo-rectal cancer – post fluoropyrimidine and irinotecan failure 2. Metastatic colo-rectal cancer – post fluoropyrimidine failure and unsuitable for irinotecan PAMIDRONATE see DISODIUM PAMIDRONATE PROCARBAZINE HYDROCHLORIDE Cap (s29) 50 mg Natulan

RITUXIMAB Inj 100 mg, 10 ml Mabthera Inj 500 mg, 50 ml Mabthera 1. Transplant related NHL – initial therapy 2. Low grade NHL – post anthracycline failure 3. Low grade NHL – post standard chemotherapy failure and unsuitable for anthracycline treatment TENIPOSIDE Inj 50 mg per 5 ml amp THIOGUANINE Tab 40 mg THIOTEPA Eye Drops, 15 mg Inj 15 mg vial Vumon Lanvis Thio-tepa S Thio-tepa

VINCRISTINE SULPHATE Inj 1 mg per ml, 1 ml prefilled syringe Inj 1 mg per ml, 1 ml Inj 1 mg per ml, 2 ml prefilled syringe Inj 1 mg per ml, 2 ml Inj 1 mg per ml, 5 ml Inj 1 mg per ml, 2 ml Inj 1 mg per ml, 1 ml Inj 2 mg VINDESINE SULPHATE Inj (s29) 5 mg vial

TRASTUZUMAB Inj 150 mg Herceptin Inj 440 mg multi-dose vial Herceptin 1. Metastatic breast cancer – patients with tumour expressing HER2 ≥ 2+

VINORELBINE Inj 10 mg per ml Navelbine Inj, 50 mg per 5 ml Navelbine 1. Metastatic breast cancer – post anthracycline/taxane therapy 2. Metastatic breast cancer: – unsuitable for anthracycline/ taxane therapy 3. Advanced lung (NSCLC) cancer

INDEX

A Actinomycin D ....................................................... 18 Adriamycin ............................................................ 19 Adrucil .................................................................. 18 Amsacrine ............................................................. 18 Amsidyl ................................................................. 18 Anexate ................................................................. 15 Aredia ................................................................... 19 Asparaginase ........................................................ 18 Azamun ................................................................. 18 Azathioprine .......................................................... 18 B Basiliximab ............................................................ 15 BICNU ................................................................... 18 Blenoxane .............................................................. 18 Bleomycin sulphate ............................................... 18 C Camptosar ............................................................ 20 Capecitabine ................................................... 15, 18 Carboplatin ............................................................ 18 Carbosin ............................................................... 18 Carmustine ............................................................ 18 Ceenu .................................................................... 20 Ceftriaxone ............................................................ 15 CellCept ................................................................. 16 Cerubidine ............................................................. 19 Cisplatinum ........................................................... 18 Cladribine .............................................................. 18 Clozapine .............................................................. 15 Clozaril .................................................................. 15 Colaspase ............................................................. 18 Cosmegen ............................................................. 18 Crisantaspase ........................................................ 19 Cycloblastin .......................................................... 18 Cyclophosphamide ................................................ 18 Cyclosporin ........................................................... 15 Cymevene ............................................................. 15 Cytarabine ............................................................. 19 Cytosar-U .............................................................. 19 Cytoxan ................................................................. 18 D Dacarbazine .......................................................... 19 Daclizumab ........................................................... 15 Dactinomycin ........................................................ 19 Daunorubicin ......................................................... 19 Daunorubicin citrate liposome ................................ 19 Daunoxome ........................................................... 19 Deoxycoformycin .................................................. 19 Desflurane ............................................................. 17 Disodium pamidronate ........................................... 19 Docetaxel .............................................................. 19 Doxorubicin ........................................................... 19 22 Doxorubicin HCl .................................................... 19 Doxorubin ............................................................. 19 Drotrecogin alfa ..................................................... 17 DTIC ..................................................................... 19 E Efudix .................................................................... 18 Eldisine ................................................................. 21 Eloxatin ................................................................. 21 Emthexate ............................................................. 20 Endoxan ................................................................ 18 Epirubicin .............................................................. 19 Erwinase ............................................................... 19 Erythropoietin beta ................................................. 15 Estracyt ................................................................. 19 Estramustine sodium phosphate ............................ 19 Etopophos ............................................................. 19 Etoposide .............................................................. 19 Etoposide phosphate ............................................. 19 F Filgrastim .............................................................. 15 Filgrastrim with sorbitol .......................................... 19 Fludara IV .............................................................. 19 Fludara oral ........................................................... 19 Fludarabine phosphate ........................................... 19 Flumazenil ............................................................. 15 Fluorouracil ........................................................... 18 Folinic acid ............................................................ 19 G Gancyclovir ........................................................... 15 Gemcitabine hydrochloride .................................... 19 Gemzar ................................................................. 19 Glivec .................................................................... 15 Granocyte 13 ......................................................... 20 Granocyte 34 ......................................................... 20 H Haloxan ................................................................. 19 Herceptin ........................................................ 16, 21 Hypnovel ............................................................... 16 I Idarubicin .............................................................. 19 Ifosfamide ............................................................. 19 Imatinib mesylate .................................................. 15 Imuran .................................................................. 18 Infliximab ............................................................... 17 Interferon 2A ......................................................... 20 Interferon Alpha N1 ................................................ 20 Interferon Alpha-2A ............................................... 20 Interferon Alpha-2B ............................................... 20 Intron A ................................................................. 20 Irinotecan hydrochloride ......................................... 20

L Lanvis ................................................................... 21 Ledertrexate .......................................................... 20 Lenograstim .......................................................... 20 Leunase ................................................................ 18 Leustatin ............................................................... 18 Linezolid ................................................................ 17 Lomustine ............................................................. 20 M Mabthera ........................................................ 16, 21 Mercaptopurine ..................................................... 20 Mesna ............................................................ 20, 21 Methoblastin .......................................................... 20 Methotrexate .......................................................... 20 Midazolam ............................................................ 16 Mitomycin-C .......................................................... 20 Mitozantrone .......................................................... 20 Mustine ................................................................. 20 Mycophenolate mofetil ........................................... 16 N Natulan .................................................................. 21 Navelbine .............................................................. 21 Navoban ................................................................ 16 Neoral ................................................................... 15 Neupogen ....................................................... 15, 19 Nipent ................................................................... 19 Novantrone ............................................................ 20 O Octreotide .............................................................. 16 Oncovin ................................................................. 21 Oxaliplatin .............................................................. 21 Oxytocin ................................................................ 16 Oxytocin with ergotamine maleate .......................... 16 P Paclitaxel ............................................................... 20 Pamidronate .......................................................... 21 Paraplatin .............................................................. 18 Pentostatin ............................................................ 21 Pharmorubicin ....................................................... 19 Platamine .............................................................. 18 Platinol .................................................................. 18 Platosin ................................................................. 18 Procarbazine hydrochloride .................................... 21 Purinethol .............................................................. 20

R Rapilysin ............................................................... 16 Recormon ............................................................. 15 Remicade .............................................................. 17 Reteplase .............................................................. 16 Rituximab ....................................................... 16, 21 Rocephin ............................................................... 15 Roferon A .............................................................. 20 S Sandostatin ........................................................... 16 Sandostatin LAR .................................................... 16 Simulect ................................................................ 15 Suprane ................................................................. 17 Syntocinon ............................................................ 16 Syntometrine ......................................................... 16 T Taxol ..................................................................... 20 Taxotere ................................................................ 19 Teniposide ............................................................. 21 Thio-tepa ............................................................... 21 Thio-tepa S ............................................................ 21 Thioguanine ........................................................... 21 Thioprine ............................................................... 18 Thiotepa ................................................................ 21 Trastuzumab ................................................... 16, 21 Tropisetron ............................................................ 16 U Uromitexan ............................................................ 21 V Velbe ..................................................................... 21 Vepesid ................................................................. 19 Vinblastine sulphate ............................................... 21 Vincristine sulphate ................................................ 21 Vindesine sulphate ................................................. 21 Vinorelbine ............................................................ 21 Vumon .................................................................. 21 W Wellferon ............................................................... 20 X Xeloda ............................................................ 15, 18 Xigris ..................................................................... 17 Z Zavedos ................................................................ 19 Zenapax ................................................................ 15 Zoledronic acid ............................................... 16, 17 Zometa ........................................................... 16, 17 Zyvox .................................................................... 17

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Title

Pharmaceutical Schedule - effective 1 December 2002

Abstract

Page 1

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