This is the text extract for Proposal to amend restrictions on nervous system pharmaceuticals, browse documents here.

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30 January 2008

PHARMAC Consultation

Proposal to amend restrictions on nervous system pharmaceuticals

PHARMAC is seeking public feedback on a proposal to alter restrictions on 13 medicines. We’re also proposing some minor changes to headings in Section B of the Pharmaceutical Schedule. This letter outlines the proposal and how you can provide your feedback on it. Proposal Summary PHARMAC is proposing to amend the restrictions that currently apply to a group of Nervous System pharmaceuticals in Section B of the Pharmaceutical Schedule, as detailed on the following pages, with effect from 1 April 2008. The medicines in the proposal include anaesthetics, antinausea agents, antiparkinson agents, anxiolytics, antipsychotics, antidepressants, and a treatment for alcohol dependence. In most cases the changes involve removal of the “Specialist” restriction, meaning that prescriptions written by other types of practitioners would not require a specialist endorsement for subsidy. Other proposed changes include allowing greater access to lignocaine with prilocaine for children with chronic medical conditions requiring frequent injections, allowing patients to collect their monthly subsidised amount of ondansetron in one go, and updating the naltrexone Special Authority criteria. PHARMAC is also proposing some minor amendments to Pharmaceutical Schedule Section B headings with effect from 1 April 2008. Feedback sought We welcome your feedback on this proposal. To provide feedback on this proposal please submit it in writing by 4 pm, Friday 15 February 2008 to: Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington 6143 Email: geraldine.macgibbon@pharmac.govt.nz Fax: (04) 460 4995

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Details of the proposal Proposed amendments to the Pharmaceutical Schedule are (deletions shown in strikethrough, additions in bold): Anaesthetics

LIGNOCAINE WITH PRILOCAINE – Special Authority see SA0323 below – Hospital pharmacy [HP3] Crm 2.5% with prilocaine 2.5% (30g OP and 5 g tubes) SA0323 Special Authority for Subsidy Initial application from any relevant practitioner only from a relevant specialist. Approvals valid for 2 years where the patient is a child with a chronic medical condition requiring frequent injections or venepuncture receiving frequent parenteral injections (i.e. intradermal, subcutaneous, intravenous or intramuscular) requiring a 21 gauge or larger bore needle. Renewal from any relevant practitioner only from a relevant specialist. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.

Antidepressants

CLOMIPRAMINE HYDROCHLORIDE – Retail pharmacy-Specialist Tab 10 mg Tab 25 mg MAPROTILINE HYDROCHLORIDE – Retail pharmacy-Specialist Tab 25 mg Tab 75 mg MOCLOBEMIDE – Retail pharmacy-Specialist Tab 150 mg Tab 300 mg

Antiparkinson agents

LEVODOPA WITH BENSERAZIDE Cap long-acting 100 mg with benserazide 25 mg – Retail pharmacy-Specialist

Anxiolytics

ALPRAZOLAM – Retail pharmacy-Specialist Month restriction Tab 250 mg Tab 500 mg Tab 1 mg

Antipsychotics (depot injections)

FLUPENTHIXOL DECANOATE – Retail pharmacy-Specialist Inj 20 mg per ml, 1 ml Inj 20 mg per ml, 2 ml Inj 100 mg per ml, 1 ml FLUPHENAZINE DECANOATE – Retail pharmacy-Specialist Inj 12.5 mg per 0.5 ml, 0.5 ml Inj 25 mg per ml, 1 ml Inj 100 mg per ml, 1 ml HALOPERIDOL DECANOATE – Retail pharmacy-Specialist Inj 50 mg per ml, 1 ml Inj 100 mg per ml, 1 ml

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PIPOTHIAZINE PALMITATE – Retail pharmacy-Specialist Inj 50 mg per ml, 1 ml Inj 50 mg per ml, 2 ml ZUCLOPENTHIXOL DECANOATE – Retail pharmacy-Specialist Inj 200 mg per ml, 1 ml

Antinausea agents

ONDANSETRON – Retail pharmacy-Specialist (a) Maximum of 12 tab per prescription; can be waived by Special Authority (b) Maximum of 6 tab per dispensing; can be waived by Special Authority (b) (c) Not more than one prescription per month; can be waived by Special Authority Tab 4 mg Tab disp 4 mg Tab 8 mg Tab disp 8 mg

The proposed change for ondansetron would mean that patients who are prescribed 12 tablets in one month would not need to return to the pharmacy to complete their prescription. Please note that the overall subsidised limit (12 tablets per month for ondansetron, not more than one prescription per month) would not change, and this limit would still be able to be waived by Special Authority for patients undergoing prolonged treatment with highly emetogenic chemotherapy and/or highly emetogenic radiation therapy for the treatment of malignancy. Treatments for alcohol dependence (“other CNS agents”)

NALTREXONE HYDROCHLORIDE – Special Authority see SA0714 below – Retail pharmacy Tab 50 mg SA0714 Special Authority for Subsidy Initial application from any medical practitioner. Approvals valid for 3 months for applications meeting the following criteria: All of the following: 1 Patient is currently enrolled in a recognised comprehensive treatment programme for alcohol dependence in a service accredited against the New Zealand Alcohol and Other Drug Sector Standard or the National Mental Health Sector Standard; and 2 Applicant works in an Alcohol & Drug Service a community Alcohol and Drug Service contracted to one of the 21 District Health Boards or accredited against the New Zealand Alcohol and Other Drug Sector Standard or the National Mental Health Sector Standard; and 3 Applicant must include the address of the service. Renewal from any medical practitioner. Approvals valid for 3 months for applications meeting the following criteria: Both: 1 Compliance with the medication (prescriber determined); and 2 Any of the following: 2.1 Patient is still unstable and requires further treatment; or 2.2 Patient achieved significant improvement but requires further treatment; or 2.3 Patient is well controlled but requires maintenance therapy. The patient must have had no more than 1 prior approval in the last 12 months.

Proposed Schedule section heading changes (page numbers refer to the relevant page of Section B of the December 2007 Pharmaceutical Schedule) · The subheading “Antipyretics and Non-Opioid Analgesics” (page 104) would be replaced with “Non-Opioid Analgesics” 3

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The subheading “Antipyretics with Codeine” (page 105) would be removed The listing of paracetamol with codeine would be moved to beneath the subheading “Opioid Analgesics” (page 105) The entire Multiple Sclerosis Treatments section (pages 140–141), including the listings of glatiramer acetate, interferon beta-1-alpha and interferon beta-1-beta, would be moved to within the Nervous System therapeutic grouping (pages 104– 124).

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