This is the text extract for Approval of a proposal regarding Sigma’s brands of furosemide tablets, ethambutol tablets and atropine eye drops , browse documents here.

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13 November 2009

Approval of a proposal regarding Sigma’s brands of furosemide tablets (Urex Forte), ethambutol tablets (Myambutol) and atropine eye drops (Atropt)

PHARMAC is pleased to announce the listing of ethambutol 100 mg and furosemide 500 mg tablets in the Pharmaceutical Schedule. This was the subject of a consultation letter dated 13 October 2009. In summary, the effect of the decision is that: § a new strength of ethambutol 100 mg (Myambutol) will be listed in Section B and in Section H of the Pharmaceutical Schedule from 1 December 2009 (it will be supplied under Section 29 of the Medicines Act 1981 until it is registered); furosemide 500 mg (Urex Forte) will be listed in Section B and in Section H of the Pharmaceutical Schedule from 1 December 2009 (it will be supplied under Section 29 of the Medicines Act 1981 until it is registered); the price and subsidy for Urex Forte and Myambutol (ethambutol 100 mg and 400 mg) will decrease upon registration by Medsafe; the price and subsidy for Atropt (atropine) 1% eye drops will increase from 1 December 2009; and Urex Forte, Atropt and Myambutol will have subsidy and delisting protection until 1 December 2012.

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Details of the proposal Sigma Pharmaceuticals (Australia) Pty Ltd’s Urex Forte, Myambutol and Atropt will be listed in Sections B and H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer and exclusive of GST) from 1 December 2009:

Chemical Presentation Brand Pack Size Current price and subsidy $4.40 N/A N/A Price and subsidy from 1 December $17.36 $57.81 $50.00

Atropine Ethambutol Furosemide

1% eye drop 100 mg tablet 500 mg tablet

Atropt Myambutol Urex Forte

15 ml 56 tablets 50 tablets

Upon gaining registration the prices and subsidies (ex-manufacturer and exclusive of GST) for Urex Forte and Myambutol (including the already listed 400 mg tablet) will reduce as shown in the table on the following page:

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Chemical

Presentation

Brand

Pack Size

Price and subsidy from 1 December $57.81 $56.84 $50.00

Ethambutol Ethambutol Furosemide

100 mg tablet 400 mg tablet 500 mg tablet

Myambutol Myambutol Urex Forte

56 tablets 56 tablets 50 tablets

Price and subsidy upon registration $48.01 $49.34 $25.00

Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by Wednesday 28 October 2009 were considered in making a decision on the proposed changes. Most responses were supportive of the proposal. The following issues were raised in relation to specific aspects of the proposal:

Theme Why does PHARMAC use the generic name furosemide rather than furosemide which is the commonly used generic name in New Zealand. Comment PHARMAC staff note that International Nonproprietary Names (INN) are the global naming standard and have been adopted by New Zealand, and that furosemide is the INN name. Clinicians would still be able to prescribe half a 400 mg tablet when appropriate. We note that this situation (i.e. the doctors’ responsibilities in prescribing unregistered medications) would occur whether or not these medications were funded. In funding an unregistered version of a pharmaceutical PHARMAC considers, among other factors, the clinical need, availability of alternative treatments and the likelihood that a product will get registered in a timely manner. PHARMAC is working with the supplier and Medsafe to facilitate registration of Myambutol and Urex Forte.

Will clinicians still be able to prescribe half a 400 mg tablet. In relation to the listings under Section 29 of the Medicines Act, doctors were concerned about the responsibility placed on them in prescribing unregistered medications.

More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

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