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20 December 2010

Notification - various pharmaceuticals supplied by Mylan

PHARMAC is pleased to announce the approval of the agreement with Mylan New Zealand Limited (Mylan) relating to the listing of various pharmaceuticals in the Pharmaceutical Schedule. This proposal was the subject of a consultation letter dated 4 October 2010 that can be found on PHARMAC’s website at http://www.pharmac.govt.nz/2010/10/04?q=various. All aspects of the proposal as consulted upon were approved. A summary of the decision is provided below; please refer to the consultation letter for full details.   Mylan’s brands of metoprolol succinate (Myloc CR) and lansoprazole (Lanzol Relief) will be listed on the Pharmaceutical Schedule from 1 March 2011. Mylan’s brands of candesartan (Candestar) and mycophenolate mofetil (Ceptolate) will be listed on the Pharmaceutical Schedule following all the necessary regulatory consents being obtained and subject to the current Special Authorities. Subsidy and delisting protection will be provided to the above brands until:

Chemical Metoprolol succinate Lansoprazole Candesartan Mycophenolate mofetil Brand Myloc CR Lanzol Relief Candestar Ceptolate Protection expires on: 31 January 2012 31 October 2012 30 June 2012 1 July 2012

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The terms of listing for verapamil hydrochloride (Verapamil SR), celiprolol (Celol), labetalol (Hybloc), nifedipine (Adefin XL), isosorbide mononitrate (Duride), and propranolol (Cardinol LA) will be amended including the provision of subsidy and delisting protection until 30 June 2014 with an option for PHARMAC to extend the listing terms until 30 June 2017. Reference pricing of nifedipine (Arrow-Nifedipine XR to Adefin XL). This will result in the subsidy for Arrow-Nifedipine XR being reduced to the level of the subsidy for Adefin XL from 1 July 2011. A patient surcharge will occur if the supplier of ArrowNifedipine XR does not reduce its price to the new subsidy level for Adefin XL as follows (prices and subsidies are ex-manufacturer, excluding GST):

Brand Form Pack size 30 30 30 30 Current price/ subsidy $8.56 $12.28 $10.70 $15.35 Subsidy from 1 July 2011 No change No change $8.56 $12.28 Potential patient surcharge from 1 July 2011 Fully funded Fully funded $3.98* $5.71*

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Adefin XL Adefin XL Arrow-Nifedipine XR Arrow-Nifedipine XR

Tab 30 mg Tab 60 mg Tab 30 mg Tab 60 mg

* The patient surcharge is based on an assumed 86% pharmacy mark-up, and no change in price.

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Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by Tuesday 19 October 2010 were considered in their entirety in making a decision on the proposed changes. The following issues were raised in relation to the proposal:

Theme It was questioned as to whether the Special Authority access criteria for Mycophenolate are appropriate. Specifically that mycophenolate should also be funded for:  Induction of remission of Lupus Nephritis (and other autoimmune disease) where Cyclophosphamide is contraindicated. Maintenance of remission where azathioprine has failed or has had intolerable side effects. Pharmaceuticals can be provided with market exclusivity by virtue of intellectual property rights. In such cases only a single supplier exists. Once the exclusivity time expires the products are open to usual market competition. In the context of PHARMAC funding this would often result in either: 1. Multiple brands being funded, with product selection being made by the clinician and pharmacist, in line with current regulations regarding substitution. 2. PHARMAC seeking to introduce price competition through a reduction in the number of funded brands. The introduction of competition for pharmaceutical technologies is important. It enables pharmaceutical access to be increased to a greater extent than budget increases alone would allow, as it result in price reductions. Indefinite monopoly status for the original product would not be a practical or desirable approach. Comment The proposal did not include any changes to the Mycophenolate Special Authority criteria. We will however review the proposed criteria to determine if any changes are appropriate.

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Concerns were raised regarding the listing of generic medicines specifically:  Multiple brands of medication should not be listed on the basis that switching patients is time consuming and errors can occur. It may result in sole supply.

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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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