23 June 2009 Proposal for sole supply arrangement for sumatriptan Proposal summary PHARMAC and Arrow Pharmaceuticals (NZ) Ltd have reached a provisional agreement for the supply of Arrow-Sumatriptan, one of the three brands of sumatriptan tablets currently funded by PHARMAC. This proposal would result in Arrow-Sumatriptan becoming the only subsidised brand of sumatriptan tablets and injection from the start of a sole supply period (to be determined at a later date, but would be between 1 April 2010 and 1 September 2010) through to 30 June 2013. In addition, the “Specialist” restriction that currently applies to sumatriptan injection would be removed when Arrow-Sumatriptan injection was listed. The maximum of 10 injections per prescription would remain. During a three month transition period prior to sole supply starting, the subsidy for all other brands of sumatriptan would be reference priced to Arrow-Sumatriptan. If GlaxoSmithKline (New Zealand) Limited and Mylan New Zealand Limited did not reduce the selling price of their brands of sumatriptan (Imigran and Sumagran, respectively), patients may need to pay a manufacturer’s surcharge if they wished to continue on these brands during the transition period. After sole supply has started, patients who wished to continue on any brand of sumatriptan other than Arrow-Sumatriptan would need to meet the cost of that brand themselves. Further details of the proposal can be found on the following pages. Feedback sought We welcome your feedback on this proposal. To provide feedback please submit an email, fax or letter by 4 pm, Wednesday 8 July 2009 to: Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington 6143 Email: geraldine.macgibbon@pharmac.govt.nz Fax: (04) 460 4995 All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal. A288009 - T09-335 Page 1 of 3 The details of the proposal There are currently three brands of sumatriptan tablets listed in the Pharmaceutical Schedule: Imigran, Sumagran and Arrow-Sumatriptan. In March 2009 we initiated a competitive process for the supply of sumatriptan tablets. Proposals could also include sumatriptan injection. Following completion of that process we have entered into a provisional agreement with Arrow Pharmaceuticals in relation to Arrow-Sumatriptan, various details of which are outlined below. Community sumatriptan listings and sole supply arrangement Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs, and Arrow-Sumatriptan injection, would be listed in Section B of the Pharmaceutical Schedule as soon as possible following Medsafe approval, but not before 1 September 2009, at the following prices and subsidies (ex-manufacturer, excluding GST): Price and subsidy $38.83 $77.66 $36.00 Chemical Sumatriptan Sumatriptan Sumatriptan Brand Arrow-Sumatriptan Arrow-Sumatriptan Arrow-Sumatriptan Formulation Tab 50 mg Tab 100 mg Inj 12 mg per ml, 0.5 ml Pack size 100 100 2 A sole supply period would commence no less than three months after the listing of ArrowSumatriptan tab 50 mg and tab 100 mg in 100-tablet packs and Arrow-Sumatriptan injection. Three months prior to the sole supply period the subsidy for all currently listed brands and pack sizes of sumatriptan would be reduced via the application of reference pricing to the listings in the table above as follows (prices and subsidies are ex-manufacturer, excluding GST): Current price and subsidy $12.00 $12.00 $22.00 $12.00 $12.00 $22.00 $80.00 Chemical Sumatriptan Sumatriptan Sumatriptan Sumatriptan Sumatriptan Sumatriptan Sumatriptan Brand Arrow-Sumatriptan Sumagran Imigran Arrow-Sumatriptan Sumagran Imigran Imigran Formulation Tab 50 mg Tab 50 mg Tab 50 mg Tab 100 mg Tab 100 mg Tab 100 mg Inj 12 per ml, 0.5 ml Pack size 4 4 4 2 2 2 2 OP Proposed subsidy $1.55 $1.55 $1.55 $1.55 $1.55 $1.55 $36.00 From the start of the sole supply period, all brands and pack sizes of sumatriptan except for Arrow-Sumatriptan tablets in the 100-tablet pack size and Arrow-Sumatriptan injection would be delisted from the Pharmaceutical Schedule, and these would be the only subsidised brands and formulations of sumatriptan until 30 June 2013. A288009 - T09-335 Page 2 of 3 Hospital sumatriptan listings and sole supply arrangement The new pack sizes and formulation of Arrow-Sumatriptan would also be listed in Part II of Section H of the Pharmaceutical Schedule, subject to Medsafe registration, as in the following table (prices are ex-manufacturer, excluding GST): Chemical Sumatriptan Sumatriptan Sumatriptan Brand Arrow-Sumatriptan Arrow-Sumatriptan Arrow-Sumatriptan Formulation 50 mg tablets 100 mg tablets Inj 12 mg per ml, 0.5 ml Pack size 100 100 2 Price $38.83 $77.66 $36.00 Arrow-Sumatriptan would have Hospital Supply Status starting no earlier than February 2010 and ending on 30 June 2013, and would have a Discretionary Variance (DV) limit of 1%. Arrow-Sumatriptan injection autoinjector An autoinjector (the Autoject Mini manufactured by Owen Mumford) specific to ArrowSumatriptan injection would be supplied free of charge to prescribers for provision to their patients. Instructions on how to use the autoinjector would be distributed to prescribers and pharmacists. More information about the autoinjector can be found on Owen Mumford’s website: http://www.owenmumford.com/om_drugdelivery/Autoject%20mini.html A288009 - T09-335 Page 3 of 3