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21 August 2009

Approval of sole supply arrangement for sumatriptan

PHARMAC is pleased to announce the approval of an agreement with Arrow Pharmaceuticals (NZ) Ltd for the supply of Arrow-Sumatriptan. This was the subject of a consultation letter dated 23 June 2009. The decision means that Arrow-Sumatriptan will become 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 expected to be between 1 April 2010 and 1 September 2010) through to 30 June 2013. This is subject to Medsafe approval of Arrow’s sumatriptan injection and of Arrow’s sumatriptan tablets in a 100-tablet pack size. The sole supply period will be preceded by a three month transition period during which the subsidies for all other pack sizes and brands of sumatriptan tablets and injection will be reduced to the level of the Arrow-Sumatriptan sole supply products via the application of reference pricing. In addition, the “Specialist” restriction that currently applies to sumatriptan injection will be removed on the date that reference pricing of the injection occurs. The maximum of 10 injections per prescription will remain. Once registration has been granted we will send another notification letter with the exact dates for the new listing of Arrow’s sumatriptan injection and 100-tablet packs, reference pricing, and the start of sole supply.

Details of the decision Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs, and Arrow-Sumatriptan injection, will be listed in Section B and in Part II of Section H 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): Pack size 100 100 2 Price and subsidy $38.83 $77.66 $36.00

Chemical Sumatriptan Sumatriptan Sumatriptan

Brand ArrowSumatriptan ArrowSumatriptan ArrowSumatriptan

Formulation Tab 50 mg Tab 100 mg Inj 12 mg per ml, 0.5 ml

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A sole supply period for Arrow-Sumatriptan will commence no less than three months after listing of the above products. Three months prior to the sole supply period the subsidy for all currently listed brands and pack sizes of sumatriptan listed in Section B of the Pharmaceutical Schedule will be reduced via the application of reference pricing to the listings in the previous table 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 ArrowSumatriptan Sumagran Imigran ArrowSumatriptan 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

New subsidy $1.55 $1.55 $1.55 $1.55 $1.55 $1.55 $36.00

Please note that it is possible, depending on timing of listing the new Arrow-Sumatriptan tablet pack sizes and the injection, that reference pricing could occur from the date of listing the new Arrow products/pack sizes. If this is the case, we will provide the market with at least two months’ notice of reference pricing occurring. Reference pricing will not occur prior to 1 January 2010. From the start of the sole supply period, all brands of sumatriptan except for the new ArrowSumatriptan products will be delisted from Section B of the Pharmaceutical Schedule, and the Arrow products will be the only subsidised brands and formulations of sumatriptan until 30 June 2013. Arrow-Sumatriptan will have Hospital Supply Status starting no earlier than February 2010 and ending on 30 June 2013, and will have a Discretionary Variance (DV) limit of 1%. An autoinjector (the Autoject Mini manufactured by Owen Mumford) specific to ArrowSumatriptan injection will be supplied free of charge to prescribers to give to their patients. Instructions on how to use the autoinjector will 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

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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