This is the text extract for Notification of Arrow-Sumatriptan reference pricing and sole supply arrangements, browse documents here.

---

26 November 2009

Sumatriptan – reference pricing and sole supply arrangements

On 21 August 2009 we announced the approval of an agreement with Arrow Pharmaceuticals (NZ) Ltd for the supply of Arrow-Sumatriptan (sumatriptan tablets and injection), which included a period of reference pricing followed by sole supply. In that notification letter we advised that we would provide the market with at least two months’ notice of reference pricing occurring if reference pricing was to occur immediately from the date of listing the new Arrow-Sumatriptan pack sizes and/or injection. In summary, this letter is to advise that: · Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs will be listed in the Pharmaceutical Schedule from 1 February 2010; The price and subsidy for Arrow-Sumatriptan tab 50 mg and tab 100 mg in 4-tablet and 2-tablets packs, respectively, will be pro-rated to the price of Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs from 1 February 2010; The subsidy for all other currently listed brands and pack sizes of sumatriptan tablets will be pro-rated to price of Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs, via the application of reference pricing, from 1 February 2010. If GlaxoSmithKline (New Zealand) Limited and Mylan New Zealand Limited do not reduce the selling price of their brands of sumatriptan tablets (Imigran and Sumagran, respectively), patients may need to pay a manufacturer’s surcharge if they wished to continue on these brands until sole supply commences; Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs will become the only subsidised brand of sumatriptan tablets in the community from 1 May 2010 until 30 June 2013; Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs will have Hospital Supply Status starting on 1 April 2010 and ending on 30 June 2013; and The listing of Arrow-Sumatriptan injection 12 mg per ml, 0.5 ml has been delayed and is likely to occur between September 2010 and November 2010, depending on the timing of Medsafe registration.

·

·

·

·

·

Further details can be found on the following pages. If you have any questions about this notification, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

A321536

Page 1 of 3

---

Further details Arrow-Sumatriptan tablets Arrow-Sumatriptan tab 50 mg and tab 100 mg will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 February 2010 at the following prices and subsidies (ex-manufacturer, excluding GST):

Current price and subsidy N/A N/A $12.00 $12.00 New price and subsidy $38.83 $77.66 $1.55 $1.55

Chemical Sumatriptan Sumatriptan Sumatriptan Sumatriptan

Brand Arrow-Sumatriptan Arrow-Sumatriptan Arrow-Sumatriptan Arrow-Sumatriptan

Formulation Tab 50 mg Tab 100 mg Tab 50 mg Tab 100 mg

Pack size 100 100 4 2

From 1 February 2010 the subsidy for all other currently listed brands and pack sizes of sumatriptan tablets listed in Section B of the Pharmaceutical Schedule will be reduced, via the application of reference pricing, to the applicable prices and subsidies in the previous table as follows (ex-manufacturer, excluding GST):

Current price and subsidy $12.00 $22.00 $12.00 $22.00

Chemical Sumatriptan Sumatriptan Sumatriptan Sumatriptan

Brand Sumagran Imigran Sumagran Imigran

Formulation Tab 50 mg Tab 50 mg Tab 100 mg Tab 100 mg

Pack size 4 4 2 2

New subsidy $1.55 $1.55 $1.55 $1.55

From 1 May 2010, all brands and pack sizes of sumatriptan tablets except for ArrowSumatriptan tab 50 mg and tab 100 mg in 100-tablet packs will be delisted from Section B of the Pharmaceutical Schedule, and Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100tablet packs will be the only subsidised brand of sumatriptan tablets until 30 June 2013. Arrow-Sumatriptan tab 50 mg and tab 100 mg in 100-tablet packs will have Hospital Supply Status starting on 1 April 2010 and ending on 30 June 2013, and will have a Discretionary Variance (DV) limit of 1%. Arrow-Sumatriptan injection Arrow-Sumatriptan injection 12 mg per ml, 0.5 ml will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule as soon as possible following Medsafe approval (we understand this is anticipated to be between September 2010 and November 2010) at a price and subsidy of $36.00 per 2 injections (ex-manufacturer, excluding GST). A sole supply period for Arrow-Sumatriptan injection will commence no less than three months after listing Arrow-Sumatriptan injection. Three months prior to the sole supply

A321536

Page 2 of 3

---

period the subsidy for the Imigran brand of sumatriptan injections will be reduced via the application of reference pricing to $36.00 per 2 injections (ex-manufacturer, excluding GST). Please note that it is possible that reference pricing could occur from the date of listing Arrow-Sumatriptan injection. If this is the case, we will provide the market with at least two months’ notice of reference pricing occurring. From the start of the sole supply period, Imigran injection will be delisted from Section B of the Pharmaceutical Schedule, and Arrow-Sumatriptan injection will be the only subsidised brands of sumatriptan injection until 30 June 2013. Arrow-Sumatriptan injection will have Hospital Supply Status starting two months after the date of listing and ending on 30 June 2013, and will have a Discretionary Variance (DV) limit of 1%. The “Specialist” restriction that currently applies to sumatriptan injection will be removed on the date that reference pricing of sumatriptan injections occurs. The maximum of 10 injections per prescription will remain. 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 Once registration of Arrow-Sumatriptan injection has been granted we will issue further notification setting out the dates for the listing of Arrow-Sumatriptan injection, commencement of reference pricing, and the start of sole supply.

A321536

Page 3 of 3