This is the text extract for Proposal to list NovoMix 30, NovoSeven RT and amend listing for Glucagen Hypokit; Closing Date: Closed; Contact: Natalie Davis, browse documents here.

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2 May 2012

Proposal to list NovoMix 30 and NovoSeven RT and to amend listing for Glucagen Hypokit

PHARMAC is seeking feedback on a proposal to fund NovoMix 30 FlexPen and NovoSeven RT and to amend the listing for Glucagen Hypokit from 1 July 2012 through a provisional agreement with the supplier, NovoNordisk Pharmaceuticals Limited. In summary, this proposal would result in:  NovoMix 30 FlexPen being fully funded in the community and in DHB hospitals from 1 July 2012. NovoSeven RT being listed in Section H of the Pharmaceutical Schedule and being available for purchase by DHB hospitals from 1 July 2012. Glucagen Hypokit being fully funded in the community and in DHB hospitals at a price of $32.00 (ex-manufacturer, excluding GST).

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Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm, Wednesday 16th May 2012 to: Natalie Davis Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: natalie.davis@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.

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Details of the proposal The following products would be listed in Section B of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST) from 1 July 2012:

Chemical Insulin aspart Glucagon hydrochloride Presentation Inj 100 iu per ml, 3 ml prefilled pen Inj 1 mg syringe kit Brand NovoMix 30 FlexPen Glucagen Hypokit Pack size 5 1 Price and subsidy $52.15 $32.00

The following products would be listed in Part II of Section H of the Pharmaceutical Schedule at the following prices (ex-manufacturer, excluding GST) from 1 July 2012:

Chemical Insulin aspart Glucagon hydrochloride Recombinant coagulation Factor VIIa Recombinant coagulation Factor VIIa Recombinant coagulation Factor VIIa Recombinant coagulation Factor VIIa Presentation Inj 100 iu per ml, 3 ml prefilled pen Inj 1mg syringe kit Combination pack (Powder and diluent for Injection), 1 mg Combination pack (Powder and diluent for Injection), 2 mg Combination pack (Powder and diluent for Injection), 5 mg Combination pack (Powder and diluent for Injection), 8 mg Brand NovoMix 30 FlexPen Glucagen Hypokit Pack size 5 1 Price and subsidy $52.15 $32.00

NovoSeven RT

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$1,163.75

NovoSeven RT

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$2,327.50

NovoSeven RT

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$5,818.75

NovoSeven RT

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$9,310.00

Note:  The listing of NovoSeven RT 8 mg would be subject to regulatory consent and therefore listing would occur from 1 July 2012 or as soon as practicable following approval (should this occur after 1 July).  A confidential rebate would apply to NovoMix 30 FlexPen. Background NovoMix 30 NovoMix 30 is an intermediate acting, biphasic insulin, composed of 30% soluble insulin aspart and 70% protamine-crystallised insulin aspart and is indicated for the treatment of diabetes mellitus.

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A funding application for insulin aspart (NovoMix 30) was reviewed by the Diabetes Subcommittee at its 18 June 2008 meeting and then by PTAC at its 24 July 2008 meeting (http://pharmac.govt.nz/2008/10/08). The Committees recommended NovoMix 30 be funded with a low priority and if cost-neutral to its comparators, respectively. Glucagen Hypokit Glucagon hydrochloride (Glucagen Hypokit) is an injectable polypeptide hormone used to treat severe hypoglycaemia. It also inhibits the tone and motility of smooth muscle in the gastrointestinal tract and can be used diagnostically to test residual beta-cell capacity. Glucagen Hypokit has been listed in Section B of the Pharmaceutical Schedule since 1997 at a price of $27.00 per unit. Should the provisional agreement with NovoNordisk be approved, it would be listed in Section B and Part II of Section H at a price of $32.00. NovoSeven RT NovoSeven RT is a recombinant coagulation factor VIIa (eptacog alfa) and is used for its role in inducing haemostasis. It is indicated for the control of bleeding and surgical prophylaxis in patients with inhibitors to coagulation Factors VIII or IX, congenital Factor VII deficiency and in patients with Glanzmann’s thrombasthenia. In April 2011, PHARMAC received advice about haemophilia treatments from the National Haemophilia Management Group which considered that a national contract for Factor VIIa was desirable.

A504045T12-624

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