This is the text extract for Notification of levetiracetam funding changes., browse documents here.

30 July 2010

Listing of Levetiracetam-Rex in the Pharmaceutical Schedule and cessation of Keppra funding via Levetiracetam Special Access

As previously notified on 11 July 2008, PHARMAC’s Board approved the funding of Rex Medical Ltd’s brand of levetiracetam (Levetiracetam-Rex) as soon as possible following Medsafe registration. Levetiracetam-Rex is now registered and listing will occur on 1 November 2010, as detailed on the following page. Access to subsidised Levetiracetam-Rex will be available without the requirement for Special Authority approval. Levetiracetam Special Access (LSA) We also previously notified that funding of the Keppra brand of levetiracetam through Levetiracetam Special Access would cease once there was a secure supply of levetiracetam funded through the Pharmaceutical Schedule. Accordingly: • • No new approvals (initial or renewal) for Keppra will be granted under LSA from 1 November 2010. All existing LSA approvals (both initials and renewals) with expiry dates beyond 1 November 2010 will remain valid until expiry or until 30 April 2011, whichever is sooner. All approvals (initial or renewal) granted between 1 August 2010 and 1 November 2010 will have a 6-month expiry date. From 1 November 2010, patients with expired LSA approvals will need to be dispensed the Levetiracetam-Rex brand in order to receive a funded product. Any clinician who considers that their patient should remain on the Keppra brand following expiry of their LSA approval would need to apply in writing to the LSA Panel Coordinator at the address below outlining the reasons why (at a minimum, patients must have been seizure-free for at least 6 months for ongoing Keppra subsidy to be considered).

The Coordinator Levetiracetam Special Access Panel PHARMAC PO Box 10 254, Wellington Phone: 04 916-7511 Facsimile: 09 929-3226 Email: lsacoordinator@pharmac.govt.nz

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A separate letter will be sent to clinicians who have patients with current LSA approvals to advise of the approval expiry date for each patient.

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Levetiracetam-Rex • Rex Medical Ltd’s brand of levetiracetam (Levetiracetam-Rex) will be listed in Section B and in Part II of H of the Pharmaceutical Schedule from 1 November 2010 at the following prices and subsidies (ex-manufacturer, excluding GST):

Pharmaceutical Levetiracetam Levetiracetam Levetiracetam Brand Levetiracetam-Rex Levetiracetam-Rex Levetiracetam-Rex Form and Strength Tablet 250 mg Tablet 500 mg Tablet 750 mg Pack Size 60 60 60 Price and subsidy $24.03 $28.71 $45.23

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Levetiracetam-Rex will be funded without the requirement for Special Authority approval. Levetiracetam-Rex will have protection from delisting and subsidy reduction until 1 July 2013.

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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