This is the text extract for Proposal to widen access to tenofovir (Viread) for ‘treatment experienced’ patients with Hepatitis B infection. Closed, browse documents here.

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30 September 2009

Proposal to widen access to tenofovir (Viread) for ‘treatment experienced’ patients with Hepatitis B infection

Summary of Proposal PHARMAC is seeking feedback on a proposal to widen access to tenofovir (Viread) for ‘treatment experienced’ Hepatitis B patients from 1 December 2009. This proposal would result in: Tenofovir disoproxil fumarate (Viread) being funded under new a Special Authority for those patients with documented resistance to lamivudine, adefovir or entecavir Tenofovir remaining funded for patients with HIV/AIDS, subject to an endorsement the listing of tenofovir in the Pharmaceutical Schedule being moved from the ‘Nucleosides Reverse Transcriptase Inbitors – Antiretrovirals’ subgroup to its own new subgroup: ‘Tenofovir’ Further details and background to the proposal can be found on the next 2 pages.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 14 October 2009 to: Greg Williams Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: greg.williams@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 listing of Tenofovir disoproxil fumarate (Viread) in the Pharmaceutical Schedule would be moved from the ‘Nucleosides Reverse Transcriptase Inhibitors – Antiretrovirals’ subgroup to its own subgroup: ‘Tenofovir’. Tenofovir would remain funded for patients with HIV/AIDS, subject to an endorsement, and access to funding for tenofovir would be widened to include patients with Hepatitis B infection resistant to lamivudine, adefovir or entecavir, via a new Special Authority as follows:

Tenofovir disoproxil fumarate – Subsidy by endorsement; can be waived by Special Authority see SAXXXX below Endorsement for treatment of HIV/AIDS: Prescription is endorsed if (i) it is co-prescribed with an anti-retroviral subsidised under Special Authority SA 0779 and the prescription is annotated accordingly by the Pharmacist or (ii) it is endorsed or prescribed by a named Specialist for the treatment of HIV/AIDS. Note: • A list of all named Specialists can be found under Special Authority Applications in the General Rules of the Pharmaceutical Schedule. • For the purposes of this endorsement all endorsements or prescribing by a named Specialist must fulfill the requirements of Retail Pharmacy – Specialist as defined in Section A: general rules of the Pharmaceutical Schedule.

SA0XXXX Special Authority for Subsidy Initial application - (Drug-Resistant Chronic Hepatitis B) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 1 year for applications meeting the following criteria: All of the following: 1. Patient has confirmed Hepatitis B infection (HBsAg positive for more than 6 months); and 2. Patient has had previous lamivudine, adefovir or entecavir therapy; and 3. All of the following: Documented drug resistance, defined as all of the following: 3.1. ALT greater than upper limit of normal; or ≥ Metavir Stage F3; and 3.2. HBV DNA greater than 20,000 IU/mL or increased ≥ 10 fold over nadir; and 4. Any of the following: 4.1. Lamivudine resistance - detection of M204I/V mutation; or 4.2. Adefovir resistance - detection of A181T/V or N236T mutation; or 4.3. Entecavir resistance - detection of relevant mutations including I169T, L180M T184S/A/I/L/G/C/M, S202C/G/I, M204V or M250I/V. Renewal - (Drug-Resistant Chronic Hepatitis B) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 2 years where in the opinion of the treating physician, treatment remains appropriate and patient is benefiting from treatment Note • Tenofovir should be stopped 6 months following HBeAg seroconversion for patients who were HBeAg positive prior to commencing this agent. • The recommended dose of tenofovir is 300 mg once daily. • In patients with renal insufficiency (calculated creatinine clearance less than 50ml/min), tenofovir dose should be reduced in accordance with the datasheet guidelines. • Tenofovir is not approved for use in children.

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The price and subsidy of tenofovir disoproxil fumarate would remain at $531.00 per pack (300 mg x 30 tablets) (ex-manufacturer, excluding GST):

Background Tenofovir disoproxil fumarate is currently listed in the Nucleoside Reverse Transcriptase Inhibitors – Antiretroviral therapeutic subgroup under a Special Authority for the treatment of confirmed HIV/AIDS. Under this proposal tenofovir would remain funded for HIV/AIDS but the Special Authority would be removed and replaced by an endorsement. This endorsement would allow clinicians to prescribe tenofovir in combination with other antiretrovirals with no additional paperwork, or endorse that a named HIV/AIDS Specialist recommended this therapy. For the avoidance of doubt, the endorsement is not meant to widen access for tenofovir with respect to HIV/AIDS therapy. In 2008, the Pharmacology and Therapeutics Advisory Committee (PTAC) and its AntiInfective Subcommittee reviewed an application from Gilead Sciences for the widening of access for tenofovir (Viread) in the Pharmaceutical Schedule to include the treatment of chronic Hepatitis B. The relevant section of the minutes from the December 2008 Anti-Infective subcommittee meeting are as follows: • The Subcommittee considered that there would be a reduction in the need for blood tests for HBV DNA load from every 3 months to every 6 months in patients undergoing tenofovir treatment compared to adefovir or lamivudine treatment. Members considered that there would be a reduction in the number of liver biopsies preformed if tenofovir was funded and that patients would switch from adefovir to tenofovir. The Subcommittee considered that there was an unmet clinical need for hepatitis B treatment and that new more potent pharmaceuticals were required to achieve viral suppression or seroconversion. Members noted that if patient’s e-antigen seroconverted and remained so for 6 to 12 months then it is unlikely they would require ongoing treatment. The Subcommittee considered that a new more potent agent was required for Hepatitis B and considered that entecavir first line monotherapy for treatment naïve patients and tenofovir as second line monotherapy or tenofovir as monotherapy for treatment naïve and experienced patients would be clinically acceptable. The Subcommittee recommended with high priority that tenofovir be listed on the Pharmaceutical Schedule using the guidelines set out in the minutes from this meeting for either treatment naïve or treatment experienced patients.

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In August 2009 PHARMAC listed entecavir under Special Authority as a first line monotherapy for treatment naïve patients. The proposed listing of tenofovir would provide the more potent second line agent in line with the PTAC recommendations.

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