This is the text extract for Notification of widening access of tenofovir, browse documents here.

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10 November 2009

Widening of access to tenofovir for the treatment of patients with treatment-resistant hepatitis B virus infection

PHARMAC is pleased to announce a decision to widen access to tenofovir disproxil fumarate (‘tenofovir’) for the treatment of patients with treatment-resistant hepatitis B virus infection. This was the subject of a consultation letter dated 30 September 2009. In summary, the effect of the decision is that, from 1 December 2009: tenofovir will be funded, subject to Special Authority restrictions, for patients with hepatitis B with documented resistance to lamivudine, adefovir or entecavir; tenofovir will remain funded, subject to an endorsement, for patients with HIV/AIDS; the Special Authority for other antiretrovirals will be amended to note that tenofovir will be counted as an antiretroviral for the purposes of access to subsidy for the treatment of HIV/AIDS; a new ‘Hepatitis B/HIV/AIDS Treatment’ therapeutic subgroup will be created, within the Antivirals therapeutic group, in Section B of the Pharmaceutical Schedule; and the listing of tenofovir will be moved from the Nucleoside Reverse Transcriptase Inhibitors therapeutic subgroup, in the Antiretrovirals therapeutic group, into the newly created Hepatitis B/HIV/AIDS Treatment therapeutic subgroup.

Details of the proposal From 1 December 2009: o Tenofovir 300 mg (Viread) will be listed in the Hepatitis B/HIV/AIDS Treatment subgroup of the Antivirals therapeutic group in Section B, and in Part II of Section H, of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excl. GST): Chemical Tenofovir disproxil fumarate o Form and Strength Tab 300 mg Brand Pack size Price and subsidy

Viread

30

$531.00

The listing of tenofovir in Section B of the Pharmaceutical Schedule will be subject to the following endorsement and Special Authority restrictions:

Endorsement for treatment of HIV/AIDS: Prescription is deemed to be endorsed if tenofovir disoproxil fumarate is co-prescribed with another anti-retroviral subsidised under Special Authority SA 0779 and the prescription is annotated accordingly by the Pharmacist or endorsed by the prescriber.

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Note: • •

Tenofovir disoproxil fumarate prescribed under endorsement for the treatment of HIV/AIDS is included in the count of up to 3 subsidised anti-retrovirals for the purposes of Special Authority SA 0779. Subsidy for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to anti-retrovirals.

SA0XXXX Special Authority for Waiver of Endorsement – Hospital pharmacy [HP1] 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. Both 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. Hepatitis B virus resistant to lamivudine with detection of M204I/V mutation; or 4.2. Hepatitis B virus resistant to adefovir with detection of A181T/V or N236T mutation; or 4.3. Hepatitis B virus resistant to entecavir with detection of I169T, L180M T184S/A/I/L/G/C/M, S202C/G/I, M204V or M250I/V mutation. Renewal - (Drug-Resistant Chronic Hepatitis B) only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment. Note • Tenofovir disoproxil fumarate should be stopped 6 months following HBeAg seroconversion for patients who were HBeAg positive prior to commencing tenofovir disoproxil fumarate. • The recommended dose of tenofovir disoproxil fumarate for the treatment of hepatitis B is 300 mg once daily. • In patients with renal insufficiency (calculated creatinine clearance less than 50 ml/min), the tenofovir disoproxil fumarate dose should be reduced in accordance with the approved Medsafe datasheet guidelines. • Tenofovir disoproxil fumarate is not approved for use in children.

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The Special Authority restriction (SA 0779) applying to other pharmaceuticals in the Antiretrovirals therapeutic group in Section B of the Pharmaceutical Schedule will be amended as follows (changes in bold):

Initial application - (Confirmed HIV/AIDS) only from a named specialist. Approvals valid without further renewal unless notified for applications meeting the following criteria: Both: 1 Confirmed HIV infection; and 2 Any of the following: 2.1 Symptomatic patient; or 2.2 Patient aged 12 months and under; or 2.3 Both: 2.3.1 Patient aged 1 to 5 years; and 2.3.2 Any of the following: 3 2.3.2.1 CD4 counts < 1,000 cells/mm ; or

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2.3.2.2 CD4 counts < 0.25 x total lymphocyte count; or 2.3.2.3 Viral load counts > 100,000 copies per ml; or 2.4 Both: 2.4.1 Patient aged 6 years and over; and 3 2.4.2 CD4 counts < 350 cells/mm . Note: Tenofovir disoproxil fumarate prescribed under endorsement for HIV/AIDS is included in the count of up to 3 subsidised anti-retrovirals. Subsidies for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals. Initial application - (Percutaneous exposure) only from a named specialist. Approvals valid for 6 weeks where person with percutaneous exposure to blood known to be HIV positive. Note Tenofovir disoproxil fumarate prescribed under endorsement for HIV/AIDS is included in the count of up to 3 subsidised anti-retrovirals. Subsidies for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals. Initial application - (Prevention of maternal transmission) only from a named specialist. Approvals valid for 1 year for applications meeting the following criteria: Either: 1 Prevention of maternal foetal transmission; or 2 Treatment of the newborn for up to eight weeks. Note: Tenofovir disoproxil fumarate prescribed under endorsement for HIV/AIDS is included in the count of up to 3 subsidised anti-retrovirals. Subsidies for a combination of up to three anti-retroviral medications, including a maximum of two protease inhibitors. Combinations including ritonavir plus indinavir or saquinavir or atazanavir will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals. Some antiretrovirals are unapproved or contraindicated for this in indication. Practitioners prescribing these medications should exercise their own skill, judgement, expertise and discretion, and make their own prescribing decisions with respect to the use of a Pharmaceutical for an indication for which it is not approved or contraindicated. Renewal - (Confirmed HIV/AIDS) only from a named specialist. Approvals valid without further renewal unless notified where the treatment remains appropriate and the patient is benefiting from treatment.

Feedback received and subsequent changes to the proposal The proposal to widen access to tenofovir for the treatment of patients with treatmentresistant hepatitis B virus infection was the subject of a consultation letter dated 30 September 2009. We appreciate all the feedback we received and acknowledge the time people took to respond. All consultation responses received by 14 October 2009 were considered in their entirety in making the decision on the proposal. Consultation feedback on the proposal was generally supportive. The following issues were raised in relation to specific aspects of the proposal:

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Theme

Comment

Some of the feedback suggested that there was a misconception that the proposal would result in an increase in the maximum number of antiretrovirals funded in combination for HIV/AIDS A request was made to further widen access to tenofovir to include therapy in post liver transplant as antiviral prophylaxis in combination with lamivudine.

Changes have now been made to the endorsement and to the Special Authority for Antiretrovirals to clarify that this is not the case. PHARMAC staff will request clinical advice from PTAC regarding the use of tenofovir for this indication. We note that the Antiinfective Subcommittee of PTAC has considered adefovir for hepatitis prophylaxis following liver transplantation and recommended funding adefovir for this indication with a medium priority. The note specifying that tenofovir should be stopped 6 months following HBeAg seroconversion for patients who were HBeAg positive prior to commencing tenofovir is in line with the advice received from the Anti-Infective Subcommittee of PTAC. We would be happy to take further advice from the Subcommittee if evidence is provided suggesting that an alteration in the wording is warranted.

Two responders considered that tenofovir should be stopped 6-12 months following seroconversion, rather than 6 months as proposed, for patients who were eAg positive before starting on tenofovir.

More information PHARMAC appreciates the work by pharmacists following complicated Special Authority changes such as this one. We will be providing a detailed letter to all HP1 pharmacies explaining the process for prescriptions for tenofovir and other funded antiretrovirals. 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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