Decision regarding funding of the HIV treatments dolutegravir (Tivicay) and abacavir sulphate with lamivudine (Kivexa)

Medicines Decision

PHARMAC is pleased to announce that the approval of an agreement with GlaxoSmithKline NZ Limited for the funding of the HIV treatments, dolutegravir (Tivicay) and abacavir sulphate with lamivudine (Kivexa).

This was the subject of a consultation letter dated 8 September 2016. No changes were made to the proposal following consultation.

In summary, the effect of the decision is that from 1 November 2016:

  • Dolutegravir (Tivicay) will be will be fully funded in DHB hospitals and the community, subject to certain clinical criteria being met; and
  • There will be a decrease in the price and subsidy of abacavir sulphate with lamivudine (Kivexa).

Details of the decision

Dolutegravir (Tivicay)

  • Dolutegravir (Tivicay) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2016 at the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical and presentation

Brand

Pack size

Price and subsidy

Dolutegravir tab 50 mg

Tivicay

30

$1,090.00
  • A confidential rebate will apply to Tivicay which will reduce its net price to the Funder.
  • Dolutegravir will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria (which are the same criteria as all other currently funded antiretroviral medications):

SA1364 Special Authority for Subsidy

Initial application — (Confirmed HIV) 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:
    1. Symptomatic patient; or
    2. Patient aged 12 months and under; or
    3. Both:
      1. Patient aged 1 to 5 years; and
      2. Any of the following:
        1. CD4 counts < 1000 cells/mm3; or
        2. CD4 counts < 0.25 x total lymphocyte count; or
        3. Viral load counts > 100000 copies per ml; or
    4. Both:
      1. Patient aged 6 years and over; and
      2. CD4 counts < 500 cells/mm3.

Notes: Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.

Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.

Renewal — (Confirmed HIV) only from a named specialist. Approvals valid without further renewal unless notified where the treatment remains appropriate and the patient is benefiting from treatment.

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.

Notes: Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.

Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.

Some antiretrovirals are unapproved or contraindicated for this 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.

Initial application — (post-exposure prophylaxis following non-occupational exposure to HIV) only from a named specialist. Approvals valid for 4 weeks for applications meeting the following criteria:

Both:

  1. Treatment course to be initiated within 72 hours post exposure; and
  2. Any of the following:
    1. Patient has had unprotected receptive anal intercourse with a known HIV positive person; or
    2. Patient has shared intravenous injecting equipment with a known HIV positive person; or
    3. Patient has had non-consensual intercourse and the clinician considers that the risk assessment indicates prophylaxis is required.

Notes: Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.

Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.

Renewal — (second or subsequent post-exposure prophylaxis) only from a named specialist. Approvals valid for 4 weeks for applications meeting the following criteria:

Both:

  1. Treatment course to be initiated within 72 hours post exposure; and
  2. Any of the following:
    1. Patient has had unprotected receptive anal intercourse with a known HIV positive person; or
    2. Patient has shared intravenous injecting equipment with a known HIV positive person; or
    3. Patient has had non-consensual intercourse and the clinician considers that the risk assessment indicates prophylaxis is required.

Initial application — (Percutaneous exposure) only from a named specialist. Approvals valid for 6 weeks where the patient has percutaneous exposure to blood known to be HIV positive.

Notes: Tenofovir disoproxil fumarate prescribed under endorsement for HIV is included in the count of up to 4 subsidised antiretrovirals.

Subsidies for a combination of up to four antiretroviral medications. The combination of a protease inhibitor and low-dose ritonavir given as a booster (either as part of a combination product or separately) will be counted as one protease inhibitor for the purpose of accessing funding to antiretrovirals.

Renewal — (Second or subsequent percutaneous exposure) only from a named specialist. Approvals valid for 6 weeks where the patient has percutaneous exposure to blood known to be HIV positive.

  • Dolutegravir will be listed in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML) under the following restrictions (which is the same current restriction as the other funded strand transfer inhibitor):

Restricted

Initiation — Confirmed HIV

Both:

  1. Confirmed HIV infection; and
  2. Any of the following:
    1. Symptomatic patient; or
    2. Patient aged 12 months and under; or
    3. Both:
      1. Patient aged 1 to 5 years; and
      2. Any of the following:
        1. CD4 counts < 1000 cells/mm3; or
        2. CD4 counts < 0.25 x total lymphocyte count; or
        3. Viral load counts > 100000 copies per ml; or
    4. Both:
      1. Patient aged 6 years and over; and
      2. CD4 counts < 500 cells/mm3.

Initiation — Prevention of maternal transmission

Either:

  1. Prevention of maternal foetal transmission; or
  2. Treatment of the newborn for up to eight weeks.

Initiation — Post-exposure prophylaxis following non-occupational exposure to HIV

Both:

  1. Treatment course to be initiated within 72 hours post exposure; and
  2. Any of the following:
    1. Patient has had unprotected receptive anal intercourse with a known HIV positive person; or
    2. Patient has shared intravenous injecting equipment with a known HIV positive person; or
    3. Patient has had non-consensual intercourse and the clinician considers that the risk assessment indicates prophylaxis is required.

Initiation — Percutaneous exposure

Patient has percutaneous exposure to blood known to be HIV positive.

  • Tivicay will have protection from delisting and subsidy reduction until 1 November 2019.

Abacavir sulphate with lamivudine (Kivexa)

  • Abacavir sulphate with lamivudine (Kivexa) will continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 November 2016 at the following amended prices and subsidies (ex-manufacturer, excluding GST): 

Chemical and presentation

Brand

Pack size

Current price and subsidy

New price and subsidy

Abacavir sulphate with lamivudine tab 600 mg with lamivudine 300 mg

Kivexa

30

$630.00

$427.29
  • A confidential rebate will apply to Kivexa which will reduce its net price to the Funder.
  • Kivexa will have protection from delisting and subsidy reduction until 30 June 2019.
  • There are no other changes to the current listing of abacavir sulphate with lamivudine tablets that would happen as a result of this decision.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 23 September 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme

Comment

Several responders suggested consideration of an amendment to the Special Authority criteria to remove the severity criteria in the form of the CD4 count threshold that is currently in place.

PHARMAC notes that an application has been received by PHARMAC for widening of funded access to antiretrovirals and it is currently under consideration.

Details of this application and our assessment of it can be found on PHARMAC’s Application Tracker(external link).

Several responders noted that Triumeq tablet is available (dolutegravir with abacavir and lamivudine in a single tablet regimen).

PHARMAC notes that Triumeq is registered with Medsafe.  We have, to date, not received a funding application for Triumeq.

Should we receive a funding application, it would be assessed via PHARMAC’s standard process.

One responder requested that the wastage or OP rule be applied to these medicines.

The OP or wastage rules do not currently apply to Kivexa. PHARMAC notes that both of these treatments are used to treat a chronic condition and we consider that it is unnecessary to apply the wastage rule or OP to products where ongoing chronic treatment is expected.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.