Proposal relating to two HIV treatments (Tivicay and Kivexa)

Medicines Consultation Closed

PHARMAC is seeking feedback on a proposal to list a new treatment for HIV, dolutegravir (Tivicay) and to amend the listing of a currently funded HIV treatment, abacavir sulphate with lamivudine (Kivexa). This proposal has arisen as a result of a provisional agreement with GlaxoSmithKline NZ Limited.

In summary, this proposal would result in, from 1 November 2016:

  • Dolutegravir (Tivicay) being funded via Special Authority criteria in the community and DHB hospitals for the treatment of HIV;
  • a decrease in the price and subsidy of abacavir sulphate with lamivudine (Kivexa); and
  • delisting and subsidy protection being applied to each of Tivicay and Kivexa.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 9am Friday, 23 September 2016 to:

Katie Appleby
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143

Email: dolutegravir@pharmac.govt.nz

Fax:     04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.  PHARMAC will give due consideration to any such request. 

Details of the proposal

Dolutegravir (Tivicay)

  • Dolutegravir (Tivicay) would 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 would apply to Tivicay which would reduce its net price to the Funder.
  • Dolutegravir would 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):

SA 1364 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 prophylaxisis 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 would 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:
  3. Patient has had unprotected receptive anal intercourse with a known HIV positive person; or
  4. Patient has shared intravenous injecting equipment with a known HIV positive person; or
  5. 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 would have protection from delisting and subsidy reduction until 1 November 2019.

Abacavir sulphate with lamivudine (Kivexa)

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

Chemical and presentation

Brand

Pack size

Current price and subsidy

Proposed Price and subsidy

Abacavir sulphate 600 mg with lamivudine 300 mg

Kivexa

30

$630.00

$427.29
  • A confidential rebate would apply to Kivexa which would reduce its net price to the Funder.
  • Kivexa would 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 proposal.

Background

Dolutegravir

Dolutegravir (Tivicay) tablets are indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 12 years of age and weighing 40 kg or more. It is in a class of treatments known as integrase strand transfer inhibitors (INSTI). It works by preventing HIV from replicating. It does this by blocking the HIV enzyme known as integrase. Blocking this enzyme prevents the HIV virus from inserting its viral DNA into the DNA of the host CD4 cell. Other treatments in this class include raltegravir which is also available under Special Authority.  

Tivicay is generally administered as one tablet once daily (all other currently funded INSTI treatments are twice daily).

In November 2014, the Anti-Infective Subcommittee of PTAC advised that dolutegravir has a similar clinical effect to raltegravir; however members considered that dolutegravir was a more virologically active agent.

The Subcommittee noted that dolutegravir is not licensed for children aged under 12 years whereas raltegravir is licensed from infancy. Members considered that dolutegravir’s once daily formulation may provide some advantage over other therapies in terms of enhanced compliance. The Subcommittee noted that there is the possibility of a drug-drug interaction between dolutegravir and metformin.

The Subcommittee recommended the listing of dolutegravir on Section B and Part II of Section H of the Pharmaceutical Schedule for the treatment of HIV infection, under the current Special Authority and restrictions applying to antiretroviral therapy for HIV treatment, only if cost-neutral for the life of the raltegravir patent.

The full minutes from this discussion are available on the PHARMAC website via:

https://connect.pharmac.govt.nz/apptracker/s/global-search/dolutegravir(external link)

Abacavir sulphate with lamivudine

Abacavir sulphate with lamivudine (Kivexa) tablets are currently listed on the Pharmaceutical Schedule. Kivexa is indicated in antiretroviral combination therapy for the treatment of HIV infection in adults and adolescents from 12 years of age.

Abacavir sulphate with lamivudine (Kivexa) is funded subject to the same Special Authority criteria that apply to other HIV treatments.