Decision relating to widening funding criteria for antiretroviral agents for the treatment of HIV

Medicines

Decision

PHARMAC is pleased to announce the approval of the proposal to widen the funding criteria of antiretroviral agents for the treatment of HIV to take effect from 1 July 2017.

This was the subject of a consultation letter dated 8 May 2017.

The proposal was approved as consulted on with no changes.

In summary, the effect of the decision is that:

  • Funded access to antiretroviral agents for the treatment of HIV will be widened to enable early treatment of patients with confirmed HIV infection, regardless of disease severity.
  • The requirement for patients with confirmed HIV to meet a disease threshold to access funded antiretroviral treatment, as measured by CD4 counts or viral load, will be removed.

Details of the decision

Antiretrovirals – for early treatment of HIV infection

  • Funding criteria for funding of HIV antiretroviral agents will be widened in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 July 2017 to enable early treatment of people with HIV infection.
  • To effect this change, the current Special Authority initial application and hospital restriction for antiretrovirals for people with confirmed HIV infection will be amended as follows (additions in bold, deletions in strikethrough, only affected criteria are shown):

Special Authority for Subsidy

Initial application - (Confirmed HIV) only from a named specialist. Approvals valid without further renewal unless notified where the patient has confirmed HIV infection. unless notified for applications meeting the following criteria:

Both:

Confirmed HIV infection; and

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:

2.3.2.1 CD4 counts < 1,000 cells/mm³; or
2.3.2.2 CD4 counts < 0.25 × total lymphocyte count; or
2.3.2.3 Viral load counts > 100000 copies per ml; or

2.4 Both:

2.4.1 Patient aged 6 years and over; and
2.4.2 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.

For the avoidance of doubt, there will be no change to the Special Authority criteria for antiretroviral use for other indications (e.g. prevention of maternal transmission, prevention post exposure) and the antiretroviral renewal criteria.

The hospital restrictions for non-nucleosides reverse transcriptase inhibitors, nucleosides reverse transcriptase inhibitors, protease inhibitors and strand transfer inhibitors as listed in Part II of Section H of the Pharmaceutical Schedule would be amended from 1 July 2017 as above. 

Feedback received

We appreciate all the feedback we received and acknowledge the time people took to respond. All consultation responses received by 26 May 2017 were considered in their entirety in making a decision on the proposed changes. All responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme Comment
Strongly supportive of the proposal. Successful viral suppression reduces the risk of transmission. Noted.
Less people would be affected by the proposal than outlined by PHARMAC in the consultation. PHARMAC has adjusted its patient number estimates having considered consultation feedback. We estimate that widening access would result in an additional 135 patients being eligible for treatment.
One responder provided support for vocationally registered general practitioners having access to Special Authority access and prescribing to reduce barriers to access and burden on DHB services HIV is a notifiable disease and named HIV specialists are selected and approved by the Ministry of Health.  While the Special Authority must be applied for by a named HIV specialist, any prescriber can write prescriptions.
Request that the wastage rule is applied to all antiretrovirals since pharmacy are left with broken packs of medicine, which they consider a financial risk to community pharmacy. PHARMAC note that most dispensings for antiretrovirals are for 30 days and pack sizes are usually in monthly increments. We consider broken packs are currently uncommon.
Request widening of funding of Truvada for prophylaxis. PHARMAC has not received a funding application for pre-exposure prophylaxis however we are expecting to receive one.  In any event, we will be seeking advice on funding for pre-exposure prophylaxis at the next sub-committee meeting.

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.