Proposal to fund HIV pre-exposure prophylaxis (PrEP)
14 November 2017
What we’re proposing
PHARMAC is seeking feedback on a proposal to widen funded access to emtricitabine with tenofovir disoproxil fumarate tablets (brand name Truvada) for HIV pre-exposure prophylaxis (PrEP) for people at a high risk of contracting HIV.
Consultation closes at 5 pm on Tuesday, 5 December 2017 and feedback can be emailed to email@example.com.
What would the effect be?
From 1 March 2018, emtricitabine with tenofovir disoproxil fumarate (Truvada) would be funded for people who are at high risk of contracting HIV infection.
People who meet the funding criteria would initially be able to get emtricitabine with tenofovir disoproxil fumarate for PrEP from or on the advice of an HIV specialist, with ongoing funding renewals available from general practitioners trained in prescribing PrEP.
People receiving funded access to PrEP would need to have tests for sexually transmitted infections, and be regularly monitored for risk of side effects from treatment. Patients would also be required to receive advice on ways to reduce the risk of HIV and sexually transmitted infections.
Funding applications for the initiation of PrEP would be only accepted from or on the recommendation of named HIV specialists. Renewal applications for PrEP would be accepted from any relevant practitioner.
Who we think will be interested
This proposal will likely be of interest to, among others:
- people who are at risk of HIV infection, HIV/AIDS support groups, sexual health support groups;
- sexual health services, infectious disease specialists, general practitioners, public health services, DHBs; and
- suppliers of antiretrovirals and sexual health products.
About PrEPEmtricitabine with tenofovir disoproxil fumarate is a combination tablet containing two antiretrovirals. It can be used as a pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV, in combination with safer sex practices, in adults at high risk of infection.
Emtricitabine and tenofovir disoproxil fumarate (Truvada) has been listed on the Pharmaceutical Schedule since 2012 and is funded currently for treatment of HIV and post-exposure prophylaxis for HIV.
Emtricitabine with tenofovir disoproxil fumarate, when used for PrEP, is a single tablet taken orally once per day. If adhered to completely, PrEP almost entirely eliminates the risk of HIV infection.
The use of PrEP by people at high risk of contracting HIV infection has been associated with major reductions in HIV infections in overseas settings, and this is what would be expected for New Zealand.
Why we’re proposing this
PHARMAC has been closely following developments in medicines that may prevent HIV infection. Truvada was granted registration for use for PrEP by Medsafe earlier this year. Following this PHARMAC worked closely with the New Zealand AIDS Foundation (NZAF) to support them in preparing a funding application for PrEP, which was submitted to us in September 2017.
The application was considered in November 2017 by the Anti-Infective Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC).
The minutes of this meeting have not yet been finalised, however funding of emtricitabine with tenofovir disoproxil fumarate for PrEP was recommended with a high priority for men and transgender females who have sex with men and who are at a high risk of contracting HIV. The Subcommittee considered that there was very good evidence that PrEP reduces HIV infection rates in this high-risk population.
Details about our proposal
From 1 March 2018, a new therapeutic subgroup (TG2) would be created within the Antivirals group, called ‘HIV Prophylaxis and Treatment’, and the listing for emtricitabine with tenofovir disoproxil fumarate would be moved from the Antiretrovirals subgroup to this new subgroup.
The Special Authority for antiretrovirals would no longer apply to emtricitabine with tenofovir disoproxil fumarate; instead the following criteria would apply:
EMTRICITABINE WITH TENOFOVIR DISOPROXIL FUMARATE – Subsidy by endorsement; can be waived by Special Authority
Endorsement for treatment of HIV: Prescription is deemed to be endorsed if tenofovir disoproxil fumarate is co-prescribed with another antiretroviral subsidised under Special Authority SA1651 and the prescription is annotated accordingly by the Pharmacist or endorsed by the prescriber.
Note: Emtricitabine with tenofovir disoproxil fumarate prescribed under endorsement for the treatment of HIV is included in the count of up to 4 subsidised antiretrovirals, and counts as two antiretroviral medications, for the purposes of Special Authority SA1651.
Special Authority for Waiver of Rule
Initial application only from a named specialist or medical practitioner on the recommendation of a named specialist. Approvals valid for 3 months for applications meeting the following criteria:
- Patient has tested HIV negative; and
2.1 All of the following:
2.1.1 Patient is male or transgender female; and
2.1.2 Patient has sex with men; and
2.1.3 Patient is likely to have multiple episodes of condomless anal intercourse in the next 3 months; and
2.1.4 Any of the following:
18.104.22.168 Patient has had at least one episode of condomless receptive anal intercourse with one or more casual male partners in the last 3 months; or
22.214.171.124 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or
126.96.36.199 Patient has used methamphetamine in the last three months; or
2.2 All of the following:
2.2.1 Patient has a regular partner who has HIV infection; and
2.2.2 Partner is either not on treatment or has a detectable viral load; and
2.2.3 Condoms have not been consistently used.
Renewal only from a relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:
All of the following:
- Applicant has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis; and
- Patient has undergone testing for HIV, syphilis, and a full STI screen in the previous two weeks; and
- Patient has had renal function testing (creatinine, phosphate and urine protein/creatinine ratio) within the last 12 months; and
- Patient had received advice regarding the reduction of risk of HIV and sexually transmitted infections and how to reduce those risks; and
- Patient has tested HIV negative; and
6.1 All of the following:
6.1.1 Patient is male or transgender female; and
6.1.2 Patient has sex with men; and
6.1.3 Patient is likely to have multiple episodes of condomless anal intercourse in the next 3 months; and
6.1.4 Any of the following
188.8.131.52 Patient has had at least one episode of condomless receptive anal intercourse with one or more casual male partners in the last 3 months; or
184.108.40.206 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or
220.127.116.11 Patient has used methamphetamine in the last three months; or
6.2 All of the following:
6.2.1 Patient has a regular partner who has HIV infection; and
6.2.2 Partner is either not on treatment or has a detectable viral load; and
6.2.3 Condoms have not been consistently used.
A similar change would be made in Part II of Section H of the Pharmaceutical Schedule.
To provide feedback
PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Tuesday, 5 December 2017 to:
Dr Lindsay Ancelet
Therapeutic Group Manager
PO Box 10254
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.
Last updated: 14 November 2017