Notification on emtricitabine with tenofovir for prep in HIV

NOTIFICATION

Decision to fund HIV pre-exposure prophylaxis (PrEP) 7 February 2018

What we’re doing We’re pleased to announce our decision 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 from 1 March 2018.

Any changes to the original proposal?

This decision follows a consultation letter of 14 November 2017. PHARMAC would like to acknowledge and thank all those who shared their feedback, stories, and information with us.

There is one change to the funded criteria from those consulted on. The Special Authority criteria have been amended to include all transgender people instead of only transgender females.

Who we think will be most interested This decision will likely be of most interest to:   

people who are at risk of HIV infection, HIV/AIDS support and consumer 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.

What will the effect of this decision be?

For Patients From 1 March 2018, emtricitabine with tenofovir disoproxil fumarate (Truvada) will be funded for people who are at high risk of contracting HIV infection.

People who meet the funding criteria will 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.

For Prescribers Funding applications for the initiation of PrEP will be only accepted from or on the recommendation of named HIV specialists. Renewal applications for PrEP will be accepted from any relevant practitioner.

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Refer to Details about this decision – Applicants and the term “Named Specialist” section below for more information.

Details about this decision The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.

Section B changes From 1 March 2018, a new therapeutic subgroup (TG3) will be created within the Antivirals group of Infections – Agents for Systemic Use, called ‘HIV Prophylaxis and Treatment’, and the listing for emtricitabine with tenofovir disoproxil fumarate will be moved into this new subgroup.

The Special Authority for antiretrovirals (SA1651) will no longer apply to emtricitabine with tenofovir disoproxil fumarate; instead the following criteria will 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 emtricitabine with 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: Both: 1 Patient has tested HIV negative; and 2 Either: 2.1 All of the following: 2.1.1 Patient is male or transgender; 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: 2.1.4.1 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 2.1.4.2 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or 2.1.4.3 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: 1 Applicant has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis; and

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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 Either: 6.1 All of the following: 6.1.1 Patient is male or transgender; 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 6.1.4.1 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 6.1.4.2 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or 6.1.4.3 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.

Section H (Hospital Medicines List) changes From 1 March 2018, a new therapeutic subgroup (TG3) will be created within the Antiretrovirals subgroup (TG2) of Infections, called ‘HIV Prophylaxis and Treatment’. The listing for emtricitabine with tenofovir disoproxil fumarate will be moved into this new subgroup.

The restriction for emtricitabine with tenofovir disoproxil fumarate will be replaced with the following criteria (note that the restrictions on uses other than PrEP are unchanged): Restricted Initiation – Confirmed HIV Patient has confirmed HIV infection.

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: 2.1 Patient has had unprotected receptive anal intercourse with a known HIV positive person; or 2.2 Patient has shared intravenous injecting equipment with a known HIV positive person; or 2.3 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.

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Initiation – Pre-exposure prophylaxis Re-assessment required after 3 months Both: 1 Patient has tested HIV negative; and 2 Either: 2.1 All of the following: 2.1.1 Patient is male or transgender; 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: 2.1.4.1 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 2.1.4.2 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or 2.1.4.3 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.

Continuation – pre-exposure prophylaxis Re-assessment required after 3 months All of the following: 1 Applicant has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis; and 2 Patient has undergone testing for HIV, syphilis, and a full STI screen in the previous two weeks; and 3 Patient has had renal function testing (creatinine, phosphate and urine protein/creatinine ratio) within the last 12 months; and 4 Patient has received advice regarding the reduction of risk of HIV and sexually transmitted infections and how to reduce those risks; and 5 Patient has tested HIV negative; and 6 Either: 6.1 All of the following: 6.1.1 Patient is male or transgender; 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 6.1.4.1 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 6.1.4.2 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or 6.1.4.3 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.

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Applicants and the term “named specialist” Initial access Initial community applications are limited to “a named specialist or medical practitioner on the recommendation of a named specialist.” “Named specialist” here refers to a list of named HIV specialists; the Ministry of Health processes applications to be on the list, sets criteria to demonstrate knowledge of HIV, and organises a panel of HIV Specialists to determine if a clinician meets those criteria. Named specialists currently prescribe antiretroviral treatments for the treatment of HIV. We intend to make a list of named specialists available before the 1 March listing date. If you are a clinician who is interested in becoming a named specialist, you can contact the Ministry of Health at geoffrey_roche@moh.govt.nz.

If a medical practitioner is applying “on the recommendation of a named specialist”, this means they need a named specialist to consider the case and support the Special Authority application. It is up to the specialist to decide how to do this but could be as simple as discussing the case by phone or email.

Ongoing access Renewals may be from any practitioner, with the requirement that the applicant requesting the renewal has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis. The Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) provide online training courses at http://www.ashm.org.au/HIV/training/.

Background to the decision PHARMAC has been closely following developments in medicines that may prevent HIV infection. Truvada was granted Medsafe approval for use for PrEP last year. Since early 2017 we have been working 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).

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.

Our response to what you told us We’re really grateful for the time people took to respond to this consultation. We have listened to you and a summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made is below.

If you have any questions about this decision, enquiry@pharmac.govt.nz or call 0800 66 00 50.

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Feedback theme

PHARMAC response

Most respondents were overwhelmingly supportive of the proposal to fund emtricitabine with tenofovir disoproxil fumarate for HIV PrEP.

Noted.

Thank you to everyone who shared their feedback, personal stories, and information with us.

Applicant restrictions A number of respondents requested that initial prescribing be widened to include sexual health physicians or general practitioners that have completed a PrEP training module.

HIV treatment is a specialist area that requires appropriate training, experience and ongoing clinical practice. Accordingly, the Ministry of Health sets criteria for approval, and currently runs the application process for clinicians to be approved for prescribing antiretroviral medications in New Zealand. All applicants are assessed and approved by a panel of HIV Specialists.

Any clinician may apply for initial Special Authority funding following consultation and on the recommendation of a named specialist.

We note this may occur via phone or email conversation and does not require a face to face consultation. Renewals may be done by any practitioner who has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis.

PHARMAC staff note that the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) provide New Zealand appropriate online learning modules for PrEP at http://www.ashm.org.au/HIV/PrEP/.

We intend to work with other appropriate organisations to support clinicians who wish to upskill in prescribing PrEP and make training and education more accessible in New Zealand PHARMAC intends to review the applicant criteria after 12 months, to ensure they are appropriate.

Clarification of the term ‘named specialist’.

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‘Named specialist’ refers to named HIV specialists who are approved to prescribe antiretrovirals (see above for information on process). This wording is consistent with the current prescribing rules in the Schedule for antiretroviral prescribing for treatment of HIV and post-exposure prophylaxis.

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Feedback theme

PHARMAC response

Widening to other patient groups The gender criteria should be amended to include all transgender people.

The eligibility criteria have been amended to include all transgender people.

Access should be widened to include women at high risk (with several specific groups of women mentioned, such as African women, sex workers, and women who have receptive anal intercourse).

The eligibility criteria are based on clinical advice from the Anti-Infective Subcommittee of PTAC and international guidelines regarding those people considered at high risk. The final Subcommittee minutes will be published on the PHARMAC website in the near future.

We would welcome a funding application with evidence of the risk of HIV infection in any groups of women.

Access should be widened for people who are travelling overseas.

See above. We would welcome a funding application with evidence of the risk of HIV infection in those travelling overseas.

Access should be widened for people using illicit drugs other than methamphetamine.

See above. Methamphetamine was included in the eligibility criteria as its use carries a higher risk of HIV infection than other illicit drugs. We note that those using illicit drugs may meet the other high risk criteria.

We would welcome a funding application with evidence of the risk of HIV infection following use of other drugs.

Access should include those who play the insertive part in sex

See above. We would welcome a funding application with evidence to the risk of HIV infection in those who meet the other criteria but are having insertive, not receptive, anal intercourse.

Testing criteria Some respondents suggested inclusion of criteria relating to the clinical management of individuals on PrEP, including: 

The initial criteria to have been tested HIV negative should require the test be within the previous two weeks.

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Liver transaminases should be checked prior to first prescription.

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Exclude chronic hepatitis B infection.

Serum phosphate monitoring is considered unnecessary if normal renal function has been confirmed.

Special Authority criteria are a tool to manage expenditure risks and to ensure funded medicines are targeted to individuals that need it; they are not generally a clinical management tool. The funding criteria are consistent with overseas guidelines.

We consider these issues are suitable to leave at the specialist’s discretion. A specialist is better placed to determine if an HIV negative result is timely, if other tests are appropriate, and if a patient with hepatitis B infection could receive this regimen.

The inclusion of this monitoring is consistent with overseas guidelines.

Approval times Various requests to extend initial approval and renewal times.

Clinical advice considered regular check-ups are required to manage the risk of side-effects of antiretroviral use and diagnosis and treatment of sexually transmitted infections.

Costs

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Feedback theme

PHARMAC response

Service costs and support costs will increase.

We have noted these additional costs in our analysis.

There will be additional pressure on various services.

This pharmaceutical should be funded as an original pack, or have a wastage rule applied.

We are working with NZAF, clinicians, and the Ministry of Health to ensure services are aware of and are prepared for the additional workload.

Since this treatment will be taken regularly we consider that original pack and wastage rules are not required.

Risky behaviour This proposal may lead to reduced condom use.

Condom use should still be promoted.

PHARMAC fully funds condoms on prescription. Condoms continue to be the primary and recommended method of preventing transmission of HIV and other sexually transmitted diseases.

The eligibility criteria for PrEP limit funding to people not using condoms, and the renewal criteria require the person receive education on how to reduce the risk of HIV.

Funding treatments is not appropriate where the patient has put themselves at risk.

PHARMAC does not consider the cause of a health need when deciding whether to fund a pharmaceutical for it.

Post-decision work

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PHARMAC should monitor the results of the funding decision.

PHARMAC staff will continue to work with the Ministry of Health Sexual and Reproductive Health, Systems Outcomes team regarding monitoring of best practice and outcomes.

PHARMAC should review the funding criteria in the future, such as after 12 months or after 2-3 years.

PHARMAC intends to review the funding criteria after 12 months, to ensure they are appropriate.

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