Proposal to fund HIV pre-exposure prophylaxis (PrEP)

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:

Both:

1. Patient has tested HIV negative; and
2. Either:
   1. All of the following:
      1. Patient is male or transgender female; and
      2. Patient has sex with men; and
      3. Patient is likely to have multiple episodes of condomless anal intercourse in the next 3 months; and
      4. Any of the following:
         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. A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or
         3. Patient has used methamphetamine in the last three months; or
   2. All of the following:
      1. Patient has a regular partner who has HIV infection; and
      2. Partner is either not on treatment or has a detectable viral load; and
      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
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 had 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:
   1. All of the following:
      1. Patient is male or transgender female; and
      2. Patient has sex with men; and
      3. Patient is likely to have multiple episodes of condomless anal intercourse in the next 3 months; and
      4. Any of the following
         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. A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 3 months; or
         3. Patient has used methamphetamine in the last three months; or
   2. All of the following:
      1. Patient has a regular partner who has HIV infection; and
      2. Partner is either not on treatment or has a detectable viral load; and
      3. Condoms have not been consistently used.

A similar change would be made in Part II of Section H of the Pharmaceutical Schedule.