Decision to fund HIV pre-exposure prophylaxis (PrEP)

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:
   1. All of the following:
      1. Patient is male or transgender; 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; 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. 6Any 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.

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:
   1. 2.1   Patient has had unprotected receptive anal intercourse with a known HIV positive person; or
   2. 2.2   Patient has shared intravenous injecting equipment with a known HIV positive person; or
   3. 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.

Initiation – Pre-exposure prophylaxis

Re-assessment required after 3 months

Both:

1. Patient has tested HIV negative; and
2. Either:
   1. All of the following:
      1. Patient is male or transgender; 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.

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:
   1. All of the following:
      1. Patient is male or transgender; 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.