From a PrEP PBS Listing to Where?

By Daniel Storer, Policy Analyst, Australian Federation of AIDS Organisations (AFAO)

Information in this blog was originally presented at the National Association of People With HIV Australia (NAPWHA) Treatment Officers Network (TON) Meeting, 19 April 2018.

It has been a lengthy process to list Pre-Exposure Prophylaxis (PrEP) on Australia’s Pharmaceutical Benefits Scheme (PBS).

Truvada was the first PrEP medicine approved by the Therapeutic Goods Administration (TGA) in May 2016. This was followed by the approval of two generic bioequivalents of Truvada, manufactured by Mylan and Lupin Generic Health, when the patent holder’s patent expired on 1 August 2017.

Prior to the approval of the third generic version of Truvada manufactured by Lupin Generic Health, Gilead and Mylan made independent submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for PrEP to be listed on the Pharmaceutical Benefits Scheme (PBS). Both submissions were deferred by the PBAC to enable additional modelling to be obtained on the estimated uptake of PrEP among low to medium risk gay and bisexual men. The Australian Federation of AIDS Organisations (AFAO) kept contact with Gilead and Mylan after the deferral and both expressed reluctance to meet the price PBAC recommended for approval. AFAO initiated contact with Lupin Generic Health, to create more competition among the generic manufacturers pursuing a contract with the government to supply subsidised PrEP through PBAC.

​The entry of Lupin Generic Health into the marketplace had the intended effect of forcing a reduction in the price offered by manufacturers for PrEP to be listed on the PBS. PrEP was recommended for listing on the PBS on 9 February 2018 and listed on the PBS on 1 April.

Prior to this, access to PrEP was limited. While it was possible to get a prescription, the medicine was prohibitively expensive, as PrEP was not subsidised. State and territory funded access trials operated across the country, but access to these trials was affected by location, availability, cost and eligibility criteria.

Although many who are eligible for PrEP are already taking it, an estimated 17,500 people eligible are not. The effort and time that went into advocating for PrEP to be listed on the PBS now needs to be reoriented toward health promotion and education to increase uptake of PrEP so that the public health benefit of PrEP can be realised.

Health promotion needs to address the specific needs of eligible HIV negative gay and bisexual men who are not currently using PrEP. While state and territory organisations and health departments are making concerted efforts to reach as many eligible people as possible, an intensive nationally coordinated PrEP health promotion and education response needs to be conceived and delivered.

This should include promotion of ‘on-demand’ PrEP use. This form of administration can be adopted by people who have infrequent or planned episodes of risk. Instead of ongoing daily use of medication on demand use requires two tablets, two – 24 hours prior to exposure to risk and then one tablet at 24 hours and then again at 48 hours after exposure. On demand PrEP is now included in the national prescribing guidelines, and appropriate and clear messaging needs to be produced and distributed to ensure this method of dosing is used safely.