PrEP listing decision deferred


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An HIV prevention advocate has vowed to keep fighting for pre exposure prophylaxis to be PBS listed

Following the announcement by the Pharmaceutical Benefits Advisory Committee that it will defer its decision on the listing of PrEP on the PBS, ACON—a NSW HIV prevention and LGBTI health organisation—says it has committed to continuing to advocate for affordable access to the ground-breaking HIV prevention drug.

PrEP is an antiretroviral treatment taken by HIV negative people at high risk of acquiring HIV to prevent infection, which was approved by the TGA in May last year.

The listing requested is an Authority Required (streamlined) listing for PrEP in adults at high risk of HIV infection.

“The PBAC deferred making a recommendation on tenofovir with emtricitabine for HIV Pre-exposure Prophylaxis (PrEP) to seek further information regarding its cost-effectiveness based on the model developed by the Kirby Institute,” the PBAC noted in its decision to defer.

“Specifically the Committee requested additional analyses considering alternative uptake scenarios where the extent of uptake is reduced and use is limited to medium and high risk individuals, and varying the tenofovir with emtricitabine price.

“The PBAC noted the results for the Kirby model were presented for a number of scenarios based on different uptake in individuals at high, medium or low risk of infection. Only two of the scenarios presented considered use in individuals at high and medium risk of infection, the population which the PBAC agreed to be appropriate.

“Further, both of the scenarios assumed 90% uptake in high risk individuals and the PBAC considered that this level of uptake was unlikely to be achieved in clinical practice.

“The PBAC considered alternative scenarios assuming lower uptake in medium and high risk individuals would be informative.

“The PBAC considered that the acceptable incremental cost effectiveness ratio (ICER) for PrEP would be at the low end of the range previously accepted for other population preventative interventions with large opportunity costs.

“The PBAC considered the utilisation estimates were highly uncertain and difficult to predict, however utilisation was likely overestimated.”

ACON warns that without federal subsidy, the treatment remains too expensive for most people.

It says that the onus is now on the sponsoring companies and PBAC to enter negotiations immediately to resolve the outstanding issues for this essential new innovation in HIV prevention.

ACON President Dr Justin Koonin says PrEP has proved to be an important HIV prevention option for many people and is a vital tool in ending HIV transmissions in NSW.

“We know that PrEP works. What we need now is to ensure that those who would benefit most from it are able to access it in an affordable way,” Dr Koonin says.

“However, time is of the essence and we strongly urge PBAC to take into consideration that there are, on average, three new HIV diagnoses every day in Australia.

“Prevention of HIV is cheaper than a lifetime of treatment and we urge all involved to move on this issue soon.”

Studies have shown that PrEP is extremely effective at preventing HIV transmission, he says.

He cites recent demonstration projects throughout Australia such as the “incredibly successful”  Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) as showing strong results.

Currently, over 6,600 people at high risk of acquiring HIV are being protected by PrEP, he says.

“NSW is leading the way in terms of PrEP access not only nationally, but internationally as well. Our community has clearly demonstrated that it is ready to incorporate biomedical strategies, such as PrEP, into their lives as part of the range of HIV prevention options,” Dr Koonin said.

“HIV remains an incurable, lifelong condition which has a range of implications, including treatment costs for every individual with HIV for the rest of their lives. We know PrEP works and we know that EPIC-NSW, which has been running since March 2016, has been making a real impact.

“We have seen strong leadership on this issue in NSW from the NSW Government and the NSW health system, now we need the Australian Government and associated national regulatory and funding bodies to do the same.”

ACON CEO Nicolas Parkhill says that there are still ways to access low-cost PrEP in NSW through certain arrangements.

“For people at significant risk of contracting HIV in NSW, the EPIC-NSW study is still recruiting. We have had fantastic engagement from a range of clinicians and services, which means there places available right across the state.”

He encouraged high-risk Australians to find out if they are eligible to the study by calling 1800 451 624.

 

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