PrEP – the regulatory pathway and steps to equitable access
Not there yet. From CTAC’s Jack Mohr and Gordon Shallard-Brown, a guest post on the steps required to make PrEP affordable and accessible in Canada
Truvada as pre-exposure prophylaxis (PrEP) is highly effective at preventing new HIV infections. Despite being approved for use in the USA in 2012, and by Health Canada in February 2016 (after being submitted by the manufacturer, Gilead, in 2015) Canadians who are interested in starting PrEP have been stymied by the length of the regulatory process and the cost involved.
So what is that process?
Step one of a three step regulatory pathway a drug goes through before being listed on public drug plans is the Common Drug Review (CDR), which is participated in by all public drug plans except Quebec. New drugs are assessed by the Canadian Drug Expert Committee (CDEC), a sub group of the Canadian Agency for Drugs and Technology (CADTH). They in August 2016 recommended public drug programs reimburse PrEP, so long as Gilead reduce the price, prescribers are HIV experienced and PrEP is part of a sexual health program.
Step two will see Gilead negotiating with the pan-Canadians Pharmaceutical Alliance (pCPA), who negotiates prices on behalf of all public drug plans. A successful negotiation leads to a letter of intent (LOI), As of January this year negotiations hadn’t started, and it’s not known when they will, or how long they might take.
Step three is a price listing agreement – a contract between each drug plan and the manufacturer, based on the LOI. However, a plan can decide not to list a drug and manufacturers can focus on negotiations with areas where the most people need their drug.
Because of the uncertain regulatory pathway timelines, and the unique position of PrEP as the first HIV prevention drug, it’s impossible to know when public drug plan listings will happen. 10 million people rely on Canada’s 18 public drug plans – federal, provincial and territorial – for prescription drugs, but currently only Quebec and the Non-Insured Health Benefits program for First Nations and Inuit feature Truvada for HIV PrEP.
So, what is the way forward for fair and equitable PrEP access? Firstly, listing PrEP as an open benefit on all public drug plans (Truvada is over $1,000 a month for those paying out of pocket). Publicly listing PrEP would play a big role in tackling a disease that primarily affects people experiencing health inequalities; the pCPA needs to prioritize negotiations with Gilead to increase the availability of PrEP.
There also needs to be an expansion of PrEP delivery. The CDR recommendation that only HIV experienced providers provide PrEP raises concerns about overloading those deliverers and issues of rural access. Efforts to enable healthcare providers to prescribe and monitor the use of PrEP need to be supported.
A continuation of effective, culturally relevant, community based PrEP information campaigns (e.g. thesexyouwant.ca by the Gay Men's Sexual Health Alliance of Ontario and the Aboriginal PrEP project at 2-Spirited People of the 1st Nations) are vital. They need to be supported with federal funding to nationalize their efforts.
Finally, the Federal Initiative to Address HIV/AIDS in Canada needs to include prevention options such as PrEP in order to meet Canada’s commitment to the UN’s 90-90-90 target.
The Canadian Consensus Statement on the health and prevention benefits of HIV antiretroviral medications and HIV testing highlighted the importance of PrEP as part of a comprehensive response to ending our national HIV epidemic, and the need to address issues of inequality and respond to HIV through a human rights lens in order to effectively implement PrEP.
We know fair and equitable access to PrEP will prevent further HIV infections and increase engagement in sexual healthcare; we now need the policies and leadership to make it happen.
About the authors:
Jack Mohr is a Policy Researcher at CTAC and will be hosting a free webinar, PrEP Regulatory Pathway and Steps for Equitable Access, on Tuesday, 21 March 2017 from 2:00 to 3:00 pm ET. For more information and to register please visit here.
Gordon Shallard-Brown is a Communications Consultant at CTAC