Over a decade ago, clinical trials began in the United States, where HIV negative men were given an antiretroviral drug, Truvada, to find out if it could reduce their risk of HIV. This is the same drug that people living with HIV take to reduce their viral load count. Initial studies showed the risk reduction was 43%, however, after many other studies have been conducted over the years, Truvada has been proven to reduce the risk of HIV transmission by up to 99% when taken daily. Throughout all the trials that have been conducted in every jurisdiction over the years, not a single person in any of the studies who took Truvada daily became HIV positive!
With all the great advances with Truvada and other antiretroviral drugs, there has been significant endorsement of the use of PrEP world wide, including the World Health Organization endorsing the use of Truvada as PrEP in 2014, as an important measure to reduce the HIV transmission rates.
However, Canada, which has been a world-leader in research and treatment for people living with HIV, has been painfully lagging behind in adopting the use of Truvada as PrEP. Truvada has been approved for use in Canada as a treatment for people living with HIV; however, Health Canada has not approved the use of the drug as PrEP. This is because the drug manufacturer, Gilead Science, has to submit a formal application to Health Canada. There had been talks about an application years ago, however, these discussions broke down and the application was never submitted.
This summer there has been increased pressure put on Gilead Sciences to submit their application to Health Canada. Recently an open letter was submitted to the company, endorsed by many leading men’s health and HIV/AIDS resource organizations across Canada, including the Health Initiative For Men (HIM, Vancouver), AIDS Committee Toronto (ACT), AIDS Vancouver, Canadian Association of Nurses in HIV/AIDS Care (CANAC), CATIE, and Vancouver Coastal Health Regional HIV Program, amongst many others.
Additional pressure has come from the medical community, the media, and individuals who see and understand the benefits, and who desperately want access to the drug; however, there has been little or no movement on the matter. In a time of digital technology, the world is moving at the speed of now, and the process of getting Truvada as PrEP into the hands of eagerly waiting Canadian gay men is moving at a snails pace at best.
Vancouver, British Columbia recently held the International AIDS Society Conference, where the topic of PrEP was again discussed. It has again brought increased media presence and discussion of PrEP to the forefront of the gay community, who are clamoring for financial access and approval for the drugs.
“Health Initiative for Men (HIM) supports the goals of the recent Vancouver consensus signed at the International AIDS Society Conference 2015 – we believe that as part of a combination prevention effort, PrEP must be made available to protect those at high risk of acquiring HIV – specifically gay men,” said Jody Jollimore, director of research and strategic partnerships at the Health Initiative for Men.
Gay men living in Montreal have access to a provincial program where Truvada as PrEP is funded, and in Toronto, a pilot program is underway, allowing patients to access the drug. However, for the rest of Canadians, who want to be proactive in reducing their risk, are coming against brick walls at almost every turn.
For the lucky handful of Canadians who have found a physician specializing in HIV who, and who is willing to prescribe Truvada as PrEP off-label (for its non-approved / unintended use), have worked with their insurance companies for drug coverage; which takes a significant amount of time, perseverance, and dedication. However, in recent months, those who have been previously covered are suddenly finding out their claims are now being denied, citing that the drug is not approved by Health Canada for that intended use, therefore they will no longer cover the costs. This is forcing patients to either stop taking the drugs, or fund the costs themselves, which ranges from $800-$1,200 per 30 days.
Insurance companies are smart. They know that the provincial governments will pay for HIV medication for people who are HIV positive. In British Columbia, the BC Liberal government will not fund the cost of Truvada as PrEP through the Provincial Drug Program or PharmaCare, but they will pay for the drug treatment for someone who is living with HIV.
“The Centre for Excellence does not provide coverage of Truvada for pre-exposure prophylaxis,” said Terry Lake, Minister of Health at the Province of British Columbia, in a letter addressed to MLA Spencer Chandra Herbert, received May 28, 2015. “As the Centre for Excellence notes on its webpage, physicians may choose to prescribe this medication for off-label use, and individuals who receive a prescription may pay for it themselves, or may receive coverage through third-party insurance plans.”
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Essentially, drug companies don’t want to pay out a claim for a drug that they believe should be paid for by provincial governments, and the provincial government doesn’t want to pay the cost to keep tax-paying citizens healthy. Funding is they key issue for most people who want to be on Truvada as PrEP; and if the provincial government is willing to cover the cost as post-exposure, they should be paying for the costs to keep people HIV negative through pre-exposure treatments, including Truvada as PrEP.
To put it plain and simple, Truvada as prevention is $800-$1,200 per month, to keep a person HIV negative; however, if they seroconvert, and become HIV positive, the cost to the provincial government drug program can easily exceed $3,500 per month. Granted, PrEP isn’t for everyone, but for those who work in adult entertainment, escort, are in a serodiscordant relationship (one partner is HIV negative and the other is HIV positive), or has multiple sexual partners on a regular basis, they deserve the option to have access to medications that can keep them HIV negative.
Essentially, Canadian governments and insurance companies would rather gay men get HIV, than to pay the cost to prevent them from getting it in the first place! Every jurisdiction is passing the buck to someone else, leaving Canadian doctors and gay men frustrated, knowing that their friends and partners in other first-world jurisdictions are able to access the treatment and get it fully covered through private insurance or government funded drug programs.
Here’s what needs to happen immediately to get Canada back on track and back into the position as a world-class leader in HIV:
- Gilead Sciences needs to get their application for Truvada as PrEP to Health Canada right away.
- Health Canada then needs to act swiftly, by reviewing and approving the application at once, without hesitation.
- Regardless of the timing of the first two items, the Provincial health ministries across Canada need to approve the funding of Truvada as PrEP through the provincial drug programs for those who do not have health insurance or cannot afford it, so doctors can at least prescribe the drug off-label for the short term and patients can get funding while the regulatory process in in progress.
- Public health and community outreach organizations need to create dynamic education and awareness campaigns to support the use of PrEP as a prevention option.
As a sign of optimism, Karen Chow of Gilead Sciences Canada recently confirmed the organization is back in talks with Health Canada to submit an application of Truvada as PrEP; however there is no known timeline on when their application will be submitted or how long it will take Health Canada to review the submission.