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Sep14

Common Drug Review recommends public drug plans in Canada reimburse PrEP

Wednesday, 14 September 2016 Written by // Guest Authors - Revolving Door Categories // Social Media, As Prevention , Activism, Gay Men, Treatment Guidelines -including when to start, Current Affairs, Treatment, Revolving Door, Guest Authors

Glenn Betteridge with a PrEP update on another chapter in the promise and perils of Truvada for HIV prevention in Canada

Common Drug Review recommends public drug plans in Canada reimburse PrEP

Background

On 26 August 2016, Canada’s national health technology assessment body published its Final Recommendation for Truvada as HIV pre-exposure prophylaxis (PrEP).1 The Canadian Drug Expert Committee (CDEC) recommended that Truvada for HIV PrEP be reimbursed under public drug plans in Canada, subject to two conditions.

Truvada, marketed in Canada by Gilead Sciences, is safe and highly effective at preventing HIV-negative people from getting HIV when taken daily, and has been approved by Health Canada for this use.2 While the science is clear, accessing Truvada for HIV PrEP in Canada has been murky for years. Only in 2015 did Gilead Canada apply to Health Canada for approval to sell Truvada—long part of the backbone of HIV treatment regimens—for HIV prevention. Based on Health Canada’s approval in February 2016, Gilead is now going through the four-step process to get Truvada included in federal, provincial and territorial public drug plans for use as PrEP. The positive recommendation from CDEC is just one step, albeit a crucial one, in increasing access to PrEP via public drug plans in Canada.

Truvada was approved for sale in Canada as an HIV treatment in 2006. Some gay men with robust private drug insurance plans and access to PrEP-friendly doctors have been getting Truvada as PrEP “off-label” for years. Recently a small but increasing number of people have been importing generic Truvada for PrEP into Canada. As for reimbursement under public plans, people in Quebec with its universal plan and people eligible for the drug through the fed’s First Nations and Inuit Health program have been officially able to get reimbursement for Truvada as PrEP.

A positive development

The CDEC Final Recommendation to reimburse Truvada for HIV PrEP through public drug plans is a positive development. Truvada has proven safe and highly effective at reducing the risk sexually acquired HIV when taken daily by HIV-negative people. The monthly retail cost of Truvada for HIV PrEP is between $800 and $1000. Many of the people most in need of Truvada for HIV PrEP may not have private prescription drug insurance to cover some or all of the cost, or money to pay for Truvada out of their income or savings.

If federal, provincial and territorial public drug plans list Truvada for HIV PrEP, people at high risk of HIV—especially socially and economically marginalized people—people who are eligible for public drug coverage will be able to access the PrEP at a relatively low cost or for free.

Cause for concern and caution?

CDEC’s Final Recommendation includes two conditions and two “notes, which raise potential cause for concern and caution.

First the caution: The CDEC recommendation sets the framework for upcoming negotiations between Gilead and the public drug programs, where they will bargain about price and other cost-based conditions for public listing. Truvada—as both an HIV treatment and a novel drug for HIV prevention—is relatively expensive (between $800 and $1000 per month). At the same time, it is difficult to figure out with any certainty the number of people at high risk of HIV who are in need of PrEP and who might be prescribed Truvada. This makes it challenging for each government drug plan to estimate how much money the plan might be required to spend on Truvada for HIV PrEP.

Now the concern: CDEC has placed two conditions on its positive reimbursement recommendation, and added two notes. One of the conditions is intended to make clear to Gilead that it must reduce the price of Truvada in order to get it listed on the public plans. At the extreme, if Gilead will not lower Truvada’s price to what the public drug plans are willing to pay, Truvada for HV PrEP might not make it through the pCPA negotiation process.

While this concern may seem farfetched, England and Australia have decided against publicly listing Truvada for PrEP and France is relying on generic FTC/TDF for its public PrEP programs. A more likely outcome in Canada is that Gilead will reduce the price and the public drug plans will incorporate CDEC’s prescriber and program related conditions into their listing criteria and categories as a way to further contain costs. If this happens, Truvada for HIV PrEP might not be as accessible under public drug plans as many people in the community have called for.3

The political backdrop

The health technology assessment and negotiation processes for public drug plan listing of Truvada as HIV PrEP are taking place at a time when Canadian federal, provincial and territorial governments are working separately and collectively to contain their prescription drug expenditures. Within this context, the pathway along which name-brand drugs have to travel to be eligible for reimbursement under public drug programs increasingly functions as a cost-containment mechanism.4 Given that the potential budget impact of Truvada for PrEP on public drug programs is tough to determine with any certainty, the public plans might proceed with caution when deciding whether or not to list.

"CanPrEP—an alliance of community and community-minded individuals and organizations who came together in the fall of 2015 to increase access to and uptake of PrEP—has tried to insert community views and voices into the upcoming pCPA negotiations. Not prepared to settle for a phone call with the pCPA’s administrative office, we fought for the opportunity and made detailed written submissions to the public drug plans."

When considering the CDEC’s conditions and notes, it is also important to keep in mind that even where all 18 public drug plans in Canada list a medication, access to the medication can vary widely. Truvada for treating HIV provides a good example of the multiple many and varied ways the same medication is listed on the different public plans—including the fact that only some of the provinces offer it as a general or open benefit, many provide it through special or exceptional programs for HIV or high-cost drugs, and two plans already reimburse Truvada for HIV PrEP based on how Truvada was listed for HIV treatment. CDEC’s conditions and notes regarding who can prescribe Truvada for HIV PrEP, and in what context, might create barriers to PrEP access for people who get their medications under public drug programs. Whether the conditions and notes ultimately result in barriers to PrEP access under public drug plans, and the extent to which they do, will probably depend on three factors: (1) the terms and conditions of listing worked out in the pCPA negotiation process between Gilead and the public drug plans; (2) the particular structure and rules of each public drug plan; and (3) whether the drug plan is ready, willing and able—in terms of resources and technical capacity—to enforce any restrictive criteria, rules or procedures it might place on Truvada for HIV PrEP.

Next up: secret negotiations and continued community action

Over the coming months, who will be able to access PrEP through public plans, under what conditions, through what process and how much they might have to contribute will come into sharper focus.

In the short term, community advocates and front-line providers promoting access to PrEP will consult with people with expertise in interpreting CDEC recommendations and understanding how such recommendations can shape public drug plan negotiations and public drug plan listing. We will also continue the PrEP access advocacy started by Vancouver-based HIM in spring 2015, when it wrote an open letter to the president of Gilead Canada demanding the company seek Health Canada approval for Truvada as PrEP.

CanPrEP—an alliance of community and community-minded individuals and organizations who came together in the fall of 2015 to increase access to and uptake of PrEP—has tried to insert community views and voices into the upcoming pCPA negotiations. Not prepared to settle for a phone call with the pCPA’s administrative office, we fought for the opportunity and made detailed written submissions to the public drug plans. The pCPA negations between Gilead and the public drug plans take place behind closed doors, based on mostly confidential information and, if successful, will result in a confidential agreement between Gilead and the public drug plans who participate in the negotiation.

Meanwhile my colleagues will continue their community-driven campaigns calling for affordable, equitable and timely access to Truvada for HIV PrEP. Because the majority of people at risk of HIV who are eligible for public drug plans live in the bigger provinces, given our scarce human and financial resources we are focusing grass-roots advocacy on provincial governments—the civil servants, ministers of health and publicly funded provincial HIV programs responsible for HIV drugs—to make PrEP accessible to all those who need it, without budget-driven restrictions that lack a compelling medical or scientific basis.

The efforts are being spearheaded to local HIV and gay men’s health organizations. Check out the LIST PREP NOW campaign in Ontario, the Affordable PrEP Access Now! campaign being led by HIM in BC, and the activities of the Edmonton Gay Men’s Health Collective on their website and on Facebook. These campaigns could use your support.

CTAC has published a preliminary analysis of the CDEC recommendation and the potential implications for the listing of Truvada for HIV PrEP on public drug plans in Canada.

1 The CDEC Final Recommendation for Truvada as HIV PrEP can be accessed online. Within the Canadian Agency for Drug and Technology in Health (CADTH), the Canadian Drug Expert Committee (CDEC) carries out the core function of the Common Drug Review (CDR). Truvada is the brand name of the pill that combines the anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate (FTC/TDF).

2 Before a pharmaceutical company can sell a drug in Canada, Health Canada must approve the drug. If the pharmaceutical company wants public drug plans in Canada to list the drug for reimbursement (in other words, to pay for the drug) the company must make an application to the Canadian Agency for Drugs and Technology in Health (CADTH). Within CADTH, the Canadian Drug Expert Committee (CDEC) carries out the core functions of the Common Drug Review (CDR) process. Based on a review of the evidence (clinical, economic, and from patients and health care providers) and the pharmaceutical company’s submission, CDEC makes a recommendation to public drug plans about whether the plans should reimburse the cost of a drug for people enrolled in a public drug plan.  CDEC assesses name brand drugs (i.e., not generic drugs) for health conditions other than cancers. If the pharmaceutical company wants the Quebec public drug plan to list the drug, it must make a separate application to Quebec’s Institut national d’excellence en santé et en services sociaux (INESS). INESS performs the same type of drug review function as CADTH, but provides its recommendation exclusively to Quebec’s public drug plan.

3 For examples of community campaigns calling for affordable, equitable and timely access to Truvada for HIV PrEP, see the LIST PREP NOW campaign in Ontario, the Affordable PrEP Access Now! campaign in BC, and work by the Edmonton Gay Men’s Health Collective described on their website and on Facebook.

4 There are four inter-dependent processes in the public drug plan reimbursement pathway for name-brand patent-protected medications. To get a public plan to list a drug for reimbursement a drug manufacturer must successfully move its drug through all four processes: (1) application to Health Canada to assesses the drug’s safety, effectiveness and manufacturing process; (2) application for a health technology assessment, undertaken by CADTH or INESS in Quebec, to determine the extent to which the drug represents good value for money in light of its price, effectiveness and adverse effects when compared with already publicly listed drugs to treat the same condition; (3) negotiations with the pan-Canadian Pharmaceutical Alliance, representing all the public drug plans in Canada; and (4) a price listing agreement with the public drug plan—there are 18 federal, provincial and territorial drug plans in Canada. Each of these processes takes place mostly behind closed doors, with little or no public access to information brought forward by the drug manufacturer or access to the information considered by, or the deliberations of, decision-makers. For more information about drug development, approval, pricing and public drug plan listing in Canada, please watch CTAC’s short video, Approval and Public Listing of Drugs in Canada.

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