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pCPA Negotiations for CF Modulators: What Does this Mean for Access?

The pCPA has agreed to begin negotiations with Vertex Pharmaceuticals? What does that mean? 

This means the public drug plans – those provided by the federal, provincial and territorial governments –  are starting negotiations with Vertex. The goal of these negotiations is to come to an agreement for public coverage for both the first and second generation CFTR modulator drugs: Kalydeco and Orkambi. 

Both Orkambi and Kalydeco are already approved by Health Canada. 

Trikafta, a break-through drug with the potential to treat 90% of Canadians living with CF, is not presently included in pCPA negotiations, as it is yet to be submitted to Health Canada, the first step in the Canadian drug approval process. 

Cystic Fibrosis Canada hopes these negotiations for Orkambi and Kalydeco will help to encourage Vertex to submit Trikafta to Health Canada.

How does today’s announcement impact access to cystic fibrosis (CF) modulators in Canada? Can I get them anytime soon?

This announcement is good news! It means that we are one step closer to getting life-changing disease modifying drugs to Canadians with cystic fibrosis, but there is still work to do. 

The  announcement says that public drug plans across Canada are interested in negotiating with the manufacturer, Vertex Pharmaceuticals, on Kalydeco and Orkambi. If the negotiations are successful, more public drug plans can start providing better public coverage for Kalydeco and Orkambi. We will then need to turn our attention to the provincial and other public plans to ensure they all offer public coverage for both Kalydeko and Orkambi. 

And it gives us hope that the manufacturer and our governments can work together to expedite access to Trikafta. Access to Trikafta still has many hurdles to clear. All drugs must go through the Canadian drug review processes, and Trikafta has yet to start this journey. Like Orkambi and Kalydeco before it, the manufacturer will need to apply for and receive Health Canada approval for Trikafta, and to have its maximum price set by the Patented Medicines Prices Review Board (PMPRB). It must then undergo health technology assessment through the Canadian Agency for Drugs and Technologies in Health (CADTH), and the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec, and will also need to clear some separate justification reviews. 

It could take years for Trikafta to get through the regulatory, review and reimbursement process. This is why we need our governments and Vertex to work together to fast-track this drug.

Why isn’t Symdeko a part of these negotiations?

The pCPA requires that drugs be reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH), or the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec, before considering them for public reimbursement. The bodies conduct Health Technology Assessments that inform the reimbursement decision-making processes of our public drug programs.

Both Kalydeco and Orkambi have been reviewed by these bodies. Vertex Pharmaceuticals has yet to submit Symdeko for review. For more information, please contact Vertex directly.

Does this mean that Vertex will submit Trikafta to Health Canada for review?

Cystic Fibrosis Canada hopes these negotiations will help to encourage Vertex to submit Trikafta to Health Canada, and we will continue to lobby the company to submit as soon as possible. We are however aware that changes to the regulatory process, and specifically to pricing regulations imposed by the PMPRB, have led many pharmaceutical manufacturers to hesitate before submitting their drugs to Health Canada. We encourage you to reach out to Vertex should you have any questions about their company and the drug products.

What is the pCPA?

The pan-Canadian Pharmaceutical Alliance (pCPA) is the body that negotiates drug prices on behalf of the public payers, including all provincial governments and the federal government. The pCPA conducts joint provincial/territorial/federal negotiations for brand name and generic drugs in Canada.

What is the difference between the pCPA and the Patented Medicines Prices Review Board (PMPRB)? Where do they fit in the Canadian drug review system? 

When a drug comes to Canada it must go through the Canadian drug review and reimbursement system. The drug must go to various review bodies before it is eligible for public reimbursement. Both the Patented Medicine Prices Review Board (PMPRB) and pan-Canadian Pharmaceutical Alliance (pCPA) are part of the system. They are considered to be the bookends of drug pricing in Canada

When a drug comes to Canada it must first be approved by Health Canada for safety, efficacy, and quality. It also goes to the PMPRB, which sets the maximum price that can be charged for the drug. The PMPRB is an independent quasi-judicial body that regulates the maximum amount that companies can charge for their medicines in Canada. This is done at the point of entrance for a drug in Canada. It must go to the PMPRB for a maximum price ceiling price and through the Health Canada Review in order to be sold in Canada.

After the approval of Health Canada – the drug also goes to a body known as the Canadian Agency for Drugs and Technologies in Health (CADTH) and, in Quebec, the Institut national d’excellence en santé et en services sociaux (INESSS). Both conduct Health Technology Assessment, which governments look to to inform decisions about public reimbursement of drugs. CADTH makes non-binding recommendations to provincial and federal drug programs on whether drugs should be publicly covered. Governments don’t always follow this advice, but most do.

After the CADTH recommendation, if the provinces and federal governments want to move ahead with price negotiations on a given drug, the drug can go to the pan-Canadian Pharmaceutical Alliance (pCPA) which conducts the price negotiation on behalf of the public payers. Federal, territorial and provincial public plans are members of the pCPA. 

How long will the pCPA and Vertex negotiations take? 

There is no time limit on negotiations. They could go quickly, or they could go slowly. From our standpoint, we are pressuring provincial governments and Vertex to get to an agreement fast so that people with CF can finally get the medicines they need.

Where would I be able to find more information on this?

 Please visit the pCPA website for more information. 

After the negotiations end, will CF medications, like Trikafta, be available?

In order for Trikafta to come to Canada, it must still go through the Canadian drug regulatory review and reimbursement system—which could take years. This is why we are asking all governments and Vertex to work together to fast-track the drug review and reimbursement bodies, to align these processes to quickly review Trikafta, and having these bodies work simultaneously instead of sequentially where possible. 

Canada doesn’t have a process to fast track these types of drugs, so we need to continue to push for all bodies to work together to get Trikafta to people quickly. We continue to fight for a fast and fair process for these types of medicines.

What can I do to help get access to Trikafta? 

Unless our governments get their processes aligned, it could take years for Trikafta to get through the regulatory, review and reimbursement process once it is submitted to Health Canada. Many people with CF don’t have time to wait. They may be hospitalized, need transplants or even pass away during this time. This is unacceptable. We need to come together as a community and advocate to both provincial and federal elected officials. We are calling on all governments to fast track Trikafta through the various review bodies to get the drug to those who need it now. 

If you would like to help, write to your provincial elected official to ask them to encourage their Ministers of Health, the federal government, and the various drug review and reimbursement bodies to align the review and reimbursement processes for Trikafta.

During the week of June 15, 2020 we also expect to see a new consultation opportunity on guidelines for the Patented Medicines Prices Review Board (PMPRB). We will provide more information on how you can work with your federal elected official upon review of the guidelines.

Who should I speak with about this?

Speak to both your local provincial and federal elected officials. We need all levels of government to fast track Trikafta through the regulatory, review and reimbursement process. People need access to Trikafta now and do not have years to wait.