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Volunteer Advocate

Trikafta Can't Wait

Save the date

Join Cystic Fibrosis Canada for a Facebook Live Rally for Trikafta on the day Health Canada announces the decision from their review of Trikafta. This is expected on or before Wednesday 23rd June, 2021.  

After more than a year of tireless advocacy work from the cystic fibrosis community in Canada, this decision will hopefully see this life changing drug approved for sale in Canada. . Let's come together as a community and hear from our government relations experts and advocates on the next steps to gaining access to life changing modulators. Because #CFcantwait 

Date: June 21, 22 or 23  
Time: 6pm EST 
Format: Facebook Live 

Join the #CFcantwait Campaign 

We’re calling on provincial governments to cover life-saving CF drugs, including Trikafta, without delay.   

Life-changing cystic fibrosis drugs, Kalydeco and Orkambi, have been sitting with provincial governments, who have the decision-making power to fund them, for more than a year while Canadians with cystic fibrosis wait and become sicker without access. The ‘miracle drug’ Trikafta, that could change the lives of 90% of the Canadian CF population, could soon be tied up in the same red tape. 

We need your help to tell provincial elected officials that Canadians living with cystic fibrosis can’t continue to wait. You can take action in any of these ways: 

Let’s go further, together, to end the wait. 

TRIKAFTA IS COMING TO CANADA

Our collective message has finally been heard. CF can’t wait. We need Trikafta now, and we will soon have it.

Following a year of tireless advocacy from the Canadian cystic fibrosis community, Cystic Fibrosis Canada, its partners and clinicians, the decision has been made to bring the new CF medicine, Trikafta, to Canada.

Health Canada confirmed on 23 December 2020 that an application to bring Trikafta to Canada was accepted for review. On 28 December 2020, the manufacturer confirmed that Trikafta has been accepted for priority review - meaning a review timeline of 180 days has begun, though this timeline could change if Health Canada needs to request additional information.

The Canadian Agency for Drugs and Technologies in Health (CADTH), an important drug review body that evaluates the cost effectiveness of drugs, has also indicated that a review is underway for Trikafta for age 12 plus for patients with at least one F508del mutation. The CADTH review is a promising indication that the manufacturer was granted an ‘aligned review,’ the fastest review route possible. We are awaiting further confirmation of this.

This is a milestone we fought hard for as a community, one that should have come sooner, but is here now thanks to the relentless will and determination of the cystic fibrosis community.

Review our FAQs for additional information.
Visit our Trikafta page, for more information about the drug.

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COMMUNITY VOICES SHARED IN TRIKAFTA REVIEW PROCESS

Thank you to more than 1,500 people impacted by cystic fibrosis who completed Cystic Fibrosis Canada’s community survey to help inform our patient group submissions to the Canadian Agency for Drugs and Technologies in Health (CADTH), Institut national d'excellence en santé et services sociaux (INESSS), and BC Pharmacare. The survey closed on January 26, 2021.

Each of the review bodies mentioned conduct a cost effectiveness review of new medications. As part of their reviews of Trikafta, these organizations want to learn more about the experience of people living with cystic fibrosis and their caregivers, which is where our submissions, with your input, play a role.

What lies ahead

We look forward to confirmation that an application has been submitted to Health Canada to bring Trikafta to Canada and are monitoring the Health Canada website closely for this news.

The Federal Minister of Health has publicly committed to fast track Trikafta. This could shorten review and assessment processes by various government bodies, like Health Canada and the Patented Medicine Pricing Review Board (PMPRB), that can take from one to two years to a year or less.

While the application to Health Canada is a critical step, we still face hurdles to get Trikafta into the hands of Canadians who need it now. Rest assured, we won’t stop until that happens.

Stay tuned for next steps that will include turning our sights to the provincial governments, where we’re already pushing for access to all CF modulators through public drug programs. Our work on stopping implementation of the PMPRB guidelines and creating a fast and fair process for rare disease medicines will also continue, so that Canadians with CF don’t have to wait for future game-changing therapies.

FAQs

The rough timeline for approval can depend on the type of review that is undertaken by Health Canada. 

The first step is for the manufacturer to submit a request for priority review preferably with an aligned review. The Health Minister confirmed on November 17th 2020, that Vertex was granted priority review status for Trikafta. Since the manufacturer has applied for and has been granted a ’priority review’, Health Canada approval - which permits the drug to be for sale in the Canadian market -  could be completed in six months. 

If the manufacturer consents to an ‘aligned review’, several government review bodies will work in parallel, at the same time. For instance, the Health Technology Assessment done by the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et en services sociaux (INESSS) would happen at the same time as (or in alignment with) the Health Canada review, as would the Patented Medicine Prices Review Board’s (PMPRB) pricing review. See this short video overview of the Canadian drug review and reimbursement system for more information on the entire review process. All in, an aligned review may take 12 months or less.

If an aligned review is not granted it could take up to two years or more to get the drug through the drug review and reimbursement system, however Cystic Fibrosis Canada will be working to ensure this is not the case. We will continue to press for the fastest review possible. We are encouraged that, in a meeting with Cystic Fibrosis Canada, the federal Minister of Health committed to fast-track the drug through Health Canada for approval and pricing review by the PMPRB. 

On the whole, Canada does not have a fast and fair process for game-changing rare disease medicines, like Trikafta. Cystic Fibrosis Canada continues to pressure our federal and provincial governments to put such a process in place to ensure future innovative therapies do not face barriers to access.

In a recent meeting with Cystic Fibrosis Canada, the Federal Minister of Health committed to fast track Trikafta through Health Canada for approval and pricing recommendations, which could shorten what is typically a one or two year process to less than a year. She also stated her commitment to fast-track the drug publicly on Friday, 6 November in the House of Commons. This likely means the Minister will grant an aligned review if the company applies for one. 

When Cystic Fibrosis Canada met with Minister Hajdu we also asked her to work with the provinces to ensure that Trikafta can be covered through public drug programs quickly. The Minister said she has been in conversations with the provinces about them moving quickly to reimburse the drug. It’s important to note, however, that the Minister does not have jurisdiction over provincial drug pricing, which is negotiated with the manufacturer through the panCanadian Pharmaceutical Alliance (pCPA), who we are also asking to expedite any negotiations involving Trikafta and other CF modulator drugs, including Orkambi and Kalydeco.

Depending on your plan, if you have private insurance you may be able to access the drug shortly after Health Canada approves it for sale in Canada, or after subsequent review and assessment processes are done (see this short video overview of the Canadian drug review and reimbursement system for more details). However, the drug will not become available on public plans until pan-Canadian Pharmaceutical Alliance (pCPA) price negotiations are complete and provinces list the drugs on their formularies. 

There are no timelines on pCPA negotiations and even after negotiations are completed provinces can independently choose whether or not they will list the drug. Cystic Fibrosis Canada will continue our efforts to have the drug negotiated quickly as part of a package with other CF modulator drugs, Orkambi and Kalydeco.

The court case could affect the PMPRB’s pricing of the drug, but not the process of review by Health Canada that determines if the drug can be sold in Canada. For that, Health Canada looks at safety, efficacy and quality of a drug. 

Health Canada approval is separate and independent of the PMPRB, though the review processes can be aligned, as discussed in an earlier Q&A response. Likewise, the CADTH and INESSS Health Technology Assessment reviews should not be affected by changes to the PMPRB guidelines, and both the CADTH and INESSS assessments are included in the aligned review.  

See this short video overview of the Canadian drug review and reimbursement system for more details.

Yes. The Special Access Programme (SAP) provides life-changing and life-saving medicines that are not available in Canada. With a Health Canada approval, Trikafta will become available for sale in Canada, so the drug will not be made available through the SAP for any new requests. 

The manufacturer has informed Cystic Fibrosis Canada  that patients receiving Trikafta through the SAP will continue to receive the drug from the manufacturer until they receive other coverage, either through private or public insurance.

Cystic fibrosis gene modulator drugs, Orkambi and Kalydeco, are currently subject to pricing negotiations between the public drug plans, through the pan Canadian Pharmaceutical Alliance, and the manufacturer. These negotiations started in May 2020. An agreement would mean the provinces and other public plans can choose to add Orkambi and/or Kalydeco to their provincial drug formularies for public access.

Symdeko has not yet been submitted by the manufacturer for a Health Technology Assessment. Because it is approved by Health Canada for sale in Canada, Symdeko is available through some private insurance plans. Generally speaking, our federal and provincial public drug programs will not negotiate for medicines that have not been through a Health Technology Assessment review by review bodies CADTH and INESSS. 

Cystic Fibrosis Canada continues to urge the manufacturer to put Symdeko through CADTH and INESSS review so that the price of this drug can be negotiated, which would allow for listing of the drug on federal and provincial formularies for public access.

The manufacturer has stated that they have decided to bring their new CF medicines to Canada. To our knowledge, the manufacturer has promised to submit Trikafta, but has not yet done so. We are eagerly awaiting news out of Health Canada that a submission has been received. This will be posted to their website. 

It is not yet possible to determine which individuals are likely to be eligible. Health Canada determines the indications for and clinical use of drugs in its product monographs. 

Cystic Fibrosis Canada is working with our network of Canadian cystic fibrosis clinicians on the development of recommended prescribing criteria, which we will share with federal and provincial drug program leads to inform their decision-making.

Thank your Member of Parliament for helping us get Trikafta into Canada. Talk to your provincial elected official. Tell them that the drug is going through the process that will ultimately lead to our public drug plans. Ask them to speak to their respective ministers of Health and drug program managers about expediting price negotiations of Kalydeco and Orkambi and to add Trikafta. Explain that there presently are no timelines on these negotiations and that CF can’t wait. Tell them that Trikafta needs to have public coverage now.

Stay tuned to our website - Cystic Fibrosis Canada is currently updating our advocacy resources and will soon have fresh materials to guide your conversations and actions.

You can also consider joining Cystic Fibrosis Canada’s National Advocacy Network. Our advocates can have a significant impact on the way CF issues are addressed in Canada. Working with CF Canada’s guidance, training and support, advocates build relationships with elected and non-elected officials in order to increase support for programs, services and policies that can improve the health and quality of life for people with cystic fibrosis.

Access to some medicines to treat COVID-19 symptoms have received expedited authorization through an Interim Order signed by the Minister of Health. The Interim Order was made under subsection 30.1(1) of the Food and Drugs Act (the Act), which allows the Minister to make temporary interim orders if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. The existence of such legislation highlights the broken nature of Canada’s drug review and reimbursement system, but it does not allow other drugs to receive similar treatment by the system under this Order. CF Canada continues to advocate for a review and reimbursement system that treats all drugs fairly.