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Volunteer Advocate

Trikafta Can't 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, CF Canada, its partners and clinicians, Cystic Fibrosis Canada have received information that the decision has been made to bring new CF medicines to Canada. The Minister of Health has confirmed that an application to bring Trikafta to Canada is in progress and with a ‘priority review’ to speed the approval process with Health Canada. 

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.

Read more about this news here.
Review our FAQs for additional information.
Visit our Trikafta page, for more information about the drug.

COMMUNITY BRIEFING

Understanding that there is great anticipation around this Trikafta application and what lies ahead, we hosted a community briefing  to respond to questions, explain next steps in the drug approval process and outline our plans to continue to push to get Trikafta into the hands of Canadians as quickly as possible.

English briefing
Hosted by: Kelly Grover, John Wallenburg and Kim Steele
When: 6:00- 7:00pm EST Thursday 12th November, 2020

French briefing
Hosted by: Kelly Grover, John Wallenburg and Olivier Jerome
When: 7.30- 8.30pm EST Thursday 12th November, 2020
Webinar recording coming soon.

WEBINAR SERIES: ACCESS TO MODULATORS

Cystic Fibrosis Canada is hosting a webinar series focused on answering your questions regarding the access to CF modulators in Canada. We are happy to announce that the first webinars of the series will take place this December. Recordings will be available in the days following the webinars.

Understanding CF Modulators

This webinar will feature information on how CF modulators and Trikafta work and what these treatments mean for the CF community. Clinical trials will also be addressed and a clinician will present their viewpoint on access to modulators.

English
Hosted by : Kim Steele, Dr. John Wallenburg and Dr. Martha McKinney
When: 6:00- 7:00pm EST Thursday 3rd December, 2020
To attend : https://bit.ly/39cIrIp
French
Hosted by : Olivier Jérôme, Dr. John Wallenburg, Dr. Christelle Bergeron and Dr. André Cantin
When: 7:30- 8:30pm EST Thursday 3rd December, 2020
To attend : https://bit.ly/3fy8Z7S

Modulators in Canada’s health system

This webinar will present Canada’s health and drug access systems. Our experts will expose the steps Trikafta and other CF modulators need to go through to get in the hands of Canadians living with CF.

English
Hosted by : To be confirmed
When: 6:00- 7:00pm EST Thursday 10th December, 2020
To attend : link will be provided soon
French
Hosted by : To be confirmed
When: 7:30- 8:30pm EST Thursday 10th December, 2020
To attend : link will be provided soon

Stay tuned for more webinars in the new year!

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.