HEALTH TECHNOLOGY ASSESSMENTS
As part of Canada’s drug review and reimbursement process, new drugs are reviewed by Canada’s Health Technology Assessment (HTA) bodies who consider the cost effectiveness of new medicines. The main HTA bodies In Canada are:
- Canadian Agency for Drugs and Technologies in Health (CADTH)
- Institut national d'excellence en santé et en services sociaux (INESSS)
WHAT ARE CADTH AND INESSS?
CADTH is an independent, not-for-profit organization responsible for providing informed decisions about the cost effectiveness of drugs and medical devices in Canada. CADTH provides non-binding recommendations to federal, provincial and territorial governments on whether or not to cover the cost of medications through their public plans.
CADTH recommendations are used by all Canadian provinces, except Quebec, which has its own review board, INESSS. Some provinces, like B.C., also have province specific reviews; unlike Quebec, these provinces also rely on the CADTH decision to inform their reimbursement decisions. That said, provinces do not have to adhere to the recommendations, which are non-binding, and can decide to cover drugs individually.
For Quebec residents, INESSS conducts its own cost-effectiveness reviews of new medicines. It issues recommendations concerning their adoption, use and coverage by the public plan, and develops guides to clinical practice in order to ensure their optimal use.
Since 2018, reviews of new drugs conducted by CADTH and INESSS can occur alongside the Health Canada review, if the manufacturer applies for and is granted an “aligned review”. In this case, a review takes approximately 6-12 months. If the drug does not receive an aligned review, CADTH and INESSS review after Health Canada has approved the medicines for sale in Canada, and a review can take up to a year or more.
Cystic Fibrosis Canada advocates for all cystic fibrosis treatments to receive a fast and fair review within the Canadian drug review and reimbursement system. We continue to work with the CF community and our community partners to advocate for a nation-wide strategy to improve access to drugs for rare diseases and CF medicines, calling on our federal and provincial governments to work with private insurers, employers,manufacturers, clinicians, researchers, health charities and patient groups to implement this strategy now.
TRIKAFTA IS REVIEWED BY CADTH for 12+
In 2021 CADTH shared their recommendation for Trikafta. Despite a positive recommendation to list the drug, the overly restrictive criteria CADTH recommended was not what we had hoped for. Please see our press release for more details.
Patient, physician and researcher groups provided feedback on the recommendations. In collaboration with CF clinicians and researchers , Cystic Fibrosis Canada made multiple submissions to provide feedback to CADTH. Read the three submissions made to CADTH to respond to their recommendation for Trikafta:
- Cystic Fibrosis Canada’s submission
- CF CanAct Clinical trials network submission
- Canadian Cystic Fibrosis Clinic Directors submission
CADTH and INESSS review for ages 6+
CADTH and INESSS are currently undertaking Health Technologies Assessments of Trikafta for ages 6 and up with one copy of the F508del mutation. Cystic Fibrosis Canada provided submissions aiming to demonstrate the profound impact of this drug if it is made accessible for all eligible Canadians, regardless of their lung function.
Clinicals trials for children aged 6-11 and a recent study on the long-term effects of taking Trikafta show that people with stronger lung function still experienced significant benefits by taking Trikafta . We’ve woven this evidence, along with feedback from the CF community into our submissions and we look forward to sharing it with decision makers.
You can read our submissions here: