The Canadian Agency for Drugs and Technologies in Health (CADTH) has unveiled a groundbreaking approach to improve access to innovative treatments for severe, rare, or debilitating illnesses in Canada. CADTH’s new category of recommendations, known as time-limited drug reimbursement recommendations, aims to expedite patient access to promising new therapies while addressing evolving challenges in drug development and regulation.
Under this framework, CADTH will recommend public funding for a drug or drug regimen for a defined period, contingent on the manufacturer conducting ongoing clinical studies to resolve evidence uncertainties. CADTH will later reassess these recommendations based on the accumulating evidence, leading to a final reimbursement decision.
The move comes in response to the changing pharmaceutical landscape, with more complex therapies targeting smaller patient populations and conditions with limited treatment options. Regulatory bodies both in Canada and globally have granted accelerated approvals for such treatments based on early evidence, prompting the need for faster patient access. CADTH’s time-limited reimbursement category aligns with these shifts and aims to meet the evolving needs of policymakers.
The criteria for drugs eligible for time-limited recommendations include Health Canada’s Notice of Compliance with Conditions (NOC/c), robust evidence-generation plans for phase III clinical trials, and a commitment by the drug sponsor for timely reassessment. The alignment of CADTH’s process with Health Canada’s policies aims to streamline drug approval and reimbursement pathways.
Suzanne McGurn, CADTH President and CEO, expressed the hope that this initiative encourages drug manufacturers to introduce new therapies to Canada while enabling governments to expand access to innovative treatments effectively.
The initial eligibility criteria represent a starting point, with potential expansions based on future experiences. CADTH plans to evaluate the process’s impact and stakeholder needs after issuing the first 3 to 5 recommendations or after 18 months, with the expectation that the time-limited recommendation process will continue during this evaluation period.
CADTH’s introduction of time-limited recommendations complements its existing recommendation options, offering a flexible approach to enhancing access to innovative therapies. This initiative, developed through consultations with various stakeholders, reflects CADTH’s commitment to fostering innovation and enabling timely access to healthcare innovations.
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