The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health.

Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions recommended by CADTH to meet the cost-effectiveness threshold for reimbursement. Of these assessments, 57% (59/103) recommendations included a price reduction of greater than 70% off the list price. Eight percent (8/103) were not cost-effective even at a 100% price reduction. Of the 47 assessments that had a clear benefit, in 21 (45%) CADTH recommended a price reduction of at least 70%. The median time to price negotiation (not including time to engagement) for assessments that received at least 70% vs >70% price reduction was 2.6 vs 4.8 months. This study showed that there is a divergence between drug sponsor's incremental cost-effectiveness ratio (ICER) and CADTH revised ICER leading to a price reduction to meet the $50,000/QALY threshold. For the submissions with clear clinical benefit the median length of engagement (2.5 vs 3.3 months) and median length of negotiation (3.1 vs 3.6 months) were slightly shorter compared with the submissions where uncertainties were noted in the clinical benefit according to CADTH. This study shows that using a $50,000 per QALY threshold for oncology products potentially impacts timely access to life saving medications.

Do reimbursement recommendation processes used by government drug plans in Canada adhere to good governance principles?

In democratic societies, good governance is the key to assuring the confidence of stakeholders and other citizens in how governments and organizations interact with and relate to them and how decisions are taken. Although defining good governance can be debatable, the United Nations Development Program (UNDP) set of principles is commonly used. The reimbursement recommendation processes of the Canadian Agency for Drugs and Technologies in Health (CADTH), which carries out assessments for all public drug plans outside Quebec, are examined in the light of the UNDP governance principles and compared with the National Institute for Health and Care Excellence system in England. The adherence of CADTH's processes to the principles of accountability, transparency, participatory, equity, responsiveness and consensus is poor, especially when compared with the English system, due in part to CADTH's lack of genuine independence. CADTH's overriding responsibility is toward the governments that "own," fund and manage it, while the agency's status as a not-for-profit corporation under federal law protects it from standard government forms of accountability. The recent integration of CADTH's reimbursement recommendation processes with the provincial public drug plans' collective system for price negotiation with pharmaceutical companies reinforces CADTH's role as a nonindependent partner in the pursuit of governments' cost-containment objectives, which should not be part of its function. Canadians need a national organization for evaluating drugs for reimbursement in the public interest that fully embraces the principles of good governance - one that is publicly accountable, transparent and fair and includes all stakeholders throughout its processes.