L’évaluation des médicaments pour la couverture d’assurance médicaments doit se faire par une agence nationale qui agit de manière transparente, équitable et inclusive, et qui rend des comptes publiquement.
The federal Minister of Health has initiated an external review of eight pan-Canadian health organizations. One of these is the Canadian Agency for Drugs and Technologies in Health (CADTH), which evaluates and recommends new drugs for insurance coverage within all federal, provincial and territorial public drug plans, except those in Quebec. CADTH describes itself as “an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs.” These decisions frequently lead to Canadians being denied access to potentially life-saving or life-transforming innovative medicines.
Why? One reason, we argue, is that CADTH’s drug review processes do not adhere to good governance principles, as we explored in a recent article in the peer-reviewed journal ClinicoEconomics and Outcomes Research. Governance is something few Canadians think much about. But decisions made using processes that fail to follow good governance principles can negatively impact Canadians’ lives.
CADTH has separate processes for the review of cancer drugs and all other drugs; its reviews of noncancer medications result in only about half of these drugs being recommended for coverage by public plans. The outcome is that patients’ access is delayed or denied to new drugs, including drugs for diseases that have no other treatments, such as Orkambi for cystic fibrosis. Orkambi received a priority regulatory review (meaning Health Canada considered that the drug filled an unmet need), but CADTH recommended that public drug plans not cover it, denying Orkambi’s benefits to several hundred cystic fibrosis sufferers.
What are good governance principles? These are the main ones relating to drug reimbursement recommendations:
- accountability: decision-makers should be accountable to everyone impacted by their decision,
- transparency: processes and information should be directly accessible to all concerned and enough information provided to understand and monitor them,
- equity: all involved should have opportunities to improve or maintain their well-being,
- participation: everyone impacted by the decision should have a voice in decision-making directly or through legitimate representatives,
- consensus: differing interests should be reconciled to reach broad agreement on what is in the best interest of all participants and
- responsiveness: organizations and processes should serve all involved.
How do CADTH’s drug recommendation processes match up to these requirements? Let’s start with accountability. Over three-quarters of CADTH’s directors are employed by or closely associated with federal, provincial or territorial governments, with six being directly responsible for drug plans. CADTH is “owned by, and reports directly to” federal, provincial and territorial deputy ministers of health. Health ministries provide 85 percent of CADTH’s annual operating budget of over $30 million. CADTH is not independent, as it claims. CADTH’s clear accountability is to the governments that own and control it and for which it is producing recommendations. CADTH should also be accountable to patients, especially those with unmet needs whose health depends on access to new, innovative drugs.
CADTH has an expert committee to review cancer drugs and another to review all other medications. Meetings of these committees are not transparent. They are not open to patients, pharmaceutical manufacturers, the public or the media, and their proceedings are not publicly available. Patient groups and individuals can submit written comments but are not allowed to comment on draft reports (other than reports on cancer drugs), although drug manufacturers can.
Participation of everyone involved in decision-making processes is important if these processes are to be credible and citizens are not to feel excluded. The cancer drug committee includes three patient representatives, but the other committee has none. Patients are denied genuine participation in CADTH’s drug recommendation processes, except with respect to cancer drugs. The absence of real accountability, transparency and participation in CADTH’s drug recommendation processes means that opportunities do not exist for everyone involved to improve or maintain their well-being or for reaching true consensus. Accountability and transparency are fundamental principles of good governance, and all participants, particularly patients, should have an opportunity to improve their well-being by being engaged throughout the process and having a voice in decision-making.
The principles of good governance should be incorporated into reimbursement recommendation processes but aren’t, because CADTH has become a willing partner of federal, provincial and territorial governments’ initiatives to contain new drug costs. This was plainly demonstrated in a recent analysis of CADTH’s recommendations for medications for rare disorders. The positive recommendation rate for rare disorder drugs with an estimated annual cost of more than $55,000 was only 26 percent, whereas the rate for those costing less than $55,000 was 83 percent.
The current federal government was elected in 2015 on a platform of openness, accountability, transparency and fairness. The external reviewers of the pan-Canadian health organizations should recommend that federal, provincial and territorial governments apply these democratic values to drug reimbursement assessments to provide Canadians with a national organization for evaluating drugs for public drug plan coverage that fully embraces the principles of good governance ― one that is publicly accountable, transparent and fair and includes all participants throughout the process.
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