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 ‚Äúan independent, not-for-profit organization responsible for providing Canada‚Äôs health¬†care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs.‚Ä̬†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‚Äôs drug recommendation processes match up to these¬†requirements? Let‚Äôs¬†start with¬†accountability.¬†Over¬†three-quarters of¬†CADTH‚Äôs¬†directors¬†are employed by or¬†closely¬†associated with federal, provincial or territorial governments,¬†with six being directly responsible for drug plans.¬†CADTH¬†is¬†‚Äúowned¬†by,¬†and reports directly to‚Ä̬†federal,¬†provincial and territorial¬†deputy¬†ministers of¬†health. Health¬†ministries¬†provide 85¬†percent¬†of CADTH‚Äôs annual operating budget of¬†over¬†$30¬†million.¬†CADTH is not independent, as it claims.¬†CADTH‚Äôs¬†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¬†‚Äē one¬†that is¬†publicly accountable, transparent and fair and¬†includes¬†all¬†participants¬†throughout¬†the¬†process.¬†¬†

Photo: Shutterstock, by LaryLitvin.

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John Adams is co-founder, president and CEO of Canadian PKU and Allied Disorders, and chair of the Best Medicines Coalition. He is co-chair of the Disability Tax Fairness Alliance.
Dr. Nigel Rawson is a pharmaco-epidemiologist, a pharmaceutical policy researcher, president of Eastlake Research Group and the author of Drug Safety: Problems, Pitfalls and Solutions in Identifying and Evaluating Risk.

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