HESA Committee Report

Canada’s Government is pleased to present its response to the Standing Committee on Health’s report:  Prescription Drugs Part 1 - Common Drug Review: An F/P/T Process, which was tabled in the House of Commons on December 12, 2007.  The Government commends the Committee for conducting such an extensive review of the Common Drug Review’s (CDR’s) mandate and performance.  The report emphasizes the continuing value and high quality of the CDR’s work while recognizing areas for improvement.

The CDR, housed within the Canadian Agency for Drugs and Technologies in Health (CADTH), is a successful federal, provincial, and territorial collaboration on pharmaceuticals management. It provides rigorous, evidence-based formulary listing recommendations to all jurisdictions, except Quebec, which does not participate. While each jurisdiction is ultimately responsible for deciding whether a drug will be listed on its drug plan formulary and thus publicly funded, the CDR ensures that a drug’s therapeutic benefits and cost are evaluated under a consistent, evidence-based framework. This function is distinct from Health Canada’s regulatory role, which is to determine whether a drug can be sold in Canada based on an assessment of safety, quality, and efficacy.  Health Canada does not assess a drug’s added value for patients and society, nor whether any such value is commensurate with its cost.  It is important to note that CADTH is accountable to the Conference of Federal/Provincial/Territorial Deputy Ministers (except Quebec) through a Board of Directors appointed by the Deputies.

Public drug plans benefit directly from CDR evaluations, recommendations and advice, as a common review reduces duplication across drug plans, while facilitating consistent and timely decision-making across the country.  The CDR also provides more timely and higher quality reviews than many jurisdictions could produce on their own.

The Government of Canada recognizes that the CDR is a federal, provincial, and territorial collaboration and that work must be undertaken with participating jurisdictions to ensure that the CDR continues to assist governments with the difficult decisions they must make when determining which drugs should be publicly funded and under what criteria and conditions.

The CDR fulfills a vital role in the healthcare system by helping governments ensure that publicly reimbursed drugs provide benefits commensurate with their costs.  The Committee’s report affirms the importance of this role while recognizing areas for improvement. 

Recommendation 1

The federal government work with its provincial and territorial CDR counterparts to require an independent, external performance evaluation of the CDR within a year, and at five year intervals, and to make them immediately available to the public.

The Government of Canada supports ongoing performance evaluation as a means of increasing accountability and assisting the CDR in making improvements.  The CDR’s last performance evaluation was undertaken in 2005, and the Government of Canada is pleased that the CDR has already taken steps to improve its functioning in response to the evaluation’s recommendations.  The evaluation was updated in 2007 and is publicly available on the CADTH website at www.CADTH.ca.

The Government of Canada has taken steps to ensure that performance evaluation is an integral part of the CDR’s operation, by incorporating requirements for independent evaluations into its multi-year funding agreements with CADTH.   Future funding agreements will contain similar evaluation requirements, and thus address the Committee’s recommendation for ongoing performance evaluation.

The Government of Canada will pursue discussions with participating provincial and territorial governments on the appropriate timing and scope of the next CDR evaluation.

Recommendation 2

The federal government work with its provincial and territorial CDR counterparts to enhance transparency by increasing the level of scientific and price information disclosure through discussions with pharmaceutical manufacturers at the time of submission.

The Government of Canada supports enhanced transparency of the CDR, recognizing that manufacturers may be reticent to share what they believe to be confidential business information.  However, there may be information not currently accessible which falls outside the scope of confidential business information that should be available to stakeholders and the public.  Access to such information would help clinicians and patients understand the basis upon which CDR recommendations are made.  In its regulatory oversight of products, the Government of Canada is familiar with the challenges associated with protecting confidentiality while increasing the quantity and quality of information available to the public. 

The Government of Canada is pleased that the CDR has undertaken new initiatives to increase transparency.  For drugs under review as of November 2007, via postings on the CADTH website, the CDR will make available the clinical and pharmacoeconomic reports used by the CDR’s key independent analytical body, the Canadian Expert Drug Advisory Committee (CEDAC), as well as summaries of CEDAC’s discussions regarding each drug.  In addition, a plain language version of CEDAC’s recommendations and the reasoning behind each, will also be made available online.

The Government of Canada is interested in pursuing discussions with CADTH, drug manufacturers and participating provincial and territorial governments on measures to improve the transparency of information on drugs reviewed by the CDR.

Recommendation 3

The federal government work with its provincial and territorial CDR counterparts to increase the current level of public involvement in the CDR through public attendance at open CEDAC meetings and the creation of a public advisory body.

The Government of Canada supports increased public involvement in the CDR process and is pleased that the CDR has already taken an important step by adding two public members to CEDAC.

The Government of Canada recognizes that increased public involvement can lead to better decisions as well as confidence in the fairness of decision-making processes.  In 2005, Health Canada held ground-breaking public forums as part of its reviews of non-steroidal anti-inflammatories and silicone gel-filled breast implants.  In addition to providing the public with an opportunity to participate in these deliberations, the lessons learned from these forums informed Health Canada’s recently launched Review of Regulated Products: Policy on Public Input (2007), which proposes a variety of tools to incorporate public input in regulatory decision-making on an ongoing basis. 

The Government of Canada is interested in pursuing discussions with participating provincial and territorial governments on further opportunities for appropriate public involvement in the CDR process.

Recommendation 4

The federal government work with its provincial and territorial CDR counterparts to create a set of specific appeal criteria which, if met, would lead to a new and distinct appeal process for CEDAC recommendations which will;

• Require a separate group of expert reviewers;
• Extend requests for appeal beyond manufacturers to the public; and
• Establish a clear time frame for an appeal decision.

The Government of Canada supports improved dispute resolution processes in the CDR, recognizing that early opportunities to resolve disputes are beneficial.  However, there is no compelling argument to implement a formal appeal process beyond the existing “request for reconsideration” process given the facts that complete scientific and price information are not in the public domain and that CDR recommendations are not binding on any party.

The Government of Canada is interested in pursuing discussions with participating provincial and territorial governments on possible refinements to the CDR’s current request for reconsideration process as well as other opportunities to resolve disputes throughout the CDR process.

Recommendation 5

The federal government work with its provincial and territorial CDR counterparts to urge CADTH to establish a specifically designed approach for the review of drugs for rare disorders and for first-in-class drugs.

The Government of Canada supports the idea of exploring options to increase the adaptability of the CDR for all types of drugs, including drugs used to treat special populations such as those suffering from rare diseases.

Adaptable review processes, tailored to the known risks, benefits, and new indications of a drug over its life cycle, are consistent with the Government of Canada’s work to modernize the regulatory framework for licensing drugs.   Through the Food and Consumer Safety Action Plan, the Government of Canada is putting measures in place to strengthen its scientific and regulatory tools, processes and capacity.  These measures will help to increase the adaptability of Canada’s regulatory system for all drugs, including drugs for rare diseases.

Determining whether it is appropriate to reimburse the costs of drugs for rare diseases poses significant challenges for governments in light of their high costs and limited evidence of effectiveness.  Therefore, there is merit in exploring approaches to assessing these drugs as one of the first steps to increasing the adaptability of the CDR’s drug assessment process.

The Government of Canada is interested in pursuing discussions with CADTH, participating provincial and territorial governments, and other stakeholders, on suitable approaches to assessing drugs to treat rare diseases.

The Government of Canada supports the role of the CDR and is committed to discussing with other governments, CADTH and stakeholders opportunities to ensure that the CDR continues to contribute to the health of Canadians and the Canadian healthcare system.