Consultation On New CDR Transparency Initiatives, Canada

Main Category: Pharma Industry / Biotech Industry
Article Date: 09 Oct 2007 - 4:00 PDT

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As announced in CDR Update Issue 39 and at the Common Drug Review (CDR) Information Session for Industry in June 2007, the Canadian Agency for Drugs and Technologies in Health (CADTH) is taking steps to further increase the transparency of its CDR process and recommendations. This is in response to the CDR Evaluation and requests for more information from stakeholders, including the pharmaceutical industry and patient advocacy groups.

Since the CDR's inception, CADTH and the Canadian Expert Drug Advisory Committee (CEDAC) have been supportive of increased transparency. This is evidenced by the posting of CEDAC recommendations and reasons for recommendation and the posting of the progress of submissions under review on the CADTH web site (http://www.cadth.ca). Increasing transparency beyond these activities should provide an even greater understanding of the CEDAC recommendations and reasons for recommendation. CADTH is seeking the support and co-operation of the pharmaceutical industry with these new initiatives.

In developing the expanded transparency initiatives, CADTH has considered the input that it has received to date from its various stakeholders. This expansion means additional steps for both the CDR and industry; however, CADTH has been careful not to increase the time or processes associated with delivering CEDAC recommendations. Before implementing the transparency initiatives, CADTH wishes to solicit further input from its stakeholders on the aspects that directly affect them.

The goals of the transparency initiatives are (1) to increase understanding of recommendations by releasing key information related to each recommendation and (2) to increase accessibility of recommendations to the general public by providing information in plain language.

CADTH plans to begin publishing three additional documents for each drug reviewed by the CDR, starting with the drugs considered by CEDAC at their November 2007 meeting. The new documents include:

- an overview combining the CDR clinical and pharmacoeconomic reports
- a summary of the CEDAC discussion relating to the drug
- a plain language version of the CEDAC recommendation and reasons for recommendation.

Since the new documents may contain unpublished information provided in confidence by the drug manufacturer, the manufacturer will have an opportunity to review them to identify strictly confidential material and any inaccuracies. Based on the manufacturer's feedback and prior to publishing the documents on the CADTH web site, the CDR will black out the confidential information in the overview and summary of CEDAC discussion or remove the information in the plain language recommendation and reasons for recommendation. The CDR will indicate that the information has been removed at the manufacturer's request and will make any necessary corrections.

A procedure has been developed for the new CDR documents, with steps that correspond to the existing Procedure for the Common Drug Review. This will ensure that manufacturers are able to anticipate and plan for their opportunities to review the additional documents.

CADTH invites your feedback on the following four documents:

- Common Drug Review (CDR) Transparency Procedure (a brief description)
- CEDAC Recommendation and Reasons for Recommendation (Plain Language) Template
- Overview Template
- Summary of CEDAC Discussion Template

Specifically, we would appreciate receiving comments on:

- timelines in the CDR Transparency Procedure
- general content of the templates
- format of the templates

and any other comments you wish to provide.

http://www.cadth.ca

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