CDR Update - Issue 34

In This Issue

• Revisions to the CDR Procedures and Submission Guidelines
• Employment Opportunities

Revisions to the CDR Procedures and Submission Guidelines

The Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers have been revised and posted on the Common Drug Review (CDR) section of the CADTH web site (www.cadth.ca). The documents are dated February 2007.

The changes are effective immediately. If any of the changes impact on a submission, which you are in the process of preparing, please contact the Manager of CDR Reviews, Sandy Pagotto. She can be reached by e-mail at sandyp@cadth.ca or by phone at (613) 226-2553, ext. 479.

Revisions to the Procedure for Common Drug Review – Effective Immediately

Minor editorial changes have been made throughout the Procedure for Common Drug Review. The following outline lists significant revisions, in the order they first appear in the document:

• change – effective March 1, 2007, and for the duration of the interim Joint Oncology Drug Review, CDR will not accept submissions for oncology drugs (Section 1.1.2).
• clarification – the Advisory Committee on Pharmaceuticals (ACP) or drug plans can submit requests for advice regarding previous Canadian Expert Drug Advisory Committee (CEDAC) recommendations and reasons for recommendations (Section 1.1.4).
• clarification – submissions are generally reviewed on a “first-come, first-served basis”. CDR may need to schedule the consideration of a submission or resubmission to a CEDAC meeting other than the posted targeted date (Section 1.1.8).
• change – tracking of CDR reviewers’ review time starts when the reviewers receive the submission or resubmission binders instead of at the time that the submission or resubmission is deemed complete. The targeted review timeframe for reviewers remains unchanged at 45 business days (Section 2.1.2 and Section 3.2).
• clarification – for a request for advice regarding a previous CEDAC recommendation or reasons for recommendation, the review steps are the same as those for submissions described in Sections 5, 6 and 7 (Section 4).
• clarification – CDR can make reference to a confidential price in the CEDAC recommendation and reasons for recommendation with the manufacturer’s permission. If permission is declined, CDR may indicate that the manufacturer requested that the price be kept confidential, pursuant to the CDR confidentiality guidelines (Section 6.2.2 and Appendix 2, Item 4).
• change – the time to complete administrative tasks is not included in the calculation of total review time (Section 8).
• addition and change – a definition for “confidential price” has been added to the CDR definitions, and the definition of recommendation has been expanded (Appendix 1).
• change – “confidential price” has been included in the definition of “confidential information” in the confidentiality guidelines (Appendix 2).

Revisions to the Common Drug Review Submission Guidelines for Manufacturers – Effective Immediately

Some minor editorial changes have been made throughout the Common Drug Review Submission Guidelines for Manufacturers. The following outline lists significant revisions, in the order they first appear in the document:

• change – effective March 1, 2007, and for the duration of the interim Joint Oncology Drug Review, CDR will not accept submissions for oncology drugs (Section 4.1.2 and Appendix 3).
• clarification – submissions are generally reviewed on a “first-come, first-served basis”. CDR may need to schedule the consideration of a submission or resubmission to a CEDAC meeting other than the posted targeted date (Section 4.1.5).
• clarification – when providing the names of contacts in the covering letter, the manufacturer may designate the consultant(s) preparing the submission as contacts [Section 4.2.1 (a) and Section 5.2. (a)].
• clarification – the term “proposed price” has been replaced with “confidential price”, which is a more accurate term [Section 4.2.1 (a) and 4.2.1(g)].
• change and clarification – the required lists of studies have been consolidated into one table [Section 4.2.1 (e) and Appendix 8].
• clarification – of the requirements for submissions or resubmissions regarding pricing and availability information, and also that the submitted price must be used in the pharmacoeconomic evaluation and budget impact analyses [Section 4.2.1 (g), Section 5.2 (f) and Appendix 10].
• addition – applicant must indicate whether the submitted price is the current marketed price or a confidential price [Section 5.2. (a)].
• change – contact information for Ontario and New Brunswick has been updated (Appendix 1).
• addition and change – a definition for “confidential price” has been added to the CDR definitions, and the definition of recommendation has been expanded (Appendix 2).
• change – “confidential price” has been included in the definition of “confidential information” in the confidentiality guidelines (Appendix 5).
• clarification – CDR can make reference to a confidential price in the CEDAC recommendation and reasons for recommendation with the manufacturer’s permission. If permission is declined CDR may indicate that the manufacturer requested that the confidential price information be kept confidential, pursuant to the CDR confidentiality guidelines (Appendix 5. item 4).

Employment Opportunities

The CDR Directorate is currently recruiting for the position of Clinical Reviewer. If you’re interested in joining our growing team of professionals, visit career opportunities on the CADTH web site.