CDR Update - Issue 38

June 29, 2007

In This Issue

CDR Expansion to Drugs with New Indications

Effective October 1, 2007, the Common Drug Review (CDR) will accept submissions for drugs with new indications. Eligible drugs include those that were marketed prior to the establishment of CDR and have since received approval for a new indication, when they meet the requirements described in the Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers.

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 CDR section of the CADTH web site. The documents are dated July 2007.

If any of the changes impact on a submission that you are in the process of preparing, please contact the Director, CDR, Sandy Pagotto at sandyp@cadth.ca or (613) 226-2553, ext. 479.

Revisions to the Procedure for Common Drug Review – Effective October 1, 2007

The major revisions include:

  • change – Drugs with New Indications have been added to the list of drugs eligible for review by CDR, as indicated below (Section 1.1.2)

    Drugs with New Indications are Drugs either previously reviewed by CDR or marketed prior to the establishment of CDR that have received an NOC or NOC/c for a New Indication and:
    • the Drug has a restricted listing in one or more Drug Plan Formularies and the Drug Plans have agreed that it should be submitted; or
    • the Drug is not listed in any of the Drug Plan Formularies and the Drug Plans have agreed that it should be submitted; or
    • the Drug Plans have requested the review of the Drug with New Indications.
      Notes:

    1. Submissions for Drugs with New Indications are to contain clinical and pharmacoeconomic information relating to the New Indication only.

    2. Priority Review can be requested for Drugs with New Indications. (Section 1.1.9)

  • clarification – the definition of New Drugs has been expanded to provide clarification regarding line extensions (Section 1.1.2)
  • change – the Order of Review has been revised as follows (Section 1.1.8):
    • Submissions or Resubmissions assigned a Priority Review status
    • Reconsiderations, Drug Plan Requests for Clarification
    • Regular Submissions for New Drugs, New Combination Products containing a New Active Substance or Drugs with New Indications
    • ACP or Drug Plan initiated reviews, ACP Requests for Advice
    • New Combination Products containing existing Drugs; New “Me-too” Drugs such as those that are structurally very similar to existing drugs and that largely duplicate the action of the existing drugs
    • Resubmissions
  • change – the section relating to the Review of a Resubmission based on a New Approved Indication (Section 3.3.3 in February 2007 version) has been deleted as this type of Resubmission is now considered a Submission for a Drug with a New Indication (Section 2)

Revisions to the Common Drug Review Submission Guidelines for Manufacturers – Effective October 1, 2007

The major revisions include:

  • change – Drugs with New Indications have been added to the list of drugs eligible for review by CDR (Section 4.1.2)
  • clarification – the definition of New Drugs has been expanded to provide clarification regarding line extensions (Section 4.1.2)
  • change – the Order of Review has been revised (Section 4.1.5)
  • change – the economic model has been designated a Category 1 requirement. Three copies of the model in an unlocked (or executable) format are required, as well as documentation detailing the methods used in the modeling exercise and basic user information [Section 4.2.1 (f)]
  • change - supporting references should be clearly identified in the Executive Summary when a Manufacturer has specified a restricted listing recommendation (e.g., for a specific population) [Section 4.2.1 (b)]
    NOTE: While the other changes in the CDR Procedures and Submission Guidelines take effect October 1st, CADTH requests that manufacturers start complying with this requirement effective August 1, 2007.
  • change – the specified modules of the Clinical Overview and Clinical Summary from Module 2 of the Common Technical Document OR the Clinical Studies section of the Comprehensive Summaries are now to be provided in hard and electronic format (in Microsoft Word on CD) [Section 4.2.1 (e)]
  • change - data generated after the trial was provided to Health Canada is to be included in the submission to CDR. Typically, the studies submitted to CDR are the same as those submitted to Health Canada and sometimes these studies are ongoing, with data collected after submission to Health Canada. The data resulting after the study has been submitted to Health Canada is required. This data will be accepted in a variety of formats, including late draft, Clinical Study Report, synopsis, abstract, or conference proceedings [Section 4.2.1 (e)]
  • change – if no references are provided to support the validity of the outcome measures used in the submitted studies, a statement is required to confirm that a search has been undertaken but no references have been located [Section 4.2.1 (e)]
    NOTE: a bibliography of included references, supporting the validity of outcome measures, is no longer required.
  • change and clarification – the list of all published and unpublished studies included in the submission should indicate where they are located in the submission, including the section and page number [Section 4.2.1 (e) and Appendix 8]
  • change – the list of drug plan contacts and addresses for sending submission copies has been updated (Appendix 1)
  • change – the Submission and Resubmission Checklists have been revised to reflect the submission requirement changes noted in this CDR Update (Appendix 7)

CDR Consultations

We are requesting feedback from interested parties on three proposed changes to the CDR Procedures and Submission Guidelines. The topics to be addressed include:

  1. CDR Priority Review process
  2. Clinical Study Reports
  3. Health Canada Reviewers’ Report.

Please visit CDR Consultations – July 2007 on our web site for more details. The deadline for comments is July 31, 2007.