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CADTH » Search All Products » Common Drug Review » CDR Update » CDR Update — Issue 71

CDR Update — Issue 71

CDR Changes and Document Revisions — Effective Immediately

The following clarifications and changes related to extensions to the embargo period are effective immediately and will be reflected in the revised Procedure for Common Drug Review, which will be posted in the next few weeks.

The clarifications and changes include:

  • that requests for extensions of the embargo period are granted only for the purpose of preparing and filing a Request for Reconsideration or a Resubmission based on a Reduced Price during the Embargo Period
  • that if a manufacturer does not file a Request for Reconsideration or a Resubmission based on a Reduced Price when an extension to the embargo period has been granted, CDR has the discretion to issue the notice of recommendation immediately or at any time up to the scheduled release time of the Final Recommendation as if either the Request for Reconsideration or Resubmission based on a Reduced Price had been filed
  • an amendment to the definition of “Embargo Period” to capture extensions to the 10-day period.

The following sections of the Procedure for Common Drug Review are being revised to incorporate the clarifications appearing in bold font:

Section 8.5.1 Manufacturer’s Request for Reconsideration [item 8.5.1 (d)]

d)   The Manufacturer may request an extension of up to twenty (20) extra Business Days in addition to the ten (10) Business Days allowed in 7.5.1 (c) solely for the purpose of preparing and filing the Request for Reconsideration (i.e., a total of 30 Business Days for preparing and filing the Request for Reconsideration).

  • However, the request for the extension must be made in writing within ten (10) Business Days of receiving notification of the CEDAC Recommendation, the Manufacturer must provide adequate reasons for the requested extension, and the Manufacturer must indicate when the Request for Reconsideration will be submitted.
  • The Manufacturer must file a Request for Reconsideration when an extension is granted.
  • The length of the extension will have an impact on the date of the CEDAC meeting at which the Request for Reconsideration will be scheduled.
  • If a Manufacturer fails to file a Request for Reconsideration within the specified time, after requesting and being granted an extension to the Embargo Period, the CDR Directorate may decide to either: immediately deem a Final Recommendation to have been made (as described in Section 9.1.1), or to issue a Final Recommendation (as described in Section 9.1.1) at a date no later than the end of the extended schedule for completing the review of the Request for Reconsideration provided for in Section 8.5.

Section 8.6.1 Manufacturer’s Resubmission Based on Reduced Price During Embargo Period (item 8.6.1[f])

f)    The Manufacturer may request an extension of up to twenty (20) extra Business Days in addition to the ten (10) Business Days allowed in section 8.6.1 (e) solely for the purpose of preparing and filing the Resubmission based on a Reduced Price during Embargo Period (i.e., a total of 30 Business Days).

  • However, the request for the extension must be made in writing within ten (10) Business Days of receiving notification of the CEDAC Recommendation, the Manufacturer must provide adequate reasons for the requested extension, and the Manufacturer must indicate when the Resubmission based on a Reduced Price will be submitted.
  • The Manufacturer must file a Resubmission based on a Reduced Price during Embargo Period when an extension is granted.
  • The length of the extension will have an impact on the date of the CEDAC meeting at which the Resubmission, which is based on a Reduced Price during Embargo Period, will be scheduled.
  • If a Manufacturer fails to file a Resubmission based on a Reduced Price within the specified time, after requesting and being granted an extension to the Embargo Period, the CDR Directorate may decide to either: immediately deem a Final Recommendation to have been made (as described in Section 9.1.1) or to issue a Final Recommendation (as described in Section 9.1.1) at a date no later than the end of the extended schedule for completing the review of the Resubmission provided for in Section 8.6.

Section 9.1.1 Final Recommendation

      A final determination of a Submission, Resubmission, or Request for Advice (made by ACP, or one or more Drug Plans regarding a previous CEDAC Recommendation) shall be deemed to have taken place:

  • when a Recommendation has been made and:
    • a Manufacturer does not file, or waives the right to file, a Request for Reconsideration of the Recommendation or a Resubmission based on a Reduced Price during the Embargo Period within the specified time.
    • if a Manufacturer fails to file either a Request for Reconsideration of the Recommendation or a Resubmission based on a Reduced Price after requesting and being granted an extension to the Embargo Period, the CDR Directorate may decide to either: immediately deem a Final Recommendation to have been made (as described in this Section 9.1.1) or to issue a Final Recommendation (as described in this Section 9.1.1) at a date no later than the end of the extended schedule for completing the review of the Request for Reconsideration or a Resubmission based on Reduced Price as described in Section 8.5 and Section 8.6.

Definitions — Definition of Embargo Period

Embargo Period — refers to a period of time (ten [10] Business Days) following the issuance of the Recommendation and Reasons for Recommendation or such extended period of time as may be granted by the CDR Directorate (under Section 8.5.1 or Section 8.6.1) during which the Recommendation and Reasons for Recommendation are neither acted on by Drug Plans nor are they publicly available.

Personnel News

Several organizational changes and staff appointments have been made to reflect CADTH’s “Next Chapter” initiatives. Full details are available under Executive News on the CADTH website. The following changes are pertinent to the Common Drug Review (CDR):

Barb Shea (former Acting Senior Vice-President, Science Directorates) was appointed Vice-President, Products and Services, with oversight of CADTH’s drug formulary recommendation service, the rapid review service, health technology assessment program, and the optimal use program. Reporting to Barb Shea in this new appointment are the following individuals:

  • Denis Bélanger (former Acting Senior Director, Canadian Optimal Medication Prescribing and Utilization Service [COMPUS]) has assumed responsibility as Director, Formulary Recommendations (CDR) and Rapid Response Services (HTIS).
  • Trinh Luong (former Director, Submissions and Operations, CDR), has assumed responsibility as Director, Health Technology Assessment and Optimal Use (HTA and COMPUS).

Sandy Pagotto (former Acting Senior Director, CDR) has assumed responsibility as Director, Environmental Scanning and Program Development. Sandy now reports to Jane Farquharson, who has been appointed Acting Vice-President, Programs, leading the areas of environmental scanning, program development, partnerships, outreach, and impact.

As a result of the above changes, all CDR submission-related inquiries should be directed to Elizabeth Kozyra, Submissions Officer, CDR. Elizabeth may be reached by email at elizabethk@cadth.ca or by telephone at 613-226-2553, ext. 1516.