First CDR Reviews Completed

First CDR Reviews Completed

The first CDR drug reviews are going to the Canadian Expert Advisory Committee (CEDAC) on April 28, 2004. CEDAC will review the briefs prepared by the CDR Directorate for five drugs (Axert, Combigan, Evra, Iressa and Reyataz).

The participating federal, provincial and territorial drug plans will consider the formulary listing recommendations made by CEDAC, and also the mandates, priorities and resources of their individual plans, when deciding whether to list the drugs on their formularies. The plans have provided strong support for the CDR program to date and remain committed to considering the CEDAC recommendations in a timely manner.

CDR Submission Contact Information and Submission Status Reports Revised

Appendix 1 of the Submission Guidelines for Manufacturers has been updated and posted on the CDR – Submission Guidelines section of the CCOHTA web site www.ccohta.ca. Appendix 1 contains a listing of the participating drug plans and contact information for sending submissions.

The format for the Submission Status reports has been revised to identify the targeted CEDAC meeting at the start of the review process. The new form collapses some of the previous timeframes into one but will transparently provide an accurate view of a of a specific submission’s progress through the CDR process. There have been no changes in our target timeframes. Reports for new submissions will be in the revised format.

Other Submission News

CDR has received five drug submissions in addition to the five to be reviewed at the April 28th CEDAC meeting.

Three submissions received in February (Replagal, Fabrazyme and Viread) are scheduled for the June 16th CEDAC meeting, a submission made at the end of March (Neulasta) will be reviewed at the July 21st meeting, and an April submission for Adderall XR is slated for the August 18th meeting.

Detailed Submission Status reports for each submission and the CEDAC meeting schedule for the remainder of 2004 are available on the CDR section of www.ccohta.ca.

CDRC Committee Information Online

Information on the Common Drug Review Committee (CDRC) is now available on the CDR - Committees section of www.ccohta.ca. Along with a brief description of the committee and the CDRC Terms of Reference, there is a list of members’ names and a link to each of the participating drug plans.

April 1st CDRC Meeting

The CDRC held a productive in-person meeting at CCOHTA April 1, 2004. The objective was to give members from the participating drug plans an overview of CDR’s development in the past year, as well as time to discuss challenges and opportunities for CDR at the present and in the coming year.

One of the past year’s challenges was the arrival of the first five CDR submissions within eight business days – requiring diligent efforts by CDR staff and reviewers to produce solid, yet timely, work. CDRC members also reviewed suggested improvements to the CDR processes and documents based on experience gained in the first set of CDR reviews. CDRC meets regularly via teleconference.

CDR Stakeholder/Outreach Activities

The CDR Directorate’s activities have included ongoing liaison with stakeholders from industry and patient/consumer groups by delivering presentations, participating in meetings and responding to inquiries and concerns.

So far in 2004, CDR presentations have been delivered to The Conference Board of Canada (Leaders’ Roundtable on Health), the Canadian Association of Professional Regulatory Affairs, the Canadian Pharmacists Association and a Postgraduate Course in Clinical Drug Development and Regulation held at the University of Ottawa.

Directorate staff have met with, or responded to inquiries from, the Best Medicines’ Coalition, the Canadian Treatment Action Council and Canada’s Research-Based Pharmaceutical Companies (Rx&D), among others. Transparency and communications with stakeholders continues to be a CDR priority.

Staffing Developments and Vacancies

There have been some CDR personnel adjustments to meet CCOHTA and CDR Directorate needs. With the approval of the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS), Barb Shea was appointed Vice President of COMPUS and CDR. Elaine MacPhail accepted the role of Director, CDR.

More clinical reviewers and other team members are required now that the permanent CDR is fully operational. See Careers on www.ccohta.ca for a list of openings.

Recent staff additions include: health economist Karen Lee and communications officer Sandy Fox. Information requests can be directed to Sandy Fox at (613) 226-2553, ext. 233 or sandyf@ccohta.ca.