CDR Update — Issue 62

In This Issue

• New Pilot Project: Subsequent Entry Biologics — Effective Immediately

New Pilot Project: Subsequent Entry Biologics — Effective Immediately

CDR Update — Issue 59, released June 30, 2009, announced that submissions for drugs reviewed by Health Canada as subsequent entry biologics (SEBs) should be filed with the Common Drug Review (CDR). Based on its experience reviewing the first SEB submission, CDR has initiated a pilot project. The need for the pilot arises from the fact that SEBs are a new category of Health Canada submissions with different data requirements. The purpose of the pilot process is to determine the CDR requirements for the SEB submissions; establish the evaluative framework for conducting the CDR review; and through interactions with Health Canada, gain an increased understanding of Health Canada’s approach to assessing SEBs.

The Procedure for Common Drug Review and CEDAC Terms of Reference (as amended from time to time) shall be deemed to be amended to the extent necessary to give effect to the SEB pilot project outlined in this CDR Update for such time as the pilot project is in effect.

Details of Subsequent Entry Biologics Pilot

A. Manufacturer’s Submission Requirements for SEBs

Manufacturers should:

• Follow the current CDR Submission Guidelines for Manufacturers for submission requirements.
• In addition to the existing submission requirements, provide in table format (see examples below) a comparison of the SEB with similar products currently marketed in Canada. The tables should include, but are not limited to, details on dosage, dosage form, administration, pharmacokinetic and pharmacodynamic parameters, immunological testing results, key trial outcomes and results, costs of the drug, and any supporting costs.
• Submit rationale for the choice of the reference product if it is not marketed in Canada.
• Submit information on factors considered when initially choosing or subsequently changing to another similar biologic product — this could include sources such as clinical trials or practice guidelines for submission requirements.

B. Participating Drug Plans’ Identification of Issues

As per the current Procedure for Common Drug Review for regular submissions, participating drug plans should forward to CDR issues related to the SEB that they would like to have addressed during the review.

C. CDR’s Review of the SEB Submission

• CDR will conduct the review of the SEB submission as outlined in the Procedure for Common Drug Review, including a systematic review of the clinical information and a critique of the manufacturer’s economic evaluation.
• CDR will send the review reports to the manufacturer for comment in accordance with the Procedure for Common Drug Review.

D. CEDAC Advice — CEDAC Subsequent Entry Biologic Advice Document

• CEDAC will provide a CEDAC SEB Advice document that will include a summary of the evidence considered by CEDAC, responses to the drug plan questions, and listing guidance (which may or may not include a recommendation) where possible.
• CDR will issue the CEDAC SEB Advice document to drug plans and the manufacturer within five to seven business days following the CEDAC meeting.
• The CEDAC SEB Advice document will be embargoed for 10 days, during which time the manufacturer will have an opportunity to request a reconsideration of the advice — on the condition that the CEDAC SEB Advice is not supported by the evidence that had been submitted or identified in the CDR Reviewers’ Reports.
• The CEDAC SEB Advice document will be posted on the CADTH website when final.

E. Evaluation

The pilot project will be evaluated after three SEBs have been reviewed. The findings from the evaluation will assist in identifying the submission requirements for SEBs and will guide the development of an evaluative framework.

F. Stakeholder Feedback

Stakeholder feedback will be sought at the end of the pilot project.

Sample Tables for Comparison of the SEB and Similar Products