CDR Update — Issue 70

CDR Process Changes and Document Revisions

The Canadian Agency for Drugs and Technologies in Health (CADTH) is announcing a number of changes and updates to the Common Drug Review (CDR) program and its key documents, the Procedure for CDR and the CDR Submission Guidelines for Manufacturers.

Patient Group Input into the CDR Process

As announced on May 13, 2010 (in CDR Update, Issue 69), patients now have the opportunity to formally submit input to the CDR through patient groups. They are being asked to provide the perspectives of patients on drugs that are undergoing CDR review. This patient input or evidence will be incorporated throughout the CDR drug review process, including incorporation into the deliberations and formulary listing recommendations of the Canadian Expert Drug Advisory Committee (CEDAC). Detailed information about the patient input process may be found on the Patient Input page of the CADTH website.

Changes to the CDR documents to reflect this new patient input initiative are found in Table 1.

Table 1: Location of Changes Related to Patient Input in CDR Documents
Change	*Procedure for CDR*	CDR Submission Guidelines for Manufacturers
Patient Group Input Process	Section 2	Not applicable
Addition of patients’ perspectives to CEDAC review criteria	Section 8.2.3 and Appendix 1: Definitions	Appendix 2: CDR Definitions

Incorporation of Changes Announced in December 2009

The changes and clarifications announced in December 2009 (CDR Update, Issue 65), have been incorporated into the CDR documents as described in Table 2 below.

Table 2: Location of Changes Announced in December 2009, in CDR Documents
Change	Procedure for CDR	*CDR Submission Guidelines for Manufacturers*
Pre-NOC and Post-NOC Priority Review Definitions ? changed to include drugs with new indications, as well as new drugs. Pre-NOC and Post-NOC Priority Review definitions are the same.	Sections 1.1.2, 1.1.8, and 4.2	Sections 4.1.2 and 4.1.7
Voluntary Withdrawal of Submissions ? reasons will be posted on the CADTH website	Section 1.2.2 (b) and (c)	Not applicable
Pages allotted for Manufacturer’s Comments on CDR Reviewers’ Reports ? vary according to length of report	Section 7.2	Not applicable
Response to Request for Clarification ? opportunity to bring requests to CEDAC meetings added	Section 8.4.2	Not applicable
Days Allotted for Manufacturers’ Comments on Plain Language CEDAC Recommendations ? changed to 10 business days	Section 9.1.3	Not applicable

Combination Products (Funded Components) — Streamlined Requirements and Review: Effective August 1, 2010

Effective August 1, 2010, the submission requirements and the review process for combination products (funded components) will be changed. Combination products (funded components) are combination products containing two or more drugs that are already funded by CDR-participating drug plans. These combination products may contain funded non-prescription drugs, but at least one component must be a prescription drug. The review of these agents will be streamlined. All other new combination products will follow the regular review process and must meet regular CDR submission requirements.

The tailored approach for reviewing combination products (funded components) and modified submission requirements were posted for stakeholder feedback in December of 2009. Table 3 summarizes the feedback received and CADTH’s action or response.

Table 3: Feedback Related to Combination Products (Funded Components)
Feedback	CADTH Action/Response
Manufacturers should be given the opportunity to comment on CDR’s assessment of the manufacturer’s submitted information.	Manufacturers will be given three business days to provide comments. CDR reviewers will not prepare replies.
Is CDR reappraising Health Canada’s assessment of bioequivalence?	CDR is not reappraising bioequivalence. CDR requires this information as confirmation that the combination is bioequivalent to the components administered individually.
Why is there a need to resubmit bioequivalence information in a different format?	The table format in the CDR template allows for the bioequivalence information for the components to be shown in one table.
Health Canada bioequivalence requirements are evolving and CDR will need to ensure that these are reflected in CDR requirements.	CDR will be following the changes and will ensure that they are reflected in the CDR requirements for combination products (funded components).

Document changes related to combination products (funded components) are described in Table 4.

Table 4: Location of Changes Related to Combination Products (Funded Components) in CDR Documents
Change	*Procedure for CDR*	*CDR Submission Guidelines for Manufacturers*
Definition	Sections 1.1.2 and 3.2	Sections 4.1.2 and 4.4
Submission Requirements	Not applicable	Section 4.4
Template for Combination Products (Funded Components)	Not applicable	Appendix 16 (described in Section 4.4e)
Checklist for Submission	Not applicable	Appendix 7c
Review Process	Section 3.2	Not applicable
Manufacturer’s Comments ? a maximum of 3 pages and 3 business days allotted	Section 7.2	Not applicable

Other Changes ? Effective Immediately

Other changes to the CDR documents are described in Table 5 and are effective immediately.

Table 5: Location of Other Changes in CDR Documents
Change	Procedure for CDR	CDR Submission Guidelines for Manufacturers
**Time Frames for CDR Procedures** ? moved to front of Procedure for CDR, immediately after Figure 1, a flowchart describing the CDR process	Moved to page 4	Not applicable
Product Profiles ? product profiles are no longer required in any type of submission. Because product monographs are submitted as searchable PDF files on CDs, there is no longer a need for the concise product profiles.	Not applicable	Requirement deleted from document
Naming electronic files ? All electronic files submitted on CDs should be labelled with a file name that contains the brand name and type of file ? e.g., Brand Name xx-product monograph.pdf	Not applicable	Applies to all electronic file references that are required for a submission or resubmission
Participating drug plan information changes i. Contact information for Prince Edward Island changed ii. Submission requirements for Department of National Defence (DND) changed	Not applicable	Appendix 1: Participating F/P/T Drug Plans
CONSORT diagram ? updated	Not applicable	Appendix 8: CONSORT Reporting Standard for Documenting Patient Flow
Table template for listing studies i. Reminder that all parts of the template must be completed as per instructions in the footnotes. ii. When available, a PDF of an abstract or publication should be inserted in the last column of the table.	Not applicable	Appendix 9: Table Template for Listing Canadian and International Published and Unpublished Studies