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CDR Update — Issue 87

Procedure for Posting CDR Clinical and Pharmacoeconomic Reviews on the CADTH Website

Posting CDR Clinical and Pharmacoeconomic Review Reports on the CADTH website —effective for all Submissions and Resubmissions received on or after April 1, 2013:

The Canadian Agency for Drugs and Technologies in Health (CADTH) invited stakeholder comments and feedback on the Proposed Approach for Posting the Common Drug Review (CDR) Clinical and Pharmacoeconomic Review Reports on the CADTH website (CDR Update 84, posted in December 2012). CADTH would like to thank all stakeholders who responded to the consultation. Feedback was received from drug manufacturers, industry advocacy groups, and patient advocacy groups. CADTH has reviewed and considered all stakeholder feedback and has finalized the procedure for posting CDR Clinical and Pharmacoeconomic Review Reports on the CADTH website (details are provided below).

CADTH will be implementing these changes effective on April 1, 2013 and will subsequently incorporate them into the Procedure for Common Drug Review and CDR Confidentiality Guidelines documents.

Procedure Changes 

CADTH will publish the CDR Clinical and Pharmacoeconomic Review Reports on the CADTH website for all CDR Submissions (i.e., all Submissions and Resubmissions for New Drugs, Pre-NOC [notice of compliance] Submissions; New Combination Products; Drugs with New Indications; Formulary Working Group or Drug Plan-initiated Drug-related reviews; or Requests for Advice) received on or after April 1, 2013. This procedural change will allow public access to the CDR Clinical and Pharmacoeconomic Review Reports that were provided to the Canadian Drug Expert Committee (CDEC) members for their deliberations.

Manufacturers will be responsible for the identification of any confidential information in the CDR Clinical and Pharmacoeconomic Review Reports and for submitting requests for redaction (see Table 1) before these reports are published on the CADTH website.

  • All requests for redaction must be accompanied by clearly stated rationale.
  • At the same time as Manufacturers are asked to provide comments on the draft CDR Clinical and Pharmacoeconomic Review Reports, they will be asked to identify any confidential information and submit a request for redaction (see Table 2 for timelines).
  • Although Manufacturers must provide comments on the CDR reports within the time frames described in the Procedure for Common Drug Review (January 2013), (that is no change to the original comment period); they will have an additional three business days to identify the confidential information and submit a request for redaction (see Table 2).
  • CADTH staff will redact confidential information from Clinical and Pharmacoeconomic Review Reports, based on the Request for Redaction of Confidential Information from the Clinical and Pharmacoeconomic Review Reports forms completed by the Manufacturer. A summary of information that is disclosed can be found in Table 3.
  • The Manufacturers will be sent the reports with redactions at the same time as they are sent the confidential embargoed CDEC recommendation. At this point, the Manufacturer will have 10 business days to review and confirm the redactions.
  • The CDR Clinical and Pharmacoeconomic Review Reports will generally be posted at the same time as the Final CDEC Recommendation is posted on the CADTH website.
  • CADTH may elect to update a previously posted report should the redacted information become available in the public domain.

Note: The CDEC members will continue to receive and consider all material provided in CDR Clinical and Pharmacoeconomic Review Reports, including confidential information, for their deliberations.

In the case of a disagreement expressed by the Manufacturer regarding redactions in the CDR Reports, CADTH may require additional time to resolve the disagreement in consultation with the Manufacturer. This additional time could delay publication of the CDR Clinical and Pharmacoeconomic Review Reports; however, any such delays will not affect the timelines for issuing Final CDEC Recommendations.

Table 1: Request for Redaction of Confidential Information from the CDR Clinical and Pharmacoeconomic Review Reports

DRUG UNDER REVIEW

Drug Name:

Generic Name (Brand Name) 

Manufacturer:

 

Date:

Day/Month/Year 

SUBMITTED PRICE

 Confidentiala

 Not Confidential

INFORMATION TO BE REMOVEDb

Please specify the report, the page number, and the exact wording

Please provide the rationale for removing information

 

 

 

 

 

 

 

 

CDR = Common Drug Review.

a If the submitted price is confidential, please use the next section of this table to specify the location of the price in the reports. Confidential submitted prices will be redacted from CDR Clinical and Pharmacoeconomic Review Reports; however, the outputs of economic models (e.g., incremental cost-effectiveness ratios) will not be redacted as they are not considered confidential by CADTH.

b Please ensure that information requested for redaction is not available in the public domain, including regulatory websites (e.g., United States Food and Drug Administration, Health Canada, the European Medicines Agency).

Table 2: Time Allotted for Reviewing and Redacting CDR Reports

Submission Type

Time Allotted for Manufacturers (Business Days)

Time for Manufacturer’s Comments on CDR Reportsa

Additional Time to Identify Confidential Material

Total Time Available for Identifying Confidential Material

Regular Submission

7

3

10

Post-NOC Priority Reviewb

3

3

6

Combination Product
(Funded Components)

3

3

6

Resubmission Based on New Cost Information

3

3

6

Request for Advice

3

3

6

CDR = Common Drug Review; NOC = notice of compliance.

aPlease note that there is no change to the time allotted for Manufacturer’s to submit written comments on the CDR Clinical and Pharmacoeconomic Review Reports. Comments must be submitted in accordance with the current Procedure for Common Drug Review (January 2013).

bOccurs when a Manufacturer has been offered and chosen the shortened time frame of three business days instead of seven.

Table 3: Past and Current Disclosure of Key CDR Review Information 

CDR Review Information

CDR Process for Disclosure

Past

Current

CADTH Reports

 

 

  • CDEC Final Recommendations

Disclosed

No changes

  • CDR Clinical Review Report

Not disclosed

Disclosed

  • CDR Pharmacoeconomic Report

Not disclosed

Disclosed

  • Summary of Patient Group Input

Not disclosed

Disclosedb

  • Manufacturer’s comments on draft reports and CADTH responses

Not disclosed

No changes

Clinical Submission Information

 

 

  • Manufacturer’s Clinical Summary

Not disclosed

No changes

  • Common Technical Document

Not disclosed

No changes

  • Clinical Study Reports

Not disclosed

No changes

Pharmacoeconomic Submission Information

 

  • Non-confidential Price

Disclosed

No changes

  • Confidential Price

Not disclosed

No changes

  • Outputs from economic models

Disclosed

Disclosed

  • Pharmacoeconomic model

Not disclosed

No changes

  • Budget Impact Analyses

Not disclosed

No changes

Additional Submission Information:

 

 

  • Market research data

Not disclosed

No changes

  • Manufacturing processes

Not disclosed

No changes

CADTH = Canadian Agency for Drugs and Technologies in Health; CDR = Common Drug Review; 
CDEC = Canadian Drug Expert Committee. 

a CADTH will be implementing these changes effective on April 1, 2013 and will subsequently incorporate them into the Procedure for Common Drug Review and CDR Confidentiality Guidelines documents.

b Refers only to the Summary of Patient Group Input that is incorporated into the CDR Clinical Review Report.