- CDR Consultation – Patient Input Template for Subsequent Entry Biologics (SEB)
- CADTH has developed a patient input template for SEBs and is now seeking feedback on the proposed template.
- Feedback should be emailed by June 6, 2014 to feedback@cadth.ca.
- Temporary Suspension of a CDR Review Due to Incomplete Information
- CADTH has recently encountered CDR submissions with insufficient information, leading CDEC to defer the drug under review to a subsequent meeting.
- CADTH will continue to work with manufacturers to try to avoid the need to temporarily suspend CDR reviews; however, this procedure will be invoked in all situations where incomplete information is preventing the CDR review team from completing a thorough assessment of a submission or resubmission.
- CDR Procedure for Pipeline Notification and Notification of Pending Submissions
- Based on stakeholder feedback and discussion with the CDR-participating drug plans, CADTH is implementing the following two-step approach for forecasting pending CDR submissions:
- Step 1: Voluntary Advanced Notification (12 months)
- Step 2: Mandatory Notification of Pending Submission or Resubmission (20 business days)
- Changes to Eligible Pre-NOC Submissions – Effective Immediately
- CADTH is revising the eligible pre-NOC submission description as currently included in the Procedure for Common Drug Review and of the Common Drug Review Submission Guidelines for Manufacturers.
- The submission type will be expanded to include all eligible submissions types from manufacturers (i.e., new drugs, drugs with a new indication[s], new combination products, new combination products [funded components], and subsequent entry biologics).
- Until the guidelines are updated, manufacturers wishing to submit a pre-NOC submission for a new combination product are asked to contact CADTH regarding the Category 1 and Category 2 submission requirements by emailing requests@cadth.ca.
- Clarification Regarding CDR Submissions for Subsequent Entry Biologics (SEBs)
- CADTH anticipates multiple SEBs for the same reference product will be marketed by different suppliers in Canada for the same indication(s). To address this issue, the first SEB that is filed with CADTH for any given reference product will be reviewed through the CDR process on a case-by-case in consultation with the CDR-participating drug plans.
- All manufacturers should contact CADTH before filing a CDR submission for an SEB atrequests@cadth.ca.
- Clarification Regarding the Revised CDR Priority Review Process
- Any CDR submissions or resubmissions with a priority review request received by CADTH up to May 29, 2014, will receive decisions on their priority review requests on or before June 19, 2014.
- CDR submissions or resubmissions received by CADTH after May 29, 2014 will follow the priority review procedure as outlined in CDR Update —Issue 102, with a target date of 15 business days from the date of receipt.
- The review of CDR submissions or resubmissions for which a priority review is granted will be initiated on a first-come, first-served basis determined by the date CADTH deems the submission or resubmission complete.