Pangaea Express: New CADTH Procedure and Submission Guidelines
CADTH has posted its new Procedure and Submission Guidelines for the CADTH Common Drug Review that combines two previously separate documents, Procedure for the CADTH Common Drug Review and Submission Guidelines for the CADTH Common Drug Review. This document incorporates all the revisions that were previously announced in a number of past CDR Update newsletters.
This new Procedure and Submissions Guidelines also includes new revisions such as pharmacoeconomic requirements, patient input process, temporary suspension of a review, and others. For a complete list of previous and new changes, please go to CDR Update — Issue 138. These procedural requirements will need to be followed for all submissions and re-submissions received on or after July 27th, 2018.
The Therapeutic Review Framework and Process has been revised that will allow for the reassessment and potential revision of existing recommendations that were previously issued through the CDR process. This will allow CADTH to reconsider a drug’s use when new evidence becomes available.
Also new is the CADTH Pharmaceutical Review Update that will consolidate all the previous communications: CDR Update, pCODR Update, Therapeutic Review Update, and Updates for Patient Groups. All subscribers to these updates will automatically receive the CADTH Pharmaceutical Review Update. As well there will be a new archive document that will hold previous postings for CDR Updates, Therapeutic Review Updates and Updates for Patient Groups.
This “reconsidering a drug’s use when new evidence becomes available” could affect various drug recommendations and manufacturers will need to be ready to address CADTH reassessment requirements.
For more information, please contact Marla Weingarten at firstname.lastname@example.org, Consultant, The Pangaea Group.