CADTH released its Pharmaceutical Reviews Update — Issue 15 on April 29, 2020. Please find below MORSE Consulting’s summary of this update.
|1. COVID-19 Update||CADTH will continue to deliver on core activities, including the completion of ongoing drug reviews and initiation of new reviews in accordance with target timelines, and progress reports will continue to be posted on the CADTH website. Pre-submission and expert committee meetings will be held virtually. Sponsors and patient groups are requested to notify CADTH if they anticipate delays in completing their own tasks related to drug reviews.|
|2. Consultations on CADTH Drug Review Procedures Postponed||Planned consultations related to aligned drug review processes have been postponed, due to the COVID-19 pandemic. Stakeholders will be notified when a time frame for the consultation has been determined.|
|3. New Expert Review Committee for Plasma Protein Products||CADTH announced that Drs. Irene Sadeck and Andrew Shih have been appointed as members of the newly formed Canadian Plasma Protein Product Expert Committee (CPEC), a subcommittee of the Canadian Drug Expert Committee (CDEC). The full membership of CPEC is not currently listed on the CADTH website.|
|4. Revised Procedure for the Sponsor Review of CADTH pCODR Reports||Based on feedback from sponsors, CADTH announced a change to pCODR procedures, to provide sponsors with a copy of the complete CADTH Pharmacoeconomic Report in addition to the executive summary, to facilitate validating the handling of non-disclosable information and the identification of errors in the latter document, prior to it being posted to the CADTH website.|
|5. Clarification of Requirements for Budget Impact Analysis||CADTH procedure documents have been amended to clarify that as part of category 1 requirements, sponsors are required to include copies of all supporting documentation for their pan-Canadian Budget Impact Analysis.|
|6. Clarification of Stakeholder Feedback on pCODR Expert Review Committee Initial Recommendations||CADTH announced a revision to pCODR procedures to clarify the stakeholder feedback process on the pERC Initial Recommendation. Specifically, any commentary on the content of the clinical or pharmacoeconomic reports must be related to the pERC Initial Recommendation.|
|7. Updated Fees for CADTH Pharmaceutical Reviews||CADTH has adjusted its annual fee based on the Consumer Price Index. See new fees below.|
|8. Quarterly Update to the Canadian Drug Expert Committee (CDEC) Meeting Schedule||CADTH has updated its meeting schedule. See new meeting schedule below.|
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