CADTH Pharmaceutical Reviews Update, Issue 16

Consultations on Enhanced and Aligned Review Processes and Program Updates.

CADTH released its Pharmaceutical Reviews Update — Issue 16 on June 25, 2020. It includes two consultations with respect to enhanced and aligned review processes, in addition to program update announcements. Highlights of the consultations and program updates are described below.

Topic	MORSE Note
Consultations – Feedback due to CADTH by August 10, 2020
Consultation on Alignment of Drug Reimbursement Review Procedures	This consultation invites stakeholder feedback on a revised procedure that CADTH is proposing for all its drug reimbursement review processes (i.e., pCODR, CDR, and PPP). CADTH’s objective is to align their procedures, submission requirements, and internal processes. Confidentiality Guidelines The consultation includes a list of information sources that CADTH would not consider confidential, and that would be subject to disclosure if included in CADTH reports and recommendations; highlights of the list include: all clinical data submitted by the sponsor, including ad-hoc or post-hoc analyses, regardless of publication status or plans to publish methods, results, and interpretation of indirect treatment comparisons and pharmacoeconomic evaluations submitted by the sponsor, information related to the sequencing of therapies, and submitted prices. CADTH notes that some types of submitted information may be deemed by CADTH to be confidential, including, market research data, implementation plans for how the product could be provided in the health care system, and confidential business information. Sponsors must clearly identify it as such in their submission and provide a rationale for its redaction. Pharmacoeconomic requirements Proposal to accept cost minimization analyses for drugs meeting all of the following: is an addition to a therapeutic class that includes a reimbursed drug demonstrates comparable clinical effects based on direct or indirect evidence is anticipated to result in equivalent or less cost to the health system. Stakeholder input Proposal to enhance and align stakeholder input via: issuing a call for patient group and clinician group input for all reimbursement reviews and accepting comments on the draft recommendations from all groups providing input input from drug programs early in the review phase, a summary of which will be included in the clinical report, and subsequent formal written feedback from drug programs on draft recommendations. Reconsideration options Proposal to establish three categories of reconsideration requests: Major revision requests would be those requiring a change in recommendation category or change to eligible patient population and would involve discussion and deliberation of the full expert committee; any substantial change would require another draft recommendation be issued. The process could take two to three months. Minor revision requests would be those relating to changes in criteria for the patient population of interest, implementation guidance, or reasons for the recommendation and would require discussion and deliberation with a subpanel of the expert committee. The recommendation would be made final with or without minor revisions. The process could take one month. Editorial revision requests would be to provide clarity which could be addressed by CADTH staff, and would create no delay in timelines. Major and minor revision requests would be accepted from sponsors and drug plans only; editorial requests would be accepted by the former in addition to patient and clinician groups providing input to the review. Remaining differences between oncology and non-oncology drug reviews Despite the proposed changes to align drug reimbursement review procedures, CADTH notes that the following application types would remain for oncology drugs only: applications from clinician groups submissions for unapproved indications for oncology drugs marketed in Canada where there is sufficient clinical evidence to support a review and when the drug may address an unmet need. The full consultation document may be found here.
Consultation on the Health Canada, CADTH, and INESSS Aligned Review Process	Proposal to: make participation in the information sharing process mandatory for all pre-NOC submissions revisions to the consent letter to reduce the need for Health Canada to distribute relevant information separately to CADTH and INESSS Full details may be found here.
Other CADTH Program Updates
Process for Drugs with Expanded Health Systems Implications	CADTH announced revisions to the CADTH Optimal Use process to accommodate reviews for products that are not particularly suited to the drug reimbursement review process; e.g., cell and gene therapies that pose significant implementation challenges. Details provided here.
Changes to the Provisional Algorithm Process for Oncology Drugs	Changes to this process include: Eligible drugs are those that receive a pERC recommendation in favour of reimbursement and for which drug programs request a provisional algorithm. Work will begin after a final recommendation has been issued and is expected to be completed one to three months following the recommendation. Manufacturers whose products may be directly impacted by the algorithm may participate in the process. Details regarding the provisional algorithm process may be found here.
Clarification of Economic Requirements	Minor changes were made the to the economic requirements related to: congruence test to inform the number of model runs required presentation of parametric distributions for survival data breakdown of costs in budget impact analyses, and the flexibility to apply the model to any participating drug plan.
Revised Fee Schedule	The fee schedule has been revised to include a: schedule A fee for all submissions (on or after June 30, 2020) for drugs with new indications and resubmissions schedule D fee for reconsideration requests for oncology drugs targeting pERC meetings October 2020 and beyond schedule F for drugs reviewed through the process for Drugs with Expanded Health System Implications. The revised fee schedule may be found here.

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