CADTH Pharmaceutical Reviews Update — Issue 16

Updates for Patients and Communities

Canada's Drug Agency understands that patients and patient groups may have new or heightened responsibilities (both personally and professionally) as a result of the COVID-19 pandemic. Thank you for continuing to contribute patient input to our drug reviews and to offer stakeholder feedback. Please contact us to discuss options if you’re having difficulties gathering insights, preparing patient input, or offering feedback.

To support patient groups and patients contributing to the consultation on Canada's Drug Agency drug reimbursement review procedures, the patient engagement team will host a short webinar to highlight the aspects of the proposed procedure changes that involve patient groups. The webinar will take place on Thursday, July 9, 2020, at 11:00 a.m. EDT. Watch for an invitation to register. For those who can’t join live, the webinar will be recorded and made available on the Canada's Drug Agency website. In addition to written submissions, comments shared by patient groups and patients during the webinar will be included as stakeholder feedback.

Canada's Drug Agency Program Updates

1.  Consultation on the Canada's Drug Agency Drug Reimbursement Review Procedures

Canada's Drug Agency is inviting stakeholder feedback on a revised procedure for its drug reimbursement review processes (i.e., pan-Canadian Oncology Drug Review, Common Drug Review, and Interim Plasma Protein Product Review). This work has been undertaken to improve and align the Canada's Drug Agency procedures, submission requirements, and internal processes. The new proposed procedures have been established by adapting the best practices of each of the individual drug review processes (based on transparency, efficiency, timeliness, sustainability, and equity).

Complete details of the proposed procedures, along with a summary document, are provided in the Summary of Proposed Procedures for Canada's Drug Agency Drug Reimbursement Reviews.

To provide comments on the proposal, please use the Survey Monkey feedback template. Feedback must be received by 5:00 p.m. EDT on August 10, 2020. If you have any questions about the feedback process, please email Canada's Drug Agency. We thank you in advance for your interest in the Canada's Drug Agency drug reimbursement review process.

2.  Consultation on the Health Canada, Canada's Drug Agency, and INESSS Aligned Review Process

The Aligned Reviews Between Health Canada and Health Technology Assessment Organizations process was launched in June 2018 as part of Health Canada's Regulatory Review of Drugs and Devices (R2D2) initiative. This is a joint initiative between Health Canada, Canada's Drug Agency, and INESSS that established a process to facilitate information sharing between Health Canada and the health technology assessment (HTA) agencies (Canada's Drug Agency and INESSS). The aligned review process is currently optional for sponsors that are filing HTA submissions on a pre-Notice of Compliance (NOC) basis.

As described in the initial announcement regarding the aligned review process, Health Canada, Canada's Drug Agency, and INESSS committed to continuously monitoring participation rates by sponsors, and adjusting the aligned review process as required to ensure that it provides benefits to all participants. Health Canada, Canada's Drug Agency, and INESSS have conducted an initial evaluation of the aligned review process and are seeking feedback on two proposals to enhance the processes for all stakeholders:

• a proposal to make participation in the information-sharing process mandatory for all HTA submissions that are filed on a pre-NOC basis
• a proposal for minor revisions to the consent letter to reduce the need for Health Canada to distribute information separately to Canada's Drug Agency and INESSS.

Complete details regarding the proposed revisions to the aligned review process are provided in Proposed Enhancements to the Health Canada, Canada's Drug Agency, and INESSS Aligned Review Processes.

To provide comments on the proposal, please use the Survey Monkey feedback templates (English or French). Feedback must be received by 5:00 p.m. EDT on August 10, 2020. If you have any questions about the feedback process, please email Canada's Drug Agency. We thank you in advance for your interest.

3.  Canada's Drug Agency Process for Drugs With Expanded Health System Implications

As previously announced in November 2019, Canada's Drug Agency had undertaken an internal review of our drugs and devices processes for the purposes of optimizing how cell and gene therapies are reviewed by Canada's Drug Agency. This work led to the establishment of the following:

• revisions to the drug review processes (i.e., Canada's Drug Agency Common Drug Review, Canada's Drug Agency pan-Canadian Oncology Drug Review, and Canada's Drug Agency Interim Plasma Protein Product Review Process) that will accommodate the majority of cell and gene therapies (announced in January 2020)
• revisions to the Canada's Drug Agency Optimal Use process to accommodate a subset of pharmaceuticals that are perceived to pose significant implementation challenges for multiple components of the public health care system and, therefore, require an expanded review process.

Canada's Drug Agency will be apply the expanded process to products that are not necessarily well-suited to the Canada's Drug Agency drug reimbursement review processes. For example, novel products that could require complex and broad changes throughout the health care system for adoption to occur in a timely manner. Canada's Drug Agency Process for Drugs with Expanded Health System Implications provides an overview of the Canada's Drug Agency new process for drugs with broad health system implications.

4.  Changes to the Provisional Algorithm Process for Oncology Drugs

As part of the ongoing initiative to align its drug reimbursement review process, Canada's Drug Agency has undertaken an internal review of the provisional algorithm process that was launched in the summer of 2019. The objective of this review was to introduce efficiencies for Canada's Drug Agency, provide greater clarity to sponsors regarding the required documentation for the provisional algorithm process, and further enhance the transparency of the process for pharmaceutical manufacturers. The revisions to the process are summarized in Table 1 and include the following important changes:

• new proposed place in therapy template
• new timelines for establishing provisional algorithms
• new process for engaging drug manufacturers regarding provisional algorithms
• new review template for communicating provisional algorithms.

Table 1: Revisions to the Provisional Algorithm Process for Oncology Drugs

pCODR = Canada's Drug Agency pan-Canadian Drug Review; pERC = pCODR Expert Review Committee.

5.  Clarification of Economic Requirements

Canada's Drug Agency has made a minor adjustment to the description of the requirements in the economic evaluation (specifically relating to the congruence test to inform the number of model runs required to produce stable results, and the presentation of parametric distributions when using survival data) and budget impact analysis (specifically relating to the breakdown of costs by perspective, and the flexibility of the model to apply to any Canada's Drug Agency-participating drug plans).

The Procedures for the Canada's Drug Agency Common Drug Review and Interim Plasma Protein Product Review and the Procedures for the Canada's Drug Agency pan-Canadian Oncology Drug Review have been updated to reflect these revisions.

6.  Revised Fee Schedule for Canada's Drug Agency

The Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews has been revised to reflect the following changes:

• Canada's Drug Agency has undertaken a review of drug program costs from 2018 to 2019 and 2019 to 2020. This analysis has demonstrated that the level of effort required to complete the review of projects that are assigned a schedule B application fee (i.e., submissions for drugs with new indications and resubmissions) is consistent with those that are currently assigned a schedule A application fee. As a result, Canada's Drug Agency is adjusting the fee schedule for pharmaceutical reviews to accurately reflect the costs of these projects. The schedule B fee will be discontinued and all submissions and resubmissions received on or after June 30, 2020, will be subject to a schedule A fee.
• As part of the Canada's Drug Agency cost-recovery initiatives, a schedule D fee is currently applied for reconsideration requests in the Common Drug Review and Interim Plasma Protein Product Review processes; however, this is not applied in the pan-Canadian Oncology Drug Review (pCODR) process. Effective for all pCODR submissions and resubmissions targeting the October 2020 meeting of the pCODR Expert Review Committee and thereafter, a schedule D fee will apply for requests for reconsiderations that are filed by industry sponsors.
• The Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews has been updated to reflect the new schedule F fee for drugs that are reviewed through the Canada's Drug Agency Process for Drugs with Expanded Health System Implications.