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CADTH Pharmaceutical Reviews Update — Issue 16

Last updated: June 25, 2020
Product Line: Pharmaceutical Review Update
Issue: 16
Result type: Report

Updates for Patients and Communities

CADTH 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 CADTH 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 CADTH’s website. In addition to written submissions, comments shared by patient groups and patients during the webinar will be included as stakeholder feedback.

CADTH Program Updates

1.  Consultation on CADTH’s Drug Reimbursement Review Procedures

CADTH 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 CADTH’s 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 CADTH 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 CADTH. We thank you in advance for your interest in CADTH’s drug reimbursement review process.

2.  Consultation on the Health Canada, CADTH, 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, CADTH, and INESSS that established a process to facilitate information sharing between Health Canada and the health technology assessment (HTA) agencies (CADTH 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, CADTH, 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, CADTH, 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 CADTH and INESSS.

Complete details regarding the proposed revisions to the aligned review process are provided in Proposed Enhancements to the Health Canada, CADTH, 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 CADTH. We thank you in advance for your interest.

3.  CADTH Process for Drugs With Expanded Health System Implications

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

  • revisions to the drug review processes (i.e., CADTH Common Drug Review, CADTH pan-Canadian Oncology Drug Review, and CADTH Interim Plasma Protein Product Review Process) that will accommodate the majority of cell and gene therapies (announced in January 2020)
  • revisions to the CADTH 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.

CADTH will be apply the expanded process to products that are not necessarily well-suited to CADTH’s 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. CADTH Process for Drugs with Expanded Health System Implications provides an overview of CADTH’s 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, CADTH 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 CADTH, 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

Previous process Revised process
Eligibility for provisional algorithm

Provisional algorithm work undertaken for all drugs filed for review through the pCODR process

Provisional algorithm work will be undertaken:

  • for oncology drugs that receive a pERC recommendation in favour of reimbursement
  • when CADTH receives direction from the drug programs that a provisional algorithm is required for implementation.

Required documentation

Filing a proposed algorithm is optional for the sponsor of the drug under review

A new mandatory submission template has been created for sponsors to clearly articulate their proposed place in therapy for the drug. This template has detailed instructions for sponsors and will be screened by CADTH prior to acceptance for review. This will help inform the drug programs about the need for CADTH to develop a provisional algorithm. 

Timing for initiation

Provisional algorithm work is initiated in the pre-submission phase (i.e., three to four months prior to an application being received by CADTH)

Provisional algorithm work will be initiated in the implementation phase (i.e., when a final recommendation has been issued in favour of reimbursement).

Timing for completion

Provisional algorithm work is completed at the time the pERC final recommendation has been issued

Provisional algorithm work is completed one to three months after a pERC final recommendation has been issued (depending on complexity, number of industry participants, and availability of clinical specialists).

Industry participants

Industry participation is limited to the sponsor of the drug under review through the pCODR process

Industry participants will include:

  • the sponsor of the drug under review through the pCODR process
  • all other manufacturers whose products may be directly impacted by the algorithm established by CADTH.

Algorithm reporting

Provisional algorithms are to be reported in the pERC final recommendation documents (only if the recommendation is in favour of reimbursement)

Provisional algorithms will be reported in a distinct CADTH report that is separate from all documentation related to the oncology drug submission(s) that triggered the need for the development of the algorithm.

pCODR = CADTH pan-Canadian Drug Review; pERC = pCODR Expert Review Committee.

5.  Clarification of Economic Requirements

CADTH 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 CADTH-participating drug plans).

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

6.  Revised Fee Schedule for CADTH

The Fee Schedule for CADTH Pharmaceutical Reviews has been revised to reflect the following changes:

  • CADTH 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, CADTH 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 CADTH’s 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 CADTH Pharmaceutical Reviews has been updated to reflect the new schedule F fee for drugs that are reviewed through the CADTH Process for Drugs with Expanded Health System Implications.