CADTH Pharmaceutical Reviews Update — Issue 1

New CADTH Pharmaceutical Reviews Update

CADTH is pleased to announce the launch of the CADTH Pharmaceutical Reviews Update, a new consolidated publication that will be used to communicate updates to our drug review processes. This new update replaces the following individual communications: CDR Update, pCODR Update, Therapeutic Review Update, and Updates for Patient Groups.

All subscribers to CDR Update and/or pCODR Update will automatically receive the CADTH Pharmaceutical Reviews Update.

CADTH will routinely archive postings for the new Pharmaceutical Reviews Update as these become outdated. The archived updates (including those from previous issues of CDR Update, Therapeutic Review Update, and Updates for Patient Groups) will be available in the CADTH Drug Program Updates (Archive).

Updates for Patients and Communities

Over the next few months, we’ll be reaching out to patient groups that are already familiar to CADTH, as well as to groups we’d like to know better, to explore potential roles and membership criteria for the new patient advisory committee that was mentioned in the CADTH 2018-2021 Strategic Plan. We’ll also be seeking ideas from patient groups and interested individuals on how activities at CADTH meet, and could better meet, international best practices for patient involvement in health technology assessment.

Consultations on CADTH’s Pharmaceutical Review Programs

CADTH is inviting stakeholder comments and feedback on the following proposals:

1. Strengthening the process for establishing reimbursement criteria in CDR recommendations.
2. Posting of CADTH responses to manufacturer feedback received for draft CDR review reports.
3. Addressing non-submissions by manufacturers

1. Strengthening Process for Establishing Reimbursement Criteria in CDR Recommendations

The CADTH Canadian Drug Expert Committee (CDEC) often specifies clinical criteria as part of its reimbursement recommendations. Stakeholders have recently indicated that there is a need for CADTH to improve the CDR processes for establishing reimbursement criteria. Specifically, jurisdictions have requested greater detail and consistency in the initiation, renewal, and discontinuation criteria included in CDEC recommendations. CADTH is committed to working with all stakeholders to improve the quality of the reimbursement criteria included in CDEC recommendations; as such, CADTH has identified several opportunities to improve the CDR process to facilitate the development of initiation, renewal, and discontinuation criteria in CDEC recommendations. These will build on CADTH’s commitment to enhance the CDR process — particularly for complex treatments, such as drugs for rare diseases — and will impact all phases of the CDR review process (i.e., intake, initiation, review, deliberations, and recommendation). Please access the consultation details at the following link: Strengthening Process for Establishing Reimbursement Criteria in CDR Recommendations

2. Posting of CADTH responses to manufacturer feedback received for draft CDR review reports

CADTH is initiating stakeholder consultation on a revision to the CDR procedure to publicly post manufacturer comments and corresponding CADTH responses. As part of this initiative, CADTH is proposing that it shift the current redaction process so it occurs after CADTH’s responses to the manufacturer’s comments have been finalized and are provided to the manufacturer for information. Please access the consultation details at the following link: Posting of CADTH responses to manufacturer feedback received for draft CDR review reports.

3. Addressing Non-Submissions by Manufacturers

CADTH has recently encountered a number of situations where manufacturers with eligible products have declined to file submissions with the CDR or pan-Canadian Oncology Drug Review (pCODR) processes. This creates challenges for participating drug plans that are receiving requests for reimbursement for products that the manufacturer has declined to participate in the CDR or pCODR process. CADTH is proposing a formalized process for publicly communicating situations where a manufacturer has declined to file a submission. Please access the consultation details at the following link: Addressing Non-Submissions by Manufacturers

How to Submit Your Feedback

To provide feedback on the proposals above, please use this feedback template. The completed template must be saved in one of the following formats:

• Microsoft Word document (.doc or .docx)
• unlocked PDF document that permits copying and pasting of text.

Feedback should be presented clearly and succinctly, in 11-point font, and must be received by CADTH by 5:00 p.m. ET on September 10, 2018. For feedback to be considered, you must identify yourself to CADTH. Only one response per organization will be considered. If more than one response is received, only the first will be considered.

If you have any questions about the feedback process, please email us at [email protected]. We thank you in advance for your interest.

CADTH Program Updates

Pan-Canadian Oncology Drug Review (pCODR)

1. Expanding Clinician Input Under the CADTH pCODR Program

In April 2018, CADTH received stakeholder feedback on proposed changes to the clinician input process for the CADTH pan-Canadian Oncology Drug Review (pCODR) program. We would like to thank all of the stakeholders who responded to the consultation. Having integrated this stakeholder feedback, CADTH is pleased to now launch a revised clinician input template for a cancer drug under review.

Effective August 9, 2018, all submissions that are posted as a pending review will have a drug- and indication-specific template for clinicians to provide their input. The new template will be located on the CADTH Web page for the corresponding drug and indication, and will include the following information in the template to provide context for clinician input:

• generic drug name and brand name
• indication and funding request
• links to the clinical trial description and the clinical trial publication being submitted for review (if available).

In addition to the standard set of questions, there may be additional questions regarding the implementation of the drug in clinical practice. A link to the clinician input template for each drug will be provided in the email notification of upcoming drug reviews. The method for submitting through the CADTH Collaborative Workspaces, and the deadline of ten (10) business days after the submission is received, remain unchanged.

CADTH is also pleased to extend the clinician registration to actively practising oncology pharmacists and oncology nurses. In addition to registering with the pCODR program and providing their declaration of conflict of interests, oncology pharmacists and oncology nurses must provide their input as a joint submission with an oncologist or a physician who treats cancer patients, or with a group of oncologists or physicians who treat cancer patients.

Stakeholders providing feedback during the consultation have identified that streamlining the registration process, email notifications, and input submission process would facilitate clinician participation. At this time, there are no changes to these processes, although CADTH is continuing to work on streamlining them.

We strongly encourage clinicians to register with the pCODR program well in advance to ensure eligibility to provide input and feedback on a future submission or resubmission and to receive notification of upcoming submissions. For more information about the registration process, please visit the CADTH website at https://www.cadth.ca/pcodr-registration.   

We have created a list of FAQs to offer guidance to clinicians on the eligibility criteria and how to provide high-quality input and feedback on a submission or resubmission. To ensure procedural fairness, the requirements for eligible clinicians are set out in the pCODR Procedures andpan-Canadian Oncology Drug Review Submission Guidelines.

As part of this update, CADTH has also made revisions to a number of its templates for the pCODR program. Submitters should ensure that they only use the latest version of the template posted on the CADTH website and made available in the CADTH Collaborative Workspaces.

2. Putting the CADTH pCODR Priority Review Process On Hold

Effective immediately, CADTH has put the pCODR priority review application process on hold. All submissions under review that have met priority review criteria will maintain their priority status until they have received a Notification to Implement a pERC Final Recommendation or they have been withdrawn. In addition, pending submissions (issued one month in advance of the anticipated filing date) posted on the CADTH website on or before August 9, 2018 that have requested priority review will have their requests assessed upon submission and, if granted, maintained until they have received a Notification to Implement a pERC Final Recommendation or they have been withdrawn.

In the absence of a backlog of pCODR submissions, the current priority review process does not have any material impact to the order of the review. In the future, CADTH will review the pCODR priority review process, as required, in consultation with the jurisdictions and stakeholders. This change aligns with the CADTH CDR program.

3. Revising the Submission Screening Duration for the CADTH pCODR Program

Effective immediately, the pCODR program is revising the screening period for all submissions received, including new submissions, biosimilars, and Requests for Advice, from five (5) business days to ten (10) business days of its receipt. This change aligns the screening duration for all CDR and pCODR submissions and resubmissions.

Common Drug Review (CDR)

1. Joint CADTH-INESSS Engagement of Clinical Specialists

To promote efficiency in the CADTH and Institut national d’excellence en santé et en services sociaux (INESSS) processes, the two agencies are planning a pilot process to jointly engage with clinical specialists on selected drug products. Other stages of the review processes will continue to be completed independently, including the deliberation and recommendation phases. Further details regarding this pilot process will be announced in Fall 2018.

2. Procedure and Submission Guidelines for the CADTH Common Drug Review

CADTH has made a few minor revisions to the Procedure and Submission Guidelines for the CADTH Common Drug Review. These include replacing references and links to CDR Update with the new CADTH Pharmaceutical Reviews Update and some small corrections to the checklists in the appendix.

Other Announcements and Initiatives

1. Drug Reassessments

CADTH initiated stakeholder consultation on the reassessment of drugs through the therapeutic review process in July 2017 and implemented a revised process in June 2018. In addition to therapeutic reviews, CADTH is currently examining opportunities for the reassessment of drugs through other existing and novel review pathways in order to better meet the needs of its stakeholders. Further communication and stakeholder consultation on these initiatives is anticipated in fall 2018.

2. Real World Evidence

CADTH has established an internal working group to develop a strategic framework for addressing real world evidence in our drug review processes. CADTH has established partnerships with Health Canada and the Institute of Health Economics and will be co-hosting a multi-stakeholder Real World Evidence Summit on October 21, 2018 in conjunction with the Canadian Association for Population Therapeutics conference in Toronto.