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STAY TUNED: CADTH to Evaluate CAR T-Cell Therapies. Information on review process below – stakeholders, patient groups and clinicians will have an opportunity to provide their insight at a future date

Since the FDA approved the first gene therapy in 2017, Canadian patients, health care providers, and decision-makers have been anticipating the arrival of chimeric antigen receptor (CAR) T-cell therapies in Canada. During this time, CADTH has been considering how to effectively and rigorously assess the clinical effectiveness and value that these therapies may bring to patients and the health care system.

Today, we are pleased to provide further details about how our reviews of CAR T-cell therapies will proceed.

Review Process

CAR T-cell therapies are ushering in a new approach to treating cancer and other serious conditions. Given the unique aspects of these health technologies, CADTH will review CAR T-cell therapies through its health technology assessment process for medical devices and clinical interventions, and not through its pan-Canadian Oncology Drug Review (pCODR) or Common Drug Review (CDR).

This approach is being implemented in direct response to feedback from federal, provincial, and territorial Ministries of Health and the Canadian Association of Provincial Cancer Agencies (CAPCA), and is consistent with that being taken by several other health technology assessment bodies, including the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec.

Assessments will be led by CADTH, with recommendations, advice, and guidance from the Health Technology Expert Review Panel (HTERP). HTERP’s current member composition will be supplemented with individuals who have the applicable clinical expertise and who are leading the implementation of CAR T-cell program planning provincially.

Transparency, collaboration, and stakeholder engagement are central to each assessment that CADTH undertakes, and our appraisals of CAR T-cell therapies will be no different. Stakeholders, including patient groups and registered clinicians, will have the opportunity to provide their insight and perspective on these new treatments. For indications specific to cancer, we will also work closely with the Canadian Association of Provincial Cancer Agencies to ensure that any operational and implementation issues are effectively addressed.

Our assessments of CAR T-cell therapies will include a clinical and health economics review, patient and clinician input, manufacturer input, and a comprehensive review of implementation considerations. Reports for each component of the review will be released publicly on the CADTH website. There will be opportunities for feedback on interim versions of these reports.

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CADTH invites stakeholder feedback on proposed revisions to the clinician engagement process for its pan-Canadian Oncology Drug Review (pCODR) program [Closes 20-April-2018]

CONSULTATION: Proposed Revisions to the pCODR Clinician Engagement Process

CADTH invites stakeholder feedback on proposed revisions to the clinician engagement process for its pan-Canadian Oncology Drug Review (pCODR) program.

March 20, 2018
Deadline to Submit Feedback:
April 20, 2018 at 5:00 p.m. ET by email to pcodrinfo@cadth.ca

Link to the consultation document:

Proposed Revisions to the Clinician Engagement Process for CADTH’s pan-Canadian Oncology Drug Review Program

How to Submit Your Feedback:

  • Only one response per organization will be considered. If more than one response is received, only the first response received will be considered.
  • To provide feedback, you must identify yourself — feedback provided by individuals who do not identify themselves and the organization they represent will not be considered.
  • Feedback should be presented clearly and succinctly.
  • Feedback must be provided in 11-point font using this feedback template and saved as a Microsoft Word document (.doc or .docx).
  • Please submit your feedback by April 20, 2018 at 5:00 p.m. ET via email topcodrinfo@cadth.ca.

Next Steps:

Following the consultation period, CADTH will carefully assess all stakeholder feedback. Any decisions about changes to the current pCODR clinician engagement process will be announced in a pCODR Update.

Background:

In February 2016, CADTH launched a pilot project to expand clinician participation in the pCODR process, with the goal of gaining insight into local issues and identifying areas of unmet need. As of December 31, 2017, 169 oncologists have registered to participate and 36 of 41 reviews (88%) have included clinician input. During this pilot phase, CADTH has received input from registered clinicians through a survey, the pCODR Expert Review Committee, and the Provincial Advisory Group on ways to enhance the process.

With the goal of enhancing clinician engagement opportunities, CADTH is proposing the following key changes to the current process:

  • A new template for clinician input, including customized questions that are more specific to the drug and indication that is under review by the pCODR program.
  • Expanding the eligibility criteria beyond oncologists to include oncology pharmacists and oncology nurses who are part of a multi-disciplinary team caring for cancer patients and who meet the proposed criteria.

     

It is important to note that the pCODR program’s submission and review timelines, notification of pending drug reviews, and process requirements to provide feedback will not change.
CADTH continues to foster relationships with the clinician community and believes that increasing the opportunity for input into the pCODR process will enhance the quality of our reviews and contribute to broader discussions about drug funding decisions in Canada.

If you have questions about our proposed changes, please contact us at pcodrinfo@cadth.ca.

About CADTH

CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our health care system. CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Learn more at: www.cadth.ca.