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pCODR invites the input of clinicians and patient groups on Blinatumomab (Blincyto) for Ph+ B-cell precursor Acute Lymphoblastic Leukemia (tentative target date: September 17, 2018 by 5:00 p.m. Eastern Time)

See below the information on how to submit feedback to CADTH pCODR on Blinatumomab for Ph+ B-cell precursor ALL. 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. Please remember that clinicians, tumour groups and patient groups need to be registered with pCODR to submit input directly.  After a registration is submitted, the process can take two business days.  In addition, both C17 and N2 are registered and can submit input.


The CADTH pan-Canadian Oncology Drug Review (pCODR) is anticipating that a submission will be made for blinatumomab (Blincyto) for Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL).

The manufacturer has indicated that it will seek funding for blinatumomab (Blincyto) for the treatment of patients with relapsed or refractory Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) ALL.

Patient groups and clinicians that have registered with pCODR are invited to provide input by using the applicable templates: Patient Input Template for CADTH CDR and pCODR Programs or the pCODR Registered Clinician Input on a Drug Review template, which are available at Process in Brief (www.cadth.ca/pcodr/process-in-brief).

The targeted deadline for receiving patient group and registered clinician input on blinatumomab (Blincyto) for ALL is September 17, 2018 by 5:00 p.m. Eastern Time. This date is tentative and will be confirmed on the CADTH website once the submission has been filed by the manufacturer. Patient group and registered clinician submissions can be made through the CADTH website once the submission has been filed.

Patient groups and clinicians that have not yet registered with pCODR and would like to provide input are invited to visit pCODR Registration for details on registration.

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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.

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.