Once Health Canada has approved a cancer drug for use in Canada, the country’s provinces and territories must decide if the drug will be eligible for public reimbursement. The CADTH pan-Canadian Oncology Drug Review (pCODR) plays an important role in their decision-making processes.
Through the pCODR process, CADTH conducts thorough and objective evaluations of clinical, economic, and patient evidence on cancer drugs, and uses this evaluation to provide reimbursement recommendations and advice to provincial and territorial public drug plans (with the exception of Quebec) and provincial cancer agencies.
Because of its pan-Canadian scope, the pCODR process reduces duplication of effort by individual funders and ensures that reviews are done in a timely and consistent manner. To shorten the time between Health Canada regulatory approval and a CADTH reimbursement recommendation, a pCODR application may be made while a drug is still being reviewed by Health Canada; however, the CADTH cancer drug reimbursement recommendation is not issued until Health Canada approves the drug for use in Canada.
The pCODR process brings objectivity and credibility to the cancer drug review process, allowing for greater understanding by all stakeholders while ensuring that individual provinces and territories can make funding decisions informed by evidence that has been carefully evaluated by oncology-specific experts.
The evidence examined during the review comes from many sources, including patient group input; clinical studies demonstrating the safety, efficacy, and effectiveness of the drug compared with alternatives; therapeutic advantages and disadvantages relative to current accepted therapy; cost and cost-effectiveness relative to current accepted therapy; and implementation issues related to adoption feasibility.
CADTH notifies patient groups at the outset of a pCODR review and invites them to provide input. This step in the process captures patients’ experiences and perspectives of living with a medical condition for which a drug under review is indicated, their experiences with currently available treatments, and their expectations for the drug under review.
Reimbursement recommendations are made by the CADTH pCODR Expert Review Committee (pERC) comprised of medical oncologists, physicians, pharmacists, economists, an ethicist, and patient members. The drug plans and cancer agencies make their final reimbursement and coverage decisions based on the CADTH recommendations and other factors, such as their program mandates, jurisdictional priorities, and budget impact.
Step 1.0 Pre-submission Planning Activities
Either a drug manufacturer or a tumour group may submit an oncology drug to CADTH for a pCODR review. Before this submission is made, pCODR works with the manufacturer or tumour group (“the submitter”) to prepare them for the submission process. This preparation includes setting up pCODR supports to assist both submitters and stakeholder groups through the review process, obtaining input from the Provincial Advisory Group (PAG), and notifying appropriate stakeholder groups of the pending review. It also involves determining the appropriate membership for the Clinical Guidance Panels and Economic Guidance Panel, as well as identifying additional resources and expertise that will take part in the review.
Step 2.0 Preparing and Submitting a Request for Drug Review
It is important that the submitting tumour group or drug manufacturer follow pCODR’s Submission Guidelines, which help prepare the information required to start the review process.
Step 3.1 Screen Submission and Initiate Review Process
CADTH screens pCODR submissions by reviewing the content against a screening checklist to ensure that the submission meets the requirements outlined in the Submission Guidelines. Once the submission is deemed complete, CADTH initiates the pCODR review process.
Step 3.2 Collecting Patient Advocacy Group Information
During pre-submission planning, patient advocacy groups are notified of a pending submission and invited to provide relevant information. Guidance for providing patient input, including a patient input template, is available in the pCODR Patient Input and Feedback section of cadth.ca. Patient information is collected by CADTH and becomes input to the pCODR review.
Step 4.1 Conducting a Clinical Review
The membership of the Clinical Guidance Panels is confirmed during pre-submission planning, and varies depending upon the type of cancer treated by the drug under review. Supported by a Methods Team, the Clinical Guidance Panels review the submission and integrates the input provided by the various stakeholder groups. A Clinical Guidance Report is prepared for consideration by the pCODR Expert Review Committee (pERC).
Step 4.2 Conducting an Economic Review
The Economic Guidance Panel membership is confirmed during pre-submission planning. This panel reviews the submission and integrates the input provided by various stakeholder groups, as well as the Clinical Guidance Panel. An Economic Guidance Reportis prepared for consideration by pERC.
Step 4.1.1/4.2.1 Clarifying Information with a Submitter During the Review
Throughout the clinical and economic reviews, the pCODR reviewers are able to ask questions of the submitter. A formal checkpoint meeting is also held during the review process to provide the reviewers with an opportunity to seek more clarity directly from the submitter. Responses to the questions posed during this part of the review process provide information that may be included in the final guidance reports.
Step 5.0 Summarize and Review with pERC
At a pre-specified meeting date, CADTH provides pERC with information about the reviews, as well as the inputs from the various stakeholder groups. pERC reviews all the information presented to the committee, deliberates upon it using a deliberative framework, and formulates an Initial Recommendation.
pERC Deliberative Framework
Step 6.0 Prepare and Publicly Post Initial Recommendation and Reviews
The Initial Recommendation and a detailed discussion of how the recommendation was made are posted on cadth.ca. The clinical and economic guidance reports are also posted on cadth.ca.
Step 7.1, 7.2, 7.3 Get Input from Stakeholders
After the Initial Recommendation is posted, the submitter, manufacturer (if not the submitter), the registered patient advocacy group(s), and the Provincial Advisory Group have an opportunity to provide feedback. The feedback is submitted to pCODR using a feedback template.
Step 7.4 Assess Eligibility for Early Conversion
The pERC Chair and three pERC Members assess the feedback provided on the pERC Initial Recommendation to determine if it is eligible to convert to a Final Recommendation without requiring pERC reconsideration.
If any of the criteria for early conversion are met, editorial changes to the recommendation may be made, and the Final Recommendation will be posted on cadth.ca. This step allows for more timely recommendations in a limited set of instances. If the pERC Initial Recommendation is not eligible for early conversion, it is returned to pERC for further deliberation and reconsideration at the next possible pERC meeting.
Step 8.0 Summarize and Review with pERC
All feedback is noted, summarized, and provided to pERC, which meets to deliberate and reconsider, if appropriate, the Initial Recommendation. A Final Recommendation is made, which may or may not differ from the Initial Recommendation. There are limited circumstances for which this process step of reconsideration is not required.
Step 9.0 Prepare and Publicly Post Final Recommendation and Post All Feedback Received
The Final Recommendation and a detailed discussion of how the recommendation was made are posted on cadth.ca. All feedback on the Initial Recommendation is posted, along with the Final Recommendation.