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Process in Brief

The following describes the process that is used by CADTH's pan-Canadian Oncology Drug Review (pCODR). More information is available in the Guidelines, Procedures, and Templates section.

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 (a)    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 3.2 (b)    Collecting Registered Clinician Information

During pre-submission planning, registered clinicians are notified of a pending submission and invited to provide relevant information. Guidance for providing clinician input, including a clinician input template, is available in the pCODR Clinician Input and Feedback section of cadth.ca. Registered clinician 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 Report is 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.

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.