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Process in Brief

Process in Brief

The following describes CADTH's pan-Canadian Oncology Drug Review (pCODR) process. 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 review through the pCODR process. Before this submission is made, CADTH works with the manufacturer or tumour group ("the sponsor") to prepare them for the submission process. This preparation includes setting up supports to assist both sponsors 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

Sponsors must file submissions and resubmission in accordance with the content, format, and organization stipulated in the Procedures for the CADTH pan-Canadian Oncology Drug Review. All submissions and resubmissions filed by manufacturers for drugs are subject to an application fee.

Step 3.1 – Application and Screening Process

CADTH screens applications in the order they are received and in accordance with the requirements and checklists described in the Procedures for the CADTH pan-Canadian Oncology Drug Review. The screening period for a submission or resubmission is 10 business days. Note: The date the submission is received at CADTH is considered day zero for the purposes of calculating timelines. Once the submission has been accepted for review by CADTH, the key milestones for the review are posted on the CADTH website.

Step 3.2 (a) – Collecting Patient Group Information

During pre-submission planning, patient 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 pCODR Patient Input and Feedback. 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. Clinicians are required to register through the Registration Page only once. Guidance for providing clinician input, including a clinician input template, is available in  pCODR Clinician Input and Feedback. Registered clinician information is collected by CADTH and becomes input to the pCODR review. Registered clinicians will receive notifications via email of all upcoming drug reviews through CADTH’s pCODR process. The email notification will have information pertaining to the drug and indication under review, the link to the clinician input template, and the deadline date for submitting input.

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 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, CADTH reviewers are able to ask questions of the sponsor. 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 sponsor. Responses to the questions posed during this part of the review process provide information that may be included in the final clinical and economic reports.

Step 5.0 – Summarize and Review with pERC

At a pre-specified meeting date, CADTH provides pERC with information about the drugs under review, 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 includes a detailed discussion of how the recommendation. The recommendation and the clinical and economic reports are posted on the CADTH website.

Step 7.1, 7.2, 7.3 – Get Input from Stakeholders

After the initial recommendation is posted, the sponsor, manufacturer (if not the sponsor), the registered patient group(s), and the Provincial Advisory Group have an opportunity to provide feedback. The feedback is submitted to CADTH using a standardized feedback template.

Step 7.4 – Assess Eligibility for Early Conversion

The pERC Chair and three pERC Members will assess the feedback provided on the initial recommendation to determine if it is eligible to convert to a final recommendation without requiring reconsideration by the expert review committee.

If the criteria for early conversion are met (i.e., no substantive comments about the initial recommendation), editorial changes to the recommendation may be made, and the final recommendation will be posted on the CADTH website. This step allows for more timely recommendations in a limited set of instances. If the initial recommendation is not eligible for early conversion (e.g., substantive comments relating to the recommendation), it is returned to the expert review committee 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 the expert review committee, 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 includes a detailed discussion of how the recommendation was made and is posted on the CADTH website. All feedback on the initial recommendation is posted, along with the final recommendation