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.
- pCODR Pre-submission Guidelines
Last updated: April 12, 2011 - pCODR PAG Input on a Review Template
Last updated: July 21, 2011
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.
- pCODR Submission Guidelines
Last updated: February 1, 2016 - pCODR Disclosure of Information Guidelines
Last updated: May 2, 2011 - pCODR Procedures
Last updated: February 1, 2016 - Guidelines for Manufacturers on Application Fees for pCODR
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.
- pCODR Patient Engagement Guide
Last updated: June 4, 2012 - A Guide for Patient Advocacy Groups: How to provide patient and caregiver input for a pCODR drug review
Last updated: October 9, 2013 - Strengthening Your pCODR Submission: An Overview
Last updated: August 27, 2015 - Strengthening Your pCODR Submission: Collecting and Presenting Information
Last updated: August 27, 2015 - Patient Input Template for CADTH CDR and pCODR Programs
Last updated: June 13, 2017 - pCODR Patient Group Conflict of Interest Declarations
Last updated: June 13, 2017
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.
- Frequently Asked Questions: New Pilot to Increase Opportunity for Clinician Input and Feedback in CADTH pan-Canadian Oncology Drug Review Process
- pCODR Registered Clinician Input on a Drug Review
- pCODR Registered Clinician Conflict of Interest Declaration
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).
- pCODR Clinical Guidance Report Template
Last updated: April 13, 2011
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.
- pCODR Economic Guidance Report Template
Last updated: July 21, 2011
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.
- pCODR Checkpoint Meeting Template
Last updated: July 21, 2011
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
Last updated: March 2011
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.
- pCODR Submitter or Manufacturer Feedback on a pERC Initial Recommendation
Last updated: April 28, 2011 - pCODR Patient Advocacy Group Feedback on a pERC Initial Recommendation
Last updated: April 27, 2011 - pCODR Registered Clinician Feedback on a pERC Initial Recommendation
Last updated: February 1, 2016 - pCODR PAG Feedback on a pERC Initial Recommendation
Last updated: May 4, 2011
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.
- pCODR Procedures
Last updated: May 17, 2011
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.