CDR Update — Issue 69

CADTH Launches Patient Group Input to CDR

The Canadian Agency for Drugs and Technologies in Health (CADTH) is pleased to announce that, as of May 13, 2010, patient groups may formally provide input into CADTH’s Common Drug Review (CDR) process. Patient groups are encouraged to provide the patient perspective regarding drugs being reviewed by CDR. The patient input or evidence will be incorporated throughout the CDR review process in a systematic way. For example:

Health outcomes and issues identified by patients will be used to develop the review protocol – a critical step that clearly focuses the drug review
Patient input will be included in the CDR clinical and economic reports prepared for the Canadian Expert Drug Advisory Committee (CEDAC)
Patient input will be incorporated into the CEDAC deliberations and the resulting formulary listing recommendations for the CDR-participating drug plans.

This approach is designed to allow for a continuum of patient input from the CDR review up to and including the decision-making step taken by the jurisdictions. It has been developed in consultation with the participating drug plans, other international drug review agencies, and stakeholders, including patients. The consultation feedback received on the patient input process is summarized in Table 1.

More details on the patient input process may be found on the Patient Input page of the CADTH website. This includes a Guide for Patient Group Input to the Common Drug Review and a Template for Submitting Patient Group Input to be used when providing patient input.

Notification of Calls for Patient Input

CADTH will post the names of all pending and received drug submissions to CDR and the respective deadlines for providing patient group input on the Patient Input page of its website. Patient groups and individuals are encouraged to visit this page or subscribe to "Calls for Patient Input" e-alerts using the Subscribe button on the CADTH website. The patient input deadlines will also be added to the CDR Drug Database record for each drug submission.

Reminder to Industry to Advise CDR of Pending Submissions

As outlined in CDR Update, Issue 68, CADTH is requesting that manufacturers notify CDR of pending submissions at least two weeks before filing the submissions. This will increase the time patient groups have to prepare their patient input submissions. The information CADTH will post for each drug submission includes: brand name, generic name, manufacturer, indication and the tentative submission date. A Template Table for Notice of Pending Submissions has been posted on the Filing a Submission web page for manufacturers to use when providing this information to CDR.

Summary of Consultation Feedback on Proposed Patient Input Approach

In December 2009, CADTH posted a proposed approach for feedback to get broad input into the development of a systematic and meaningful approach for obtaining and using patient input in CDR reviews of drugs. CADTH thanks all the stakeholders who submitted comments and suggestions.

The consultation feedback was helpful in refining the patient input process and the supporting documents. Much of the feedback followed common themes. These themes and CADTH’s actions or responses to the feedback are summarized in the following table.

Table 1. Summary of Consultation Feedback on Proposed Patient Input Approach
Stakeholder Feedback	CADTH Action / Response
Fifteen business days (3 weeks) for submitting patient input is too short; however, overall timelines for CDR review should not be extended.	An explanation that patient input is required early in the review of the drug (i.e., at protocol development) so that patient-important outcomes and issues can be meaningfully used was added to patient input documents. Manufacturers are asked to provide two-week advance notice of pending submissions. Pending submissions will be posted on the CADTH website thereby increasing the amount of time for patient input to 25 business days (5 weeks). Patient groups anticipating new drugs for their conditions may prepare, in advance, some of the information requested in the template.
Clarification of Conflict of Interest requirement	Clarification in the CDR documents that declared conflicts of interest do not preclude the use of the input. The declarations are required for transparency.
Acceptance of input from others (individuals, health care providers, etc.)	CDR documents were revised to clarify that individual patients may contact a patient group to request that their input be included in a patient group submission.
Definition of testimonials (i.e., avoid “individual or personal testimonials”)	CDR documents revised to clarify that objective information representative of the majority of patients in the patient group is the most useful. Anecdotes about personal experiences may be provided as supporting examples.
Weighting of patient input in making recommendations	Patient group input is considered another source of evidence in the review of a drug. No formal weighting to the different forms of evidence has been established. Issues and outcomes important to patients will be considered throughout the CDR/CEDAC process.
Transparency about how patient input will be used in the review and recommendation process	Descriptions of how patient input is collected and will be used has been incorporated into the CDR documents. Patient input will be included in the CDR review reports. Patient input will be included in the CEDAC deliberations and recommendation documents.

Evaluation of the Patient Group Input Process

CADTH intends that the patient input process be user-friendly, and will be evaluating the process on an ongoing basis to determine if changes are required. Therefore, we would be grateful for feedback on this new initiative. Feedback may be submitted to cdrfeedback@cadth.ca.