Frequently asked Questions

Eligibility

Q: Does the Scientific Advice program offer advice at the post-phase III trial stage?

The Scientific Advice program now offers advice after protocols for pivotal trials are finalized. Questions can include topics related real-world evidence generation plans, economic modelling plans, as well as feedback on the trial population, comparators, and outcomes. We do not offer advice on the results of existing data.

Q: Does the Scientific Advice program offer advice on proposed economic evaluation plans?

Yes, as long as information regarding the economic evaluation plans and question related to the plans are included in the Briefing Book for Scientific Advice and all eligibility requirements are met.

Read more about the type of advice offered through the Scientific Advice program.

Process

Q: How many questions can an applicant submit to Scientific Advice?

Applicants should consider the amount of information that can be discussed in a Scientific Advice meeting when determining the final number of questions to submit. As a general rule, 10 questions is usually the maximum that can be discussed at the meeting for the standard process; however, this is dependent on the complexity of the questions. More or fewer questions may also be reasonable. We may provide feedback on the number of questions planned for the meeting, if there are concerns.

Q: How will the Scientific Advice team use the information regarding past or anticipated Scientific Advice from a regulatory agency, or another health technology assessment agency (HTA), that is requested as part of the Briefing Book?

If minutes from regulatory Scientific Advice are provided (this is optional), we will consider the regulatory Scientific Advice already provided in developing the Record of Scientific Advice. This may assist in avoiding conflicting advice in some cases or in the suggestion of ways to address the needs of HTA, while still addressing regulatory needs, if possible.

Q: What is the difference between a Scientific Advice meeting and a Reimbursement Review presubmission meeting?

Parallel Scientific Advice

Q: For Parallel Scientific Advice with Canada’s Drug Agency (CDA) and NICE (National Institute for Health and Care Excellence), can Health Canada and Institut national d'excellence en sante et en services sociaux (INESSS) participate as observers?

No. Health Canada or INESSS may not participate as observers in the Parallel Scientific Advice process with CDA-AMC and NICE. Applicants may wish to consider applying for Parallel Scientific Advice with Health Canada and CDA-AMC, with INESSS participating in an observatory role.

Confidentiality

Q: Can applicants share the Record of Scientific Advice with other companies or with other HTA agencies?

According to the Confidentiality Guidelines for Scientific Advice, all documents submitted by applicants and produced by CDA-AMC as part of the Scientific Advice Program are to be kept confidential between the applicant and CDA-AMC (including authorized recipients and patient representatives, as applicable) except as agreed by expressed, advance, or written permission from both CDA-AMC and the applicant, or as required by law or by order of a legally qualified court or tribunal. For Parallel Scientific Advice, the applicant agrees to the disclosure and exchange of information related to the project with the participating organizations.

Q: Will members of the drug expert committees have access to the Record of Scientific Advice, if available, as background information for their deliberations on a drug reimbursement review?

No. Members of the drug expert committees at Canada’s Drug Agency will not have access to the Record of Scientific Advice, nor will they be aware that the drug under review previously received Scientific Advice.

Read more about confidentiality or conflict of interest for the Scientific Advice Program.

Expert Involvement

Q: How does Canada’s Drug Agency choose experts to participate in the Scientific Advice Program?

Experts are chosen based on their relevant clinical and HTA expertise. The assessment of conflicts of interest is also part of the process.

Read more about the involvement of experts in the Scientific Advice Program.

Q: Are representatives from publicly funded drug plans involved as experts in the Scientific Advice Program?

The Scientific Advice Program includes clinical experts and HTA experts as part of the process. A representative from publicly funded drug plans is not included as one of the experts for a Scientific Advice application.

Q: Are members of the Canadian Drug Expert Committee or the pan-Canadian Oncology Drug Review Expert Review Committee (pERC) involved as experts for the Scientific Advice Program?

Current members of drug expert committees will not be involved as experts for Scientific Advice (exceptions may apply). However, past members could be engaged as experts, if appropriate.

Read more about the involvement of experts in the Scientific Advice Program.

Q: Will CDA-AMC consult the applicant in the selection of experts and/or will the external experts selected be mutually agreed upon by CDA-AMC and the applicant?

No. The applicant will not have input into selecting the experts who participate in Scientific Advice. The applicant may suggest the type of clinical specialty or designations a clinical expert should ideally have. We will be interested in feedback from applicants on the quality of discussion and input provided by the experts we select. We will use this input to help us select appropriate and effective experts for future Scientific Advice applications.

Patient Involvement

Q: Why is CDA-AMC requesting information about patient engagement activities in the Briefing Book and how will the information be used in the context of providing Scientific Advice?

Patient engagement in clinical trial design is being discussed in various forums internationally. If applicants have sought input from patients in their product development plans related to the design of pivotal clinical trials, we require this information so it can be taken into account when preparing the Scientific Advice. All information related to consultations with patients on clinical trial design should be included; however, the country where the consultations were carried out should also be indicated. If applicants have not sought this type of input from patients, it should simply be indicated in section 4.5 of the Briefing Book (Summary of Patient Engagement, if available).

Q: Do patient representatives attend the Scientific Advice meeting?

No. Patient representatives do not attend the Scientific Advice meeting according to the standard Scientific Advice process at this time. For Parallel Scientific Advice with CDA-AMC and NICE, patient representatives may be invited to attend and participate in the Scientific Advice meeting.

Q: Does the applicant have the ability to suggest whether or not patient involvement is required in an application for Scientific Advice?

No. Patient involvement is part of the Scientific Advice process for all applications. However, applicants have the opportunity to determine what, if any, information submitted by them or produced by CDA-AMC as part of the Scientific Advice Program is shared with patient representatives. Applicants indicate permission to share information as part of the online application form for the Scientific Advice Program. Applicants also have the option of completing a Patient Drug Information Form, which will be shared with patient representatives in order to provide background information on the drug to enable a relevant conversation with CDA-AMC staff.

Read more about patient involvement in the Scientific Advice Program.

Conflict of Interest

Q: Will applicants be able to highlight the Scientific Advice received through the Scientific Advice Program within a subsequent submission to the Reimbursement Review Program?

According to the Scientific Advice disclaimer, the Scientific Advice provided to the applicant may not be taken into account in any future CDA-AMC assessments or recommendations. The Scientific Advice provided is not permitted to be included as part of a submission to the Reimbursement Review Program. These processes have been put in place in order to maintain the integrity of the reimbursement review process and minimize any perceived biases that may result from the disclosure of any advice received.

Fees

Q: If an application is submitted but the preferred time period for a Scientific Advice meeting date is unavailable, can the application be withdrawn without penalty?

An application is reviewed for eligibility and the availability of preferred meeting dates before the approval and confirmation of the application. Once the application is approved and the time period for the Scientific Advice meeting has been mutually agreed to, the confirmation letter will be issued. The applicant may withdraw the application before the confirmation letter is issued, without penalty. Once the confirmation letter is issued, withdrawal of the application will be subject to payment of any invoices issued. Please read more about the fee for Scientific Advice.

Q: What are the consequences for applicants if they change the Scientific Advice meeting date or if they cancel the meeting?

Changes in meeting dates, after confirmation by both parties, are challenging for CDA-AMC. We require as much advance notice as possible to manage date changes. We will attempt to accommodate date changes; however, accommodation cannot be guaranteed. CDA-AMC reserves the right to charge an additional fee of up to CA $10,000 should the reserved meeting time be changed by more than 1 week from the agreed-upon time frame.

If an applicant withdraws from the Scientific Advice program, CDA-AMC will not refund fees already paid. Any invoice that has been issued will be considered owing to CDA-AMC, should the applicant withdraw before rendering payment. 

Please read more about the fee for Scientific Advice