Last Updated : August 13, 2015
- COVID-19
- Eligibilty
- Process
- Parallel Scientific Advice
- Confidentiality
- Expert Involvement
- Patient Involvement
- Conflict of Interest
- Fees
COVID-19
Q: Are there any modifications in the process during the COVID-19 pandemic?
Until further notice, all Scientific Advice meetings will be held virtually using video-conferencing technology. All efforts will be made to maintain the security and confidentiality of the meetings. Recording will not be permitted by any party.
Read about the Scientific Advice process
Eligibilty
Q: Does the Scientific Advice Program offer Scientific Advice at the post-phase III trial stage?
Our Scientific Advice Program does not offer Scientific Advice once a phase III trial (or pivotal trial) has been initiated. We provide early Scientific Advice on prospective drug development plans at a stage where the feedback provided can still be incorporated into development plans. We do not offer advice on the analysis of existing data.
Q: Does the Scientific Advice Program offer Scientific Advice on proposed economic evaluations, as well as on proposed clinical development plans?
Yes, as long as these questions are posed 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, ten (10) questions is usually the maximum that can be discussed at the meeting; 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 slated 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 our Scientific Advice. This may assist in avoiding conflicting Scientific 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 drug reimbursement review pre-submission meeting?
| Scientific Advice Meeting | Pre-Submission Meeting | |
|---|---|---|
| Purpose | To assist in drug development planning by providing feedback on evidence requirements from an HTA and payer perspective | To facilitate efficient submission preparation and filing; sponsors can introduce drugs and clarify procedural and/or application requirements |
| Timing | Very early in the drug development process (a number of years before Health Canada approval and before pivotal trials have been initiated) | Late in the drug development process (within 12 months of filing the application for our drug reimbursement review) |
| Scope | Includes communication with the sponsor, consultation with experts, and preparation by us; results in the creation of our product (Record of Scientific Advice) | Meeting with sponsor; no product |
Parallel Scientific Advice
Q: For parallel Scientific Advice with us and NICE National Institute for Health and Care Excellence, can Health Canada and Institut national d'excellence en santA 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 us and NICE. Applicants may wish to consider applying for parallel Scientific Advice with Health Canada and us, with INESSS participating in an observatory role.
Confidentiality
Q: Can applicants share our 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 us as part of the Scientific Advice Program are to be kept confidential between the applicant and us (including authorized recipients and patient representatives, as applicable) except as agreed by expressed, advance, or written permission from both us 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 our expert committees have access to our Record of Scientific Advice, if available, as background information for their deliberations on our drug reimbursement review?
No. Members of our expert committees will not have access to our 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 our Scientific Advice Program.
Expert Involvement
Q: How do we choose experts to participate in the Scientific Advice Program?
Experts are chosen based on their relevant clinical, economic, and HTA expertise. The assessment of conflicts of interest is also part of the process.
Read more about the involvement of experts in our Scientific Advice Program.
Q: Are representatives from publicly funded drug plans involved as experts in our Scientific Advice Program?
Our Scientific Advice Program includes clinical, economic, 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 our Canadian Drug Expert Committee (CDEC) or pan-Canadian Oncology Drug Review Expert Review Committee (pERC) involved as experts for the Scientific Advice Program?
Current members of our expert committees will not be involved as experts for our Scientific Advice. However, past members could be engaged as experts, if appropriate.
Read more about the involvement of experts in our Scientific Advice Program.
Q: Will we consult the applicant in the selection of experts and/or will the external experts selected be mutually agreed upon by us and the applicant?
No. The applicant will not have input into selecting the experts who assist in developing our Scientific Advice. The applicant may suggest the type of clinical specialty or designations a clinical expert engaged by us 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 our future Scientific Advice applications.
Patient Involvement
Q: Why are we requesting information about patient engagement activities in the Briefing Book and how will the information be used in the context of providing Scientific Advice on the design of phase III studies?
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 our 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 our Scientific Advice meeting?
No. Patient representatives do not attend our Scientific Advice meeting according to our standard Scientific Advice process at this time. For parallel Scientific Advice with us 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 our Scientific Advice?
No. Patient involvement is part of our Scientific Advice process for all applications. However, applicants have the opportunity to determine what, if any, information submitted by them or produced by us as part of our Scientific Advice Program is shared with patient representatives. Applicants indicate permission to share information as part of the online application form for our 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 our staff.
Read more about patient involvement in our Scientific Advice Program.
Conflict of Interest
Q: Will applicants be able to highlight the Scientific Advice received through our Scientific Advice Program within a subsequent submission to the drug reimbursement review?
According to our Scientific Advice disclaimer, the Scientific Advice provided to the applicant may not be taken into account in any of our future assessments or recommendations. The Scientific Advice provided is not permitted to be included as part of a submission to our drug reimbursement review. These processes have been put in place in order to maintain the integrity of the drug formulary 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 prior to 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 us. We requires as much advance notice as possible to manage date changes. We will attempt to accommodate date changes; however, accommodation cannot be guaranteed. We reserves the right to charge an additional fee of up to $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 our Scientific Advice Program, we will not refund fees already paid. Any invoice that has been issued will be considered owing to us, should the applicant withdraw before rendering payment. Please read more about the fee for Scientific Advice
Last Updated : August 13, 2015