Guidelines for pre-meetings in connection with single technology assessments (STAs)
Published:
|
Updated:
Changes
Pre-meetings with the Norwegian Medical Products Agency (NoMA) are not obligatory, but may be arranged on request.
This guide provides brief information for health technology developers (HTDs) that would like a pre-meeting regarding submission of documentation for the single technology assessment (STA) of medicinal products or medical devices.
NOMA expects the HTD to be familiar with the relevant guidelines and template for submission of documentation prior to the pre-meeting.
Submission Guidelines for Single Technology Assessment of Medicinal products
Submission Template for Singel Technology Assessment of Medicinal Products
Submission Guidelines and template for Single Technology Assessment of Medicinal Devices
The objective of pre-meetings
NOMA offers guidance in order to identify and discuss any uncertainties regarding the STA, the decision-making process, and the preparation of documentation for the STA of a particular pharmaceutical or medical device (including diagnostic interventions). Pre-meetings are held to guide HTDs in ensuring that the documentation that will be submitted is acceptable and relevant. This can speed up assessment. Views put forward during pre-meetings are not binding. Assessment of a product will normally not start until the actual documentation dossier has been received and formally accepted.
Procedure and time-frame
The HTD must contact NOMA and request a pre-meeting. The request should be sent to blaresept@noma.no, sykehus@noma.no or hta.medical.devices@noma.no (depending on the relevant source of funding of the product). Do not send the request to an individual assessor at NOMA.
The HTD should submit a meeting agenda and presentation (PowerPoint or similar), outlining the issues that should be discussed with NOMA, no later than 1–2 weeks before the meeting. A list of participants with e-mail addresses should also be enclosed in the e-mail. Pre-meetings normally last about an hour.
Pre-meetings are normally conducted digitally (Teams).
Recommended format and content of the meeting
Pre-meetings should not be used simply to give a presentation of a product or a comprehensive description of clinical characteristics. Pre-meetings should focus on issues that you wish to discuss with NOMA regarding the documentation for the STA. Any questions you would like answered during the meeting should be clearly stated in the presentation shared in advance. The presentation should also contain information on PICO, with justification and discussion in respect to the choices you would like to make when preparing documentation for the STA, including:
- Patient group (P)
- Intervention (I) (including therapeutic position in Norwegian clinical practice)
- Comparator (C)
- Outcomes (O)
- Relevant studies
- Justification and choice of method for pharmacoeconomic analysis
On the basis of the submitted agenda and issues, NOMA will assess the necessity of holding a pre-meeting.
Minutes
No agreed minutes will be prepared for pre-meetings.