Purpose of preassessment/ preparatory meetings
NOMA offers guidance that can be used to identify and discuss any ambiguities that may arise in the process and preparation of documentation for STA of a given drug. Preparatory meetings also can contribute to more efficient processing of applications. However, the views put forward during these meetings are not binding. The actual processing normally starts after the analyses are formally received and accepted.
Procedure and timetable
Each pharmaceutical company can contact NOMA and request for a preassessment meeting. Enquiries about meetings are sent to email@example.com (contact person: Hilde Røshol).
Agenda for the meeting including issues that the applicant would want to discuss should be submitted no later than 1 – 2 weeks before the meeting. A list of participants should also be attached. The time frame of a preassessment meeting is normally about 1 hour.
Recommended form and content of the meeting
It should be noted that a pure product presentation is not desirable. Preparatory meetings shall focus on issues potential applicants want to discuss with NOMA and in accordance with the agenda. Part of the documentation submitted in advance should include PICO with a discussion around choices the potential applicant wants to make in preparing the economic analysis, this means;
- (P) Patient group - which patients in comparison to approved indication, 1st line/2nd line etc.
- (I) Intervention - place in Norwegian clinical practice
- (C) Comparator
- (O) Outcome
- Reason and choice of economic analysis method
An agreed set of minutes for the preparatory meetings will not be done. Any minutes prepared are internal to the parties. However, this should not prevent the applicant from sending this in to NOMA as part of an orientation.