Preparatory meetings are advisory in nature and hence not binding.
It is assumed that applicants are familiar with NOMA’s template for submitting the reimbursement application an the guidelines for pharmaco-economic analyses.
Purpose of preparatory (preassessment) meetings
NOMA offers adice that can aid in identifying and discussing uncertainties relating to the reimbursement process and the preparation of the reimbursement application. This can contribute to a more efficient application assessment process. Views put forth during the preassessment meeting are not binding. The actual assessment procedure does not start until an application is submitted and accepted formally in addition to the market authorization being granted.
Procedure and timeframe
Each pharmaceutical company must contact NOMA requesting for a preparatory meeting. The request should be sent to firstname.lastname@example.org - not to an idividual NOMA employee.
The agenda, documentation or issues to be presented and discussed must be submitted to NOMA no later than one week before the meeting (email@example.com). The list of participants should also be attached. The timeframe for preassessment meetings is about 1 hour. If the agenda and documentation are not submitted to NOMA one week in advance the meeting is cancelled without further notice.
Recommended form and content of the meeting
It is emphasized that pure product presentations or extensive presentations of clinical characteristics are not desirable. The focus of the meeting should be issues listed in the submitted agenda. Documentation submitted in advance should include the PICO with a critique of the choices the company wants to make in the preparation of economic analysis, suchh as:
- Patient Group (P) - which patients compared to the approved indication, 1st/2nd line etc.
- Intervention (I) - place in Norwegian clinical practice
- Comparator (C)
- Outcome (O)
- Reason and choice of method of economic analysis
Consensual minutes for parties involved will not be drafted. Any minutes prepared are internal to the parties involved. However, this should not prevent the applicant from sending the minutes to NOMA as part of their briefing.