Before a new pharmaceutical (or a new indication) can be funded by the public sector, an HTA must be carried out based on documentation submitted by the pharmaceutical company. Section 14-4 of the Regulation on Medicinal Products describes the key aspects of the documentation that must be submitted.
A derogation is made in Section 14-4, third paragraph, from the documentation requirements for the following categories if it can be documented that use of the pharmaceutical will not lead to either a change in benefit or an increase in resource use:
- New pharmaceutical form
- New strength
- Generic pharmaceuticals
- Bioequivalent pharmaceuticals
Pharmaceuticals which fall under these categories and which are appropriate for funding via the National Insurance scheme (pre-approved reimbursement): Fill in the price information and price application form (Prisopplysnings- og prissøknadsskjema), including column L.
Pharmaceuticals which fall under these categories and which are relevant for funding via the health authorities (Specialist Health Service): Fill in the price information and price application form (Prisopplysnings- og prissøknadsskjema), excluding column L.