A health economic evaluation is a prerequisite for a medicine to be subject to national managed introduction, in order to be able to determine whether the treatment is cost effective. The Dental and Pharmaceuticals Benefits Agency (TLV) is responsible for the health economic evaluation.
For a prescribed medicine, the pharmaceutical company applies for reimbursement to the TLV, and the Pharmaceutical Benefits Board makes the decision on which medicines should be subsidized. For medicines used in hospital care that are selected for national managed introduction, the New Therapies Council asks the TLV to perform the health economic evaluation, and the TLV will ask the company to submit the required documentation. The TLV presents a report on the evaluation to the New Therapies Council, which serves as a basis for the decision on recommendation for use. The pharmaceutical company plays an important role in providing TLV with clinical documentation for their evaluation.
The TLV may start the health economic evaluation at the time of a positive opinion from the CHMP. Already before this, the pharmaceutical company and the TLV may conduct a dialogue to explore the requirements for the evaluation. The enables a fast process and the possibility of having results from the evaluation within a few months after marketing authorisation. Read more on the TLV web site.