Health Economic Evaluation
As a rule, all medicines that are covered by national joint introduction must undergo a health economic evaluation, to investigate whether the cost of the medicine corresponds to society's willingness to pay. The health economic evaluation is carried out by the Dental and Pharmaceuticals Benefits Agency (TLV).
Time for application for health economic evaluation
TLV receives documentation to start the health economic evaluation from the pharmaceutical company in the event of a positive opinion from the European Medicines Agency's Scientific Committee (CHMP). Even before that, the company and TLV can have contact to investigate the conditions for the evaluation.
Health economic evaluation of prescription medicines
For requisition medicines that are covered by national joint introduction, which make up the majority of the cases handled by the New Therapies Council, the New Therapies Council usually ask TLV for a health economic evaluation.
TLV asks the companies concerned to submit information about the pharmaceutical for their report. When the report is ready, TLV presents it at the New Therapies Council's meeting. The Council can then decide on a recommendation about the medicine.
For prescription medicines, the Pharmaceutical Benefits Board at TLV decides whether the medicine should be subsidised, after the company has applied for this and a health economic evaluation has been carried out.