Prerequisites for monitoring pharmaceuticals. Swedish titel: Förutsättningar för uppföljning av läkemedel
The task of the Dental and Pharmaceutical Benefits Agency (TLV) is to determine whether a pharmaceutical product or dental care procedure shall be subsidized by the state. TLV may also impose restrictions limiting prescriptions according to the patient’s ability to pay. During the decision-making process regarding subsidies, information is usually required about conditions that apply outside clinical studies, which means that the results from clinical trials alone are often inadequate. Supplementary data required by TLV is usually compiled through observation studies/non-interventional studies/cohort studies and register studies. Such studies do not generally include intervention, but focus on how a given treatment actually works in everyday situations.
The aim of the pilot project is to develop methods for collaboration between the pharmaceutical industry, the Sahlgrenska Academy and Region Västra Götaland within the framework of Gothia Forum. It involves clinical research for the evaluation of TLV’s monitoring requirements and will be carried out by following up the actual use of a specific drug with monitoring requirements from TLV.
Project leading: Åsa Vikingson