Reimbursement Decisions for Pharmaceuticals in Sweden: The Impact of Disease Severity and Cost Effectiveness.

OBJECTIVE: The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is the government body responsible for deciding whether outpatient drugs are to be included in the pharmaceutical benefits scheme. This paper analyzes the impact of cost effectiveness and severity of disease on reimbursement decisions for new pharmaceuticals. METHODS: Data has been extracted from all decisions made by the TLV between 2005 and 2011. Cost effectiveness is measured as the cost per quality-adjusted life-year (QALY) gained, whereas disease severity is a binary variable (severe-not severe). In total, the dataset consists of 102 decisions, with 86 approved and 16 declined reimbursements. RESULTS: The lowest cost per QALY of declined reimbursements is Swedish kronor (SEK) 700,000 (€ 79,100), while the highest cost per QALY of approved reimbursements is SEK1,220,000 (€ 135,600). At a cost per QALY of SEK702,000 Swedish kronor (non-severe diseases) and SEK988,000 (severe diseases), the likelihood of approval is estimated to be 50/50 (€ 79,400 and € 111,700). CONCLUSIONS: The TLV places substantial weight on both the cost effectiveness and the severity of disease in reimbursement decisions, and the implied willingness to pay for a QALY is higher than the often cited 'rule of thumb' in Swedish policy debates.

The impact of health economic evaluations in Sweden.

The responsibility for healthcare in Sweden is shared by the central government, county councils and municipalities. The counties and municipalities are free to make their own prioritizations within the framework of the state healthcare laws. To guide prioritization of healthcare resources in Sweden, there is consensus that cost-effectiveness constitutes one of the three principles. The objective of this paper is to describe how cost-effectiveness, and hence health economic evaluations (HEE), have a role in pricing decisions, reimbursement of pharmaceuticals as well as the overall prioritization and allocation of resources in the Swedish healthcare system. There are various organizations involved in the processes of implementing health technologies in the Swedish healthcare system, several of which consider or produce HEEs when assessing different technologies: the Dental and Pharmaceutical Benefits Agency (TLV), the county councils' group on new drug therapies (NLT), the National Board of Health and Welfare, the Swedish Council on Health Technology Assessment (SBU), regional HTA agencies and the Public Health Agency of Sweden. The only governmental agency that has official and mandatory guidelines for how to perform HEE is TLV (LFNAR 2003:2). Even though HEEs may seem to have a clear and explicit role in the decision-making processes in the Swedish healthcare system, there are various obstacles and challenges in the use and dissemination of the results.