OBJECTIVES:

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) decides on the inclusion of outpatient drugs in the pharmaceutical benefits scheme (reimbursement). The objective was to describe the decisions made by TLV up to 2016.

METHODS:

Data from each decision made by TLV between January 2016 and May 2022 was collected. Variables extracted included product and indication specific information, existence of a confidential price agreement, and reimbursement outcome.

RESULTS:

459 decisions were identified of which 18% were rejections. Approximately 41% of decisions were based on cost-effectiveness evaluations and 51% of decisions were either cost or price comparisons, with 6% using multiple of these methods and the remainder omitting such information. Decisions that included cost-effectiveness evaluations resulted in relatively more rejections than other types. 61% of decision documents cited the indication severity, with 21% of these reporting a range instead of a single level. Of the decisions that refer to severity, 17% are high severity and 36% are very high severity. Analysis of decisions for high and very high severity indications with cost-effectiveness analyses (82%) revealed that such applicants receive a rejection more frequently than average (30% and 21% respectively). Overall, the most common therapeutic area assessed was oncology (17%) followed by haematology (12%). 14% of decisions were for combination treatments, of which 33% were for oncology. Orphan drugs, generics, and biosimilars each made up a relatively small proportion of decisions. Confidential price agreements existed in 22% of decisions and 40% of these agreements were made for very high severity treatments.

CONCLUSIONS:

The majority of TLV decisions for outpatient products in Sweden result in full or restricted reimbursement. Nonetheless, a greater than average rejection rate is observed when cost-effectiveness evaluations are used and indications are high or very high severity, indicating an increased sensitivity for such products, which is likely linked to their higher prices.