OBJECTIVES:

Managed entry agreements (MEAs) increase the chance of access to new technologies where traditional reimbursement routes are unfeasible. In Sweden, MEAs have been used for prescription drugs in the context of three-party deliberations since 2015. The aim of this study was to assess how the MEAs have developed over time.

METHODS:

All MEAs available in December 2018 were reviewed and data were extracted on number of agreements per year, type of agreement (group vs individual), disease area as well as rationale for the MEA.

RESULTS:

Sixty-one MEAs including 49 different prescription drugs were made within the context of three-party deliberations until 2018 (auto-immune diseases 26%, oncology 26%, haemophilia 18%, infectious diseases 16% and other 14%). The majority of MEAs were negotiated within group assessments (61%), where multiple products are negotiated simultaneously. The number of MEAs have increased by approximately 450% between 2015 and 2018, with a corresponding increase in number of group assessments; 23 MEAs in 2018 compared to four in 2015.

The rationale behind the MEAs was uncertainty in: number of patients treated (n=3, 5%), treatment effect (n=3, 5%), treatment duration (n=6, 10%), a combination of number of patients and treatment effect (n=4, 7%), number of patients and treatment duration (n=8, 13%), treatment duration and effect (n=8, 13%) or all three (n=2, 3%). In 44% of MEAs, the rationale was not stated, these MEAs all related to group assessments.

CONCLUSIONS:

The number of MEAs has increased considerably between 2015 and 2018. For almost half of the MEAs the rationale was not stated. All these cases were MEAs related to group assessments, where the rationale can be assumed to be budget control. The increasing number of group assessments suggest that Swedish payers may primarily view MEAs as a tool for reducing budget impact.