PMU64 HTA Best Practice for Inpatient Therapies: Comparing Sweden and Netherlands

Abstract

Several markets have very distinct HTA processes for therapies used in the outpatient versus inpatient setting. In Sweden, the HTA body (the TLV) issued recommendations for outpatient medicines but inpatient drugs were reimbursed without any pharmacoeconomic assessment by each county council. Similarly, in the Netherlands the HTA body (CVZ/Zorginstituut) appraised outpatient therapies, with inpatient medicines reimbursed automatically upon marketing authorisation. However, both Sweden and Netherlands introduced new processes for inpatient medicines. In Sweden, since 2011, a national coordinating group of Swedish county councils (NT) can request selected in-patient therapies undergo a health economic assessment by the TLV, based on which the NT conduct price negotiations and issue a national recommendation. In Netherlands, a ‘lock’/sluice was introduced in July 2015 for high cost inpatient medicines for financial negotiations prior to reimbursement. This research compares inpatient drugs evaluated by Sweden’s NT and Netherland’s ‘lock’ system. All publicly-available NT recommendation and reimbursement ‘lock’ documents were screened and key information extracted (21/01/2015-29/06/2020). In Sweden, 113 drug:indication pairings were evaluated by the NT council. 52% (59/113) were in oncology and 20% (23/113) were for rare diseases. 43% (49/113) NT decisions were recommendations, 17% (19/113) restricted recommendations (special price discount agreements [5/19], restrictions in reimbursed population [4/19]), 23% (26/113) rejected, and 17% (19/113) other (deferred/unclear). In Netherlands, 36 therapies were identified that were subject to the ‘lock’ system. 78% (28/36) were for oncology and 50% (18/36) were for orphan indications. 58% (21/36) had been removed from the lock after an average of 11.1 months (range: 1.2-21.7). Many more therapies are being appraised under the NLT system in Sweden, which applies to all new inpatient treatments than the reimbursement lock system in the Netherlands, which only applies to high budget impact inpatient therapies.