OBJECTIVES: Innovative therapies usually lack long-term trial outcomes data and real-world effectiveness evidence at the time of market authorization. Due to these uncertainties their public reimbursement poses challenges for payer and market authorization holder alike. Risk-sharing agreements have been proposed to diminish these challenges. Introduced in 2017, the Conditional Reimbursement System (CRS) enabled confidential agreements with the Pharmaceuticals Pricing Board (PPB) in Finland. The CRS presents possibilities for innovative pricing models, and potentially gives access to medications that might not become available for patients otherwise. Since 2017, around 50 medications have been reimbursed through the CRS. We studied how the CRS has affected reimbursement access to innovative oncological and hematological medicines in Finland.

METHODS: The reimbursement application and decision data provided by PPB (01/2011-11/2021: 50 oral medications, 237 applications, 209 decisions, 24 ongoing processes) were analyzed through the PICOSTEPS assessment framework. The control period prior to CRS was set to 2012-2016; CRS was considered as being implemented from 2018 onwards, with 2017 considered a transition year. Outcomes included changes in reimbursement dossier approval rates and time to reimbursement between these time frames.

RESULTS: The average approval rates for the first submitted dossier increased from 35.1% in 2012-2016 to 89.3% in 2018-2021. Average time to reimbursement was shortened by 46.6% (i.e., 1 year, from 794 to 424 days) after the CRS was permitted. Compared to 2015-2016, reimbursement was obtained 1.9 years faster after CRS was fully implemented. Typically, only one application process is needed to achieve reimbursement nowadays, while previously, on average, two applications were needed (range: one to four).

CONCLUSIONS: Patient access to new cancer medicines has been drastically improved by the introduction of a flexible and innovative pricing and reimbursement model. CRS has improved access and decreased the assessment burden for new hematological and oncological medicines in Finland.