Implementation of conditional reimbursement schemes in HTA practice: Experiences from the Netherlands

Objectives: In 2007, the National Healthcare Institute (ZIN) initiated conditional financing (CF) of expensive hospital drugs as an example of conditional reimbursement schemes (CRS). CF is a 4-year procedure encompassing initial HTA assessment (T= 0) followed by additional data collection via outcomes research (separately assessing appropriate use & cost effectiveness in routine practice) and re-assessment (T= 4). This study aims to review performance and experiences with CF in the Netherlands to date. Methods: All dossiers for drugs that underwent the full CF procedure were reviewed. Using a standardised data abstraction form, 2 researchers independently extracted information on procedural and methodological aspects (i.e. related to implemented outcomes research & evidence assessment). A scoring algorithm was used to assess both aspects. Results: Forty-seven candidates were nominated for CF; 44 underwent T= 0 assessments and 10 T= 4 assessments. The CF procedure extended beyond 4 years for 8 of the 10 candidates. For the 10 candidates, applicants clearly defined study designs and data collection methods for outcomes research proposals addressing 14 of 20 research questions posed in T= 0 reports. ZIN provided discussion points and recommendations regarding research proposals for 16 of 20 research questions. Applicants implemented recommendations fully in 2 cases and partially in 14. Sufficient data was available at T= 4 to answer 13 of 20 research questions posed at T= 0. However, discussion points remained regarding implemented outcomes research for all 10 candidates at T= 4. ZIN advised to continue reimbursement for 6 candidates and to stop reimbursement for 2. In 2 of the 6 candidates, reimbursement was continued on the condition of additional evidence generation beyond T= 4. Two candidates did not receive a final recommendation. Conclusions: Theoretically, CF provides a valuable option for enabling quick but conditional access to medicines in the Netherlands. However, procedural and methodological aspects related to scheme design and implementation may affect its value in decision-making practice.