IMPLEMENTATION OF CONDITIONAL REIMBURSEMENT SCHEMES IN HTA PRACTICE- EXPERIENCES FROM THE NETHERLANDS
Author(s)
Makady A1, Nijmeijer H2, de Boer A3, Hillege JL4, Klungel O5, Goettsch W1
1The National Healthcare Institute (ZIN), Diemen, The Netherlands, 2Radboud University Medical Centre, Nijmegen, The Netherlands, 3Utrecht University, Utrecht, The Netherlands, 4University Medical Center Groningen, Groningen, The Netherlands, 5Utrecht University, UTRECHT, 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.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
HT4
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Risk-sharing Approaches
Disease
Multiple Diseases