From 2006 to 2012, the Zorginstituut Nederland (ZIN), the national health technological assessment (HTA) agency in the Netherlands, implemented conditional financing of expensive hospital medicines (a type of conditional reimbursement scheme).
Conditional financing is a 4-year procedure encompassing an initial assessment of a medicine (T=0), followed by additional data collection within routine practice, and then re-assessment of the medicine with the additional data (T=4). The criteria for including a medicine in the conditional financing scheme include: a large budget impact (> €2.5 million per year), strong evidence for added therapeutic value, and uncertainties about a medicine’s cost-effectiveness and/or about the appropriate use of the medicine in routine or usual practice.
A study was conducted to review the performance and experience with conditional financing in the Netherlands between 2006, when the procedure was initiated, until the end of 2016 to capture the re-assessment of medicines entered in the scheme.
What was examined?
The study included both an analysis of dossiers as well as interviews & focus group.
Dossier analysis
- All dossiers for medicines that underwent the full 4-year conditional financing procedure were reviewed.
- Using a standardised data abstraction form, 2 researchers independently extracted information on procedural, methodological and decision-making aspects (i.e. related to implemented outcomes research, evidence assessment & appraisal).
- A scoring algorithm was used to assess all three aspects.
Interviews and focus group
- 12 public stakeholders were interviewed.
- A focus group of 6 HTA assessors was convened.
- Directed content analysis was conducted on validated summaries of interviews and the focus group.
What were the findings and conclusions?
Findings from the dossier analysis
- Procedural aspects:
- Forty-seven medicines were nominated for conditional financing during this time period.
- 44 underwent an initial assessment (T=0) and 11 of these underwent the full procedure. However, for 10 of the 11 medicines, the procedure extended beyond 4 years.
- Methodological aspects:
- Of the 22 research questions posed in T=0 reports of the 11 candidates:
- 16 had a well-defined research protocol with clearly defined study designs and data collection methods.
- 18 research proposals were provided with discussion points and recommendations from ZIN.
- Of the 20 research proposals that were given recommendations by ZIN:
- 8 fully implemented the recommendations in the research presented at the end of the procedure (T=4) and 12 partially implemented the recommendations.
- Of the 22 research questions posed in T=0 reports of the 11 candidates:
- 15 had sufficient data to answer the question at the end of the procedure (T=4) and 7 did not.
- However, discussion points remained regarding implemented outcomes research for all 10 candidates at T=4.
- Of the 22 research questions posed in T=0 reports of the 11 candidates:
- Decision-making aspects:
- ZIN advised to continue reimbursement for 9 candidates and to stop reimbursement for 2.
- In the 9 candidates that had continued reimbursement, this was continued on the condition of additional evidence generation for 6 candidates beyond T=4.
Findings from the interviews and focus groups
- Procedural aspects:
- The 4-year window was queried as arbitrary and not tailored to different products.
- It was felt that there is weak governance in relation to stakeholder responsibilities, start- and stop-criteria, as well as monitoring during the period of data collection.
- Methodological aspects:
- Quality of the outcomes research was perceived as being generally poor with low patient numbers in outcomes studies and there were concerns with change in the standard of care throughout the duration of the outcome studies.
- Quality of generated data was also generally poor with little insight into registries created.
- Decision-making aspects:
- There was skepticism about the extent to which the outcome research contributed to ZIN’s advice.
- Little attention was paid to what would happen next such as the consequences of discontinuation decisions or methodological vs. judicial & political aspects.
Conclusions
- Theoretically, conditional financing provides a valuable option for enabling quick access to medicines in the Netherlands. However, procedural and methodological aspects related to scheme design and implementation may affect its value for decision-making in practice.
- Future policies for conditional financing should incorporate learnings from previous experiences to increase value in national decision-making practice
What are the limitations of this study?
- Stakeholder interviews and focus groups were only held with public decision-making bodies and partners. At the moment, the research team is working on augmenting findings with experiences of non-public stakeholders with conditional financing, such as the pharmaceutical industry, academic hospitals, clinician professional syndicates and patient organisations.
Key contributors
Amr Makady and Wim Goettsch, Zorginstituut Nederlands (ZIN) and Utrecht University
H. Nijmeijer, Radboud Medical Centre, Nijmegen
O.H. Klungel, Utrecht University
A. de Boer, Utrecht University
H. Hillege, University Medical Centre Groningen