Conditional Financing of Drugs in the Netherlands: Past, Present, and Future—Results From Stakeholder Interviews

Abstract

Background: Conditional financing (CF) of hospital drugs was implemented in the Netherlands as a form of managed entry agreements between 2006 and 2012. CF was a 4-year process comprising 3 stages: initial health technology assessment of the drug (T ¼ 0), conduct of outcomes research studies, and reassessment of the drug (T ¼ 4). Objectives: To analyze stakeholder experiences in implementing CF in practice. Methods: Public and private stakeholders were approached for participation in stakeholder interviews through standardized email invitations. An interview guide was developed to guide discussions that covered the following topics: perceived aims of CF, functioning of CF, impact of CF, and conclusions and future perspectives. Extensive summaries were generated for each interview and subsequently used for directed content analysis. Results: Thirty stakeholders were interviewed. Differences emerged among the stakeholders on the perceived aims of CF. Conversely, there was some agreement among stakeholders on the shortcomings in the functioning of CF, the positive impact of CF on the Dutch healthcare setting, and improvement points for CF. Conclusions: Despite stakeholders' belief that CF either did not meet its aims or only partially did so, there was agreement on the need for new policy to address the same aims of CF in the future. Nevertheless, stakeholders diverged on whether CF should be improved on the basis of learnings identified and reintroduced into practice or replaced with new policy schemes.

What influences the outcome of active disinvestment processes in healthcare? A qualitative interview study on five recent cases of active disinvestment

“…Conditional reimbursement, or coverage with evidence development is the reimbursement of (new) healthcare interventions under a specific condition, often the requirement of collecting real-world (cost-)effectiveness data. It has been proposed as a policy-tool to delay the final reimbursement decision, decreasing the uncertainty on the (cost-)effectiveness and/or budget-impact of new interventions, while making these interventions available to patients at an early stage [42,43]. However, conditional reimbursement has also been described as creating a wedge effect, i.e.…”

Performance-based managed entry agreements for new medicines in OECD countries and EU member states

“…The process to enter into performance-based MEAs, collect and analyse data, make decisions based on data analysed and to exit from MEAs should be transparent to ensure that stakeholders are accountable. In addition, governance processes should address independence, data ownership, audit, transparency, and appeal (Klemp, Frønsdal and Facey, 2011[4]; MacLeod and Mitton, 2010 [58]). It has been suggested that these should ensure "independence of the scheme from any parties with a vested interest in its outcomes", in particular independence of investigators and decision makers from influence by clinicians, patients and firms but also independence of investigators from payers (MacLeod and Mitton, 2010, p. 106 [58]).…”

“…In addition, governance processes should address independence, data ownership, audit, transparency, and appeal (Klemp, Frønsdal and Facey, 2011[4]; MacLeod and Mitton, 2010 [58]). It has been suggested that these should ensure "independence of the scheme from any parties with a vested interest in its outcomes", in particular independence of investigators and decision makers from influence by clinicians, patients and firms but also independence of investigators from payers (MacLeod and Mitton, 2010, p. 106 [58]). While it may not be possible to achieve independence of investigators in practice because both payers and firms usually have an interest in the outcomes of MEAs and may also be involved in data collection and analysis, processes should minimise conflicts of interest and allow for independent scrutiny.…”

Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries

“…However, reimbursement is unlikely for products manufactured under HE with an uncertain benefit/risk balance. Stakeholders are exploring financial models for hospital products, such as conditional financing [36].…”