Governance of conditional reimbursement practices in the Netherlands

Abstract

When entering the market, orphan drugs are associated with substantial prices and a high degree of uncertainty regarding safety and effectiveness. This makes decision making about the reimbursement of these drugs a complex exercise. To advance on this, the Dutch government introduced a conditional reimbursement trajectory that requires a re-evaluation after four years. This article focuses on the origins, governance and outcomes of such a conditional reimbursement trajectory for orphan drugs. We find that the conditional reimbursement scheme is the result of years of discussion and returning public pressure about unequal access to expensive drugs. During the implementation of the scheme the actors involved went through a learning process about the regulation. Our analysis shows that previous collaborations or already existing organisational structures led to faster production of the required data on cost-effectiveness. However, cost-effectiveness evidence resulting from additional research seems to weigh less than political, judicial and ethical considerations in decision making on reimbursement of orphan drugs in the Netherlands.

Pricing and reimbursement experiences and insights in the European Union and the United States: Lessons learned to approach adaptive payer pathways

“…This was developed to allow therapies with economically and clinically limited datasets to be temporarily approved for reimbursement and reevaluated after 4 years. During this period, pharmaceutical companies worked to establish the therapy's therapeutic value and cost‐effectiveness in daily practice . An assessment committee reviewed the data collected, followed by an appraisal committee and reevaluation of the reimbursement outcome.…”

The evolution of the cancer formulary review in Canada: Can centralization improve the use of economic evaluation?

“…Efficiency considerations often fall by the wayside and are trumped by evidence of clinical benefit, political and/or other considerations (Martin et al, ; Eddama and Coast, ; Boon et al, ; Armstrong et al, ). There is no agreement on what these decision criteria should be, how important they should be relatively to one another, nor is there a common framework for how they should be used in combination (Chabot and Rocci, ; Boon et al, ; Franken et al, ; McDonald et al, ; Franken et al, ; Cleemput et al, ; Drummond, ; Franken et al, ). There is also a lack of guidance to the interpretation of evidence, including PE (Wranik, ; Franken et al, ).…”

Solidarity in Insuring Financial Risks of Illness: A Comparison of the Impact of Dutch Policy Reforms in Health Insurance and Disability Insurance since the 1980s

“…Worldwide, it has become common to require an economic evaluation for decision-making (Taylor et al 2004), which is referred to as the "fourth hurdle". Nevertheless, in the Netherlands economic evidence does not seem to influence reimbursement decisions as much as other considerations (Boon et al 2015;Roseboom et al 2017). We conclude that solidarity on the dimension of material coverage has increased in some respects and decreased in others.…”