"The issue is, in part economic. But at root ethical." - Ethical aspects of the Dutch reimbursement system for orphan drugs.
Ommen, D.D. van
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BACKGROUND A national discussion about reimbursement of expensive orphan drugs is started in July 2012, in the Netherlands. Concept advices about the reassessments of reimbursement of three drugs, written by CVZ to minister Schippers of VWS, were leaked to the press. The advices stated that the drugs should not be part of the basic insurance anymore. CVZ argued in the definite advice, based on cost-effective analyses, that the drugs should be part of an alternative financial arrangement to stimulate effective treatments and transparent start and stop criteria for the use of drugs in question. Rationing of health care seems to be needed. PURPOSE This thesis focused on the ethical aspects of orphan drug reimbursement. Since people concerned claimed that the discussion was not about the price of the drugs, I was curious to know about the ethical aspects. Furthermore, this thesis focused on orphan drugs in particularly. Orphan diseases are in most cases unknown for its pathophysiology, very rare, severe, life-threatening, and patients cannot be treated or only for a very high price. Also, reassessment of the reimbursement of many orphan drugs lies ahead. Combined with the expectation that the amount of personal medicines will grow, due to the progress made in the field of genetics, the ethical dilemma of reimbursement is put on edge. FINDINGS There is inequality in life and health care, as illustrated by orphan-diseased patients. The moral dilemma herein is equality in opportunity versus (maximized) utility. Reimbursement of orphan drugs is in conflict with the dilemma, because an increase in reimbursed orphan drugs leads to an increased claim to the health care resources. Therefore, just allocation must be provided. Several ethical rules are of great importance, but interfere with each other: principle of equality, of necessity, of utility, social status and solidarity. Problem is that they interfere. Priorities must be set, for patients suffering from life-threatening diseases. Combined with the limited budget, rationing of healthcare is necessary. Other ethical aspects are the rule of rescue, limited evidence on orphan drugs due to low prevalence and the temporary reimbursement. INTERPRETATION In my opinion, it is clear that stringent rules are needed in the Netherlands and improvements must be made. The advice of CVZ can be an important step forward. Rationing of health care can be done by determining the most important ethical aspects on which decision making will be based. Furthermore, effectiveness could be tested per patient, although there are many drawbacks yet to this approach. Another suggestion is to only fully reimburse any first drug for a life-threatening orphan disease. However, how to prevent the risk of discouraging the development of better drugs? I regret the decision of minister Schippers of VWS to not use the advice of CVZ, only the part of negotiating with manufacturers. It is probably all about the money, after all.