희귀의약품 보험약가결정: 문제점과 시사점
Issues with Orphan Drug Pricing in South Korea
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초록
소수의 희귀질환 치료를 목적으로 하는 희귀의약품은 질환의 소수성과 의약품시장의 독점성으로 인해 건강보험 약가결정과 상충됨에 따라 우리나라에서 최근 공급거부의 상황을 야기시킨바 있다. 희귀의약품 특히 극소수의 환자에게 고비용이 소요되는 필수의약품인 초희귀의약품(ultraorphan drugs)은 쌍방독점시장으로 협상결렬의 문제, 소수질환자에게 과도한 보험재정을 지출함으로써 제기되는 건강가치에 대한 형평성 문제, 비용효과적인 의약품의 선별적 등재라는 원칙의 일관성 유지와의 상충의 문제, 그리고 보험재정의 지속가능성 측면에서 문제제기가 될 수 있다. 이러한 다양한 문제에 대한 정책적 대안으로, 별도의 재원을 통한 관리, 다양한 협상기법을 통해 가격을 결정하는 방안, 그리고 공급 거부에 대한 방편으로 긴급도입인정의약품의 적극적 활용 등의 검토를 제안 해 본다.
Abstract
Orphan drugs to treat rare diseases constitute a unique market structure, with strong monopoly at the producer side. The various characteristics embedded with orphan drugs create an environment which often in conflict with health policy goals of a health care system. For example in Korea, conflicts between the orphan drug producers and the public insurer generated the problem of drug supply refusal in recent years. Facing this as a health policy issue, this study examines diverse aspects involved surrounding orphan drug pricing and supply in the Korean context. In particular, ultraorphan drugs, orphan drugs with higher need of patient protection from insurer perspective, are susceptible to breakdown of price negotiations. The end result of negotiation breakdown takes the form of supply refusal, due mainly to supplier's dissatisfaction with the proposed reimbursement price by the insurer. Moreover, for the health system's perspective, funding high priced ultraorphan drugs within a limited public insurance budget often implies a painful trade-off, that many patients with more common diseases may have to forego highly cost-beneficial treatments. Facing all kinds of social and economic issues involved, this study investigates related concerns with the pricing and supply of orphan drugs first, and then a number of health policy options are offered within the Korean public health context.
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