신약의 가격지불에서 위험분담계약의 동향과 고찰
Risk-Sharing Agreement on the Pricing and Reimbursement of New Drugs
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초록
보건의료에서 약제비 지출이 빠르게 상승하고 최근 도입되는 신약들이 고가화되면서 보험급여 및 약가 결정 시점에서 의사결정에 따른 재정적 위험이 증가하고 있다. 이러한 배경에서 유럽 등 일부 국가에서 신약의 급여 및 약가결정의 위험을 보험자와 제약회사 간에 분담하여 지불계약을 하는 위험분담계약이 증가하고 있다. 위험분담계약은 신약을 실제 진료상황에서 사용하여 나타난 치료효과를 평가하여 급여 및 약가의 결정에 연계하는 방식으로서, '성과에 연계한 지불'과 '조건부 지속 치료', '근거생산 조건부 급여' 등의 유형이 있다. 위험분담계약은 우수한 치료효과의 가능성이 있으나 근거가 불확실한 신약의 급여를 성과에 연계하여 의사결정할 수 있는 대안으로 고려될 수 있으나, 시행과정이 복잡하고 적지 않은 사회적 비용과 자원이 요구된다. 그리고 아직까지 제도시행의 경험이 풍부하지 않으며 제도의 실효성에 대한 평가도 부족한 실정이다. 따라서 위험분담계약은 신약에 일반적으로 적용할 수 있는 제도가 되기는 어려우며, 시판 후 효과성 및 비용효과성에 관한 근거를 생산할 필요가 있으며 보험재정에 미치는 영향이 큰 일부 신약에 한하여 제한적으로 고려할 수 있는 방안의 하나가 될 수 있을 것이다.
Abstract
Recently, there has been increasing interest in a new coverage and reimbursement schemes for new drugs, which involve the concept "pay-for-performance" and "risk-sharing". Faced with challenges from new drugs with promising effectiveness but with insufficient evidence and pressure on health care budget, third-party payers in developed countries have tried the new evidence-based pharmaceutical pricing and reimbursement system which is called risk-sharing agreement. Under the risk-sharing agreement, drug companies agree to refund the cost if a drug fails to meet agreed performance targets when used under appropriate conditions. This study introduces three types of the scheme: performance-linked reimbursement; conditional treatment continuation; coverage with evidence development. Risk-sharing agreement has the potential to reduce risk in health care decisions in times of new health technology and to ensure predictable health gains for a given drug expenditures. However until now it has not gained wide-spread acceptance because of its feasibility issues. Moreover it has not been fully evaluated yet. Risk-sharing agreement should thus be considered only for a few innovative drugs treating life-threatening diseases, for very specific target populations as an option to deal with insufficient evidence and to ensure access to essential medicines.
참고문헌 (26)
- 박병주, "근거중심 보건의료" (2009), 고려의학
- 박실비아, "신의료기술의 패턴변화에 따른 의사결정제도의 발전방향 - 의약품 허가제도와 약가제도를 중심으로" (2009), 한국보건사회연구원
- Bogglid, M, "Multiple sclerosis risk sharing scheme: two year results of clinical cohort study with historical comparator", BMJ, 339, pp.b4677~ (2009)
- BOPA(British Oncology Pharmacy Association), "Position statement on "risk sharing" schemes in oncology", ~ (2008)
- Bowen, J.M, "Conditionally funded field evaluations and practical trial design within a health technology assessment framework", Journal of the American College of Radiology, 6(5), pp.324~331 (2009)
- Carlson, J.J, "Paying for outcomes: innovative coverage and reimbursement schemes for pharmaceuticals", Journal of Managed Care Pharmacy, 15(8), pp.683~687 (2009)
- Carlson, J.J, "Linking payment to health outcomes: A taxonomy an examination of performance-based reimbursement schemes between healthcare payers and manufacturers", Health Policy, 96(3), pp.179~190 (2010)
- Chapman, S., "Setting up an outcomes guarantee for pharmaceuticals: new approach to risk sharing in primary care", BMJ, 326(7391), pp.707~709 (2003)
- Chapman, S, "Outcomes guarantee for lipid-lowering drugs: results from a novel approach to risk sharing in primary care", British Journal of Cardiology, 11, pp.205~210 (2004)
- Dagher, R, "Accelerated approval of oncology products: a decade of experience", Journal of National Cancer Institute, 96(20), pp.1500~1509 (2004)
- Department of Health(UK), "The pharmaceutical price regulation scheme 2009", ~ (2008)
- Dhalla, I.A, "Perspectives on the National Institute for Health and Clinical Excellence's recommendations to use health technologies only in research", International Journal of Technology Assessment in Health Care, 25(3), pp.272~280 (2009)
- GAO, "Science, business, regulatory, and intellectual property issues cited as hampering drug development efforts", ~ (2007)
- Hutton, J, "Coverage with evidence development: an examination of conceptual and policy issues", International Journal of Technology Assessment in Health Care, 23(4), pp.425~435 (2007)
- IHS Global Insight, "NICE rebuffs kidney cancer drugs for second time despite offers of price-sharing agreements", ~ (2009)
- McCabe, C, "Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective", Annals of Oncology, 20(3), pp.403~412 (2009)
- McCabe, C, "Continuing the scheme is unjustified", BMJ, 340, pp.1285~1288 (2010)
- NICE, "Beta interferon and glatiramer acetate for the treatment of multiple sclerosis", Technical Appraisal Guidance No. 32, ~ (2004)
- NICE, "Bortezomib monotherapy for relapsed multiple myeloma", Technical Appraisal Guidance No. 129, ~ (2007)
- OECD, "Pharmaceutical pricing policies in a global market", ~ (2008)
- Pollack, A, "Drug deals tie prices on how well patients do", New York Times, ~ (2009), 2009. 4. 23
- Pouvourville, G, "Risk-sharing agreements for innovative drugs: A new solution to old problems?", European Journal of Health Economics, 7, pp.155~157 (2006)
- Rafetery,J, "Costly failure of a risk sharing scheme", BMJ, 340, pp.1282~1284 (2010)
- Senior, M, "More Velcade-style risk sharing in the UK?", Euro Pharma Today, ~ (2009), 2009. 1. 21
- Towse, A, "Can't get no satisfaction? Will pay for performance help?", Pharmacoecoomics, 28(2), pp.93~102 (2010)
- Wlodarczyk, J.H, "Public funding of bosentan for the treatment of pulmonary artery hypertension in Australia: cost effectiveness and risk sharing", Pharmacoeconomics, 24, pp.903~915 (2006)