고가 및 희귀 의약품의 급여 절차 및 관리

Abstract

The objective of this study is to understand current status of benefit processes of high-cost, orphan drugs which have uncertainties in financial and clinical evidence for patient access. In Korea, the indispensable drug program, risk sharing agreement (RSA), and cost-effectiveness exemption drugs program have been launched for assure treatment of patients in life threatening conditions without alternatives. Australia has RSA and Life Saving Drug Program (LSDP) for similar patients and drugs. UK has Patient Access Scheme (PAS) and Cancer Drug Fund (CDF). Canada has Exceptional Access Program (EAP) and Drugs for Rare Diseases (DRD) by each province. When we compare the drugs which are under the three special processes in Korea with other three countries, most of them are managed by RSA in Australia and UK. Especially, most of the drugs under the indispensable drug program in Korea, are managed by LSDP in Australia which is separate fund from pharmaceutical benefit scheme. UK also have CDF, separate fund from National Health Service, for evidence generation for high cost cancer drugs which show uncertainties at the point of decision making. From this comparison, we can have several implications for improve Korean National Health Insurance (NHI) processes for high cost, orphan drugs. Globally, the high cost, orphan drugs have been approaching for health care system adoption and managed entry scheme including risk sharing agreement has beed increasing for solving clinical and financial uncertainties. It needs to consider that this increasing of global RSA gives us the bigger uncertainty of prices we reference for the NHI decision making. In addition, the separate fund for high cost cancer drugs and orphan drugs during evidence generation to solve clinical and financial uncertainties.