Pricing and Reimbursement Frameworks in China, Japan and South Korea with Focus on Key Reimbursement Drivers

Abstract

Objectives: China, Japan and South Korea are rapidly adapting to the global trends in pricing and reimbursement frameworks while also leading in a certain sense. The objective of the current review is to understand the key drivers and associated HTA reforms. Methods: We conducted a literature search of healthcare policies, and reforms impacting reimbursement and market access across major Asian markets. Information sources included HTA websites and systematic keyword searches. Results: National Health insurance schemes are integral to reimbursement framework worldwide. China implemented national-level drug price negotiation process and updated its NRDL in 2017 by adding >300 new drugs with negotiated price cuts up to 70%. NRDL inclusion is based on clinical value, safety, demand, and price negotiations. Recent NRDL additions like abiraterone acetate in mCRPC indicate growing reimbursement opportunities for innovative drugs with higher clinical value or in therapy areas with high unmet need. Japan also initiated pilot phase of its new decision-making process of economic evaluations for pricing and reimbursement. Pilot phase included seven drugs and six devices including nivolumab for melanoma/lung cancer and trastuzumab for breast cancer. The health ministry of Japan plans to implement pricing reforms by cost-effectiveness assessment and annual repricing for all drugs. South Korea being the first Asian country to consider pharmacoeconomics data, has a well-established and transparent programme for pharmaceuticals and medical devices. HTA reforms in South Korea include ‘Parallel Review program’ and ‘combining regulatory and HTA submissions under unique application’ for reducing market access time and ‘conditional approval’ for innovative technologies ahead of comprehensive safety and efficacy data. Conclusions: HTA success in key Asian markets is heavily dependent on clinical value, innovation and standard CER practices with focus on population-specific unmet need and pricing negotiations. Approaches like ‘Parallel review program’ expedited HTA assessment in South Korea rather indicate more foresight and maturity with HTA reforms.