Korea’s Ministry of Health and Welfare (MOHW) plans to announce in November which rare disease drugs it has selected for a pilot program to list these treatments on national health insurance within 100 days. Eleven drugs made the shortlist, and three were dropped because they did not meet the overseas listing requirement. MOHW first discussed choosing five drugs but may select more.
Under the pilot, the Health Insurance Review & Assessment Service (HIRA) completes its reimbursement review in about one month instead of up to 150 days, and price negotiations are skipped. Selected drugs are priced at about 90% of the adjusted lowest price across eight reference countries (US, UK, Germany, France, Italy, Switzerland, Japan, and Canada). After listing, their price and reimbursement terms can be adjusted based on real-world treatment outcomes.
Companies will present to MOHW in early November before final selections are made. The ministry will consider whether alternative treatments exist, how severe the disease is, the impact on the insurance budget, and each company’s plan for post-listing evaluation. Shortlisted drugs include Winrevair (Merck) for pulmonary arterial hypertension, Hemgenix (Genezen) for hemophilia B, and Qalsody (Biogen) for a genetic form of ALS.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.