The time it takes for rare disease treatments to be listed for health insurance coverage will be shortened from the current roughly 240 days to as little as 100 days. The government said it will delay the expense-effectiveness assessment until after listing and simplify the price negotiation process through a pilot program to improve patients' access to treatments.
The Ministry of Health and Welfare said on the 30th it will accept public applications from pharmaceutical companies and target drugs to join the "pilot program for expedited listing of rare disease treatments" from July 1 to Aug. 31.
Previously, an expense-effectiveness assessment had to be conducted before listing, followed by negotiations on the drug price and the aggregates of drug expenditures, but under the pilot program, the expense-effectiveness assessment will be conducted after listing based on real-world clinical outcomes.
Negotiations on the drug price and the aggregates of drug expenditures will also be replaced with pre-agreed contract terms. The drug price will be set at 90% of the adjusted lowest price among the eight overseas countries (A8), and the aggregates of drug expenditures will be provisionally set at the amount requested by the pharmaceutical company (capped at 30 billion won), then adjusted afterward to reflect actual claims and other factors.
The government plans to use this to cut the current roughly 240-day listing period for health insurance coverage to within 100 days.
Eligible applications are rare disease treatments that have been approved or are undergoing approval procedures and are listed in at least three of the A8 countries, including the United States, the United Kingdom, Germany, France, Italy, Switzerland, Japan, and Canada.
After the application period ends, the ministry will comprehensively evaluate the availability of alternative therapies, disease severity, fiscal impact, and plans to ensure stable patient access to treatment, and will select up to five drugs.
Pharmaceutical companies wishing to participate must submit the application form, the applying drug, and materials related to the post-assessment to the Health Insurance Review & Assessment Service by 6 p.m. on Aug. 31.