use this option, companies must conduct R&D in Germany and accept an additional 9% discount, placing a considerable burden on manufacturers. Another key revision introduces a mechanism that relaxes some pricing restrictions if at least 5% of participants in clinical trials for a new drug are enrolled in Germany. This rule is intended to encourage companies to pursue local research and development, thereby further strengthening healthcare innovation within the country.AMNOG has been successful in balancing rapid drug adoption and cost containment, yet future efforts must include deeper collaboration with precision medicine and international health technology assessment (HTA) to adapt to evolving healthcare needs.One major difference from the German system is that Japan’s pricing approach is administered directly by the government, rather than through direct negotiations with health insurers.Japan’s drug pricing system incorporates periodic revisions to correct discrepancies between official prices and actual market transaction prices. Traditionally, these revisions were conducted every two years, but rising social security costs have prompted a move toward annual revisions. Although narrowing the gap between official and real market prices helps restrain overall healthcare spending, some pharmaceutical companies claim that frequent revisions make revenue forecasting difficult, possibly undermining incentives for new drug development.In contrast, Germany allows pharmaceutical companies to freely set the price during the first six months after a new drug enters the market, followed by negotiations based on scientific assessments of additional benefits. This system places emphasis on flexibility and cost-effectiveness. Yet it also faces challenges such as potentially high launch prices and a complex evaluation process. Overall, Japan’s system excels in stability, while Germany’s system emphasizes flexibility. Moving forward, Japan may need to make further use of cost-effectiveness evaluations (HTA), while Germany may consider relaxing or adapting certain evaluation criteria to sustain both the quality and affordability of healthcare. Lessons learned from each country could provide valuable insights to guide and enhance the other’s future policy decisions.However, recent advancements in medical technology have posed new challenges for AMNOG. Gene therapies and precision medicines, for instance, target relatively small patient populations, making traditional randomized controlled trials difficult to apply. Consequently, more flexibility is required in both the method of evaluating additional benefits and the negotiation process for drug pricing.In addition, the Medical Research Act (enacted in 2024) introduced several significant revisions to AMNOG. One such revision is the “confidential reimbursement option,” which allows pharmaceutical companies to keep reimbursement prices undisclosed. This measure aims to prevent Germany’s prices from being used as reference prices in other countries, thereby avoiding a potential loss of global competitiveness. However, to Under Japan’s universal health insurance system, the Ministry of Health, Labour and Welfare (MHLW) sets official pharmaceutical prices known as the “Drug Price Standards.” When a new drug is included in the national health insurance list, committees under the MHLW and the Central Social Insurance Medical Council deliberate on the price, which is then officially published as the “drug price.”A combination of comparative methods and cost-based calculations is used to determine new drug prices. Under the comparative method, factors like safety are comprehensively evaluated. Additionally, foreign average prices are taken into account to balance Japan’s drug costs with global market levels. Japan and Germany each employ different approaches to reconcile the dual goals of controlling healthcare expenditures and promoting the availability of new drugs. In Japan, the government sets uniform prices and regularly addresses discrepancies between listed and actual market prices. This method offers stability and equity among different regions, but it also places pressure on pharmaceutical companies that struggle to project revenues, especially for innovative therapies. Moreover, as high-priced drugs become more common, there is a growing call for more flexible pricing strategies.Japan’s Pharmaceutical Pricing System: Official Prices and Regular RevisionsComparison and Future Outlook: Stability vs. Flexibility16
元のページ ../index.html#17