규제 속 약가 조정 난제 - 히트뉴스

Calls for Policy Flexibility as Three-Year Restrictions Hamper Supply Stability There are growing calls for a more flexible application of regulations, as pharmaceuticals with increased ceiling prices are barred from submitting adjustment requests for three years. According to industry sources, the government implemented drug price adjustment guidelines in December last year to ensure the stable supply of essential medicines. Eligible drugs for price adjustment applications include: ① Medicines with no viable substitutes. ② Drugs essential for clinical care. ③ Cost-effective medications that share identical ingredients and administration routes, produced by a single manufacturer. In exceptional cases—such as infectious disease outbreaks or urgent supply shortages—requests from central administrative bodies are considered. Other factors, including social demand, disease specificity, and the sensitivity of certain patient groups, such as pediatric populations, are evaluated on a case-by-case basis. The adjustment process involves agreements on ceiling prices, estimated claim amounts for the first year post-adjustment, reimbursement details, and a 13-month supply plan. Pharmaceutical companies negotiate price increases based on production costs and available quantities. Drugs like pseudoephedrine hydrochloride, magnesium hydroxide, micronized budesonide, acetaminophen, lactulose concentrate, cefditoren pivoxil, and tulobuterol have had their ceiling prices raised under this system. Despite price adjustments, issues such as persistent supply shortages and rising import costs remain unresolved. Post-adjustment management also presents hurdles. Pharmaceuticals undergoing price adjustments face a three-year restriction on further adjustment requests. They are reclassified under the post-management usage-volume linked pricing system from "Category C" to "Category A," with fixed expected claim amounts. An industry representative stated, "The ceiling price for unstable supply drugs is based on production capacity. If additional production is required, the three-year restriction creates challenges. Exceptions or incentives to encourage production are essential." Another insider added, "While the three-year rule may be necessary from the government’s perspective, allowing preemptive reviews to synchronize adjustments with this period could improve flexibility. A more adaptable policy is needed to address supply concerns effectively."