- Policy
- Price of Pulmicort raised again upon request
- by Lee, Tak-Sun Dec 23, 2024 05:49am
- The price of asthma and bronchitis drug ‘Pulmicort Respule Nubuliser Suspension (budesonide, AZ), which had been raised in December last year, will again be raised in just one year. The move is intended to proactively address the drug’s global market shortage. According to industry sources on the 20th, the insurance price ceiling for
- Policy
- Gilead starts trial for its autoimmune disease drug in KOR
- by Lee, Hye-Kyung Dec 20, 2024 05:47am
- The B- and T-Lymphocyte Attenuator (BTLA) autoimmune disease treatment will enter clinical trials in Korea. The Ministry of Food and Drug Safety approved Gilead Sciences' application for a ‘multicenter, randomized, placebo-controlled Phase 1b clinical trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and phar
- Policy
- Keytruda’s reimb for gastric cancer will be redeliberated
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- The application to expand the gastric cancer indication for the immuno-oncology drug Keytruda (pembrolizumab, MSD) has been given a ‘redliberation’ decision. The drug is currently seeking reimbursement for 17 indications, but financial issues have prevented a conclusion. The Health Insurance Review and Assessment Service’s Cancer Disea
- Policy
- Basic refund type-drugs granted early RSA termination
- by Lee, Tak-Sun Dec 20, 2024 05:46am
- Only drugs categorized as a basic refund type are possible when a pharmaceutical company wishes to terminate the Risk Sharing Agreement (RSA) early. However, pharmaceuticals on the cost-effectiveness evaluation waiver track, demonstrating cost-effectiveness, can be submitted for negotiation through the renewal of the agreement. The Nati
- Policy
- Cinacalcet impurities spread…Huons recalls product
- by Lee, Hye-Kyung Dec 19, 2024 05:53am
- The detection of excess 'N-nitroso cinacalcet' impurity has led to the recall of the kidney drug cinacalcet hydrochloride. The Ministry of Food and Drug Safety announced on the 17th that Huons’ Calcepara Tab 25 mg (cinacalcet hydrochloride) with 3 manufacturing numbers TTB201 (2025-08-16), TTB301 (2026-05-18), and TTB302 (2026-05-21) will be
- Policy
- Sanofi signs PVA negotiations for hemophilia drug 'Alprolix'
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- The ceiling price for Sanofi's 'Alprolix,' a new treatment for hemophilia B, is expected to decrease through price-volume agreement (PVA) negotiations. This drug was approved in May 2017, and reimbursement listed in June of the following year. According to industry sources on December 18, the National Health Insurance Service (NHIS) a
- Policy
- Hyperphosphatemia treatments undergo generation change
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Drugs that improve hyperphosphatemia in patients with chronic kidney disease are undergoing a generation change in the domestic market. Following the launch of the new drug Nephoxil Cap (ferric citrate, Kyowa Kirin Korea) last year, generic drugs containing sevelamer have continued to grow, and news of the withdrawal of existing drugs is
- Policy
- Prior notification of drug permit changes extended to 2025
- by Lee, Hye-Kyung Dec 19, 2024 05:52am
- The operation of the pilot program, 'Advance Notification System for Drug Change Permit', which allows drug manufacturers and importers to apply for change permits on their preferred date, will be extended. According to industry sources on the 18th, the Ministry of Food and Drug Safety (MFDS) will extend the pilot project until December 31 ne
- Policy
- Generic drugs without originals released in KOR
- by Lee, Tak-Sun Dec 18, 2024 05:54am
- Generic versions of drugs whose original versions are unavailable in Korea are expected to be released one after another. This is becoming a Korean phenomenon, where original drugs withdraw from the domestic market due to low drug prices and generics fill the void. According to industry sources, the National Health Insurance Service has
- Policy
- Reimb of PE exemption drugs can be ex officio rejected
- by Lee, Tak-Sun Dec 16, 2024 05:53am
- In the future, drugs that sign refund-type risk-sharing agreements will be reviewed briefly by the Health Insurance Review and Assessment Service, focusing on changes, when a drug is reimbursed through the signing of the risk-sharing agreement more than 3 times. In addition, if a drug applies as a drug that can skip submission of pharma
