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- 2025-12-19 08:22:11
- 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 recalled by the manufacturer. The cinacalcet hydrochloride-based formulations are used for the treatment of secondary hyperparathyroidism in patients with chronic kidney failure undergoing dialysis, and the original drug product, Regpara Tab (cinacalcet hydrochloride), was first recalled on November 20th. List of approved cinacalcet drugs In early October, an Indian drug manufacturer decided to recall the drug due to the detection of nitrosamine impurities in the cinacalcet ingredient, raising the possibility of a recall in Korea. In early November, the U.S. Food and Drug Administration (FDA) announced a voluntary recall on its website after nitrosamines were found to exceed the FDA's recommended daily allowable intake limit. In Korea, Kyowa Kirin Korea recalled some lot numbers of two products, Regpara Tab 25mg and 75mg, due to excessive impurities detected in stability tests. The source of the N-nitroso cinacalcet is believed to be the reaction between the raw materials and excipients. Regpara Tab was launched in Korea in 2011 and became popular as soon as it was launched because it induces a decrease in parathyroid hormone (PTH) while reducing serum phosphorus (P), serum calcium (Ca), and Calcium-phosphorus product (CaxP) levels and it is easy to take once a day without the side effects caused by vitamin D preparations. In particular, generics have been entering the market at a rapid pace since the patent expired in 2017, and there are currently 11 generics approved for cinacalcet in Korea. According to the import and manufacturing performance of drugs disclosed by the Ministry of Food and Drug Safety, 2 doses of the original, Regpara, posted sales of KRW 5.8 billion at the current exchange rate. Alvogen Korea's ‘Cinacet Tab,’ Daewon Pharmaceutical's Repatzin Tab,’ and Yuyu Pharmaceutical's ‘Beneph Tab’ have posted figures of more than KRW 1 billion, while Calcepara Tab, which has been recalled, has posted nearly KWR 143.1 million. An MFDS official said, “Since impurities were detected in ingredients, excipients, and other components, we asked generic drug manufacturers to test whether excess N-nitroso cinacalcet were detected. We plan to consider necessary measures based on the results.” In response to the manufacturer's request for temporary ease of the tolerance standard and the opinions of medical expert organizations on its medical necessity, the MFDS will reportedly take measures such as temporarily raising the impurity threshold. However, manufacturers will be required to notify the agency within a month and implement a countermeasure plan for reducing impurities within 3 years. Meanwhile, Huons is conducting research to ensure that products exceeding the impurity standard are not distributed. It is considering various measures such as shortening the use period and removing or reducing impurities. “We are conducting various studies to reduce the risk of impurities, such as reduction measures,” said a Huons representative, ”and we will complete the research and development faster than the specified period so as not to disrupt the supply for patients.”
- Policy
- Sanofi signs PVA negotiations for hemophilia drug 'Alprolix'
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Product photo of Alprolix 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) and Sanofi-Aventis Korea agreed on Alprolix's PVA negotiations (TYPE-NA). Alprolix has been considered for the PVA negotiation for the first time after it was reimbursement listed in June 2018. The TYPE-NA negotiation is conducted when the ceiling price is adjusted by the TYPE-GA price or when the bill amount of the same product has increased by more than 60% or 10% from the previous year's bill, and the increase is more than KRW 5 billion. The current negotiation was possible because Alprolix's ceiling price had not been adjusted due to TYPE-GA negotiation, and it met the criteria for TYPE-NA negotiation four years after the first listing. This biological drug received approval in May 2017 as a daily preventive therapy to suppress and prevent bleeding, manage pre- and post-operative care, and reduce the frequency of bleeding in hemophilia B. The pharmaceutical company accepted price 100% below the weighted average price of substitute medicines and was exempted from undergoing the drug negotiation process. It only negotiated for the expected claim amount and successfully listed for reimbursement in June 2018. The ceiling price is KRW 1,181. Meanwhile, the Swedish biotechnology group Sobi owns Alprolix's global sales rights. Sobi partners with Sanofi to sell Alprolix. Sobi established a joint venture with Handok in South Korea in April, named 'Sobi-Handok.'
- 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 also arising. According to industry sources on the 18th, Fosrenol Tab (lanthanum carbonate), which was supplied by JW Pharmaceuticals in Korea, will be discontinued. Fosrenol has been imported and sold by JW Pharmaceuticals from Takeda. With the termination of the supply contract, its supply to the domestic market is expected to be gradually discontinued by February next year. Fosrenol is a non-calcium phosphate binding agent that was approved in Korea in January 2006. It formed a three-way tie with Renvela (Sanofi) and Invela (SK Chemical) as a treatment for hyperphosphatemia in 2022. However, Fosrenol’s competitiveness weakened as generic drugs containing sevelamer carbonate, such as Renvela and Invela, were released to the market in July 2022, and the new drug Nephoxil Cap was launched last year. Last year, sales of Renvela, Invela, and Fosrenol all declined. Renvela’s sales fell to KRW 9.2 billion in 2023, down 4% from the previous year, and Invela’s sales fell to KRW 7.4, down 15%. Fosrenol's sales were flat at KRW 4.1 billion ($4.1 billion), the same as the previous year. The emergence of sevelamer generics and new drugs are disrupting the existing market structure. Nephoxil, which was launched last year, is a drug for hyperphosphatemia in chronic kidney disease patients undergoing hemodialysis and is particularly praised for lowering the risk of side effects such as hypercalcemia and vascular calcification of calcium-based binders with iron-based binders. In particular, Kyowa Kirin Korea, which supplies the drug, not only succeeded in getting the drug on the reimbursement list within a year by accepting the weighted average price of KRW 377, which is 90% of the weighted average price of alternative drugs, showing competitivity in drug price. Not only new drugs but also the highest-selling sevelamer drug has seen its number of tablets increase to 9 due to the emergence of generics. This situation explains why Fosrenol, which showed stagnant sales, eventually withdrew from the domestic market. On the 5th, 3 Fosrenol products also withdrew their domestic marketing authorizations. “The market for hyperphosphatemia treatments has recently seen intensified competition as non-calcium-based drugs with fewer side effects have gained prominence due to expanded reimbursement,” said a pharmaceutical industry insider. ”In addition, the introduction of new drugs has weakened the competitiveness of existing products.”
- 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 next year to collect sufficient data to evaluate the system and in consideration of industry demand. The Advance Notification System for Drug Change Permit is a system in which the MFDS and drug manufacturer/importer discuss the date of a drug’s permit change in advance, taking into account the manufacturing and import schedule of the company before processing the change, and then approving the change according to the applicant's desired date. The system had been operated only for new drugs, orphan drugs, and advanced biopharmaceuticals until now. Still, as of May 30, the system had been expanded to include drugs subject to production, import, and supply interruption reports. In the case of drugs subject to production, import, and supply interruption reports, their inclusion in the system may be subject to change according to the list announced by the Health Insurance Review and Assessment Service in late December. Drug manufacturers and importers must obtain a change permit from the head of the MFDS when changes are made to authorized drugs, and then manufacture and import products reflecting the changes. Previously, when the MFDS’s approval process for a drug permit change application was completed, its approval was processed without any notification, making it difficult for companies to predict the date of approval. To address this, the MFDS has established an advance notification system for drug permit changes and plans to institutionalize it through evaluation after completion of the pilot program. The system allows a company that applies for a change permit and enter a notice of the desired change period into the NEdrug system after the MFDS completes review. The change date must be set after the statutory deadline, and extensions can be requested within the statutory period of the civil complaint. Adjustment of the date of change approval through the advance notification system is only applicable to cases where it is necessary to process (extend) the period later than the original processing period due to the manufacturing and import schedule of the drug in question in order not to affect the existing approval process.
- Policy
- Generic drugs without originals released in KOR
- by Lee, Tak-Sun Dec 18, 2024 05:54am
- Takeda 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 begun negotiations for the reimbursement of a generic version of Otezla (Apremilast). Otezla is Amgen's treatment for psoriatic arthritis and psoriasis, which was approved in November 2017 but withdrawn from the market in June 2022. The drug had difficulty being listed for reimbursement. The drug had become the top-selling oral psoriasis treatment in the global market but was not even properly showcased in the Korean market due to the reimbursement hurdle. The analysis is that the drug missed its prime reimbursement time while changing hands three times, from Celgene, BMS, to Amgen. In the meantime, competitors such as Cosentyx, Stelara, Skyrizi, and Taltz entered the reimbursement market, weakening Otezla’s competitiveness in the domestic market. In Korea’s situation, as the price of the later entrants is set lower than their competitors, the pharmaceutical company’s concerns have deepened. In addition, with the patent’s expiry date approaching and the domestic generic companies’ patent challenges against Amgen, the company announced Otezla’s withdrawal from the market. As a result, generic products without original versions are on the verge of receiving reimbursement in Korea. The drugs are: Dong-A ST’s Oteria Tab, Daewoong Pharmaceutical's Apsola Tab, Chong Kung Dang's Otebell Tab, Dongkoo Bio Pharm’s Otemila Tab, and Han Lim Pharm’s Psopre Tab. In October, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) held a review on the adequacy of Otezla generics and determined that their reimbursement was adequate if their price was less than the assessed value. As a result, the pharmaceutical companies accepted a price lower than the assessed value and moved on to the negotiation stage with the NHIS. Now that they have accepted the assessed value and moved on to the negotiation stage, it is expected that the products will be launched with reimbursement in the first half of next year at the latest. Takeda’s P-CAB class gastroesophageal reflux disease drug ‘Vocinti Tab (vonoprazan fumarate)’ is also expected to be the first generic product to enter the reimbursement market without an available original drug. This is because generic development by domestic pharmaceutical companies is in full swing, and Vosinty withdrew its license on the 12th. Generic companies are aiming for an early market launch by avoiding Vosinty’s patent. The product patent for Vosinty Tab expires in December 2027, but it can be released in October next year if the patent’s extended term is invalidated through patent avoidance. Vosinty also has missed the golden time for reimbursement in Korea. It is analyzed that it lost its competitiveness as domestic pharmaceutical companies' P-CAB class products such as K-CAB and Fexuclue Tab were first released on the domestic market. An industry official said, “U generic companies have the advantage of greater flexibility in drug pricing because their drug development cost is relatively low. They can enter the domestic health insurance market with a relatively lower price than the original companies, Therefore, it will be interesting to see how generic drugs without original drugs perform in the domestic market.
- 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 pharmacoeconomic evaluation data but does not meet the requirements, such application can be rejected without committee deliberation. HIRA released a revision to the 'Detailed Evaluation Criteria for New Drugs and Other Drugs Subject to Negotiation' on the 12th that contains the changes above. The revision, which was finalized after deliberations by the Drug Reimbursement Evaluation Committee on the 5th, reflects improvements to the system for rewarding the innovation value of new drugs reported to the Health Insurance Policy Review Committee last year. HIRA has already revised the criteria once to reward the new drugs’ innovative value once in August. The new revision contains simplification of review for drugs that have signed 3 or more risk-sharing contracts. Specifically, it is possible to briefly review refund-type drugs, excluding multiple RSA-type drugs, starting from the evaluation related to the expiration of the second risk-sharing contract period (in the case the drug is signing the third or further risk-sharing contract), focusing on changes. There are also new requirements set to reject applications for ineligible PE exemption drugs. If an applicant applies for a determination that a drug falls under Article 6 (Drugs deemed essential for medical treatment) or Article 6.2 (Drugs that can waive the submission of pharmacoeconomic evaluation data) of the Regulations on Evaluation Criteria and Procedures for Eligibility for Medical Treatment Benefits, etc.’ HIRA stated that this addition was made to “clarify the processing criteria for drugs that are waived submitting pharmacoeconomic evaluation data for but fail to submit required data to improve work efficiency.”
- Policy
- NHIS to expand the special estimate case system in 2025
- by Lee, Tak-Sun Dec 16, 2024 05:52am
- The National Health Insurance Service (NHIS) (Chairman: Jung Ki Suck) has announced plans to expand the reimbursement criteria for special cases of new rare diseases, starting on January 1, 2025. The NHIS aims to enhance essential medical support for individuals who currently do not benefit from receiving healthcare, including patients with rare diseases. The NHIS' special estimate case system lowers the national health insurance partial co-payments, reducing the burden of co-payments to help alleviate the financial burden on patients with severe diseases, such as cancer and rare diseases. When this special estimate case system is applied, patients receive hospitalization·outpatient co-payment rates of 0-10%. The NHIS has been expanding the reimbursement criteria for special estimate cases of rare diseases by collaborating with the Korea Disease Control and Prevention Agency (KDCA) and consulting with academic organizations and experts, then proceeding with a rare disease management committee (Ministry of Health and Welfare, MOHW) and special estimate cases committee (NHIS) reviews·decisions. This year, the NHIS has expanded special estimate cases to 66 new rare diseases, including 'achalasia (K22.0).' Rare diseases to be covered by special estimate cases system taking effect on January 1, 2025, will be increased from 1248 to 1314 cases. Following the expansion, new patients with rare diseases will pay a co-payment corresponding to 10% of the medical fee for diseases registered under the special estimate cases system and side effects directly caused by those diseases. Approximately 14,000 individuals are expected to benefit from lowered medical fees. "The NHIS will continue to collaborate with the MOHW and KDCA to identify rare diseases with severe symptoms that incur high medical costs and requires long-term treatment, thereby enhancing essential healthcare security for vulnerable populations," Kim Nam-hoon, NHIS's senior director of reimbursement, stated.
- Policy
- HLB Pharma applies for reimb of 'Citrelin ODT' for SCD
- by Lee, Tak-Sun Dec 16, 2024 05:52am
- HLB Pharma HLB Pharma has reportedly applied to the Health Insurance Review and Assessment Service (HIRA) for reimbursement of 'Citrelin ODT,' a domestically distributed treatment for spinocerebellar degeneration. This product was approved in South Korea in 2015, but it has been distributed to the Korean market as a non-reimbursed drug. However, with the successful completion of its recent Phase 4 trial, involving Korean patients, the company may now attempt to obtain reimbursement for the drug. According to industry sources on December 16, the HIRA received an application for the reimbursement of Citrelin ODT and has begun its review. Citrelin ODT 5mg (taltirelin) received approval from the Ministry of Food and Drug Safety (MFDS) in Korea on February 6, 2015. It is orally administered twice daily after a meal to improve ataxia caused by spinocerebellar degeneration. Spinocerebellar degeneration (SCD), an inherited cerebellar disorder, is a degenerative disease affecting the cerebellum or spinal cord with an unknown cause. It accompanies degenerative symptoms, including ataxia, optic atrophy, and muscle spasm. Ataxia can lead to the loss of the capacity to control arm and leg muscles, causing gait and language dysfunction. It is reported to significantly hinder patients' quality of life. HLB has signed an exclusive agreement with Japan's Osaka Synthetic Chemical Laboratories (OSCL), the Citrelin ODT developer, and has been distributing the drug in South Korea. In 2017, the company attempted to obtain reimbursement. At the Drug Reimbursement Evaluation Committee (DREC) held in October 2017, a decision for re-evaluation was issued due to insufficient evidence for reimbursement approval, such as textbooks and guidelines. It was decided that the drug needed to be re-evaluated to see if it was necessary for medical use and meeting the reimbursement criteria when the company additionally submitted documents regarding the effectiveness of the drug. After that, the review held in January 2018 concluded that the drug is non-reimbursable due to insufficient evidence proving its clinical effectiveness and its costs being higher than that of other substitute drugs. Since the decision, the company has been focusing on proving the drug's clinical effectiveness by conducting a Phase 4 clinical trial involving Korean patients. Recent results from Phase 4 clinical trials were published in the 'Journal of Movement Disorder,' a SCI-grade international journal. The clinical trial involved a total of 160 study participants, 79 receiving the treatment drug and 81 receiving a control, randomly assigned. The results showed that the drug significantly reduced the K-SARA (Korean version of Scale for the Assessment and Rating of Ataxia), an objective evaluation index for ataxia, after 24 weeks of treatment. The company stated that they have confirmed this statistical significance. It is reported that Citrelin ODT is distributed at about KRW 12,000 per tablet. It costs about KRW 9 million annually. Confirming effectiveness in Korean patients is expected to impact reimbursement listing reviews for national health insurance positively. When the drug gets listed in the reimbursement list, patients will be able to afford the drug at a much cheaper price. Attention has been drawn to whether Citrelin ODT will be listed for reimbursement 10 years after it was approved in South Korea.
- Policy
- Otezla generics enter negotiations for reimb
- by Lee, Tak-Sun Dec 13, 2024 05:52am
- Dong-A STGeneric to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, is being considered for reimbursement negotiations with the National Health Insurance Service (NHIS). Attention has been drawn to whether a generic drug will be listed for reimbursement, the process in which a company with the original drug gave up. According to industry sources on December 11, the NHIS has recently included five products containing apremilast to the list of drugs for price negotiations. These medicines include 5 products: Dong-A ST's 'Otelia,' Daeowoong Pharmaceutical's 'Apsola,' Chong Kun Dang's 'Otebell,' Dongkoo Bio's 'Otemila,' and Hanlim Pharm's 'Psopre Tab.' Otezla received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea in November 2017. However, the company withdrew from the Korean market due to difficulty listing the drug for reimbursement. Amgen voluntarily withdrew approval in June 2022. However, Otezla's sales have been skyrocketing in the overseas market. It recorded no.1 among oral psoriatic treatments in global sales last year. It is reported that Otezla recorded sales of US$3.984 billion (about KRW 5.5 trillion) last year worldwide. Recognizing Otezla's superior effectiveness and marketability, Korean pharmaceutical companies have been putting efforts into registering the drug in the reimbursement market ahead of the original drug. Pharmaceutical companies with generics successfully avoided two cases of active ingredient patents registered in South Korea. They have successfully overcome the patent challenge by signing an agreement with Amgen for the remaining usage patent. Based on these outcomes, they received approval from the MFDS in April. Generics have entered the market that the original drugs withdrew. For instance, Dong-A ST launched the Otelia tab in July as non-reimbursed. The Drug Reimbursement Evaluation Committee (DREC) review held in October ruled that medicines would be appropriate for reimbursement coverage if the company accepted the drug price below the evaluated amount. Analysis suggests that relevant pharmaceutical companies have accepted the drug price below the evaluated amount and proceeded with the negotiation phase with the NHIS. Because most companies tend to accept a drug price negotiation exemption criterion when they accept the drug price below the evaluated amount, they are likely to proceed with the negotiations for the expected claim amount. Then, they could conclude the negotiation early and be more likely to reach an agreement. Meanwhile, besides the current discussions for apremilast, the NHIS has started negotiating with the reimbursement expansion for Darzalex. Janssen, which owns Darzalex, is proceeding with getting reimbursement for DVTd therapy (Darzalex+bortezomib+thalidomide+dexamethasone) as a first-line treatment for multiple myeloma.
- Policy
- Martial law impacts the launch of the Pharma-Bio Committee
- by Lee, Jeong-Hwan Dec 13, 2024 05:51am
- The National Bio Committee directly under the President, which was scheduled to be launched this month, has been disrupted by President Suk-Yeol Yoon’s declaration of emergency martial law. As the National Assembly is in the early stages of voting on an impeachment bill against President Suk-Yeol Yoon, who was supposed to chair the committee, the establishment of the National Pharmaceutical and Biotech Control Tower is at risk of being canceled. According to the Ministry of Health and Welfare on the 10th, the first meeting of the National Bio Committee, originally scheduled for sometime this month, has been postponed indefinitely. The MOHW explained that it has not received a specific date for the launch of the committee nor a date for its future launch. The National Bio Committee, a body directly under the president, is responsible for deliberating on policies such as R&D and approval in the pharmaceutical and biotech sectors. The Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Trade, Industry, and Energy, all of which are related to the industry, have been jointly preparing for its launch. Sang-Yeop Lee, Vice President of the Korea Advanced Institute of Science and Technology (KAIST), was internally designated as the Civilian Vice Chairman, and more than 20 bio experts in the field of biotechnology, including Bit-nae-ri Kim, Director at the Institute for Basic Science, Han-Seung Ko, head of Samsung Electronics' Future Business Planning Division, and Young-Tae Kim, President of Seoul National University Hospital, were scheduled to participate as civilian committee members. In particular, the controversial inclusion of a global pharmaceutical company executive among the civilian members has stirred up controversy, and the confusion surrounding the Bio Committee grew greater with the rise of the impeachment situation due to President Yoon's declaration of martial law. The government's plans to become one of the top five global bio powerhouses and create blockbuster national drugs have been compromised. In the midst of the state of impeachment, President Yoon has stated that he will leave his term and stabilization plan to his party, and the opposition party has stated that they will repeat the impeachment vote every Saturday, virtually halting all schedules for the National Bio Committee. The pharma and biotech industry has expressed regret that the martial law and impeachment aftermath has unexpectedly shaken the establishment of the Bio Committee. “There were concerns that the National Bio Committee, directly under the president, would overlap with the Bio Health Innovation Committee, an organization directly under the prime minister, but the pharmaceutical industry still had high expectations,” said a pharmaceutical industry official. ”We do not expect the Bio Committee, chaired by the president, to be able to play its role in the situation where the impeachment bill is presented in the National Assembly.” “We have effectively lost one window to directly appeal to the president for policies to strengthen state support for domestic pharmaceutical companies aiming to develop global new drugs,” the official said, adding, ”It is the hope of the pharmaceutical industry to wait for the political turmoil to be cleared up quickly and for the committee's launch and operation plan to materialize.
