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- 2025-12-24 12:42:40
- Policy
- 16 drugs including Venclexta receive reimbursement in 1H
- by Kim, Jung-Ju Jun 28, 2021 05:50am
- A total of 14 products were newly listed on the insurance benefit list to improve patient access in the first half of this year. Also, two drugs benefited from the reimbursement criteria expansion that was applied to already-listed new drugs. This expanded coverage is interpreted as a result of the government’s decision to flexibly apply coverage for drugs according to the patients’ needs and social importance. The government estimates that around 760,000 patients in Korea will be benefiting from the change. The coverage will financially cost around 115.6 billion won per year, which indicates that the coverage expansion for drugs is being carried out faster than the previous year. During the first half of this year, from January to June, a total of 16 drugs (based on each drug’s representative strengths) were listed on the drug benefit list. These include new drugs that were newly listed and those whose criteria (indication, administration criteria, etc) were expanded to enhance coverage. New drugs that were newly listed this month include the hemophilia A treatment Afstlya inj.; bacteremia treatment Daptocin inj., Boryung Daptomycin inj., and Dapto Inj.; nocturnal hemoglobinuria treatment Ultomiris inj.; and hyperlipidemia treatment Praluent Pen inj.. Also, the reimbursement criteria for the already-listed choric lymphocytic leukemia treatment Venclexta tab. was expanded to enhance coverage. The number of domestic patients expected to use the drugs that were newly listed or received expanded reimbursement varies greatly by product. For the Venclexta tab., the number of patients that will benefit from the expanded reimbursement is expected to be around 75. Also, the number of patients to benefit from the newly listed Ultomiris is 92. Contrary to such drugs that are expected to benefit less than 100 patients, the glaucoma treatment Eybelis Eye Drops is expected to benefit around 45,000 patients. Also, the blood sugar regulator Xultophy Flex Touch inj. that was newly listed in May is expected to benefit 12,756 patients, and Parkinson treatment Equfina Film Coated tab. that started its reimbursement process in January this year is expected to benefit 7,000 patients. The number of beneficiaries greatly varies due to policies that now allow flexible expansion of NHI coverage to high-price drugs that are used for a small number of rare diseases, that were established based on the increased social maturity that can now accept such policies. Due to the new listings and expanded benefit criteria, the government and payer are expected to spend around 115.6 billion won a year to grant access to around 76,769 patients.
- Policy
- Billing for α-GPC is managed
- by Lee, Jeong-Hwan Jun 28, 2021 05:50am
- The HIRA plans to consider the need to manage claims by selecting Choline alfoscerate, which is under controversy over reducing adaptation certificates, as the "selection focused item." The MFDS plans to periodically monitor pharmaceutical companies that have been clinically reassessed, block unnecessary clinical extensions, and take administrative action against pharmaceutical companies that have failed to reassess. On the 24th, the HIRA and the MFDS responded to Nam In-soon's criticism of the Democratic Party of Korea about Choline alfoscerate. She ordered the HIRA to review and implement follow-up measures to prevent Choline alfoscerate from prescribing drugs based on reduced benefit due to the lack of proven efficacy and effectiveness of other than dementia. The HIRA said it will collect opinions from the public and medical circles and decide whether to select and manage Choline alfoscerate as a selective target after deliberation and resolution process of the central screening coordinator committee. It is a proactive screening system that selects items that need to improve medical trends, such as increased medical expenses, screening problems, and social issues, and makes intensive screening after prior notice to induce improvement in autonomous medical trends of medical institutions. The HIRA will make efforts to make sure that Choline alfoscerate is not prescribed for other than dementia in front-line medical institutions. In addition, the HIRA said it is currently monitoring claims, amounts, and actual number of employees after the suspension of execution of Choline alfoscerate's benefit standard notice. "We will continue to monitor Choline alfoscerate's claims and come up with follow-up measures with related agencies," The HIRA said. "We will continue to re-evaluate the benefit adequacy of the system to streamline spending structure for health insurance fiscal sustainability of health insurance." She ordered the MFDS to block pharmaceutical companies from indiscriminately extending the clinical re-evaluation period of Choline alfoscerate and start managing pharmaceutical companies that have not submitted clinical plans. The MFDS said it will monitor the progress of clinical re-evaluation periodically and speed up the process of changing or canceling permits if it is deemed ineffective or insufficient. The MFDS said 11 items from eight companies that did not participate in the clinical re-evaluation are being subject to secondary administrative measures under the Pharmaceous Affairs law. The first disposal will be suspended for two months, the second disposal will be suspended for six months, and the third disposal will be revoked. The MFDS announced on the 10th that it had previously notified the procedure of changing permission to delete "emotional and behavioral changes, senile caustic depression," which is not included in the scope of clinical re-evaluation. The intention is that there is a need for management only for "secondary symptoms and metamorphic or degenerative cerebral substrate syndrome caused by cerebrovascular deficits" where clinical re-evaluation has been decided. The MFDS said, "To reevaluate the validity quickly, we adjusted and approved the clinical trial period after consulting experts based on the progress of clinical trials of similar adaptive items and data on insurance claims by the HIRA." The MFDS replied, "We will closely review the re-evaluation process and take administrative action against non-submitted pharmaceutical companies."
- Policy
- The number of items has plummeted due to regulatory impact
- by Lee, Tak-Sun Jun 28, 2021 05:49am
- Recently, More and more items are being removed due to the expiration date. Pharmaceutical companies have sorted out the items due to strong regulations on impurities and penalties for drug prices of consignment items. According to the MFDS on the 23rd, a total of 63 new drugs have been approved this month. On the contrary, there are 226 items which permits have been deleted, almost four times more. From January 1 to June 23 this year, 1,224 items were licensed. On the other hand, 2,229 items were deleted, nearly doubling. Most of the deleted items have expired five-year period, and they have not submitted data that proves the safety and validity of the license renewal. Since 2018, the MFDS has operated a renewal system for item evaluation and has been evaluating it every five years. Pharmaceutical companies are required to submit data such as safety management, quality, and status of foreign use to renew their permits. As a result, items withdrawing from the market are often given up their permits. Analysts say that this pattern has become worse recently. An industry official said, "We submitted an evaluation of the possibility of impurities for all medicines by June, and decided not to renew the license because some items are difficult to proceed." An official from another company said, "Most of the consignment items are given permission as penalties are given at drug prices." "There have been far more cases of deletion recently because there are no items to put on the market," he said. Items subject to regulation due to the detection of impurities are likely to be removed. Satan or Tidin drugs, which have been a problem recently, are representative. Even if these items are sold, lot release is possible only when tests prove that there are no impurities.
- Policy
- NA LJC to review ‘1+3 bill for generics’ tomorrow
- by Lee, Jeong-Hwan Jun 25, 2021 05:51am
- The National Assembly's Legislation and Judiciary Committee will review the revision of the Pharmaceutical Affairs Act that contains the bill for the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission an agenda for review at the NA Legislation and Judiciary Committee’s general meeting that will be held on the 25th. If the revision passes the Legislation and Judiciary Committee, it will be processed and deliberated at the plenary session that is planned on the 29th, and may likely be legislated by June. On the 24th, the vice-chairpersons of the ruling and opposition party of NA’s Legislation and Judiciary Committee are discussing the agendas that will be presented at the plenary session on Monday. One thing to note is that the bills passed by the Health and Welfare Committee on the 16th, including the one to revise the Pharmaceutical Affairs Act, have also been included as agendas at the Legislation and Judiciary Committee meeting. The revised Pharmaceutical Affairs Act passed by the Health and Welfare Committee includes the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission, designation of Day of Medicine as a Statutory Anniversary, mandatory preparation and submission of Contract Sales Organization (CSO) expenditure report, penalizing illegal purchasers of specialty drugs, and compulsory marking of safety precautions in Braille and voice codes. The revision also includes the bills to legislate the conditional approval system for Phase III trials, mandatory registration of oversees API manufactories, increasing the number of Central Pharmaceutical Affairs Council members to 300 at most, strengthening regulations for the cancelation of false or unlawfully approved National Lot Release drugs, and the establishment of the Vaccine Safety Technology Support Center. In other words, whether the bill to regulate generics and drugs requiring data submission will be able to pass the final legislative threshold by passing the plenary session of the National Assembly this month will depend on deliberations of the Legislation and Judiciary Committee on the 25th. The Legislation and Judiciary Committee can decide to pass or continue to review the bills passed by the Health and Welfare Committee. If the bill is passed by the Legislation and Judiciary Committee, the final procedure will be carried out at the plenary session on the 29th. When the government finally promulgates the bill, the individual bills will then come into effect according to the by-laws. An official from the Legislation and Judiciary Committee said, “Discussions on the agenda for the plenary session have not yet been completed by the vice-chairpersons. For now, the bill by the Health and Welfare Committee, including the revised Pharmaceutical Affairs Act, is included in the agenda for the plenary session."
- Policy
- MFDS investigates impurities of Sartan and Varenicline
- by Lee, Tak-Sun Jun 25, 2021 05:50am
- The MFDS has launched a full investigation as the risk of impurities in Sartan and Varenicline, a non-smoking treatment supplement, has been raised among hypertension drugs. Recently, some products have been recalled due to the detection of impurities such as carcinogens in Canada and other countries. However, in the case of Sartan, both raw materials and finished products are planned to be investigated, and in the case of Varenicline, only the finished products were ordered to be tested by related companies. The MFDS announced on the 22nd that it is conducting a safety investigation of high blood pressure treatment containing satan series and Varenicline, a non-smoking treatment aid. Antihypertensive drugs including satan are the three components of Irvesartan, Losartan, and Valsartan. The survey will be conducted to verify the safety of domestic products as impurities exceeding provisional management standards were detected in overseas-related medicines. The MFDS has already sent an official letter to a local pharmaceutical company to encourage them to review their own investigation as a precautionary measure. An official from the MFDS said, "We will work closely with related companies to obtain test results as soon as possible, and put safety first according to the results and promptly take necessary measures." "There have been no cases of impurities detected in the drug in Korea yet," he added. AZBT which is not a nitrosamine, but is known to have a mutation (the property that causes genetic mutations). The MFDS estimates that AZBT occurs due to the reaction of Br-OTBN (4'-Bromomethyl-2-cyano-biphenyl) and Sodium Azide (NaN3). The impurity of Varenicline is "N-nitroso-varenicline," which is said to be caused by the reaction of nitrite and Varenicline remaining in the finished drug manufacturing process. The MFDS said that Varenicline is an example of the original company Pfizer's own discovery of the problem, and that drugs from the same manufacturer as those recovered from overseas have not been distributed in Korea, and are under investigation by Pfizer's own investigation.
- Policy
- Zopista's price cut by 23%, Gefitinib by 22%
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- The premium pricing period for Huons' Zopista has ended., and the price will fall by 23.9% at most for its strengths. Also, Hanmi Pharmaceutical applied for a voluntary price cut of its ‘Gefitinib Tab,’ and its price will fall by 22.1%. The premium pricing term for five zoledronic acid monohydrate products including Boryung Pharmaceuticals’ ‘Zoledron inj. 5mg/100mL’ will return to its original price upon expiry of their premium pricing term. The MOHW will make an amendment to the ‘Drug benefit list and maximum ceiling price table’ that contains the abovementioned changes on July 1st. ◆Term expiry for newly listed premium pricing items = The government has been providing a premium of 59.5% for newly listed generics for 1 year from the date of its initial listing. The premium rate applied increases to 68% for innovative pharmaceutical companies. However, if products of the same ingredient are produced in 3 or fewer companies even after the 1-year term has expired, the premium applied is maintained for a maximum of 5 years until the number of products increases to 4 or more. Five newly listed zoledronic acid products face premium pricing term expiry next month. The products are Boryung Pharmaceutical's Zoldron Inj. 5mg/100mL, Penmix's Penmix Zoledronic Acid Inj. 5mg/100mL, PharmGen Science's Oncebone Inj. 5mg/100mL, Dongkwang Pharm.'s Dongkwang Zoledronic Acid Inj. 5mg/100mL, and Dong Sung Bio Pharm's Zomedron Inj. 5mg/100mL. The products will be applied a price of 164,163 won from next month. ◆Term expiry for extended premium pricing items = The government allows products to maintain the premium pricing until 4 or more products of the same ingredient are listed even after the period of 1 year if the products with the same ingredient are produced in 3 or fewer companies. Nine extended premium pricing products containing the eszopiclone ingredient face premium pricing term expiry next month. The discounts that will be applied for each product and strength are as follows: Huons' Zopista Tab. 1mg, 2mg, 3mg by 23.9%, 23.7%, 23.2%, respectively; Yungjin Pharmaceuticals Yungjin Zopiclone Tab. 1mg, 2mg, 3mg by 4.1%, 5.4%, and 6% respectively; and Myungin Pharm's Zoss Tab. 1mg, 2mg, and 3mg by 10.3%, 10.3%, and 9.9% respectively. ◆Price ceiling adjustments according to voluntary price cut applications = When a pharmaceutical company submits a request to lower its drug price to an amount lower than the ceiling price set for the product, the government adjusts the insurance drug price of the product to the requested amount. The price of Hanmi Pharmaceutical's ‘Gefitinib Tab.’ will be reduced by 22.1%, and Jinyang Pharm’s ‘Jintozet Tab. 10/40mg’ will be adjusted to a 17.3% lower price.
- Policy
- Leclaza will be reimbursed for non-small cell lung cancer
- by Lee, Hye-Kyung Jun 24, 2021 05:54am
- From July 1, Yuhan Corporation's "Leclaza (Lazertinib)" will be reimbursed at the stage of secondary administration of non-small cell lung cancer. The HIRA announced that it will conduct an opinion inquiry until the 25th on the revised announcement (proposal) based on drugs prescribed and administered to cancer patients. If there is no disagreement, it will be applied from 1 July. Leclaza was approved by the MFDS on January 18 as an anti-cancer drug used to treat patients with EGFR-TKI-positive local progressive or metastatic non-small cell lung cancer. According to the HIRA's review of textbooks, guidelines, and clinical papers to set the standards, there was no mention of the drug in textbooks or guidelines as a new drug developed domestically. As a result of a single-group, phase I/II of clinical trial of local progressive or metastatic non-small cell lung cancer patients previously treated with EGFR-TKI, the median value of the progressive survival period was reported to be 9.5 months. In addition, T790M positive patients with 240mg of FDA approval content showed a median value of 11.0 months and an objective response rate of 57.9%, which is currently approved and paid for the same certificate of medical utility. The standard was set the same as Tagrisso( Osimertinib). Cross-dosing benefits are not recognized if a Tagrisso-administered patient intends to change to Leclaza after the disease progresses. However, if a patient want to change the administration to Leclaza due to serious side effects after Tagrisso is administered, it can be recognized on a case-by-case basis.
- Policy
- Standards for Trelegy Ellipta will be established
- by Kim, Jung-Ju Jun 24, 2021 05:54am
- Five drugs, including Trelegy Ellipta, a treatment for COPD are scheduled to be registered for insurance in accordance with next month's schedule, and salary standards will be established and changed accordingly. The MOHW has partially amended its notice of 'details on the criteria and methods of applying care benefits' to ensure proper insurance coverage of the drug and has entered into an inquiry. The drugs that will be applied to the revision include Trelegy Ellipta, Rosuvaco Soft Cap, Rosumega Soft Cap, and Pentosin 350mg and Ultomiris, which will be registered on June 1st. Among them, the drugs listed as of June 7 are likely to be partially changed following the Health Insurance Policy Committee's deliberation and resolution. ◆Trelegy Ellipta = COPD treatment, Trelegy Ellipta (Vilanterol trifenate + Flutisone furoate + Umeclidinium inhaler), is scheduled to be listed on the 1st of next month. The MOHW has made sure that patients who are being administered with the same compound and single drugs at the same time with the drug will be paid even if they want to switch to the drug. ◆Omega-3-acidethylesters 90 and Rosuvaco Soft Cap = Omega-3-acidethylesters 90 and Rosuvaco Soft Cap, a complex type of dyslipidemia treatment such as Rosuvaco Soft Cap and Omega-3-acid ethyl esters 90), are scheduled to be registered as of June 1st. ◆Pentosin 350mg, etc.= Compound skin infections caused by Gram-positive bacteria and Pentosin 350mg, an antibiotic, are scheduled to be registered on June 7, and the standards will be established to be used as secondary drugs within the scope of permission for Daptomycin. Detailed criteria for recognition should include nursing benefits if administration fails to administer Vancomycin or Teicoplanin to Staphylococcus aureus, which includes endocarditis by Meticillin-resistant strains, or if they cannot be administered due to side effects of both drugs. ◆Ultomiris= Adult PNH Treatment Ultomiris is scheduled to be registered on June 7, and the standards will be established by referring to the existing PNH Treatment Standards. PNH in adults is a disease in which hemolysis and blood clots occur in blood vessels due to acquired abnormalities of hematopoietic stem cells and damage to organs in the body, such as kidney function abnormalities. The benefit will be recognized within the scope of permission, and the patient will have to pay the full price of the medicine. Because it increases sensitivity to major meningococcal infections, all patients must be given a meningococcal vaccine at least two weeks before administration, and re-vaccinated in accordance with the latest vaccination guidelines. However, if the drug needs to be administered immediately, the meningococcal vaccine will be administered at the same time and antibiotics can be treated at the same time. Details of the procedures, methods, and composition of the committee for the pre-approval of the drug were determined by the director of the HIRA, and matters requiring medical judgment in the pre-approval of the drug were subject to the committee's decision. The MOHW has decided to confirm the revision after a review of opinions by the 25th..
- Policy
- Janssen's Sporanox is also expected to convert to imports
- by Lee, Tak-Sun Jun 22, 2021 05:50am
- Janssen Korea, which has decided to operate its Hyangnam plant by this year, will also import the antifungal drug "Sporanox (Itraconazole)." As a result, co-marketing with Yuhan is expected to end. According to industries on the 21st, Janssen's Sporanox Cap is going to convert its imports by changing its license at the end of June. Sporanox has long led the market as an oral antifungal drug licensed in 1989. However, other ingredients such as fluconazole have advanced, and other products have recently been in the spotlight, recording ₩3.4 billion in sales based on UBIST last year. In 2008, Janssen and Yuhan signed a co-marketing contract, and Janssen decided to supply the same ingredient of "Lyposil Cap" to Yuhan. Although Sporanox Cap and Lyposil Cap were produced at the Hyangnam plant, co-marketing with Lyposil Cap is expected to end with the import of Sporanox Cap. Lyposil Cap had a small percentage of sales among Yuhan products. Based on UBIST, Rx amount was only ₩7.49 million. As Janssen decided to operate its Hyangnam plant until this year, many products, including Invega ER, Topamax Springkle Cap, Junista SR, Concerta OROSER, and Ultracet, have been converted to imports so far. Now only a few items such as Tylenol and Ultracet ER are being manufactured, but these items will also be converted to technology transfers or imports by the end of the year to change their permits. Established as a production hub plant in Asia-Pacific in 1983, Janssen's Hyangnam Plant has been supplying major products such as Tylenol. Whanin acquired Hyangnam Plant in November last year for about ₩46 billion.
- Policy
- Quality issues alarmed the pharmaceutical industry
- by Jun 22, 2021 05:50am
- Recent cases of GMP violations by Korean pharmaceutical companies have served as an opportunity to guard against risks throughout the industry. In addition, there are opinions that it should be improved in the wake of this incident. Until now, actual changes in standards for GMP have been sluggish according to global level. Only a few companies aiming to expand overseas have voluntarily attempted to improve. Looking at the recent cases, most small and medium-sized companies have been commissioned to produce pharmaceutical drugs to the domestic market, but even large companies, which are consignment companies, cannot avoid responsibility. The consignee lacked quality control, and the trustee had to meet the customer's needs. What efforts are being made in the industry? Dailypharm held the 42nd Future Forum under the theme of 'KGMP Ethics and Compliance! How to Lead' on the 16th and listened to industry opinions. Professor Lee Jae-hyun of Sungkyunkwan University is the head of the group, Lee Sam-soo, CEO of Boryung, Chung Myung-hoon, deputy director of the MFDS' drug quality management department, and Kim Eun-young, CEO of Waters Korea, attended the panel to express their opinions. From the left, Lee Jae-hyun, professor at SKKU, Lee Sam-soo, CEO of Boryㅕng, Chung Myung-hoon, director of the MFDS, and Kim Eun-young, CEO of Waters Korea Labor shortages, lack of technology, and lack of awareness are the causes of the situation CEO Lee Sam-soo analyzed that both environmental and technical factors played a role in the frequent occurrence of drug quality problems. According to him, there were 477 pharmaceutical manufacturers in South Korea as of 2019, and each manufacturer produced ₩49.9 billion. Among them, the average of the bottom 80% is only ₩189 billion. More than 100 finished drugs are owned per company. There was a huge shortage of manpower per plant. There are about 500 factory managers that should be mandatory, and 500 QM and manufacturing managers are also needed. The generic licensing process is also easier than that of advanced countries. CEO Lee said, "In the U.S. and Europe, generics should also have all CTD (Common Technical Document) formats, but in Korea, drugs for data-based re-evaluation are only required." There was a lack of research on quality factors or processes to be considered from the product design stage, consideration of subtle changes that occur while scaling up, and reflection of changes in pharmaceuticals, standards, and equipment. "Let's restore confidence in pharmaceuticals." No matter how important quality management is, it is useless without the will of management. Therefore, the new Drug Quality Management Innovation TF, which was established at the KPBMA, is noteworthy. The TF will be joined by Lee Sam-soo, CEO of Boryung, Kwon Ki-beom, vice-chairman of Dongkoo, Ildong's CEO Yoon Woong-seop, and Huons Global vice-chairman Yoon Sung-tae, and Hee-mok Won, chairman of the KPBMA. The team is based on owners and representative directors who can make decisions. The main role of TF is to identify each company's permission and cases of non-compliance with GMP, analyze the causes, and present solutions. It will also find matters that need to be improved. It also has a working group of TF that focuses on GMP experts from 15 businesses such as factory manager, QM manager, and research institute head. They listen to the field's opinions and share their opinions with the MFDS. Industries are actively supporting amendments to 1+3 Pharmaceutical Act by actually operating TF. The industry agreed with the MFDS that the introduction of Quality by Design (QbD) and data integrity should be emphasized to improve quality control. The purpose of the TF is to achieve various education, meetings, information sharing, and system improvement to realize these goals. CEO Lee said, "We intend to expand human resources education by opening online seminars and curricula of the association, visit each other among manufacturing plants, and share data." "We will also achieve quantitative and qualitative improvements by supplementing QA/QC personnel and supporting regular training." In order to spread the introduction of QbD, it should be accompanied by support measures. QbD, the industry believes that carrot-and-stick policies are needed to achieve a common goal of data completeness. CEO Lee said, "QbD is key to both risk assessment and statistics, and in order to become a smart factory, auxiliary tools such as PAT must be applied together." Real-time analysis does not follow simply by doing QbD. "It will cost tens of billions of won to install analysis equipment and sensors for auxiliary tools, so it will not be easy to introduce unless it is a blockbuster item." As a result, industries are strengthening regulations on quality management while also requesting support measures. It applies tax benefits for facilities/equipment necessary for QbD or data completeness, rapid review of related items, and preferential treatment of drug prices. "We will discuss with innovative TFs and actively consider operating a developmental GMP system," said Chung Myung-hoon, an official who attended as a representative of the MFDS. "We will listen to various opinions such as difficulties of small and medium-sized companies so that we can actively improve the constitution of the industry."
