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- 2025-12-24 19:51:36
- Policy
- New reimbursed price for Imfinzi, Venclaxta and Blincyto
- by Kim, Jung-Ju Mar 20, 2020 06:25am
- From next month, health insurance reimbursement would be granted on AstraZeneca Korea’s locally advanced non-small cell lung cancer (NSCLC) treatment Imfinzi (durvalumab) and AbbVie Korea’s chronic lymphocytic leukemia (CLL) treatment Venclaxta (venetoclax). Two treatments have accepted risk sharing agreement (RSA) terms set down on the negotiation table by Korea’s National Health Insurance Service (NHIS). Amgen’s leukemia treatment Blincyto (blinatumomab) would lower its price by four percent considering the financial impact for increased reimbursed use with expanded indication. According to pharmaceutical industry, Ministry of Health and Welfare (MOHW) is planning to revise the ‘List of Reimbursed Drugs and Maximum Reimbursed Price’ with the said changes. The revision would come in effect from Apr. 1. ◆Imfinzi: The immunotherapy has been approved to treat unresectable, locally advanced NSCLC patients with no progression after platinum-based concurrent chemoradiation therapy (CCRT). The company has submitted an application to Health Insurance Review and Assessment Service (HIRA) for reimbursement listing on Dec. 21, 2018, immediately after receiving an approval from Ministry of Food and Drug Safety (MFDS) in the same month. At a Cancer Deliberation Committee meeting convened in early November last year, HIRA has decided it would be feasible to provide reimbursement on the drug. The committee’s decision was based on clinical study proven clinical efficacy improved than placebo, and also the committee judged its cost-effectiveness would accept ICER value better than the placebo. The refund and expenditure cap type RSA, proposed by the company, was at an acceptable level. The refund type and expenditure cap type of RSA stipulate the applicant company to pay back a set amount of drug reimbursement claim to National Health Insurance Service (NHIS), and to return a certain ratio of the claimed amount exceeding the expected cap. The drug negotiated drug pricing with NHIS from then on to last month As a result, the reimbursed price of the drug would be at 3,350,930 won per 0.5 g and 804,223 won per 0.12 g. ◆Venclaxta: Venetoclax is an orally administered anticancer treatment used to treat CLL as third or later-line treatment, and it is approved as a monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been treated with chemo-immunotherapy and B cell receptor inhibitor, previously. From last May last year, the pharmaceutical company has submitted a reimbursement application to HIRA, immediately after MFDS’ green light, and received a nod from Drug Reimbursement Evaluation Committee (DREC) in last December. DREC official said the treatment has demonstrated clinical efficacy and is eligible for pharmacoeconomic evaluation (PE)-exemption track. The three PE-exemption track qualifications include; an anticancer used for treating life-threatening disease with no alternative option at the same level of treatment; a treatment approved by MFDS based on single-group clinical data without placebo and has difficulty producing evidential data with limited number of patients; a treatment listed for reimbursement in at least three countries out of the seven countries the committee has chosen to refer their adjusted average values. A drug can qualify for the PE-exemption track after qualifying all three conditions. Then after, the company has successfully reached an agreement with NHIS last month on pricing negotiation under the expenditure cap type RSA. The reimbursed price would be at 4,469 won per 10 mg, 22,341 won per 50 mg, and 44,682 won per 100 mg. ◆Blincyto: The anticancer treatment has been approved to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive or negative immature B cell acute lymphoblastic leukemia (ALL). From October 2016, the treatment has been provided with reimbursement in Korea for patients at age over 18. The company has applied for expanded reimbursement to HIRA in February last year, after expanding its indication to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive acute ALL in January last year. At the June meeting convened last year, Cancer Deliberation Committee said selective reimbursement would be granted for remission consolidation therapy to reduce non-reimbursed criteria. The treatment already has essential coverage on its remission induction therapy indication. Its expanded reimbursement was finalized by Drug Reimbursement Evaluation Committee (DREC) in last December. DREC’s decision was based on the treatment’s clinical efficacy and its cost-effectiveness qualification for PE-exemption track for the expanded reimbursement. In this month, the company has finally reached an agreement on negotiated pricing with NHIS. The key was to lower the price by four percent to lessen the financial impact. The negotiated price was decided at 2,346,000 won, reduced from the original price of 2,442,800 won.
- Policy
- Antiepileptic drug Fycompa may face follow-on drugs soon
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- Antiepileptic drug Fycompa Drugs using same substance as Eisai’s Fycompa film coated tablet, used to treat patients with partial-onset seizure, is preparing for a market release. Myung In Pharm and Whan In Pharm recently requested for negative scope confirmation on Fycompa’s crystalline form patent (to be expired on Oct. 14, 2026) to evade infringement. As the prescription volume of Fycompa has been steadily increasing, follow-on drug manufacturers are keeping a close eye on the legal proceeding. According to pharmaceutical sources on Mar. 18, Myung In has requested for a negative scope confirmation on Fycompa’s patent on Feb. 28, followed by Whan In on Mar. 13. Myung In and Whan In, prominent in the Korean central nervous system (CNS) market, are seemingly preparing for the first generic of Fycompa. However, a follow-on drug would have to wait more than three years or so to fully commercialize the drugs as Fycompa still has ongoing post-marketing surveillance (PMS) and substance patent in effect. Fycompa is a non-competitive α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) glutamate receptor antagonist. It has been approved by Ministry of Food and Drug Safety as a new mechanism to treat epilepsy but it is a subject for PMS for six years. During the PMS period, approval application from a latecomer drugs are rejected. Fycompa’s PMS period is to end on July 9 next year. For Myung In and Whan In to receive preferential sales approval for an exclusively launched generic, it would be more advantageous for them to apply for it after July 10 next year. But even after its approval, the follow-on drug would face the barrier of substance patent. The patent is to expire on Oct. 13 2023. Myng In and Whan In have challenged the crystalline form patent, but they have not taken any action on the actual substance patent. The U.S. Food and Drug Administration (FDA) has approved Fycompa in 2017 as a monotherapy for treating partial-onset seizures with or without secondarily generalized seizures in people with epilepsy aged four and older. According to UBIST, the treatment’s outpatient prescription volume, started at around 2 billion won in 2017, has been growing up to 2.7 billion won and 3.4 billion won in 2018 and 2019, respectively. The industry sees that this once-daily treatment has potential to grow further with medication convenience for the patients, which is why the two Korean companies are assertively challenging the original.
- Policy
- Boryung’s imported quadrivalent vaccine gets greenlit
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- After receiving an approval on imported quadrivalent influenza vaccine, Boryung Biopharma now owns three manufactured or imported vaccine items. Sources predict the Korean company would choose an item to launch and its quantity based on the purchase price. On Mar. 16, Ministry of Food and Drug Safety (MFDS) granted an approval on Boryung Biopharma’s quadrivalent influenza vaccine Afluria prefilled syringe. The vaccine is used on people aged over five years to adults for prevention of influenza virus type A and influenza virus type B infection. The quadrivalent vaccine targets two type A viruses and two type B viruses. It prevents one more type of viruses than the existing trivalent vaccines. So far, MFDS has approved 11 quadrivalent vaccines from nine companies including SK Bioscience, GC Pharma, GlaxoSmithKline (GSK), Sanofi Pasteur, Boryung Biopharma, Korea Vaccine, Ilyang Pharmaceutical and Dong-A ST. And among them, two are imported complete vaccines—Fluarix Tetra by GSK and Vaxigrip Tetra by Sanofi Pasteur. The newly approved Afluria is an imported complete vaccine Boryung Biopharma, which is manufactured by Seqirus, an Australian-based biotechnology company CSL Limited’s subsidiary. Boryung Biopharma also manufactures other quadrivalent influenza vaccines, such as Boryung V Tetra Vaccine and Boryung VII Tetra Vaccine. The company brings the source solutions from GC Pharma and Sanofi and fills the syringe with the vaccine at Jincheon plant. As a result, the Korean company owns total of three quadrivalent line-ups with two manufactured and one imported. The company official commented on Afluria and said, “The release date has not been set, yet. As we have some time left until the beginning of flu season in September, we would review the market situation thoroughly and decided on the release schedule.” The pharmaceutical industry predicts quadrivalent vaccine supply price could fluctuate with the heated competition in the market, and because the vaccine type is now a part of National Immunization Program (NIP) distributed through Public Procurement Service. Especially for Boryung Biopharma, the solution purchase price from GC Pharma and Sanoif could be affected depending on the related policy changes. Considering the prime cost of three approved vaccines, the Korean vaccine company is expected to enter the market with strategic price. According to IQVIA data, Boryung Biopharma’s quadrivalent vaccine sales volume from last year has reached 7.2 billion won. Currently, SK Bioscience and GC Pharma that manufacture both the solution and complete vaccine are topping the marketing by generating 13.1 billion won and 12.4 billion won, respectively. Whereas GSK importing the vaccines are closely tailing the two top companies by making 7.9 billion won. The quadrivalent vaccine market would have to see if Boryung Biopharma with competitive line-up would bring an impressive impact on the market with forthcoming pricing policy.
- Policy
- MFDS “All Korean and U.S. COVID-19 test kits use RT-PCR"
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- On Mar. 15, Korea’s Ministry of Food and Drug Safety (MFDS) has dismissed the news articles accusing Korea’s COVID-19 test kit is not even adequate for an emergency use, citing the U.S. Food and Drug Administration’s (FDA) review. According to earlier news reports by a number of Korean media, Rep. Mark Green has reportedly claimed during a congressional hearing that the test kit from Korea is unreliable by citing the U.S. FDA would not approve of using the kit in the U.S. Regarding the issue, MFDS confirmed the antibody test kit referred by the news article is not the kit the Korean health authority has cleared for emergency. The ministry official also elaborated the four emergency test kits approved by the U.S. FDA are also using the same reverse transcription polymerase chain reaction (RT-PCR) technique as the Korean kits. MFDS official stressed, “All five COVID-19 test kits approved for emergency in Korea use real-time RT-PCR technique that MFDS and Korea Centers for Disease Control and Prevention (KCDC) have verified. The Korean Society for Laboratory Medicine is continuously monitoring the accuracy of those kits, and we have not received any reports of an inaccurate diagnosis to this date.”
- Policy
- All traveler record accessible via DUR from Mar. 18
- by Lee, Hye-Kyung Mar 18, 2020 06:37am
- From 2 p.m., Mar. 18, information of all travelers entering Korea would be provided to healthcare providers via Drug Utilization Review (DUR) system and International Traveler Information System (ITS). Health Insurance Review and Assessment Service (HIRA) has been providing real-time information of travelers from China, Italy, Iran, Singapore, Japan, Thailand, Vietnam, Taiwan, Malaysia, France, Germany, Spain, the U.K., the Netherlands, Hong Kong, Macao, where COVID-19 has spread, and those who came in contact with confirmed cases through DUR system. However, as the outbreak has been spreading throughout the world, the Central Disaster and Safety Countermeasures Headquarters (CDSCH) has announced on Mar. 17, “Starting from Mar. 19, all travelers entering Korea from overseas would undergo special immigration procedure.” Accordingly, HIRA is also expanding its server to provide all inbound travelers’ information to healthcare providers using ITS. The traveler’s information would be disclosed on a real-time pop-up window in the DUR system, accessible to hospital, clinic, and pharmacy, as a part of the page with information regarding healthcare institute registration, medical counseling, and pharmaceutical prescription and dispense. To confirm the DUR system properly working and providing travelers’ information, a healthcare institute’s registration desk could type in test name and registration number on the National Health Insurance reimbursement billing software and check the pop-up window. Doctors can also access the information by inputting test name and registration number on the page for diagnosis and prescription, which would appear on a pop-up window when running DUR system. Pharmacists can input the test name and registration number on the dispensing software and check pop-up window when running the DUR system. Healthcare institutes, without an installed ITS, may download an update patch (‘Infectious Disease Related ITS version July 1, 2019’) available on HIRA Healthcare Institute Business Portal website (https://biz.hira.or.kr) under ‘Monitoring’ category.
- Policy
- Ranexa by Menarini was approved in Korea
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- 'Ranexa', a new treatment for cardiovascular disease, has approved Ranexa is a Ranolazine-based drug that was approved by the US FDA in January 2006. The MFDS approved Menarini Korea's 'Ranexa' (Ranolazine) as a new drug to treat angina. Ranexa is a drug developed by CV Therapeutics, which was acquired by Gilead, and Menarini owns domestic rights. Ranexa attracted attention as an angina pectoris drug that was released over 20 years after the US FDA approval in January 2006. The mechanism of action of Ranolazine, the main component of the drug, is known to exhibit antianginal effects through inhibition of late sodium influx from heart cells. Currently, the primary treatment for angina pectoris is a beta-blocker or calcium antagonist (CCB), which is also used as a drug for hypertension. Ranexa is licensed as a combination therapy for symptomatic treatment of stable angina patients who are not adequately controlled or intolerant to primary angina treatment. In clinical trials, it was confirmed that the combination effect was high. In the core trial CARISA, Ranexa was added to the treatment of Atenolol 50 mg once a day, Amlodipine 5 mg once a day, or Diltiazem 180 mg once a day. 823 patients (23% of women) were randomized to receive Ranexa 750 mg twice a day, Ranexa 1000 mg twice a day, or placebo for 12 weeks. As a result, when the drug was used as an additional therapy, it was proved that it showed excellent efficacy in terms of prolonging exercise time after 12 weeks at both doses of Ranexa (Ranolazine) compared to placebo. Compared to placebo, the number of angina attacks per week and the amount of fast-acting Nitroglycerin was significantly reduced for one week. The ERICA test (565 subjects) added to Amlodipine 10mg once daily treatment also significantly reduced the number of angina attacks and fast-acting Nitroglycerin use for one week compared to placebo. Angina is acute pain or pain during exercise or activity. Atherosclerosis or atherosclerotic lesions are the causes. In Korea, there are data on the NHIS which has 645,000 patients as of 2017. The total medical expenditure spent on angina treatment was also very low at ￦771 billion in 2017. As a result, it is expected that it will be booming as new drugs have appeared in the domestic market after a long time. As of 2018, Ranexa's worldwide sales amounted to $ 760 million (about ￦915 billion).
- Policy
- Avigan is not imported for COVID-19
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- AviganIt was found that the health authorities decided not to import special cases of 'Avigan' (Favipiravir), a new H1N1 flu treatment used in Japan as a treatment for COVID-19. This is because there is not enough clinical evidence to use COVID-19 as a treatment. It is said that the KCDC did not make any special requests to the MFDS to decide on special import through the emergency introduction system. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee on Avigan's import exceptions concluded that Avigan'streatment efficacy base for COVID-19 is insufficient. Avigan is a drug developed by Fujifilm Toyama Chemicals, a subsidiary of Fujifilm in Japan, and is an antiviral agent with a mechanism to suppress RNA virus proliferation. In Japan, it has been approved for use when Tamiflu is not effective against influenza viruses. However, it has not yet received an item license in Korea. Lee Eui-kyung, the Minister of Food and Drug Safety, has been spotlighted on the 25th of last month by saying she was considering a special plan for imports from Avigan. In Japan, it is currently recommended for worsening symptoms in mild patients for COVID-19. However, the World Health Organization (WHO) is not raising Avigan as a candidate for clinical trials of COVID-19. It is known that the Central Pharmaceutical Affairs Review Committee also concluded that the efficacy data for COVID-19 patients is insufficient, and that it is negative for domestic patients because of the risk of side effects such as fetal toxicity. Officials from the MFDS said that drugs that have not obtained domestic permission can be imported through the emergency introduction system, but to use the emergency introduction system, the KCDC must make a request through Central Pharmaceutical Affairs Review Committee. However, there was no such request from the KCDC. He said, "Even if Avigan is not imported, the stock of domestic COVID-19 treatment is sufficient." Currently, in Korea, patients with COVID-19 are using HIV treatment, Kaletra (Lopinavir/Ritonavir), and an anti-malarial drug, Hydroxychloroquine, In addition, clinical trials of Gilead's antiviral drug 'Remdesivir' have been approved, and it has also begun to be administered to domestic patients.
- Policy
- Would HIRA disclose DREC review result to drug industry?
- by Lee, Hye-Kyung Mar 18, 2020 06:34am
- Health Insurance Review and Assessment Service (HIRA) is contemplating on expanding the scope of disclosure regarding the Drug Reimbursement Evaluation Committee (DREC) deliberation. The contemplation would focus on whether or not to extend details of the deliberation to pharmaceutical companies after sufficiently reflecting their opinion as a stakeholder. And the government agency would ponder on including pharmacoeconomic evaluation result and the time taken from application submission to DREC deliberation within the disclosed information. In 2017, HIRA decided to disclose the DREC deliberation result to a selected news media, but now the agency disseminates a press release to news media first, and posts the information on its website. However, the industry has been criticizing the provided information as it has been limited to reviewed item’s name, company, benefit and effect, and final review outcome. HIRA official said, “The government agency would reflect various stakeholders’ opinions on the scope of provided information of DREC deliberation. We would set down a number of proposals.” On June 9, 2017, HIRA unveiled the DREC review outcomes to news media for the first time. A day after the new drug reimbursement feasibility was reviewed in the sixth DREC meeting of the year on June 8, 2017, HIRA distributed the result fast to news media that requested the information. A decade after forming DREC, the agency broke the non-disclosure principle of DREC review. DREC was established under HIRA a year after the positive listing system was implemented in December 2006. The committee evaluates new drugs’ adequacy of insurance reimbursement based on clinical efficacy, cost-efficiency, listing status in foreign country, necessity in treatment, reimbursed drug and financial status of National Health Insurance. The latest DREC deliberation result disclosed on HIRA website as press release on Mar. 6. The provided information only includes the name of reviewed item and pharmaceutical company, the drug’s effect and reimbursement feasibility review result. After moving the headquarters to Wonju, HIRA has been convening DREC meeting on first Thursday of every month. The government agency reports the meeting’s result to the president of HIRA, and the agency disseminates press release on the day after. When the committee’s deliberation result was unveiled for the first time, the same criticism on the insufficient scope of provided information was raised. The current reimbursement listing procedure requires HIRA’s Pharmacoeconomic Evaluation Subcommittee and DREC reimbursement feasibility review first, and Health Insurance Policy Deliberation Committee’s (HIPDC) final decision followed by National Health Insurance Service’ (NHIS) pricing negotiation. HIRA would likely to ponder on the issue considerably as it would pressure NHIS if a DREC-reviewed item with detailed information disclosed fails to pass the pricing negotiation stage.
- Policy
- The NHIS recalculates ￦2 billion refund for pharmaceuticals
- by Lee, Hye-Kyung Mar 17, 2020 06:29am
- The NHIS has taken corrective action to settle the refund amount of the refund-type risk sharing agreement (RSA) through an internal audit. In the case of RSA drugs that have a 'double drug price' that differs from the drug price and the actual selling price, the NHIS notifies the pharmaceutical company of the payment of the medical institution's claims. If RSA drugs are administered within the scope of the reimbursed standard, the patient pays only 5%(co-payment), and the pharmaceuticals must return the drug cost corresponding to the refund rate to the NHIS. If RSA drugs are administered outside the scope of the reimbursed standard, the patient pays the full amount of the drug first, and the pharmaceutical company refunds cash directly to the patient based on the data from the NHIS. In the process, it was revealed that the amount of the difference of about ￦2 billion was generated by the NHIS overestimating or underestimating some RSA drug refunds from January 1 to December 31 of last year. According to the 'Annual Audit Report for 2019' released by the NHIS recently to Alio, corrective action was taken by not properly managing the drug cost after management, such as neglecting notice of drug refunds to pharmaceutical companies through internal audits. In particular, fiscal dispositions such as the settlement of over ￦2 billion was refunded by companies that had been excessively and under-reimbursed. Meanwhile, the Audit Office of the NHIS conducted a total of 134 times, including comprehensive and planned audits, to request ￦21.6 billion of financial measures, including 2588 administrative and identification measures such as improvement, recommendation, and notification, and post-management of other collection deficit management (recovery).
- Policy
- The MFDS encourages production of KF80 masks
- by Lee, Tak-Sun Mar 16, 2020 06:29am
- In order to encourage the KF80 standard health mask to be produced, the MFDS decided to temporarily grant permission to change items that are currently approved under the KF94 standard to KF80. It is judged that the KF80 has less filter requirements than the KF94, which can lead to an increase in mask production. However, there is criticism that the MFDS recommended KF94 to block the virus in the early days of the COVID-19 epidemic, but as the demand for masks increased, KF80 and cotton masks could also be used, causing confusion in the mask supply and demand policy. The Ministry of Food and Drug Safety prepared a rapid approval plan for health masks according to the COVID-19 pandemic, and informed the first-line manufacturers (importers) on the 9th . The main contents of the rapid approval plan are ▲ temporary permission to change the new filter ▲ temporary permission to change the final mask for health ▲ rapid approval of the imported health mask. First, it is possible to change the filter standard of the health mask. Currently, the filter is a core ingredient of the health mask, and as a rule, it is permitted as a new item when the filter is changed. However, However, filters for air conditioners and air purifiers can be used for health masks temporarily. KF94 standard health masks are also permitted to change permission to KF80 temporarily. Currently, it is classified as KF80, KF94, and KF99 and is permitted as a separate item. Changing the KF94 mask that has already been approved to KF80 will have different efficacy effects, standards and test methods. The efficacy and effectiveness of KF94 is 'protecting the respiratory tract from particulate harmful substances such as yellow dust and fine dust and infectious agents', but if it is changed to KF80, there is no 'effectiveness and effectiveness' of 'protecting the respiratory system from infectious sources'. In addition, dust collection efficiency is changed from 94% to 80%. An industry insider said, "Change from KF94 to KF80 can reduce the filter requirement by 30%". Imported health masks are also quickly approved. It is a policy that permits prompt approval if imported mask raw materials and all product standards are equal to or higher than the Ministry of Food and Drug Safety's notice or guidelines. In the case of test reports, foreign test reports were also accepted. It is said that the US N95, the European FFP2, and the KN95 in China are more than the equivalent of the health mask standards in Korea. This measure will be temporarily operated until the effective date of emergency supplies and demands for masks and hand sanitizers. In the situation where the supply and demand of health masks is not smooth, it is interpreted as a way to increase production. When President Moon visited the mask maker on the 6th, Choi Kyu-bok, CEO of Yuhan-Kimberly, suggested that “the filter requirement for KF94 is 20-30% higher than that of KF80. If it is mainly produced in KF80, it will reduce the amount of filter shortage”. President Moon also said it was a "very good plan". However, there is a criticism that the countermeasure against this was that the Ministry of Food and Drug Safety recommended a health mask of KF94 or higher in the early days of the Corona 19 epidemic to prevent viruses, and recently changed to KF80 and cotton mask. The Ministry of Food and Drug Safety recommended in the end of January that "KF94" and "KF99" masks are recommended to prevent infections such as new coronavirus". However, on the 12th, if there were respiratory symptoms such as coughing, or if a healthy person cares for a suspicious person, a visitor to a medical institution and a worker in the occupational group at high risk of infection and transmission recommended a health mask of KF80 or higher. On the 3rd of this month, the use of cotton masks is also helpful when there is no high risk of infection or there is no health mask. According to the initial recommendations from the MFDS, manufacturers were more immersed in the production of KF94 masks in high demand, leading to a shortage of KF80 masks. Recently, it has been reported that a reversal phenomenon in which the price of the KF80 mask is more expensive than the KF94 mask is also occurring. Meanwhile, the KF80 mask can block more than 80% of fine particles with an average size of 0.6 μm, and the KF94 and KF99 masks can block more than 94% and 99% of particles with an average size of 0.4 μm, respectively. KF stands for Korea Filter, and the number after it means particle blocking performance.
