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- 2025-12-22 04:24:55
- Policy
- Generic for Dukarb to be released next month
- by Lee, Tak-Sun Jan 18, 2023 06:04am
- DukarbGeneric for Dukarb, a compound combined with Amlodipine in the new hypertension drug Kanarb developed by Boryung pharmaceutical, is expected to release in time for the expiration of the patent next month. Eight items from four companies approved last month will go to the market first, and they will be calculated at 53.55% of the initial price of every single ingredient. Among the same ingredient products approved this month, consignment items will be 15% cheaper depending on the standard requirements, and salary registration is expected to be possible only in March. According to industries on the 17th, as generics for Dukarb, which was approved in December last month, applied for benefits, the salary is expected to be applied from February 2, the day after the patent expires. Items licensed in December last month are Dunarb 30/2.5mg, Dunarb 60/2.5mg, Fimadipine 30/2.5mg, Fimadipine 60/2.5mg, Hana Pharmaceutical Fimaone-S 30/2.5mg, Fimaone-S 60/2.5mg, Aliko Pharmaceutical Ardewka 30/2.5mg, and Ardewa. All of these products are produced on consignment by Alico Pharmaceutical, and since they applied for drug prices in the same month, they are all considered data-submitted drugs, and the upper limit is expected to be 53.55% of the first price of a single ingredient. The original Dunarb, which was added as an innovative pharmaceutical company, is also expected to go down at the same price. Dunarb's first generic is different from amlodipine. The original Dunarb is Amlodipine Besylate, whereas the late drugs are S-Amlodipine Besylate 2.5. Since it is not the same ingredient as Dunarb, the drug price is calculated at the highest price according to the drug price standard. However, the drug price of the product approved in January is different. Products licensed in January are also 2.5 mg of S-Amlodipine Besylate, which are considered generics of the four products listed first, and consigned items without direct BA will be 15% cheaper as the standard requirements are applied. Of course, entrusted items with direct BA and DMF requirements are expected to be equally calculated at 53.55%. There was a difference in drug prices depending on the time of approval. None of the items released this time have the same active ingredients and content as Dukarb 30/5mg. This is because Dukarb 30/5mg is registered separately as a patent, and the composition patent lasts until August 8, 2031. Late pharmaceutical companies filed a passive trial to confirm the scope of rights to avoid the patent, but it was rejected in March last year. As a result, an appeal is currently underway in the Patent Court. Due to the failure of patent avoidance, the license of the capacity item is being delayed. Since Dukarb 30/5mg is the flagship capacity of about half of the market along with Dukarb 60/5mg, generic pharmaceutical companies are expressing regret over the failure of the first trial to evade patents. In addition to the approved generics, Fimasartan salt change generics are also reportedly preparing for approval.
- Policy
- MOHW-NECA issues notice on colorimetric assay
- by Kim, Jung-Ju Jan 18, 2023 06:04am
- The National Evidence-based healthcare Collaborating Agency (President: Kwang Hyub Han) announced the amendments to the notice on the new health technology, ‘colorimetric assay’ for anti-Xa apixaban testing, that had been deliberated as a safe and effective health technology at the 10th MOHW New Health Technology Assessment Committee meeting in 2022. The New Health Technology Assessment system was introduced in 2007 to assess the safety and clinical efficacy of new health technologies (acts of medical practice including treatment method, and testing method), and is implemented to prevent indiscriminate use of unverified medical technology and to protect the people's right to health. The anti-Xa apixaban assay technology, the ‘colorimetric assay, ‘is a test that quantifies the concentration of apixaban in plasma samples through colorimetric assay for patients that were administered apixaban and require monitoring for apixaban concentration. As it is safe as an in vitro test that uses patient samples and is recommended as a test to monitor the concentration of apixaban in patients that are administered apixaban when clinically necessary in textbooks and guidelines, the technology was determined to be a valid technique with an acceptable level of correlation to the current standard test method, liquid chromatography-tandem mass spectrometry. Meanwhile, the results of the new Health Technology Assessment were notified under Article 53-3 of the Medical Service Act and Article 4 of the Rules on New Health Technology Assessment and may be found on the MOHW and NECA’s Center for New Health Technology Assessment website.
- Policy
- Dupxient deemed adequate for reimb in children with AD
- by Lee, Tak-Sun Jan 13, 2023 06:01am
- The atopic dermatitis treatment ‘Dupixent’ was deemed adequate for reimbursement in children and adolescents. Therefore, attention is now focused on whether Dupixent will become the first biological agent to be reimbursed for atopic dermatitis in children and adolescents. The Health Insurance Review and Assessment Service announced that it had passed the agenda at the first 2023 Drug Reimbursement Evaluation Committee (DREC) meeting that had been held on the 12th. At the meeting, DREC concluded that Sanofi-Aventis Korea’s ‘Dupixent Prefilled Inj. 200, 300mg (dupilumab, genetical recombination)’ was appropriate for reimbursement in treating 'atopic dermatitis in children and adolescents.' With the drug passing HIRA's stage, pediatric and adolescent atopic dermatitis patients will be able to receive reimbursement after the company completes drug pricing negotiations with the National Health Insurance Service. In Korea, Dupixent is reimbursed for adult patients with atopic dermatitis since January 2020.
- Policy
- Lee Jong-sung, who pointed out Moon Care
- by Lee, Jeong-Hwan Jan 13, 2023 06:01am
- Lee Jong-sung, a member of the National Assembly's Health and Welfare Committee, pointed out that Moon Jae In Care's health insurance coverage rate has fallen and said he will take the lead in making policies for normalization. Rep. Lee Jong-sung posted this message on his social media on the 11th. Representative Lee criticized the failure of Moon Care conducted by the Democratic Party of Korea based on the results of the 2021 survey on health insurance patient medical expenses. Lawmaker Lee pointed out that the guaranteed rate fell last year compared to the previous year, and that it did not show a significant increase compared to before the implementation of Moon Care. In particular, Rep. Lee pointed out that Moon Care has increased the coverage rate of general hospitals or higher and the coverage rate of primary medical institutions at the clinic level has fallen by 4.1%p, confirming the concentration of higher hospitals. Rep. Lee said he would make efforts to normalize health insurance as a health and welfare committee member to solve the problem. Hee said, "The guaranteed rate in 2021 was 64.5%, down 0.8 percentage point from the previous year, and it rose only 1.8 percentage points compared to 2017," adding, "It is a natural lesson that even if you use your finances, you should not spend them wisely where you need them." Hee said, "I have continuously raised Moon Care issues such as the collapse of the medical delivery system, non-reimbursed balloon effect, and financial waste, including the concentration of upper-level hospitals," adding, "However, the Moon administration and the Democratic Party have been busy promoting a performance by hiding the health insurance budget deficit." In particular, the health insurance coverage rate for the disabled also decreased compared to last year. It must be improved, he said. "In the place where 20 trillion won in taxpayers' money was invested, only a poor report card remains." The Welfare Committee will also make efforts to establish a health insurance system for the weak in line with the Yoon Suk Yeoln government's stance on normalizing health insurance, he added.
- Policy
- Sama Pharm’s formoterol to receive clinical reevaluations
- by Lee, Hye-Kyung Jan 12, 2023 04:29am
- After the authorities issued a notice on conducting clinical reevaluations for the active ingredient formoterol fumarate, Sama Pharm, the only company that maintained its authorization for the ingredient, was found to have submitted a clinical trial protocol for its acute bronchitis indication among its 3 approved indications (bronchial asthma, acute bronchitis, asthmatic bronchitis). The Ministry of Food and Drug Safety ordered clinical reevaluations to be conducted for 16 tablet and syrup products that contain formoterol fumarate on December 23, 2020 and requested companies to submit their clinical trial protocols by March 31, 2021. However, all companies that own items other than the 3 items that were the first to receive marketing authorization in 1986 – Sama Pharm’s Atock Tab. Sama, and Sama Atock Tab. 20μg – have voluntarily withdrawn their licenses after the notice. According to the minutes of the advisory meeting of the Central Pharmaceutical Affairs Council that was recently disclosed by the MFDS, the CPAC approved the adequacy of Sama Pharm’s clinical trial protocol (its scope of effect·efficacy, trial period) but requested the company to submit data that adequately describes the basis for calculating the number of trial subjects. The minutes also showed that Sama Pharm first submitted clinical trial protocols for bronchial asthma and acute/chronic bronchitis but received administrative disposition for non-submission of supplementary materials, and then resubmitted a clinical trial protocol only for its acute bronchitis indication. Also, the company set the efficacy endpoint for the reevaluation as the 'improvement of wheezing,’ and the MFDS determined the endpoint reasonable in consideration of the pharmacological action of the active ingredient, the age of the test subjects, and expert advice from the Korean Academy of Tuberculosis and Respiratory Diseases. However, to address concerns about bias due to subjective judgment on the improvement of wheezing in the evaluation index, the CPAC ordered trial objectivity to be secured through a clinical trial design (placebo-controlled, double-blind). Regarding the validity of the scope of efficacy and effect verification in the clinical trial, one committee member pointed out, "As the trial will only prove efficacy and effectiveness in pediatric patients with acute bronchitis, its actual scope of use in the field will be different” Another member said, “The drug has been long used in the field, therefore, the drug is expected to be used for indications other than acute bronchitis even though the clinical trial is conducted only for acute bronchitis.” Meanwhile, the MFDS had recommended against the use of long-acting beta-agonists (LABAs) such as formoterol as monotherapy in asthma patients based on the US FDA’s analysis. The FDA had also issued such a guideline based on a study that showed that using LABA alone may increase the risk of exacerbation of severe asthma symptoms.
- Policy
- Take the burden off the hospital bills
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- The NHIS announced that it had expanded the scope of particular calculation for rare diseases and chronic kidney dialysis patients subject to particular calculation of health insurance from January 1 this year to ease the burden on the medically vulnerable. The expansion will significantly reduce the burden on patients by lowering the burden on them from 20% of hospitalization and 30% to 60% of outpatients to 10% of both hospitalization and outpatients. First of all, it is expected that about 4,000 people with the disease will benefit from medical expenses reduction as special calculation cases will be applied to 42 new rare diseases, including "polycystic kidney, common chromosome dominance." The NHIS has been working with the Korea Centers for Disease Control and Prevention, which manages rare diseases, to collect opinions from patient groups and experts, and has been reviewed and resolved by the Ministry of Health and Welfare and the Corporation. With this expansion, the number of rare diseases subject to the particular calculation will increase to 1,165. Accordingly, patients with new rare diseases will pay 10% of their own charges for treatment of diseases registered for particular calculation and complications with clear medical causality with the disease, and health insurance subscribers with a median income of less than 120% (less than 130% for children) can receive 10% of their own charges through the Korea Centers for Disease Control and Prevention. In addition, special cases for calculating patients with chronic renal failure apply to outpatient treatment on the day of dialysis and inpatient treatment related to the procedure. Previously, failure to receive dialysis on the same day due to unavoidable reasons such as blood vessel surgery or bleeding after hemodialysis may cause excessive dialysis or financial burden. Based on expert advice and medical evidence, the system has been improved to allow dialysis vascular procedures and surgery. The improvement of the system is expected to further benefit artificial kidney dialysis patients, who have not been subject to special cases due to failure to perform dialysis after vascular procedures and surgery for dialysis. Lee Sang-il, senior executive director of the corporation, said, "The NHIS will continue to work with related agencies such as the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention to strengthen essential medical coverage for the vulnerable by continuing to find and calculate rare and severe incurable diseases that require long-term treatment."
- Policy
- Erbitux deal is in renegotiation
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- MerckThe third Risk Sharing Agreement (RSA) contract for Erbitux, a treatment for metastatic direct bowel cancer and cranial cell cancer, is being prolonged. It is known that renegotiations have been underway since the first round of negotiations with the National Health Insurance Service broke down. Erbitux's second RSA contract period has ended as of June last year. According to the corporation and the industry on the 7th, Merck and the NHIS are negotiating for a third contract as Erbitux's renewal of RSA has ended. Erbitux signed its first RSA for Refund contract in 2014. And after four years of the contract, he succeeded in renewing his contract in 2018. It was the first case of renewal as an RSA drug. The renewal period ended in June last year, and negotiations have been underway for a third contract. The first round of negotiations broke down in August of that year, and it was found that renegotiations were currently underway after going through the HIRA Drug Benefit Evaluation Committee again. The renegotiation period is 60 days. As negotiations are currently underway, the effectiveness of the existing RSA contract is maintained. However, in the worst case, if the renewal fails, the burden on patients is expected to increase. Erbitux is currently supplied at an upper limit of 222,325 won per bottle. When a refund contract is signed, the pharmaceutical company will refund a certain percentage of the insurance claim to the NHIS. However, the refund rate is not known. Erbitux recorded sales of 42.4 billion won as of IQVIA 2021. Meanwhile, as of July 2022, a total of 60 RSA contracts were counted. Among them, 18 items were maintained to renew their contracts, 24 items were initially maintained, and 18 items were expired. RSA was introduced in 2014.
- Policy
- NHI coverage rate 64.5% in 2021...Fell 0.8% YOY
- by Lee, Tak-Sun Jan 11, 2023 05:59am
- The National Health Insurance Service announced that Korea’s health insurance coverage rate in 2021 had fallen slightly from the previous year to 64.5%. On the 10th, the NHIS announced so through the ‘NHI Patient Medical Expense Survey 2021’ report on the 10th In 2021, the NHI coverage rate decreased by 0.8%p YoY to record 64.5%, and the non-reimbursement burden rate increased by 0.4%p YoY to record 15.6%. The NHI coverage rate is calculated by dividing the insurer’s reimbursement expenses by the sum of the insurer’s reimbursement expenses, legal copayment amount, and non-reimbursed medical expenses. The total coverage rate in medical institutions has decreased due to decreased coverage rates in clinics despite the increased coverage in general or higher-level hospitals. The expanded scope of reimbursement for ultrasounds [chest (amended in April 2021), heart (Sep 2021)] and the reduced use of advanced hospital wards (single-bed ward) led to a 0.5%p increase in the coverage rate in general or higher-level hospitals to 69.1%. The coverage rate in clinic-level institutions fell 4.1%p due to the increase in the proportion of non-reimbursed medical services (+4.8%p) such as manual therapy (rehabilitation and physical therapy expense), and multifocal intraocular lenses for cataract surgery (treatment material). However, the coverage rate for severe and high-cost medical treatments has increased continuously. The coverage rate for the 4 major diseases was 84.0%(+0.1%p), and the coverage rate of the Top 30 severe and high-cost diseases (leukemia, pancreatic cancer, lymphoma, etc.) was 82.6% (+0.5%p), and Top 50 diseases (Top 30+dementia, pulmonary tuberculosis, etc.) was 80.3% (+0.2%p). The coverage rate of those that belong to the age group - ‘5 years or younger (71.0%),’ and ’65 years or older (70.3%)’ - was higher than other age groups. However, in the case of those in the ’65 years or older' group, their coverage rate in tertiary hospitals, general hospitals, and hospitals has increased, but their coverage rate in clinic-level institutions has fallen by 0.9%p from the previous year due to their increased use of manual therapy and multifocal intraocular lenses for cataract surgery, etc. By income level, the NHI coverage rate (including the effect of the copayment ceiling system) of those in the lower-income bracket was higher than that of those in the higher-income quintile group (as classified by quintile of health insurance premiums), and the effect of the copayment ceiling system was found to be greater in the lower-income quintile group.
- Policy
- “Will dvlp blockbusters and systemize non-F2F treatment”
- by Lee, Jeong-Hwan Jan 10, 2023 05:35am
- The government will reinforce R&D support in the pharmaceutical industry to develop 2 new global blockbuster drugs by 2027, by increasing public-private investments and expanding customized policy support. The government also selected the institutionalization of non-face-to-face treatment and increasing the admissions quota of medical schools as key policies required to reinforce essential healthcare, and expressed its will to promote the policies promptly through the operation of a permanent consultative body. On the 9th, the Ministry of Health and Welfare announced the above as part of its 2023 major task plan. ◆Full-fledged support to fostering the biohealth industry and exports=The MOHW will be preparing measures to train 110,000 manufacturing and research personnel by 2027 and lay the foundation for fostering the biohealth industry. Also, through the operation of the WHO training hub for mid to low-income countries, the authorities promote partnerships between vaccine and raw material companies in Korea and abroad to support overseas expansions of Korean companies. It will also promote a pre-entry/post-evaluation system through an integrated review system for innovative medical devices and extending deferment period for new health technology assessments, etc., and promote the expansion and commercialization of treatment opportunities for advanced regenerative medicine Also, a pan-ministerial governance body called the ‘Pharma-Bio Innovation Committee’ will be organized to provide efficient and borderless support ranging from basic R&D to commercialization. Biohealth exports will also be strategically supported. In Korea, biohealth exports have been growing 19.5% on average annually from USD 12.5 billion in 2017 to USD 25.4 billion in 2021. The Comprehensive Plan for Healthcare Exports contains measures to support the creation of 2 global blockbuster new drugs by 2027 and systematic measures for Korea to achieve the 5th place in medical device exports. To this end, a plan for the pharma-bio industry and the medical device industry will be established by January next year. More specifically, the authorities will public-private investments and reinforce customized support. This year, it will expand R&D by investing KRW 3.8 trillion in the pharmaceutical industry and KRW 1.6 trillion in the medical device industry. At the same time, the government will invest in the K-Bio vaccine fund in earnest and create an additional fund worth KRW 1 trillion by 2025. In line with the movement to strengthen licensing and regulations in major countries, the government will actively respond to protect Korea’s industry and implement strategic support by industry and region to develop new markets. ◆Strengthening welfare for the weak and essential healthcare= The MOHW will also operate a permanent consultative body to promptly implement policies including the systemization of non-face-to-face treatment and increasing the admissions quota of medical schools. In the mid-to-long term, the MOHW will present a comprehensive healthcare vision in consideration of its relation and consistency with various other policies, such as the reform of the healthcare delivery system. The healthcare development plan will be prepared by the second half of this year. Specifically, in order to expand essential healthcare, which was a topic of focus last year, the first stage will be to establish a reinforced system for severe, urgent, childbirth, and pediatric treatments. Also, the pediatric treatment support plan will further be supplemented by reflecting opinions from public hearings. In the second stage, MOHW will provide support for essential healthcare, in areas that have difficulty providing proper treatment due to lacking medical environment or a lack of professional manpower. In order to resolve the imbalance between regions and areas of treatments that remain, compensation in fields that lack supply will be strengthened, and public policy fees such as regional fees will continue to be developed. Also, eligibility for catastrophic medical expenses will be lowered, the amount raised, and applicable diseases expanded. ◆ Establishing health security and driving entry to new markets with advanced technology = The MOHW will also prepare for the rise of future pandemics and rare diseases by investing in new technologies in the bio sector. To prepare for infectious diseases, the government will localize essential vaccines that are import-dependent and also develop next-generation vaccines and treatments. By 2029, the MOHW will support KRW 215.1 billion to localize essential vaccines, support KRW 21 billion for the development of mRNA vaccines, and KRW 46.4 billion for the development of antivirals. To advance technology for disease control, prevention, and medical safety, the MOHW will invest KRW 85.7 billion by 2027, and KRW 28.8 billion by 2027 with the goal of developing non-face-to-face treatment technology for use in future pandemics. Also, it will prepare a 'Korean ARPA-H' that supports target-oriented strategic R&D tasks such as technologies for treating rare diseases to its success. In order to prepare for the transformation into a digital and data-oriented medical paradigm, the MOHW will develop the MyData service model as well as pioneer models for digital transformation such as smart hospitals, while operating transformation expansion support centers to provide customized support for the smartization of public-private hospitals.
- Policy
- ↑63% of the average annual SA bill
- by Lee, Tak-Sun Jan 10, 2023 05:33am
- Among ultra-high-priced drugs with an annual drug cost of more than 10 million won per patient, RSA contract drugs have increased significantly. It was confirmed that the claims for RSA drugs increased by an average of 62.6% per year. This fact was found in the "Research on the Performance Evaluation and Development Direction of RSA" conducted by the Industrial-Academic Cooperation Group of Seoul National University (Professor Lee Tae-jin), at the request of the NHIS. The results of this study were partially released on the 2nd through the management information disclosure system (Alio) of public institutions. The research team surveyed the cost of claiming risk-sharing drugs among high-priced drugs exceeding 10 million won per year from 2010 to 2021, and the number of RSA drugs increased from 31.9 billion won in 2014 to 959 billion won in 2021. The amount is equivalent to an average annual increase of 62.6%. RSA drugs accounted for 57% of the total 1.6927 trillion won in claims for expensive drugs in 2021. RSA emergency high-priced drugs increased only 4.9% annually from 50.8 billion won in 2014 to 65.8 billion won in 2021. The research team evaluated, "The RSA system seems to have provided new opportunities for high-priced drugs." In the meantime, he suggested financial management measures for expensive drugs that need to check the RSA system and evaluate the performance of the financial-based types, Refund type, and Expenditure Cap type. However, the research team added, "One-shot treatments, which have recently received great attention, are not included in this analysis, so we propose additional analysis including one-shot treatments in the future, and in the long run, it is necessary to establish a high-priced financial monitoring system based on this data extraction and analysis." The research team also said that it is necessary to prepare financial management measures for RSA non-emergency drugs. The research team explained, "Among non-RSA drugs, anti-cancer drugs are not expensive, and hemophilia drugs and enzyme drugs are high," adding, "Hemophilia drugs are worth 200 billion won in 2021, and enzyme drugs are worth 100 billion won, which has steadily increased." "Unlike RSA drugs, where financial uncertainty is managed, non-RSA drugs have no financial management plan other than price cuts at the expiration of patents," he said. "It is necessary to review re-evaluation or renegotiation considering environmental changes such as changes in foreign prices and listing alternative treatments." The research team said, "To reduce the uncertainty of ultra-low benefit, different approaches are needed depending on the type of uncertainty, the prospect of resolving uncertainty, and decision-making uncertainty. If the primary goal is to apply the CED method, it is better to apply the refund or Expenditure Cap type." As of July 2022, a total of 60 drugs were found to have signed RSA contracts. Anti-cancer drugs and rare disease treatments have increased their registration rates since the introduction of risk-sharing systems, and from 2015 to 2021, the drug cost of risk-sharing drugs increased by 50.9% annually, and RSA drugs averaged about 1.8 million won. RSA is an anticancer drug or rare disease treatment without an alternative and can be applied to serious diseases, omitted drugs submitted by PE, or phase 3 conditionally licensed drugs. When the NHIS RSA contract is signed, pharmaceutical companies will refund a certain percentage to the corporation based on their finances and performance.
