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- 2026-05-03 10:13:37
- 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.
- Policy
- nAMD & DME tx Vabysmo is about to be approved in Korea
- by Lee, Hye-Kyung Jan 09, 2023 06:10am
- The domestic approval of Vabysmo, the first and only dual-specific antibody biological drug related to eye diseases developed by Roche, is imminent. Vabysmo has been approved as an nAMD treatment and DME treatment in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, and was approved by the U.S. FDA in January last year. According to industries on the 5th, the Ministry of Food and Drug Safety recently completed a safety and effectiveness review of Vabysmo. If the review is completed without any problems, product approval is expected to take place soon. Vabysmo is the first and only ophthalmic injection approved by the FDA for nAMD and DME simultaneously. Depending on the patient's anatomical evaluation and vision results, vision can be improved and maintained by administering it every one to four months after the first four monthly administrations. It is estimated that more than 40 million patients suffer from one of the neovascular age-related nAMD treatments and DMEs worldwide, and the number of patients is gradually increasing as the population ages and the prevalence of diabetes increases. Until now, the standard therapy for the two diseases had to be administered every one to two months. However, in phase 3 of the Vabysmo global clinical trial, the patient group receiving Vabysmo at intervals of up to 4 months was found to have achieved a non-mean level of vision improvement compared to the patient group receiving Eylea every 2 months. It is evaluated that the convenience of patients has been improved by improving the administration cycle for up to four months. The international journal Nature Review Drug Discovery expects Babysmo's estimated sales to reach $1.129 billion within five years. Currently, four new nAMD drugs licensed in Korea are Avastin, Lucentis, Eylea, and Beovu.
- Policy
- PMS standards lowered for Sanofi’s hemophilia drug
- by Lee, Hye-Kyung Jan 06, 2023 05:57am
- The post-marketing surveillance (PMS) term for Sanofi’s hemophilia treatment ‘Eloctate’ and ‘Alprolix’ has been extended, and the number of subjects reduced. With the risk that the items may be canceled if the company fails to complete PMS for the drugs within the term set within the year, the authorities decided to extend the reevaluation term, including the submission of the risk management plan (RMP), by 3 years to collect more cases in consideration of the need for various hemophilia treatments and how they are being used in the field. The Ministry of Food and Drug Safety recently disclosed the results of the Central Pharmaceutical Affairs Council’s Drug Reexamination Subcommittee meeting to adjust the PMS period and the number of subjects for hemophilia treatments. Alprolix and Eloctate received marketing authorization in May and August 2017, respectively, and each is subject to reexaminations by May and August this year, respectively. According to the new ‘Notice on the Standard for Drugs subject to Reexaminations including New Drugs, etc.,’ the company may apply to adjust the number of surveillance subjects after at least half of the period elapses from the date of marketing authorization to the expiration date of the reexamination period until at least one year remains to the expiration date of the reexamination period. Sanofi was unable to sell the half-life extending hemophilia A treatment Eloctate and hemophilia B treatment Alprolix in the market for 3 years due to the transfer and acquisitions process between the previous license-holder UCB Korea and Sanofi, and due to the need to prepare inspection laboratories according to Korea's regulations on imported drugs. The two hemophilia treatments were not designated as rare disease treatments at the time of their approval and were required to collect 600 cases according to the set standards. However, due to their deferred sales in the market and difficulty collecting hemophilia patients, etc., Sanofi applied to adjust the number of surveillance subjects. The MFDS explained, “The company had applied to collect even fewer cases during initial discussions. The 65 and 35 case adjustments the company applied for this time show efforts on the company’s part as well.” According to the grounds for adjustments described by the company, the rate of adverse events was 10%, and the committee members' opinion was that the 65 and 35 people set for PMS would be the minimum target number. Other committee members said, “Hemophilia treatments are mainly used specifically by the Korea Hemophilia Foundation, therefore, it is difficult to collect a lot of cases. Patients mostly visit KHF clinics rather than university hospitals, therefore, not many patients can be enrolled. Therefore, the company seems to have applied to enroll a realistically possible number of subjects for PMS.” The MFDS also said, “The number of subjects for PMS under review will apply when the drugs are not registered as KHF drugs. If the drugs are registered as KHF drugs, the company will be able to collect more information.” Also, the reexamination period for the two drugs will be extended by 3 years each from the previous 6 years. As a result, the PMS period will be 9 years, and the subject number of patients 65 and 35 for Eloctate and Alprolix, respectively. Hemophilia is a rare intractable disease that develops in 1 in 10,000 people worldwide and is a disease that causes hemostasis issues when one of the coagulation factors in the blood is deficient or insufficient. As of 2019, there were 2,509 hemophilia patients in Korea. Among them, the most – 1,746 patients (69.6%) - had factor VIII deficiency, or Hemophilia A, followed by 434 patients (17.3%) with factor IX deficiency, or Hemophilia B.
- Policy
- Termination of PVA research services
- by Lee, Tak-Sun Jan 06, 2023 05:56am
- With the completion of the study that derived the improvement plan for PVA, attention is being paid to how it will be reflected in the actual policy. The industry expects the maximum cut rate, which is currently limited to 10%, to change. The NHIS also said it would come up with measures to improve the maximum reduction rate through research services. On the 2nd, the "Research on the Performance Evaluation and Improvement of the PVA System" was posted on the Public Institution Management Information Disclosure System (ALIO), which the National Health Insurance Service provided to Ewha Womans University Industry-Academic Cooperation Group (Professor Bae Seung-jin). The study was conducted from June 29 to December 29 last year. The contents of the study consisted of the background of the study, the status of the PVA system, overseas case review, in-depth interviews with stakeholders, scenario analysis, review, and conclusion. The original text was not disclosed. The reason for the non-disclosure is that it contains information on the size of claims, price cuts, and cost-effectiveness of certain drugs, which includes a number of confidential in management and business, and the research results are not disclosed because careful internal review and consultation with related agencies are needed to improve PVA. The results of the study are private, but the study is expected to be reflected in the actual system improvement policy. An NHIS official said, "The research results will be used and reflected in actual policies," and explained, "When the review is completed in the future, the research results can be converted to public." The study is known to have proposed an improved maximum reduction rate and a reference formula reduction rate. The maximum reduction rate of PVA is 10%, and the formula is set based on the rate of increase in actual claims compared to the previous year or expected claims. The average cut rate remained at 4-6%. It was 4.6% in 2017, 4.2% in 2018, 5.6% in 2019, 5.5% in 2020, 6.2% in 2021, and 5.2% as of August last year. In August, Jeong Hae-min, head of the NHIS' drug management office, said, "Research services are being conducted to analyze the overall PVA and come up with a reasonable system improvement plan. It includes adjusting the maximum cut rate and developing a reference formula considering the increase in billing amount." Accordingly, the study is expected to adjust the maximum reduction rate and develop a new reference formula. Meanwhile, PVA was introduced in December 2006 as part of the follow-up management of drug cost optimization measures. The main goal is to prepare a mechanism for lowering the upper limit through negotiations with pharmaceutical companies in order to share financial risks if drug costs have increased at a certain level. Through this, the NHIS is securing the soundness of insurance finances and inducing the proper use of drugs.
- Policy
- Approval of Pfizer’s JAK inhibitor Xeljanz Srup imminent
- by Lee, Hye-Kyung Jan 04, 2023 05:32am
- Pfizer’s JAK inhibitor ‘Xeljanz Syrup (tofacitinib citrate) 1mg/mL’ may soon receive marketing authorization in Korea. According to industry sources on the 3rd, the Ministry of Food and Drug Safety completed the safety and efficacy review for the marketing authorization application Pfizer Korea submitted for Xeljanz Syrup. Generally, items receive marketing authorization soon after MFDS completes the safety and efficacy review. Three items, 5mg and 10mg strengths of ‘Xeljanz Tab’ and 11mg strength of ‘Xeljanz XR,’ which are tablet formulations, are currently approved in Korea. The drug that completed the safety and efficacy review this time is a syrup formulation that can be used to treat polyarticular course juvenile idiopathic arthritis (pcJIA) in pediatric patients and adolescents ages 2 years or older. By weight, patients with pcJIA weighing 10kg-20kg will take 3.2mL of Xeljanz Syrup twice a day, those weighing 20kg-40kg will take 4mL of Xeljanz Syrup twice a day, and those weighing 40kg or more will take 5mL of Xeljanz Syrup twice a day. The tablet formulation of Xeljanz was only prescribed to pediatric patients weighing 40kg or more, but the syrup formulation has the benefit of being allowed to be prescribed regardless of weight. Xeljanz is the first and only JAK inhibitor in Europe to be approved to treat polyarticular JIA and pediatric psoriatic arthritis (PsA). The drug is currently approved by the EU to treat adults with moderate to severe rheumatoid arthritis, adults with psoriatic arthritis, adults with moderate to severe ulcerative colitis, children from 2 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) or juvenile psoriatic arthritis.
- Policy
- Koselugo is the only non-reimbursed drug among 21
- by Lee, Tak-Sun Jan 03, 2023 05:41am
- The Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) reviewed 21 items last year, among which only 1 failed to pass deliberations and be determined non-reimbursable. This non-reimbursed drug was the neurofibroma treatment ‘Koselugo Cap.’ Among the other 20, 9 were recognized to be adequate for reimbursement, and 11 received a partial nod under the condition that reimbursement is adequate if the company accepts a price lower than the assessed price for their drugs. Upon review of the products that filed applications for reimbursement based on results of the 12 DREC meetings that were held in 2022 on the 2nd, Dailypharm found that only 1 of the 21 products that received review was determined non-reimbursable. Koselugo Cap failed to pass the DREC review last March. Since then, AstraZeneca submitted supplementary data and reapplied for Koselugo’s reimbursement, and is expected to undergo receive another DREC review in the near future. The 9 items that were deemed adequate for reimbursement were: Kymriah Inj, 5 items including Resyno-ONE Inj, Loviqua Tab, Zogensma Inj, Emgality, Zerbaxa Inj, 10 items including Azelblock Tab, Ajovi Prefilled Syringe Inj·Auto Injector Ing, and 2 items including Reba-eye Eye Drops 2%. Other than the 10 azelnidipine-containing items including Azelblock Tab and the 2 items including Reba-eye Eye Drops 2%, all other drugs that passed the DREC review succeeded in reimbursement listing. In the case of the 2 items including Reba-eye Eye Drops 2%, the reimbursement agenda for the drugs passed DREC review in December and is undergoing NHIS pricing negotiations. 11 Items that received conditional approval last year were: Ryaltris Sanal Spray Sol, Sonazoid Inj, Dopa Check Inj, 4 items including Fexclue Tab, Dorenion Patch·Dohesive Patch, Reyvow Tab, Epclusa Tab, Bosevi Tab, Doveprella Tab, Trimbow Inhaler, and Erleada Tab. Among the drugs, all 8 drugs other than Reyvow Tab, Trimbow Inhaler, and Erleada Tab succeeded in reimbursement. Reyvow Tab was found to have not accepted DREC’s condition. In the case of Trimbow Inhaler, and Erleada Tab, the drugs received the conditional nod from DREC in October and December, respectively, therefore final results on their reimbursement are expected to be heard soon.
- Policy
- The fast track of tx for serious dz without a substitute
- by Lee, Tak-Sun Jan 03, 2023 05:40am
- Prior consultations will be newly established before the main negotiation to quickly register anticancer drugs without alternative drugs and treatments for severe and rare diseases. Accordingly, the negotiation period for the drug will be reduced from 60 days to 30 days. The NHIS announced on the 30th some revisions to the drug price negotiation guidelines containing such information. According to the amendment, among PE drugs, drugs that are evaluated as RSA (Expenditure Cap drugs or Refund) will have a negotiation period of 30 days. These drugs, etc. can be consulted in advance before the main negotiation if ordered by the Minister of Health and Welfare. Accordingly, the target drugs may undergo prior consultation by providing data to the NHIS 15 days before submission to the HIRA Drug Benefit Evaluation Committee to determine their benefit adequacy. Therefore, in this negotiation, the negotiation period will be reduced from 60 days to 30 days. The NHIS has decided to apply the guidelines from January 1 next year. Earlier, the HIRA also supported the introduction of a preliminary consultation system by specifying drugs that can omit submission of economic evaluation data through the "revision of regulations on evaluation criteria and procedures such as whether drugs are eligible for medical care benefits." According to the revision, the standard for PE omission drugs is established that "the target patients are few." There are no products or treatments with equal therapeutic positions as drugs used in children, and cases of clinically significant improvement in quality of life have been added to be recognized by the committee. As Canada is included in the drug price reference country, PE can be omitted for drugs that are publicly paid in more than three of the eight foreign countries (Japan, France, Germany, Italy, Switzerland, the United Kingdom, the United States, and Canada). This was also applied to the detailed evaluation criteria for drugs subject to negotiation, such as new drugs, which are the HIRA internal guidelines. All of them will go into effect on January 1 next year.
