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- 2025-12-24 06:33:40
- Policy
- 17 new drugs including Verzenio got to expand coverage
- by Kim, Jung-Ju Oct 08, 2020 06:23am
- Apparently, total 13 new drugs have been listed for healthcare reimbursement this year. Total four already-listed drugs had their reimbursement expanded with the coverage enhancement policy. The record demonstrates the social consensus has flexibly expanded healthcare coverage even on expensive drug for a limited patient size. Daily Pharm surveyed new drugs and already-listed new drugs that the South Korean healthcare authority granted new reimbursement or expansion with extended indication or administration standard. The statistics found total 17 drugs have received the new benefit. When including various doses listed together, the total number of drug items with the new benefit doubles. Based on the date of reimbursement provision, a chronic constipation drug Rucalo was newly listed, and Rafinlar plus Meqsel combination therapy for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation expanded the reimbursement standard for the combination. Locally advanced NSCLC treatment Imfinzi and chronic lymphocytic leukemia treatment Venclexta were applied with reimbursement as of Apr. 1. An acute lymphocytic leukemia treatment Blincyto also expanded the coverage on the same day. The South Korean health authority listed a new drug for hemophilia Hemlibra as of May 1, when a new drug for juvenile-onset hypophosphatasia Strensiq, a severe psoriasis treatment Skyrizi and a breast cancer treatment Verzenio were also newly listed on June 1. On the same day, the reimbursement standard on breast cancer therapy Ibrance was revised to expand its coverage. A severe asthma treatment Xolair and a multiple sclerosis treatment Mavenclad were newly listed on July 1 and on Aug. 1, respectively. A NSCLC treatment Tecentriq’s reimbursement was expanded on Aug. 1 as well. In-vitro fertility-aiding Rekovelle and cytomegalovirus treatment Prevymis won reimbursement as of Sept. 1. And a Parkinson’s disease treatment Ongentis and a metastatic Merkel cell carcinoma treatment Bavencio have been listed from this month. The expanded coverage on the said drugs would provide yearly healthcare reimbursement benefit of approximately 144.81 billion won to 243,707 patients in South Korea. One of the treatments on the list would treat patients in Korea as many as 110,000, but some would only benefit 10 or even less patients. A few years ago, the ‘evidence-based’ drug pricing and evaluation hindered listing expensive drugs targeted for a small number of patients. But this year’s listing for pharmaceutical reimbursement shows the National Health Insurance benefit priority order has become more flexible for those drugs that can create social consensus.
- Policy
- Abbott accused of sponsoring academic society too often
- by Lee, Jeong-Hwan Oct 07, 2020 06:08am
- Global pharmaceutical and medical device company Abbott has been accused of providing questionable financial benefit to healthcare providers that exceeded the legal amount stipulated in the ‘Korean Sunshine Act.’ Apparently for a year, Abbott has sponsored Korean Society of Interventional Cardiology (KSIC) an approximate total of 250 million won for the participants in 12 overseas academic conferences and convened product presentations for their medical devices in grilled beef restaurants. On Oct. 5, Democratic Party Lawmaker Ko Young-in reprimanded, “Abbott has been providing suspicious amount of financial benefit for KSIC as if it were their private pot of money.” The Korean Sunshine Act, or “K-Sunshine Act,” was enforced to mandate pharmaceutical and medical device companies to report their expenditure for financial benefit provision, but Lawmaker Ko argued the law has been useless. The lawmaker pointed out the regulation was implemented three years ago, but the Ministry of Health and Welfare Committee (MOHW) has barely reviewed any of those reports. He claimed the ministry has sampled and reviewed only four pharmaceutical and medical device companies’ reports filed in 2018. Regarding the reports, Lawmaker Ko raised an issue regarding Abbott’s report on the financial benefit provision. The reports submitted to the lawmaker’s office found that Abbott has sponsored KSIC a total of 250 million won for the society’s participation in 12 overseas academic conferences from February 2018 to March 2019. Basically, Abbott has offered about 45 percent of all the overseas conferences the academic society participated during the same period of time, as its website posted schedules of total 29 overseas conferences. The sponsored amount varied from maximum 50 million won to 50,000 won per event, and the report did not specify how many members of the society have received the out-of-pocket expense for the conference. And the company also reportedly spent total of 227,290 won (16,235 per person) for food and beverage provision for 14 associates from a hospital on Mar. 28, 2018, from 6 p.m. to 9 p.m. Out of all expenditure reports submitted by Abbott, it was the only on product presentation for an individual healthcare institute. The lawmaker’s office checked the restaurant located in Busan City mainly serve grilled beef menu ranging from Bulgogi priced at 16,000 won to special beef cuts priced at 23,000 won per portion During the product presentation, the company briefed about their product ‘Architect,’ which is an immunoassay analyzer frequently used in hospitals since a decade ago. Lawmaker Ko pinpointed the product is too universally used already for a private product presentation. And considering the product is massive system equipment, the lawmaker was suspicious if the presentation was properly conducted in a restaurant setup. Moreover, Lawmaker Ko criticized MOHW for monitoring the expenditure reports from only four companies for last three years. According to MOHW’s survey on expenditure report monitoring on pharmaceutical and medical device industries, 73.8 percent of the pharmaceutical industry was complying, whereas only 24.1 percent of the medical device industry was complying. Ultimately, only 1,962 companies out of 6,206 companies (30 percent) have filed and achieved the reports. 188 companies, or 6.5 percent of the two industries, said they were not even filing the reports. The Pharmaceutical Affairs Act stipulates the companies to file and archieve expenditure report on provided financial benefit for five years, and they are to submit them when demanded by the Minister of Health and Welfare. The companies that have not filed or archived the report along with the ledger and evidential materials would be ordered to correct their practice and fined up to 2 million won. Lawmaker Ko stated, “MOHW would have to properly operate and toughen the report monitoring according to the K-Sunshine Act that aims to cut the illegal ties between pharmaceutical and medical device industries and healthcare providers and hospitals. The production cost of pharmaceuticals and medical devices would be raised and ultimately push up the National Health Insurance premium and medical service fee, if the healthcare providers and hospitals continue to receive excessive sponsorship from the companies for introducing new technology.” “As the industries used to provide rebate worth billions of wons, the current fine of 2 million won could be easily ignored by the responsible industries. The fine should be raised and the reports should be mandatorily submitted or reviewed every year, or even rather publicly opened like in the U.S. for the public to verify,” Lawmaker Ko added.
- Policy
- Mishandled flu vaccines' recognition was announced in 10 hr
- by Lee, Jeong-Hwan Oct 06, 2020 06:24am
- Criticism was raised that the KDCA announced the suspension of vaccination after about 10 hours of being aware of the flu vaccine exposure to room temperature, causing damage to the public. The KDCA announced to domestic medical institutions that Shinsung Pharm’s vaccines would be halted at 11 pm on the 21st of last month, and the recognition of exposure to room temperature was delayed at around 1:30 pm on the same day. On the 5th, Kang Ki-youn, a member of the People Power Party made this claim through the results of an investigation by the KDCA. He pointed out that after the KDCA reported the flu vaccine exposure at room temperature, it was delayed in decision-making, such as finding out the situation and stopping vaccination, resulting in increased damage and confusion between the public and medical institutions. According to him, it was around 1:30 p.m. on the 21st of last month when the KDCA recognized that Shinsung Pharm’s vaccines were exposed to room temperature through a report. Afterwards, the KDCA sent a text message to medical institutions at 11 o'clock on the same night with the details of the suspension of vaccination. As of the last 2 days, the total number of vaccinations supplied by Shinsung Pharm was 704 after the announcement of discontinuation of vaccination. He said that hospitals that were not properly aware of the vaccination stopped at 11 p.m. late on the 21st was vaccinated from the morning of the 22nd. He criticized that it should have been announced much earlier with faster decision-making after receiving the report.
- Policy
- Additional evidences asked for 3 patients using Spinraza
- by Lee, Hye-Kyung Oct 06, 2020 06:23am
- The South Korean health authority has asked three preliminary approval applicants seeking to use spinal muscular atropy (SMA) treatment Spinraza with coverage to submit supplementary evidences. After the initial approval on reimbursed use of Spinraza, the applicant has to hand in monitoring report every four months before administering the maintenance dose. As a result, 28 out of 31 cases of the monitoring report have been cleared, and three cases have been ended. On Sept. 29, Health Insurance Review and Assessment Service (HIRA, President Kim Sun-min) disclosed the outcomes of four pre-administration reimbursement review cases deliberated by the Healthcare Review & Assessment Committee in August. One of most expensive new drugs in the world, Sprinraza costs 92.35 million won per 5 ml vial and it requires a healthcare institute to apply for pre-administration approval for reimbursed use. Depending on the reimbursement standard on Spinraza, the health authority approves of the coverage on the drug in patients qualifying all following conditions—positive genetic testing of a deletion or mutation in the survival motor neuron 1 (5q SMN-1) gene, onset of SMA symptoms from age three or less, and not on permanent ventilator. In terms of a 16-year-old male patient with a record of scoliosis surgery and a myelogram, HIRA asked for the related imaging evidence for submission, as the previously submitted evidence could not sufficiently prove if he is able to take continuous intrathecal administration with lumber puncture. A female patient aged 35 was also requested to provide more evidences of her SMA-related symptoms and signs onset before she reached 36 months. Another female patient aged 25 with a record of scoliosis surgery was asked to provide a doctor’s opinion on feasibility of intrathecal administration with lumber puncture by running a myelogram. Also she has to submit a specialist doctor’s opinion, except from her own doctor, regarding her respiratory function as she is currently using a ventilator. Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab). Only two out of four applications from patients with paroxysmal nocturnal hemoglobinuria (PNH) were cleared. One case of reevaluation and 44 monitoring reports were passed for reimbursement. All five applications on using Soliris with reimbursement for treating atypical hemolytic uremic syndrome (aHUS) were denied, but 10 monitoring reports were passed for further reimbursed use. Moreover, HIRA reviewed and green lit all four preliminary applications for reimbursed treatment with ventricular assist device (VAD).
- Policy
- Daewoong's DWP16001, approved for Phase III clinical trial
- by Lee, Tak-Sun Oct 05, 2020 06:22am
- The SGLT-2 diabetes treatment drug being developed by Daewoong is entering phase III of clinical trial. This drug is expected to become the first domestic SGLT-2 diabetes drug if it obtains product approval. On the 29th of last month, the MFDS approved phase III clinical trial plan for Daewoong's new drug candidate 'DWP16001'. DWP16001 is a SGLT-2 inhibitor drug such as Forxiga (AZ), Jardiance (Boehringer Ingelheim), and Suglat (Astellas) that are commercially available in Korea. Daewoong is developing and introducing substances from GC Pharma in May 2016. Inhibition of SGLT-2 Diabetes treatment has a mechanism of selectively inhibiting SGLT-2, a transporter that reabsorbs glucose from the kidneys, preventing glucose from being reabsorbed, and controlling blood sugar by excreting it in the urine. It is also famous as a 'fat-losing diabetes medicine' because it has weight control effects. SGLT-2 inhibitor drugs and DPP-4 inhibitory drugs are rivals in the domestic diabetes treatment market. According to UBIST, Forxiga's outpatient prescriptions amounted to ₩17.6 billion in the first half of this year, up 10.1% year-on-year. Sales of Jardiance was ₩16.8 billion, up 66.7% year-on-year, and Suglet’s sales amount was ₩1.6 billion, up 16.7% year-on-year. Daewoong has been jointly selling Forxiga in cooperation with AstraZeneca since 2018. It can be said that distribution network has already been established before the development of new drugs. In addition, Daewoong is selling DPP-4 diabetes treatment Zemiglo (LG Chem), showing its strong influence in the diabetes drug market. This phase IIII clinical trial of DWP16001 is conducted to evaluate the safety and efficacy of a combination therapy with Metformin in patients with type 2 diabetes who have insufficient glycemic control with Metformin and monotherapy in type 2 diabetes patients. Phase III clinical trial of monotherapy is conducted at Seoul National University Hospital for 140 domestic patients. The phase III clinical trial of Metformin combination therapy will be conducted in 190 patients at Seoul St. Mary's Hospital. It is interpreted as a strategy to simultaneously acquire major indications by conducting two-tracks. Daewoong revealed the results of phase I clinical trial of DWP16001 through a poster presentation at the '2019 European Association for the Study of Diabetes (EASD)' held in Barcelona, Spain in September last year. According to the results, in phase I, DWP16001 showed excellent urinary glucose secretion (glucose excreted in the urine) at a dose of 1/100 compared to drugs of the same category. In addition, when repeated administration for 15 days, the daily urinary glucose secretion of the active control group was 40g, while the daily urinary glucose secretion of the DWP16001 group was 50g or more. Daewoong received approval for phase II clinical trial from the MFDS in May last year, and approved phase III clinical trial within 1 year and 5 months, and is proceeding with commercialization plans smoothly. Daewoong plans to release this drug in Korea in 2023.
- Policy
- Health vice-minister answers questions on MOHW drug pricing
- by Kim, Jung-Ju Oct 05, 2020 06:21am
- Kang Do-tae (Master’s degree in Public Administration at Seoul National University) has been appointed as a first second vice-minister of Ministry of Health and Welfare (MOHW) to lead the health sector of the ministry amid COVID-19. And during an interview on him, the vice-minister expressed his commitment to not only focus on the infectious disease control but also to pay attention to healthcare development planning the administration is firmly pressing on. A month into his new appointment, the second vice-minister is in charge of the entire health sector including the healthcare and pharmaceutical industry. During an interview with the industry news media, Vice-minister Kang affirmed his approach on the health policies and determination to communicate with the industry as much as possible. He also said more comprehensive and systematic healthcare developing roadmap would be taken by sufficiently surveying opinions from various stakeholders. However, he was particularly careful on speaking about sensitive issues like choline alfoscerate substitution prescription and non-proprietary name prescription, coverage on Korean herbal medicine, and alternative exam date for medical school students who were on strike. Following is the detailed interview with the vice-minister. ▶The Korean pharmaceutical industry is complaining about the skewed regulatory policy, namely the generic pricing system revision. While the administration is pressing on the coverage enhancement, the public is criticizing on the insufficient fostering initiative for the Korean pharmaceutical industry and unilateral policy execution. Regarding the criticisms, what is your opinion on them and how do you plan to approach the said policies? “Since the valsartan contamination incident in 2018, the notion of generally amending the generic management system has been suggested. MOHW then discussed with the Ministry of Food and Drug Safety (MFDS) and collected the pharmaceutical industry’s opinions to revise the drug pricing system to ultimately improve the generic quality management and competitiveness. We would push on with the pricing policies announced already, but also sufficiently communicate with the industry when setting up detailed action plans. While streamlining the pricing system, we would constantly seek for policies to foster and support the pharmaceutical industry—the key emerging industry of the country. The ministry has drawn up and started executing the biohealth industry innovation strategy plan and the Second Five-year Comprehensive Plan (2018-2022) for Pharmaceutical Industry Fostering and Supporting, which includes R&D investment expansion, major specialist training, and biohealth technology innovation ecosystem establishment. The ministry would continue to provide supports for the industry for its further innovation and better global competitiveness.” ▶Pharmaceutical companies are urging the government to differentiate pricing as a new drug, when an anticancer therapy adds a new indication. The industry apparently wants to communicate with the government on its stance, but they say the government has not been responding. What is your opinion on the matter? “A new drug pricing system that gives different pricings on a drug based on indication could help improving the access to needed treatments. But we need to first evaluate if such system can be realized within the current National Health Insurance (NHI) and its billing and payment system. Also, the indication-based differentiated pricing should be decided after surveying a wide array of stakeholders including the relevant government bodies, industries and civic groups. Regarding the communication with the pharmaceutical industry, the ministry would regularly convene a meeting with the related industry organizations for their in-depth opinions.” ▶Recently, the court has ruled to halt the reimbursement reduction order on choline alfoscerates. With the decision, would you say the reevaluation on other drugs are also on hold or halted as well, or that the ministry is planning to continue on with the reevaluation program according to the newly written reevaluation clause within the revised reimbursement regulation? “So far, the National Assembly, the media and civic groups have pointed out how reevaluation is needed for those drugs with questionable clinical efficacy. As a first case, we have selected and reevaluated drugs with choline alfoscerate, and newly added a legal basis within the National Health Insurance reimbursement standard to adjust reimbursement on already-listed drugs through reevaluation. Other drugs would be reevaluated next year, and we would fully communicate with the pharmaceutical industry, experts and civic groups during the process.” ▶While the trend of pharmaceutical companies signing deals with CSOs is becoming more apparent, is there any CSO management plan including the expenditure report management the MOHW is preparing? “There have been concerns of the industry finding new means to provide rebate as more companies are working with CSO. Accordingly, the ministry is to also seek measures, based on the Pharmaceutical Affairs Act, to prevent CSOs providing rebate by penalizing them with business suspension. Also the CSO would be responsible to document financial benefit provided to healthcare providers and to file expenditure report under the supervision of the consigner. By raising awareness of the expenditure report system that requires healthcare providers and pharmaceutical industry to verify the report, the ministry would encourage the CSOs to be better self-managed.” ▶Until now, the government has acknowledged the necessity of generic substitution and non-proprietary prescription, but turned them down due to conflict between the healthcare providers and pharmacists. What is your opinion on the issue? “There are so many different opinions suggested by the medical and pharmaceutical experts from health industries to academic societies regarding the government promoting non-proprietary prescription and generic substitution. So we would need to first create a social consensus to reflect not only the medical and pharmaceutical industries, but also the public.”
- Policy
- Off-label coverage on Cellcept and Mabthera expanded
- by Kim, Jung-Ju Oct 05, 2020 06:21am
- From next month, the off-label reimbursement would be expanded on Roche Korea’ immunosuppressant Cellcept Capsule (mycophenolate mofetil) and chronic lymphocytic leukemia and rheumatoid arthritis treatment Mabthera injection (rituximab). Lilly Korea’s psoriatic arthritis and ankylsoing spondylitis treatment Taltz Prefilled Syringe Injection (ixekizumab) would receive reimbursement as a second-line treatment on severe case of ankylsoing spondylitis. South Korea’s Ministry of Health and Welfare (MOHW) has partially revised the ‘Healthcare Reimbursement Standard and Application Details (Pharmaceuticals)’ to reflect the said changes as of Oct. 1. First, an oral mycophenolate mofetil Cellcept would expand the coverage based on indications approved in South Korea and overseas, textbooks, clinical guideline, clinical literature, and related academic recommendations. The new coverage on Cellcept would apply on patients with advanced diffuse cutaneous systemic sclerosis and systemic sclerosis associated interstital lung disease. The reimbursement would be granted for patients with diffuse cutaneous systemic sclerosis, who have not sufficiently responded to one or more types of other immunosuppressant, such as azathioprine, and scored over 12 points in modified Rodnan Skin Score (mRSS). Also, patients with systemic sclerosis associated interstital lung disease, who have not sufficiently responded to one or more types of other immunosuppressant, such as azathioprine, and their Forced Vital Capacity (FVC) ranging from 45 percent to under 80 percent. For both diseases, 250 mg to 3,000 mg of the drug would be administered daily. The off-label use of the rituximab injection would obtain reimbursement, when treating children with chronic nephritic syndrome. The new off-label coverage would be available to patients with steroid-dependent nephritic syndrome frequently relapsing regardless of receiving steroid and immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil), patients with steroid-dependent nephritic syndrome who do not demonstrate remission or frequently relapsing regardless of receiving steroid and immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil), and patient who cannot use steroid or immunosuppressant (cyclosporine, cyclophosphamide, tacrolimus or mycophenolate mofetil). The reimbursement would be provided for an initial administration of 375 mg/ m2 (maximum 500 mg), and another follow-up administration after three to six months (maximum twice a year). The treatment can be re-administered, if the patient relapses. However, patients with chronic or acute infection, who received live attenuated vaccine within a month, or who test absolute neutrophil count (ANC) under 500/ mm³ would not be eligible for the administration. The reimbursement on an ixekizumab treatment, Taltz Prefilled Syringe Injection would be additionally granted as a second-line treatment on patients with severe case of ankylsoing spondylitis by referring to the reimbursement standard on interleukin-17 inhibitors (IL-17i). Patients with severe and active ankylsoing spondylitis, who do not respond well to one or more types of tumor necrosis factor-α (TNF-α) inhibitor or halted treatment due to adverse reaction, would be eligible for the coverage. The sustained administration of six months with reimbursement would be approved to patients scoring 50% on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or reduced more than two (scale 0 to 10) after using the treatment for 16 weeks. The evaluation would be conducted every six months from then on, and the sustained administration would be allowed if the patient maintains the evaluation result from the first 16 weeks. Also the coverage would be granted for patients, who do not respond to the treatment or have to halt the administration due to adverse reaction, but switching to a TNF-α inhibitor (etanercept, adalimumab, infliximab or golimumab injection) that has not been used before or to a secukinumab injection. However, in such case, the patient has to submit a doctor’s recommendation on the switch. As the reimbursement on Taltz Prefilled Syringe Injection has been expanded to patients with ankylsoing spondylitis, the treatment’s substance name would be added to golimumab’s reimbursement standard as an option for switch. Janssen Korea’s Simponi Prefilled Syringe Injection 50 mg is the most famous brand name for golimumab.
- Policy
- A government-ruling party, pay attention to Syntekabio
- by Lee, Jeong-Hwan Oct 05, 2020 06:21am
- As it is known that the drug efficacy of the new drug substance for COVID-19 being developed by Syntekabio is more than twice that of Remdesivir, a government-ruling party is paying attention to this. On the 28th, Lee Nak-yeon, leader of the Democratic Party and Representative Han Jeoung-ae (General Manager of the National Disaster Recovery Committee), Seo Youngseok (Health and Medical Special Committe), Jo Seounglae, Kim Youngbae, and Han Junho visited the KRIBB in Daedeok Innopolis in Daejeon. Yong Hong-taek, head of the R&D policy department of the Ministry of Science and ICT, attended. On this day, the government-ruling party met with an official who took the lead in the development of COVID-19 treatment and vaccine to discuss the current status of treatment and vaccine, and to discuss a message to the public. Jang Seong Kim, the KRIBB’s chairman, explained that the efficacy of Syntekabio's COVID-19 treatment candidate was twice as high as that of the standard treatment Remdesivir. Syntekabio's new drug substance is known to have a therapeutic effect of 94.3% compared to 44.3% of Remdesivir as a result of animal experiments conducted through the KRIBB. Lee Nak-yeon expressed interest by encouraging the researchers of the KRIBB, and at the same time confirming whether the COVID-19 candidate is twice as effective as Remdesivir in animal experiments. He said, “Amid the COVID-19 crisis, we must protect the quarantine and economy and prepare for the future. The KRIBB, which developed the world's fourth primate infection model, is making a feat of stabilizing the COVID-19 clinical trial. We want to hear how our party can help.”, also he added, “the expansion of research facilities and data centers seemed urgent and we will help.”
- Policy
- Pfizer Korea withdraws a lot of OTC products
- by Lee, Tak-Sun Oct 05, 2020 06:20am
- Pfizer Korea has withdrawn a large number of domestic OTC products. There are only three items left. According to the MFDS on the 28th, Pfizer Korea recently withdrew permission for seven items, including Stresstabs Plus and Caltrate plus. Accordingly, only three items left by Pfizer Korea were Minulet, Alesse, and Cofrel. Even this is not sold directly by Pfizer Korea. Ildong has been selling Minulet and Alesse, and Cofrel has been discontinued due to a manufacturer’s problem. The suspension of Pfizer's OTC department was announced last year when it merged with GSK. The domestic copyright of major items, such as the OTC products, Advil, Caltrate, and the multivitamins, Centrum, has already been transferred to GSK. In December 2018, when the two companies announced the merger of the Consumer Health Care, they reported that GSK owns 68% and Pfizer owns 32%.
- Policy
- Bavencio, listed on next month at ₩1,226,243/bottle
- by Kim, Jung-Ju Sep 29, 2020 06:21am
- Bavencio (Avelumab) by Merck, used for the treatment of metastatic Merkel cell carcinoma, will be covered by insurance benefits at ₩1,226,243 per bottle starting next month. Since it is an expensive drug, it will follow the RSA track, and will be listed as a refund type in which pharmaceutical companies reimburse a certain percentage of the drug claims to the HIRA, and a expenditure cap. The MOHW announced that the 'revision of Criteria for pharmaceutical reimbursed list & upper limit table' with the above contents was submitted to the agenda of the 17th plenary meeting of the Health Insurance Policy Deliberation Committee on the afternoon of today (25) and was deliberated and resolved. Merkel cell carcinoma is a neuroendocrine cancer that occurs in the skin, and Bavencio is an injection drug that has been approved for 'a monotherapy for the treatment of metastatic Merkel cell carcinoma in adults'. It is treated by intravenous infusion at 10mg/kg every two weeks for 60 minutes. It is a rare cancer that occurs in a very small number of populations (0.35 per 100,000 males and 0.15 per 100,000 females). Life expectancy is less than 2 years. The number of patients for this product in Korea is known to be around 10. On March 22 last year, the company obtained an item permission from the MFDS and submitted an application for insurance registration on May 2 of the same year. After deliberation by the Economic Evaluation Subcommittee under the Pharmaceutical Benefits Advisory Committee held on April 17 of this year, it was officially proposed on June 11, two months later. At that time, the committee recommended the use of this drug in the treatment of metastatic Merkel cell cancer according to the evidence in textbooks and clinical practice guidelines, so it has clinical utility. It was determined that the result of the economic evaluation (cost-effectiveness analysis, ICER) compared to chemotherapy was reviewed at an acceptable level. The Korean Cancer Association and the Korean Cancer Study Group also said that it is a drug that can be considered as a preferred treatment method for patients with metastatic Merkel cell boxes who have failed the first line treatment. It was listed in the excluded countries A7 (US, Japan, France, Germany, Italy, Switzerland, and the UK), and the adjusted average price is ₩1,317,952 per bottle. After passing the committee, when discussing the price of a new drug with the NHIS, the company proceeded with negotiations by following the RSA refund type and Expenditure Cap type. This is a contract in which a pharmaceutical company refunds a certain percentage of the drug billed amount and a certain proportion of the excess of the estimated cap amount to the NHIS. The two sides agreed to ₩1,226,243 taking into account the level of drug prices and fiscal impact of excluded countries. The fiscal impact analysis value is about ₩301 million per year, and the registration date is October 1.
