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2026-05-04 12:09:28
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Policy
↑The cost of drugs for severe dz by ₩1.79 trillion
by
Lee, Tak-Sun
Jun 29, 2022 05:53am
The proportion of drug costs for four major serious diseases such as cancer and rare diseases is increasing significantly every year. Another reason is the increasing number of expensive new drugs that are listed. As the proportion of drug costs for these four major serious diseases increases, the need for efficient financial management measures is also expected to increase. According to the "2021 reimbursed drug claim status" published by the HIRA on the 27th, the cost of drugs for the four major diseases was 5.6 trillion won last year, accounting for 26.4% of the total drug cost of 21.2097 trillion won. The four major serious diseases refer to cancer, cerebrovascular, heart, and rare and symptomatic incurable diseases. Among them, most of them are cancer and drugs for rare and symptomatic incurable diseases. The cost of drugs for the four major serious diseases increased by 1.79 trillion won in four years from 3.8107 trillion won in 2017. The share of the total drug cost also increased significantly from 23.5% in 2017 to 26.4% in 2021. At this rate, it is expected to exceed 30% soon. Among the four major serious diseases, the proportion of cancer disease drug costs also increased from 12% in 2017 to 14.2% in 2021. In addition, the proportion of drugs for rare and symptomatic incurable diseases also increased from 10.8% to 11.6%. Analysts say that drug costs are also increasing as the health insurance coverage rate for the four major serious diseases is strengthened. However, analysts say that the pace of increase in drug costs will exceed expectations as new drugs targeting certain cancers or rare diseases are increasingly priced. Kymriah, which was recently registered, was listed for 3603 million won, Spinraza 92.35 million won, and Lutathera 22.1 million won. On top of that, the proportion of high-priced drugs for cancer and rare diseases is expected to increase as one-shot treatments worth more than 1 billion won, such as Zolgensma and Luxturna, are waiting for reimbursement one after another. Analysts say that the voluntary reduction in drug prices for MSD's diabetes drug Januvia as MSD Kymriah was listed as the primary drug for non-small cell lung cancer in February is also a case in point of view. The proportion of total drug costs in health insurance medical expenses has been stably managed. Last year, the proportion of drug costs was 24.06%, down from 25.09% in 2017.
Policy
Fexclu reimb at ₩939, Kadcyla reimb extended from July
by
Kim, Jung-Ju
Jun 29, 2022 05:53am
Four items including Daewoong Pharmaceutical’s Fexclu Tab (fexuprazan hydrochloride) will be listed at ₩939 per tablet starting next month as latecomers of the homegrown novel drug K-CAB indicated to treat erosive gastroesophageal reflux disease (GERD). Also, reimbursement of Kadcyla (trastuzumab emtansine), Roche Korea’s second-line treatment for breast cancer, will be extended to cover its treatment as ‘adjuvant treatment of patients with early breast cancer after surgery’, and will accordingly receive a new drug price. The Ministry of Health and Welfare held the 14th Health Insurance Policy Deliberation Committee meeting (Chair: 2nd Vice Minister of Health and Welfare, Ki-Il Lee) today (28th) and announced that the listing and reimbursement extension proposals for 2 new drugs and 1 previously listed drug have been passed after deliberation at the HIPDC meeting. The listing of 4 latecomer fexuprazan hydrochloride drugs including Fexclu Tab 40mg, and reimbursement extensions of two items - Kadcyla inj. 100mg and 160mg – passed deliberations and will be applied reimbursement starting July 1st. ◆4 items including Fexclu Tab. 40mg = Four fexuprazan hydrochloride latecomers used to treat erosive gastroesophageal reflux disease (GERD) will be concurrently listed for reimbursement. The 4 items are Daewoong Pharmaceutical’s Fexclu Tab, Hanall Biopharma’s Abcito Tab, Daewoong Bio’s We Cab Tab, and iN Therapeutics’ Veloxcab Tab. The companies had received marketing authorization from the Ministry of Food and Drug Safety for their respective drugs from December 30th last year to January 11th of this year and applied for reimbursement listing from December 27th last year to January 13th of this year. Upon receiving the reimbursement request, HIRA’s Drug Reimbursement Evaluation Committee reviewed the 4 drugs on the 12th of last month and passed the agenda on to the NHIS. During deliberations, DREC decided that the four drugs’ clinical benefit is non-inferior to K-CAB, and is adequate for reimbursement at ₩939, which is 90% of the weighted average of its alternatives. The NHIS then carried out negotiations on the expected claims amount of each item with the companies from May 25th to June 17th. The drug price has been set at ₩939 per each 40mg strength tablet. ◆ Kadcyla Inj 100mg and 160mg = Kadcyla Inj, Roche Korea’s treatment for locally advanced or metastatic breast cancer, had been listed for reimbursement since August 2017. This time, a reimbursement standard for Kadcyla to be administered ‘for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment’ will be added. The company had received additional approval for the above indication on August 8th, 2019 from the MFDS, and requested a reimbursement extension on the same day to HIRA. HIRA had deliberated on the agenda at the DREC meeting held on October 16th of the same year, on August 26th in 2020, and on February 10th. DREC had set the reimbursement standards for Kadcyla in consideration of the reimbursement evaluations made abroad and the additional fiscal sharing plan proposed by the company, after which the DREC members discussed whether the drug should submit pharmacoeconomic evaluation data and be evaluated for its cost-effectiveness. In the case of pharmacoeconomic evaluations, Kadcyla had significantly improved invasive disease-free survival compared to its alternative Herceptin (trastuzumab) and was required to demonstrate its cost-effectiveness. After PE evaluations, DREC decided that the drug’s ICER level was within an acceptable range and is therefore cost-effective. As a result, members at the DREC meeting passed Kadcyla in consideration of how its PE evaluation value was at an acceptable level compared with Herceptin and is listed for reimbursement in all A7 countries. The company thereafter agreed with the NHIS on applying the Utilization cap / Fixed cost per patient type of RSA for Kadcyla's reimbursement, under which the company is required to refund the excess amount used to the NHIS. The agreed price was set at ₩1,956,328 per vial for Kadcyla Inj 100mg, and at ₩2,930,920 for Kadcyla Inj 160mg.
Policy
Low strength Esomezole Plus Tab priced same as Eso Duo
by
Lee, Tak-Sun
Jun 28, 2022 06:09am
Hanmi Pharmaceutical has decided to set the ceiling price of its gastroesophageal reflux disease (GERD) treatment combo ‘Esomezole Plus (esomeprazole+ magnesium hydroxide)’ at the same level as Chong Kun Dang’s ‘Eso Duo (esomeprazole+sodium bicarbonate)’ to directly target Eso Duo in the market. Its lower strength formulation, in addition to its higher strength, is setting out to the market at the same price as Chong Kun Dang’s Eso Duo. According to the Ministry of Health and Welfare, Esomezole Plus 20/350mg Tab will be listed for insurance benefit at a ceiling price of ₩720 from the 1st of next month. This is the same price as Eso Duo 20/800mg Tab. Both products contain 20mg of esomeprazole. Hanmi Pharmaceutical had also listed Esomeprazole Plus 40/350mg Tab at the same price as Eso Duo 40/800mg Tab, at ₩920 in April this year. This is interpreted as a head-on challenge made by Hanmi against the current market-leading product, Eso Duo. Eso Duo, a combination of the PPI esomeprazole and an antacid ingredient, is the product that mainstreamed such combinations in the GERD treatment market. Esomeprazole, which is weak in stomach acid is complemented by an antacid to provide a quicker effect. The drug was released in 2018 and exceeded ₩10 billion in sales, the record set for blockbusters, in the year of its release. Last year, its outprescription sales amounted to ₩18.2 billion according to UBIST. In particular, its growth continued despite the release of dozens of Eso Duo generics last year. Although Hanmi has dominance over the GERD monotherapy market, it is a latecomer to the PPI+antacid combination market. Therefore, the company seems to be pushing to overthrow the current leader in the combination drug market, Eso Duo. Although 29 Eso Duo generics are currently listed in the market, no other drug has the same price set for their drugs higher and lower strength formulations as the original. In addition, Esomezole Plus contains a different antacid from Eso Duo. This means that Hanmi could have listed its drug for a higher price, in line with the highest price of esomeprazole, but had lowered its price to compete with the market leader Chong Kun Dang. Therefore, industry eyes are on who will seize victory among the two companies that have the best sales power in Korea. The pride is in line for the two companies, and whether Chong Kun Dang, the pioneer in the combination drug market will continue exerting its dominance in the market, or whether Hanmi, the sole leader of the monotherapy market will become a sensation in the combination drug market remains to be seen.
Policy
Phase 3 of Danicopan will be conducted in Korea
by
Lee, Hye-Kyung
Jun 28, 2022 06:09am
Phase 3 clinical trials of Danicopan (ALXN2040), which is called a competitive drug for rare drug Soliris, will be conducted in Korea. The MFDS recently approved a phase 3 clinical trial for patients with seizure night hemoglobinuria (PNH) who had previously been administered Danicopan in a clinical trial commissioned by IQVIA. This clinical trial is an additional therapy for C5i and is a long-term extension (LTE) test to characterize Danicopan's safety and effectiveness. It is conducted at Seoul St. Mary's Hospital, Sung Vincent Hospital, Severance Hospital, Chungnam National University Hospital, Seoul Asan Hospital, and Samsung Medical Center. Danicopan is a PO Factor D inhibitor as a candidate for complement-mediated rare disease treatment such as Paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopy (C3G). In a phase 2 clinical trial conducted in PNH patients, it was found that the average hemoglobin level was increased in combination with the monoclonal antibody drug Soliris binding to C5 complement protein, reducing the need for blood transfusion. Danicopan was designated as an innovative treatment by the US FDA in September 2019 after being designated by the US FDA as a rare drug for the treatment of paroxysmal night hemoglobinuria in 2017. Danicopan is a drug that is being developed for use with C5 protein monoclonal antibodies to treat paroxysmal night hemoglobinuria (PNH), which only exhibited sub-optimal responses when treated using only C5 protein inhibitors. The FDA decided to designate innovative treatments based on positive efficacy and safety data derived from phase 2 clinical PNH combined test of Danicopan.
Policy
The first COVID-19 vaccine is expected to be approved
by
Lee, Hye-Kyung
Jun 28, 2022 06:09am
Seo Kyung-won, Director General of the National Institute of Food and Drug Safety EvaluationSK Bioscience's "SKY Covione," Korea's No. 1 COVID-19 vaccine, is expected to receive product permission within this month. Seo Kyung-won, Director General of the National Institute of Food and Drug Safety Evaluation, held a briefing at 10 a.m. on the 27th and said, "We will hold a final inspection committee within this month as possible and conclude the final item approval." The MFDS held a meeting of the safety and effectiveness verification advisory group for SKY Covione, which received item permits on April 29, and held the Central Pharmaceutical Affairs Council on the 26th to decide whether to recognize safety and effectiveness. According to the progress of the COVID-19 vaccine permit review, the final item approval will be granted after the 2nd Central Pharmaceutical Affairs Council and the 3rd final inspection committee following the 1st verification advisory meeting. Director Seo said, "SKY Covione is a meaningful vaccine that has been developed in Korea and completed everything from raw materials to commercialization," adding, "It is difficult to say the final approval date, but we are doing our best to take place within this month." The final inspection committee is a process of final inspection to see if the results of the first and second consultations are properly reflected in the permit, which leads to item approval immediately after this step. Meanwhile, the Central Pharmaceutical Affairs Council discussed whether to recognize the safety and effectiveness of SKY Covione and determined that safety, such as abnormal cases in clinical trials, was acceptable. The approval review is currently being conducted with two basic vaccinations, and additional booster shots will be decided after the clinical trial is completed. She added, "Additional vaccination is a clinical trial stage, and it is necessary to discuss with related ministries such as KDCA in the future whether the fourth additional vaccination is possible in preparation for the re-pandemic of COVID-19 in the fall."
Policy
Fenofibrate regardless of meals will be listed next month
by
Lee, Tak-Sun
Jun 28, 2022 06:09am
Fenofibrate tablets, which can be taken regardless of meals, will be listed for the first time in Korea. Fenofibrate is a drug used for primary hyperlipidemia. Existing drugs should be administered after meals. Therefore, the newly registered product is expected to improve the convenience of patients. According to the MOHW on the 24th, Yuhan's Fenowell 145mg will be listed at 339 won on the 1st of next month. Fenowell 145 mg is the only Fenofibrate tablet with 145 mg. In addition, it has the advantage of oral administration regardless of meals. It is used for primary hyperlipidemia such as hypercholesterolemia (Type IIa), hypercholesterolemia and hypertriglycerideemia (Type IIb, Type III), and hypertriglycerideemia (Type IV). Adults can take only one tablet (145 mg) a day regardless of meals. Existing Fenofibrate formulations should be administered orally immediately after meals at a dose of 160 mg. It is considered absorption in the stomach. Fenowell 145mg is absorbed by the gastrointestinal tract so it can be taken regardless of food intake. The original is Abbott's Tricor, which was approved by the US FDA in 2004. It is a drug that has not been introduced in Korea. Fenofibrate cholins can also be taken regardless of meal. There is TG Fenon, Daewon Pharmaceutical of Fenocholine by Korea Pharma. Hanmi's Fenocid can be taken regardless of meal. These items are now leading the market with this convenience. Yuhan preoccupied the related domestic market in November 2020 with the approval of Fenowell 145mg. In the same month, GC Pharma was also approved for the same product, Neofeno 145 mg. This product is commissioned by Yuhan. GC Pharma's product is not listed this time, so Yuhan is the only one that sells it with 145mg tablets. The price of 339 won is also cheaper than the existing tablets. Currently, the upper limit of 160mg of Fenofibrate tablets ranges from 316 won to 356 won. Excluding three of these products, the remaining 18 products are listed at the highest price of 356 won. Analysts say that despite the improved convenience of taking drugs, the price is also cheaper, which may serve as a factor for replacing prescriptions. GC Pharma's Lipidil supra, a leading item in the market, recorded 16.5 billion won in outpatient prescriptions last year. The total domestic market is also worth 90 billion won. Attention is being paid to whether the new limited product, which upgraded existing products, will be able to change its competitive structure in the market.
Policy
The use of Benzalconium chloride is not interrupted
by
Lee, Hye-Kyung
Jun 27, 2022 05:58am
As a result of reviewing the feasibility of safety management measures for drugs containing Benzalconium chloride used as humidifier disinfectants, it was concluded that there was no basis for restricting the use of drugs. Benzalconium chloride is used as daily necessities such as hand sanitizers, nose sanitizers, eyewash, preservatives, preservatives, antibacterial tissues, floor cleaners, and other medicines such as surgical tool disinfectants and skin disease treatments. According to the minutes of the Central Pharmaceutical Review Committee recently released by the MFDS, the safety of Benzalconium-containing drugs should be considered separately from repeated inhalation toxicity tests of Benzalconium chloride conducted by the Ministry of Environment. In the case of drugs, it is tested at 100% purity, but according to the repeated inhalation toxicity test conducted by the Ministry of Environment, the purity of Benzalconium chloride is 50.5%, which is not suitable for the toxicity test criteria for drugs. Although the nasal spray containing Benzalconium chloride has been used for a long time, there are no data that the product has caused problems in the respiratory system so far, so there were opinions that excessive information could cause fear to users. When comprehensively reviewing related data such as conference data, it is not enough evidence to stop using Benzalconium chloride in medicines based on the Ministry of Environment's report on repeated inhalation toxicity. The prevailing opinion was that the MFDS should end up with strengthening safety use and changing permits for information disclosure rather than suspending the use of Benzalconium-containing drugs. The MFDS said, "As a result of a comprehensive review of safety, efficacy, and adverse reactions, it should be judged in consideration of benefits and risks in medicines. We will collect opinions from external experts and provide accurate information." Rather than reflecting safety information only on precautions for use, it is necessary to ensure that meaningful information is delivered for patients who have no choice but to use drugs containing Benzalconium chloride, such as asthma treatments, according to their doctor's instructions, said a member. The MFDS reviewed various measures such as inquiring opinions on changing usage precautions to provide accurate information to consumers, and expressed its opinion that it would communicate between related ministries.
Policy
Is "Platform of Drug Delivery" starting?
by
Lee, Jeong-Hwan
Jun 24, 2022 05:46am
The Ministry of Science and Technology recently decided on the demonstration exception of OTC teleconference bending machine at the 22nd ICT regulatory sandbox meetingWill the new government's implementation of the OTC teleconference bending machine demonstration special case serve as a signal for full-fledged activation of the "drug delivery platform"? Analysts say that as the government introduced the OTC teleconference bending machine, which is virtually not allowed by the Pharmaceutical Affairs Act, regulations on platform operators such as drug delivery apps are also likely to be eased significantly in the future. In particular, the Ministry of Science and ICT seems to be more proactive in looking at deregulation as the situation develops rather than the MOHW at the forefront of management and regulation of non-face-to-face treatment and drug delivery apps. On the 23rd, the health and medical community is paying keen attention to the direction of the new government's digital platform policy operation. Yoon Seok-yeol's government has decided to foster the digital online platform industry as a national task. In order to revitalize new industries, it is in a position to boldly break down existing regulatory barriers and collect opinions from industries quickly and actively. The OTC teleconference bending machine regulation special case seems to be the result of reflecting this new government policy. The problem is that the OTC teleconference bending machine is a regulatory exception that is relatively local and has little ripple effect. Digital platform technology is not used in that electronic devices are installed inside and outside existing pharmacies to allow the sale of general drugs in some efficacy groups with the pharmacist's OTC teleconference bending machine medication map. In the end, it is evaluated that deregulation of digital platforms in the health care sector will gradually flow in the direction of activating drug delivery platforms. The new government is implementing a one-sided policy of deregulation of digital platforms every day. The Ministry of Science and Technology is planning to lead the promotion of platforms by jointly announcing strategies for developing digital platforms within this year. Minister of Science and Technology Lee Jong-ho recently held a policy forum with digital platform companies such as Naver, Kakao, and Coupang and promised to "establish a private-led self-regulatory organization." The plan is to increase the effectiveness by providing legal grounds for establishing and supporting self-regulatory organizations so that the private sector, not the government, can set up platform regulations on its own. Of course, health and medical platform companies such as drug delivery apps did not attend the forum, but the wider the scope of the government's promotion of the platform industry, the more likely the drug delivery apps will also benefit from deregulation. The opposition Democratic Party of Korea is expressing some concern about the stance of the new government. Even if the digital platform industry is fostered, the Democratic Party of Korea believes that deregulation should be applied conservatively in health care fields such as non-face-to-face treatment and drug delivery apps. It's directly related to national health It takes into account the fact that it can bring considerable shock waves to the health care delivery system such as local clinics and the ecosystem of pharmacies. An official from the Democratic Party's policy committee said, "The OTC teleconference bending machine was applied by the government to the regulatory sandbox track after it was put on hold during the legislative debate in the National Assembly. Although it was allowed, I don't think the actual ripple effect will be significant, he said. "However, there will definitely be an effect of activating platform operators such as drug delivery services." The OTC teleconference bending machine is an agenda limited to pharmacists in a way, but the activation of health care platforms such as non-face-to-face treatment and drug delivery apps will have a great impact on the medical community and the pharmaceutical community, the official said. It will be necessary to respond to platform regulations in the health care sector," he added.
Policy
A suspected Monkeypox patient entered Korea
by
Lee, Jeong-Hwan
Jun 24, 2022 05:46am
With two suspected Monkeypox infections confirmed to have entered Korea, President Yoon ordered accelerated approval of vaccines and antiviral drugs from quarantine authorities. On the 22nd, President Yoon ordered, "Strengthen the management of entry and quarantine through airports and closely monitor the additional occurrence in Korea." Currently, the quarantine authorities are conducting tests on one foreigner suspected of being infected with Monkeypox and one Korean among domestic arrivals. A suspected foreign infection entered the country by air on the 20th. From the 19th, blistering skin lesions occurred along with systemic symptoms such as sore throat and lymph node disease, and visited a hospital in Busan on the morning of the 21st. The hospital reported a suspected foreigner as a suspected monkeypox case and is currently being treated in an isolation bed. The suspected Korean entered Incheon International Airport from Germany at around 4 p.m. on the 21st and reported himself suspiciously to the Korea Centers for Disease Control and Prevention and was classified as a doctor by the airport quarantine office and the central epidemiological investigator. Suspected patients are suspected of monkeypox in consideration of clinical symptoms or epidemiological associations, but there are no test results that meet the test criteria for diagnosis. The suspected patient was transferred to Incheon Medical Center for treatment after waiting for an airport quarantine facility. The quarantine authorities plan to hold a briefing as soon as the results of the Monkeypox diagnostic test and epidemiological investigation are released. In the news, President Yoon ordered the rapid distribution of vaccines and treatments and ordered the introduction of third-generation smallpox vaccines and Monkeypox treatments in Korea. President Yoon ordered, "If necessary, prepare fully so that the vaccines and treatments currently secured can be quickly distributed to the medical field and complete the introduction of additional third-generation vaccines and antiviral drugs for Monkeypox as soon as possible."
Policy
Abnormal cases of Inlyta in PMS for 9 yrs is 82.8%
by
Lee, Hye-Kyung
Jun 24, 2022 05:45am
As a result of a post-marketing survey of Korea Pfizer Pharmaceutical's kidney cancer treatment Inlyta, the incidence of abnormal cases was 82.88% regardless of the causal relationship. As a result of conducting PMS on 111 people over 9 years for re-examination, 92 people (338 cases in total) showed abnormal cases regardless of causality. Among them, 7.31% of the serious adverse drug reactions that cannot be excluded from the causal relationship and 14.41% of the unexpected adverse drug reactions. The MFDS announced that it plans to reflect it from September 21st after completing a preliminary notice of changes to permits according to the results of PMS. Serious drug adverse reactions in 7 out of 111 patients were pulmonary artery thrombosis, cerebral infarction, anemia, helplessness, and diarrhea. Unexpected adverse drug reactions appeared in 16 out of 111 people, and side effects such as rhinitis, gingivitis, pneumonia, edema, chest discomfort, acne, difficulty in urination, difficulty in swallowing, toothache, peripheral neuropathy, and gout appeared. Meanwhile, Inlyta was approved for domestic market on August 22, 2012. At the time of approval, it was given 6 years of re-examination for indications of progressive renal cell cancer that failed to treat one systemic therapy, but the PMS period increased to 9 years as it maintained non-reimbursement for 3 years due to delayed registration. According to the AXIS phase 3 comparing the treatment effects of Inlyta and Nexavar, the median duration of progression-free survival in the Inlyta administration group was 8.3 months, which reduced the disease progression risk by about 34% compared to 5.7 months in the Nexavar administration group.
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