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- 2026-05-15 22:34:47
- 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.
- Company
- Celltrion Stops Developing Inhalation-type COVID Antibody Tx
- by Kim, Jin-Gu Jun 29, 2022 05:53am
- Celltrion announced on the 28th that it will suspend phase 3 clinical trials of inhalation-type antibody treatments that were being developed as COVID-19 treatments. Celltrion explained the reason for the clinical suspension that the business feasibility of the COVID-19 treatment will be insignificant due to the difficult global clinical environment. Celltrion judged that the business feasibility would be insignificant as the number of phase 3 clinical patients required by global regulators is larger than expected amid the rapid transition of coronavirus to endemic diseases due to the global spread of Omicron subvariations and expansion of vaccinations. According to Celltrion, global regulators are avoiding "fast-track" procedures such as emergency approval in line with full-fledged entry into Endemic. Regulatory agencies are reportedly increasing the threshold as several global pharmaceutical companies have recently failed to prove their effectiveness due to weakening pathology in clinical trials of COVID-19 treatments for standard risk groups, not high-risk groups. Celltrion has previously completed phase 1 clinical trial of inhalation-type antibody treatments and approved a global phase 3 clinical trial plan for inhalation-type cocktail COVID-19 treatments, which added CT-P63, a candidate substance for COVID-19 treatments. However, Celltrion plans to closely monitor the current status of the COVID-19 pandemic in the future and continue to manage and research on the pool of COVID-19-responding cocktail candidates that have been built since the beginning of the pandemic. It will continue to study the development platform of mRNA vaccines and oral COVID-19 treatments that can prepare for future pandemics. Celltrion is developing oral COVID-19 treatment products under generic licenses secured at the group level to expand access to treatments in low- and middle-income countries, and aims to supply them early next year. An official from Celltrion said, "Celltrion has actively contributed to overcoming the global pandemic by focusing on the development of antibody treatments for the first time in Korea and supplying them at home and abroad, but the clinical and licensing environment of COVID-19 treatments is changing." He added, "We will reorganize the direction of developing COVID-19 treatments by watching international environmental changes in the face of an endemic transition, and focus on developing various pipelines currently facing clinical and permission."
- Company
- Patent challenge for gastritis drug Rebamipide expanded
- by Kim, Jin-Gu Jun 29, 2022 05:53am
- 30 generic companies participated in the patent dispute for Yuhan's acute and chronic gastritis treatment "Recomid SR." According to the pharmaceutical industry on the 24th, 20 pharmaceutical companies, including Kyung Dong, recently requested a passive judgment on the scope of rights to Recomid SR's patent. Prior to them, 13 pharmaceutical companies, including Mother's, also challenged the same patent. However, Dongkwang, Samjin, and Huons, which previously requested a patent trial, voluntarily withdrew. As a result, a total of 30 companies are challenging Recomid SR patents. Mother's are the first companies to file a claim as well as Kyung Dong, Nexpharm, Daewoong Bio, Dahannupharm, Dongkook, Dongwha, Litepharmtech, Vivozon, Samil, SCD, Sinil, CMG, Arlico, Alvogen Korea, HLB, Aprgen, YS, Withus, Unimed, Reyonpharm, Ilhwa, Genuonesciences, Joonghun, GLPharma, Pharmgen Science, BNC Korea, Korea Pharma, Hutecs, and Hanlim. The reason why 30 generic companies challenged the patent is that Recomid SR grew rapidly in the pharmaceutical industry. The drug was jointly developed by Yuhan Corporation, GC Pharma, Daewoong Pharmaceutical, and Daewon Pharmaceutical. It received permission in December 2020 and released the product at the same time in March last year. Yuhan Corporation will entrust the production of the remaining three companies. Patents are also in Yuhan Corporation. Recomid SR is taken twice a day. According to the MFDS, the combined production performance of the four companies reached 15 billion won in the 10 months since its release in March last year. Sales of Yuhan's Recomid SR is 5.8 billion won, GC Pharma's Mucotect SR is 4 billion won, Daewon Pharmaceutical's Bidreba SR is 2.9 billion won, and Daewoongs Mucotra SR is 2.4 billion won. In contrast, the combined production performance of the four existing products was only 3.7 billion won. The original pharmaceutical company for Rebamipide is Otsuka. In 1991, Mucosta was granted permission. Production of tablets last year was 16.7 billion won. On top of that, Otsuka was approved for Mucosta SR in January last year and released the product a month later than Yuhan Corporation. SR Product's performance last year was 3.5 billion won.
- 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."
- Company
- Kwangdong will sell GSK’s allergic rhinitis treatment
- by Chon, Seung-Hyun Jun 28, 2022 06:09am
- Kwangdong Pharmaceutical announced on the 27th that it has signed a sales partnership agreement with GSK for its allergic rhinitis treatment, ‘Avamys nasal spray.’ Avamys, which was granted marketing authorization in Korea in 2009 is a steroid nasal spray indicated for the treatment of seasonal and perennial (year-round) allergic rhinitis in people 2 years of age and older. It mainly helps reduce the symptoms of allergic rhinitis such as itchy eyes, nasal congestion, runny or itchy nose, etc., and may be prescribed at the doctor’s discretion in various departments including otolaryngology, internal medicine, and pediatrics. Avaymys contains the active substance fluticasone furoate 0.05g that is provided in a spray-type device that is easy to spray into the nasal cavity and may be sprayed up to 120 times. Its 24-hour relief of allergy symptoms is also considered one of its biggest conveniences. An official from Kwangdong Pharmaceutical said, “We have decided to expand our business relations based on the strong trust established between the two companies since 2015 when we began working with GSK for the sale and distribution of their vaccine. We hope to further contribute to improving the allergic rhinitis treatment environment for the suffering patients and HCPs with Avamys.”
- 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.
- Company
- Oral SMA drug Evrysdi may be prescribed at general hospitals
- by Eo, Yun-Ho Jun 27, 2022 05:58am
- The oral spinal muscular atrophy (SMA) treatment ‘Evrysdi’ may be prescribed at general hospitals. According to industry sources, Roche Korea’s SMA treatment Evrysdi (risdiplam) passed the drug committee (DC) reviews of several medical institutions including Seoul National University Hospital. Evrysdi was first approved in Korea in November 2020 ‘to treat SMA in adults and children 2 months of age and older.’ In the US, its indication has recently been extended to cover infants less than 2 months of age. As the first oral option introduced in the field of SMA, Evrysdi has the advantage of allowing customization according to age and weight. However, its reimbursement listing process is making little progress. The drug applied for listing in July last year but had made no progress so far. Currently, Biogen’s ‘Spinraza (nusinersen)’ is listed for reimbursement in SMA, and Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) is under drug pricing negotiations with the National Health Insurance Service. As Roche Korea may accept a relatively lower price for Evrysdi than the other high-priced drugs above, this reimbursement competition may also be worth attention in the future. Meanwhile, Evrysdi’s efficacy has been demonstrated through the FIREFISH trial conducted on infants from 2 months to 7 months of age, and the SUNFISH trial conducted on children and adults from 2 years to 25 years of age. In the SUNFISH trial on 180 Type 2 or 3 SMA patients, Evrysdi improved motor function at month 12, as measured by the Motor Function Measure 32 (MFM-32) score from baseline. Also, in the FIREFISH trial that was conducted on infants 2 to 7 months of age with Type 1 SMA, 88% of the patients that were administered Evrysdi for 2 years survived the 2 consecutive years without ventilator support. Based on the Bailey Infant Development Test (BSID-III) that measures infant development and motor activity, 59% of the infants that were administered Evrysdi were able to sit without support for at least 5 seconds. Also, 65% of the infants were able to control their neck for 1 year, 29% were able to turn on their buttocks, and 30% were able to stand with support.
