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- 2026-05-03 20:52:20
- Policy
- Darzalex succeeded in renewing his contract with RSA
- by Kim, Jung-Ju Dec 26, 2022 06:07am
- Darzalex, a treatment for multiple myeloma by Janssen Korea, has succeeded in negotiating a contract renewal with the NHIS. As a condition for renewal of the contract, the drug price was reduced by 2% by content, and RSA plans such as refund rate and cap were also set. According to the industry, the Ministry of Health and Welfare will push for a revision of the "drug benefit list and upper limit table," which includes Darzalex price cut, based on the renewal of the RSA contract between the NHIS and the company. This drug is used to treat multiple myeloma, which failed to treat at least three treatments, including proteasome inhibitors and immunomodulatory agents, and the alternative drug is Dexamethasone which is listed in all of the A77 countries (the United States, France, Germany, Italy, Britain, Switzerland, and Japan). When the RSA-applied drug approaches the expiration of the contract period, the NHIS evaluates the clinical usefulness and cost-effectiveness of the drug in advance. Based on the results, the corporation and pharmaceutical companies renegotiate RSA negotiations on the reduction price, expected claim amount, refund rate, and cap. The drug succeeded in signing its first RSA contract with the NHIS on April 8, 2019, as a Refund with Expenditure Cap, and was set to expire in early April next year. The company conveyed its intention to renew the contract to the NHIS, and renegotiated with the NHIS from September 23 to the 24th of last month after the NHIS review. As a result, the drug price by content was reduced by 2%. The NHIS expected to cut the drug price to 2% compared to the existing upper limit, which is expected to reduce the budget for health insurance. The time to apply the cut price is April 8th next year.
- Policy
- Dong-A ST’s Forxiga prodrug Dapapro 5mg listed for reimb
- by Lee, Tak-Sun Dec 26, 2022 06:07am
- Following the reimbursement listing of the 10mg formulation of Dapapro Tab, the first follow-on drug of the antidiabetic SGLT-2 inhibitor Forxiga that had been developed by Dong-A ST, the 5mg lower-strength formulation of the drug is also soon to be listed with reimbursement. When listed, Dapapro Tab 5mg will be the only dapagliflozin drug to be reimbursed and will have the potential to exclusively take over the market. Reimbursement of the original Forxiga 5mg has been removed from the list. According to industry sources on the 23rd, Dong-A ST’s Dapapro Tab 5mg will be listed at an insurance ceiling price of KRW 456 per tablet. Dong-A ST had already launched Dapapro Tab 10mg with reimbursement for KRW 684 per tablet starting this month. This was the first Forxiga latecomer to be listed for reimbursement. Other Forxiga latecomers can only be released after the original drug’s patent expires in April. Therefore, the company is expected to make every effort to preoccupy the market before the entry of its competitors. Dong-A ST was able to release its product before patent expiry because its product is a prodrug that has a different chemical structure from the original. However, once absorbed, the structure changes and the drug shows the same effect as the original. Dong-A ST was able to invalidate 917 days added to Forxiga’s substance patent through its prodrug strategy, with the court ruling in favor of Dong-A ST in the passive trial to confirm the scope of the patent that was filed against Forxiga’s substance patent. However, the final winner of the patent suit is yet to be determined as there is a high possibility that AstraZeneca, the patent holder, will appeal. However still, DongA-ST decided to release Dapapro Tab 10mg to preoccupy the market. The Dapapro Tab 5mg that will soon be listed will also be released to the market. Moreover, DongA-ST’s Dapapro Tab 5mg is the only 5mg formulation to be reimbursed. The original Forxiga 5mg Tab had been removed from the reimbursement list in October 2018. As the 5mg strength is the recommended initial dose for patients who have not been treated with drugs for diabetes before in combination with metformin, it is expected to be quite well used in the market. However, AstraZeneca is focusing on the main dose, 10mg strength of dapagliflozin. This is why its combination drugs containing 5 mg of dapagliflozin, Xigduo XR Tab 5/500mg, and Xigduo XR Tab 5/1000mg still remain reimbursed. Therefore, Dong-A ST will be on its own in the dapagliflozin 5mg market until AstraZeneca’s patent expires in April next year. However, dozens of dapagliflozin follow-on drugs are expected to pour in after patent expiry. In addition, Daewoong Pharmaceutical is also aiming for an early release of its SGLT-2 class new drug 'Envlo Tab.’ Therefore, competition among domestic companies in the SGLT-2 inhibitor market will intensify after April. Therefore, from Dong-A ST’s perspective, the next four months will serve as an important period for them to measure the drug’s performance.
- Policy
- Zavicefta has been approved for domestic use
- by Lee, Hye-Kyung Dec 26, 2022 06:06am
- .The Ministry of Food and Drug Safety (Director Oh Yu-kyung) announced on the 22nd that it has approved Korea Pfizer Pharmaceutical's "Zavicefta 2g/0.5g (Ceftazidime/Avibactam)," a new antibiotic drug. This drug is a combination of Cefalosporin-based antibiotic Ceftazidime and avibactam, a newly developed beta-lactam inhibitor. Permitted efficacy and effect are ▲Infection treatment in the complex abdominal cavity for adults and children over 3 months old ▲Infection treatment in the complex urinary tract including nephritis for adults and children over 3 months old ▲Infection treatment in hospitals for adult patients over 18 years old. It is a drug developed by Zavicefta AstraZeneca and sold the development and copyright of the global market outside the U.S. in the low-molecular antibiotic business to Pfizer on August 24, 2016. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities to patients by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Exclude Australia from the drug price reference country?
- by Lee, Tak-Sun Dec 26, 2022 06:06am
- Insurance authorities, which are seeking to expand drug reference countries from seven to nine from next year, are expected to exclude Australia from strong opposition from the pharmaceutical industry. It is said that the government has turned to a careful review after a meeting with the Vice Minister of Health and Welfare and the pharmaceutical industry held last week. The HIRA is expected to finalize the plan announced by internal regulations within this week and announce it soon. According to industries on the 22nd, there is a possibility that an amendment excluding Australia will be announced in the revised bill, which was announced by adding Australia and Canada to the drug price reference country. Earlier, the HIRA announced on the 21st of last month a revision to regulations on evaluation standards and procedures, including whether drugs are subject to concessionary benefits, including the U.S., Britain, Germany, France, Italy, Switzerland, and Australia. It will take effect on 1 January next year. The HIRA explained the revision, "We are using the adjusted price, which translates the drug price of seven foreign countries (A7), to evaluate the adequacy of new drug benefits, but we want to improve transparency and clarity and supplement its validity." When the revision was announced, the pharmaceutical industry strongly protested. In addition to the KPBMA, which represents domestic pharmaceutical companies, KRPIA, which has multinational pharmaceutical companies, issued a statement and made clear its opposition to the addition of Australia. Domestic pharmaceutical companies are concerned that the addition of Australia, which has low generic drug prices, could significantly lower the domestic generic drug price in the re-evaluation of registered drugs that reflect this. Foreign pharmaceutical companies are also strongly opposed to the revision that if Australia, which has low drug prices, is added, the price of new drugs will be lowered, further reducing patient accessibility. At a meeting with Park Min-soo, the second vice minister of the Ministry of Health and Welfare, pharmaceutical organizations, and CEOs of pharmaceutical companies on the 16th, the industry expressed concern about Australia's addition to the reference country. At the meeting, Vice Minister Park also said, "We will listen to the opinions of the field under the stance of increasing the sustainability of the health insurance finance and carefully look at ways to improve the system, including insurance drug price policies." It seems to have changed to a careful review. For now, the Ministry of Health and Welfare is said to have presented its revised opinion, and it is believed that it felt burdened to announce the existing plan as it is, conscious of the controversy within the HIRA. A senior HIRA official also said, "As the purpose of the amendment was to supplement the validity of the existing calculation formula, we are carefully considering ways that all stakeholders can accept." The HIRA is expected to draw up a final draft as early as this week and immediately announce the amendment without further notice.
- Policy
- Revlimid's benefit for multiple myeloma maintenance therapy
- by Lee, Tak-Sun Dec 23, 2022 06:05am
- Revlimid, a treatment for multiple myeloma, is eligible for maintenance therapy for hematopoietic stem cell transplantation patients. The effective date is January 1 next year. The HIRA has launched an opinion survey on the revision of the anti-cancer drug standard. According to the revision, benefits will be newly established for maintenance therapy for newly diagnosed multiple myeloma patients who have reacted more than stable stool after transplanting Revlimid into autologous hematopoietic stem cells. The administration starts six months after the end of the transplant, and as a result of the response evaluation, the administration was stopped when the disease progressed. In response, the HIRA said that Lenalidomide, including Revlimid, is a drug licensed to maintain multiple myeloma patients who have been newly diagnosed with autologous hematopoietic stem cell transplants, and that this therapy is mentioned as standard treatment in textbooks, and is also recommended by the NCCN Guidelines (2022) and ESMO Guidelines (2021). In particular, in a random assignment, double-blind, and phase 3 clinical trial (CALGB) for patients with multiple myeloma who received a newly diagnosed autologous hematopoietic stem cell transplant, it was confirmed that it was clinically useful compared to those who did not perform maintenance therapy, and added that benefit standards were set. The clinical trial results showed 57.3 months of progression-free survival median (mPFS) (28.9 months in the control group) and 113.8 months of total survival median (mOS) (84.1 months in the control group). The revised bill also introduced a combination of adjuvant and Fluorouracil + Leucovorin for biliary tract cancer. Pediatric combination therapy among "Dasatinib + chemotherapy" has been modified and supplemented for acute lymphocytic leukemia. This is in response to a request to change the Korean Pediatric Blood Oncology Association. At the same time, Niraparib monotherapy (more than 4th round) was deleted from ovarian cancer, ovarian cancer, and primary peritoneal cancer palliative, while Paclitaxel + Cisplatin (Intra-peritoneal) combination therapy was also deleted for other cancers.
- Policy
- Lucentis biosimilar price set 63% lower than original
- by Lee, Tak-Sun Dec 23, 2022 06:05am
- Samsung Bioepis Biosimilars of the macular degeneration treatment Lucentis (ranibizumab), which are set to be listed for reimbursement in Korea next month, are expected to be launched at a price much lower than their original. As a result, the burden borne by these patients is expected to be reduced significantly. According to industry sources on the 21st, the Lucentis biosimilars that are expected to be listed with reimbursement next month will be launched at a price 44~63% lower than the original version’s insurance ceiling price. Chong Kun Dang’s LucenBS Inj is set to be listed at KRW 300,000 per vial. The original version with the same ingredient of the same strength, Lucentis Inj 10mg/mL (3mg/0.3mL) is priced at KRW 820,636 per vial. When listed, CKD’s product will be 63.4% cheaper than the original. Samsung Bioepis’s Amelivu Inj is set to be listed at KRW 463,773. The original version with the same ingredient of the same strength, Lucentis Inj 10mg/mL (2.3mg/0.23mL) is priced at KRW 828,166. When listed, Samsung Bioepis’s product will be 44% cheaper than the original. Even if the original drug's ceiling price drops by 30% after the listing of biosimilars, Chong Kun Dang's LucenBS will still be 47.7% cheaper and Samsung Bioepis’s Amelivu 20% cheaper. Lucentis had been considered a drug with a high patient burden due to its high price. In particular, due to the strict reimbursement standards, patients unable to meet the standards had to pay the full amount without reimbursement. The situation had been eased somewhat since 2017 after the limit on the number of uses had been lifted, somewhat reducing the burden on patients. With the listing of cheaper biosimilars, patients are expected to have a broader range of choices and less burden from treatment costs. Lucentis’s annual sales in Korea have recorded KRW 35.1 billion (based on IQVIA 2021). Just one-third of the sales will be KRW 10 billion. This is why the two companies opted to release their biosimilars at a drastically reduced price to penetrate the market. Also, Chong Kun Dang brings its strong sales power, and Samsung Bioepis partners with Samil Pharm, an ophthalmology drug-specializing company, to start full-scale sales and marketing activities.
- Policy
- New reimbursement standards set for Kymriah·Zolgensma
- by Kim, Jung-Ju Dec 22, 2022 05:52am
- New reimbursement standards have been set for high-priced pharmaceuticals like Kymriah and Zolgensma, the so-called ‘one-shot treatments.’ Also, reimbursement standards will be newly established for the second CGRP-targeted therapy for migraine, Ajovy (fremanezumab), and the new tuberculosis drug Dovprela 200mg (pretomanid) that had been the first to be developed in half a century, as the drugs will be listed for reimbursement starting on January 1. The Ministry of Health and Welfare issued a pre-announcement of an administrative notice for the ’Proposed Partial Amendment of Details Regarding the Standards and Methods for Applying Medical Care Benefits (drugs)’ that contain the details stated above, and will be collecting opinions until the 28th. First, a new standard will be established for the reimbursement management of high-priced pharmaceuticals. With ‘one-shot treatments’ Kymriah and Zolgensma being listed this year, a new reimbursement standard was needed for the management of such high-priced drugs. Thus, the government and the Health Insurance Review and Assessment Service established new reimbursement standards that specify those subject to reimbursement management and how they can prepare a medical care benefit expense statement. Under the new standards, the follow-up management period for Kymriah has been set to 1 year when administered for non-Hodgkin lymphoma, and Zolgensma to 5 years. Also, new reimbursement standards were set for the Ajovy autoinjector and Ajovy pre-filled syringe, the CGRP-targeted new therapies for migraine, as well as the new tuberculosis drug Dovprela tab, which are set to be listed on the 1st of next month. In the case of Ajovy, response evaluations with headache diaries and MIDAS should be performed within a month before administration and every 3 months thereafter. If the number of monthly migraine days is not reduced by over 50% from baseline at any response evaluation, administration will be discontinued. The administration period was set to 12 months, and switching between anti-CGRP migraine prevention drugs is not accepted for reimbursement. In the case of Dovprela 200mg, patients must first apply in advance and are granted reimbursement by the KDCA to receive reimbursement. The details for the KDCA’s approval including its procedure, method, and committee member composition will be determined by the KDCA commissioner. The Praluent pen inj 75mg (evolocumab) and other alirocumab injections will be extended reimbursement to patients confirmed with heterozygous familial hypercholesterolemia (heFH) as diagnosed by a score of 6 or higher on the Dutch (2004) diagnostic criteria or ‘definite heFH or possible heFH' under the Simon Broome (2006) standards. The government and HIRA explained that it had received an opinion from a relevant academic society that patients with a high LDL-C level (over 190mg/dL) with a family history should be regarded as heFH patients and be treated accordingly. Clinical literature (RUTHERFORD-2, 2015) showed studies were conducted with patients with definite heFH or possible heFH based on Simon Broome (2006) standards, and NICE had described heFH as “patients with a score of 6 or higher on the Dutch (2004) diagnostic criteria or definite heFH or possible heFH' under the Simon Broome (2006) standards.” Also, with Nuvorozet tab. 40/2.5/5/10mg being newly listed next month, the government and HIRA decided to add the combination to the list of oral fixed-dose combinations that have already been listed for reimbursement. The new combination added is ‘S-amlodipine+telmisartan+rosuvastatin+ezetimibe.’ Also, reimbursement standards for the 25mg strength of K-Cab 50mg (tegoprazan) will be extended with its listing next month. In addition to its already-reimbursed indications as ▲treatment of erosive and non-erosive gastroesophageal reflux disease, ▲ treatment of gastric ulcer, the drug will be additionally reimbursed as ‘maintenance therapy after the treatment of erosive GERD (only the 25mg strength).' 10mg strengths of Lucentis inj and Lucentis prefilled syringe (ranibizumab) are also set to be newly listed for reimbursement. Therefore, reimbursement standards for the ingredient will be modified, and in consideration of the differences in indication by product, a new phrase was added to allow the administration of the drug within the scope of each drug’s indication.
- Policy
- Lucentis biosimilar enters KRW 35B market in Korea
- by Lee, Tak-Sun Dec 21, 2022 06:05am
- Samsung Bioepis’s Lucentis biosimilar that was released in the US in June Competition in the macular degeneration treatments market is expected to intensify with the imminent entry of the first biosimilar of ‘Lucentis’ in the Korean market. Sales of Lucentis alone had been nearly KRW 35 billion in Korea last year. Lucentis biosimilars from Chong Kun Dang and Samsung Bioepis were preannounced to be listed for reimbursement starting next month. According to industry sources on the 20th, the Ministry of Health and Welfare issued an administrative notice announcing the partial amendment to the reimbursement standards of some pharmaceuticals that included the introduction of Lucentis biosimilars. Previously, 2 Lucentis biosimilars were approved in Korea this year. Samsung Bioepis first received approval for its biosimilar under the name ‘Amelivu inj’ in May, followed by Chong Kun Dang’s ‘LucenBS inj’ in October. Both products are expected to be released with reimbursement next month. Like Lucentis, the two biosimilars will be reimbursed for all 4 indications: neovascular wet age-related macular degeneration (AMD), macular edema caused by diabetes, macular edema caused by retinal vein occlusion, and choroidal neovascularization secondary to pathologic myopia. Amelivu will be sold by Samil Pharmaceutical, which specializes in ophthalmic treatments. Samsung Bioepis and Samil Pharmaceutical signed a commercialization agreement for Amelivu in June this year. LucenBS is the second biosimilar to be developed by Chong Kun Dang. Its first biosimilar product,’Nesbell,’ which is a biosimilar of the anemia treatment NESP, was approved in November 2018. Considering the considerable size of the domestic market for Lucentis in Korea, Chong Kun Dang is expected to launch a large-scale marketing campaign to take a share of the market. The domestic macular degeneration treatment market is currently shared by two products – Bayer’s ‘Eylea,’ and Novartis’s Lucentis. According to IQVIA, their sales last year were KRW 70.5 billion for Eylea and KRW 35.1 billion for Lucentis. The global macular degeneration treatment market size is around KRW 13 trillion. This is why domestic biosimilar companies are also eyeing the global market. Samsung Bioepis released its Lucentis biosimilar ‘Byooviz’ in June in the US and is planning to also advance into the European market. In the case of Chong Kun Dang, the company is working to advance into Japan and Southeast Asia. Also, Celltrion, Sam Chun Dang Pharm, and Samsung Bioepis are developing Eylea biosimilars.
- Policy
- Shingrix will be released as a national lot on the 16th
- by Lee, Tak-Sun Dec 21, 2022 06:05am
- GSK shingles vaccine against herpes zoster preventionShingrix (GSK), a shingles virus vaccine, received a national lot release on the 16th and began full-scale vaccination. It was also stocked in general hospitals, and vaccinations began this week. On the 16th, the Ministry of Food and Drug Safety released four production numbers (six in total, 0.5ml in packaging) with an expiration date of October 31, 2024. The National lot release is a system in which the Ministry of Food and Drug Safety allows only suitable items to be sold through quality inspection. Shingrix products approved for shipment were immediately stocked at general hospitals and vaccination began this week. GSK held a press conference on the 15th to commemorate its launch in Korea. In Korea, GC Pharma and Kwang Dong sell together. Shingrix is the first shingles vaccine in Korea that has been approved by combining GSK's immune enhancer with a non-live antigen. Two global phase 3 (ZOE-50 and ZOE-70) conducted on 15,411 adults over the age of 50 have a 97.2% preventive effect and more than 90% preventive effect in all age groups over the age of 70. This is because existing commercially available products have a preventive effect of less than 70%. It is known that the price is a little high. Shingrix is inoculated twice every two months, and it is known to cost about 500,000 won for two vaccinations. Zostervax, which is most commonly used to prevent shingles, is only inoculated once and sold for about 150,000 won.
- Policy
- Pfizer & Novartis generic drugs disappear from the market
- by Lee, Tak-Sun Dec 20, 2022 06:06am
- All generic drugs released by Novartis and Pfizer Korean branches in the domestic market have disappeared. Although it was successfully released, it is interpreted that it left the market after losing a lot of competition with domestic pharmaceutical companies. According to industries on the 19th, Novartis' Pneumast 10mg and Pneumast 3mg were removed this month due to voluntary withdrawal of item permits. Pneumast is an organon asthma treatment Singulair generic drug licensed by Novartis Korea in October 2012. In the domestic market, Singulair generic was released in December 2011. Pneumast came out belatedly, and it is analyzed that it failed to show off its presence among numerous domestic generics. Sandoz, a generic subsidiary that Novartis recently decided to spin off, has also withdrawn from the Singulair generic business in the Korean market. As the benefit of Pneumast of Novartis Korea was deleted, all generic drugs under the name of Novartis Korea disappeared. Earlier in June 2020, Novartis withdrew its license to treat hyperlipidemia, Atorvin. Atorvin is Viatris' Lipitor generic drug. Pfizer also lost all generic drugs in a few years. Pfizer introduced Pfizer Vitals, a generic brand, in 2012. It was a business that LG Chem produced and sold licensed products by Pfizer. All products that were approved at that time have disappeared. Norvasc V withdrew the permit due to the Balzartan impurity incident in December 2019, followed by Montelu V in February 2020, Cilo V in May 2021, and Clo V in December 2021. In addition, in December 2021, Norvasc T, a high blood pressure compound, was involved in the false preparation of Jeil's data, and the license was revoked. As a result, domestic generics of Pfizer and Novartis have all disappeared. "At first, foreign pharmaceutical companies put forward their brands and quality through quality generics, but it was difficult to compete with domestic pharmaceutical companies with large hospital distribution networks based on their sales power," said an official in the domestic pharmaceutical industry.
