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- 2026-06-30 12:24:17
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- Get rid of Imotun & Godex which waste taxpayers' money
- by Dec 22, 2022 05:52am
- Pharmaceutical Society for a Healthy Society (CEO Shin Hyung-geun) has called for the expulsion of Imotun and Godex. In a statement on the 21st, the Pharmaceutical Association for Health Society argued that maintaining health insurance benefits for six-component compounds (Godex) including avocado-soya unexamined (Imotun) and adenine hydrochloride (60 billion won) are not valid in terms of clinical usefulness, cost-effectiveness, and social needs. They said Imotun and Godex are drugs whose clinical usefulness is unclear. "Although Imotun's clinical usefulness is based on the recently revised rheumatology textbook, there is no SCI-listed clinical journal that validates knee osteoarthritis patients over the past four years, and foreign rheumatology textbooks and guidelines related to the International Osteoarthritis Society are all described at the supplement level as preferred." In addition, France, the original developing country that first licensed Imotun as a drug, concluded in 2013 that it does not recommend Imotun as a salary due to its unclear clinical usefulness, and no one in developed countries supports the purchase of Imotun. Chong Kun Dang, a domestic seller, also conducted clinical trials on 300 people at university hospitals in Korea from 2013 to 2016, but it is pointed out that related results have not been disclosed. It is the position of the health drug that Imotun and Godex are not cost-effective and that social demands are low. They said, "Imotun and Godex are basically drugs that are difficult to confirm their effectiveness, and patients have no choice but to take the medicine according to their prescription regardless of their economic situation." Even if it is supported by health insurance benefits, Imotun must spend 3,400 won and Godex 17,000 won per month, he said. "In addition, Imotun is a drug that threatens health insurance finances of 40 billion won per year and Godex is 60 billion won per year, and social needs to be evaluated to delete benefits." The Pharmaceutical Society for the Health Society said, "Over the past few years, we have demanded the removal of drugs that are not clinically useful, including Colin Alpo, but as of December 2022, not a single drug has been removed from health insurance benefits. The reason why this revaluation system was not implemented properly is that the Ministry of Health and Welfare is looking at pharmaceutical companies, he said. "The Ministry of Health and Welfare should review the decisions of Emoton and Godex's Pharmaceutical Evaluation Committee and quickly come up with new measures to control unnecessary drug use."
- 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.
- Company
- PO SMA tx Indication of Evrysdi expands
- by Eo, Yun-Ho Dec 21, 2022 06:05am
- Evrysdi, a PO SMA treatment, can be used for infants under 2 months in Korea. According to related industries, Evrysdi recently obtained approval from the Ministry of Food and Drug Safety to expand the indication. Accordingly, Evrysdi can be administered to newborns before symptoms appear in Korea. The expansion of neonatal indications was based on the results of phase 2 clinical RAINBOWFISH. In the study, the efficacy, safety, pharmacokinetics, and pharmacokinetics of Evrysdi were evaluated for asymptomatic SMA patients who were genetically diagnosed up to 6 weeks of age regardless of the number of SMN2 genes. The primary target point was set as the proportion of patients who could sit without assistance or support for 5 seconds. By the time of the data cutoff, a total of 26 patients were registered. Their age was 28.5 days (central value), and they were diagnosed with SMA based on genetic testing but had no symptoms. Evrysdi, the first PO option as an SMA treatment, has the advantage of being able to be customized according to age and weight. The process of registering insurance benefits is still slow. It is not on the HIRA's public list of any committees. It remains to be seen whether Evrysdi will be able to expand its coverage in 2023 along with the expansion of the indication. Meanwhile, Biogen's Spinraza and Novartis' Zolgensma are currently listed in the SMA area in Korea.
- 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.
- Opinion
- [Reporter’s View] Preserve the industry's willpower
- by Dec 21, 2022 06:05am
- Even before the world was able to recover from the COVID-19 pandemic, a global economic recession has arrived to further the damage. With the rise in the price of raw materials, the price of every single consumable including food such as flour, sugar, and cooking oil, as well as fuel, utility bills, etc. have risen. Every day, you can see a flood of articles that report “the price of noodles has risen” or that “eggs cost a fortune these days.” In the age of rising prices, only the price of pharmaceuticals seems to be on the decline. In Korea, the price of pharmaceuticals is on a constant decline under strong state control. The only exception was the price of cold medicine. Their price was recently raised due to a surge in demand for cold medicine during the COVID-19 pandemic. This premium pricing was proposed by the government as a ‘joker card’ to incentivize companies that were reluctant to manufacture more cold medicine due to concerns over deficits. The increase, which was a mere KRW 40 raise from the previous KRW 50 to KRW 90, was a rare exception made under special circumstances. Looking at the government’s recent policy direction, the prospects for pharmaceuticals are even dimmer. More drugs will be subject to reimbursement reevaluations that had significantly affected domestic pharmaceutical companies. Choline alfoscerate drugs have already taken a blow, and other ingredients including streptokinase, almagate, and avocado-soya have been subject to reevaluations and received reductions in their scope of reimbursements or price cuts. These reevaluations are expected to continue on next year. New drugs are not much better off, either. The government recently announced plans to include Australia and Canada as drug price reference countries. Australia is known to have one of the lowest drug prices among developed countries. As the drug prices in Australia are similar to or lower than that of Korea, the industry had criticized how the government is seeking to add these countries to further lower the state’s pharmaceutical expenditures. Industry concerns are rising on how if Australia is included as a drug price reference country, drug prices in Korea, which are already on the lower side in the global market, will be set even lower. While manufacturing and distribution costs are all on the rise, it is clear that the price of end products, the medicines, will continue to fall in Korea. Even the development of new drugs is not easy to carry out. Biotechs specializing in new drug development have also been experiencing a series of hardships. Investments dried up due to concerns over a prolonged economic downturn, and the listing has also become increasingly difficult. CEOs of bio companies are worrying about their business in the coming year. Clinical results do not come out right away, and they need to hold on to the depleting investment funds no matter what. Most of them are in a position to worry about corporate survival. Has the government already forgotten its big talk on how the pharmaceutical and bio-industry is the next-generation growth engine amid concerns over an economic recession? With the government tightening up regulations on the industry contrary to its promise, the industry is grappling for survival in the narrowing market. Despite the hardship, the industry had produced 35th and 36th homegrown new drugs and presented new candidates in the largest Asian oncology society meeting this year. However, these achievements were only made by a select few large pharmaceutical companies, which goes to show how much more support will be needed to nurture the growth of the domestic pharmaceutical bio industry. The ‘Impossible is Nothing’ campaign that became so popular with the World Cup described the importance of willpower. However, in the case of the pharmaceutical and bio-industry, it is rather the government’s willingness to preserve the industry's willpower that’s so important.
- Company
- Organon sold 3 types of infertility & contraceptives
- by Dec 21, 2022 06:05am
- Organon announced on the 19th that it will conduct direct sales and marketing of infertility and contraceptive products. According to Organon, the company will directly sell and market the infertility treatments Puregon and Organutran, and the implantable contraceptive Impranon in the body from next year. The company explained that it is a strategic business decision to realize the promotion of women's health. The goal is to strengthen competitiveness in infertility and contraception markets, including existing women's health products. Impranon will start direct marketing on January 1, 2023. Puregon and Orgalutran will be in charge of Organon Korea after the co-promotion contract with Han Wha, scheduled for the first half of next year. The three products that are converted to direct sales are representative infertility and contraceptive drugs sold in Korea over the past 20 years. Puregon has established himself as a representative of follicle-stimulating hormone, an ovulation-inducing agent. Orgalutran is a GnRH antagonist and has been used to prevent early ovulation spikes in women undergoing hyperovulation induction for assisted reproduction.Impranon is a long-term persistent reversible contraceptive inserted under the skin, with a 99% contraceptive effect lasting up to three years. CEO Kim So-eun said, "We will make significant progress in promoting women's health by strengthening expertise and differentiating based on various women's health product portfolios."
- Company
- Verzenio attempts reimb in early breast cancer in Korea
- by Eo, Yun-Ho Dec 20, 2022 06:06am
- The anticancer drug ‘Verzenio’ is attempting reimbursement listing for early breast cancer in Korea. According to industry sources, Lilly Korea has recently submitted an application for the reimbursement listing of its CDK4/6 inhibitor ‘Verzenio (abemaciclib)’ as a treatment for early-stage breast cancer with a high risk of recurrence. The company has been rapidly progressing its reimbursement procedure since the drug’s indication was expanded last month. The drug was approved by the Ministry of Food and Drug Safety as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence, in combination with endocrine therapy. Verzenio’s efficacy in early breast cancer was demonstrated through the monarchE trial. The Phase III monarchE trial was the only trial to confirm successful results in 20 years as an adjuvant treatment for HR+/HER2- early breast cancer in combination with endocrine therapy in 20 years. The results from Cohort 1 of the monarchE trial, which became the basis for the indication expansion last month, showed that Verzenio+endocrine therapy not only demonstrated a reduction in the risk of recurrence compared to endocrine therapy alone through an improvement in invasive disease-free survival (IDFS), but it also confirmed a reduction in risk of remote recurrence through an improvement in distant relapse-free survival (DRFS). Joohyuk Sohn, Professor of Medical Oncology at Severance Hospital said, “Early breast cancer patients mainly experience recurrence after primary treatment in their first 1-2 years. This is why these patients need a more effective adjuvant treatment to reduce the risk of recurrence and death. An unmet medical continued to exist in the field due to a lack of new treatment options for patients with HR+/HER2- early breast cancer after the introduction of aromatase inhibitors in the early 2000s." Verzenio is currently reimbursed in Korea for the treatment of HR+, HER2- advanced or metastatic breast cancer ▴ in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; ▴in combination with Faslodex for women with disease progression following first-line therapy.
- 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.
- Company
- MSD-Boryung Bio will copromote Prodiax 23 in Korea
- by Dec 20, 2022 06:05am
- On the 19th, MSD Korea announced it has selected Boryung Biopharma as its new distributor and supplier for its pneumococcal vaccine, ‘Prodiax 23.’ Under the agreement, Boryung Biopharma will be distributing and supplying both the private and contract Prodiax 23 products under the National Immunization Program starting January 1, 2023. MSD Korea’s copromotion agreement with its previous supplier, HK.Inno.N, is set to end at the end of this year. MSD Korea explained that the agreement had been made after reviewing the company’s vaccine product portfolio and long-term strategy from various angles. Boryung Biopharma’s main portfolio consists of vaccines and biological agents and owns a stable cold chain system. MSD Korea believed that Boruyng Biopharma’s experience in directly supplying flu vaccines for the NIP will create a synergy effect. MSD’s 23-valent pneumococcal polysaccharide vaccine, Prodiax23, was approved in 2000. The vaccine covers the widest spectrum of serotypes among pneumococcal vaccines available in Korea. People aged 65 or older may receive pneumococcal vaccines for free under the NIP. Jaeyong Cho, Executive Business Unit Director of Vaccines at MSD Korea, explained, “The interest and demand for our pneumococcal vaccine has been rising in line with the rising public interest in infectious respiratory diseases. Our agreement with Boryung Biopharma was made to instantly and actively respond to this rise in demand.”
