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- 2025-12-23 07:51:12
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- New AD drug Adtralza enters last stage to reimb in KOR
- by Eo, Yun-Ho Nov 27, 2023 06:06am
- The atopic dermatitis treatment ‘Adtralza’ is entering its final stages of receiving reimbursement in Korea. According to industry sources, the Ministry of Health and Welfare recently issued a negotiation order for Leo Pharma Korea’s interleukin-13 (IL-13) inhibitor for atopic dermatitis, Adtralza (tralokinumab). Under the order, the company will soon start pricing negotiations with the National Health Insurance Service. Adtralza was approved in Korea in August this year, and its reimbursement agenda passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review earlier this month. More specifically, the drug is indicated for the treatment of moderate-to-severe atopic dermatitis in adult (18 years and older) and adolescent patients (12 years to 17 years of age) who are not adequately controlled or not recommended to use topical therapies. The recommended dose of Adtralza is an initial dose of 600 mg (four 150 mg injections) followed by 300 mg (two 150 mg injections) administered every other week as a subcutaneous injection. At the prescriber's discretion, every fourth week dosing may be considered for patients who achieve clear or almost clear skin after 16 weeks of treatment. This freedom in dosing adjustment offers new dosing convenience for patients with moderate-to-severe atopic dermatitis in Korea. Adtralza is a biological drug that selectively targets interleukin-13 (IL-13). Although Sanofi-Aventis Korea's 'Dupixent (dupilumab)' blocks both IL-4 and IL-13, it is difficult to simply compare the mechanisms of the two drugs. Adtralza’s clinical efficacy and safety were confirmed through four Phase III trials (ECZTRA 1, ECZTRA 2, ECZTRA 3, ECZTRA 6) that were conducted on 2,265 adult and adolescent patients with moderate-to-severe atopic dermatitis. In ECZTRA 3, patients were treated with subcutaneous injections of Adtralza or placebo, with concomitant topical corticosteroids (TCS) every two weeks, similar to the treatment method in actual practice. Study results showed that 38.9% in the tralokinumab treatment group achieved IGA (Investigator’s Global Assessment) 0/1 at week 16, which was 12.7% higher than that of the placebo group. The rate of patients who showed 75% improvement in Eczema Area and Severity Index (EASI 75) at Week 16 was 56.0% in the Adtralza-treated group, a clinically significant improvement compared with the 35.7% in the placebo group. Among patients who responded after 16 weeks, a high EASI-75 achievement rate of over 90% was observed in both the patients whose dosing intervals were maintained to 2 weeks or extended to 4 weeks at Week 32. Sang Wook Son, Professor of Dermatology at Korea University Ansan Hospital, said, “Atopic dermatitis is an area where there is a high unmet need for new treatment options that can effectively manage various patient characteristics. Therefore, we have high expectations for the new treatment option that was introduced to the field that offers both clinical benefit and ease in administration.”
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- Sales of K-anticancer drugs Leclaz and Rolontis rise in KOR
- by Chon, Seung-Hyun Nov 24, 2023 05:37am
- New anticancer drugs developed by domestic companies are gradually increasing their influence in their home market. Sales of Yuhan Corp’s lung cancer treatment Leclaza are expected to exceed KRW 20 billion this year. Also, cumulative sales of Hanmi Pharmaceutical's neutropenia treatment Rolontis have exceeded KRW 10 billion just 2 two into its launch. According to the pharmaceutical research institution IQVIA on the 22nd, sales of Leclaza increased by 30.2% YoY to reach KRW 6 billion in Q3 this year. Leclaza is a treatment for non-small cell lung cancer that was approved as the 31st novel homegrown drug in January 2021. Leclaza entered the prescription market in earnest with its reimbursement listing in July 2021. Leclaza generated sales of KRW 1.5 billion and KRW 2.6 billion in Q3 and Q4 2021, respectively. Last year, sales reached KRW 16.1 billion, exceeding the KRW 10 billion mark just in the second year of its release. Leclaza posted sales of around KRW 5 billion each in Q1 and Q2 of this year, and the sales increase was greater in Q3 this year. Leclaza’s cumulative sales by Q3 this year became KRW 16.4 billion. If this trend continues, sales are likely to exceed KRW 20 billion in its third year of release. Quarterly Leclaza sales (Unit: KRW 1 mil, Data: IQVIA) In the early stages of its release, Leclaza had made a smooth start. As new anticancer drugs need to directly compete with promising new drugs from multinational pharmaceutical companies, it is not easy for local homegrown new anticancer drugs to achieve commercial results. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products posted annual sales that exceeded KRW 10 billion. If the drug is reimbursed as a first-line treatment, its rate of market expansion may accelerate further in the future. Leclaza was first approved as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who developed a resistance to a specific gene (T790M) after being previously treated with 1st generation or 2nd generation EGFR-TKIs. Recently, it also received approval as a first-line treatment. The Ministry of Food and Drug Safety approved the change to extend Leclaza’s indications to ‘first-line treatment of non-small cell lung cancer’. Fueled by the approval, Yuhan Corp applied for the reimbursement of Leclaza as a first-line treatment to health authorities in Korea. Also, the company announced plans to provide Leclaza as a first-line treatment free of charge until reimbursement approval. The company plans to provide the clinical trial formulation of Leclaza as a first-line treatment to patients free of charge using an Early Access Program (EAP). Without reimbursement, the drug costs KRW 6 million per month. Sales of Hanmi Pharmaceutical Rolontis in Q3 were KRW 2.9 billion, which is twice what it had made in the same period last year. Rolontis is administered for the treatment or prevention of neutropenia in cancer patients who receive myelosuppressive chemotherapy. As a granulocyte colony-stimulating factor (G-CSF) class that stimulates the granulocyte to increase neutrophil production, the drug has a similar mechanism of action with Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim).’ In Korea, Rolontis was approved in March as the 33rd novel homegrown drug and started to be sold in Korea after being listed for reimbursement in November 2021. Sales of Rolontis continued on an upward trend since generating its first sales in Q1 last year. Last year, it posted sales of KRW 3.2 billion. This year, it made KRW 7.7 billion in just three quarters and exceeded KRW 10 billion in cumulative sales for the first time since its launch. Quarterly Rolontis sales (Unit: KRW 1 mil, Data: IQVIA) Rolontis is a homegrown novel drug that was approved by the U.S. FDA. Hanmi had licensed-out Rolontis’s technology to Spectrum Pharmaceuticals in 2012 and received FDA approval for the drug under the brand name, Rolvedon. Rolvedon initially received FDA approval after the technology was licensed-out to Spectrum Pharmaceuticals, and in April, Spectrum was acquired by Assertio Holdings, a pharmaceutical company specializing in central nervous system, pain, and inflammation. In the US market, Rolvedon recorded sales of USD 15.6 million (about KRW 20 billion) in Q1 and USD 21 million (about KRW 28 billion) in Q2, continuing growth in the US market as well.
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- MSD vaccines will be sold by Boryung·Kwangdong
- by Kim, Jin-Gu Nov 24, 2023 05:37am
- The domestic sales rights for 8 types of MSD vaccines have changed hands recently. Although HK Inno.N was in charge of joint sales for MSD vaccines in Korea, the vaccines will be separately sold by Boryung Biopharma and Kwangdong Pharmaceutical each. After signing a copromotion agreement with MSD for its vaccines at the end of 2021, HK Inno.N began joint sales last year. However, with this transfer of sales rights, the company is effectively withdrawing from the vaccine business after 2 years. According to industry sources on the 23rd, MSD’s partner in joint sales and distribution of its 8 vaccines will be changed from HK Inno.N to Boryung Biopharma and Kwangdong Pharmaceutical starting next year. The companies recently signed a copromotion contract for this purpose. Boryung Biopharma will sell the shingles vaccine ‘Zostavax,’ the pneumococcal vaccine ‘Prodiax 23,’ the rotavirus vaccine ‘RotaTeq,’ and MSD’s new pneumococcal vaccine ‘Vaxneuvance.’ Vaxneuvance Is a 15-valent pneumococcal conjugate vaccine, which gained attention as the first pneumococcal vaccine to be authorized in Korea in 13 years. Kwangdong Pharmaceutical will sell the HPV vaccines ‘Gardasil,’ and ‘Gardasil 9.’ The copromotion partners for the hepatitis A vaccine ‘Vaqta’ and the measles/mumps/rubella vaccine 'MMR2' have not been determined yet. The pharmaceutical industry predicts that it is highly likely that MSD will sign an agreement with a third party other than Boryung Biopharma and Kwangdong Pharmaceutical for the two vaccines. On this, an MSD official said, “We have signed a new copromotion agreement for Zostavax, Prodiax 23, Vaxneuvance, RotaTeq, Gardasil, and Gardasil 9. But we are separately reviewing sales for Vaqta, MMR2.” Seven of MSD’s vaccines other than the Vaxneuvance that was recently approved had been sold by HK Inno.N until now. HK Inno.N signed a copromotion and distribution agreement with MSD Korea in November 2021. With the transfer, HK Inno.N is effectively withdrawing from the vaccine business after two years. Analysis suggests that a gap worth KRW 200 billion in annual sales will be inevitable during this process. According to the market research institution IQVIA, last year's sales of the 7 vaccines in discussion amounted to KRW 204.9 billion. Compared to the KRW 150.4 billion they had posted in 2021 before HK InnoN took over copromotion, sales increased by 36% in a single year. This year, it recorded cumulative sales of KRW 146.2 billion by Q3. If this trend continues, the vaccines are expected to record sales of around KRW 200 billion, similar to last year.
- Company
- Reimb for 7 of 13 Keytruda indications to be rediscussed
- by Eo, Yun-Ho Nov 24, 2023 05:37am
- Although it was well expected, the road to reimbursement extension for Keytruda is not going so smoothly. The company had applied to extend reimbursement for the drug to 13 additional indications in bulk earlier this year. According to industry sources, 4 indications of MSD Korea’s PD-1 inhibitor Keytruda (pembrolizumab) for Triple-Negative Breast Cancer (TNBC), head and neck squamous cell carcinoma, endometrial carcinoma, and bladder cancer were deliberated at the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee on the 22nd but received a ‘rediscussion’ decision. When adding this to the 3 indications - esophageal cancer, endometrial, and colorectal cancer – that received a rediscussion decision from CDDC in October, a total of 7 indications have been unable to pass the CDC stage until now. Although CDDC review for the other 6 indications is in discussion, whether those will be able to produce positive results remains in question when considering the current state of results. As a Risk Sharing Agreement (RSA) drug, each indication must go through an evaluation procedure equivalent to that of a new drug in order to receive extended reimbursement. Indications approved through Phase III trials must undergo pharmacoeconomic evaluation to prove cost-effectiveness, and indications approved based on Phase II trials must also undergo negotiations to apply for pharmacoeconomic evaluation exemptions. Therefore, it remains to be seen whether the discussion on expanding Keytruda's reimbursement, which continues to receive 'rediscussion' decisions, will produce results in 2024. In June, MSD applied to extend reimbursement to 13 indications for its Keytruda. The indications were: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer,▲persistent, recurrent, or metastatic cervical cancer,▲ advanced endometrial carcinoma, ▲advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer.
- Company
- Shingrix lead mkt again…shakes shingles vaccine mkt
- by Chon, Seung-Hyun Nov 23, 2023 05:37am
- The annual KRW 40 billion shingles vaccine market has shown rapid changes. GlaxoSmithKline's (GSK) new shingles vaccine 'Shingrix' took an unrivaled lead in the Korean market. Shingrix’s market share exceeded 50% this quarter powered by its strong preventive effect despite its high price. According to the market research institution IQVIA on the 22nd, the market for preventive vaccines for shingles in Q3 was KRW 19.5 billion last year, up 70.5% YoY. The shingles vaccine market, which had posted quarterly sales of around KRW 10 billion last year, had increased greatly this year. The shingles vaccine market grew 147.0% YoY to record KRW 21.9 billion in Q1 this year, then again rose 124.1% to post KRW 23.5 billion in Q2 this year. The new vaccine Shingrix drove the market expansion. Shingrix, which started vaccinations in December last year, showed off its presence by occupying 28.9% of the market with sales of KRW 6 billion in Q1 this year. In Q2, the drug quickly rose to lead the shingles vaccine market with sales of KRW 11.1 billion. Shingrix's share of the shingles vaccine market in Q3 reached 50.5% and continued on its unrivaled lead in the market. Sales of shingles prevention vaccine (Unit: KRW 100 mil, Data: IQVIA) The greatest benefit of Shignrix is its strong shingles prevention effect. In a Phase III clinical trial (ZOE-50) that was conducted on adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group at 3.2 years of follow-up, and in another Phase III clinical trial (ZOE-70) conducted on adults aged 70 years and above, Shingrix showed an 89.8% efficacy at 3.7 years of follow up. This is superior to the 5% protection in adults aged over 50 years of age and 41% in adults aged 70 years and above demonstrated with the use of Zostavax. The prevention rate of SKYZoster is also known to be similar to Zostavax. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or those with solid cancer, blood cancer, or solid organ transplant patients who have an increased risk of shingles are also eligible to receive vaccination with Shingrix. At the time of its release, Shingrix's significantly higher price than existing vaccines was pointed to as an obstacle to the vaccine’s early settlement into the market. vaccines. The price of Shingrix, which is administered two times in total, is set at around KRW 500,000 to 600,000. This is more than twice as high as the existing vaccine, which costs KRW 150,000 to 200,000. However, Shingrix rapidly increased its market share in the market thanks to its superior efficacy despite the high price. Also, the sales support from 2 domestic pharmaceutical companies contributed to Shingrix’s rapid market penetration. GSK started domestic sales of Shingrix in partnership with two companies, GC Biopharma and Kwangdong Pharmaceutical. Existing shingles vaccine products such as SkZzoster and Zostavax saw slower sales growth. SK Bioscience’s SKYZoster’s sales in Q3 were KRW 5.1 billion, which is a 5.0% decrease YoY. SKYZoster’s had led the shingles market in Q1 and Q2 this year but then lost the lead to Shingrix. SKYZoster is a shingles vaccine developed by SK Bioscience with its proprietary technology. The vaccine has proven its non-inferiority compared to its competitor (Zostavax) in adults aged 50 or older in 8 domestic clinical institutions. In October 2017, SK Bioscience obtained approval for SKYZoster from the Ministry of Food and Drug Safety for 'preventing shingles in adults over the age of 50'. Before its approval, MSD's Zostavax was the only vaccine available in the market. Before then, the market was dominated by MSD's Zostavax, but the introduction of SKYZoster has converted the market into a competitive system. However, as SKYZoster’s price is less than half of that of Shingrix, there have been estimates that the actual amount of vaccinations made could be larger for SKYZoster than for Shingrix. Zostavax’s sales in Q3 had fallen 25.6% YoY to record KRW 4.5 billion. Zostavax’s in Q1 this year rose by 18.9% YoY to reach KRW 6 billion but then fell in Q2 and Q3. Zostavax gave up its lead to SKYZoster in Q4 last year and then was even surpassed by Shingrix, ranking 3rd in the market. Zostavax's market share in Q2 had only been 23.0%.
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- SK Bioscience & Hilleman Laboratories develop Ebola vaccine
- by Kim, Jin-Gu Nov 23, 2023 05:37am
- SK Bioscience announced on the 22nd that it signed a memorandum of understanding (MOU) with Hilleman Laboratories, an international non-profit research institute, for the joint development of a second-generation Zaire Ebola virus vaccine. Hilleman Laboratories was established in 2009 as an equal joint venture between MSD and Wellcome Trust, a medical research support foundation. SK Bioscience had signed an agreement with Hilleman Laboratories in October to jointly research and develop a new vaccine and platform. Through the new MOU, the parties specified the subject vaccine and the parties’ role in vaccine development. MSD’s Ervebo and Johnson & Johnson’s Zabdeno are the only Ebola virus vaccines available as of now. Hilleman Laboratories had worked with MSD to improve process efficiency and storage stability to optimize product productivity and thermostability and recently succeeded in discovering a 2nd generation Ebola vaccine candidate. Under the new MOU, SK Bioscience will work with Hilleman Laboratories to develop a 2nd generation Ervevo, which has an improved vaccine production process, production efficiency, and thermostability. When developed, SK Bioscience and Hilleman Laboratories plan to secure the price competitiveness of the vaccine and supply the vaccine to low- and middle-income countries. If commercialized, the global supply of a 2nd generation Ervevo will be manufactured on consignment by SK Bioscience at its vaccine facility, Andong L House. For this, the company signed a CDMO agreement with MSD for its 2nd generation Ebola vaccine in May this year. Dr Raman Rao, CEO of Hilleman Laboratories said, "Developing more affordable and accessible vaccines is core to our mission at Hilleman Laboratories. Through our partnership with SK Biosciences, we will commit ourselves to create positive outcomes for global public health, especially in affected regions of Central and Western Africa.” Jaeyong Ahn, CEO of SK Bioscience said, "Developing a vaccine to prevent viruses causing diseases with a high fatality rate, such as Ebola-Zaire, is essential to protect humanity. We plan to successfully complete the project and expand our cooperation with global companies and institutions and grow into a global company."
- Company
- Leukemia drug Xospata’s reimb limit may be resolved
- by Eo, Yun-Ho Nov 23, 2023 05:37am
- Astellas Korea is working to resolve the issue of the reimbursed number of cycles approved for its acute myeloid leukemia treatment ‘Xospata.’ Dailpharm’s coverage showed that the agenda on expanding reimbursement standards for Astellas Korea’s Xospata, a drug for patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, has recently passed the Health Insurance Review and Assessment Service’s Cancer Reimbursement Evaluation Committee review. The company applied for the reimbursement extension in November, and the progress has been made 6 months after the agenda passed the Cancer Disease Deliberation Committee in May. However, since Xospata waived the pharmacoeconomic evaluation process, the drug would also have to undergo drug pricing negotiations with the National Health Insurance Service for its reimbursement extensions. Therefore, whether its reimbursement can be extended to cover more cycles will depend on when the agenda is submitted to the Drug Reimbursement Evaluation Committee for review and whether it passes the review. The drug is indicated as monotherapy for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+). However, only patients who are eligible for allogeneic hematopoietic stem cell transplantation can receive reimbursement, for up to 4 cycles. Other than the financial issues, there are no specific reasons to limit the number of administration cycles for Xospata. In the ADMIRAL trial, Xospata was used without limiting the treatment period, and the NCCN guidelines also issued a ‘Category 1’ recommendation for the drug without restricting its treatment period. The current best option to cure AML patients is hematopoietic stem cell transplantation, but this is accompanied by a high risk of recurrence, and transplantation is not an option for the large number of elderly AML patients that exist. Therefore, there is no suitable treatment alternative other than Xospata available for patients who cannot undergo hematopoietic stem cell transplantations, and these patients are still using the chemotherapy that was developed over 40 years ago due to ineligibility for reimbursement of Xospata. Xospata targets both types of FLT3 mutations, FLT3-ITD and FLT3-TKD, and may be self-administered at home as a single oral tablet once daily without frequent hospital visits. Also, Xostapa has demonstrated improved safety and efficacy compared with existing chemotherapy.
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- Reimb of COVID-19 drugs necessary with eased crisis level
- by Eo, Yun-Ho Nov 22, 2023 05:30am
- Whether COVID-19 treatments will be able to be listed for reimbursement before Korea's COVID-19 containment measures are lifted remains under attention. Two COVID-19 treatments, Gilead Science Korea’s ‘Veklury (remdesivir)’ and Pfizer Korea’s ‘Paxlovid (nirmatrelvir+ritonavir),’ are currently under review by the Health Insurance Review and Assessment Service after the companies filed applications for their reimbursement. The government had previously announced that it would work to reimburse COVID-19 treatments in H2 2024 as part of its COVID-19 risk level management roadmap. This means that the COVID-19 treatments that are being supplied free of charge will be converted and become purchased products like general medicine. When Phase 2 of the COVID-19 risk level management roadmap, which will further ease the disease control and prevention system, is implemented next month, COVID-19 will then be regarded as a Grade 4 infectious disease like influenza. Not dangerous because it’s an endemic?... Improving awareness remains a key issue However, the road to reimbursement for these treatments is not easy. Not only are the prices expensive, but the sharp decline in the public’s sense of crisis is also playing a significant role. COVID-19 has shifted from a pandemic into an endemic, but it is still producing variants that threaten high-risk patients such as those with underlying diseases and the elderly. The 'Excess mortality during COVID-19’ submitted by the Korea Disease Control and Prevention Agency in October to the office of Democratic Party of Korea Rep. Choun Sook Jung, a member of the National Assembly Health and Welfare Committee, that cites data from Statistics Korea, the number of excess deaths continued to be on the rise until recently due to the aftermath of COVID-19. According to the report, ‘excess deaths’ from COVID-19 had exceeded 65,000. ‘Excess deaths’ refer to additional deaths beyond the number of deaths normally expected to occur at a particular period. This figure indicates how many more deaths occurred compared to when COVID-19 had not occurred. Eun-Joo Choo, Professor of Infectious Diseases at Soonchunhyang University Bucheon Hospital, said, “COVID-19 is still a disease that requires active treatment and management, and many patients are still being hospitalized for the disease. Its treatments need to be listed with reimbursement immediately upon the closure of the free support system next year to ensure treatment access for the patients and to secure essential drugs.” Both drugs are necessary...due to different roles Although both were approved as COVID-19 treatments, Veklury and Paxlovid differ in terms of indication, and formulation, among others. Veklury has been verified to have slowed down disease progression in many COVID-19 patients, reducing the time to recovery and thereby reducing the burden on Korea’s medical system. It was approved to treat COVID-19 in adults and pediatric patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease. It can be administered regardless of the severity of the patient’s disease and aids in quicker recovery by offering a lower risk of disease progression with earlier treatment. Also, it is a treatment whose efficacy and safety have been proven through several clinical trials and RWE and is the only COVID-19 treatment that can be used on patients with severe COVID-19. In particular, it has little drug-drug interactions (DDI), and comes in an injectable formulation that can be administered to patients who have difficulty taking oral medications. Paxlovid, which comes in an easy-to-take oral formulation, is approved to treat mild-to-moderate COVID-19 in adults who are at risk of progressing to severe COVID-19, which includes hospitalization and death. Paxlovid needs to be taken within five days of developing symptoms and is administered twice daily for 5 days. In the EPIC-HR trial that was conducted on non-hospitalized symptomatic adult subjects with COVID-19 who are at high risk of progressing to severe disease and have no prior history of vaccination, Paxlovid significantly reduced the proportion of people with COVID-19-related hospitalization or death from any cause through 28 days of follow-up by 86% compared to placebo among patients treated within 5 days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment.
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- Mitsubishi’s Lou Gehrig's disease drug Radicut's sale soars
- by Nho, Byung Chul Nov 21, 2023 05:48am
- The latecomer injection formulations are taking over the Lou Gehrig's disease treatment market that had been occupied by injectables in the past. According to the industry’s pharmaceutical distribution performance data, Mitsubishi Tanabe Pharma Korea's Radicut Inj (edaravone) has occupied 39% of the market share in the related treatment market 8 years after receiving marketing authorization, narrowing the gap with YooYoung Pharm's Yooritek (riluzole, 41%). Radicut, which was approved in 2015 by the Ministry of Food and Drug Safety, had posted sales of KRW 500 million, KRW 1.3 billion, KRW 1.1 billion, KRW 1.6 billion, KRW 2.2 billion, and KRW 0.9 billion in H1 of 2018, 2019, 2020, 2021, 2022, and 2023, respectively. It has outperformed Sanofi Aventis’s Rilutek since 2020. During the same period, Sanofi Aventis’s sales of Rilutek were KRW 1.2 billion, KRW 2.6 billion, KRW 0.1 billion, KRW 0.3 billion, KRW 0.7 billion, and KRW 0.4 billion, respectively. After posting record-high sales of KRW 2.6 billion in 2019, Rilutek recorded sales worth KRW 0.4 billion in H1 this year, drawing a downward-sloping performance curve. Until earlier this year, Yooyoung Pharm was the only domestic company to supply Lou Gehrig's disease treatment. Therefore the fact that it had recorded record-breaking performance of KRW 2.4 billion in 2020 and 2021 with Yooritek against global pharmaceutical companies Sanofi and Mitsubishi is one aspect to note. Clockwise from the top: Yooyoung Pharm’s Yooritek, Mitsubishi Tanabe Pharma Korea’s Radicut, and Sanofi’s Rilutek Radicut is indicated to slow down the progression of functional impairment in patients with amyotrophic lateral sclerosis (ALS). Rilutek and Yooritek are indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Lou Gehrig's disease is a rare condition that cannot be cured until now. Its annual drug cost is around KRW 3.3 million, which is relatively cheap compared to the ultra-expensive rare and anticancer drugs that cost hundreds of millions of won. Another interesting aspect is that Radicut, which contains edaravone, was initially prescribed as a treatment for cerebral infarction, and then added an indication for Lou Gehrig's disease. Radicut’s efficacy and effect in suppressing the progression of functional impairment have been confirmed through clinical trials conducted on Lou Gehrig patients in Japan. Lou Gehrig's disease is a representative rare and intractable neurological disease that selectively degenerates only motor neurons, causing irreversible paralysis of limbs and respiratory muscles. Most patients affected with Lou Gehrig's disease die within 2 to 5 years after onset without mechanical ventilation. It is estimated that there are approximately 350,000 patients worldwide and 2,000 to 3,000 in Korea. It occurs in approximately 1 to 2 people per 100,000 per year, and its incidence increases from the late 50s. Its incidence rate is 1.4 to 2.5 times higher in men than in women. Meanwhile, SK Chemicals also succeeded in listing Teglutik (200ml), a suspension formulation containing riluzole, that it imported from the Italian pharmaceutical company Italfarmaco at an insurance price of KRW 134,970 earlier this year. The ceiling insurance price is KRW 133,970 per vial for a 15-day use. Therefore, the price is the same as the price of existing tablet formulations (KRW 4,499 per day) in terms of daily dosage. As it comes in a suspension formulation, it is administered directly using oral syringes, and through percutaneous endoscopic gastrostomy (PEG) tubes for those who have difficulty taking it directly. Patients with Lou Gehrig's disease often experience dysphagia (difficulty swallowing) an early symptom due to weakened tongue and throat muscles. Although tablets are considered more convenient for intake take than injections in general, for Lou Gehrig's injections are more convenient than tablets for the reason above. This is why Mitsubishi Tanabe Pharma Korea’s injectable Radicut is rapidly expanding its market share. Therefore, patients with dysphagia had difficulty taking the table formulation of riluzole, which was administered twice a day.
- Company
- IL inhibitor reimb as 1st-line Tx for ankylosing spondylitis
- by Eo, Yun-Ho Nov 21, 2023 05:48am
- Interleukin inhibitors may soon be available as first-line treatment for ankylosing spondylitis in Korea. On the 20th, the Ministry of Health and Welfare announced an amendment notice that contains a plan to expand insurance reimbursement for the 2 IL-17A inhibitors approved in Korea - Novartis Korea's 'Cosentyx (secukinumab)' and Lilly Korea's 'Taltz (ixekizumab)’ – as treatments for ankylosing spondylitis. With the notification, the reimbursement standard extension for the two drugs, which had remained pending for over a year, is expected to be implemented within the year. Novartis and Lilly both submitted an application for reimbursement extension for their respective drugs based on the ‘ASAS-EULAR axSpA treatment recommendations 2022’ in July last year. Although the actual process for their reimbursement extension was completed earlier this year, time was wasted due to a delay in final approval on the Ministry of Health and Welfare’s part. Interleukin inhibitors are available with reimbursement as a first-line treatment for ankylosing spondylitis in over 30 countries. In Korea, both drugs are currently only approved for use with reimbursement in the second-line treatment setting, after patients are prescribed TNF-α inhibitors. The grade of recommendation and level of evidence for IL-17A inhibitors were raised to Grade A and 1a in the 2022 update of the ASAS-EULAR recommendations, to the same level as TNF-α inhibitors. The guidelines referred to how both agents are currently being used as first-line biological agents to treat ankylosing spondylitis and officially confirmed their equal therapeutic positions as treatments for ankylosing spondylitis. Moreover, the use of TNF-α inhibitors is associated with tuberculosis. So patients had to undergo prior therapy to treat latent tuberculosis before using TNF-α inhibitors. However, despite the anti-TB treatment, the occurrence of tuberculosis due to the use of TNF-α inhibitors is still reported in several studies. Therefore, another treatment option was dire for patients who are at high risk of infection such as tuberculosis, or who have comorbidities, such as heart failure, and have complications in being prescribed TNF-α inhibitors. The number of ankylosing spondylitis patients has rapidly increased by nearly 50% over the past 10 years (35,592 in 2013, 52,616 in 2022). It is a disease that mainly occurs at a young age, and domestic patients go through about 40 months of wait until they receive an accurate diagnosis. In addition, patients can receive a disability level up to Level 2 at the highest, rendering it a serious disease and eligible for exemption from military service.
