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- 2026-04-08 16:59:23
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- Potential of AVEO Oncology acquired by LG Chem
- by Jan 24, 2024 05:46am
- LG Chem's subsidiary AVEO Oncology is showing results in intractable cancers. AVEO, which was acquired by LG Chem in 2022 for about KRW 750 billion, specializes in developing new anticancer drugs and has recorded annual sales of about KRW 200 billion. AVEO owns Fotivda (tivozanib), which has been approved in the U.S. for the treatment of Stage III or higher renal cell carcinoma. In addition to Fotivda, AVEO is developing first-in-class drugs for refractory cancers such as head and neck cancer and triple-negative breast cancer through novel mechanisms of action. According to industry sources on the 23rd, AVEO’s head and neck cancer drug candidate, ficlatuzumab, recently entered Phase III clinical trials. Ficlatuzumab is a new head and neck cancer drug candidate that targets hepatocyte growth factor, or HGF, and c-MET. In the trial, AVEO is evaluating the efficacy and safety of ficlatuzumab in combination with Merck’s Erbitux(cetuximab) in patients with recurrent or metastatic (R/M) human papillomavirus(HPV)-negative head and neck squamous cell carcinoma. In the Phase II study, ficlatuzumab+Erbitux demonstrated superior efficacy compared with Erbitux monotherapy. After 2 years of follow-up in 58 patients with head and neck cancer, the ficlatuzumab plus Erbitux combination achieved a median progression-free survival (PFS) of 3.7 months and an objective response rate (ORR) of 19%. Two patients achieved a complete response (CR) and four patients achieved a partial response (PR). Overexpression of c-Met was associated with a reduced risk of disease progression in the HPV-negative arm. The efficacy of Erbitux monotherapy was not demonstrated during the same period. AVEO is also exploring the potential of ficlatuzumab in combination with chemotherapy in patients with pancreatic cancer and acute myeloid leukemia in early clinical trials. In both studies, ficlatuzumab demonstrated efficacy activity and an acceptable tolerability profile. AVEO plans to further evaluate the efficacy of ficlatuzumab in various solid tumors. AVEO develops candidate substances for intractable cancers, including triple-negative breast cancer and pancreatic cancer In addition, AVEO is also accelerating the development of its oncology pipeline. Among them, the new drug candidate in the fastest clinical stage is AV-203. AV-203 is designed to inhibit both ligand-dependent and -independent HER3 signaling. Ligand specifically binds to the receptor. HER3 is a receptor whose expression has been identified in a number of solid tumors, and to date, no new cancer drugs have been developed that target this biomarker. In addition to AV-203, Daiichi Sankyo's patritumab is currently being evaluated for HER3-mutated breast cancer. AVEO has completed a Phase Ia study of AV-203 in patients with advanced solid tumors. AV-203 was well tolerated in multiple tumor models, including breast, head and neck, lung, ovarian, and pancreatic cancers. In the trial, AV-203 demonstrated early signs of activity in HER3-responsive ligands, heregulin or neuregulin, that was consistent with those confirmed through preclinical data. Therefore, AVEO plans to continue to a Phase 1b study. AVEO is also conducting clinical trials for its AV-380. AV-380 is an innovative new drug candidate that targets growth differentiation factor 15 (GDF15). GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Cancer cachexia is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue. 80% of cancer patients are known to suffer from cachexia. Preclinical data confirmed that inhibiting GDF15 with AV-380 can reverse the effects of cachexia. In addition, AVEO is also conducting a preclinical study for AV-353 in patients with triple-negative breast cancer in collaboration with the Mayo Clinic in Minnesota, USA. AV-353 is an inhibitory antibody specific to Notch 3, a signaling pathway that is important in cell-to-cell communication involving gene regulation mechanisms that control multiple cell differentiation processes during the entire life cycle. The Notch 3 receptor pathway has been implicated in multiple diseases, including cancer, cardiovascular diseases, and neurodegenerative conditions. AVEO is leveraging its Human Response Platform to secure its drug pipeline. All of its drug candidates in development including ficlatuzumab, AV-203, AV-380, and AV-353, were developed using AVEO's proprietary Human Response Platform.
- Company
- ‘I believe in MSD Korea and the Korean government'
- by Eo, Yun-Ho Jan 24, 2024 05:46am
- Patrick Tung Executive Director, Regional Market Access Head, Asia Pacific at MSD Applying for reimbursement extensions to 13 indications at the same time is an unprecedented move. This move was made by MSD Korea for its immuno-oncology drug Keytruda (pembrolizumab), and the case has been marked as a ‘historical first’ ever since the introduction of the positive-listing system in Korea. Applying for the reimbursement of 13 indications is not an easy task. Since Keytruda is a risk-sharing agreement (RSA) drug, each indication must undergo an evaluation process similar to that of a new drug to be eligible for reimbursement. Indications approved through Phase III trials must go through a pharmacoeconomic evaluation review to prove cost-effectiveness, while those approved based on Phase II trials must negotiate with the government and waive the pharmacoeconomic evaluation process. As expected, the process was not easy. Since applying for reimbursement extensions last year, Keytruda has had 7 indications submitted to the National Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee, but none have crossed the threshold. The remaining 6 indications are scheduled to be presented in the first CDDC meeting of the new year in 2024. Dailypharm met up with Patrick Tung, Head of Market Access at MSD Asia Pacific, to find out more about the company’s plans to expand Keytruda's reimbursement coverage in Korea. -It's 13 indications. You've gained quite a lot of attention with the simultaneous application. Why did you use this strategy to extend reimbursement for Keytruda in Korea? The 13 indications we applied for this time are all aggressive cancers that threaten patients' survival, but for which no or only a few alternative options exist. Therefore, there remained a dire need for improved access to treatments that have verified efficacy. Keytruda has demonstrated its value in all 13 of the indications. We believe it is our responsibility to improve access so that as many patients as possible can enjoy the therapeutic benefits of Keytruda. To help address the unmet need in the treatment field, we decided to apply for a reimbursement extension for all 13 indications at once. - There must have been some heated discussions within the company before applying, What were your biggest concerns? What advice did you give to the Korean team? When you put the patients first, applying for the reimbursement extension by itself was not a difficult decision. Our only concern was that since we were applying for so many indications at once, it would take quite some time for the government officials to review and process the application. Rather than advice, I have expressed my support for the Korean team. The market access team at MSD Korea is made up of skilled and experienced professionals, so I'm sure they'll eventually get it done. -Do you expect the reimbursement standard to be extended to cover all 13 indications? Honestly, it is difficult to predict the outcome at this point. However, I believe we will be able to find a solution as long as we share the common goal of improving access to treatment for cancer patients in Korea. Our Korean team and MSD are ready to work together to find that solution. However, this is the first time MSD has ever applied for the reimbursement of 13 indications at once as well. As this is unprecedented in Korea, HIRA will also need to conduct a thorough review taking many factors into consideration. – How is Keytruda being reimbursed in countries in the Asia-Pacific region? It is reimbursed in some countries and the cost is fully by the patient in others. However, in general, reimbursement for Keytruda is increasing worldwide across multiple indications. The number of reimbursed indications has been increasing in particular in the Asia Pacific region. For example, many countries, including Australia, Taiwan, and Singapore, have been continuously making efforts to extend reimbursement for Keytruda. For example, in Australia, the Pharmaceutical Benefits Advisory Committee gave a positive recommendation and confirmed Keytruda’s reimbursed use for early triple-negative breast cancer and metastatic or recurrent triple-negative breast cancer this year, following last year's approvals for cervical cancer and urothelial cancer. - Is there a reimbursement system that you would like Korea to refer to? Over the past year, we have seen reimbursement progress made for several indications in Australia. Taiwan is also making significant progress in expanding Keytruda’s reimbursement, and encouraging discussions are being made in some emerging countries as well. While it's difficult to replicate what is being done in these other countries, many countries, such as Australia and the United Kingdom, are taking a flexible approach to reimbursement for products with multiple indications. Also, Canada and other European countries have introduced concepts such as Multi-Year Multi-Indication, which allows drugs to be priced and contracted based on prescription volume, which allows the countries to reduce the time to reimbursement compared to the current system. A proposal to adopt a similar concept has recently been submitted in Australia and is currently being reviewed by the PBAC. Of course, the situation in these countries is very different from Korea, including their ICER threshold, but can still be good cases to consider when devising ways to move more flexibly within the current system. - What factors in the Korean reimbursement environment do you believe are contributing to the relative delay in Korea’s reimbursement of innovative cancer drugs compared to other countries? Korea seems to have a great and very rigorous insurance system. In any country, you need a system that is flexible enough to accommodate new products that provide real value to patients when they come to market. We do not need to ‘reinvent the wheel.’ It's about learning from the past and finding ways to make new products work within the existing regulatory environment. Also, it's not just the system that needs to be flexible. Flexibility is also needed in the funding of innovative medicines. The UK has a Cancer Drug Fund to ensure rapid access to cancer drugs, so creating a fund like this can be a good idea. We understand that the Cancer Drug Fund has been so successful that the UK has created an additional Innovative Medicines Fund to expand the range of eligible drugs.
- Policy
- Handok-Sanofi launches hypertension combo drug Aprovasc
- by Lee, Tak-Sun Jan 24, 2024 05:45am
- Aprovasc, a hypertension combination drug co-developed by Handok and Sanofi Aventis Korea, will enter the market in earnest with reimbursement on the 1st of next month. The product is a combination drug of ARB-class irbesartan, which was developed by Sanofi, and CCB-class amlodipine besylate. This is the first irbesartan-amlodipine combination released to the market. It was approved in Korea in November last year and completed the reimbursement listing process time. According to industry sources on the 23rd, three dosage forms of Aprovasc Tab will be listed starting on Feb. 1. The drug is indicated for essential hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy. Aprovasc received premium pricing as an incrementally modified new combination drug and for being a product of Handok’s, a company designated as a Korea Innovative Pharmaceutical Company. As a result, Aprovasc Tab 300/5mg will be listed at KRW 119.2/tablet. Aprovasc Tab 150/5mg and Aprovasc Tab 150/10mg also received a 68% premium in their pricing, but Handok listed them at lower prices, at KRW 854 and KRW 988, respectively. Aprovasc has gained industry attention as the two companies - Sanofi and Handok had partnered on the drug from development to sales. irbesartan (brand name: Aprovel) is an ARB-class hypertension drug developed by Sanofi. The two companies signed a license agreement in October 2019 for the development, manufacture, and licensing of Aprovasc in Korea. Since then, Handok has conducted domestic clinical trials and confirmed superior blood pressure-lowering effects compared with irbesartan monotherapy in two Phase III trials. The two companies will also collaborate on sales activities. Handok will be in charge of the manufacturing, and the two companies will copromote the drug in the highly competitive domestic hypertension combination drug market. Currently, the ARB+CCB hypertension combination drug market is crowded with products such as Hanmi Pharmaceutical’s Amosartan, Boehringer Ingelheim’s Twynsta, Novartis’s Exforge, Daiichi Sankyo’s Sevikar, and Chong Kun Dang’s Telminuvo that post annual prescriptions (based on UBIST) of more than KRW 50 billion. With such viable competitors already occupying the market, the industry expectation is that Handok and Sanofi will have difficulty generating high sales in the short term as a late entrant. However, the industry also predicts that the product will be able to secure basic demand from patients who had difficulty controlling their blood pressure while being on Aprovel, as the irbesartan monotherapy drug Aprovel is the best-selling antihypertensive drug with an annual prescription volume of KRW 10 billion.
- Policy
- New drug Zavicefta Inj, and more completed drug pricing nego
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Pfizer Korea’s new drug The two drugs Pfizer Korea’s ‘Zavicefta Inj’ and ‘Dulackhan Easy Syrup,’ which were in negotiations for a drug pricing increase due to short supply, have reached agreements in negotiations with the National Health Insurance Service (NHIS), and they are expected to receive reimbursements starting next year. The chronic kidney disease treatment ‘Kerendia Tab’ and genetic retinal disease treatment ‘Luxturna’ have completed drug pricing negotiations and are awaiting reimbursement next month. According to industry sources on the 19th, NHIS recently updated the listing of pharmaceuticals that have completed the drug pricing negotiations. The updated listing of new drugs that have completed negotiations included Kerendia Tab 10 mg/20 mg (finerenone, Bayer Korea), Luxturna (voretigene neparvovec, Novartis ), Zavicefta Inj 2g/0.5g (ceftazidime/avibactam). Among the drugs, Zavicefta Inj has omitted the upper limit amount negotiations and proceeded to the negotiations of the estimated amount of claim. Kerendia was approved by the Ministry of Food and Drug Safety (MFDS) in May 2022 as a treatment for chronic kidney disease in adult patients with type 2 diabetes. According to the American Diabetes Association’s (ADA) Standards of Care in Diabetes, Kerendia is suggested for use in combination with SGLT-2 inhibitor in patients who have an increased risk of cardiovascular events or sustained chronic kidney disease progression or those who are unable to use the SGLT-2 inhibitor. Accordingly, it is expected that Kerendia will be used more frequently in combination with SGLT-2 inhibitors, including Forxiga and Jardiance, which are used in treating chronic kidney disease. Starting next month, Chong Kun Dang Pharmaceutical will be responsible for sales and marketing of Kerendia. Luxturna is indicated for use in pediatric and adult patients who have sufficient surviving retinal cells but lost vision due to inherited retinal dystrophy caused by biallelic RPE65 mutations. Luxturna, a gene therapy, is a ‘one-shot treatment’ that can be administered as a single dose. The drug has garnered attention to whether it would pass the hurdle of insurance benefit due to its high price, with a non-reimbursement price of up to 1 billion won. Finally, the company secured the reimbursement listing through a risk-sharing agreement (RSA) with the NHIS, reducing the burden of insurance benefit expenses. Pfizer's Zavicefta Inj is a combination drug that combines "ceftazidime," a third-generation cephalosporin antibiotic, with "avibactam," an enzyme inhibitor that inhibits the function of beta-lactamase enzymes responsible for breaking down beta-lactam antibiotics, to maintain its antimicrobial potency. Zavicefta Inj has emerged as an alternative treatment option for treating multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria, which previously had limited available treatment options. Two products that contain Lactulose Solution as their active ingredient have successfully reached an agreement in drug price negotiations, namely "Lactuse Syr" by Access Pharma and "Dulackhan Easy Syrup" by Chong Kun Dang Pharmaceutical. These Lactulose-based formulations, used for pediatric constipation, have been known as chronic shortage drugs due to limited supply compared to demand. Lactuse Syr, an imported item facing shortages, is anticipated to see increased availability in the market due to a rise in its drug price. Dulackhan Easy Syrup production is expected to increase following another drug pricing increase after 2022. Gilead Science Korea's Biktarvy Tab has completed the price-volume agreement type 'Na', which is expected to result in a reduction in drug pricing.
- Policy
- Samsung Bioepis receives approval for its Soliris biosimilar
- by Lee, Hye-Kyung Jan 23, 2024 06:02am
- Samsung Bioepis Samsung Bioepis has received approval for its Epysqli (eculizumab),’ a biosimilar of the ultra-high-priced rare disease treatment Soliris (eculizumab) in Korea. At the same time, it was granted first generic exclusivity until October 19th of this year, allowing Samsung Bioepis to market its biosimilar exclusively for the next nine months. In Korea, Soliris only has a patent for its 'method of treating hemolytic disease' that expires in February 2025, but the Patent Court of Korea cited a ruling by the Intellectual Property Trial and Appeal Board on December 22 last year and ruled IPTAB’s ‘invalidation ruling as legitimate.’ Among eculizumab biosimilars, Epysqli has become the first to receive approval in Korea, but Amgen’s ‘Bekemv’ was granted marketing authorization from the European Medicines Agency (EMA) in April last year. On the 19th, the Ministry of Food and Drug Safety approved Epysqli for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Epysqli is a biosimilar of Soliris, which posts annual sales of about KRW 5 trillion ($3.76 billion) around the globe, and conducted a global Phase III trial on PNH patients from August 2019 to October 2021. It received final approval in June 2022, 19 months after applying for domestic marketing authorization. Soliris is an orphan drug, which means patents for each indication are protected separately. The patent for Soliris’s PNH indication, which is prescribed the most, expired in April 2020 in Europe and will expire in the U.S. in March 2027. Therefore, only the patent for the ‘method of treating hemolytic disease' that is set to expire in February 2025 remains for Soliris. In June 2022, Samsung Bioepis filed a patent invalidation trial against Soliris’s developer Alexion to the IPTAB while applying for the Epysqli trademark and marketing authorization, and received an invalidation ruling. Eculizumab is mainly prescribed for PNH, a condition that causes patients to pass blood-colored urine at night due to hemolysis, a phenomenon in which hemoglobin is released from red blood cells. It can be caused by mutations in the X chromosome, which is involved in the production of proteins that make up the red blood cell membrane. The exact incidence of PNH remains unknown. It mainly affects adults in their 20s and 30s. About 10% of all patients are children. Without treatment, 20% to 50% of patients die within 6 years of diagnosis, signifying its high treatment demand.
- Company
- SGLT2i+DPP4i combos' performance falls short of expectations
- by Kim, Jin-Gu Jan 23, 2024 06:02am
- A large number of 'SGLT-2 inhibitor (SGLT2i)+DPP-4 inhibitor (DPP4i)' combinations entered the market after Korea’s insurance reimbursement was extended to cover ‘SGLT-2 inhibitor + DPP-4 inhibitor’ combinations, however, their sales performance in the first year is falling short of expectations. Of the major products that have been on the market since May, only 3 generated more than KRW 2 billion in prescriptions by the end of the year. Of the more than 30 dapagliflozin+sitagliptin combination products released since September, most prescriptions sold less than KRW 100 million by the end of the year. In the field, prescribers are noting how the extended reimbursement is applied to the 3 drug combinations of SGLT2i+DPP4i+metformin. Therefore, rather than adding metformin to the newly launched SGTL2i+DPP4i two-drug combination drugs, prescribers have been mainly prescribing the combination by adding a single SGLT2i agent to existing DPP4i+metformin combination drugs. SGLT2i+DPP4i combo mkt size KRW 8.8 bil… Esglito>Zemidapa>Qtern According to the pharmaceutical industry on the 23rd, the outpatient prescription market for SGLT2i+DPP4i combination was KRW 8.8 billion last year. Behringer Ingelheim's Esglito (empagliflozin+linagliptin)’ has shown the highest prescription performance, generating KRW 2.7 billion in prescription sales in the 8 months following its reimbursement listing in May last year. This was followed by LG Chem's Zemidapa (dapagliflozin+Zemiglo) and AstraZeneca's Qtern (dapagliflozin+saxagliptin), each of which recorded KRW 2.1 billion. Qtern is being sold by Ildong Pharmaceutical in Korea. The rest of the combination drugs have all posted less than KRW 1 billion in sales. Chng Kun Dang’s ‘Exiglu-S Tab (dapagliflozin+sitagliptin) posted KRW 600 million, Dong-A ST’s Sugadapa (dapagliflozin+evogliptin) posted KRW 500 million, and AstraZeneca's Sidapvia (dapagliflozin+sitagliptin) for KRW 200 million. Of these, all products other than Sidapvia, have been sold in earnest since their reimbursement listing in May last year. Sidapvia was launched in September last year after the patent expiry of Januvia (sitagliptin). The drug is manufactured and supplied by SK Chemicals in Korea. Other dapagliflozin+sitagliptin combinations launched alongside Sidapvia have accumulated less than KRW 100 million in prescriptions from September until the end of the year. Industry expresses performance is 'below expectations'...Different response from when the 96 companies were approved The market was formed after reimbursement was extended to combination therapy in Korea for diabetes in April last year. At the time, the government extended reimbursement to the SGLT2i+DPP4i+metformin combination. In May, the SGLT2i+DPP4i combination drugs were approved The pharmaceutical industry had initially predicted that demand would rise for combination products, especially those that combined SGLT2i and DPP4i since it was the first time the combined use of SGLT2i and DPP4i was reimbursed in Korea. In fact, the pharmaceutical industry had shown great attention, with 96 companies receiving approval for the 2-drug combo around the period of the reimbursement expansion. In April, the patent for the flagship SGLT2i class drug Forxiga (dapagliflozin) expired. The companies that owned original DPP4i drugs rushed to launch combination products that contained dapagliflozin. In September, the patent for Januvia (sitagliptin), the flagship DPP4i class drug, also expired. The expiration of the patents for the top drugs in each class led to a flurry of launches of dapagliflozin+sitagliptin combinations. But now last year's outpatient prescription performance results are out, and the industry consensus is that the performance of the 2-drug combinations is a disappointment. Even when considering that it was the first year of sales, it was not up to expectations. When taking the dapagliflozin+sitagliptin two-drug combination as an example, 34 companies have launched their product since September, but their combined prescription sales amounted to only KRW 1.4 billion. The average prescription per company is less than KRW 50 million. Combination drugs that used original drugs fared similarly. Taking Esgliteo, the highest-selling drug last year that posted KRW 2.7 billion as an example, its components, the single-agent drugs ‘Jadiance (empagliflozin)’ and ‘Trajenta (linagliptin),’ generated prescription sales of KRW 58.1 billion and KRW 61.3 billion, respectively, last year. "Prescribing the more familiar DPP4i+metformin combination"...New combinations at a crossroads The industry has raised various interpretations on the lower-than-expected performance of the drugs. First of all, one analysis was that the new combination drugs were not well received in the field. The government's diabetes benefit extension was for the three-drug combination of SGLT2i+DPP4i+metformin. The SGLT2i-DPP4i two-drug combination by itself is not covered. As a result, prescribers were left to choose one of three options: SGLT2i+DPP4i combo and metformin, SGLT2i+metformin combo and DPP4i, or SGLT2i and DPP4i and metformin. The problem is that prescribers were relatively more familiar with the SGLT2i+metformin or DPP4i+metformin combinations that were already on the market, compared with the more newly introduced SGLT2i+DPP4i combinations. "To use the newly approved SGLT2i+DPP4i combinations, patients would need to change all of their existing medications, whereas DPP4i+metformin combinations require patients to add a single SGLT2i to their existing medications, so there is less patient resistance," explained one endocrinologist. "Also, the combination drugs are not very competitive price-wise when compared with prescribing each drug separately," he added. In the case of the dapagliflozin plus sitagliptin combination, supply issues with sitagliptin also played a role. In the case of sitagliptin, one contract manufacturer manufactures products for 10 or more companies. The production capacity of the contract manufacturers has reportedly become overwhelmed, manufacturing the ingredients for so many companies. Some companies are also reportedly having difficulty producing products for companies due to difficulty procuring raw materials that need to be imported from India. However, there is also industry opinion that it is too early to tell whether SGLT2i+DPP4i combination products will be successful in the market. As there is still a possibility that the sitagliptin contract manufacturers will be able to stabilize their supply, and as related products are in the early stages of their launch, there remains enough potential for future market expansion.
- Policy
- Korean patients pay ₩10.5M for ₩300M Luxturna
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Novartis Luxturna (voretigene neparvovec-rzyl, Novartis), the first gene therapy for Inherited Retinal Dystrophy (IRD), is set to be reimbursed from the 1st of next month and is expected to significantly reduce the burden of those suffering from IRD in Korea. Although the price limit for Luxturna had been set at KRW 325.8 million per vial, the out-of-pocket cost borne by each patient is expected to be about KRW 10.5 million with the insurance reimbursement. According to industry sources on the 22nd, Luxturna will be listed for reimbursement under the risk-sharing system with a price cap of KRW 325.8 million per vial from next month. Novartis has signed 3 types of risk-sharing agreements with the National Health Insurance Service, including the refund type, expenditure cap type, and performance-based refund type RSA. The drug is used for adult and pediatric patients who have sufficient viable retinal cells but have lost vision due to IRD caused by a mutation in the RPE65 gene. The number of affected by IRD is estimated to be around 9 per year. Novartis’s Luxturna is a one-shot treatment that can treat a disease with a single administration, and the third among one-shot treatments to receive reimbursement approval in Korea, following Kymriah and Zolgensma. Currently, Luxturna is listed in 6 of the A8 countries – the US, France, Japan, Italy, Switzerland, and the UK. The A8 adjusted average price is KRW 875.11 million for both eyes. In Korea, Luxturna will be listed at a lower price of KRW 652 million. If used on one eye, the total cost is KRW 325.8 million. If you apply the 10% copayment rate, the cost is KRW 32.58 million, but if you apply the out-of-pocket maximum system, the cost borne by the patient drops to KRW 10.5 million. The estimated claims amount for the drug in the first year is about KRW 5.86 billion based on the list price, but the NHIS expects the actual financial expenditure to be less than this, considering the risk-sharing agreement signed for the drug. In addition, to ensure cost-effectiveness, Novartis needs to submit long-term follow-up data from Phase III clinical studies. The data will be evaluated at the end of the risk-sharing agreement period. Luxterna applied for reimbursement upon its approval in September 2021 and received insurance reimbursement in 2 years and 4 months. Meanwhile, Novartis decided to lower the price of its chronic heart failure treatment ‘Entresto Film Coated Tab’ from KRW 1,690 to KRW 1,683 per tablet upon Luxturna’s reimbursement.
- Company
- Will Verzenio secure expansion for early breast cancer?
- by Eo, Yun-Ho Jan 23, 2024 06:02am
- Lily Korea ‘Verzenio’, which faced difficulties in expanding its reimbursement standards last year, is now drawing attention to see if it will pass the review this time. According to industry sources, Lily Korea’s CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st. Their second attempt to expand the reimbursement is for Verzenio’s indication in early-stage breast cancer. Verzenio faced challenges in initial attempt to expand its indication for early-stage breast cancer when it was presented to the Cancer Disease Review Committee. Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May of the previous year, but the result was ‘reimbursement standards non-established.’ After five months, Verzenio re-submitted its reimbursement application to the HIRA in October. After Verzenio was resubmitted, a national petition was posted on the Cheong Wa Dae public petition website in the same month, advocating for ‘the reimbursement of Verzenio as a targeted treatment for early-stage breast cancer’. In the most recent application, clinical evidence was added, including the five-year outcomes from the monarchE study, presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The data used for the follow-up research were based on the four-year data presented at the 2022 San Antonio Breast Cancer Symposium held in December and an article published in The Lancet Oncology. The primary endpoints, which were invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), showed clinically significant differences between the Verzenio treatment group and the control group (endocrine therapy alone) that was even more pronounced in five-year data compared to the four-year data. In year 5, the primary endpoint invasive disease-free survival (IDFS) demonstrated an approximately 8% difference. Verzenio appears to have a potential carry-over effect through the fifth year even after the completion of the two-year treatment period. Besides the endocrine therapy letrozole generic, Verzenio is the only treatment option available in HR+/HER2- type early-stage breast cancer. On November 18, 2022, Verzenio received expanded approval for its use in combination with endocrine therapy in the adjuvant treatment of patients with HR+/HER2- high-risk early-stage breast cancer and who have lymph node-positive recurrence. The following are specific indications: ▲Four or more lymph node metastases, ▲1-3 lymph node metastases with a tumor size of 5 cm or larger, ▲Histological grade 3 limited recurrent high-risk patients.
- Policy
- Luxturna, Kerendia, & Raspirin will get new reimb standards
- by Lee, Jeong-Hwan Jan 22, 2024 05:49am
- On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notification on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements.” New reimbursement standards will be established for Novartis’s Luxturna, a one-shot retinal dystrophy treatment, Hanmi Pharmaceutical’s Raspirin Cap, and Bayer’s Kerendia Tab 10 mg, as they are set to be listed for reimbursement. Reimbursement standards will be set for Takeda’s Obizur, a treatment for acquired hemophilia A, and Pfizer’s Zavicefta Inj, a new antibiotics drug, as they are in the process of reimbursement listing. On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notice on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements” and will collect opinions by the 29th. ◆Luxturna Inj= an ophthalmic drug Luxturna will be eligible for reimbursement for pediatric and adult patients with inherited retinal dystrophy caused by biallelic RPE65 mutations who meet all of the following conditions and have sufficient surviving retinal cells. Patients must have a genetic diagnosis of biallelic pathogenic or likely pathogenic RPE65 mutations. Reimbursement will be approved for patients who are aged four years or older but younger than 65 years at the time of administration. The maximum corrected visual acuity in both eyes should be 0.3 or less, or the visual field in both eyes should be less than 20 degrees. In addition, there must be enough surviving retinal cells, and all the following conditions must be met. The thickness of the posterior part of the retina in optical coherence tomography findings should exceed 100 μm. Based on fundus examination, the area in the posterior part of the retina without atrophy or pigment degeneration should be at least three times the size of the optic disk. The visual field measured with Goldmann III4e isopter or its equivalent should remain within the central 30 degrees of vision. Patients who have undergone intraocular surgery within the past six months or have had infections in or around the eyes will be excluded from the treatment group. Luxturna, a gene replacement therapy given as a single dose, is eligible for reimbursement once in a lifetime. It should be administered exclusively by a retinal specialist experienced in macular surgery. According to the revised standards for managing reimbursement of high-cost drugs, patients receiving Luxturna must provide reimbursement information on the reimbursement statement for four years, adhering to the specified reimbursement claim procedure, assessment claim form, statement format, and preparation guidelines. ◆Raspirin Cap= Reimbursement will be approved for patients who are being treated with a combination therapy of Aspirin and rabeprazole, meeting reimbursement standards. ◆Kerendia 10 mg= Reimbursement will be approved for adult patients with chronic kidney disease associated with type 2 diabetes who are receiving the drug in combination with a standard therapy (ACE inhibitor or angiotensin II receptor blocker) and meet all conditions, even if they have been stably treated with the maximum tolerated labeled dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker for more than four weeks. However, patients in NYHA class II~IV with consistent symptoms will be excluded from reimbursement eligibility. ◆Obizur= Reimbursement for Obizur will be applied for the treatment of bleeding episodes in adults with acquired hemophilia A. The treatment is intended for patients who meet one of the following conditions: who have an antibody titer of greater than 5 Bethesda Units (BU), who have antibody titer of less than 5BU and a lack of clinical response to high doses of antihemophilic factor, or who have a recent history of an antibody titer of less than 5BU and who had a clinical response to Obizur after having a lack of clinical response to high doses of antihemophilic factor. Obizur can be administered to hospitalized patients and outpatients in hospitals. Treatment costs can be reimbursed when the drug is used according to the recommended methods of administration and dosage. Patients should also refer to precautions, including warnings, adverse reactions, and general precautions. Patients should be diagnosed and receive prescriptions by hematologists specializing in hematology-oncology in the department of internal medicine or hematology-oncology specialists in the department of pediatrics. ◆Zavicefta Inj= Reimbursement will be approved for patients with documented cases of complicated intra-abdominal infections, complicated urinary tract infections, or when carbapenem antibiotics have failed in treating hospital-acquired and ventilator-acquired pneumonia, or when multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria are present. Additionally, a prescription recommendation must be attached. ◆Forxiga and Jardiance= Reimbursement for Forxiga (ingredient: dapagliflozin) 10 mg and Jardiance Tab (ingredient: empagliflozin) 100 mg, which are SGLT-2 inhibitor-mediated diabetes treatments, will be expanded for patients undergoing treatment for chronic heart failure. Specifically, reimbursement will be approved for patients having chronic heart failure with reduced left ventricular ejection function, falling into NYHA class Ⅱ∼Ⅳ, having a Left Ventricular Ejection Fraction (LVEF) of ≤ 40%, and undergoing a standard treatment with a stable dose.
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- Sotatercept receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 22, 2024 05:49am
- Sotatercept, a new drug candidate for pulmonary arterial hypertension (PAH), has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced the drug’s designation in the first orphan drug designation announcement it made in the new year. Sotatercept, which is being developed by Merck, is being regarded to have changed the treatment paradigm for PAH. The substance, which is a combination of a protein complex, activin, and the transforming growth factor-β (TGF-β), reverses disease progression by blocking abnormal signaling between cells in the pulmonary blood vessels. Pulmonary arterial hypertension is a condition characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. which leads to heart failure. In Korea, about half of the patients with PAH die within 5 years. More than 10 drugs are available for the condition in Korea, including phosphodiesterase type 5 inhibitors and endothelin receptor antagonists, but many patients suffer from severe symptoms despite being on a combination of two or three drugs. The efficacy of the drug has been confirmed in the pivotal Phase III STELLAR trial. Patients were randomized 1:1 to sotatercept or placebo to assess the efficacy and safety of the drug. Results showed that the sotatercept group improved in 6-minute walk distance (6MWD, primary endpoint) by 40.1 m, compared with a decline of –1.4 m in the placebo group Also, 38.9% of patients in the sotatercept group achieved all of the multi-component improvement endpoints, the secondary endpoint of the study, which included an improvement of 30m or more in the six-minute walk test. This was 4 times longer than the 10.1% in the placebo group. The US FDA will decide whether to approve sotatercept by March 26, the target action date it had set under the Prescription Drug User Fee Act (PDUFA).
