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- 2026-05-05 11:26:33
- Policy
- Delayed actual transaction price cuts slash expected savings
- by Lee, Tak-Sun Feb 26, 2024 05:25am
- The implementation of the actual transaction price system intended to reduce the drug price has been postponed. Since the system was initially scheduled to take effect in January, the price monitoring investigation reached conclusion. However, the price adjustments are being delayed for various reasons. Pharmaceutical companies may benefit from the delay, but it results in financial loss for the National Health Insurance Service (NHIS) due to reduced effects of financial savings. According to industry experts on the 22nd, the price cutting of the actual transaction prices of drugs has been repeatedly delayed. It is unlikely to be implemented in March as it has not been included in this year’s Health Insurance Policy Review Committee agenda. Since the post-listing price cuts following the re-evaluation of the upper price limit are scheduled to begin in March, price cutting of the actual transaction prices of drugs is expected to be postponed. This delay is intended to allow the payer to take effective management of returns and budgets into account. However, it is unclear whether the policy changes will take effect in April. Financial savings may be negatively affected due to the delay in policy implementation. The government implements an actual transaction price system biannually. This system investigates the actual prices of drugs distributed in hospitals, except for national and public hospitals. If a drug’s actual price distributed is lower than the upper limit price, it is subject to a discount rate of 10%. The investigations exclude low-priced drugs and drugs that have been listed as shortage prevention drugs (SPD). The NHIS can expect financial savings through the system. The 2019 actual transaction price investigation resulted in price cutting of 3900 drugs, leading to annual financial savings of 42.1 to 112.9 billion won in 2020 and 2021, according to ‘Research on the comprehensive improvement of the actual transaction price system based on the effectiveness evaluation (P.I: Professor Kim, Jinhyun of Seoul National University).’ According to government data, adjusting the upper limit price of 3829 drugs based on the actual transaction price investigation resulted in a net estimated financial savings of 79.6 billion won in 2022. Since a price cutting of drug prices based on the actual transaction price investigation saves a minimum of 40 billion won annually, 10 billion savings in the first quarter are estimated to be lost due to delays in the implementation. The Ministry of Health and Welfare (MOHW) stated that the price cuts of the actual transaction price have been delayed because their review of National Essential Drugs and drugs in short supply is incomplete. The implementation timeline will be decided later, according to the MOHW. Every month, the price of drugs on the drugs shortages list has been increasing. In March, The prices of 49 items of tulobuterol patch are expected to increase by an average of 13.9% of the upper limit price. An additional designation of National Essential Drugs is planned for the first half of the year. However, critics argue that the NHIS is causing financial losses by delaying the price cuts not only for drugs under investigation but also for those where investigations have already concluded. The point is that the drugs in short supply or National Essential Drugs represent only a small fraction of the items investigated for actual transaction prices, and these can be adjusted during post-management. Another point is that the government is refraining from taking risks before the upcoming general election. The government may proceed with implementation cautiously because price cutting of drugs in short supply may lead to public criticism. “Is the government reluctant to take risks before the upcoming general election, despite their goal of efficiently managing finances by assessing the financial structure of national insurance?” a pharmaceutical industry representative emphasized. “If the government continues to delay the implementation, their expected financial savings will be reduced,” a representative added.
- Company
- Shingrix leads shingles vaccine mkt…occupies 44% of mkt
- by Chon, Seung-Hyun Feb 26, 2024 05:24am
- The new shingles vaccine, Shingrix, has risen to lead the market in its first year of sales. It quickly gained 44% of the market share with its strong shingles prevention effect despite its high price. Since the addition of Shingrix, the market has doubled in size. According to the drug research institution IQVIA, the shingles vaccine market was worth KRW 87 billion last year, expanding 105.8% from the previous year. The domestic shingles vaccine market has been declining every year after reaching KRW 89.9 billion in 2019. In 2022, the market size was KRW 42.3 billion, less than half of what it was 3 years ago. The analysis is that the pandemic has caused the premium vaccine market to shrink. Annual size of shingles vaccine market (Unit: KRW 100 million, Data: IQVIA) However, the introduction of the new Shingrix has revitalized the shingles vaccine market. In last year’s shingles vaccine market, Shingrix posted the most sales, posting KRW 38.5 billion in sales. The vaccine, which has been available since December 2022, began to exert its presence in Q1 last year with sales of KRW 6 billion, occupying a 28.9% share. In Q2 last year, it quickly became the leading shingles vaccine, posting KRW 11.1 billion, and continued to lead in Q3 and Q4, posting KRW 9.9 billion and KRW 11.1 billion, respectively. Shingrix’s share of the shingles vaccine market last year reached 44.2%. In other words, the vaccine took the market by storm, occupying nearly half of the total market in its 1st year of release. In Q4 last year, the company's market share rose to 50.2%, further solidifying its lead. 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 comparable 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 supported by 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. Sales of shingles vaccines (Unit: KRW 100 million, Data: IQVIA) Existing shingles vaccine products such as SKYZoster and Zostavax saw sales increase from the previous year, but their market share declined due to Shingrix. SK Bioscience’s SKYZoster’s sales had risen 33.3% YoY to record KRW 26.2 billion last year. SKYZoster is a live attenuated vaccine for the prevention of shingles that was 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, the company 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 in the market, and the introduction of SKYZoster had sparked market competition. SKYZoster's growth slowed during the pandemic after posting KRW 34.1 billion in sales in 2019. In 2021, sales fell to 18.2 billion won, a 46.7% drop in two years. SKYZoster rebounded in 2022 with 19.7 billion won in sales and grew even more last year. However, its market share fell from 46.5% in 2022 to 30.1% in one year due to the rise of Shingrix. In the case of Zostavax, it posted sales of KRW 22.4 billion last year, up 0.5% YoY. In 2019, Zostavax posted KRW 55.9 billion in sales, occupying 62.1% of the market share. However, its sales have been on a downward trend since then, and its share shrank to 25.7% last year.
- Company
- Samsung Bioepis’s Eylea biosimilar Afilivu approved in KOR
- by Son, Hyung-Min Feb 26, 2024 05:24am
- Samsung Bioepis announced on the 23rd that it has obtained domestic approval for its Eylea biosimilar ‘Afilivu.’ The approval marks the 2nd ophthalmic disease treatment Samsung Bioepis has received approval for after being granted approval for its Lucentis biosimilar Amelivu. Eylea is a macular degeneration treatment developed by the multinational pharmaceutical companies Regeneron and Bayer. Samsung Bioepis plans to comarket both Amelivu and Afilivu with Samil Pharm. The companies released Amelivu last year and signed an agreement for Afilivu in February this year. Samsung Bioepis conducted a Phase III clinical trial for its Eylea biosimilar in 449 patients with wet age-related macular degeneration from June 2020 to March 2022 in 10 countries, including the U.S. and South Korea. In the clinical trial, Afilivu demonstrated bioequivalence in terms of efficacy and safety with Eylea. "With the approval of Afilivu, we have once again demonstrated our biopharmaceutical research and development capabilities. We will continue to strive to contribute to addressing unmet medical needs in the field of ophthalmic diseases in Korea."
- Company
- Eylea continues to lead AMD mkt despite new competition
- by Son, Hyung-Min Feb 26, 2024 05:24am
- The entry of new drugs in the macular degeneration treatment market made little impact on Eylea’s sales. Eylea continued to top the macular degeneration treatment market last year, posting sales of KRW 96.7 billion. The Eylea biosimilars Vabysmo and Lucentis, which were released last year, have shown little presence in the market yet. According to the market research institution IQVIA on Thursday, Eylea’s revenue last year was KRW 96.7 billion, up 20.2% from the KRW 80.4 billion it had made in 2022. Eylea is a vascular endothelial growth factor-A (VEGF-A) inhibitor for macular degeneration that was developed by Bayer and Regeneron. The drug was approved in Korea in 2013 and entered the market in earnest the following year after receiving reimbursement approval. Although Eylea’s sales were lower than that of its competitor Lucentis until 2015, the market demographic changed in Q3 2016. Since then, Eylea’s sales have continued to grow, reaching KRW 46.8 billion in 2019, and then KRW 60.3 billion in 2020. In 2022, it surpassed the KRW 80 billion mark and reached the KRW 100 billion mark the last year. However, Eylea now has to fend off an onslaught of biosimilar competitors due to the expiration of its patent last month. Celltrion, Samsung Bioepis, and Sam Chun Dang Pharm have all made a bid with their Eylea biosimilars. The original developers, Bayer and Regeneron, are preparing to develop a higher-dose version of Eylea in preparation for the entry of biosimilars. The companies plan to launch a higher-dose formulation to increase the dosing interval. The two companies plan to seek approval for the higher-dose Eylea for all of their approved indications, including diabetic macular edema (DME), wet age-related macular degeneration (wAMD), and retinal vein occlusion. Novartis’s Lucentis posted sales of KRW19.8 billion last year, down 20.2% from the previous year. Lucentis’s sales have declined steadily since 2020, when it generated KRW 37 billion in sales. In 2022, the company reported sales of KRW 29.4 billion, and even less, to record sales of less than KRW 20 billion last year. Lucentis uses the same mechanism of action to inhibit VEGF-A as Eylea but has a shorter dosing interval. Lucentis must be administered once a month, compared to Eylea, which can be administered once every two months. Eylea’s efficacy had demonstrated superior vision improvement to Lucentis in patients with severe vision loss due to diabetic macular edema. Therefore, Novartis plans to focus on marketing its next macular degeneration drug, Beovu. Like Eylea, Beovu can be dosed once every 2 months. Beovu, which was released in Korea in Q3 2021, generated sales of KRW 8.6 billion in the same year. Since then, its sales have continued to grow, generating sales of KRW 16.5 billion in 2022 and KRW 21.3 billion last year. Total sales of new drugs and biosimilars that entered the market last year amount to KRW 19 billion The Lucentis biosimilars and Roche's Vabysmo, which were newly launched last year, did not make much of an impact in the market the past year. Chong Kun Dang’s LucenBS, which was the first Lucentis biosimilar to enter the market, sold KRW 500 million, and Amelivu, which is comarketed by Samsung Bioepis and Samil Pharm, sold KRW 800 million last year. Chong Kun Dang sought to turn the atmosphere around with a price cut. The company cut the price of Lucentis from KRW 300,000 to KRW 150,000 this month. The original Lucentis costs KRW 580,000 per vial and Samsung Bioepis' Amelivu costs KRW 350,000 per vial. Because its competitor has significantly reduced the price of its drug, attention is rising to what Samsung Bioepis will do in the next as well. Vabysmo, which had gained great attention even before its launch, generated KRW 600 million in sales last year. However, the real competition is expected to start this year, as Vabysmo was granted reimbursement in October last year. Vabysmo is a macular degeneration treatment that was developed by Roche. The drug not only inhibits VEGF but also blocks the angiopoietin-2 (Ang-2) pathway to inhibit neovascularization. Blocking both pathways independently has been shown to be more effective than blocking VEGF alone in reducing inflammation, leakage, and abnormal blood vessel growth. In particular, in clinical trials, Vabysmo improved visual acuity at a level non-inferior to that of Eylea in the TENAYA and LUCERNE trials that compared its safety and efficacy with Eylea. Its duration of response lasted 24 months. In other words, Vabysmo achieved comparable efficacy to other treatments with once every 4 months dosing compared to the once every 1-2 month dosing required for other treatments. In the global market, Vabysmo’s sales are already closing in on that of Eylea. Vabysmo generated approximately USD 3.56 trillion in global sales last year, more than half of Eylea’s $7.8 trillion, in just 2 years after its launch.
- Company
- Kay Bae appointed as KRPIA chair, also overseeing NZ, AUS
- by Eo, Yun-Ho Feb 26, 2024 05:24am
- Kay Bae, KRPIA Chair Kay Bae (53), Sanofi-Aventis Korea Country Lead, literally has become the ‘center’ of the pharmaceutical company. Bae, who was recently appointed as a Country Lead to manage subsidiaries including Korea, New Zealand, and Australia of the Sanofi Group, is appointed as a new Chair of the Korean Research-based Pharmaceutical Industry Association (KRPIA). As the head of the organization representing Korean multinational companies and big pharma Sanofi’s major Asian-Pacific countries, Bae emerged as a key player in multifaceted communication. Bae’s KRPIA appointment was a surprise because Bae declined an offer for the position multiple times when the KRPIA chair position became vacant. Bae’s interests and Korean-like modesty may likely have influenced her previous decisions, but the analysis suggests that Bae may have declined offers previously because of her commitment to her primary appointment (Sanofi-Aventis Korea Country Lead). This time, Bae may have been in a situation where she could no longer decline KRPIA’s offer. KRPIA’s board of directors (BOD) list shows that new members have joined the board following many CEO transfers within the multinational pharmaceutical companies in one to two years. Rumor has it that Sang Kyung Noh (61), Amgen Korea’s CEO, was the only other candidate besides the previous Chairman Oh Dong-Wook (54), Pfizer Korea’s CEO, for the head of KRPIA. The KRPIA board of directors 2024 (Member companies in alphabetical order): Soyoung Kang of AbbVie Korea, Sang Kyung Noh of Amgen Korea, Junil Kim of Astellas Pharma Korea, JinA Lee of Bayer Korea, Hye Young Lee of BMS Pharmaceutical Korea, Jaeyeon Choi of Gilead Sciences Korea, Maurizio Borgatta of GSK Korea. Christoph Hamann of Merck Korea, Ji-young Sohn of Moderna Korea, Albert Kim of MSD Korea, Jae (Byungjae) Yoo of Novartis Korea, Dong-Wook Oh of Pfizer Korea, Kay Bae of Sanofi-aventis Korea.Although her business responsibilities have expanded, Bae has taken on the role of the chair. Sanofi has recently undergone a restructuring that combines Korean, New Zealand, and Australian corporations. In addition, Sanofi will integrate business divisions previously operated independently into a unified business system. In other words, Bae will have greater decision-making power and expanded roles within the company. There will be many overseas business trips as well. There are concerns regarding whether Bae can commit to the organization since she has additional business in the busiest period. On the other hand, Bae is expected to do well, considering her role as a control tower. In an era of high drug prices, KRPIA works diligently for drug pricing of new drugs. The KRPIA plays a critical role in the organization, suggesting reform in drug pricing system and communicating with the government. Amid this situation, Bae will be responsible for determining the core message of the organization representing pharmaceutical companies in Korea while also overseeing New Zealand and Australia, which are Korea’s drug pricing reference counties. After a long period of vacancy, the primary positions of KRPIA are now filled, indicating vitality. New wheels are turning. It is to be watched whether the executive team under Bae's leadership can achieve more than just protecting drug prices. They need to negotiate with health authorities using sound reasoning and judgement, resulting in an agreement that prioritizes 'improving patient accessibility.' “Global pharmaceutical companies face a rapid healthcare and medical atmosphere. Based on KRPIA’s patient-centered vision, we will engage in various efforts to provide patients in Korea with rapid and broadened treatment benefits of innovative new drugs,” Bae stated as she was appointed as KRPIA’s chair. Meanwhile, Bae became the longest-serving CEO of a multinational company last year when Kim Dae-jung (64), former CEO of Daiichi Sankyo, retired. Bae was appointed as the CEO of Genzyme Korea in 2010 and has served as the Country Lead of the Sanofi-Aventis Korea and Sanofi integration management committee (then Sanofi-Aventis, Sanofi Pasteur, Genzyme, Merial) for over ten years since 2013. Bae represents a female CEO in a multinational pharmaceutical company. Bae started her business career at Novartis and later joined Genzyme. Bae led the integration process when Genzyme was fully acquired by Sanofi in 2019.
- Company
- New Alzheimer’s drug Leqembi closer to drug marketing
- by Eo, Yun-Ho Feb 26, 2024 05:24am
- Leqembi (lecanemab), a drug jointly developed by Eisai and Biogen. A new Alzheimer’s treatment ‘Leqembi’ is expected to receive approval for marketing in Korea. The Ministry of Food and Drug Safety (MFDS) is conducting a final assessment of Leqembi (lecanemab), a drug jointly developed by Eisai and Biogen, for marketing approval. Leqembi’s application for approval was submitted last year, indicating an expected approval date in the first half of the year. The drug will be indicated as a treatment of ‘Mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.’ Leqembi has been shown to reduce the rate of disease progression and to slow cognitive and functional decline through selectively binding to β-amyloid (βA), which is known as an agent that causes Alzheimer’s disease. This drug achieved statistically significant results in both the primary endpoint and secondary endpoint in the Clarity AD study. Notably, Leqembi-treatment group had reduced functional decline of the brain by 27% compared to the placebo group during the 18 months. Although Leqembi is recognized for its effectiveness in delaying dementia in the market for Amyloid-targeted therapy, the characteristic side effects associated with the treatments have remained a recurring issue. Leqembi-associated ARIA side effects refer to brain swelling and small spots of bleeding detected in magnetic resonance imaging (MRI) scans. Depending on how side effects appear, the side effects are further categorized as ‘ARIA-E,’ defined by vasogenic edema of the brain and sulcal effusion, and ‘ARIA-H,’ defined as microhemorrhage and hemosiderosis. It remains to be watched whether Leqembi can overcome side-effects associated with amyloid-targeting new drugs and make a mark in the Alzheimer’s market. Leqembi was approved in China last January, following the United States (July 2023) and Japan (September 2023).
- Company
- Alecensa prepares to solidify its lead in lung cancer mkt
- by Son, Hyung-Min Feb 23, 2024 05:49am
- Alecensa is showing a strong position in the targeted therapy market for ALK-positive lung cancer in Korea. Last year, Alecensa generated KRW 34.9 billion in sales, far outpacing the runner-up, Takeda Alunbrig's KRW 13.6 billion. As the only ALK-targeted therapy that has demonstrated efficacy in early-stage lung cancer, Alecensa is likely to continue its lead in the market for the foreseeable future. According to the market institution IQVIA on the 22nd, Alecensa sold KRW 34.9 billion last year, up 0.5% from KRW 34.7 billion in 2022. Alecensa's sales have been on a steady rise since surpassing KRW 5 billion in Q3 2019 and have posted average quarterly sales of over KRW 8 billion since 2021. Alecensa is a second-generation ALK-positive targeted therapy developed by Roche. Targeted therapies for ALK-positive cancer are classified into 3 categories: first-generation drugs like Pfizer’s Xalkori; second-generation drugs like Roche’s Alecensa and Takeda’s Alunbrig; and third-generation drugs like Pfizer’s Lorviqua. With the possibility rising for Alecensa’s use in early-stage lung cancer, the drug is expected to continue solidifying its lead in the market According to clinical data presented at last year's European Society for Medical Oncology Congress 2023 (ESMO 2023), Alecensa showed effect as adjuvant chemotherapy. In the clinical trial, Alecensa improved disease-free survival (DFS) over platinum-based chemotherapy. The Alecensa-administered group showed a 76% reduction in recurrence or death and a 78% reduction in the risk of CNS progression or death. Although Alecensa does not yet own an indication for early-stage lung cancer in Korea if it adds the indication, the drug will likely remain the market leader for some time. Takeda's Alunbrig posted sales of KRW 13.6 billion last year, up 23.6% YoY. Alunbrig's sales have been growing steadily since surpassing KRW 2 billion in Q3 2021. Alunbrig's strength is that it can be taken once daily with or without meals. In the case of Alecensa, 4 capsules need to be taken twice daily, for a total of 8 capsules per day. Also, Alunbrig is available in 3 different strengths to help patients find the right dose. Pfizer's Lorviqua generated KRW 11.7 billion in sales last year, a 216.2% increase from 2022. Lorviqua, which was released in the Korean market in Q1 2022, has posted more than KRW 3 billion in sales since Q3 2022 after a level period of KRW 200 million in sales in Q1 and Q2. Lorviqua’s sales rise started in full swing after being granted reimbursement as a second-line treatment for ALK-positive lung cancer in September 2022. Currently, Lorviqua is only available for patients who have failed with the use of Xalkori, Alunbrig, or Alecensa. Pfizer is currently seeking to expand its reimbursement to the first line. On the other hand, Pfizer's Xalkori was the only ALK-targeted therapy to see a sales decline. Xalkori generated KRW 9.9 billion in sales last year, which was a 13.1% YoY decline. After generating KRW 8 billion in sales in Q1 2019, Xalkori’s sales plummeted to KRW 4.8 billion in Q2. The decline in Xalkori sales is related to the release of second- and third-generation targeted therapies. These drugs demonstrated a higher effect with improved safety over Xalkori. Second- and third-generation targeted therapies are said to have lower drug toxicity, fewer adverse events, and better efficacy than first-generation drugs. Also, Second- and third-generation targeted therapies also have the advantage of a greater penetration rate into the central nervous system (CNS), including the brain.
- Company
- Alteogen expands license agreement with MSD
- by Kim, Jin-Gu Feb 23, 2024 05:49am
- Alteogen officially announced on the 22nd that it will receive an additional USD 20 million (approximately KRW 26.7 billion) from the multinational pharmaceutical giant MSD under the terms of their modified agreement. In June 2020, Alteogen signed a non-exclusive licensing agreement with MSD for its proprietary human hyaluronidase technology (ALT-B4). At the time, The upfront payment was USD 160 million. MSD is using the technology to develop a subcutaneous (SC) formulation of Keytruda (pembrolizumab). Alteogen explained that the original agreement had been modified into an exclusive agreement. The company will grant exclusive licensing rights to the Keytruda line of products that MSD is developing by adding ALT-B4. However, the non-exclusive agreement will continue to apply to non-KEYTRUDA development projects. As part of the modified agreement, Alteogen will receive an additional USD 20 million in payments independent of the original upfront payment. This amount represents 93% of Alteogen's consolidated sales revenue of KRW 28.8 billion last year. The additional milestone payments Alteogen could receive have also been expanded. Alteogen was previously eligible to receive up to USD 3.865 billion in milestone payments based on regulatory approval, patent extension, and cumulative net sales of the Keytruda family of subcutaneous injection formulations that are applied to the ALT-B4 technology. The modified agreement increases the maximum amount of milestones Alteogen is eligible to receive by USD 432 million to USD 4.298 billion (KRW 5.7 trillion). A condition for royalties based on commercial sales has also been added. Alteogen will receive a percentage of sales of the Keytruda product line each year as royalties even after the agreement period for the patent term, until March 2040. An official from Alteogen said, "We expect to receive the additional payment under the modified agreement on or before the 25th of next month.”
- Company
- 2 ADC drugs being discussed for reimb after Enhertu
- by Eo, Yun-Ho Feb 23, 2024 05:49am
- Trodelvy and Padcev are now being considered for follow-up discussions in the Economic Evaluation Committee. The two next-generation ADC drugs following ‘Enhertu’ draw attention as they are currently being considered reimbursement listing in South Korea. Gilead Science Korea’s Trodelvy (Sacituzumab govitecan), used to treat triple-negative breast cancer (TNBC), and Astellas Pharma Korea’s Padcev (enfortumab vedotin), used to treat bladder cancer, have cleared the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). The drugs are now being considered for follow-up discussions in the Economic Evaluation Committee. The two drugs are known as antibody-drug conjugates (ADCs) and have demonstrated improved benefits compared to existing therapies in clinical trials. However, determining their domestic prices is challenging due to their high pricing. ‘Enhertu (trastuzumab deruxtecan)’ set a precedent as ADC drugs. In May of last year, Enhertu cleared the review by the Cancer Diseases Review Committee, and within eight months, it passed the Drug Reimbursement Evaluation Committee (DREC). Currently, Enhertu has entered the negotiations for drug pricing. The clearance of Enhertu by DREC may indicate positive outcomes for Trodelvy and Padcev. Considering Enhertu’s limited flexibility in price range during cost-effectiveness evaluation, DREC's approval of Enhertu this round suggests government proposed an ICER value in the mid-to-late range of 50 million won. Trodelvy and Padcev may have a higher chance of positive outcomes. Of course, the course of listing may depend on the results of their clinical evaluation and values. It will be interesting to see the outcomes for two ADC drugs awaiting review from the DREC this year after clearing the Cancer Disease Review Committee. Trodelvy is the first Trop-2 targeting ADC. It is comprised of monoclonal antibody that binds Trop-2, an antigen expressed on cell surfaces, and a TOP1 inhibitor payload ‘SN-38’ that destroys cancer cells. Trodelvy, a second-line or later therapy for patients with metastatic triple-negative breast cancer, is the only approved treatment, excluding cytotoxic chemotherapy, by the Ministry of Food and Drug Safety (MFDS) for use in the entire patient population regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines classify Trodelvy as Category 1 for second-line or later therapy in adult patients with metastatic triple-negative breast cancer. Padcev has a Category 1 priority recommendation in the NCCN guidelines. Padcev is a novel treatment option for urothelial cancer patients who have disease progression or relapsed following cancer immunotherapy and platinum-containing chemotherapy and are not eligible for previous standard-of-care treatment options. In March of last year, Padcev was approved in Korea as a monotherapy for patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors.
- Policy
- Competition intensifies in 3-combo drug mkt for COPD·asthma
- by Lee, Tak-Sun Feb 23, 2024 05:48am
- GSK’s triple therapy for COPD, Competition in the market for three-drug combinations used to treat COPD (chronic obstructive pulmonary disease) and asthma has become somewhat complicated. Kolon Pharma’s Trimbow, which was introduced in January, triggered the competition, and GSK’s Trelegy Ellipta, which had enjoyed its sole lead in the market till then, strengthened its line-up in response. According to industry sources on the 22nd, GSK Trelegy Ellipta will be reimbursed for the treatment of asthma in addition to COPD starting next month. The Ministry of Health and Welfare issued a pre-announcement of the amendment to the revised drug reimbursement standards that Trelegy Ellipta will be reimbursed for the treatment of "severe asthma that is not adequately controlled with a combination of moderate-or high-dose inhaled corticosteroids and a long-acting inhaled beta-2 agonist,” starting on March 1st. With the reimbursement, Trelegy Ellipta’s competitivity in the market will increase further as it will be available for severe asthma in addition to its existing indication for moderate-to-severe COPD in adults. Trelegy Ellipta had been dominating the Korean market with its low drug price but is now facing competition with Kolon Pharm's Trimbow inhaler which was introduced in January. Moreover, the new inhaler can be used for both asthma and COPD. With Trelegy Ellipta’s reimbursement also extended to COPD, the two drugs will now be fully engaged in a one-on-one competition. The price of Trelegy Ellipta is slightly less expensive. Its price remains the same at KRW 45,602 per box even with the coverage expansion. Trimbow is only KRS 1,000 more expensive, at KRW 46,669. However, Trimbow seems to have scored a win by obtaining a higher price than Trelegy Ellipta. Trimbow has both asthma and COPD indications, and was regarded as an alternative to Novartis’s triple therapy ‘Enerzair Breezhaler 150/50/160μg’ (upper limit price KRW 65,502) for asthma and ‘Trelegy Ellipta (upper limit price (upper limit price KRW 45,602)’ for COPD, and was priced below 90% of the weighted average price of the two drugs. If Trimbow only owned an indication for COPD, its price would have been set lower than that of Trelegy Ellipta, however, owning the two indications allowed for the drug to receive a price higher than that of Trelegy Ellipta. Therefore, the competition between the two drugs are likely to begin in earnest due to their similar indications and prices. In addition to adding the asthma indication Trelegy Ellipta, GSK was successful in receiving reimbursement for its higher-dose Trelegy 200 Ellipta Inhaler to the list this time. However, Trelegy Ellipta 200® Inhaler is only used for asthma. Therefore, its alternative, ‘Enerzair Breezhaler 150/50/160μ (upper limit price KRW 74,115)’ became the basis for its pricing negotiations. As a result, Trelegy Ellipta 200® Inhaler was listed at KRW 65,500 per box, after accepting a price below 90% of its alternative. With the reimbursement extension for its Trelegy Ellipta and the new listing of the Trelegy Ellipta 200®, GSK will now be able to adopt a two-track strategy in Korea’s asthma inhaler market. Industry analysis is that the new additions will contribute to broadening the choice for patients in Korea, with the lower-priced Trelegy Ellipta and the higher-priced, higher-dose Trelegy Ellipta 200. Also, GSK voluntarily reduced the price of its 2 inhaled single-agent products to help ease the financial burden of the patients. The price of Arnuity 100 Elipta (fluticasone furoate) for asthma was reduced from KRW 19,973 to KRW 17,376, and Incruse Elipta (umeclidinium bromide) for COPD was reduced from KRW 38,438 to KRW 34,978. The measure is considered to have been made in strategic response to the introduction of Kolon’s triple therapy product. Going forward, a key question for the triple combination market is whether AstraZeneca will introduce its Breztri Aerosphere in the market. The drug received conditional approval from the Drug Reimbursement Evaluation Committee in May of last year, that its reimbursement would be adequate if it is priced below the assessed value. The company has since applied for reevaluation to DREC, but no results have been disclosed since. However, when listed, it would be difficult for Breztri Aerosphere, which only has an indication for COPD, to receive a price higher than that of Trelegy Ellipta, which currently has the lowest price.
