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- 2026-06-25 07:30:37
- Company
- Evenity and Prolia sales surge...combined sales rise 47%
- by Kim, Jin-Gu Dec 12, 2023 05:38am
- Amgen’s two osteoporosis treatments, Prolia (denosumab) and Evenity (romosozumab) are repeatedly posting high growth in sales. Together, these two treatments generated over 130 billion won in Q3 sales, dominating the osteoporosis treatment market in Korea. In the first-line, osteoporosis treatment is trending towards sequential Evenity followed by Prolia for high-risk fracture osteoporosis patients. With this approach increasingly becoming the norm, the analysis is that these two treatments are deemed to be making a synergistic effect, leading to improved outcomes. Prolia's Q3 cumulative sales up 33% YoY…over 150 bil won expected by the end of the year According to the market research institution IQVIA, Prolia’s cumulative sales in Q3 were 111.5 billion won, representing an increase of 33% year-over-year (YoY) from the 83.8 billion won last year. Prolia was approved in September 2014 in Korea. It is a biologic for osteoporosis that targets RANKL, an essential protein for the formation, function, and survival of osteoclasts that destroys the bone. Prolia began seeing an upward sales trend after its reimbursement as a second-line treatment in 2017. The sales growth became steeper after Prolia received expanded reimbursement as a first-line treatment in April 2019. Quarterly sales of Prolia In 2019, Prolia's sales were 47.3 billion won, and this nearly doubled to 92.1 billion won in 2021 over two years. Last year, its annual sales expanded to exceed 100 billion won. If the current sales growth continues, its annual sales are projected to reach close to 150 billion won by the end of the year. The analysis is that both the expansion of reimbursement and enhanced sales efforts contributed to Prolia's growth. Amgen has been co-marketing Prolia with Chong Kun Dang since September 2017. This method of collaboration involves Amgen focusing on general hospitals, while Chong Kun Dang handles the drug's sales and marketing in secondary hospitals and clinics. Evenity's salses rise 61% YoY… accelerated by Prolia’s sales growth Evenity, which was released following Prolia, is showing an even steeper growth. This year, its cumulative sales for Q3 reached 19.7 billion won, an increase of 61% YoY. Evenity is an osteogenic agent with a dual effect of promoting bone formation and inhibiting bone resorption. Amgen's strategy for marketing for Evenity is 'sequential Evenity followed by Prolia' regimen. Evenity is administered monthly for one year for patients with osteoporosis at high risk of fracture to rapidly increase bone density and reduce fracture risk. The patients are then administered Prolia, once every six months, to continue treatment over a longer period. The pharmaceutical industry’s analysis is that this treatment approach is increasingly becoming common in clinical prescription settings. Also, the analysis is that this sequential administration of Evenity followed by Prolia is contributing to the sales growth. Evenity was approved in Korea in June 2019. It was listed for reimbursement in Dec. 2020, which led to significant sales starting the following year. The sales from Evenity increased by 42%, from 12.3 billion won in 2021 to 17.4 billion won last year. It is forecasted that the sales will exceed 25 billion won by the end of this year. In fact, two treatments from Amgen have effectively dominated the osteoporosis treatment market in Korea. Combined, these two products recorded sales of 131.2 billion won up to Q3, representing a YoY increase of 37% from the 96 billion won recorded in the last year. Quarterly sales of major OP treatments With the rapid rise in sales of Amgen's two treatments, the existing bisphosphonate class of osteoporosis treatments generally showed poor performance. Hanmi Pharmaceutical's RaboneD Cap. recorded a 9% decrease in sales, down from 7.3 billion won in Q3 last year to 6.7 billion won in Q3 this year. Meanwhile, sales of Daewoong Pharmaceutical's Daewoong Zoledronic Acid Inj. also fell 20%, from 5.2 billion won to 4.1 billion won. During the same period, Jeil Pharmaceutical's Bonviva and Bonviva Plus recorded a 26% decrease in sales, dropping from 6.4 billion won to 4.7 billion won. Jeil Pharmaceutical has been in charge of the domestic sales of Bonviva and Bonviva Plus since October last year, taking over the rights from Handok. Bonviva Plus is Vitamin D reinforced version of Bonviva. Among the major bisphosphonate class treatments, Eli Lilly's Forsteo Inj. showed an increase in sales. Forsteo Inj.'s cumulative sales in Q3 amounted to 11.6 billion won, showing a growth of 19% YoY.
- Policy
- KIDS ‘Oral VEGFR-TKI use may increase risk of AAD’
- by Lee, Hye-Kyung Dec 12, 2023 05:38am
- The Korea Institute of Drug Safety & Risk Management (President: Jeong Wyan Oh, KIDS) announced that the use of Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor (VEGFR-TKI) was associated with an increased risk of aneurysm and artery dissection occurrence. The findings were published in the internationally recognized American Medical Association (AMA) journal, JAMA Network Open (IF=13.8) on November 29. Recently, the U.S. FDA identified an association between VEGF-TKI inhibitors such as sorafenib and pazopanib and the development of aneurysms and arterial dissection through an analysis of the FDA Adverse Event Reporting System (FAERS) data and reflected the results in the indication of identified drugs. Korea’s Ministry of Food and Safety also reflected the association in the indications of affected drugs after conducting a safety information review. The MFDS conducted a study to investigate the risk of aneurysm and arterial dissection associated with the use of VEGFR-TKIs in the Korean population, after deeming that prior epidemiologic studies were lacking in Korea. The study collected information on 127,710 cancer patients aged 40 years or older who were prescribed VEGFR-TKIs or capecitabine based on the National Health Insurance Service’s insurance claims data (2007-2020) and followed them for 1 year after use. Among patients receiving VEGFR-TKIs, the incidence of AAD within 1 year of treatment initiation was 6.0 per 1000 person-years (1,000 subjects observed for 1 year). The incidence of AAD in those receiving capecitabine was 4.1 per 1000 person-years, showing that the risk of AAD occurrence was significantly higher by 1.48 times (95% CI, 1.08-2.02) among patients prescribed VEGFR-TKIs than those receiving capecitabin. The incidence and risk of AAD were significantly higher among patients treated with VEGFR-TKIs than those treated with capecitabine in females (2.08 times), older adults aged 65 years or older (1.42 times), and patients with dyslipidemia (1.58). KIDS President Oh said, “The study holds significance as that it demonstrated the possibility of an association between aneurysm and arterial dissection and the use of VEGFR-TKIs in cancer patients in Korea. This is expected to not only increase the treatment effect but also reduce socioeconomic losses and contribute to building a safer drug use environment."
- Company
- AZ will withdraw its KRW 50 bil Forxiga from KOR mkt
- by Kim, Jin-Gu Dec 12, 2023 05:38am
- Forxiga (dapagliflozin), an SGLT-2 inhibitor class diabetes drug worth KRW 50 billion a year, will withdraw from the domestic market. According to industry sources on the 11th, AstraZeneca Korea recently made the decision to discontinue supply of Forxiga in Korea. However, the company will continue to supply its dapagliflozin and metformin combination drug Xigduo in Korea. An official from AstraZeneca told Dailypharm, "We have decided to discontinue the domestic supply of Forxiga in Korea to reorganize our portfolio. We have started discussions with the Ministry of Food and Drug Safety regarding withdrawing our marketing authorization. We will do our best to ensure that there is no interruption in domestic supply before withdrawing the drug in the first half of next year." The decision to discontinue the supply is deemed to have been made upon the expiration of Forxiga’s patent. Forxiga’s substance patent expired in April. Since then, a total of 60 companies have launched generic versions of Forxiga simultaneously, heralding fierce competition. Forxiga’s prescription performance has been declining ever since the launch of its generics. According to market research institution UBIST, Forxiga’s outpatient prescriptions in Q3 totaled at KRW 13.7 billion, up 4% YoY. However, this is the second consecutive quarter the drug saw a decline in sales from the KRW 14.5 billion it had posted in Q1 this year, just before its patent expiry. This is likely due to the increased competition following the release of the large number of generics. In fact, Forxiga’s generics generated prescription sales of KRW 5.9 billion in Q2 and KRW 10.6 billion in Q3. The generic's share of the dapagliflozin diabetes drug market has increased to 30% within 6 months of its launch. Quarterly prescriptions of Forxiga andn Xigduo Forxiga’s full withdrawal is expected to create a void worth KRW 50 billion in the diabetes treatment market. And this void is expected to be filled by Forxiga genetics and generics of another SGLT-2 inhibitor, Jardiance (empagliflozin). Also, generic competition is expected to intensify in the process. Forxiga was previously copromoted in Korea by Daewoong Pharmaceutical. Daewoong plans to fill the Forxiga gap with based on its SGLT-2 inhibitor diabetes drug, Envlo (enavogliflozin).
- Policy
- MOHW agrees to review current prior authorization system
- by Lee, Jeong-Hwan Dec 12, 2023 05:38am
- Director Chang-hyun Oh Medical professionals are raising concerns about significant disparities in approval rates of the 'rare diseases drug prior authorization system,' which differ by patients and by diseases, and the ambiguity of the criteria. The government appears to be failing to provide a direction for system improvement and address these concerns. However, the government also agreed that significant disparities do exsit in the approval rates of prior authorization by diseases and by medical institutions. Thus, it has expressed plans to improve the approval rate through case-by-case feedback. On 11th, Oh Chang-hyun, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, spoke at the National Assembly roundtable discussion for the institutional improvement of the rare disease drug prior authorization system, saying, “We’re considering various systemic improvements to enhance patient access to high-cost drugs, and investigating why approval rates vary for the same drug in different diseases." The low approval rate of Soliris (eculizumab) for aHUS (atypical hemolytic uremic syndrome) sparked this issue of disparity in the reimbursement approval rate following prior authorization review. aHUS is a severe genetic rare disease. Up to 79% of patients die, require dialysis or experience permanent renal damage within 3 years of diagnosis. The prior authorization system allows reimbursement eligibility decisions to be made for each individual patient prior to treatment so that high-priced rare diseases treatments can be provided to patients in need. Individual cases are determined by an expert prior authorization subcommittee. The review started in 1992 and was expanded to include medications in 2007. The approval rate for Soliris, a treatment for aHUS (atypical hemolytic uremic syndrome), is currently below 30%. In contrast, the approval rate for the same drug for Paroxysmal Nocturnal Hemoglobinuria (PNH) is around 90%. Medical professionals and patients have consistently raised concerns that the disparities in prior authorization rates for the same medication by different diseases and by medical institutions, are causing difficulties in patient treatment. In response, Shin Hyun-Young, a member of the Democratic Party of Korea, hosted a symposium to discuss improvements to the prior authorization system, gathering opinions from government agencies and experts. Oh Chang-hyun, Director of Pharmaceutical Benefits at Ministry of Health and Welfare, who attended the symposium said that he is aware of the concern regarding the disparity in pre-approval rates, and is committed to finding solutions to the issue. Director Oh revealed that out of the 18 new drugs approved this year (2023), only two are subject to the prior authorization system. He explained, "The decision was not due to financial reasons, but because of the high cost, uncertainties, and misuse concerns. The Health Insurance Review and Assessment Service (HIRA) is working on an improvement plan." "The prior authorization rate for most drugs is above 80%, but in the case of Soliris, its approval rate last year for PNH was 90.7%, while being below 50% for aHUS," said Director Oh, adding, “There is a need to scrutinize why there are disparities in approval rates by different diseases and to strictly enforce compliance requirements for medical institutions seeking approval.” Director Oh stated, “Approval rates would improve if we conduct a statistical analysis on the reasons behind the many rejections that were made, and providing this feedback to individual medical institutions and doctors." Oh stressed, “The reliability of the data will go up during the process, and the Ministry is considering transitioning drugs with a long-term stable approval rate from prior approval to post approval.” Likewise, the MOHW acknowledged the problem regarding disparities in the prior authorization system rates, but hadn't yet established a specific and finalized improvement plan. However, improvements are expected soon, as the Ministry is working to address the issue quickly in collaboration with HIRA. Panelist Choi Seungwon, Director of Doctors News, suggested that the MOHW should create and reinforce a channel for clear communication and discussion with medical professionals and patients about the reasons for rejections. Director Choi said, “Patients should not suffer due to systemic uncertainties. The prior authorization system should be based on the principle that it’s better that nine guilty ones escape, rather than let one innocent suffer,” he stressed, “It’s the doctor’s duty to their patients to provide an explanation. The government should be able to explain how it will communicate its decisions in cases where medical professionals and patients find rejection decisions unacceptable." "A system that specifies which person and method of inquiry should be used to inquire about the government’s disapproval decision, is necessary and must be included as part of the prior authorization system," said Director Choi Seungwon, adding, “We ask Director Oh to preprare this."
- Company
- Reimb at a halt for one-shot IRD drug Luxturna
- by Eo, Yun-Ho Dec 12, 2023 05:38am
- Reimbursement discussions for the one-shot retinal disease treatment Luxturna is being delayed in Korea. According to Dailypharm coverage, Novartis Korea failed to reach an agreement with the National Health Insurance Service on the drug price of uxturna (voretigene neparvovec) for inherited retinal dystrophy (IRD) within the 60-day deadline and will enter into extended negotiations. This suggests that the two parties involved (government-pharmaceutical company) were unable to reach an opinion regarding finances for the drug. Although the company had applied for reimbursement of the drug in September 2021, no progress had been made on its listing for a while and was finally presented as an agenda for deliberation by HIRA’s Drug Reimbursement Evaluation Committee in March this year. However, the drug failed to pass DREC review and receive reimbursement standards at the time. The company supplemented and reapplied for the drug’s reimbursement thereafter, thanks to which the company was able to start reimbursement negotiations. As disagreements over the terms of the risk-sharing agreement (RSA), including the refund rate, had previously stalled DREC deliberations, this may have played a role in stalling the pricing negotiations between NHIS and Novartis Korea as well. An official from Novartis said, “Luxturna is the only treatment option available for patients with IRD. As both the company and the government are well aware of this, we will do our best to overcome our differences within the extended negotiation period." Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, 1.6 points higher than the 0.2 points in the control group.
- Policy
- Roche’s DLBCL treatment Columvi approved in Korea
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Commissioner Oh Yu-Kyoung of the Ministry of Food and Drug Safety (MFDS) announced on the 7th that MFDS has approved Roche Korea's rare disease drug 'Columvi (glofitamab)' for the treatment of diffuse large B cell lymphoma (DLBCL). The drug is a CD20/CD3 bispecific monoclonal antibody that binds to CD3 on the surface of T cells and CD20 on B cells. Columvi provides a new treatment opportunity for DLBCL patients who had relapsed or were refractory after two or more lines of systemic therapies. Columvi (Glofitamab) binds to the CD3 and activates the T cells, it simultaneously binds to CD20, to redirecting B cells closer to activated T cells and inducing cytosis. The MFDS stated that based on their regulatory science expertise, they will continue to promptly supply treatments that have proven safety and effectiveness.
- Policy
- Pfizer conducts trial for its RSV drug sisunatovir in KOR
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Pfizer will be conducting a clinical trial for its Respiratory Syncytial Virus (RSV) treatment PF-07923568 (sisunatovir) on infants and children in Korea. On the 7th, the Ministry of Food and Drug Safety approved Pfizer Korea's ‘Interventional, phase 1B, randomized, double-blinded, sponsor-open, placebo-controlled, multicenter, dose-finding study to evaluate the safety, tolerability, and pharmacokinetics of sisunatovir in pediatric participants up to 60 months of age with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).’ The study will be conducted at Seoul National University Bundang Hospital, Severance Hospital, Seoul National University Hospital, and Korea University Anam Hospital. As a type of common cold, RSV is an acute respiratory infection caused by the infection of the respiratory syncytial virus. It is highly contagious, affecting nearly all children by the age of 2. Most children and adults recover within a week or two without treatment, but it requires attention as it can progress to severe cases in high-risk groups such as infants, those immunocompromised, and the elderly. According to the U.S. Centers for Disease Control and Prevention, RSV causes up to 120,000 hospitalizations and up to 10,000 deaths in the U.S. each year among those aged 65 and older. Currently, AstraZeneca's ‘Synagis’ is the only licensed antibody preventive treatment for RSV that can be administered to pediatric patients. Pfizer acquired sisunatovir, a novel candidate substance for RSV when it acquired the UK-based antiviral drug developer ReViral last year. Pfizer paid up to $525 million to ReViral, including an upfront payment and future development milestone payments. Pfizer expects ReViral’s programs to generate annual sales of $1.5 billion or more. Meanwhile, other large multinational pharmaceutical companies have also jumped into the RSV prophylaxis game, and are making tangible results. Just this year, the US FDA approved GSK’s ‘Arexvy,’ Pfizer’s ‘Abrysvo,’ and AstraZeneca and Sanofi’s pediatric RSV treatment ‘Beyfortus.’ In Korea, companies such as SK Bioscience and EUGiologics have been working to develop RSV vaccines.
- Company
- Taked’a new CMV drug Livtencity passes DREC review in 1 yr
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The reimbursement adequacy evaluation for the cytomegalovirus (CMV) treatment ‘Livtencity’ has been completed in 1 year since the drug received approval in Korea. According to industry sources, Takeda Pharmaceuticals Korea submitted its reimbursement application for Liventity (maribavir) in Q3, and the agenda has passed the review of the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 7th of this month. Therefore, the company will now proceed to drug pricing negotiations with the NHIS if the Ministry of Health and Welfare gives the negotiation order. Whether negotiations will be successful, and a new treatment option will be introduced and rise as an alternative for patients who are resistant to existing drugs, remains to be seen. CMV is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action, if resistance to one drug develops, likely, that the patient will not respond to other treatments as well. However, the introduction of Livtencity brings hope to these patients for secondary treatment. Livtencity has almost no side effects compared to existing drugs and offers an alternative if resistance to the existing treatments develops. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December last year. Also, Livtencity has passed the Drug Committees (DCs) of tertiary hospitals in Korea including Samsung Medical Center, Saint Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions such as the Kyungpook National University Hospital, Jeonbuk National University Hospital, and Chonnam National University Hwasun Hospital.
- Company
- Trulicity sales fall 30%...affected by supply shortage
- by Kim, Jin-Gu Dec 11, 2023 05:02am
- Sales of the GLP-1 receptor antagonist class treatment Trulicity had fallen 30% in 1 year. This is estimated to have been due to the prolonged domestic supply disruptions. Major insulin products that experienced sporadic supply shortages have experienced a sharp decrease in sales. In the case of Xultophy, its sales, which had surged to KRW 4.8 billion in Q2 fell to KRW 3.1 billion in Q3. In the case of Soliqua, its sales, which had remained at the KRW 2 billion level, sur soared to KRW 4 billion in Q3. On the other hand, the two other insulins that have been experiencing shortages – Tresiba and Ryzodeg - saw stable sales in Q3 this year. Trulicity posts record high sales in Q2→sales drop in Q3 due to prolonged supply disruption Pic of TrulicityAccording to the market research institution IQVIA on the 11th, Eli Lilly’s Trulicity’s sales in Q3 were KRW 11 billion. This is a 30% drop from the KRW 15.8 billion it posted in Q3 last year. Trulicity is a GLP-1 receptor antagonist class diabetes drug. GLP-1 analogs are developed using the hormone glucagon-like peptide-1 (GLP-1), which is involved in the regulation of blood sugar in the body. GLP-1 hormone stimulates insulin secretion immediately after a meal to lower blood sugar and reduces insulin secretion when blood sugar falls below a certain level to help prevent hypoglycemia. The drug’s performance this quarter is in stark contrast to last quarter's record quarterly revenue. Trulicity's revenue had been growing rapidly until Q2 this year. It crossed the KRW 15 billion mark for the first time in Q3 last year and soared to USD 18 billion in Q2 this year. However, sales fell sharply in Q3. The industry analysis is that its performance is finally experiencing the aftermath of the domestic supply disruption that has been in full swing since Q3, which led to a sharp drop in sales. Trulicity's supply issues began to surface in Q2 this year. In late June, Lilly notified its sales and marketing partner, Boryung, of its difficulties in supplying Trulicity 0.75mg/0.5ml in Korea. Quarterly sales of Trulicity (Unit: KRW 100 million Data: IQVIA) Then, the company started to have difficulties supplying the 1.5mg/0.5ml dosages as well. Initially, Lilly estimated that it would be able to resume domestic supply in mid-October, but in mid-October, the company pushed back the estimate to November. And this was only for the 1.5mg/0.5ml dose, with no exact timeline set still for the 0.75mg/0.5ml dosages. The industry expectation is that if the disruption continues beyond Q4, Trulicity's sales will decline further. Xultophy’s sales fall, Soliqua’s sales rise… Major insulin sales fluctuate due to shortages Sales of major insulin injections, which have been in short supply for most of the year, are also showing fluctuations in sales. In Korea, Novo Nordisk’s Tresiba, Ryzodeg, Xultophy, Sanofi-Aventis’s Xultophy, Tuojeo, and Lilly’s Humalog have been experiencing shortages one after another since Q2 this year. Sales of major products have fluctuated greatly in the process. For example, Xultophy’s sales plummeted from KRW 4.8 billion in Q2 this year to KRW 3.1 billion in Q3. In the case of Xultophy, its domestic supply began to be disrupted around August. Novo Nordisk initially predicted that it would be able to resume supply in September, but pushed back its prediction to November. On the other hand, Sanofi-Aventis' Soliqua saw a significant increase in sales in Q3. The company reported sales of KRW 4 billion in Q3, up 63% from KRW 2.4 billion in Q3 last year. Since Q2 2021, Soliqua has consistently generated sales of KRW 2 billion to 2.4 billion every quarter. However, in Q3 this year, the company first marked sales of KRW 4 billion with Soliqua since its launch in Korea. The industry analysis shows that the demand for Soliqua’s sales rose due to the unstable supply of other insulin products. Quarterly sales of major insulin products (Unit: KRW 100 million, Data: IQVIA) However, sales of products saw little change. Novo Nordisk's Tresiba, Ryzodeg, and Lilly's Humalog have been experiencing sporadic shortages, but on the surface, their sales have remained stable. Tresiba sold KRW 10.9 billion in Q3 this year, flat YoY. Tresiba has been consistently generating sales in the high KRW 10 billion to low KRW 11 billion range since Q3 last year, after posting sales of KRW 10.9 billion. In the case of Ryzodeg, the company recorded sales of KRW 8.8 billion in Q3 this year. This is a 4% increase from KRW 8.4 billion in Q3 last year. Humalog posted sales of KRW 5.2 billion in Q3. This is a 4% decrease compared to the KRW 5.4 billion it posted in Q3 last year The industry analyzed that Tresiba, Ryzodeg’s sales remained level due to the spread of the stock shortage issue in the market, which led to an increase in temporary demand for stockpiling.
- Company
- Double-dose Trelegy Ellipta in reimb process for asthma
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The double dose of Trelegy Ellipta, which was approved for asthma, not COPD, is making rapid progress for reimbursement listing in korea. According to the pharmaceutical industry, GSK Korea has recently started reimbursement pricing negotiations with the National Health Insurance Service for its Trelegy 200 Ellipta (fluticasone furoate ·umeclidinium ·vilanterol). On the 9th, Trelegy 200 Ellipta has successfully passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee. Therefore, industry eyes are on whether Trelegy Ellipta's reimbursement would be expanded to asthma in addition to its COPD indication. Trelegy 200 Ellipta has demonstrated its efficacy through the Phase 3 CAPTAIN study, which compared Trelegy Ellipta and dual combination therapy FF/VI(fluticasone furoate / vilanterol) in 2436 adult asthma patients who are age 18 and over and whose asthma is uncontrolled despite treatment with dual combined therapy ICS/LABA. As the primary endpoint, each cohort’s Forced Expiratory Volume in 1 second (FEV1) changes at Week 24 were evaluated. The results demonstrated statistical significance as the Trelegy Ellipta treated cohort showed 110mL improvement in FEV1 compared with the FF/VI treated cohort. The safety profile of Trelegy Ellipta for asthma treatment in the CAPTAIN study was also consistent with the known profile of the individual drug components and their combinations. The common side effects were nasopharyngitis v(13-15%), headache (5-9%), upper respiratory tract infection (3-6%), and the adverse reactions were comparable in all treatment cohorts. Trelegy Ellipta was the first triple combination therapy for COPD to be approved in Korea in May 2018. Its specific indication for COPD is as a maintenance therapy for patients with moderate to severe cases that are inadequately controlled by a combination of a long-acting beta2-agonist (LABA) and an inhaled corticosteroid, or a LABA and a long-acting muscarinic antagonist (LAMA). Currently, patients who use Trelegy Ellipta are granted reimbursement when they meet one of the following three standards: ▲patients whose FEV1 values are less than 60% of the predicted normal value despite combination therapy with LABA and LAMA or those who have experienced acute exacerbations more than twice a year, ▲patients whose symptoms such as dyspnea are not adequately controlled despite combination therapy with LABA and inhaled corticosteroids, ▲patients receiving a combination of vilanterol trifenatate /fluticasone furoate inhaler, which has the same dosage as Trelegy Ellipta, and umeclidinium inhaler, as well as those on a combination of ICS/LABA and LAMA monotherapy with the same dosage as Trelegy, who wish to switch to Trelegy in compliance with its approved indications.
