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- 2026-04-09 09:45:01
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- Enhertu posts KRW 7.4 bil in H1 sales without reimb
- by Kim, Jin-Gu Sep 01, 2023 05:44am
- Daiichi Sankyo Korea’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab deruxteca); has raised sales of over KRW 7 billion in H1 this year without reimbursement. According to the market research institution IQVIA on the 31st, Enhertu posted sales of KRW 7.4 billion in H1 this year, making KRW 2.2 billion in Q1 and KRW 5.2 billion in Q2. Even without reimbursement listing, sales of the drug had exceeded KRW 7 billion. This indicates the many breast cancer patients in need of the treatment. The non-reimbursed cost of Enhertu is known to be in the KRW 5 million range per injection. Enhertu is an antibody-drug conjugate (ADC) that was approved by the Ministry of Food and Drug Safety in September last year. It is used to treat HER2-positive breast cancer. More specifically, Enhertu is indicated to treat unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting, and locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, the drug’s indication was extended to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. However, the drug is making small progress in terms of reimbursement listing. The drug passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review after redeliberation in May, but remains pending thereafter, without being deliberated at the 4 subsequent Drug Reimbursement Evaluation Committee meetings that followed. The next DREC meeting will be held on September 7th, but whether Enhertu will be deliberated then remains unknown. Patients have been long awaiting its reimbursement listing, to the extent that a public petition had been registered on its coverage. The petition was filed in January this year and received 50,000 consents on its need in only 5 days. The agenda was then referred to the National Assembly’s Health and Welfare Committee and started the reimbursement listing process. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. Results showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and a mPFS of 16.4 months.
- Policy
- Kanoa, the upper limit price was reduced further by PVA
- by Lee, Tak-Sun Sep 01, 2023 05:44am
- Ankook Pharm Daelim-dong office building It was found that the upper limit of the choline alposerate formulation Kanoa Soft Cap sold by Ahnook Pharm has been reduced more with PVA (use-drug linkage agent) than the Kanoa Soft Capre-evaluation of the upper limit. There are a total of 18 items that have been re-evaluated and reduced by both the PVA this time, and among them, Kanoa was the only one with a larger PVA reduction rate. According to the industry on the 31st, the upper limit of Angook Kanoa did not meet the BA directly in the re-evaluation of the upper limit amount, so the upper limit was decided to be reduced from 471 won to 445 won. According to the Ministry of Food and Drug Safety, Kanoa soft capsule is produced by Seoheung, and Kanoa tablets are commissioned by Vivozon. In this reassessment of the upper limit, the choline alfoscerate formulation was divided into 523 won if all the requirements were met, and 445 won if only one requirement was met. It is said that there are no items that do not meet both requirements, including DMF. Accordingly, the re-evaluation rate of Kanoa's cap was -5.5%. However, the actual upper limit, which will take effect from the 5th, is lower than this. The reason for this is that the cut rate of -9.3% was applied by the usage-drug linkage negotiations. The final cap is 427 won, which is the lowest price among the choline alposerate formulations. Kanoa's outpatient prescription amount was 6.8 billion won as of last year's Ubist, up 68% from the previous year. This time, there are a total of 18 items in which the drug price will be reduced at the same time according to negotiations on the re-evaluation of the upper limit and the PVA type. Among them, the results of the PVA with a large reduction rate of Kanoa have been applied. On August 23rd, the upper limit of the re-evaluation of the upper limit, which was disclosed earlier, was marked as 445 won. However, pharmacies and wholesalers seem to need to be careful because the upper limit of Kanoa is finally adjusted to 427 won.
- Policy
- MOHW ‘is discussing expanding non-face-to-face treatment’
- by Lee, Jeong-Hwan Sep 01, 2023 05:44am
- The Ministry of Health and Welfare formalized the expansion of the scope of its non-face-to-face medical treatment pilot project, and announced plans to expand the scope of first-time examinations, ease the standards for re-examination, and increase the ‘within 30 days of initial treatment’ term allowed for reexamination of acute conditions. In the case of first visit criteria, the authorities will focus on reviewing the need to improve medical access in areas that lack medical institutions at night, on public holidays, and during holidays. For re-examinations, the authorities will discuss ways to improve convenience for patients and medical institutions by addressing the complex eligibility standards and expanding the 30-day term for re-examinations. On the 31st, MOHW announced that it would begin discussing improvements with the advisory group ahead of the end of the guidance period for the non-face-to-face medical treatment pilot project. The MOHW referred to Minister Kyoo-Hong Cho’s statement on how the ministry "will periodically evaluate the performance of the pilot project supplement and develop shortcomings, to prepare a stable institutionalization plan’ on the day of implementation of the pilot project. In other words, the MOHW plans to fully utilize the test bed and prepare supplementary plans, and collect opinions fit for the purpose of the pilot project. As such, the MOHW plans to focus on improving the pilot project model by discussing setting appropriate criteria for first and repeat visits based on time and region and ensuring both the safety of non-face-to-face treatment and medical accessibility. The Ministry of Health and Welfare announced that after the end of the guidance period, it will continue to monitor illegal cases, such as the prescription of drugs that are not permitted in non-face-to-face treatment, such as narcotics and medicines that can be misused or abused. Second Vice Minister Minsoo Park said, "As this pilot project prepares for the institutionalization of non-face-to-face medical treatment, we need to make various attempts and reflect the demand in the field. We plan to collect public opinion through advisory group discussions and holding public hearings and use the results in improving the pilot project model."
- Company
- Two targeted anticancer therapies fail reimb in KOR
- by Eo, Yun-Ho Sep 01, 2023 05:44am
- Two anticancer drugs that target a very small number of lung cancer patients with EGFR exon 20 insertion mutation for which existing TKIs were ineffective, were both unable to receive reimbursement in Korea. According to industry sources, no reimbursement standards were set for both Takeda Pharmaceuticals Korea’s ‘Exkivity (mobocertinib)’ and Janssen Korea’s ‘ Rybrevant (amivantamab)’ w at the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee meeting that had been held on the 30th. This is the second time Rybrevant failed to establish reimbursement standards at the CDDC level. EGFR exon 20 insertion mutations in NSCLC are so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to reimbursement cuts. Although lung cancer in itself is not a rare disease, NSCLC with EGFR exon 20 insertion can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. However, with both drugs failing to pass the CDDC barrier, it would take some time for Korea to have extended treatment for EGFR exon 20 insertion mutation NSCLC. The key is whether the condition will be recognized for its rarity during reimbursement evaluations and the drugs be accepted as a rare cancer treatment. Meanwhile, Exkivity demonstrated its efficacy through a Phase I/II study. In the study, patients who were treated with Exkivity showed an objective response rate (ORR) of 28% and a median duration of response (DoR) of 17.5 months. In particular, the median time to response after Exkivity treatment was 1.9 months, demonstrating the rapid effect of the drug from initial treatment. Rybrevant showed an ORR of 40% in a Phase I trial, during which the drug demonstrated a complete response of 4% and a partial response of 36%.
- Policy
- The 1st results of the pharmaceutical benefit re-evaluation
- by Lee, Tak-Sun Sep 01, 2023 05:43am
- The HIRA does not plan to disclose the first results of the benefit re-evaluation reviewed by the committee on this day. After notifying the pharmaceutical company of the results, we plan to receive objections and then disclose the results during the second review. According to HIRA and the pharmaceutical industry on the 31st, the results of this year's salary adequacy reevaluation review will be discussed as an agenda item at the committee meeting held on the 6th. The ingredients subject to re-evaluation this year are Hyaluronic acid eye drops; Rebamipide, Limaprost Alfadex, Loxoprofen Sodium Hydrate, Levosulpiride, and Epinastine, etc. Among these, the market size of Hyaluronic acid eye drops, which are used for artificial tears, is the largest at approximately 200 billion won, drawing high interest from the industry. As there is great interest in Hyaluronic acid eye drops, the results are also unpredictable. However, in the pharmaceutical industry, as there is strong opposition from medical staff and there are opinions that benefits should be maintained for elderly patients, it is expected that benefits will be maintained after social discussion. An industry insider declined to comment, saying, “There is sufficient evidence for the effectiveness of Hyaluronic acid eye drops, but I don’t know how to judge it.” There are many predictions that other re-evaluation targets will not be deleted altogether even if there are reimbursement restrictions for some indications. In the case of Rebamipide, which is used for gastritis and gastric ulcers, there are many papers on its efficacy against gastric ulcers, so it is expected that reimbursement will not be maintained. The analysis also shows that there is sufficient clinical evidence for one of the two indications for Limaprost Alfadex, represented by Opalmon. The HIRA plans not to disclose the results of the first deliberation of this committee, but to notify only pharmaceutical companies. We plan to receive objections, reconsider them, and then make the results public. Last year, after the appeal, the committee deliberation was made public in October.
- Company
- Released next-generation growth hormone drug
- by Kim, Jin-Gu Aug 31, 2023 05:25am
- The domestic growth hormone drug market, which is rapidly growing, has faced a variable with the release of new products by major companies. LG Chem, the No. 1 company in the market, replaced the existing Eutropin with the next-generation product, Eutropin S, further solidifying its leading position, followed by Dong-A ST and Pfizer. In particular, Pfizer plans to add NGENLA, a once-a-week medication, to its lineup starting next month. Depending on the success of this product, considerable changes are expected in the growth hormone market in the future. Expected to exceed 250 billion won in the growth hormone market, successful replacement of LG Chem’s Eutropin S generation. According to IQVIA, a pharmaceutical market research institute, on the 29th, the size of the domestic growth hormone drug market in the first half of last year was 135.6 billion won. It increased by 18% from 114.6 billion won in the first half of last year. The domestic growth hormone drug market is rapidly growing in recent years. The market, which was worth 145.7 billion won in 2019, exceeded 150 billion won in 2020 and 200 billion won in 2021. Last year, it further expanded to 238.6 billion won. In the case of this year, it recorded 130 billion won in the first half alone and is expected to expand to more than 250 billion won by the end of the year. It was found that related sales of major companies increased together. LG Chem's combined sales of Eutropin and Eutropin S increased by 19% in one year from 42.1 billion won in the first half of last year to 50 billion won in the first half of this year. LG Chem received permission for Eutropin S in April last year. Then, at the end of last year, sales began in earnest. Compared to existing products, the expiration date has been increased from 18 months to 24 months. LG Chem explains that the expiration date has been extended, improving supply stability and making it possible to check the remaining capacity. It is an analysis that it succeeded in a natural generational change with existing products. Sales of Eutropin S increased from 5.5 billion won in the fourth quarter of last year to 19.3 billion won in the first quarter of this year and 19.7 billion won in the second quarter. Existing Eutropin sales decreased to 15.5 billion won, 5.5 billion won, and 4.9 billion won during the same period. In the case of combined sales, it has been on an upward trend since the addition of new products. Pfizer, No. 3 in the market, announces the release of NGENLA once a week. LG Chem's Eutropin/Eutropin S, Dong-A ST's Growtropin II, and Pfizer's Genotropin/Genotropin goquick pen are rapidly catching up. In particular, the increase in related sales of the two companies was found to be greater than that of LG Chem, the market leader. Dong-A ST's Growtropin II posted sales of 33.2 billion won in the first half. Compared to 21.2 billion won in the first half of last year, it increased by 57% in one year. Growtropin II, which exceeded 10 billion won in quarterly sales in the first quarter of 2022, exceeded 15 billion won in sales in the first quarter of this year, and quarterly sales are about to reach 20 billion won. Pfizer's Growtropin series is showing even greater sales growth. The combined sales of Growtropin and Genotropin goquick pen increased by 86% in one year from KRW 14.1 billion in the first half of last year to KRW 26.3 billion in the first half of this year. Genotropin, a cartridge-type product, increased by 48% from KRW 8 billion to KRW 11.8 billion, and Genotropin goquick pen, a pen-type product, increased 2.4 times from KRW 6.1 billion to KRW 14.5 billion. It is analyzed that sales of Genotropin goquick pen, a next-generation product, are gradually expanding as the domestic supply of the two products stabilizes after 2020. Pfizer plans to add a new product to its lineup. Pfizer received permission for NGENLA Prefilled Pen Injection in January of this year. This product will be applied for reimbursement from next month. NGENLA is a product that lengthens the half-life by modifying the molecule of Genotropin. If the existing Genotropin was administered daily, NGENLA is administered once a week. However, the indication is limited to the treatment of growth failure in children (3 years of age or older) due to pituitary growth hormone secretion disorders. Pfizer plans to continue supplying Genotropin even if a new treatment is released, as NGENLA has a smaller indication range than Genotropin. In addition, Merck's Saizen increased sales by 27% from 16.1 billion won in the first half of last year to 20.4 billion won in the first half of this year. Sales of Novo Nordisk Norditropin nordiflex plunged from 16.3 billion won in the first half of last year to 1.1 billion won in the first half of this year. Norditropin is known to have been discontinued in Korea since the third quarter of last year. The company initially announced the timing of domestic resupply at the end of November last year but corrected it to say that it is currently undecided. In the first half of the year, sales of Cyzen Korea Scitropin decreased by 8% from 3.8 billion won to 3.4 billion won, and Ferring Zomacton's sales increased from 1.1 billion won to 1.2 billion won.
- Policy
- Cold medicine bills increased by 90% due to the coronavirus
- by Lee, Tak-Sun Aug 31, 2023 05:25am
- Jeong Hae-min, head of the NHIS Pharmaceutical Management Department, is answering questions at the Professional Journalists Due to the increase in confirmed cases of COVID-19 last year, cold medicine bills alone increased by 90% compared to the previous year. Based on the past five years, claims for COVID-19-related drugs were the highest in 2022. The NHIS conducted negotiations on linking usage and drug price reduction for 36 items related to COVID-19 and agreed on a reduction rate by applying a correction plan. The NHIS Pharmaceutical Management Office announced this at a meeting with the Professional Journalists Council on the 29th. According to NHIS, as a result of analyzing the billing amount for 2,637 cold medicine and antibiotic items last year, cold medicine billing amounted to 664.5 billion won and antibiotic billing amounted to 1.0575 trillion won. This is an increase of 90.1% and 24.0%, respectively, compared to the previous year. When looking at trends over the past five years, the number of pharmaceutical bills related to COVID-19, which was approximately 1.5 trillion won from 2018 to 2019, decreased to 1.2 trillion won from 2020 to 2021 but recovered to 1.7 trillion won last year. The NHIS also applied this COVID-19 drug while conducting PVA ‘Type C’ negotiations this year. Jeong Hae-min, head of the Pharmaceutical Management Department, explained, "Starting in June, we have supported a stable supply of cold medicines by easing the reduction rate of cold medicines and antibiotics monitored by the Ministry of Food and Drug Safety through the COVID-19 medicine correction plan derived through consultation with the Pharmaceutical Association." As a result of the negotiations, 'multi-type' negotiations were conducted on 36 items related to COVID-19 (18 pharmaceutical companies, 22 same product groups), and an overall agreement was reached. The NHIS plans to prepare guidelines for coordination and negotiation in response to the situation in which some essential medicines have become unprofitable due to the rise in raw material prices after the coronavirus outbreak, preventing smooth supply and repeatedly being sold out. It has been pointed out that the data submitted for mediation negotiations is based on HIRA's withdrawal prevention drug application data, so the amount of data is large and complex, putting a large burden on the company. Accordingly, the NHIS explains that it has been forming a consultative body with the Pharmaceutical Association since March to discuss and collect opinions from companies, simplify submitted data, and determine the ratio of general management costs and profits to be reflected in cost analysis. The 7th council discussion was held until August, and the plan is to compile the collected opinions establish mediation negotiation guidelines around October, and hold a company briefing session.
- Company
- Hemophilia drug Hemlibra’s sales rise twofold with reimb
- by Chon, Seung-Hyun Aug 31, 2023 05:25am
- Sales of JW Pharmaceutical’s hemophilia drug ‘Hemlibra’ have surged recently. The reimbursement extensions that had been made for the drug in May had increased the number of eligible patients, raising sales by over twofold. According to the pharmaceuticals research institution IQVIA, Hemlibra’s sales in 1H this year were KRW 5.7 billion, up 61.6% YoY. Hemlibra’s Q1 sales rose 15.3% YoY to KRW 2.1 billion, and Q2 sales rose 112.0% YoY to KRW 3.6 billion. Hemlibra is a genetic recombinant drug functioning as a routine prophylaxis agent for hemophilia A caused by coagulation factor VIII deficiency. The drug employs the bispecific antibody technology which simultaneously binds to factor IX and factor X. Unlike previous coagulation factor VIII preparations, Hemlibra is the only non-factor therapy option, the injection is injected subcutaneously once every 4 weeks. It was developed by Chugai Pharmaceutical, a Japanese subsidiary of the multinational pharmacuetical company Roche. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra in Korea in 2017 and received approval from the Ministry of Food and Drug Safety in 2019. Quarterly sales of Hemlibra (Unit: KRW 1 million, Data: IQVIA) The reimbursement extension was what contributed to Hemlibra’s rapid rise in Q2 sales. Since May, Hemlibra has also been reimbursed for ‘patients aged 1 years or older with hemophilia A and do not have factor VIII inhibitors.’ Hemlibra was first reimbursed for ‘severe hemophilia A patients with inhibitors in May 2020, and has been extended to cover patients without inhibitors from May this year.’ According to JW Pharmaceutical, there are about 1,700 patients hemophilia A patients in Korea. Among them, approximately 70% of patients have severe hemophilia A. Among patients with severe hemophilia A, the overwhelming majority have no factor VIII inhibitors. The company explains that more than 60% of domestic hemophilia A patients are now eligible to receive reimbursement for Hemlibra. Hemlibra's sales surged 68.4% in Q2 compared to the previous quarter even though the reimbursement was only applied for 2 two months since May. Since its domestic release in 2020, Hemlibra’s cumulative sales have reached KRW 22.7 billion, exceeding KRW 20 billion in 3 years. The company predicted that usage would also increase rapidly with the broad reimbursement extension. Last year, Hemlibra's global sales amounted to CHF 3.82 billion (about KRW 5.7 trillion), a 27% increase compared to the previous year (CHF 3.02 billion). Currently, more than 20,000 patients in 144 countries around the world are using Hemlibra. JW Pharmaceutical expects the drug to provide great treatment benefits to patients based on its proven efficacy and safety in large-scale clinical trials. In the HAVEN1 trial that was conducted on patients with inhibitors, prophylactic treatment with Hemlibra reduced the annual bleeding rate (ABR) to 3.3 times, which is a 79% reduction compared to existing prophylactic bypassing agents. In the HAVEN3 trial, which was conducted on patients without inhibitors, Hemlibra demonstrated a 68% reduction in ABR to 1.5 compared to coagulation factor VIII prophylactic treatments. In a study that compared the effects of Hemlibra in patients with and without inhibitors, both showed similar effects and long-term effectiveness. The purpose of prophylaxis (maintenance therapy) as the standard treatment for hemophilia patients is to prevent bleeding while maintaining the patient's blood coagulation factor VIII’s activity at a certain level. Hemlibra was found to maintain a constant concentration. The company also added that Hemlibra’s safety was demonstrated through various clinical trials. The HAVEN 1-4 trials showed that most side effects among patients who received Hemlibra were mild injection site reactions.
- Company
- The obesity market doubled in 5 years
- by Chon, Seung-Hyun Aug 31, 2023 05:25am
- Saxenda widens the gap with Qsymia. The imminent release of large products such as Wegovy. The domestic obesity market is expanding at a rapid pace. As demand for weight loss through pharmaceuticals increases, the market size has more than doubled in the past five years. Saxenda's quarterly sales exceeded 20 billion won and its market share approached 50%. With the imminent release of large-scale products such as Mounjaro and Wegovy, which are popular overseas, a reorganization of the market is expected in the future. According to IQVIA, a pharmaceutical research institute, on the 31st, the size of the domestic obesity treatment market in the first half of last year was 96.7 billion won, a 17.9% increase from the same period last year. The obesity market grew 24.5% from the previous year to 44.4 billion won in the first quarter, and reached 52.3 billion won in the second quarter, a 12.9% increase from the previous year, reaching the largest size ever. This is the first time that the obesity treatment market has exceeded 50 billion won in quarterly sales. The obesity market continues to grow steadily, increasing by 39.2% over the past three years from 37.6 billion won in the second quarter of 2020. Compared to 24.3 billion won in the second quarter of 2018, it has increased by 115.2% in 5 years. As satisfaction with recently introduced obesity treatments has increased, the number of people trying to lose weight using medications has also increased significantly. Novo Nordisk's Saxenda led the expansion of the obesity treatment market. Saxenda occupied about half of the obesity treatment market and operated a robust monopoly system. In the first half of last year, Saxenda's sales increased 53.3% from the previous year to 39.6 billion won. Saxenda's sales in the first quarter increased 53.0% from the previous year to 15.9 billion won, and in the second quarter, sales increased 53.5% to 23.7 billion won, exceeding 20 billion won in quarterly sales for the first time. Saxenda, released in Korea in 2018, is the world's first obesity treatment drug approved as a GLP-1 (Glucagon-Like Peptide 1) analog. It has the same ingredients as Victoza (ingredient name: liraglutide), which is prescribed for type 2 diabetes patients, but the usage and dosage are different. Saxenda enjoyed explosive popularity as it was recognized as relatively safe because it works by the exact mechanism as GLP-1 in the human body to suppress appetite and induce weight loss. Saxenda has been leading the obesity treatment market for 19 consecutive quarters since taking the lead in the obesity treatment market with sales of 5.6 billion won in the fourth quarter of 2018, immediately after its launch. Saxenda's sales gap with the new product Qsymia narrowed to 800 million won in the first quarter of 2021, but the gap has widened significantly since then with even more rapid growth. In the second quarter of last year, Saxenda's sales gap with Qsymia reached 14.9 billion won. Saxenda's sales share in the obesity treatment market in the second quarter reached 45.3%. Qsymia recorded sales of 8.8 billion won in the second quarter, up 12.2% from the previous year, but the gap with leader Saxenda widened significantly. Qsymia, released at the end of 2019, is a drug with the same ingredient that Alvogen Korea secured domestic sales rights in the United States in 2017. It is a combination of Phentermine Hydrochloride and Topiramate. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and began domestic sales in earnest. Qsymia threatened its lead by increasing its market share to 18.4% in the first quarter of 2021, but its share has since stagnated. Qsymia's market share in the second quarter was 17.0%, significantly lower than Saxenda. The industry predicts that the market will change significantly in the future with the emergence of significant obesity treatments that have proven commercial feasibility overseas. Last April, the Ministry of Food and Drug Safety approved Novo Nordisk's Wegovy. Wegovy is a GLP-1 analog from the same family as Saxenda. Novo Nordisk improved Saxenda from once daily administration to once weekly administration. After Wegovy was launched in the U.S. market, demand soared to the point where it was out of stock. It is so popular that even Ozempic, a diabetes treatment with the same ingredients and usage method, is sold out. Eli Lilly Mounjaro received approval from the Ministry of Food and Drug Safety last June. Mounjaro is a next-generation GLP-1 analog that activates both GLP-1 and GIP receptors with once-weekly administration. Mounjaro has been approved as a treatment for type 2 diabetes and is expected to secure an indication for obesity treatment in the future. Mounjaro, which received US approval last year, recorded sales of 2 trillion won in the first half of this year. If Mounjaro is approved as an obesity treatment, it is expected to spark an obesity treatment craze along with Novo Nordisk's Wegovy.
- Company
- Reimb for the petitioned ADC drug Enhertu unclear
- by Eo, Yun-Ho Aug 31, 2023 05:25am
- Reimbursement discussions for the anticancer drug ‘Enhertu’ that received 50,000 consents in a national petition are making slow progress. Daiichi Sankyo Korea’s HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), which finally passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review after redeliberation in May, remains pending, undeliberated at the 4 subsequent Drug Reimbursement Evaluation Committee meetings. The next DREC meeting will be held on September 7th, but whether Enhertu will be deliberated then remains unknown. The drug is currently receiving review at the pharmacoeconomic evaluations subcommittee level, but no conclusion has yet been reached on the drug’s cost-effectiveness. However, with the review nearing the 150-day deadline at HIRA’s level, how the discussion will progress is gaining much attention. For reimbursement, Daiichi Sankyo was known to have prepared various plans to reduce the financial burden, such as by presenting the drug price of Enhertu at the lowest level in the world and considering applying the risk-sharing agreement (RSA) scheme. However, due to the significant efficacy of Enhertu that was demonstrated through a Phase III trial, which had not been small compared to other existing treatments, the government is having difficulty calculating an appropriate drug price. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1 Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and an mPFS of 16.4 months. Enhertu was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
