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- 2025-12-24 00:18:16
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- Discussion of reimbursement for Vyndamax is running in place
- by Eo, Yun-Ho Mar 24, 2023 05:48am
- It seems that discussions on registration of transthyretin (TTR) amyloid cardiomyopathy drug 'Vindamax' for insurance benefits are at a standstill again. As a result of the coverage, Pfizer Korea's ATTR-CM (ATTR amyloidosis with cardiomyopathy) treatment Vyndamax, (Tafamidis 61mg) passed the HIRA last year, but the schedule for presentation to the Pharmaceutical Reimbursement Evaluation Committee has not yet been set. there is. In fact, it is judged that the discussion has ceased. The passage of the standard subcommittee itself was the result of only the fourth challenge, but it disproves that the gap between the government and pharmaceutical companies remains. Vyndamax failed to designate an essential drug in its first reimbursement challenge in early 2021. Afterward, an economic evaluation was conducted in the first half of the same year and a second challenge was reached through a Risk Sharing Agreement, but the results were the same. And in April of last year, it failed to exceed the standard subcommittee again, but in the second half of last year, it barely made a step forward. However, it is judged that there were still difficulties in finding a point of agreement in terms of financial sharing. It remains to be seen whether Vyndamax will be able to supplement the data again and continue discussions on salary listing. Meanwhile, Vyndamax is virtually the only ATTR-CM treatment option. ATTR-CM has been regarded as a disease with poor treatment results because it is misdiagnosed as simple heart failure or has no treatment, even though it is fatal enough that the survival period is only 2 to 3.5 years if not treated appropriately. In this situation, Vyndamax is a drug that has been shown to reduce the occurrence of cardiovascular events in CM patients through the phase 3 ATTR-ACT study and to improve the 6-minute walking test. In the ATTR-ACT study, 441 patients have randomized to Tafamidis 80 mg, Tafamidis 20 mg, and placebo in a 2:1:2 ratio. The main secondary endpoints of the study were the change in the 6-minute walk test from baseline to 30 months, the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the KCCQ-OS score, where higher scores mean better health. As a result of the study, the Tafamidis-administered group showed a statistically significantly lower risk of all-cause death and cardiovascular-related hospitalization compared to the placebo-treated group.
- Company
- 5th time the charm for Tagrisso’s reimbursement extension?
- by Jung, Sae-Im Mar 24, 2023 05:48am
- After five attempts, the EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment ‘Tagrisso (osimertinib)’ finally crossed the first hurdle to receiving reimbursement as a first-line treatment. Although other procedures such as deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee remain, the fact that it had overcome the highest barrier to reimbursement, the Cancer Disease Deliberation Committee review, 4 years after its indication was expanded to the first line, is regarded an achievement. HIRA’s CDDC held its second 2023 Reimbursement Standard Deliberation Meeting for Anticancer Drugs on the 22nd and established reimbursement standards for Tagrisso. The CDDC determined it was appropriate to set reimbursement standards for Tagrisso as a ‘first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.’ With the decision, the drug was able to pass the first gateway for third-generation EGFR-targeted anti-cancer therapies to receive reimbursement as a first-line treatment. ◆Passes CDDC review after 5 attempts...sees fruition 4 years after indication expansion Tagrisso is a third-generation targeted anticancer therapy that targets the EGFR mutation. It inhibits both the EGFR mutation and T790M mutation that are represented by L858R and Exon 19 deletions. As the drug has a high blood-brain barrier (BBB) permeability than first and second-generation EGFR-targeted therapies, Tagrisso has shown a superior effect in patients with brain metastasis. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, the drug was unable to receive reimbursement as a first-line treatment for over 4 years. AstraZeneca had attempted reimbursement for Tagrisso at the CDDC level 4 times since 2019 and failed every attempt. When Tagrisso’s reimbursement to the first line first emerged as an agenda in the second half of 2018, the government had been in favor of extending reimbursement. However, the favorable stance faltered with the release of the Asian subgroup analysis results from a global Phase III trial in 2019. The FLAURA trial assessed the efficacy and safety of Tagrisso in the first line, and the Asian subgroup analysis results of this global trial had risen as a barrier to its reimbursement as its hazard ratio (HR) was 0.995. An HR of 0.995 indicates that the difference between Tagrisso and the control group is 0.005, which could be interpreted as the difference being insignificantly small. After such results were disclosed, the CDDC in October 2019 decided to defer its decision until the full data from the Phase 3 FLAURA trial was released. The company made its second attempt, submitting the overall OS data of FLAURA in 2020. However, due to the rapid spread of COVID-19, the CDDC meeting that was set for February of the year had been pushed back and canceled several times and finally held at the end of April. The reimbursement standards for the drug had not been set then either. Although AstraZeneca expressed their will to accept most of the cost-sharing plan proposed by the government in consideration of the Asian subgroup data, the reimbursement fell through due to strong opposition from committee members that raised the issue of the drug’s clinical efficacy. In September of the same year, the company made its third attempt powered by results from the FLAURA China study that confirmed improved OS in Asians. The FLAURA China trial data analyzed a cohort of 136 Chinese patients that included 19 Chinese patients from the global FLAURA trial as well as 117 patients from a trial that had been separately conducted. Results showed that the median PFS of the Tagrisso group was 17.8 months, which was comparable to the results from the global study. Median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. This is a higher OS improvement than the 6.8 months identified in the global trial. The third reimbursement extension discussions for Tagrisso were made in April 2021. The third attempt also resulted in failure. At the time, CDDC members concluded that the OS value from the FLAURA China trial lacked statistical significance. After the third attempt failed, patient groups rose to the occasion. After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent a joint statement to the government imploring the government to extend Tagrisso’s reimbursement to the first line as in many major countries. Academic societies also criticized how only Tagrisso is not being reimbursed as first-line treatment in Korea. 3 months after its third setback, AstraZeneca applied for the 4th time to extend reimbursement. This time, the company adopted a strategy of narrowing part of its reimbursement standards. The company excluded Exon 21 mutation from the 'EGFR exon 19 deletion or exon 21 (L858R) mutation NSCLC’ it had been indicated for. The company narrowed the criteria to 'first-line treatment for patients with EGFR exon 19 deletion and brain metastases' and reapplied for reimbursement. The plan was to increase the clinical value of the drug by excluding the patient group that showed a relatively small difference in efficacy from the control group. However, Tagrisso’s reimbursement extension was rejected at the CDDC meeting that was held in November 2021. Real-world study on first-line Tagrisso use in Japan. OS results according to gene mutation status (Data: ESMO) This reluctant sentiment on Tagrisso’s reimbursement extension was reversed at the end of last year with the release of large-scale real-world data on Tagrisso’s use in the first line in Asia and Europe. Analysis of real-world data on 660 Japanese patients confirmed a longer progression-free survival period (20.0 months) and an overall survival period of more than 3 years (40.9 months) than those identified in the Phase III trial. With this data, the company put an end to Tagrisso’s efficacy controversy in Asia. AstraZeneca took on its 5th challenge with this new data and a plan to lower drug prices as supplements. The patient organizations’ petition requestion reimbursement extension also added support. The 'Petition regarding the request for first-line treatment of the lung cancer treatment Tagrisso’ that was uploaded to the e-People website in February was sent to the National Assembly Health and Welfare Committee for deliberation after receiving over 50,000 consents. As a result, after 5 attempts in the course of the past 4 years, Tagrisso finally made it through the first barrier to its reimbursement and passed the CDDC review. ◆Can it be reimbursed within the year? Depends on DREC progress Although it has passed the high barrier of CDDC review, many procedures still remain for its reimbursement extension. For anticancer drugs, CDDC review is only the first step of many. The agenda has to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC), and then undergo pricing negotiation with the NHIS, then pass MOHW’s Health Insurance Policy Deliberation Committee (HIPDC) review to complete all the procedures required to extend benefits. Tagrisso is subject to the risk-sharing agreement (RSA) scheme and must pass the pharmacoeconomic evaluation. HIRA’s statuary evaluation period is set to 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data. After completing discussions with HIRA and passing DREC review, the company has to conduct drug pricing negotiations with NHIS for up to 60 days. Within 30 days from the period, MOHW’s HIPCD will deliberate and then issue a notification on the new drug price and then list the drug for extended reimbursement. In other words, at maximum, Tagrisso’s reimbursement extension is set to be made by the end of this year. The decisive step in advancing or delaying this timing of Tagrisso's reimbursement is expected to depend on DREC’s stage, where the pharmacoeconomic evaluation takes place. If DREC requests supplementary data repeatedly, reimbursement listing may be delayed indefinitely. In fact, several anticancer drugs have not been deliberated for over a year at the DREC level after passing the CDDC review. In the case of MSD's Keytruda, which succeeded in extending reimbursement to the first-line treatment of NSCLC after 4 years, Keytruda’s reimbursement agenda was presented to DREC 6 months after passing the CDDC review in July 2021. Although the company showed a high willingness to negotiate the reimbursement of Keytruda, the process was only completed eight months after passing the CDDC review due to a delay in its schedule, such as an unsuccessful submission for the DREC review in November 2021. AstraZeneca plans to make the best efforts to extend Tagrisso's reimbursement within the year. The company said, "We welcome the CDDC’s decision and would like to express our thanks to the government and committee members for making efforts to enable this. We will continue to do our best to complete the procedures that remain and receive the reimbursement decision”
- Company
- Neurofibromatosis Tx Koselugo makes progress for reimb
- by Eo, Yun-Ho Mar 23, 2023 04:45am
- Finally, reimbursement discussions for the new neurofibromatosis drug ‘Koselugo’ has made some progress. Results showed that AstraZeneca Korea’s new neurofibromatosis drug has passed the review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee recently. Therefore, its reimbursement can now be deliberated by the Drug Reimbursement Evaluation Committee. After the drug received a non-reimbursement decision from DREC in March, the company worked promptly and prepared the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo, and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. In contrast to the non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
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- Promoting the extension of the term of drug patents
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- Previously, patentees could legally extend the duration of a patent unlimitedly, but the government's plan is to promote it up to 'up to 14 years'. According to the pharmaceutical industry on the 21st, the Korean Intellectual Property Office recently prepared an amendment to the Patent Act to reform the system for the duration of drug patent rights. The amendment is expected to be submitted to the National Assembly through legislative acts. In the current drug patent term extension system, there is no separate upper limit (cap). In addition to the essential patent period of 20 years, it extends the time taken for clinical trials and approval and approval of drugs. In other words, the duration of drug patents can be 21 years, 27 years, or 37 years in the '20+α' method. However, the United States and Europe set an upper limit on the additionally recognized period. This means that even if it took a total of 23 years for clinical trials, licensing, etc., only 14 years (USA) or 15 years (Europe) are recognized. On the other hand, Korea and Japan do not have a separate upper limit for this period. As a result, criticism has been constantly raised in the pharmaceutical industry that the patent holder's patent term is excessively long. As part of the evergreening strategy, the original company takes a strategy of registering a new patent and extending the total duration before the patent expiration date. It is criticism.
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- Forxiga's generics will be suspended until the 7th
- by Kim, Jin-Gu Mar 22, 2023 05:47am
- Manufacturing and sales of Dong-A ST's SGLT-2 inhibitor-type diabetes treatment Dapapro are expected to be suspended by early next month. According to the pharmaceutical industry on the 20th, the Seoul Central District Court recently cited AstraZeneca's request for an injunction to prohibit infringement of patent rights filed against Dong-A ST. As a result, Dong-A ST will not be able to manufacture and sell Dapapro until the 7th of next month, when Forxiga's patent expires. Dapapro is a follow-on drug to Forxiga. Among the SGLT-2 inhibitors of Dapagliflozin, the original diabetes treatment, it is currently the only one listed as reimbursement, except Forxiga. In November of last year, Dong-A ST succeeded in avoiding part of the duration of the material patent for Forsyga alone in the first trial by using a 'prodrug' strategy. With this decision, Dong-A ST obtained the right to release a follow-on drug before the patent expiration of Forxiga. In December, Forxiga released Dapapro, a follow-up drug, for reimbursement. It was five months before the expiration of the Forxiga patent. AstraZeneca appealed to the Patent Court immediately after the first trial. At the same time, it filed an application for a provisional injunction requesting a ban on infringement of Dong-A ST's patent rights, including the manufacture and sale of Dapapro, until the second trial verdict. The Seoul Central District Court cited AstraZeneca's application for a provisional injunction. An official from AstraZeneca Korea said, "We welcome the decision of the Seoul Central District Court. Substance patents for active ingredients must be respected for the development of the pharmaceutical industry in Korea." We will work hard to do so,” he said.
- Company
- 10 years of the global launch of K-biosimilars
- by Chon, Seung-Hyun Mar 22, 2023 05:47am
- The cumulative exports of biosimilar products developed by Celltrion and Samsung Bioepis recorded 13 trillion won. Celltrion's Remsima is rapidly expanding its territory 10 years after entering the European market. Celltrion's biosimilars posted cumulative exports of 9 trillion won, and Samsung Bioepis' overseas sales of more than 4 trillion won. ◆Celltrion Health, accumulated exports of 9 trillion won by selling 4 similar types since 2013 According to the Financial Supervisory Service on the 22nd, Celltrion Healthcare's four biosimilars, Remsima, Remsima SC, Truxima, and Herzuma, posted a total of 1.71 trillion won in exports. It increased by 9.2% from the previous year and broke the record for the largest export. Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltree Healthcare is selling four biosimilars in overseas markets: Remsima, Remsima SC, Truxima, and Herzuma. Remsima is a biosimilar product of Remicade. Remsima SC is a subcutaneous formulation of Remsima. Truxima and Herzuma are biosimilar products of anticancer drugs Mabthera and Herceptin, respectively. Last year, Remsima recorded the largest export of 859.3 billion won. It increased by 6.1% from 809.6 billion won in 2021 and produced the most exports since obtaining European permission in 2013. Despite intensifying competition in biosimilars, Remsima continues to increase exports as more than 100 countries obtained item approval last year. Remsima recorded exports of 145.3 billion won in 2013, and the cumulative amount of exports for 10 years until last year totaled 5,163.1 billion won. Remsima SC exported 236.9 billion won last year, more than double the previous year's 89.6 billion won. With only two products, Remsima and Remsima SC, the joint venture achieved 1.96 trillion won in exports last year. Remsima SC made its first export of 34.8 billion won in 2020 and recorded a cumulative export performance of 361.4 billion won over the past three years. Truxima showed exports of 436.5 billion won last year, down 4.9% from the previous year. It is the second consecutive year of decline since recording 786.8 billion won in 2020. It is analyzed that the growth rate has slowed somewhat as the competition for biosimilars intensified. Truxima posted its first export of 383.2 billion won in 2017 and achieved a total of 2.6148 trillion won in overseas sales over the six years until last year. Herzuma's export volume last year was 181.7 billion won, down 13.9% from the previous year. After posting overseas sales of 211 billion won in 2021, the growth trend has slowed down. Herzuma recorded a cumulative export performance of 865.6 billion won from 2017 to last year. Celltrion's four biosimilars jointly exported a total of 9.49 trillion won for 10 years from 2013 to last year. Samsung Bioepis is also breaking new records every year. Samsung Bioepis' operating profit was 231.5 billion won, up 20.1% from the previous year, and sales were 946.3 billion won, up 11.7% from the previous year. Both operating profit and sales are the highest since its launch in 2012. Sales increased by 21.7% in two years from 777.4 billion won in 2020, and operating profit increased by 59.6% during the same period. The operating profit to sales ratio last year was 24.5%, the highest ever. Starting with the Enbrel biosimilar in January 2016, Samsung Bioepis received approval for six and five biosimilars in Europe and the US, respectively. Biosimilars of five biosimilars of Samsung Bioepis, Enbrel, Remicade, Humira, Herceptin, and Lucentis, have been approved in Europe and the United States. In Europe, it has additionally obtained approval for the sale of Avastin biosimilars. Samsung Bioepis is selling five biosimilars in Europe and three biosimilars in the US. Samsung Bioepis started selling Enbrel and Remicade biosimilars in Europe in 2016. In 2018, it introduced biosimilars to Herceptin and Humira markets and started selling Avastin biosimilar AYBINTIO in Europe in 2021. In the US, among the five licensed products, Remicade biosimilar RENFLEXIS was launched in the US market in 2017, and Herceptin biosimilar Ontruzant was launched in the US in 2020. Last year, it started selling Lucentis biosimilar BYOOVIZ in the US. Established in 2012, Samsung Bioepis generated sales of 43.7 billion won for the first time in 2013. In 2016, when the biosimilar overseas targeting began in earnest, it recorded sales of 147.5 billion won, and has continued to grow every year since. Since its launch in 2012, Samsung Bioepis has recorded cumulative sales of 4,311.2 billion won. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or royalties. Domestic sales volume is negligible. According to IQVIA, a pharmaceutical research institute, Samsung Bioepis' five biosimilars sold a total of 42.5 billion won last year. In other words, the biosimilars of Celltrion and Samsung Bioepis have exported more than 13 trillion won in total over the past 10 years.
- Company
- Dupixent likely to expand reimb to pediatrics from April
- by Eo, Yun-Ho Mar 22, 2023 05:46am
- Reimbursement of the atopic dermatitis treatment ‘Dupixent’ is expected to be expanded for pediatric and adolescent patients from April. According to sources from related industries, Sanofi-Aventis Korea recently concluded a drug price negotiation with the National Health Insurance Service for the low dose (200mg) of Dupixent (dupilumab). Thus, Dupixent will be presented to the Health Insurance Policy Deliberation Committee tomorrow (23rd). On the 23rd, JAK inhibitors such as Abbvie Korea’s ‘Rinvoq (upadacitinib)’ and Pfizer Korea’s ‘Cibinqo (abrocitinib)’ will also be discussed. Unless otherwise, treatment options for pediatric atopic dermatitis patients will be drastically expanded in April. Dupixent's journey to expand reimbursement has seem many twists and turns. Being an RSA (Risk Sharing Agreement) drug, and having added a separate dose of 200mg, Dupixent had to go through an additional cost-effectiveness review procedure with the Health Insurance Review and Assessment Service, and complete drug price negotiation with the National Health Insurance Service. If approved, Dupixent will finally see results after two years since applying for an expansion of reimbursement in April 2021. Although the specific indications may differ, the difference in speed of progress is evident when compared to JAK inhibitors such as Rinvoq and Cibinqo, which also have applied for expansion of reimbursement in atopic dermatitis. The price of JAK inhibitors are relatively lower than that of Dupixent. Rinvoq and Cibinqo were both listed for reimbursement in May last year and Rinvoq is also attempting to expand its reimbursement to pediatric adolescent patients. Meanwhile, Dupixent is the first and only biologic to specifically target and inhibit the signaling of IL-4 and IL-13, which is the fundamental cause of atopic dermatitis. As Dupixent does not have a black box warning from the US FDA, which addresses the most severe side effects, and does not require monitoring for organ toxicity during administration, it was approved without any requirement for testing when starting treatment or regular safety monitoring during treatment.
- Company
- Patent extension system for drugs to be reorganized…
- by Kim, Jin-Gu Mar 22, 2023 05:46am
- A plan to reorganize the patent term extension system of biopharmaceuticals in a manner similar to those of the US and Europe is being reviewed. In the pharmaceutical industry, it is predicted that if the reorganization plan passes the National Assembly, the patent term of some original drugs will be reduced to about one year. According to the pharmaceutical industry, the Korean Intellectual Property Office recently prepared an amendment to the Patent Act to reform the system for the patent term of drugs on the 21st. The amendment is expected to be submitted to the National Assembly in the form of legislative acts. The main point of the amendment is to set the upper limit on the remaining (valid) patent term to 14 or 15 years from the time a new drug receives approval. The pharmaceutical industry's attention is focused on how much the original drug's patent term will be shortened. In this regard, the US and Europe have systems that limit the effective patent term. This method allows the patent to be effective for up to 14 or 15 years from the time the drug has been approved. For example, even if a pharmaceutical company 'A' has been granted approval for a patent for 20+5 years (basic patent term + extended period), the entire patent term is shortened 'up to 15 years from the time of approval' by setting an upper limit. On the other hand, Korea does not have a separate limit on the patent term that is applied from the time of approval. In the current system, there are only regulations that limit the extension of the patent term to a maximum of 5 years, but no upper limit on the effective patent term. As a result, the Korean patent term of pharmaceuticals is longer than the US and Europe, with the same product and same patent. Taking Pfizer’s ALK-targeted anti-cancer drug Xalkori (ingredient: crizotinib) as an example, its remaining patent term is limited to 14 years after approval by the FDA in the US. Under the upper limit, only 1 year and 6 months (547 days) of the patent term extension was recognized for Xalkori in the United States. The situation is similar in Europe. Europe has an upper limit of 15 years from the date of initial marketing authorisation. As a result, only 2 year and 2 months (799 days) of the patent term extension was recognized for Xalkori in Europe. Since there is no separte regulation that states the upper limit in Korea, the extended patent term of Pfizer's Xalkori was fully recognized. The extended patent term approved for Xalkori in Korea is 2 years and 10 months (1034 days), which is about 8 months longer that that of Europe and about 16 months longer than that of US. If the amendment passes the National Assembly, the effective patent term of the original drug will be shortened to about 1 year. In other words, the timing of generic release in Korea will be accelerated. The key is whether the amendment will be applied only to newly introduced drugs or to existing drugs as well. If the amendment is applied to existing drugs, quite a number of drugs will be affected by the new system. According to the Korean Intellectual Property Office, as of the end of 2021, 360 drugs still have effective patent term remaining in Korea. In terms of number of patents, there are 612. Among them, 60 drugs (83 patent rights) are expected to become subject to the new system, having 'effective patent term of 15 years or more.' While the Korean Intellectual Property Office is reportedly considering the 14-year regulation, the US model, the pharmaceutical industry predicts that the effective patent term for 40 to 50 drugs may be shortened if the amendment is applied to existing drugs as well.
- Company
- Pediatric indication becomes key to sales in Korea
- by Moon, sung-ho Mar 21, 2023 05:56am
- The treatment market for pediatric and adolescent patients have grown rapidly last year. In particular, injections for pediatric and adolescent patients have gained much popularity and raised sales in reimbursed and non-reimbursed markets in hospitals and clinics. The transition from the COVID-19 pandemic to an endemic had increased focus on injections for obesity and growth, which led to great popularity. If the pediatric ‘non-reimbursed’ market had achieved great growth last year, this year, the market for reimbursed treatment for 'severe' pediatric conditions is expected to grow rapidly because major treatments for pediatric patients are attempting reimbursement in the first half of this year. First, Saxenda (liraglutide), the leader in the domestic obesity treatment market, saw rapid growth in sales last year with its expansion to the pediatric indication. #According to the market research institution IQIVA, Novo Nordisk’s Saxenda raised sales of KRW 58.9 billion last year, which is a 62.7% YoY increase. Saxenda’s sales had previously fallen for 2 consecutive years. From KRW 42.6 billion in 2019, sales had fallen to KRW 36.8 billion in 2020, then to KRW 36.2 billion in 2021. However, with COVID-19’s transition to an endemic, its sales had again surged and dominated Korea’s obesity treatment market. Saxenda’s sole lead in the market is expected to continue until new obesity treatments like Wegovy (semaglutide, Novo Nordisk), and Mounjaro (tirzepatide, Lilly) are released to the market. Saxenda’s rapid growth in sales is in line with its indication extension to children and adolescents last year. In December 2021, Saxenda’s indication was extended to treat adolescent patients aged 12 to 18 years with a BMI that corresponds to 30 kg/m2 for adults and weighs over 60 kg in Korea. In other words, the indication expansion to pediatric adolescent patients maximized sales in obesity and growth clinics and hospitals in Korea. The same goes for the growth hormone market. The growth hormone injection market, which had previously consisted of products from domestic pharmaceutical companies, has also grown into a large non-reimbursed treatment market and was evaluated to be sized at KRW 250 billion won last year with rising sales from growth clinics at front-line hospitals and clinics. If the pediatric ‘non-reimbursed’ market had achieved great growth last year, reimbursement extensions of major treatments for major pediatric conditions are expected this year. Key products include Dupixent (dupilumab) and Hemlibra (emicizumab). Both drugs received recognition for their need to extend reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and are undergoing drug pricing negotiations with the National Health Insurance Service. If the pricing negotiations between the NHIS and pharmaceutical companies progress smoothly, the drugs will be able to receive reimbursement extensions within the first half of the year. In the case of Dupixent, if reimbursement extensions are finally made to cover children and adolescents with atopic dermatitis in May, its sales are expected to continue to grow as in the previous year. In the case of Dupixent, sales increased 35% YoY from the KRW 77.2 billion in the previous year to reach KRW 104, but experts predict there is still room for additional growth. The same goes for JW Pharmaceutical’s Hemlibra. Hemlibra is currently only reimbursed to treat patients who show resistance and have antibodies to existing treatments. As most of the Type A hemophilia patients are ‘non-antibody’ patients, this means that only a very few patients are receiving reimbursement for Hemlibra. This is why parents of hemophilia A patients had been continuously raising demand for Hemlibra's reimbursement extension. According to the 2019 Hemophilia White Paper, over 90% of the 1,746 patients with hemophilia A in Korea, 1,589 patients, are non-antibody patients. Drug pricing negotiations are underway after HIRA made the decision to extend reimbursement, and if the negotiations are completed within the first half of the year, non-antibody patients will be able to use Hemlibra with reimbursement as well. Meanwhile, the financial authorities expect the health insurance claims amount to increase rapidly if Hemlibra’s reimbursement is extended to cover non-antibody patients. According to IQVIA, Hemlibra’s sales last year increased 5% YoY from the KRW 7.2 billion to reach KRW 7.6 billion last year. In other words, if reimbursement is extended to cover non-antibody patients, the drug may grow to become a large blockbuster product that brings in millions of won every year. Moreover, the pharmaceutical industry predicts that the drug will become a 'dark horse' in Korea’s hemophilia treatment market which is currently led by GC Pharma if Hemlibra’s reimbursement is extended to cover non-antibody patients. A health insurance official said, “In the case of hemophilia, around 10% are antibody patients, and 90% non-antibody patients. Therefore, if reimbursement for Hemlibra is extended to cover non-antibody patients, the drug’s sales will naturally increase significantly.”
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- Increasing male infertility
- by Eo, Yun-Ho Mar 21, 2023 05:56am
- As male infertility increases, interest in follicle-stimulating hormone preparations is increasing. So far, women's infertility treatment has been more active than male infertility treatment. 93.4%of the cost of infertility, which was carried out by 2021, was used for female infertility patients, and only 6.6%were used for male infertility patients. Infertility can occur in both men and women due to deficiency of sperm formation due to male sperm, mobility, and low pre -stimulating hormonal glands, or ovarian function of women, closure of fallopian tubes, and endometriosis. According to the Social Society of Society of Propaganda (SRS), the cause of infertility is about 40% of male factors. Looking at the number of infertility patients in domestic men, it can be seen that about 43%increased from 6,2468 to 89,350 in five years from 2017 to 2021. On the other hand, female infertility patients increased by about 11% over five years. The reason for the recent increase in male patients who are diagnosed with infertility is that the perception that there may be a cause of infertility is expanded compared to the previous one. Kim Soo -woong, a professor of urology medicine at Seoul National University Hospital, said, “Infight is that infertility is a problem of all couples, and interest in the cause and treatment of male infertility seems to be increasing. "I need a treatment option and research on continuous male infertility treatment is needed." Infertility treatments, which are used in general, have a genital-stimulating hormone. The genital stimulating hormone components include Follicle Stimulating Hormone, Human Menopausal Gonadotropin (HMG), and Human Chorionic Gonadotropin preparations. Among them, the FHS formulation is a hormone that is synthesized and secreted in the pituitary gland, which is not only involved in producing eggs in the ovaries of women but also acts as a hormone that produces sperm in the testicles of men, thereby improving the reproductive function of infertility patients. Among the FSH preparations used in Korea, 'Puregon' is the only man who has an indication of the deficiency of sperm formation caused by men's low -stimulating hormonal glands. PureGon confirmed the effectiveness of the combination of HCG, which was conducted with HCG, which was a lowly stimulating hormonal sexual dysfunction that failed to treat infertility with HCG monotherapy. According to the guidelines of the Endocrinology Society, FSH+HCG combination therapy is essential for men who are reduced in the genitals of the central central central central central central central central central central central central cavity in the treatment of reproductive ability of men. Professor Kim said, “The infertility treatment environment is far from effective infertility through male infertility diagnosis and treatment, and it is increasing the burden on infertility treatment for women. "Everybody needs to be infertile and treated in an appropriate time regardless of gender." World Health Organization (WHO) defines as infertility a couple with a normal marital relationship without contraception who are not pregnant for a year. As of 2021, the number of male and female patients diagnosed with infertility in Korea was about 250,000, up 9% from 2019, and nearly 10,000 people per year for nearly five years. Recently, the city of Seoul also announced a plan to expand infertility support to solve the problem of low outflows.
