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- 2026-04-10 15:37:14
- Policy
- Voluntary withdrawal of reimbursement for Tepmeko
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- It was found that Tepmeko, a MET mutated anti-cancer drug that failed to set reimbursement standards, recently voluntarily withdrew its application for reimbursement. Tepmeko has not been recognized as valid as a result of discussing the reimbursement standard in HIRA. According to the industry on the 10th, Merck announced its intention to voluntarily withdraw Tepmeko's application for drug reimbursement decision to HIRA. Tepmeko is a treatment for locally advanced or metastatic non-small cell lung cancer with confirmed MET exon 14 deletion. In Korea, in November 2021, it was approved simultaneously with Tabrecta, a drug in the same family, and has been undergoing a full-scale reimbursement review since last year. Metastatic non-small cell lung cancer patients with MET mutations, which Tepmeko is targeting, appear in about 3-4% of all non-small cell lung cancer patients. Although the number of patients is small, the prognosis is poor, so a cure is desperately needed. According to a presentation by Prof. Han Ji-yeon, Department of Oncology, Lung Cancer Center, National Cancer Center, at the International Conference of the Korean Lung Cancer Society last year, an analysis of 79 Asian patients who participated in the Tepmeko VISION clinical trial showed a significantly high objective response rate of 66.7%, and the second-line treatment group The response rate was 48.1%. Despite this effectiveness, the non-insured prescription price of Tepmeko in the US reaches 25 million won per month in Korean money. For this reason, patients are eagerly waiting for the application for reimbursement. Tabrecta has also failed to set reimbursement standards, so it will take more time to apply for the benefits. It is not known whether Tepmeko will reorganize its data and apply for benefits. However, since the previous application for benefits was withdrawn, even if you apply again, it will take longer than before to apply for health insurance. Assuming the worst-case scenario, if Tepmeko gives up on the domestic market, there is a possibility that Tabrecta will also be affected. In this case, only the patients are expected to suffer.
- Policy
- Innovative plans for domestic vaccines/txs to face post-pand
- by Lee, Jeong-Hwan Mar 13, 2023 05:53am
- Lim Sook-young, leader The government will promptly import vaccines and treatments for new infectious diseases that will occur in Korea after Corona 19 and improve laws and systems so that domestic products can be produced quickly. For now, only the big direction has been set, and the government plans to announce a comprehensive plan in May after consultations with related ministries and experts to prepare specific countermeasures. Attention is focused on whether government support measures can be prepared to speed up the development of domestic vaccines and treatments. On the 8th, Lim Sook-young, head of the Central Disease Control Headquarters, said at a regular Corona 19 briefing, “The government is establishing a mid-to-long-term plan to prepare for a new infectious disease pandemic that will occur in the future.” Based on the COVID-19 response evaluation over the past three years, Director Lim's will is to establish a mid-to-long-term plan to expand quarantine and medical response capabilities so that vaccines and treatments can be quickly secured and large-scale long-term epidemics can be stably managed. It plans to consult with related ministries in each field, including new infectious disease monitoring, initial response, large-scale epidemic management, daily recovery, research and development of treatments and vaccines, and improvement of laws and systems. She said, "Prevention of new infectious diseases is important first. That is why it is necessary to strengthen the surveillance system." he explained. She added, "When the scale of the epidemic increases, it is necessary to be fully prepared for hospital beds and medical response," adding, "We also need to review the compatibility of social distancing measures and various compensation issues." In particular, he said, "In the next pandemic, we need to develop vaccines and treatments more quickly and respond to infectious diseases with our own vaccines and treatments." She emphasized, “We will discover improvement tasks for each area and announce a comprehensive plan after consulting with related ministries and experts.”
- Company
- Eylea makes sole lead in the ₩100B nAMD Tx market
- by Jung, Sae-Im Mar 13, 2023 05:53am
- (from the left) Eylea, Lucentis, Beovu The sole lead held by ‘Eylea’ in the domestic macular degeneration treatment market has been further solidified last year. Also, Novartis has been aggressively promoting sales of its recently launched new drug ‘Beovu.' With Novartis focusing its sales strategy on Beovu, sales of the company’s lesser priority, 'Lucentis,’ further declined last year. According to the market research institution IQVIA on the 11th, Korea’s macular degeneration treatment market grew by 14% YoY from KRW 111.1 billion the previous year and recorded KRW 126.3 billion last year.. Neovascular (Wet) Age-Related Macular Degeneration (nAMD) is considered one of the 3 major causes of blindness in the elderly aged 65 or older. The risk increases as one grows older. The growth of abnormal blood vessels (neovascular) results in the leakage of blood, lipid, or subretinal fluid, which damage the macula and lead to vision loss. Excluding ‘Avastin,’ which is used off-label, three treatments are available for nAMD in Korea – Bayer’s ‘Eylea (aflibercept),’ Novartis’s ‘Lucentis (ranibizumab)' and ‘Beovu (brolucizumab).’ Lucentis was the first to be approved in 2007, followed by Eylea in 2013. A decade later, Beovu was approved as a new drug. Also, another new drug, Roche’s ‘Vabysmo,’ was approved in January this year. Eylea made a new annual sales record of KRW 80.4 billion last year. This is a 14% YoY increase from KRW 70.5 billion in 2021. Eylea’s strength is that it allows patients to receive customized treatment by offering a broad dosing interval ranging from a minimum of 4 weeks to a maximum of 16 weeks. The drug contributed to the establishment of the treat-and-extend (T&E) regimen in nAMD treatment, where the patients’ dosing interval is regulated after monitoring the patients during the initial 3 months of treatment. Last year, the company introduced a pre-filled syringe formulation that reduces preparation time for drug administration by preparing the accurate dose for single administration in advance. The new formulation improved the convenience of the treatment process. However, sales of Lucentis, which was 2nd place in the market, have been decreasing for 2 consecutive years. Lucentis’s annual sales decreased by 16% from the KRW 35.1 billion to record KRW 29.4 billion last year. Lucentis’s sales have been decreasing continuously after peaking at KRW 37 billion in 2020. The change occurred when Novartis, its seller, received approval for its new nAMD treatment Beovu. Lucentis has been developed by Genentech and marketed by Roche and Novartis. In Korea, Lucentis is being sold by Novartis. Novartis developed its new drug and succeeded in receiving marketing approval for the drug in 2022. The decrease in Lucentis’s sales had been an expected result with Novartis focusing its capabilities on the sales of Beovu. Also, the entry of Lucentis’s biosimilars into the market upon Lucentis’s patent expiry heated up the competition this year. Chong Kun Dang and Samsung Bioepis started selling their Lucentis Biosimilars, ‘LucenBS,' and ‘Amelivu inj’ in January this year. With both drugs listed for reimbursement, Lucentis’s drug price had been reduced by 30% ex officio from February this year. Lucentis’s position as the original drug in the market is expected to weaken further as the companies that own Lucentis biosimilars have been competitively lowering drug prices to gain an advantage earlier in the market. Meanwhile, Novartis’s new drug Beovu’s sales exceeded KRW 10 billion last year. Last year, Beovu’s sales increased 205% YoY from the KRW 5.4 billion in the previous year to record KRW 16.5 billion. Unlike other existing treatments that have dosing intervals of 4-8 weeks, Beovu has a dosing interval of up to 12 weeks (3 months). This was evaluated to have improved patient compliance by reducing the difficulties of patients that had to receive injections into the eye. The low compliance in patients with nAMD had been pointed to as a major issue that reduces the actual treatment effect of the nAMD treatments. Beovu demonstrated its non-inferiority with Eylea with its 12-week administration through a head-to-head trial. The therapeutic effect lasted until week 96. Also, the Beovu-treated group showed superior improvement in intra-retinal fluid and sub-retinal fluid compared to the Eylea-treated group The reason Beovu produces a similar effect despite the longer dosing interval is due to its molecular characteristics. Beovu’s single-chain antibody fragment (ScFv) is engineered to deliver a higher concentration of molecules compared to other treatments with multiple chains. However, HCPs have been showing divided opinions on its use due to its side effect of retinal vasculitis, which is unseen in other existing treatments. In particular, the introduction of Vabysmo, the first bispecific antibody introduced to the field of ophthalmic diseases, is expected to somewhat dilute Beovu’s strengths of 'high efficacy and convenience.’ Vabysmo is the first bispecific antibody that targets both the VEGF which is commonly targeted by existing ocular disease treatments as well as Ang-2 that is considered to be the cause of retinal disease to block both pathways. In particular, it has improved convenience in administration over other existing treatments with a dosing interval of up to 16 weeks (4 months). If listed for reimbursement, Vabysmo is expected to start a full-fledged competition with Beovu.
- Company
- Pharmaceutical companies are fiercely competing to develop
- by Kim, Jin-Gu Mar 13, 2023 05:53am
- In the hyperlipidemia combination drug market of 'statin + ezetimibe', competition to develop a two-drug combination using 'low-dose statin' is intensifying. According to the pharmaceutical industry on the 11th, Yuhan Corporation is developing a combination drug for hyperlipidemia with Ezetimibe added to Atorvastatin 5mg through its subsidiary Addpharma. Yuhan already has three products, including Atovamibe, a two-component complex. The dose of Ezetimibe is the same at 10 mg, and only the doses of Atorvastatin are different at 10 mg, 20 mg, and 40 mg. Yuhan Corporation's plan is to add a combination drug based on the 5mg dose of Atorvastatin. Rosuzet 10/2.5mg, a low-dose hyperlipidemia drug from Hanmi Pharmaceutical According to the original developer, Addpharma, the development of the corresponding dose product is currently in the final stage, and it is expected that it will be possible to apply for product approval as early as this month. If the item is approved by the Ministry of Food and Drug Safety, it will be the first product for hyperlipidemia combined with low-dose atorvastatin. In addition to Addpharma, several companies are said to be developing complex drugs with the same combination of ingredients and doses. This is the background to the prospect that competition in the market for the variety of Atorvastatin 5mg and Ezetimibe will intensify in the future. Hanmi Pharmaceutical opened the door to developing a combination drug for hyperlipidemia based on low-dose statins. In September 2021, Hanmi Pharmaceutical obtained permission for 'Rosuzet 10/2.5mg', in which Ezetimibe was added to Rosuvastatin 2.5mg. It is known that the low-dose product is rapidly increasing prescription performance after the benefit was launched in October of that year. According to UBIST, a pharmaceutical market research institute, the outpatient prescription amount of Rosuzet increased by 14% from the previous year to 140.3 billion won last year. The pharmaceutical industry believes that the addition of low-dose products contributed to the expansion of Rosuzet's overall prescription record. Recently, it is said that the monthly prescription amount has expanded to more than 1 billion won. As low-dose Rosuzet gained market acceptance, other companies jumped into developing low-dose Rosuvastatin-based combinations. Daewoong Pharmaceutical received approval for Crezet 10/2.5mg with the same ingredient and dose combination as Rosuzet in August of last year. Since February of this year, Yuhan Corporation's Rosuvamibe, HK inno.N Rovazet, and GC Pharma Daviduo have also added low-dose Rosuvastatin-based complexes to their product lineups. An official from the pharmaceutical industry said, “The core dose of Rosuvastatin was 5 mg, and Hanmi Pharmaceutical succeeded in increasing the prescription performance of Rosuzet by releasing a low-dose product that halved the dose.” There is a possibility of market success because the product is half the existing core dose (10 mg).”
- Company
- Gastric cancer is the first immuno-oncology option available
- by Eo, Yun-Ho Mar 13, 2023 05:53am
- In the field of gastric cancer, attention is paid to whether the first immuno-oncology drug insurance benefit registration can be achieved. As a result of the coverage, it is possible to propose the HIRA in April for Opdivo, an immune anticancer drug with PD-1 inhibitory mechanism, from Ono Korea Pharmaceuticals and Korea BMS Pharmaceuticals. In June 2021, Opdivo added an indication for 'combination therapy with fluoropyrimidine-based and platinum-based chemotherapy as the first-line treatment for advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma' in Korea. It is the first and only approved immune anti-cancer drug in Korea for first-line gastric cancer treatment. This drug failed to pass the HIRA committee in February of last year and submitted a re-application, and passed the cancer disease review committee in June of the same year. If it is presented to the committee in April and passed, it is expected that the first half of the year will be possible at the earliest. Opdivo was also recognized for its benefit adequacy in the UK at the end of last year. The National Institute of Health and Clinical Excellence recently recommended Opdivo for use in chemotherapy-naive patients with PD-L1 expression, HER-2 negative, advanced metastatic gastric cancer or gastroesophageal junction cancer, and esophageal adenocarcinoma. Gastric cancer is currently the second largest cancer after lung cancer, and the need to expand the reimbursement of immuno-anticancer drugs is on the rise. Gastric cancer is a typical cancer type that ranks first in the prevalence of cancer and the fourth leading cause of cancer death in Korea. If detected early, the survival rate is good, but when distant metastasis progresses, the 5-year relative survival rate drops sharply to 5.9%. In particular, HER2-negative gastric cancer patients, who account for 90% of advanced gastric cancer patients, have been receiving chemotherapy as a standard treatment since there has been no newly approved new drug in the first-line treatment for the past 10 years. Opdivo could be an alternative for these patients.
- Policy
- Pfizer’s Cibinqo to undergo NHIS negotiations for reimb
- by Lee, Tak-Sun Mar 13, 2023 05:53am
- (From top to bottom) Dupixent Prefilled Inj., Rinvoq ER Tab., and Cibinqo Tab attempts reimb to treat pediatric and adolescent AD Pfizer has accepted the conditions set by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee for the reimbursement of its Cibinqo Tab (abrocitinib) in Korea. The drug received conditional approval at the DREC meeting that was held on March 2. The committee deemed Cibinqo’s reimbursement will be adequate if the company accepts a price less than the assessed amount. According to industry sources on the 12th, Pfizer accepted DREC’s conditions and is moving on to the pricing negotiation stage with HIRA. DREC’s proposed assessment price is expected to be set at the same level or below the weighted average price of its alternatives. Other JAK inhibitors that are currently available in the market include Olumiant Tab (baricitinib, Lilly) and Rinvoq ER (upadacitinib, Abbvie), therefore, Cibinqo’s price is expected to be set below the weighted average price of these drugs. After the Ministry of Health and Welfare orders pricing negotiations, Pfizer will be conducting negotiations with the NHIS for Cibinqo’s reimbursement. Although the statutory period set for NHIS negotiations is 60 days, if Pfizer accepts a price less than the upper limit set and receives negotiation exclusions, the company can further reduce the NHIS negotiation period to 30 days. If negotiations are completed in a short period of time, the industry expects Cibinqo may be listed for reimbursement in May at the earliest. Currently, Dupixent (dupilumab, Sanofi), Cibinqo, and Rinvoq are undergoing the reimbursement listing process as a treatment for pediatric·adolescent patients with atopic dermatitis. Among the three drugs, Dupixent has been making the most rapid progress. The drug entered negotiations last month and is expected to be listed for reimbursement next month at the earliest. Rinvoq ER, which is already listed as a treatment for atopic dermatitis in adult patients, is also attempting to extend its reimbursement as a treatment for adolescent patients aged 12 years or older with moderate-to-severe atopic dermatitis. Rinvoq ER’s reimbursement to the indication has passed HIRA review by applying the scope of use expansion formula and is set to receive NHIS negotiations soon. As Rinvoq and Cibinqo are both oral JAK inhibitors aiming to receive reimbursement as a pediatric atopic dermatitis treatment, their pricing negotiations will likely be conducted at the same time and be listed at a similar period.
- Company
- GC Pharma begins develop of mRNA flu vaccine candidates
- by Hwang, Jin-joon Mar 10, 2023 05:50am
- GC Pharma researcher is conducting drug research. (Photo by GC Pharma)Invested in mRNA pilot production facilities in Hwasun Vaccine Plant in Jeollanam-do. GC Pharma announced on the 9th that it will apply Acuitas Therapeutics' Lipid Nano Particle (LNP) technology to develop mRNA flu vaccine candidates in earnest. GC Pharma signed an LNP-related Development and Option Agreement with Acuitas in Canada in April of last year. Through the study, the possibility of developing an mRNA flu vaccine was confirmed. We recently exercised our non-exclusive licensing agreement option for the LNP. LNPs safely transport nanoparticles into cells in the body to help mRNA function. It is a key technology required for mRNA-based drug development. The LNP technology owned by Acuitas, a company specializing in the development of LNP delivery systems, was also applied to Pfizer's COVID-19 vaccine COMIRNATY. GC Pharma plans to conduct a phase 1 clinical trial of its mRNA vaccine candidate in 2024. GC Pharma also started investing in mRNA production facilities. It decided to invest in mRNA trial production facilities at its Hwasun plant in Jeollanam-do, which produces the existing flu vaccine.
- Policy
- Industry unsatisfied with the proposed PVA improvements
- by Lee, Tak-Sun Mar 10, 2023 05:50am
- Companies that have released new drugs in Korea have expressed discontent over the measures to improve the price-volume agreement (PVA) system that had been recently disclosed by the National Health Insurance Service. The new measure will put drugs that undergo PVA Type A negotiations at a relative disadvantage. According to the measures for the improvement of the PVA system that were disclosed at a roundtable meeting with the press corp, the improvement contained measures to change the ‘drugs whose claims have increased by 30% or more’ condition for PVA Type A negotiations to ‘drugs whose claims have increased by 10% or more or have claims amount that exceeds KRW 5 billion.’ PVA Type A had currently only been applied to drugs whose annual claims amount increased by 30% or more from the expected claims amount during the 3 years after reimbursement listing. Each company agrees to a certain amount during negotiations with the NHIS. However, if the NHIS applies the additional measures to the system, even drugs whose claims amount had increased by only 10% will be subject to PVA if the total amount exceeds KRW 5 billion. Regarding the measure, an industry official said, “If the KRW5 billion and 10% increase condition is added to PVA Type A, this will come as a burden to companies that develop new drugs in Korea. Adding more price discount mechanisms to homegrown new drugs may discourage the local pharmaceutical companies from developing new drugs.” The official added, “The measure to vary the drug price discount rate according to the claims amount is nothing new as this was previously announced by the NHIS, but the conditions that are being added to PVA Type A require some thought. The NHIS’s improvement plan contains measures to differentiate the price cut rate into three categories according to the magnitude of the claims amount and proposes calculating the maximum discount rate based on a reference formula. In other words, the NHIS plans to differentiate the discount rate according to the claim size. On the other hand, small and mid-sized pharmaceutical companies seem to be looking forward to NHIS’s additional measures. This is because the plan offers measures that raise the annual claims amount of drugs subject to PVA negotiations from KRW 2 billion to KRW 3-5 billion. If this exclusion criteria is applied to products with an annual claims amount of KRW 5 billion as well, most products by small and mid-sized pharmaceutical companies will be excluded from receiving price discounts. Another industry official said, “The research service results that contain HIRA’s proposals have not been disclosed yet, and a working group to promote the system is scheduled to commence in May, so we are not at the stage to guess how the final plan will come about. We will have to internally discuss and weigh the advantages and disadvantages of the proposed measures.”
- Company
- Myelofibrosis New Drug Inrebic
- by Eo, Yun-Ho Mar 10, 2023 05:50am
- Inrebic, a myelofibrosis treatment option born 10 years after Jakavi, is accelerating its steps toward insurance coverage. As a result of the coverage, BMS Pharmaceutical's myelofibrosis treatment Inrebic is in the process of drug price negotiations with the NHIS. Depending on the negotiation date, it is expected that it will be possible to determine whether or not to register in April. Inrebic was approved in Korea in April of last year for the treatment of splenomegaly or symptoms related to primary myelofibrosis, polycythemia vera, and myelofibrosis after essential thrombocythemia in adult patients previously treated with Jakavi. An application for reimbursement was submitted, but in June of last year, it failed to pass the HIRA, after re-application, it passed both the Cancer Disease Review Committee and the Pharmaceutical Reimbursement Evaluation Committee last month. This drug is a JAK-2 inhibitor and is expected to be different from Jakavi, a JAK1/2 inhibitor. Inrebic is the first to obtain approval for an oral once-a-day drug that greatly reduces the burden of spleen volume and symptoms in patients with myelofibrosis who have not had a history of treatment. Myelofibrosis is a rare blood cancer that affects the bone marrow and interferes with the body's normal production of blood cells. Patients suffer from symptoms such as an enlarged spleen, fatigue, itching, weight loss, night sweats, fever, and bone pain, which affect their quality of life. experience symptoms. Jakavi was the only JAK inhibitor approved for the treatment of myelofibrosis, and there was no alternative for patients who failed treatment. Inrevic is a treatment that appeared 10 years after Jakavi in the myelofibrosis market, where there was no second-line treatment option. Inrebic is currently covered through the Cancer Drug Fund in the UK. In 2021, NICE refused to apply Inrebic for NHS coverage. However, CDF recommends the use of Inrebic within its oncology fund for the treatment of splenomegaly or other symptoms associated with the disease in patients with myelofibrosis who have previously been treated with Jakavi.
- Company
- Enbrel's share is 44% and Herceptin's share is 37%
- by Kim, Jin-Gu Mar 10, 2023 05:50am
- Mabthera, Avastin, and Humira similars also saw a sharp rise in market share new product addition effect. The share of biosimilar products in the domestic market is rapidly expanding. Enbrel biosimilars Etanercept increased its market share from 12% in 2018 to 44% last year. Herceptin similars also expanded from 9% to 37% during the same period. ◆Eucept and Remaloce, Enbrel similar, had a 44% market share with sales of 8.1 billion won last year According to IQVIA, a pharmaceutical market research institute, on the 10th, the market for Etanercept ingredient treatment last year was 18.2 billion won. Pfizer Enbrel, the original product, recorded 10.1 billion won and Enbrel biosimilar 8.1 billion won, respectively. In terms of market share, original drugs accounted for 56% and biosimilars 44%. The market share of biosimilars has risen significantly over the past four years. In 2018, Enbrel's biosimilar market share was only 12%, but it increased by 32%p in 4 years, greatly narrowing the gap with the original. LG Chem's Eucept and Samsung Bioepis' Remaloce have been released as Enbrel biosimilars. Last year's sales were 4.1 billion won for Eucept and 4 billion won for Remaloce. Until now, biosimilars have been evaluated as not impacting the domestic market, unlike Europe and the United States. It is analyzed that recently, biosimilar products are gradually increasing their influence in Korea. It is analyzed that new products have been steadily released, centered on Samsung Bioepis and Celltrion, and the preference for similar products has gradually increased in the prescription field. ◆Herceptin-similar market share 9% → 37%/ Avastin similar achieved 21% in 1 year Other biosimilars have also significantly increased their market share recently. In the case of the trastuzumab market, the share of Herceptin biosimilars increased by 28%p in 4 years from 9% in 2018 to 37% last year. Celltrion Herzuma and Samsung Bioepis Samfenet were released as Herceptin biosimilars. Last year, sales were 29 billion won for Herzuma and 5.6 billion won for Samfenet. Herzuma's sales increased 3.7 times in 4 years from 7.7 billion won in 2018 to last year. Samfenet increased 2.5 times in 3 years from 2.2 billion won in 2019. The original Herceptin sales decreased by 25% from 80 billion won in 2018 to 60 billion won last year. Original's market share declined from 91% to 63%. Avastin biosimilars are also rapidly expanding their market share. Samsung Bioepis released the Avastin biosimilar Onbevezy in the fourth quarter of 2021. Onbevezy, which recorded sales of 500 million won in the first year of its release, saw its sales skyrocket to 20.5 billion won last year. As sales soared, Onbevezy's Bevacizumab market share quickly expanded to 21%. Here, Celltrion Vegzelma, Alvogen Korea Alymsys, and Pfizer Korea Pharmaceutical ZIRABEV are aiming to enter the market. If these products are added in earnest, the share of biosimilars in the Avastin market is expected to rise further. Mabthera biosimilars' share in the rituximab market increased from 8% in 2018 to 25% last year. Currently, Celltrion's Truxima is sold alone. Humira biosimilars recorded a 9% market share last year. Samsung Bioepis released Adalloce in the third quarter of 2021, and Celltrion released Yuflyma in the third quarter of last year. Sales last year were 7.6 billion won for Adaloch and 500 million won for Yuflyma. Remicade biosimilars recorded a 38% market share last year. Celltrion Remsima posted 29.3 billion won in sales last year, and Samsung Bioepis Remaloce posted 4.9 billion won in sales. The original Remicade's sales are 55.5 billion won.
