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- 2026-04-11 14:02:56
- Policy
- Lenvima's PMS results for 6 years
- by Lee, Hye-Kyung Oct 25, 2022 05:45am
- The permission of Lenvima, a thyroid-targeted anticancer drug, will be changed based on the results of a six-year post-marketing survey conducted in Korea. The Ministry of Food and Drug Safety will prepare a change order (proposal) based on the results of the post-marketing investigation of Lenvima by Eisai Korea and conduct an opinion inquiry by the 3rd of next month. Lenvima treated patients with localized recurrent or metastatic progressive differentiated thyroid cancer who did not respond to radioactive iodine in October 2015. It obtained an item license in Korea for its effectiveness. Later, Lenvima's primary treatment for hepatocellular carcinoma and KIF5B-RET-positive lung adenocarcinoma clinical trials have expanded the condition of endometrial cancer (MSI-H) or dMMR in patients, who have undergone primary treatment, previously systemic treatment, and inadequate surgical or radiation therapy. Over the past six years, Eisai has conducted a domestic post-marketing survey of 132 people following a review. As a result, the expression rate of abnormal cases was reported as 93.94% (124/132, a total of 659 cases) regardless of the causal relationship. Among them, 8.33% (11/132 people, 15 cases) of serious drug abnormalities cannot exclude causal relationships. Diarrhea was common, and lymph node abscesses, seizures, helplessness, death, and thrombocytopenia progressed. Unexpected drug adverse reactions were 27.27% (36/132, 60 cases), commonly showing pain, edema, chest pain, decreased liver function tests, decreased eating, and liver disorders, and rarely showed lymph node abscess, follicle, urethritis, worsening systemic health, and peripheral swelling.
- Company
- Lyumjev can be prescribed in general hospitals
- by Eo, Yun-Ho Oct 24, 2022 06:08am
- The new fast-acting insulin ‘Lyumjev’ can now be prescribed at general hospitals in Korea. According to industry sources, Lilly Korea’s ‘Lyumjev (insulin lispro)’ has passed the drug committee (DC) reviews of various medical institutions including the Samsung Medical Center. Lyumjev, which was approved in Korea in December last year, has been approved for reimbursement since September this year. Its prescriptions are expected to begin in earnest after landing in more general hospitals. As mealtime insulin, Lyumjev contains the active ingredient ‘insulin lispro-aabt,’ and is used to help reduce blood sugar levels in adults with type 1 or type 2 diabetes who have difficulty managing target blood glucose levels or whose blood glucose level increases after meals. The domestic approval was made based on results from the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. PRONTO-T1D and PRONTO-T2D are treat-to-target, multicenter, parallel studies Phase III clinical trials in which patients in each treatment arm were first treated to reach the same blood sugar level, and then compared for their main therapeutic effects, including the rate of hypoglycemia, postprandial glucose (PPG) control, and period of proper blood sugar maintenance. Study results showed that Lyumjev demonstrated non-inferiority to Humalog (lispro 100U)’ in the primary endpoint, which was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks. Also, Lyumjev demonstrated superiority over Humalog in reducing 1-hour and 2-hour postprandial glucose excursions. Meanwhile, Phase I trial results on Type 1 diabetes patients have also shown that Lyumjev’s absorption of insulin into the bloodstream was faster than that of ‘Humalog,’ ‘Insulin Aspart,’ and ‘fast-acting Insulin Aspart.’ The blood glucose results of patients up to 3 hours following injection of Lyumjev were similar to those of participants without diabetes.
- Company
- Will Onureg, an acute leukemia maintenance drug be listed?
- by Eo, Yun-Ho Oct 24, 2022 06:08am
- Attention is focusing on whether Onureg will be able to be listed on the insurance benefit list. According to related industries, Onureg of BMS Pharmaceutical Korea is expected to be submitted to the HIRA Cancer Disease Review Committee on the 2nd of next month. Onureg is the only oral maintenance of acute myeloid leukemia. It was approved in Korea in March as a treatment for adult patients with acute myeloid leukemia who achieved CRi or incomplete hematological recovery after induction therapy and were not suitable for hematopoietic stem cell transplantation (HSCT). Acute myeloid leukemia is also fatal among leukemia. Without treatment, 90% of people die within a year. Even if it becomes CR, the risk of recurrence is also high because up to 100 million residual leukemia cells may remain. If proper treatment is not accompanied after CR, the recurrence rate reaches up to 50% within a year, and the median OS value is only 8 months in case of recurrence. Maintenance therapy that can prevent recurrence and maintain CR condition as stable as possible is drawing attention. Onureg proved its validity through a phase 3 study of QUAZAR AML-001 in 472 patients with acute myeloid leukemia. As a result of the study, the mOS of the patient group who took Onureg was 24.7 months, extending the survival period by 10 months from 14.8 months in the placebo group and lowering the risk of death by 31%. At the time of 1 and 2 years of treatment, the proportion of patients who survived in the Onureg group was 73% (56% in the placebo group) and 51% (37% in the placebo group), respectively, which were higher than in the placebo group. RFS also confirmed the effect of reducing the risk of recurrence as Onureg reached 10.2 months, which is 5.3 months longer than the placebo group. The proportion of patients who did not recur after 6 months of treatment was 67% in the Onureg group, higher than 45% in the placebo group, and even at one year, the proportion of patients who did not recur was higher in the Onureg group.
- Policy
- How did Zerbaxa get recognized for its benefit?
- by Lee, Tak-Sun Oct 24, 2022 06:08am
- There is an item that Rep. Choi Jae-hyung of the People's Power, who has been criticized by the pharmaceutical industry for insisting on lowering generic drug prices during the parliamentary audit, is praising his salary registration. It is the super antibiotic Zerbaxa. At the HIRA parliamentary audit held on the 13th, he said, "200 to 300 people die every year from antibiotic resistance, and Zerbaxa's benefit was a meaningful decision." He also argued that generic drug prices should be lowered to secure health insurance finances, saying that it is necessary to make a forward-looking decision to set the price of such super antibiotics. Zerbaxa is an antimicrobial agent used to treat complex intra-abdominal infections, complex urinary tract infections, and hospital-infected pneumonia. In June, the HIRA recognized the appropriateness of the benefit, which was different from the review of benefit rejection in 2019 with unclear cost-effectiveness. The reason why the evaluation results have changed is that the drug has become possible to omit PE in the meantime. In October 2020, the government revised related regulations to allow the omission of PE data on tuberculosis treatments, antibacterial drugs, and emergency detoxification drugs included in national essential drugs. The results of the recent evaluation of benefit adequacy for low-dose owners released on the HIRA website show this well. Zerbaxa was recognized for its appropriateness in a review by the Pharmaceutical Affairs and Evaluation Commission held on June 2. As a result of the evaluation at the time, "The applied product is a drug that has been approved for the treatment of complex intra-abdominal infection, complex urinary tract infection (including pyelonephritis), and hospital infection pneumonia (including ventilator-related pneumonia)." This is clinically useful, but the cost-effectiveness corresponding to the cost is unclear because the cost required compared to the alternative drug is expensive, he added. He judged, "It is an antimicrobial agent that is a national essential drug, meets the conditions for PE performance in excluded countries, and is listed in more than three excluded countries, so it is appropriate to benefit when considering the price registered in excluded countries." Although it is a drug that can omit submission of PE data, it is necessary to consider it when negotiating drug prices because the number of patients is higher than that of rare disease treatments or anticancer drugs and the financial impact of antibiotic resistance is uncertain. These contents were reflected when Benefit was applied. The Health Insurance Policy Review Committee of the Ministry of Health and Welfare explained Zerbaxa's benefit registration and judged that "the company's application price is more cost-effective than the Japanese drug price, which is the lowest price in A7. Among the A7 countries, it was listed in the U.S., Japan, Italy, and the U.K., and the average price for a bottle was 108,383 won. However, the expansion cap RSA contract was signed to reduce financial uncertainty. Through negotiations with the NHIS, if the cap exceeds a certain amount, the amount will be refunded to the corporation. The Drug Evaluation Committee selected Coliseum methane sulfonic acid as an alternative drug when determining cost-effectiveness. Two drugs are registered in Korea, with the upper limit of 20,349 won per bottle and 17,922 won per bottle, respectively, due to Seoul Medical's Colistate Inj and SCD's Colis Inj. The difference was large compared to Zerbaxa, which was listed at 60,098 won per bottle. The Drug Evaluation Committee cited that Coliseum methane sulfonic acid as an alternative drug has efficacy in bladder inflammation and pyelonephritis and that it is a drug that is recognized for "all existing antibiotics-resistant" beyond the scope of the permit. However, Zerbaxa was inevitably expensive compared to this Coliseum methane sulfonic acid, making it difficult to satisfy the cost-effectiveness. Instead, PE was exempted and the benefit adequacy was recognized while satisfying the lowest price adjusted by the A7 country.
- Policy
- Will Gilead reclaim its throne in the HCV drug market?
- by Lee, Tak-Sun Oct 24, 2022 06:08am
- Fierce competition is being expected in the hepatitis C (HCV) treatment market with the launch of Gilead’s new treatment which is priced at a lower level than the current market leader. With the new product, Gilead is aspiring to reclaim the former glory that it had enjoyed dominating the market with Sovaldi. According to industry sources on the 21st, Gilead Science Korea’s HCV treatment ‘Epclusa Tab (velpatasvir+sofosbuvir) and ‘Vosevi Tab (velpatasvir+sofosbuvir+voxilarprevir)’ will receive health insurance reimbursement from the 1st of next month. The insurance price ceiling for Epclusa and Vosevi was set at KRW 117,030 and KRW 120,836, respectively. The current market leader in the HCV treatment market is Abbvie Korea’s Mavyret (glecaprevir+pibrentasvir). Mavyret can be used in all Chronic HCV patients, in all HCV genotypes 1, 2, 3, 4, 5, or 6. Also, its treatment period is shorter than its competitors, with an 8-week regimen. On the other hand, Gilead’s Harvoni tab cannot be used in patients with genotype 3, and Sovaldi is unable for use in patients with genotype 5 or 6. Also, their treatment period is 12 weeks, which is 4 weeks longer than Mavyret. Such limitations have brought marked differences in sales of the respective drugs. Based on IQVIA data, Mavyret recorded KRW 46.6 billion, and Harvoni KRW 11.7 billion, Sovaldi KRW 0.2 billion in sales last year. Comparison of major hepatitis C treatments Faced with the need to replace Mavyret, Gilead released Epclusa and Vosevi. Both may be used in all HCV genotypes 1-6. However, to use Vosevi, the patient needs to have prior HCV treatment experience. Although both of the treatments have a longer treatment period than Mavryet, with a 12-week treatment regimen, it can be overcome by the price difference. If we calculate the treatment using the price ceiling set this time, Epclusa will cost KRW 9,835,000 and Vosevi KRW 10,152,224 won in patients without cirrhosis. This is KRW10,922,352 cheaper than Mavyret, and also cheaper than the previous Gilead products. Havoni costs KRW1,092,924 and Sovaldi KRW 10,599,624. The low price of Vosevi and Epclusa has been somewhat expected as the company accepted the weighted average price of alternative drugs proposed by HIRA in July. As their price is set at a lower level than their alternatives, the two drugs passed the HIRA DREC review in July and were listed for reimbursement in only 4 months. This is interpreted as Gilead’s determination to overcome AbbVie and restore the former glory it had with Sovaldi, the first oral drug to cure hepatitis C that had switched the paradigm. Given that Gilead and AbbVie's products can treat all genotypes, the competition in HCV is expected to narrow into a battle between Mavyret, which has a short treatment period, or the cheaper option, Epclusa.
- Company
- Lucentis biosimilar of Chong Kun Dang gets domestic approval
- by Chon, Seung-Hyun Oct 24, 2022 06:08am
- Chong Kun Dang succeeded in commercializing its second biosimilar. Chong Kun Dang announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for domestic items of the "Lucentis" biosimilar. The indication for "treatment of neovascular (habitual) age-related macular degeneration" has been approved. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration diabetes, and macular edema. Lucentis is a large product with global sales of 4.4 trillion won last year. Chong Kun Dang proved that the therapeutic effects of CKD-701 and Lucentis were equal through phase 3 clinical trials of 312 neovascular age-related macular degeneration patients at 25 hospitals, including Seoul National University Hospital, from September 2018 to March last year. According to IQVIA, a pharmaceutical research institute, Lucentis recorded 35.1 billion won in sales in Korea last year. Chong Kun Dang is the second Korean company to succeed in commercializing Lucentis biosimilars after Samsung Bioepis. Samsung Bioepis received an item license from Lucentis biosimilar Amelivu in May. Chong Kun Dang said, "We expect CKD-701 to provide patients with various treatment drug choices and expand treatment opportunities." Chong Kun Dang said, "It will be released after going through the health insurance registration process." As a result, Chong Kun Dang produced its own second biosimilar. Chong Kun Dang received domestic permission from biosimilar Nesbell for the anemia treatment NESP in November 2018. After securing differentiated raw material manufacturing technology in 2008, Chong Kun Dang established a biopharmaceutical production infrastructure in 2012 and developed Nesbell.
- Policy
- Severe AD treatments unlikely to be reimb this year
- by Lee, Tak-Sun Oct 21, 2022 05:48am
- It seems that reimbursement extensions for severe atopic dermatitis treatments like Dupxient to benefit pediatric and adolescent patients will only be possible after next year. This is because the current reimbursement review process in progress would render reimbursements within the year difficult. This news was revealed in the written QA response released by the Health Insurance Review and Assessment Service on the 13th after the NA audit. HIRA disclosed the reimbursement review progress of the treatments in response to the claim made by Rep. Young-Seok Suh of the Democratic Party of Korea on how the government should hasten reimbursement of severe atopic dermatitis treatment for pediatric and adolescent patients. In the case of Dupixent pre-filled inj 300mg, its reimbursement extension to pediatric and adolescent patients had been reviewed in January and April last year, respectively, and reported to the Ministry of Health and Welfare. In September, HIRA explained that it had requested Dupxient’s cost-effectiveness data to MOHW and that the agenda is under review. However, even though the drug is under review, it will be difficult for Dupxient to pass the Drug Reimbursement Evaluation Committee review, complete drug pricing negotiations, and be listed for reimbursement within the year. HIRA’s Pharmacoeconomic Evaluation Subcommittee’s deliberations are set to be held after December this year, and deliberations by the Drug Reimbursement Evaluation Committee will be conducted after January next year. The Dupixent pre-filled inj 200mg, which is seeking a new listing, will also be reviewed for reimbursement together with the higher-strength formulation. Reimbursement extensions for the Rinvoq SR tab also face a similar situation. Its company applied for reimbursement expansions to adolescents on September 30. HIRA said an expert advisory meeting for the drug is scheduled after December. Among the AD treatments, Pfizer’s Civinqo tab is likely to be listed the fastest. The drug applied for reimbursement listing in April, passed the Pharmacoeconomic Evaluation Subcommittee deliberations in August and is set to receive DREC deliberations after December. Dupixent pre-filled inj can be used for the treatment of adult, adolescent, and pediatric patients aged 6 years or older with moderate-to-severe atopic dermatitis. RInvoq SR and Civinqo tab are allowed for use to treat adult and adolescent patients aged 12 years or older with moderate-to-severe atopic dermatitis. However, reimbursement is only allowed for adult patients, and even this is only applied to Dupxient and Rinvoq. In a press release on the 18th, Rep. Young-Seok Suh of the Democratic Party of Korea requested expedited reimbursement of Dupisent, explaining that “Dupxient is only applied reimbursement for adult patients aged 18 years or older under HIRA’s Dupixent insurance recognition standards. Parents of young children with atopic dermatitis long for its prompt reimbursement in pediatric and adolescent patients."
- Policy
- Epclusa, a hepatitis C tx, costs 117,030 won
- by Kim, Jung-Ju Oct 21, 2022 05:48am
- Gilead Sciences Korea's Sofosbuvir/Velpatasvir-based chronic hepatitis C drugs Epclusa and Vosevi are expected to be listed on the 1st of next month at insurance drug prices of 117,000 won and 128,800 won, respectively. The government and insurance authorities expect to reduce health insurance finances as prices are agreed to be cheaper than alternative drugs during drug price negotiations. According to industries on the 20th, the Ministry of Health and Welfare is planning and proceeding with the "Amendment to the Pharmaceutical Benefits List and Salary Limit Table" on the 1st of next month based on the results of the NHIS' drug price negotiations with Gilead Science Korea. ◆Epclusa = This new drug is a combination of the HCV NS5B polymerase inhibitor Sofosbuvir and the NS5A inhibitor Velpatasvir, which is a pan-genetic drug that can be used in all genotypes. The treatment of patients with untargeted cirrhosis is also characterized by its ability to be used regardless of genotype Alternative drugs vary. Adult patients with no cirrhosis or targeted cirrhosis may use Sovaldi + Ribavirin and Ledipasvir + Sovaldi, Zepatier, Maviret/Pibrentasvir'. When used in adult patients with untargeted cirrhosis, the substitute is the combined administration of Sovaldi + Ribavirin and Harvoni + Ribavirin. For pediatric patients, it is Harvoni/Sovaldi, Maviret (Glecaprevir)/Pibrentasvir. The drug, which obtained an item license from the Ministry of Food and Drug Safety in February of this year, applied for insurance registration with the HIRA in the same month. In July, the HIRA conducted deliberation by the Drug Benefit Evaluation Committee. At the time, the committee expected that the company would accept the weighted average price of 130,019 won per party, which is a cost-effective and lower cost than alternative drugs, so there would be no additional financial need and reduction. It is listed in the United States, Japan, France, Germany, Italy, Switzerland, and the United Kingdom. After the drug passed, the company negotiated drug prices with the NHIS from August until recently and reached a final agreement with the drug price at 110,730 won. ◆Vosevi= This drug is a three-drug complex in which Voxilaprevir is added to Epclusa, and the alternative drug treatment is a complex administration of "Maviret (Glecaprevir/Pibrentasvir). The drug, which obtained an item license from the Ministry of Food and Drug Safety in March of this year, was applied for insurance registration to the HIRA in the same month. The HIRA held a committee meeting in July and presented it with Epclusa for deliberation. At the time, the committee decided that it would accept the weighted average price of alternative drugs, 190,542 per tablet, which is cost-effective, and that there would be no additional financial need due to the lower cost than alternative drugs. Among the A7 countries, it is listed in five countries: the United States, France, Germany, Italy, and the United Kingdom. Since August until recently, the company has negotiated drug prices with the NHIS and finally agreed to 120,836 won per tablet.
- Company
- Tumor-agnostic Vitrakvi lands in Big 5 tertiary hospitals
- by Eo, Yun-Ho Oct 21, 2022 05:47am
- The tumor-agnostic drug ‘Vitrakvi’ has landed in the Big 5 tertiary hospitals in Korea. According to industry sources, Bayer Korea’s neurotrophic tyrosine receptor kinase targeted anticancer drug Vitrakvi (larotrectinib) has passed the drug committees of major hospitals in Korea, including general hospitals like the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital and major medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The drug is seemingly settling quickly in the prescription market after it was listed for reimbursement in April. Vitrakvi, which received marketing approval in Korea in May last year, underwent the reimbursement listing process through the pharmacoeconomic evaluation exemption track and passed HIRA’s Drug Reimbursement Evaluation Committee review in November. Its competitor which has the same mechanism of action, Roche’s ‘Rozyltrek’ is also undergoing pricing negotiations with the NHIS. Vitrakvi is indicated for use in adult and pediatric patients with solid cancer who have progressed after using conventional treatment options or have no suitable treatment options available that have NTRK gene fusions without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity. In other words, it may be used in virtually most cancer types with an identified NTRK gene. Vitrakvi’s approval was based on data from a Phase I trial on adults 18 years and older, the Phase II NAVIGATE study on pediatric and adult patients over the age of 12, and the Phase I/II SCOUT study on pediatric patients aged 1 month to 21 years that includes those with primary CNS tumor. According to an efficacy review that was conducted on 55 patients with identified NTRK fusion in the 3 studies above, Vitrakvi’s overall response rate (ORR) was 75% and partial response 53% in various cancer types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumors, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor, cholangiocarcinoma, appendiceal carcinoma, breast cancer, and pancreatic cancer) Vitrakvi showed an effect not only in adults but also in pediatric patients. Twenty-four patients aged 1 year or less participated in the studies above, and the drug showed the same efficacy in these patients as in adult patients. As a result, Vitrakvi was approved for use in both pediatric and adult patients.
- Policy
- The head of the MFDS actively agrees with the opinion
- by Lee, Hye-Kyung Oct 21, 2022 05:47am
- Oh Yu-kyung, head of the Ministry of Food and Drug Safety, expressed her intention to actively agree to the introduction of active ingredients. Health and Welfare Minister Cho Kyu-hong avoided answering, saying that he would discuss various measures with the Ministry of Food and Drug Safety to ensure a smooth supply and demand of medicines in the era of a special crisis for infectious diseases. Seo Young-seok, a member of the Democratic Party of Korea, asked for the opinions of the Minister of Health and Welfare and the Minister of Food and Drug Safety on the introduction of active ingredient prescriptions due to the spread of COVID-19 infectious diseases. "With the spread of COVID-19, the national proposal of the Anti-Corruption and Civil Rights Commission included the prescription of ingredients as an excellent agenda," Rep. Seo said. "There was a controversy over the prescription of ingredients in order to reduce health insurance finances and drug costs." Representative Seo said, "The prescription of active ingredient should be discussed as public interest is high, not by a specific group," and stressed, "Since it is a replacement for drugs recognized by the minister, not only preparation of the same ingredient but also prescription of ingredients should be established so that they can be used systematically in the event of a national crisis."
