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- 2025-12-23 10:39:30
- 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.
- 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.
- 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.
- 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."
- Policy
- Xtandi’s use expanded... reimbursement standard changed
- by Lee, Tak-Sun Oct 20, 2022 06:02am
- The scope of use for the prostate cancer treatment Xtandi soft capsule (enzalutamide, Astellas Korea) will be expanded. Although the drug was applied reimbursement only when other drugs that suppress androgen production cannot be used, reimbursement will be applied regardless of such status starting next month. On the 18th, the Health Insurance Review and Assessment service prepared an amendment to the anticancer drug reimbursement standards that contained the changes above and started reviewing industry opinion. Under the proposed amendment, the reimbursement condition, ‘when other drugs that suppress androgen production cannot be used,' will be deleted from the standards for Xtandi’s reimbursed use in patients with metastatic castration-resistant prostate cancer who have failed docetaxel-based or other chemotherapies. On this, HIRA explained, “The condition had been set during RSA reevaluations, and the relevant standards had been revised since then. As the clinical efficacy of the indication remains the same since deliberations, we deemed it medically justifiable to delete the restrictions without changing the drug’s clinical efficacy in the indication.” Once the opinion inquiry is complete, the amended reimbursement standard will be effective from the first of next month. The reimbursement expansion that applied this time has passed HIRA’s Cancer Disease Deliberation Committee in February this year. Xtandi is a blockbuster anticancer drug that recorded sales of KRW 27.4 billion last year and is an androgen receptor inhibitor that targets the androgen signaling pathway that acts on prostate cancer cells.
- Policy
- All targets for the benefit reassessment will be negotiated
- by Lee, Tak-Sun Oct 19, 2022 05:48am
- All six active ingredients-related companies that re-evaluated their benefit adequacy with the HIRA this year will meet at the negotiating table with the NHIS. In particular, the components for which the benefit maintenance has been decided will also be negotiated with the NHIS. Streptokinase and Streptodornase will negotiate the recovery according to the results of clinical re-evaluation, and 37 companies are subject to negotiation. Some predict that it will not be easy to meet the 30-day deadline for negotiations. According to the NHIS on the 18th, a negotiation order for drugs subject to this year's drug benefit adequacy evaluation will be issued from the Ministry of Health and Welfare on the 14th and will proceed with individual companies until the 18th of next month. Except for Streptokinase and Streptodornase, which are negotiating the return, the rest of the items will be carried out by the generic management department of the drug management office of the industrial complex. The contents of the negotiations are related to supply and quality management obligations, and if there is no problem with supply, there will be no problem in concluding the negotiations. There is a possibility that the companies are not ready because the targets of this negotiation include Almagate, and Tiropramide, which have maintained salaries. In response, the NHIS is also contacting individual companies that have sanctions that have been ordered to negotiate and maintained salaries to guide them that they are subject to negotiations. Celltrion Pharmaceutical's Godex, which was the biggest concern for benefit reassessment, will also negotiate. However, negotiations on separate drug prices are not expected to proceed as Celltrion Pharmaceutical has been recognized for its appropriateness by voluntarily cutting drug prices. The problem is companies with Streptokinase and Streptodornase that have to go through negotiations with the Ministry of Drug Safety and Drug Administration Improvement in the industrial complex. On the 6th, the HIRA decided to suspend the evaluation for one year only for items agreed on in the return negotiation according to the results of the clinical re-evaluation. The companies can maintain their benefits only when they agree with the NHIS in negotiations. It is known that there are 37 target companies alone. Currently, the NHIS-related departments and pharmaceutical companies are working on strategies internally. The NHIS official said, "We plan to reach an agreement, such as the timing and rate of recovery while listening to and coordinating the opinions of the target companies." This year's drugs subject to the re-evaluation of benefit adequacy were six-component drugs, including Streptokinase and Streptodornase, Eperisone HCl, Godex, Sodium Alginate, Almagate, and Tiropramide Hydrochloride. Among them, Streptokinase and Streptodornase were conditional evaluation suspended, Eperisone HCl, and sodium Alginate were not recognized for some indicative benefit eligibility, and all other drugs were recognized for their benefit appropriateness.
- Policy
- Is it possible to benefit from the K-CAB 4th indication?
- by Lee, Tak-Sun Oct 17, 2022 10:52pm
- Attention is focusing on whether HK inno. N's new drug K-CAB for gastroesophageal reflux disease will succeed in providing additional indications. Currently, K-CAB is being reimbursed to treat erosive and non-erosive gastroesophageal reflux disease and gastric ulcer. In March 2019, K-CAB, which was first applied to the treatment of erosive and non-erosive gastroesophageal reflux disease, expanded its salary to the treatment of gastric ulcers in October last year. According to industries on the 17th, the HIRA has started reviewing the benefit standards for K-CAB. K-CAB has acquired a total of five indications so far. Among them, health insurance benefits are applied to three treatments: erosive and non-erosive gastroesophageal reflux disease treatment and gastric ulcer treatment. In the rest of the patients with peptic ulcers and chronic atrophic gastritis, antibiotic combination therapy for Helicobacter pylori eradication and maintenance indications after treatment with erosive gastroesophageal reflux disease remain non-payment. HK inno.N is trying to being reimbursed for additional indications. If K-CAB succeeds in making additional indications, Daewoong Pharmaceutical, which launched its benefit in July It is expected to gain an edge in competition with Fexuclu. Fexuclu is currently only recognized for the treatment of erosive gastroesophageal reflux disease. Fexuclu 10mg is expected to seek additional benefit as it has an indication of improving gastric mucosal lesions of acute gastritis and chronic gastritis. Fexuclu is a P-CAB-based drug such as K-CAB, and has continued to be so popular that it recorded 2.6 billion won in outpatient prescription performance (based on UBIST) for two months as soon as it was released in July. K-CAB, which has secured exclusive status as the only P-CAB drug since its launch in 2019, has seen a formidable competitive drug. However, it is analyzed that K-CAB is still superior to Fexuclu due to its wide range of use, with medical care benefits applied to the current three indications. On top of that, some predict that the gap will widen if additional indications are secured. K-CAB recorded 60.6 billion won in outpatient prescriptions in the first half of this year, and is likely to surpass 100 billion won annually this year following last year. HK inno.N also plans to lead the market by developing clinical trials to add preventive therapy indications for gastric and duodenal ulcers that induce nonsteroidal anti-inflammatory analgesics.
- Policy
- PVA, financial resources to register new drugs, not penaltie
- by Lee, Jeong-Hwan Oct 17, 2022 10:52pm
- Regarding the criticism that PVA imposes penalties on pharmaceutical companies that produce drugs with high public demand, the Ministry of Health and Welfare countered that it is a system that contributes to improving patient accessibility through new drug insurance. The Ministry of Health and Welfare also said that it is impossible to temporarily suspend the implementation of PVA until the time when exchange rates and prices stabilize. On the 17th, the Ministry of Health and Welfare responded to written questions about PVA by Baek Jong-heon and Lee Jong-sung of the National Assembly's Health and Welfare Committee. Lawmaker Baek Jong-heon pointed out that cutting drug prices as usage increases is contradictory to imposing penalties on pharmaceutical companies with high public demand. It also said it could hinder cooperation between domestic and global companies. The Ministry of Health and Welfare did not agree with the National Assembly's criticism, explaining in principle the purpose of introducing the system. However, he said he would review improvement measures according to the results of the ongoing policy research service. The Ministry of Health and Welfare said, "PVA was introduced in 2006 as part of a plan to optimize drug costs. Drugs that have excessively affected health insurance finances are subject to negotiation, he said. "We will cut drug prices within a range of up to 10%." The Ministry of Health and Welfare explained, "The finances saved by PVA are used as financial resources to improve patient accessibility through the registration of new drugs." The Ministry of Health and Welfare said, "We are conducting policy research services under the auspices of the NHIS. "We will present reasonable improvement measures through collecting opinions from stakeholders," he said. Rep. Lee Jong-sung said the system should be suspended until the time when exchange rates and prices stabilize from next year, but the Ministry of Health and Welfare opposed it, saying it needs to be carefully reviewed. The Ministry of Health and Welfare said, "The purpose of the system is to pursue the rationality of drug spending. The drug price cut also has the effect of reducing the cost of patient's copy, he said. "The temporary suspension of PVA needs to be carefully reviewed."
