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- 2025-12-22 23:03:21
- Policy
- Hemlibra's benefit speeds up to strengthen accessibility
- by Lee, Jeong-Hwan Oct 17, 2022 06:03am
- Kim Sun-min, director of the HIRA, promised to speed up the Hemophilia treatment Hemlibra benefit screening to strengthen accessibility for patients. On the 13th, Kim Sun-min, director of the HIRA, answered the on-site questioning of Kang Sun-woo, a lawmaker of the Democratic Party of Korea, at the NHIS parliamentary audit. Lawmaker Kang Sun-woo stressed that Hemlibra dramatically increases the quality of life of hemophilia patients and their families compared to other treatments that need to be intravenously administered as a subcutaneous injection. In particular, he stressed the need to expand the current standard for applying for Hemlibra benefits only to hemophiliac antibody holders to those who do not have antibodies. Director Kim Sun-min replied that she would speed up the ongoing screening of expanding Hemlibra benefits for non-antibody patients. Director Kim said, "I express my deep regret for the pain of hemophilia patients and their families."Director Kim said, "We are reviewing the clinical usefulness, safety, and cost-effectiveness of Hemlibra's expansion of non-antibody benefits. "We will try to strengthen accessibility by speeding up the screening process as much as possible," she said.
- Policy
- Proposal for improvement of omission of PE data submission
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- Critics said the HIRA's plan to improve the PE data submission system is actually reducing the scope of application of drugs that can be omitted. It is pointed out that the amendment should be fully reviewed as an amendment to destroy President Yoon Suk Yeol's pledge to expand the coverage of severe and rare diseases. On the 13th, Kang Sun-woo of the Democratic Party of Korea criticized the plan to improve the PE system submitted by the Ministry of Health and Welfare and the HIRA. In August, The HIRA announced a partial amendment to the "Regulations on Evaluation Standards and Procedures, such as whether drugs are eligible for medical care benefits," which calls for shortening the processing period of drugs that can be omitted and expanding drugs that can be used for PE biological drugs. The reason for the revision of the regulations explained by the HIRA is to expand the number of medicines that can be omitted from submitting PE data. Kang argued that contrary to the HIRA explanation, when the amendment is applied, the drugs subject to the PE system will be rather reduced. It is pointed out that the standard for "minority of target patients," which has been one of the conditions for medicines that have been omitted from submitting PE data, will be changed to the basic condition in the revision, reducing the scope of major drugs. "Developed countries such as the U.S. and the EU have 5 and 6.4 patients per 10,000 people, respectively," Kang said. "Korea should also recognize exceptions considering the disease characteristics to expand or flexibly apply the number of PE patients in line with advanced countries." Rep. Kang said, "If the meaningful quality of life improvement is proven in children, it is considered meaningful, but even in this case, the expected number of patients is limited to 200, and drugs that can prove the meaningful quality of life improvement in children are still excluded."
- Policy
- CDDC blindly opposes applying RSA to Tabrecta and Rybrevant
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- The National Assembly criticized how the Cancer Disease Deliberation Committee has been undermining the purpose of the Risk-Sharing Agreement system that waives submission of PE evaluation data and disapproved reimbursement of anticancer drugs and rare disease treatments. The committee has not allowed reimbursement of these drugs that have already been granted marketing authorization from the Ministry of Food and Drug Safety for lacking Phase III trial data, although the drugs cannot conduct Phase III trials. On the 13th, Rep. Ki-Yoon Kang of the People Power Party claimed so while referring to the data submitted by the National Health Insurance Service. According to the minutes of the CDDC meeting from 2018-2020, HIRA opposed reimbursing Tabrecta tab., which is used to treat patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. HIRA also rejected reimbursement of Rybrevant, a rare NSCLC treatment present in only 2% of all NSLCL patients with EGFR mutations in Korea. As conducting a placebo-controlled Phase III trial on the small number of end-stage cancer patients that are eligible for the drug was impossible due to ethical reasons, the companies of the two drugs demonstrated the clinical efficacy and safety of their drugs through a single-arm Phase II trial, received MFDS approval, then applied for reimbursement to HIRA after satisfying the RSA requirements. Rep. Kang criticized how the CDDC blindly opposed their reimbursement for being unable to evaluate the drug’s efficacy with only Phase II trials without considering the circumstances. According to Article 6-2 of the ‘Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits,’ the RSA Pharmacoeconomic evaluation exemption regulation was established to reinforce patient access to severe and rare disease treatments, and 2-a of the same clause allows PE exemption for drugs that were approved by the MFDS with single-arm clinical trial data that does not have a control group. Anticancer drugs like Tabrecta or Rybrevant that treat life-threatening conditions have already been recognized for their clinical efficacy by the Ministry of Food and Drug Safety through a single-arm Phase II trial, but it is ethically impossible to set up a control group that consists of severe cancer patients who have less than a year of expected survival period left. This is why there is criticism that the CDDC’s disallowance of reimbursement of these drugs under the pretext of the absence of Phase III clinical trial data undermines the purpose of the PE Waiver System which works to reinforce patients' access to treatments for severe rare diseases. In addition, Rep. Kang also criticized the CDDC's decision for violating the function of the MFDS itself, which evaluates and approves the efficacy and safety of drugs. Rep. Kang said, “The CDDC’s non-allowance of reimbursement of drugs that have no alternatives and cannot conduct Phase III trials completely contradicts the national task of increasing patient access to treatments by rapidly listing drugs that treat life-threatening conditions. CDDC should review reimbursement of anticancer drugs and rare disease treatments that are directly related to the survival of patients in accordance with regulations.” He added, “The CDDC requesting Phase III clinical data for drugs that meet the requirements of the PE exemption system is excessive administration, and the committee needs to focus on reviewing the clinical necessity in line with its original function to allow patients to receive reimbursement as soon as possible.”
- Policy
- National lot release for Moderna's bivalent COVID-19 vaccine
- by Lee, Hye-Kyung Oct 13, 2022 06:08am
- The 1.57 million courses of the bivalent vaccine manufactured by Samsung Biologics have been approved for national lot release. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the national lot release for 1.57 million courses of Moderna Korea’s domestically manufactured mRNA bivalent COVID-19 vaccine, ‘Spikevax 2’ on the 11th. The national lot release system was implemented to reaffirm the quality of a vaccine through a comprehensive evaluation of the state’s national test and the manufacture and test results of the manufacturer for each manufacturing unit (lot) before they are distributed on the market. Spikevax-2 is manufactured in Korea (by Samsung Biologics) through fill-finish processes after being supplied the API of the same Spikevax-2 vaccine that has been approved for import on September 8th from overseas. The MFDS expects the national lot release approval of the bivalent COVID-19 vaccine will contribute to the prevention of COVID-19 and will continue efforts to ensure a stable supply of quality vaccines through thorough and swift verification of COVID-19 vaccines to come.
- Policy
- The loss of health insurance is close to 200 billion won
- by Lee, Jeong-Hwan Oct 13, 2022 06:08am
- Rep. Nam In-soon said, "The Legislation and Judiciary Committee's pending bill to recover the reduction will be dealt with." Over the past decade, health insurance benefit losses amounted to 19.7 billion won for 17 cases in which pharmaceutical companies lost lawsuits related to weak cuts and re-evaluation. Critics point out that the revision of the Health Insurance Act, which calls for the recovery and refund system of drug prices, should be handled as soon as possible to prevent pharmaceutical companies from suing lawsuits to cancel drug prices. On the 6th, Rep. Nam In-soon of the Democratic Party of Korea said, "We should pass the National Assembly's Health and Welfare Committee and deal with the revision of the Health Insurance Act pending at the Legislation and Judiciary Committee as soon as possible to minimize the loss of health insurance finances and achieve pharmaceutical rights." Regarding the claim that some pharmaceutical companies are concerned that the regulation on redemption within the revision of the Health Insurance Act may neutralize the effect of suspension of execution, a principle of litigation law, Rep. Nam insisted that "it is not persuasive." Considering the ongoing administrative litigation of pharmaceutical companies, administrative trials, and applications for suspension of execution for the drug reduction, and accumulated financial losses on health insurance, she believes the National Assembly should wrap up the legislation as soon as possible. She said, "The provisions for the redemption and refund of the amendment do not limit the application for administrative litigation or suspension of execution itself." She emphasized, "It is a system operated on the premise of filing administrative litigation and administrative trial, and the purpose is to post-calculate losses incurred in the NHIS or pharmaceutical companies during the suspension period according to the characteristics of the profitable health insurance drug price system." Rep. Nam said, "If legality is recognized after the decision to suspend execution, it is similar to the purpose of the Supreme Court ruling in September 2020, which judged that the administration should take active measures the same as if there was no decision to suspend execution," adding, "It is expected to minimize health insurance financial losses and protect pharmaceutical companies' rights." "The loss of health insurance benefits for 17 cases lost by the plaintiff pharmaceutical company out of 49 administrative lawsuits is estimated to be 19.7 billion won, but the financial loss of health insurance due to the difference in drug prices before and after the decision to suspend execution of 49 administrative lawsuits," she added.
- Policy
- 99 items were granted generic exclusivity, none reimbursed
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- ▲ Boehringer Ingelheim diabetes combo drug Although 99 items were granted generic exclusivity, none of the items were granted reimbursement during the period. This was what happened to generics of Boehringer Ingelheim’s Jardiance Duo (empagliflozin+metformin hcl). Although a large number of products were approved and even obtained generic exclusivity, the drugs were unsellable in the market, and the exclusive rights granted for the products became obsolete. According to industry sources on the 11th, the generic exclusivity granted to 99 Jardiance Duo generics ended on August 15th. However, none of the items were listed for reimbursement and sold in the market during the period. This was not unexpected. Although the Jardiance Duo generics succeeded in avoiding subsequent patents and obtained generic exclusivity, they were unable to release their drugs to the market due to a substance patent that was not registered with the Ministry of Food and Drug Safety. The MFDS patent list serves as the standard for granting generic exclusivity. A substance patent for the single ingredient Jardiance is currently listed, but none is listed for Jardiance Duo. Based on the patent list, companies that manufacture Jardiance Duo generics were allowed to release their drugs after approval as they have overcome all of the registered patents by avoiding subsequent patents that are terminated after the substance patent. Thus, all Jardiance Duo latecomers that were approved from November last year to April this year were allowed to be marketed upon approval under the drug approval-patent linkage system, and their generic exclusivity period was also set based on the approval date. The end date was set until August 15th based on the products that were approved in November last year. However, substance patents need to be observed due to the risk of a dispute with the patentee regardless of whether or not it is registered on the MFDS patent list. The substance patent for Jardiance Duo is set to expire on October 23rd, 2025. Ironically, the generic exclusivity of the single-ingredient Jardiance is set to start on October 24th, 2025. In other words, generics of the combination drug Jardiance Duo were unable to be sold in the market even with the generic exclusivity. Then how were 99 items allowed to receive this obsolete generic exclusivity? This is because the restrictions set for the 1+3 consigned bioequivalence tests were implemented in July last year. Pharmaceutical companies that conducted bioequivalence tests after July 2012 could only consign manufacture of same-ingredient drugs for up to 3 pharmaceutical companies. As a result, pharmaceutical companies had entered into consignment agreements before the enforcement of this law and rushed the development of their generics, which resulted in the manufacture of such large number of Jardiance Duo generics. According to the MFDS, Dongkoo Bio&Pharma is currently manufacturing empagliflozin+metformin hcl products on consignment for 24 pharmaceutical companies (71 items in total). Such large-scale consignment manufacture was possible because the generic was developed before the enforcement of the consigned bioequivalence test restriction law. As the approved items may only be sold after 4 years from now, it seems inevitable that all of the test products manufactured for approval will have to bd discarded. This means that much social cost was wasted due to the new regulations. Couldn't the generics rather be regulated through drug prices? The Ministry of Health and Welfare had announced a drug pricing system in July 2020, one year before the enforcement of the consigned bioequivalence test restriction law. The system focused on reinforcing the standard requirements for self-bioequivalence tests and a stepped drug pricing system. Under the new system, generics are required to conduct self-bioequivalence tests and be listed within the 20th in the reimbursement list to maintain its base price, which is 53.55% of the insurance ceiling price of the original drug. However, the system could be bypassed as many items that apply for reimbursement at the same time are listed at the same time and considered a single group, and not discounted their price even if the number exceeds 20. Jardiance Duo generics will also be able to avoid the stepped pricing system by applying for the insurance price at the same time before patent expiry. However, such waste from large-scale approvals will not be made for items that were developed after the bioequivalence restrictions were set last year, as only 4 companies at most will be approved at once.
- Policy
- Ponesimod's Domestic Item License
- by Lee, Hye-Kyung Oct 12, 2022 05:50am
- Ponesimod of Janssen Korea, a rare drug for treating multiple sclerosis, has been approved for domestic items. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 11th that it has approved Ponesimo for the treatment of recurrent dysplasia in adults. The drug has been shown to reduce inflammatory reactions by blocking lymphocytes from being separated from lymphatic organs and inducing the number of lymphocytes in peripheral blood to decrease rapidly. Ponesimo is expected to reduce the occurrence of new diseases in patients with multiple sclerosis and prevent additional disorders from occurring and accumulating due to repeated and continuous symptoms. Ponesimo was designated as a rare drug in Korea on October 1 last year after being approved by the U.S. FDA in March last year as a treatment for adult patients with recurrent multiple sclerosis, including clinical solitary syndrome, recurrence-relaxation disease, and active secondary progressive disease. The Ministry of Food and Drug Safety said, "We expect that this rare drug license will contribute to improving the quality of life of patients by expanding their treatment opportunities and options." The Ministry of Food and Drug Safety said, "We will do our best to expand treatment opportunities to patients such as rare and incurable diseases by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Alvogen’s Alymsys reimbursed...compete with Avastin similar
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Samsung Bioepis’s Avastin biosimilar Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market. Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market. With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in the market. According to industry sources on the 11th, Alvogen Korea’s ‘Alymsys inj.’ will be included on the NHI reimbursement list starting this month. The maximum reimbursement price for the 0.1g dose will be KRW 208,144 per vial, the same as Samsung Bioepis’s ‘Onbevzi inj.’ The price of the 0.4g dose was also set at KRW 677,471, the same as Onbevzi. The price of its original, Roche’s Avastin inj is set at KRW 218,782 for the 0.1g dose and KRW 712,098 for the 0.4g, which is slightly higher than its biosimilars. Onbevzi enjoyed a monopoly in the biosimilar market for 1 year after being approved for reimbursement in September last year, and enjoyed a significant preoccupation effect in the market. Its sales, which reached KRW 0.5 billion in Q4 last year based on IQVIA, had continued rising to KRW 1.8 billion in Q1, and then KRW 4.1 billion in Q2. At this rate, its sales is expected to exceed KRW 10 billion only one year since its launch. With the launch of Onbevzi, Avastin’s price was also discounted. With the price reduction, its sales also dropped by KRW 20 billion from the KRW 58.9 billion in 1H of the previous year to KRW 38.1 billion in the 1H this year. Avastin is a targeted therapy monoclonal antibody that is widely indicated for the treatment of various cancers including ▲metastatic colorectal cancer, ▲metastatic breast cancer ▲non-small-cell lung cancer ▲advanced or metastatic renal cell carcinoma, ▲glioblastoma, ▲epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, ▲uterine cervical cancer, etc. Its market size exceeds KRW 100 billion in Korea. Due to its potential, biosimilar companies that had mainly stayed abroad have been launching large-scale marketing activities in the Korean market. However, Avastin’s patent emerged as a variable. Due to the patent, biosimilars were restricted from being used like the original drug, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the ovarian cancer indication. Samsung’s Onbevzi was also unable to obtain this indication due to unresolved patent issues earlier in its release. On the other hand, Alvogen’s Alymsys was approved with the said indication. This is why the release of Alymsys was expected to weaken the competitiveness of Onbevzi in the market. But the situation was once again reversed with Samsung reaching an agreement on patent issues with the original developer Genentech, and Alvogen failing to do so. Samsung recently reached an agreement with Genentech for the patent suit on Avastin, which had been ongoing since June 2020. As a result, the company was able to obtain an additional indication for epithelial ovarian cancer last month. Alvogen, on the other hand, had to delete the indication in August due to a patent dispute and received reimbursement approval for the remaining indications. This is why the reimbursement approval period was delayed by one month. Despite some indication-related issues, many experts expect biosimilars to succeed in the domestic market, considering the high usage rate of bevacizumab in various other cancers as well. Samsung Bioepis entrusted sales of its product to Boryung Pharmaceutical, which is showing prominence in the anticancer drug market, and Alvogen to the large domestic pharmaceutical company Daewoong Pharmaceuticals for its early settlement in the market. In addition, Celltrion also received approval for its ‘Vegzelma inj’ on September 28th and is working to release the drug with reimbursement within the year. Celltrion also reached an agreement on Avastin’s patent with Genetech in May and was approved for the same indication as the original, including ovarian cancer related indication. Until now, Remsima was the only product that showed a good performance in the domestic biosimilar market. It is analyzed that the domestic biosimilar market is also entering full-fledged growth, starting with the Avastin biosimilar.
- Policy
- Two companies' Ticagrelor can be reimbursed
- by Lee, Tak-Sun Oct 07, 2022 06:04am
- Brilinta was released last monthAs Kukje and Korea United Pharmaceutical newly entered the anti-thrombotic Ticagrelor market, it was reorganized into a competitive system for nine companies. Although the original Brilinta's material patent expired in November last year, only six pharmaceutical companies' products entered the market due to high manufacturing costs and lack of marketability. And although generics for exclusivity ended last August, no news of generics' benefit was heard that month. According to the industry on the 6th, Kukjel has obtained benefits for Ticagrelor since September and Korea United Pharmaceutical from this month. Kukje is competing in the market with Brilor and Korea United Pharmaceutical with Tiglor. Competition, which had been stagnant due to their participation, has resumed. Currently, Hutex Pharmaceutical Korea, Alboven Korea, Hana Pharmaceutical, Samjin Pharmaceutical, Korea United Pharmaceutical, Kukjel, Genuonesciences, and Chong Kun Dang are competing in the market. Among them, Samjin, Korea United Pharm, Kukje Pharma, Genuonescience, and Chong Kun Dang are their own manufactured products, and the rest of the products are all entrusted to Genuonescience for consignment production. There are 41 licensed generics for Ticagrelor companies, but many consigned items are believed to have given up the market due to high raw material prices. Kukje and United Pharm, which have additionally been challenged, are analyzed to have solved the cost problem through their manufacturing. However, it is not a good situation for generic companies to succeed in the market. First of all, the Ticagrelor formulation market is gradually decreasing. Original Brilinta's outpatient prescription performance is gradually decreasing, with 10.8 billion won in 2019, 9.8 billion won in 2020 and 9.7 billion won in 2021. United is also seeking to expand its market by adding Tiglor to Clopidogrel-based Clavixin and Clavixin Duo. In the medical field, Ticagrelor does not have drug resistance due to existing clopidogrel CYP2C19 gene mutation It is believed that generics can sufficiently succeed in the market because it has the advantage of fast drug expression time.
- Policy
- Innovative pharmaceutical companies' new drug tx
- by Lee, Jeong-Hwan Oct 07, 2022 06:03am
- It was also pointed out that the government is delaying the preparation of a sub-law of a clause that favors the price of new drugs developed by innovative pharmaceutical companies in the Special Act on the Promotion of the Pharmaceutical Industry. Critics say that it has not been active in subsequent legislation such as enforcement ordinances and enforcement rules for the fourth year of legislation. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea claimed, "We need to come up with a policy of preferential treatment for new drugs made by innovative pharmaceutical companies as soon as possible." Nam is criticizing the government for being indifferent to follow-up legislation even though the law on the addition of the upper limit on health insurance medical care benefits was implemented in December 2018 for new innovative pharmaceutical companies unrelated to the Korea-U.S. FTA trade issue. In particular, considering that improving the self-sufficiency rate of raw materials is an important task, it was also suggested that it is necessary to consider preferential treatment for related raw materials such as infectious disease vaccines such as COVID-19 and innovative new drugs. Rep. Nam In-soon said, "The government has designated bio-health as the so-called Big3 industry and has been pushing for a plan to promote bio-digital health as a major export industry and improve public health by spreading digital healthcare and big data-based advanced and precision medical care." Representative Nam said, "There are only generic drug preferential regulations for innovative pharmaceutical companies, but there are no drug preferential regulations for new drugs, so the contradictory situation of encouraging generic development over new drugs continues." She then said, "We are also implementing a policy that favors drug prices for the first approved new drugs in Japan and Taiwan and new drugs from companies that have conducted clinical trials in Korea." She added, "To become a global hub of bio and digital health, not only support such as preferential drug prices for innovative pharmaceutical companies, but also various support measures such as training R&D and manpower, financial support, overseas expansion support, and reduction of levies."
