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- 2026-05-03 22:10:31
- 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."
- Policy
- “No considerations made to protect generics” at NA audit
- by Lee, Jeong-Hwan Oct 17, 2022 10:52pm
- After the Ministry of Health and Welfare revealed its plan to lower the price of generics step by step at the 2022 NA Audit, the domestic pharmaceutical industry has been expressly expressing their displeasure on how pro-government the regulation is and criticized how the plan does not consider the realities of the industry. The industry relayed its concerns on how the MOHW had opted to save NHI finances by regulating the price of generics rather than protecting the domestic industry, even though the sales of generics are a major means for profit generation used by domestic pharmaceutical companies to invest in R&D of new drugs. Also, suggestions that policies to preserve drug prices or preferential pricing should be considered and pharmaceutical support for new drug development should be increased substantially if the government plans to implement such drug price-reducing policies. On the 16th, the domestic industry has been reacting sensitively to the issue of generic drug price cuts raised that had been raised at the NA Audit by the NA Health and Welfare Committee. During the NA Audit for MOHW, Rep. Jae-Hyung Choi of the People Power Party raised the need to reduce NHI expenditures through drug price cuts and expand R&D investments for new drugs, pointing out how generic drug prices in Korea are excessively high compared to those in other advanced countries overseas. MOHW Minister Kyu-Hong Cho agreed with Rep. Choi and said he will seek measures to lower the price of generics in Korea step-by-step as the price of generics in Korea is higher than overseas. On this, the domestic pharmaceutical companies have complained that the government has opted to unilaterally reduce the price of generic drugs, which is the easiest way to save NHI finances. Although financial management of insurance in other advanced countries cannot be simply compared with Korea's situation, the government is pushing this fragmentary logic, vaguely comparing the price of generic drugs to original drugs to hold as a reason to lower drug prices. The industry also claimed that the NA and MOHW’s argument that the higher price of generic drugs in Korea compared to overseas undermines the willpower to develop new drugs. In particular, they criticized how critical an issue it is that the MOHW does not properly recognize the "generic Industry as part of the domestic industry.” While many foreign countries, including the US’s Biden administration, are devising multifaceted measures to protect their own pharmaceutical bio-industry, Korea is repeatedly laying out measures that cut the price of generic drugs in its own industry to “secure financial soundness” of NHI finances. Reducing the price of generic drugs in the single-payer NHI system will only reduce the share of the pie held by the domestic industry, which in turn will increase the market share of foreign pharmaceutical companies and cause difficulties for domestic pharmaceutical companies from market contraction. Moreover, the industry demanded that MOHW should proactively consider measures to preserve generic drug prices in various situations as much as for the reduction of the same, and develop policies to provide preferential pricing for innovative new drugs and budget support for new drug development, etc. Without a drug price preservation policy that partially exempts or suspends post-drug price cuts for generic drugs that have contributed to saving NHI finances, the generic drug price cuts will only impede drivers of new drug development in pharmaceutical companies. An official from Company A said, “Pounding on generics may be the easiest way to reduce NHI finances on the government’s part, but generics are the root and cash cow of the Korean pharmaceutical industry. Not many companies are reluctant to invest in new drug development because the price of generics are so high.” “Companies that continue to invest in new drugs and IMDs despite the burden of sunken costs will face a lack of financial resources to continue the research if the price of generic drugs is reduced. In addition, Korean companies have continuously contributed to national health crises with their generics, such as in resolving the Tamiflu shortage during the swine flu incident.” “Korea has a tendency to undervalue generic drugs, undermining the social contribution that had been made by the generic drugs and periodically reducing their price. The US uses private insurance, not a single-payer system like Korea. This is one of the reasons why generic drug prices of different countries should not be compared simply.” Another domestic pharmaceutical company official from Company B also said, "President Biden has recently issued an executive order to protect the pharmaceutical and bio-industry in the US. If the Korean market is attractive because of the high generic drug prices, why wouldn’t the foreign generic companies be entering the Korean market?"
- Policy
- 780,000 doses of Comirnaty 2 will be national lot released
- by Lee, Hye-Kyung Oct 17, 2022 06:03am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that the mRNA COVID-19 vaccine imported by Pfizer Pharmaceutical Co. released 780,000 doses of Comirnaty 2 for two weeks on October 14. National lot release refers to a system that comprehensively evaluates the results of tests and testing results for each lot before vaccines are distributed on the market to check the quality once more. The Ministry of Food and Drug Safety thoroughly conducted a national lot release based on scientific evidence, putting safety first. As a result of conducting a test on 780,000 doses of 0.1 mg/mL of Comirny 2 and reviewing the manufacturing and test data of the manufacturer, it was determined that it met the approved quality standards and decided to release the national lot. The Ministry of Food and Drug Safety said it expects COVID-19 to help prevent COVID-19 as the vaccine is national lot released, and it will do its best to ensure a stable supply of quality vaccines by quickly and thoroughly verifying the COVID-19 vaccine.
- 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.
