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- 2026-05-06 03:12:19
- Policy
- No recall crisis expected to arise from losartan impurities
- by Lee, Tak-Sun Dec 08, 2021 06:00am
- Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs. The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that were found to contain azido impurities that exceed the allowed daily intake of 1.5㎍/day (1.7~88.7㎍/day) will be recalled. However, the ministry emphasized that the risk of its harm to the human body is very low and that the patients should not discontinue taking the drugs. The azido impurities that were detected this time occur specifically in the losartan ingredient, and although the properties of genetic mutations have been confirmed in the ingredient carcinogenicity has not been yet identified. In particular, an assessment of its health effect on the majority of patients who took losartan that had an excess amount of impurities than the allowed daily intake showed that the added risk of cancer from the impurities was 0.54 out of 100,000, which was a very low and negligible level. An MFDS official said, “The evaluation was based on the representative value (median value) that was set with losartan drugs that had impurities exceeding the amount allowed for daily intake. We also took into account the possibility that the drugs that had a higher amount of impurities will be taken for life (70 years).” As a result, the MFDS emphasized that even if one takes losartan drugs that contain an excess amount of impurities, it has little effect on one’s health, and that patients who were prescribed the product should not arbitrarily discontinue taking the drugs. However, the exchange, re-prescriptions, or re-dispensing measures were prepared to resolve anxiety for patients with health concerns. The exchange, re-prescriptions, or re-dispensing of the drugs can be done at no out-of-pocket cost on the patient’s part. However still, the number of re-prescriptions or re-dispensing is not expected to be high. Although all lot numbers of 241 items will be fully recalled, only some lot numbers of 54 items and none from 11 items are recalled, and identifying the drugs that are subject to recall is also a complicated process. Also, some of the items for which full recalls are being conducted for all lot numbers, some are being re-released as normal items, and may only be exchanged at hospitals rather than be re-prescribed or re-dispensed at hospitals. In fact, only 4 cases of consumer exchanges arose for sartan drugs that were recalled due to excess impurities in September. Due to this, there had been some criticism that the authorities had wasted too much time on the consumer exchange process that did not have many actual cases, delaying the recall period for the harmful drugs in business.
- Policy
- Detailed screening for α -GPC begins in earnest next year
- by Moon, sung-ho Dec 07, 2021 05:57am
- Tensions are rising as the government announces the review of the revised supplementary budget bill starting next year amid deepening concerns among pharmaceutical companies over the issue of Choline Alfoscerate. According to the pharmaceutical industry and the medical community on the 1st, it has been confirmed that the MOHW has decided to strengthen the screening of prescriptions for hospitals and clinics starting next year in accordance with the clinical re-evaluation policy for Choline Alfoscerates. Over the past two years, the MOHW has set the first target of strengthening screening according to the drug clinical re-evaluation policy as the Choline Alfoscerate formulation. In fact, the Choline Alfoscerate drug is recognized as a drug in Italy, while it is sometimes used as a health functional food in other countries, so controversy over its efficacy has continued. The MFDS ordered a "clinical re-evaluation" last year to re-evaluate the Choline Alfoscerate formulation on its own, and 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. At the same time, the MOHW reduced the benefit of Choline Alfoscerate. Since August last year, patients who have not been diagnosed with dementia have raised the drug price burden rate from 30% to 80% when using Choline Alfoscerate. Then, pharmaceutical companies actively took legal action and began to defend their sales. However, unlike the pharmaceutical industry, which is preparing such a defense strategy, some say that the actual medical field has little impact on the reduction of benefits. It was expected to have a big impact as the government decided to reduce benefits, but the actual feeling at the medical field is quite low. "In fact, the HIRA is currently not cutting according to the reduced benefit policy," said a professor at University Hospital A belonging to Korean Dementia Association, who requested anonymity. "There is no big problem with maintaining similar billing guidelines," he said. In the end, the MOHW and the MFDS have strengthened their guidelines following the reduction in benefits, but they are actually prescribing them without paying much attention to them in the actual clinical field. This is why The HIRA has announced cuts through specific screening starting next year. An official from the HIRA said, "Strengthening the screening is a situation in which we have to go through the Central Review and Coordination Committee, an organization within the institution. He said, "It is not easy to apply a specific examination yet, but we will proceed quickly and strengthen the examination of prescriptions by medical institutions from next year."
- Policy
- The original patent's negotiation period will be reduced
- by Kim, Jung-Ju Dec 07, 2021 05:57am
- The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third. It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set. The MOHW announced that it held a Health Insurance Policy Deliberation Committee this afternoon (25th) and reported on the "improvement of the drug negotiation system." The government is currently negotiating all reimbursed drugs. This is in accordance with the policy to expand the negotiated drugs from the application of new drug insurance to the entire drug from October 2020 to strengthen the quality control and stable supply management of insurance drugs after detecting Valsartan impurities in 2018. For example, in the past, negotiations between the government and companies were conducted to register new drugs, adjust drug prices, and expand the scope of use. However, since the reorganization, negotiations have been underway to adjust the original drug price (100 → 70%) and re-evaluate according to the first generic insurance application. Although the negotiation system has been expanded in this way, the problem of confusion in the operation of the system has been exposed due to insufficient detailed procedural regulations. In the case of supply and quality management contracts, unnecessary overlapping negotiations were held, such as drug price adjustments, and some pharmaceutical companies delayed the negotiation deadline of 60 days to delay the timing of drug prices falling. Some also pointed out that there are no renegotiation and procedural regulations when negotiations break down. It was pointed out that the drug negotiation procedure under the narrow law was unclear about the regulations on follow-up measures, such as exclusion of benefits, in the event of a final breakdown. The improvement plan largely sets ▲ the target to be omitted when negotiating drugs, ▲ to adjust part of the negotiation period of , ▲ to prepare renegotiation procedures in the event of a breakdown of negotiations, and ▲ to clarify that benefits are excluded in the event of a final breakdown of. Specifically, the negotiations will be omitted if there is a contract between the corporation and pharmaceutical companies. In the case of ex officio adjustment negotiations due to the application of a package reduction in drug prices, it will be shortened from the current maximum of 60 days to 20 days. This is a measure designed to reasonably shorten the negotiation period in the case of original ex officio adjustment. When negotiations broke down, renegotiation procedures were also in place. In order to prevent confusion in the clinical field, the government asked to renegotiate the drug characteristics and the progress of negotiations after deliberation by the Drug Benefit Evaluation Committee. In addition, in the case of drugs whose final negotiations have broken down, grounds have been established to exclude benefits. The government has decided to push for the standard rules for medical care benefits and the individuality of notification sometime next month. Considering administrative procedures such as legislative notices, the implementation of the amendment is expected to be possible in the first half of next year.
- Policy
- KB Pharm's generic for Vildagliptin nitrate will be approved
- by Lee, Tak-Sun Dec 06, 2021 05:54am
- The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another. These items will be able to be released early in January next year if some of their duration is confirmed to be invalid. On the 30th of last month, three dosage products of Vildagliptin-Metformin HCl, a compound of KB Pharm, were approved. It is the seventh company to launch generic for Galvusmet. However, this is the first salt-changing drug containing Vildagliptin nitrate. Pharmaceutical companies participated in the development one after another. At first, only An-gook and Hanmi Pharm, which claimed invalidation of their duration, were developed, but when the Patent Tribunal achieved results, KOREA UNITED PHARM and KB Pharm also participated in the development. The lawsuit for invalidation of the extension of the duration ended on October 28 when the Supreme Court recognized 55 of the 1,068 extended days as invalid. If some of the invalidity of the duration is finalized, material patent of Galvusment will expire on January 9 next year. In this case, other pharmaceutical companies that have not participated in the lawsuit can also launch products on the market as their substance patents are terminated. Currently, generics for Galvusmet have been approved by Hanmi Pharm, KOREA UNITED PHARM, Ahn-gook, Ahn-gook Newpharm, Shinpoong, Samjin, and KB Pharm. However, Hanmi Pharmaceutical and KB Pharm are the only pharmaceutical companies that have been approved for three doses. The rest of the pharmaceutical companies were granted only 50/500 mg. In the case of generic for Galvusmet, there are no restrictions on selling products because there are no products that have received general for inclusion. In the case of single-drug Vildagliptin, Ahn-gook Newpharm has acquired generic for exclusivity, and the same drug will be banned from selling until May 29, 2022. Last year, Galvusmet recorded 36.4 billion won in outpatient prescriptions, continuing its popularity in the diabetes treatment market. Competition is expected to intensify when the generic market opens next year.
- Policy
- Asciminib's domestic approval is at a quick step
- by Lee, Tak-Sun Dec 06, 2021 05:53am
- Novartis' Asciminib, which is attracting attention as a fourth-generation targeted anticancer drug in the chronic leukemia treatment market, is also speeding up domestic permits. The drug, which was approved by the U.S. FDA last month, has recently been approved for four clinical plans in Korea alone, boosting the analysis that it is accelerating its entry into the Korean market. According to the MFDS on the 26th, Asciminib has been approved for four clinical plans since August. Asciminib is a TKI (tyrosine kinase inhibitor) family fourth-generation targeted anticancer, and is attracting attention in that it attacks targets different from those of the first to third generations. This is because different targets reduce interference between anticancer drugs. Chronic myelogenous leukemia treatment continued to evolve in 2001 when the world's first targeted anticancer drug, Glivec, was launched. The second generation was developed into Sprycel, Tasigna, and the third generation Iclusig. The survival rate of patients is also on the rise with the release of third-generation targeted anticancer drugs, but the rate of treatment failure due to resistance is known to increase as the treatment stage goes up. As a result, expectations for fourth-generation treatments are also growing. Asiminib is set to be officially released on October 29 as the FDA decided to approve. In Korea, the MFDS designated it as a rare drug for the "chronic Philadelphia chromosome-positive chronic myeloid leukemia" disease in May and opened the way for it to be used before official approval. If it is designated as a rare drug, it will be reviewed more quickly, so the speed of domestic approval is expected to accelerate. It is interpreted that it has considered expanding indications and bridging tests after a series of clinical approval permits. In August, a phase 3b test plan was approved to evaluate long-term safety in patients who completed the Asciminib clinical trial and judged that the tester would benefit from continued administration. In addition, in September, phase 1/2 was approved to determine the dose and safety of oral Asciminib in pediatric patients with chronic Philadelphia chromosome-positive chronic myeloid leukemia previously administered one or more tyrosine kinase inhibitors. On the 4th of this month, a phase 3b plan of oral Asciminib was approved in patients with chronic myelogenous leukemia in the chronic phase who had previously been administered two or more tyrosine kinase inhibitors. And on the 22nd, a phase 3 test of oral Asciminib versus TKI was approved in patients with newly diagnosed chronic myeloid leukemia positive for Philadelphia chromosomes. Industry sources say Asciminib is expected to speed up its approval in Korea with FDA approval, adding that approval is also possible as early as next year. The U.S. FDA has fully approved accelerated approval and chronic CML patients with T315I mutations for cases where two or more of Asciminib has been treated with Philadelphia chromosome CML patients, and it is known that the same indication is being reviewed in Korea.
- Policy
- Companies in a dilemma over who bears losartan recall cost
- by Lee, Tak-Sun Dec 03, 2021 05:55am
- Pharmaceutical companies are unsatisfied with the health authorities’ request for companies to fully bear the cost of exchanging ‘losartan’ products that were found to contain azido impurities. While many companies have submitted the ‘cost-bearing letter of commitment,’ the companies have been left with a bitter aftertaste, due to the ongoing litigations and uncertainties on how much the exchanges will cost. Some companies have not submitted the letter of commitment yet. The Ministry of Food and Drug Safety had gathered the manufacturers and sellers of losartan products on the 29th of last month to request a ‘letter of commitment on bearing the cost,’ a commitment by the companies to bear the cost of exchanging, re-prescribing, and re-dispensing drugs that arise from recalls, saying that the cost should be borne by the pharmaceutical companies. After receiving the request, over half of the companies have submitted their letter by the 30th, the deadline for submitting impurity test results. Companies that submitted their letter of commitment did so because they do not expect the cost burden to be large, and that they could not disregard the government's request. An official from a mid-grade pharma company said, “ We submitted the letter of commitment as requested because we expect the number of recalls to be small, the number of products exchanged or re-prescribed by consumers to be even smaller.” As only specific lot numbers in issue are subject to recalls this time without stopping reimbursement, the companies expect the number of consumer recalls to be smaller than that for valsartan or ranitidine. In fact, the number of antihypertensive drugs that were recalled by consumers in September due to AZBT impurities was only 4, giving some credibility to these companies’ expectations. However, as there were no re-prescriptions, re-dispensing, and no public promotion activities informing the people about the recalls then, other companies believe the larger amount of recalls would increase the cost incurred as well. Another industry official said, “It may not have been so if the recalls were conducted quietly, but if the recalls become politicized, the cost of exchanging the products may grow bigger. Most of the losartan products are prescribed for long-term use, for over a month, and may become a big burden for pharmaceutical companies.” Another issue is that the letter of commitment may affect the ongoing non-existence of a debt suit being conducted on valsartan products. The suit arose after the National Health Insurance Service filed claims to pharmaceutical companies to retrieve the cost incurred while exchanging valsartan products that were found to have impurities. Companies have asserted that the indemnity claims were excessive as the unexpected impurities were only found due to the development of science and were unavoidable as the drugs were manufactured due process. However, the first trial court ruled in favor of NHIS and judged that a total of 2.03 billion won should be paid in claims for indemnity by 69 companies in September. The companies appealed, and the lawsuit is now being tried in a second trial. In this context, if the companies submit the ‘letter of commitment on bearing the cost,’ this contradicts the claims the companies had made at court and acknowledges indemnity. This is highly like to negatively affect the outcome of the lawsuit. This is why some companies have not been able to decide on whether to submit the letter of commitment. Recently, the MFDS is known to have been urging pharmaceutical companies to promptly submit the letter of commitment. A pharmaceutical company official said, “As the underdog, it would be difficult for us to reject the MFDS’ request. However, it is an unjust procedure for the government to unilaterally decide on the bearer of the costs and notify and companies to submit a letter of commitment.” Meanwhile, the MFDS is expected to soon announce a list of high blood pressure losartan drugs that contain excess azido-based impurities and start recalls from pharmacies, distributors, and consumers.
- Policy
- MFDS reviews Pfizer COVID-19 vaccine used without dilution
- by Lee, Tak-Sun Dec 02, 2021 05:54am
- On the 30th, the Ministry of Food and Drug Safety had announced that it had started reviewing the approval of Pfizer’s COVID-19 vaccine that does not require dilution – ‘Comirnaty inj. 0.1㎎/㎖ (registered name)’ – after the company applied for the authorization of its import product license. The product contains the same active ingredient as the previously approved Pfizer vaccine, ‘Comirnaty inj,’ but is more user-friendly as it may be used directly without dilution. Its single dose is 30㎍, same as that of the already approved vaccine. The ‘Comirnaty inj. 0.1㎎/㎖’ vaccine that is applying for approval this time comes in a vial with a gray cap, which can be differentiated from the purple cap of the already approved vaccine. The product has already been authorized(approved) in Europe and the U.S. The EU approval came on November 3rd and the US emergency approval on November 19th. The MFDS stressed that it will continue to be committed to the rapid provision of safe and effective vaccines for the Korean people.
- Policy
- Did Mooncare truly reinforce coverage for rare diseases?
- by Eo, Yun-Ho Dec 01, 2021 05:57am
- The voice requesting expanded coverage for patients with rare diseases had been exceptionally high this year in the 4th year of Mooncare. Starting with NA discussions held to enhance coverage of innovative new drugs for rare genetic disorders in May by the NA Health and Welfare Committee member Sunwoo Kang, NA members Byungwon Kang, Woni Kim, Young Seok Seo, Hyunyoung Shin held a public hearing to discuss ways to resolve the medically unattended areas, continuing on the effort to foster a policy environment that in which patients with rare diseases are not marginalized. The main contents that were discussed included the need to apply special exemption of calculation to diseases that are not being covered due to non-designation as a rare disease, and the strong proposal on the need to expand patient access to new rare disease treatments. The discussion continued to the NA Audit, where the NA Health and Welfare Committee member Sunwoo Kang, and members of the ruling and parties including JaeKeun In and Jongseong Lee all unilaterally urged improvement. ◆100% reimbursement rate for rare disease treatments in 2020? However, the public hearing revealed the different views held by the Health Insurance Review and Assessment Service. At the public hearing in May, HIRA presented that the reimbursement rate for rare disease treatments was 85.3%(2016~2020) and 100% in 2020. The numbers indicate that patient access to rare disease treatments is perfect. But if this is the case, why is the voice to expand reimbursement for rare disease treatments continuing to rise? 출처: 희귀유전질환 혁신신약 접근성강화를 위한 국회 토론회The results announced by HIRA were the reimbursement rate of drugs that went through the review and assessment process, not the actual reimbursement rate among all rare disease drugs. In other words, HIRA’s result excluded various factors including rejected and voluntarily withdrawn items. Data studied by the Korean Research-based Pharma Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association showed that only 50% of the pharmaceuticals that were designated orphan drugs over the past decade were listed on the reimbursement list. ◆Industry "Need to expand the pharmacoeconomic evaluation exemption system" The two associations joined forces to address the issue. Dailpharm found that KPBMA and KRPIA saw consensus on the need to expand accessibility to rare disease treatments and submitted a statement on the need to expand the pharmacoeconomic evaluation exemption system for rare disease treatments. In the statement, the two associations pointed out the existence of many rare diseases that greatly affect households with indirect medical costs and deteriorate the quality of life of patients but are not qualified for the ‘life-threatening (less than 2 years of life expectancy)’ condition that needs to be fulfilled to be able to utilize the current special exemption system (RSA and pharmacoeconomic evaluation exemption system) Therefore, the associations insisted that evaluating the ‘clinical need’ only with life expectancy does not take into account the characteristics of rare diseases, and diseases that do not meet the ‘less than 2-year life expectancy’ part of the clinical need requirement should also be allowed PE exemption if it is authorized through expedited approval processes abroad (US BTD, EU PRIME). The government had said that it would make efforts to improve access to rare disease treatments in the several public hearing and NA audits, but no specific plan or goal seems to be in place. An industry official said, “The government had recently adjusted the price evaluation criteria of PE exemption drugs by 20% from the lowest A7-adjusted price to improve the price transparency of PE exemption drugs. If the authorities decided to reduce the risk factors in price as such, they also should increase its scope of benefits.”
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited only 107,000 patients in Korea until last month, but the new listing of Bronpass Tab had increased the number of beneficiaries sevenfold to record 781,725. First, 30 drugs (based on representative dosages) were enhanced coverage being newly listed on the reimbursement list or extended reimbursement standards from January to November. Drugs that were newly listed as of the 1st this month are the severe neutropenia treatment Rolontis Prefilled Syringe inj and acute bronchitis treatment Bronpass Tab. No drugs were extended reimbursement standards this month. The two drugs that were newly listed differ greatly in the expected number of patients in Korea and annual financial requirements. Reimbursement for Rolontis Prefilled Syringe inj is expected to be applied to 4,000 people, costing ₩10 billion. On the other hand, Bronpass Tab is reimbursed for 670,000 people and will be applied to the most amount of patients among all newly listed drugs this year, however, its annual fiscal spending is relatively small, by ₩2.9 billion. This is interpreted as a result of comprehensively reflecting to flexibly expand coverage even for expensive drugs required for a small number of rare diseases and the social maturity to accommodate them. The number of beneficiaries greatly varies due to policies that now allow flexible expansion of NHI coverage to high-price drugs that are used for a small number of rare diseases, that were established based on the increased social maturity that can now accept such policies. The government and payer expect the new listing and extended reimbursement standards to cost ₩256.4 billion and grant access to 781,725 people.
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anticancer drugs, orphan drugs, and infectious disease treatments such as COVID-19 drugs. On the 25th, Prime Minister Boo-Kyum Kim held the 137th State Affairs Inspection and Coordination Conference and announced “the 8th measure for regulatory innovation to address difficulties in the new industry” The regulatory innovation that will directly affect the pharmaceutical industry is the measures made for the bio-health industry. In line with the Ministry of Food and Drug Safety, the Office for Government Policy Coordination had agreed on the need to improve the priority review system for pharmaceuticals. Currently, the MFDS has an expedited review process in place during marketing authorization for the prompt introduction of new drugs such as new drugs, anticancer drugs, orphan drugs, and infectious disease treatments. However, unlike the US FDA, the system does not specify the review period or the scope of materials submitted in detail, which undermines the administrative effectiveness and predictability of the system. On this, the Ministry of Food and Drug Safety decided to prepare specific standards on the review period and scope of submitted materials by revising the Pharmaceutical Affairs Act & Regulation on Safety of Drugs, Etc. The pre-announcement of legislation was issued on October 19th, and the revised Regulation on Safety of Drugs will be in full effect from January 21st next year. The scope of submitted materials will be specified to define the evidence data, development process, manufacturing method, dosage/administration, efficacy/effect of drugs subject to priority review. The MFDS expects the regulatory innovation to preemptively respond to the need for pharmaceuticals and promote the protection of national health. The regulations on chemical materials used for pharmaceutical manufacturing and quality inspections will also be alleviated. The MFDS exempts import requirements for raw materials that are essential for drug manufacturing when importing chemicals for drug manufacturing or quality inspection. The problem is, the MFDS reviews the cases case-by-case, only after the importer inquires to the ministry whether its chemical material is applied the exemption of import requirements. Due to this, criticism arose that the lack of criteria within the system is causing inconvenience for the importers. Accordingly, the MFDS decided to provide detailed criteria for determining substances subject to the exemption of import requirements and provide detailed case examples to aid better understanding among civilians and improve administrative processes for its employees. More specifically, the ministry plans to revise the ‘Tacts for recommending pharmaceuticals among those subject to import requirement confirmation exemption’ guidelines for business conduct in the coming December.
