- LOGIN
- MemberShip
- 2025-12-23 07:22:52
- Policy
- Kyprolis succeeded in renewing the RSA contract
- by Kim, Jung-Ju Dec 22, 2021 05:56am
- LG Chem's Eutropin Plus 24mg (Human Growth Hormone, Somatropin) and Eutropin Pen are included in the PVA, falling from as little as 1% to as much as 4%. In addition, Amgen Korea's Kyprolis 60mg (Carfilzomib) and Kyprolis 30mg will be adjusted to 4-5% lower prices, respectively, after successfully renewing their RSA contracts. According to the industry, until recently, these companies agreed to cut insurance prices through negotiations with the NHIS and the PVA to renew their contracts with RSA. Based on this, the MOHW is pushing for a revision of the "drug benefit list and upper limit table." If the revision is finalized soon, it will be applied as of January 1. First, the price of Eutropin Plus 24mg and Eutropin Pen falls to PVA type Na. In PVA, type "Na" is used as a mechanism to reduce up to 10% through negotiations if the upper limit has been adjusted by type "Ka," the claim of the same product group, which has been increased by more than 60% or more than 10% from the previous year's claim, or more than 5 billion won. Eutropin Plus 24mg will be reduced by 3.9% to 148,861 won and Eutropin Pen will be reduced by 1.1% to 182,787 won. Two drugs were adjusted to the reduced price after negotiating again with the NHIS after the RSA contract was terminated. Kyprolis 60mg will be reduced by 5.6% to 975,950 won and Kyprolis 30mg to 488,443 won, respectively, by 4.5%.
- Policy
- The MFDS approved Spikevax on the 13th
- by Lee, Tak-Sun Dec 22, 2021 05:56am
- The MFDS announced on the 13th that Moderna Korea has decided to allow manufacturing and sales items for Spikevax, which was applied on November 8. Spikevax' is a COVID-19 vaccine produced by Samsung Biologics in Korea with vaccines such as Moderna Spikevax developed in Moderna, USA, which was approved for import on May 21. Samsung Biologics receives raw material drugs and produces finished drugs through processes such as filling and marking. Spikevax is the first domestic consignment production vaccine in the mRNA method among COVID-19 vaccines licensed in Korea. The MFDS said it expects the permit to contribute to the stable supply of COVID-19 vaccines in Korea as well as to leap into a global vaccine hub. The MFDS added that it will continue to work with related ministries to strengthen the monitoring system for abnormal cases after inoculation and to provide an environment in which people can be vaccinated with confidence thorough monitoring and prompt response.
- Policy
- MFDS is speeding up the COVID-19 vaccine screening
- by Lee, Tak-Sun Dec 21, 2021 06:06am
- In 2021, the MFDS focused on speeding up the screening of COVID-19 vaccines aimed at 70% of the nation's vaccinations. As a result, the screening period for COVID-19 vaccines and treatments has been significantly advanced, contributing to the achievement of the goal. Unexpected inspections have begun on manufacturers to cope with illegal manufacturing incidents triggered by media reports. In addition, as impurity issues from overseas erupted one after another this year, drugs such as Sartan and Varenicline were recovered by inducing corporate self-inspection. Choline alfoscerate formulations, which have controversy over efficacy, were prepared in June with a clinical re-evaluation plan. ◆COVID-19 vaccine and treatment screening=As the government formalized the vaccination of the COVID-19 vaccine from the first quarter, the MFDS focused on advancing the approval period by mobilizing all personnel for product screening. As a result, vaccines were approved 40 days after receipt, and the National lot release was also completed 20 days after approval. Starting with AstraZeneca in February, Pfizer in March, Janssen in April, and Moderna vaccines in May were approved one after another. Most of them were achieved 40 days after the start of the permit review, and the National Lot Release was immediately carried out, and the vaccination began quickly. The EUA system has been enacted as a law to provide an institutional environment so that it can be urgently introduced even before formal approval. As a result, in October, Moderna vaccines commissioned by Samsung Biologics were able to receive EUA and supply them to the market. ◆Illegal manufacturing= Overseas COVID-19 vaccine confirmed the capabilities of the domestic pharmaceutical industry by selecting a domestic manufacturer as a production source, but it was also revealed that it was manufactured arbitrarily unlike permission. The MFDS, which immediately went into crackdown after hearing media reports, found that BINEX and Vivozon had illegally manufactured them in March. Additives were arbitrarily changed without permission, and some document manipulation appeared in the process. As a result, manufacturing and sales of related items were temporarily suspended and recovered. BINEX was found to have arbitrarily manufactured 32 items, including consignment and consignment manufacturing. Since then, the MFDS has set up a counter for internal complaints with the GMP special planning and inspection team and started unannounced inspections of all manufacturers. As a result, violations such as Hanall Biopharma, Chung Kun Dang, Dongin-dang, Hansol, Samsung, Jeil, and Medicakorea were found. As the MFDS proceeded with administrative measures against the caught companies, some pharmaceutical companies were treated as criminal charges. Illegal random manufacturing cases are currently under investigation by the prosecution, which is expected to have repercussions depending on the situation. ◆Choline alfoscerate, outline of clinical reevaluation= The clinical trial plan for this was finally approved in June when the MFDS issued a clinical re-evaluation order last year due to controversy over the effectiveness of the "Choline alfoscerate" drug raised by the National Assembly and civic groups. Each company decided to participate in consideration of cost and probability of success. As a result, a total of 57 companies expressed their intention to participate in the group led by Daewoong Bio and Chong Kun Dang, which have the highest sales in the market. Daewoong Bio and Chong Kun Dang conduct clinical re-evaluation of the efficacy of Choline alfoscerate's treatment of Alzheimer's dementia for 4 years and 6 months and mild cognitive impairment for 3 years and 9 months. All other indications were deleted as the revaluation effect was limited to Alzheimer's dementia and mild cognitive impairment. With the confirmation of the revaluation plan, each company has since started negotiations with the NHIS to recover benefits in the event of a clinical revaluation failure.
- Policy
- What's the HIRA's solution to the drug price?
- by Lee, Hye-Kyung Dec 21, 2021 06:05am
- Measures have been prepared to improve administrative and economic losses caused by drug returns in hospitals, clinics, and pharmacies following the revision of the monthly drug benefit list and upper limit table. The HIRA has decided to provide a revision of the drug benefit list in advance starting this month. Until now, drug price files have been provided since the revision of the notice after deliberation and resolution by the Health Insurance Policy Deliberation Committee of the MOHW. However, in the future, even before the issuance of the notice, after the Health Policy Review Committee is over, the drug price file will be provided in advance from the first day of the review. The final contents of the drug price file provided in advance can be changed depending on the results of the deliberation, so it seems that it takes time to apply the billing program. It is inconvenient to use the pre-provided drug price file to check the actual transaction price when returning and settling drugs at pharmacies and to apply the final drug price file to the billing program after issuance of the notice. The reason why the HIRA came up with such an early provision of drug price files seems to be the main reason for the monthly drug price, but the suspension of execution occurs when the upper limit of the drug is adjusted due to the reduction of the benefit range. Hospitals, clinics, and pharmacies will suffer from administrative tasks such as settlement of differences in drug prices. In particular, in the case of pharmacies, if the weighted average price is incorrectly calculated due to drug price reduction or increase, it may lead to on-site investigation and administrative disposition due to inconsistency in claims.
- Policy
- MFDS cancels all Jeil’s hypertension drugs for fabrication
- by Lee, Tak-Sun Dec 21, 2021 06:05am
- The Ministry of Food and Drug Safety issued a disposition revoking the sales licenses of all hypertension drugs manufactured by Jeil Pharmaceutical after the company was found to have submitted fabricated data for approval. A total of 44 items from 15 companies including Jeil Pharmaceutical were issued the disposition. The GMP investigation that has been initiated after Binex was found to have illegally manufactured products in March has been closing on and putting the pharmaceutical companies at risk. With HLB Pharmaceutical’s ‘Twinstel tab.’ marking the start of MFDS’ dispositions, the authorities have revoked the license of 14 companies’ hypertension drugs by the 16th. The canceled products are all same ingredient drugs manufactured by Jeil Pharmaceutical. In October, Jeil Pharmaceutical was found to have fabricated its residual solvent test data among data submitted to the MFDS for authorization, upon which all related products were discontinued and recalled. The ‘MFDS Special GMP Investigation team’ that was organized after the Binex issue had conducted an investigation from September 27th to October 8th and found the above violations. Companies that have received marketing authorizations through fraudulent means are revoked their licenses under the Pharmaceutical Affairs Act. Accordingly, the MFDS had been taking steps to revoke the license of relevant items since then. The canceled items, which are all telmisartan-amlodipine besylate combinations, include the following: Jeil Pharmaceutical’s ‘Telmiduo Tab,’ Kuhnil Biopharm’s ‘Partone Tab,’ GC Cross’s ‘Greencross Telmiamo Tab,’ Dongsung Pharm’s ‘Telmisapin Tab,’ Mcnulty Pharmaceutical’s ‘Mac duo Tab,’ Myungmoon Pharm’s ‘Telmiones Tab,’ Sungwon Adcock Pharm’s ‘Twinstan Tab,’ HLB Pharmaceutical’s ‘Twinstel Tab,’ LG Chem’s ‘Novarsc T Tab,’ Yungjin Pharm’s ‘Astel Tab,’ Yu & Life Science’s ‘Telosapin Tab,’ Joonghun Pharm’s ‘Telostar Tab,’ Theragen Etax’s ‘Twincure Tab,’ and Pharvis Korea’s ‘Troika Tab,’ As of the 16th, products from 36 companies have been revoked their licenses. Most were caused by Jeil Pharmaceutical’s license revocation due to data fabrication and other items were also caught on charges of arbitrarily manufacturing products and revoked permissions. Companies that were caught with violations this year include Medica Korea, Jeil Pharmaceutical, Samsung Pharm, Hansol Pharm, Dong In Dang Pharmaceutical, Chong Kun Dang, Hanall Biopharma, Vivozon, and Binex. Among these Binex was sent to prosecution by the MFDS’s Central Criminal Investigation Office for violating the Pharmaceutical Affairs Act.
- Policy
- Korea tightens social distancing measures again
- by Kim, Jung-Ju Dec 20, 2021 06:11am
- The surge in COVID-19 cases in Korea has led the government to once again tighten the reins on social distancing while focusing on encouraging booster shot vaccinations. Private gatherings will be once again limited to no more than four people in all areas regardless of region, and a ‘vaccine pass’ that differs the level of restrictions imposed based on vaccination status will be applied. On the 16th, the COVID-19 Central Disaster and Safety Countermeasures Headquarters (Prime Minister Kim Boo-kyum) held a meeting with central ministries and 17 regional governments at the video conference room in the video conference room of the Central Government Complex in Seoul to discuss strengthening the social distancing measures by expanding booster vaccination and expanding medical capacity to establish a continuous basis for the phased recovery to daily life. Currently, Korea’s COVID-19 urgency assessment showed Korea to be at ‘very-high’ risk in all regions - nationwide, metropolitan, and non-metropolitan areas – for two consecutive weeks since last week. The intensive care bed operation rate reached 81.6% nationwide, 86.4% in metropolitan areas, and 72.9% in non-metropolitan areas. In particular, the surge in intensive care operation rate in non-metropolitan areas with relatively low medical response capacity was deemed a major risk factor that could lead to a nationwide medical collapse. With the number of non-vaccinated people over the age of 60 that have a high probability of infection still nearing 910,000 (6.9%) and the number of cases of severe and critical COVID-19 and deaths similar in the vaccinated and non-vaccinated groups, it is necessary to protect the elderly who are not vaccinated through vaccination. With booster vaccination rates nearing 87%, the rate of mass infection is falling in long-term care hospitals and facilities, but the booster vaccination rate in those 60 years or older is still low at 46.4%. Therefore, the government decided to implement strengthened social distancing measures to block further transmission of COVD-19 in non-vaccinated people that account for half of the severe and critical COVID-19 patients and deaths and minimize individual contact to ultimately remove the overall risk factors remaining in society. The strengthened social distancing measures will be implemented for 16 days from the 18th of this month to January 2nd. The authorities readjusted the number of people allowed for private gatherings to reduce contact between individuals in consideration of the seasonal factor and the increased risk of transmission from year-end and new year gatherings and other indoor activities. Therefore, the number of people allowed for social gatherings that were 6 in metropolitan and 8 in non-metropolitan areas was reduced to 4 regardless of an individual’s vaccination status. However, the existing exclusion that was applied to immediate families in cohabitation, individuals in need of care (children, elderly, and the disabled), etc. remain effective. Also, under the changed measures, non-vaccinated individuals may now only use restaurants and cafes alone. Also, taking into account the increased risk of COVID-19 transmission if activities extend to late-night hours and are associated with alcohol consumption and non-mask use, the authorities restricted the operation hours of multi-use facilities to 9 or 10 p.m. for the next 2 weeks. Operation hours for Group 1 facilities (entertainment facilities) and Group 2 facilities (restaurants, cafes, singing rooms, public baths, indoor sports facilities) will be restricted to 9:00 p.m., and the hours for Group 3 and other facilities (movie theaters, performance centers, game arcade, multi-rooms, casinos, internet café(PC rooms), private academies, massage salons, party rooms) will be restricted to 10 p.m. Sizes of events and assemblies will also be restricted. Currently, events and assemblies with less than 100 participants are allowed regardless of vaccination status, and up to 499 vaccinated individuals may gather for events, and assemblies with over 100 participants are allowed. However, the strengthened measures restrict the number of participants to 50 regardless of vaccination status, and up to 299 vaccinated individuals may gather for events and assemblies with over 50 participants. Although events with over 300 participants (limited to those held in non-regular performance centers, sports competitions, festivals) are prohibited in principle, they may be held as an exception with prior approval from relevant ministries. For the next two weeks, all events other than essential events will be disapproved in consideration of the severe COVID-19 situation. Also, official duties and events related to essential corporate activities that were exempted from being applied the vaccine pass will be subject to the same restrictions if there are more than 50 participants (no increase in participants allowed), and exhibitions, expos, and international conferences that had been managed with a separate regulation is also applied the vaccine pass if there are more than 50 participants (no increase in participants allowed).
- Policy
- Jeil's JP-1366 has been approved for phase 3 in Korea
- by Lee, Tak-Sun Dec 16, 2021 05:51am
- Jeil's new drug candidate JP-1366 for GERD has been approved for phase 3 clinical trials and is speeding up commercialization. Currently, sales of HK inno.N's P-CAB-based new drug K-Cab are high in Korea. On the 14th, the MFDS approved a phase 3 clinical trial plan for JP-1366 applied by Onconic Theapeutics, a subsidiary of Jeil Pharmaceutical. This clinical trial is a randomized, double-blind, parallel design, activity contrast, non-isomeric, multi-organ phase 3 clinical trial that compares and evaluates the efficacy and safety of JP-136620 mg or Esomeprazole 40 mg administration in erosive esophagitis patients. JP-1366 is a treatment for gastroesophageal reflux disease in the P-CAB mechanism and is expected to be a drug that improves the limitations of existing PPI formulations. It is more effective and lasts longer than PPI. It was selected as a high-tech medical technology development project by the MOHW in 2017 and received about 2 billion won in research funds, and is being fostered as a global new drug in public-private cooperation. Clinical trials are being conducted not only in Korea but also in Europe. Onconic Theapeutics is a subsidiary of the new drug development established in May last year with 100% investment in Jeil Pharmaceutical. Currently, Jeill is developing new drug candidates such as JP-1366, a treatment for GERD, and "JPI-547," a next-generation dual-target anticancer drug. The company aims to be listed in 2024. The P-CAB-based new drug was developed by HK inno.N as K-cab for the first time in Korea in 2018. K-cab has become a treatment for GERD as soon as it is released in 2019. Sales are expected to exceed 100 billion won this year. Accordingly, not only Jeil but also other domestic companies such as Daewoong Pharmaceutical are spurring the development of new P-CAB drugs. Fexuprazan, which is being developed by Daewoong Pharmaceutical, is known to have completed clinical trials in Korea and is undergoing approval procedures.
- Policy
- The KDCA has set aside ₩299.2 billion for COVID-19 tx
- by Kim, Jung-Ju Dec 16, 2021 05:51am
- The KDCA (Chief Jeong Eun-kyeong) announced that it had decided at a Cabinet meeting on the 14th to ₩299.2 billion as a reserve for additional purchases of COVID-19 treatments. It is equivalent to ₩192 billion for oral treatment of COVID-19, ₩107.2 billion for antiviral drugs (Remdesivir) and antibody therapy (Regkirona), which are existing tx. It is aimed at pre-purchasing oral treatments and purchasing additional existing treatments as the number of confirmed patients continues to increase to 7,000 recently. Currently, the COVID-19 oral treatment has completed a pre-purchase contract for 3.12 million people (242 million people for MSD and 70,000 people for Pfizer) with global pharmaceutical companies, and an additional purchase contract will be signed in December to reflect the increase in confirmed cases. It plans to induce active use of domestic antibody treatments by expanding prescription agencies and subjects. In the case of Regkirona, prescription institutions have further expanded residential treatment centers, hospitals, general hospitals, and elderly care facilities from inpatient treatment institutions. Subject to administration were also taken so that home caregivers could be administered at short-term and outpatient treatment centers. The government expects to contribute to maintaining the medical and quarantine system by reducing the prevalence of severe patients in mild patients by introducing oral treatments and actively utilizing domestic antibody treatments in preparation for the home treatment-oriented medical system.
- Policy
- Exempt PVA for drugs with claims less than ₩10 billion
- by Lee, Hye-Kyung Dec 16, 2021 05:51am
- The pharmaceutical industry officially delivered its position that it cannot accept any of the measures set for the improvement of the detailed guidelines for the Price-Volume Agreement negotiations that were disclosed by the National Health Insurance Service. The NHIS had collected industry opinion until the 14th after disclosing the proposed revisions to the KPBMA, KRPIA, and KOBIA at the 10th public-private consultative meeting that was held on the 2nd. In particular, the KPBMA opposed both the revision of Article 6.1.1 of the guideline that calls for expanding the total claims amount set for a product group from 'less than ₩1.5 billion' to 'less than ₩2 billion,' and Article 6.1.2 that reduces 'items with an upper limit of less than the arithmetic average of drugs with the same ingredient' to 'less than 90% of the arithmetic average.' In addition, the industry added that the items that were initially listed at a low price should be added to subjects eligible for exclusion from price cuts or price cut rate reductions. The main reason why the industry opposed the improvement in the PVA guidelines was that the financial savings gained on the NHIS's part were insignificant. If the revision that expands the amount of the annual claims from less than ₩1.5 billion to less than ₩2 billion is applied, drugs that have an annual claims amount of ₩1.2 billion will also be subject to PVA negotiations if their use volume increases by over ₩800 million. If the amount is calculated at the discount rate of 6.0% in line with the reference formula, the savings amount will be around ₩120 million. The industry pointed out that “₩120 million is an insignificant amount of savings on the NHIS’s part. However, from the small-and-mid-sized pharmaceutical company’s viewpoint, a 6% drop in a drug’s price will be discouraging as the company will not invest in such a product as its main item, which will then become an obstacle to corporate growth that can be achieved from sales expansions. Therefore, from the industry’s viewpoint, the government's negotiations should be focused on mid-to-large sized items whose use exceeds ₩10 billion in line with the PVA system's purpose, and the amount subject to exclusion from PVA to be increased to be set at ₩10 billion or less. Also, on changing the ‘same ingredient’ term to ‘main component code’ for all items other than the disposable eye drops and reducing the limit from the arithmetic average to 90% of the arithmetic average, the industry requested the government retain the current guideline. The industry said, “The arithmetic average is a social convention and an absolute standard for judging whether the insurance finances can be saved, and therefore, it is in line with the system's purpose to exclude drugs that cost under the arithmetic average from negotiations. Abuse of the system, such as evading negotiations by voluntarily reducing the price to less than the arithmetic average may be well prevented by changing the time of application of the arithmetic average to the time when the monitoring starts.” With the opinion that the arithmetic average will be adjusted with the graded system for pricing generic drugs and the reevaluations planned to be implemented in July 2023 for already-listed drugs, the industry expressed concerns that enforcing the revisions will rather diminish the companies’ efforts to save NHI finances through voluntary low price listing or voluntary price cuts. In addition, the industry requested the ‘low-priced drugs’ to be added to drugs eligible for price cut rate reductions as proposed by the public-private consultative body. The currently announced guideline allows companies that voluntarily cut the price of drugs (if the 1-year period from the voluntary price cut is included in the period of analysis) may be exempted from a single negotiation under the PV guidelines or be calculated for a negotiation reference price that takes into account the voluntary price cut rate. The industry said, “Although drugs that were initially announced at a lower price (scheduled sales price) than what can be calculated have a positive effect on health insurance finances from the time of its listing, the reduced rate is not reflected during PVA negotiations. We ask that new drugs that are initially listed at a low price also be applied the exemption for one single negotiation or be reflected for its low price when assessing eligibility for PVA negotiations and in calculating the negotiation reference price.”
- Policy
- Janssen keeps the Tylenol name for its imported product
- by Lee, Tak-Sun Dec 16, 2021 05:51am
- As expected, Janssen is keeping its brand name, ‘Tylenol,' for its antipyretic analgesic. The company had dropped the license of its domestically manufactured Tylenol Tab. 500mg in line with the shutdown of its Hyangnam plant and changed the name of its imported item that was approved in August to ‘Tylenol Tab. 500mg.’ The expectations held by frontline pharmacies that the company may give up the use of its brand name and use the ingredient name, INN (International Nonproprietary Name), had been let down. According to the Ministry of Food and Drug Safety on the 14th, the product name of ‘Janssen Acetaminophen Tab.’ was changed to ‘Tylenol Tab. 500mg’ on the 13th. The product was approved for import on August 23rd. Janssen had obtained the approval for the imported item that can substitute its manufactured item in advance before the shutdown of its Hyangnam manufacturing plant that was planned for the end of this year. At the time of approval, the company had obtained approval for the drug as ‘Janssen Acetaminophen,' according to its INN mark. However, industry prospects were that this was just a temporary measure made because another approved product had existed under the ‘Tylenol Tab. 500mg’ name, As expected, the company had dropped the license for its manufactured ‘Tylenol Tab. 500mg’ since then and changed the name of its Janssen Acetaminophen to the existing brand name. Frontline pharmacies had once hoped that the drug would be released as Janssen Acetaminophen. When the COVID-19 vaccinations began in Korea, the Korea Disease Control and Prevention Agency had referred to the ‘Tylenol’ name as the medicine to use to alleviate the side effects of vaccinations, leading to the heavy purchase of only Tylenol among the various acetaminophen drugs. As a result, frontline pharmacies had faced difficulties because they could not keep up with the demand and had experienced Tylenol shortages. At the time, pharmacists had criticized KDCA for mentioning a specific brand rather than a generic name. The pharmacies had expected that the release of Janssen Acetaminophen, not Tylenol, would resolve the Tylenol-concentrated market demand. However, as companies follow profits, it would have been difficult for the company to give up its brand name as the booster COVID-19 vaccinations starting in earnest is expected to further increase Tylenol sales. According to IQVIA, Tylenol recorded ₩50.1 billion in cumulative sales by Q3 this year and recorded No.1 in the OTC market.
