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- 2025-12-24 19:51:36
- Policy
- Welfare committee passed a set of three bills about COVID-19
- by Lee, Jeong-Hwan Feb 24, 2020 06:25am
- The parliamentary welfare committee approved the three measures about COVID-19 at the plenary session on the 20th morning Three bills about COVID-19 were thus reviewed by the Legislation-Judiciary Committee. After passing through the judiciary committee, the final plenary session must be resolved before the final promulgation can be made. A revision to the infectious disease act calls for permitting the government to provide face masks for free to people who are vulnerable to infections when the country's contagious disease alert level is raised to the level above "caution", the measure also calls for doctors and pharmacists to check patients' records of foreign travel via a shared information program when they prescribe medication, for the establishment and monitoring of medical-related infections, and the increase in the number of epidemiological investigators. On the 20th, the Committee decided on 13 amendments in the Infectious Disease Prevention and Management Act, Medical Law and Quarantine Act. ◆Amendment to the Prevention and Control of Infectious Diseases Act=When a warning of abnormality was issued under the Basic Act on Disaster and Safety Management due to the spread of infectious diseases, a bill was issued to provide free masks to the vulnerable people such as children and the elderly who use social welfare facilities. In order to prevent recurrence of problems such as mask purchase disturbances, a bill that prohibits the export or export of goods such as masks and antiseptics during the period announced by the Minister of Health and Welfare if a sudden rise in prices or supply shortages such as medicines occurs due to the first-class infectious disease epidemic passed by the Welfare Committee The number of quarantine officials at the health ministry would rise to more than 100 from the current 30. In some cities, counties, and districts, there is a legal basis for mandatory epidemiological investigators. The bill also stipulates that health professionals, who are directly involved in patient care, prescription, and medication, such as medical workers, pharmacists, and heads of health care institutions, can check the patient's overseas travel information system at all times. However, the bill will not be punished even though it is not followed because the penalty clause has been deleted. ◆Amendment to the Medical Law=A bill was proposed to change the name of hospital infections to medical-related infections and legislation was passed to establish and embody justice. Evidence for compliance with medical institutions for the prevention of medical infections is also established. The medical system infection monitoring system was strengthened, and legal basis for self-reporting of infection control of medical institutions was also established. The extension of the designation and mandate of infection control personnel to all medical institutions, including local clinics, was removed from the subcommittee. ◆Amendment to the Quarantine Act=The point of Quarantine Act is that allows the Minister of Health and Welfare to ask the Minister of Justice to ban or suspend the entry into or through a country where a person is confirmed. The government has secured a legal basis for prohibiting the entry and entry of confirmed or suspected suspects in case of new infectious diseases such as COVID-19. The Minister of Welfare, Neunghoo Park, expressed his appreciation for the resolution of a set of three bills about COVID-19 by th Welfare committee. In particular, The Minister, Park requested adjustment only for the timing of the implementation of some provisions, and the Commission decided to accept the final decision. The Minister, Park said, "Some of the bills have been in force for six months after the promulgation. In consideration of the urgency and importance (of COVID-19), some provisions should be adjusted immediately and the penalty clause should be adjusted to one month of promulgation, and the provisions that define the definition of suspects, the self-containment facilities for suspected infectious diseases, and the provision of overseas travel history information provisions should be promptly promulgated, and the relevant penalties need to be adjusted one month after the promulgation".
- Policy
- Full inspection on BTX manufacturers and vaccine distributor
- by Lee, Tak-Sun Feb 24, 2020 06:23am
- Korea's Ministry of Food and Drug Safety (MDFS) plans to pin-point inspect 'botulinum toxin manufacturer' and 'chicken pox vaccine cold chain.' The focused inspection on biopharmaceutical would be completed by the first quarter. MFDS posted the 'Biopharmaceutical Manufacturer and Distributor Management Master Plan 2020 (biopharmaceutical, Korean medicine (herbal medicine), cosmetics, quasi-drug, and human tissue) on its website on Feb. 18. ◆ Special inspection on botulinum toxin and chicken pox vaccine cold chain: For the subjects of the focused inspection, MFDS headquarter and regional offices would audit botulinum toxin product manufacturer for their manufacturing and quality control in the first quarter. Currently, Medytox, Daewoong Pharmaceutical, Hugel, Huons, Pharma Research Bio, and BMI Korea are the six licensed botulinum toxin manufacturers in Korea. And the ministry plans to inspect all of them. Based on the report by a whistle-blower, the health regulators inspected the manufacturing facilities of Medytox and found quality control issue, which the company had to recall the products for. The ministry decided to further inspect every botulinum toxin manufacturers and aims to improve the credibility of the biopharmaceuticals. Previously, the regulator used to focus the chicken pox vaccine cold chain inspection on distributor, but the regulator would, for this year, inspect all process of cold chain from distributor to healthcare institute to confirm quality maintenance system and to seek improvement measures. Within the first quarter, the ministry headquarters, regional office and local government offices would cooperate to monitor the cold chain management of chicken pox vaccine. ◆ Regular inspection on seven biopharmaceutical GMPs: The three-year regular on-site inspection for the biopharmaceutical GMPs would be conducted as well. The subjects for this year’s regular inspection are Medipost (finished pharmaceutical product (FPP)), S. Biomedics (FPP), Eubiologics (FPP), CJ Healthcare (finished pharmaceutical ingredient), Corestem (FPP), Daewoong Pharmaceutical second plant (finished pharmaceutical ingredient) and TKM (FPP). ◆ Monitoring illegal advertisement of Saxenda-like self-injections: Charged for exaggerated advertisement in last year, appetite suppressant Saxenda injection and other prescribed self-injection’s mass media advertisement and illegal distribution would be monitored all year round. The mass media advertisement on poster, billboard, leaflet and online pop-up and banner ads on hospital, clinic and pharmacy website are subjects for monitoring. Also online advertisement, influencer advertisement and illegal online distribution through new media like social media channel, Youtube and Afreeca TV, are also subjects for the monitoring. ◆ Special inspection and quality test on respirator: Respirator, struggling to meet surged demand due to COVID-19, would be inspected thoroughly as well. Especially the manufacturers neglected from last year’s inspection for being temporary or permanent closed are included for this year’s inspection. The ministry would also monitor any toxic substance found in distributed respirator, and 90 cases of quality test conducted last year would be increased to 200 cases. The ministry and local government offices would cooperate and each test quality on 100 items all year. Online and offline retail stores would be monitored all the time as well.
- Policy
- NHIS fully inspects 1479 nursing facilities for COVID-19
- by Lee, Hye-Kyung Feb 21, 2020 06:36am
- National Health Insurance Service (NHIS, President Kim Yong Ik) has announced a plan to inspect all 1,479 nursing facilities and long-term care institutes to prevent spreading of COVID-19. From Feb. 17 to 18, NHIS has inspected all nursing facilities related to status of inpatient with pneumonia from unknown cause, staff and nurse with travel history of (visiting China, Hong Kong and Macau) removed from wards, and other compliance regarding COVID-19 prevention. As a follow-up measure of the long-term care institute safety control guideline, the complete inspection would be conducted on 312 institutes with foreign workers, and 754 long-term care institutes with workers who have traveled overseas in February. The long-term care institute inspection would focus on pre-training on related workers and inpatient and preventive rule compliance, management of foreign workers or local workers with travel history, testing and care for inpatient with pneumonia, and visitation control. President Kim Yong Ik stated, “As a preemptive measure to shut off spreading of COVID-19, the agency would fully inspect long-term care institute and nursing facilities to further secure patients’ safety.”
- Policy
- Stivarga renews RSA and Azilect lowers pricing by 30%
- by Kim, Jung-Ju Feb 21, 2020 06:36am
- By renewing an expiring risk sharing agreement (RSA) with National Health Insurance Service (NHIS), Bayer Korea has decided to lower the maximum reimbursed price for metastatic colorectal cancer and gastrointestinal stromal tumor (GIST) treatment Stivarga 40 mg tablet (regorafenib) by 7 percent. And the health regulator has authorized pricing reduction on idiopathic Parkinson’s disease treatment Azilect tablet (rasagiline msylate) by 30 percent. Korea’s Ministry of Health and Welfare (MOHW) plans to reflect the changes on the List of Reimbursed Drugs and Maximum Reimbursed Price. Although most of the changes would come in effect from Mar. 1, some changes would be enforced from different dates due to individual issues. ◆ RSA-renewed drug: Bayer’s Stivarga has successfully renewed soon-to-be expiring RSA with NHIS on the 40 mg tablet, indicated to treat metastatic colorectal cancer, GIST, and hepatocellular carcinoma (HCC). Stivarga 40 mg tablet took the refund type RSA track from June 1, 2016, and received reimbursement in Korea. The original RSA, typically lasting for four years, was expected to expire on coming May 31. The current reimbursed price is at 36,608 won, and the company has agreed to lower it by 7 percent to 34,045 won after renewing the negotiation. The lowered pricing would be applied from June 1, when the renewed agreement comes in effect. Accordingly, Korea now has three RSA-renewed drugs including Stivarga. Merck’s metastatic colorectal cancer treatment Erbitux (cetuximab) and Astellas Pharma’s metastatic prostate cancer treatment Xtandi (enzalutamide) have also renewed their agreements. ◆ Pricing reduction by increased volume: The maximum reimbursed pricea for Betmiga (migabegron) 50 mg and 25 mg tablets would be lowered as they are now subject for Price-volume Agreement (PVA) negotiated with NHIS. The government manages post-marketing pricing with PVA for drugs exceeding initially estimated volume and claimed amount. Under the PVA system, their prices are renegotiated and brought down. The tablet took the Type Na (나) PVA for the negotiation. Type Ga (가) PVA applies to a new drug listed with pricing negotiation, but had claimed volume over 30 percent higher than the estimated volume. For the agreement, the item has to have same company name, administration method, substance, and formulation as when it was first listed. The Type Na PVA, applied to Betmiga, is for new drug either price adjusted by Type Ga or four years passed since listing date, and accumulated claimed volume surpassed the estimation by 30 percent. It also applies when a drug’s accumulated claimed volume in a year is surged by 60 percent from the previous year, or is increased by 10 percent but the increased amount is over 5 billion won. The negotiated pricing each lowered the original prices by 5.9 percent. The maximum prices of 50 mg tablet and 20 mg tablet was dropped from 757 won to 712 won, and from 505 won to 475 won, respectively. .The new pricing would take in effect from Mar .1 .Meanwhile, another drug’s pricing would be lowered early due to expanded indication .Based on analysis of estimated additional claimed volume and the increase rate, Takeda Pharmaceuticals Korea has agreed to reduce the pricing of Adcetris (brentuximab) .Coming in effect from March, the current price of 3,262,400 won would be reduced by 3.6 percent to 3,144,953 won .◆ Government-authorized changes: Due to generic’s reimbursement listing, total ten originals or drugs with same administration method, ingredients and formulation as an original would have their maximum price brought down by the government from Mar .1 .When a first generic is listed for reimbursement, the government applies so-called ‘half-price,’ or 53.55 percent of the original’s price, on the generic .But it applies weighted pricing of 70 percent of the original’s for the first year from the point of listing .And the weighted pricing is sustained, even after a year, when there are less than three companies supplying items in the same class .The pricing is kept until the number of companies reaches over four .The prices of Lundbeck Korea’s Azilect 1 mg tablet and 0.5 mg tablet would fall by 30 percent from 3,501 won and 2,348 won to 2,451 won and 1,643 won, respectively .And the price of Lily Korea’s osteoporosis treatment Forsteo (teriparatide) has also dropped by 30 percent from 326,358 won to 228,451 won .Dong-A ST’s osteoporosis treatment Teribone SC injection 56.5 μg (teriparatide acetate) would be priced 22.2 percent lower from 73,287 to 57,001 won .Except for Forsteo, other drugs’ weighted pricing would be eliminated from next Feb .1 .The ‘half-price’ would be applied from then on .◆ Raised maximum price and voluntarily-reduced drug pricing: Prices of seven items, designated as radiopharmaceuticals, would be significantly raised from Mar .1 to secure consistent supply in Korean market .The government either accepts raised maximum pricing of radiopharmaceuticals and National Essential Drugs, or compensates for the raised pricing by negotiating with NHIS .The price of Korea Atomic Energy Research Institute’s Kaeri MIBG (1311) injection (2-iodobenzyguanidine (1311)) would be raised slight or exponentially by 0.4 percent of 120.6 percent, depending on the dose .Some other items are voluntarily lowering their prices to better compete in the market .The following six items are the case; Dong Kook Pharmaceutical’s antidepressant Dulcerin capsule (duloxetine hydrocholoride) in two doses, Dong Wha Pharm’s severe hand eczema treatment alitno soft capsule (alitretinoin) in two doses, Pharmbio Korea’s chronic pancreatitis quick symptom reliever Foichol 100 mg tablet (camostat mesilate), Hanmi Pharmaceutical’s HIV-1 infection and chronic hepatitis B virus treatment Tefovir tablet (tenofovir disoproxil phosphate) .Dulcerin 30 mg and 60 mg capsules’ would be lowered by 4 percent and 6.7 percent, respectively .Hanmi Pharmaceutical’s Tefovir tablet price would be lowered by 17.5 percent from 2,910 won to 2,400 won .
- Policy
- Generic drug for Lipiodol was approved
- by Lee, Tak-Sun Feb 21, 2020 06:35am
- Guerbet KoreaThe generic drug of Lipiodol, a special contrast agent which was controversial due to a demand for price increase by the seller, received an item license. Lipiodol may not be able to treat patients in the event of a supply disruption, since there have been no drugs of the same composition so far. With the approval of the generic drug, it is expected that the anxiety problem will be solved. The Ministry of Food and Drug Safety approved the Dongkook’s generic for Lipiodol (Iodized oil; ethyl esters of the iodised fatty acids of poppy seed) on 11th. This product was made by Dongkook Pharmaceutical, which has a high market share in the contrast medium market. Similar to Lipiodol, it is used for lymphography, salivary gland imaging and transarterial chemoembolization (TACE) in liver cancer. Lipiodol's supply disruption happened in 2018. At that time, Guerbet Korea, which sells Lipiodol, applied for drug price adjustments that said supply could be stopped if price increases were not premised due to a surge in overseas demand. At that time, the patient groups condemned Guerbet Korea for proceeding with drug price negotiations by taking patients as hostages, and the MFDS reviewed the emergency introduction (import through Korea Orphan & Essential Drug center without permission) in preparation for the supply disruption. In the end, however, the government raised the price of Lipiodol. The drug price was set at ₩190,000/10mL, which was more than three times higher than the previous August (₩52,560/10mL). There was no drug to replace Lipiodol, and It was essential medicine for patients with liver cancer. Yong-ik Kim, chairman of the NHIS, who concluded the drug price negotiations at the time, said, “We set the price at a much lower level than that suggested by the pharmaceutical company. Supply is also expected not to be difficult in the next few years”. Contrary to government evaluations, some criticized the fact that some raised their hands on the domineering of pharmaceutical companies that dominate the market. Lipiodol currently has no patents registered with the MFDS. As such, Dongkuk Pharm has no hurdles in selling generic drugs after the listing.
- Policy
- Hospitals & pharmacies will get COVID-19 benefit early
- by Lee, Jeong-Hwan Feb 20, 2020 10:41pm
- The Minister of Health and Welfare, Neung Hoo Park, noticed the implementation of an early payment within 10 days after the application for the medical expenses paid by hospitals, clinics and pharmacies which were damaged or involved in COVID-19. It will also suspend various investigations and examinations for medical institutions for a certain period of time, and will provide an environment in which it will do its best to protect COVID-19 by exempting the reduction of manpower standards due to the operation of screening clinics. On the 18th, the Minister Neung Hoo Park responded to Sang-hee Kim, a member of the Democratic Party of Korea's inquiry in the COVID-19 Business Report. Sang-hee Kim delivered on-site opinions to the Minister Neung Hoo Park on the 17th at the COVID-19 Expert Meeting with the Chairman of the KMA and the Chairman of KHA. Representative Kim urged the implementation of damage support measures, such as the lack of masks in medical institutions, the exemption system for early payment of medical benefit, postponement of various screening schedules for medical institutions, and the application of exceptions for non-compliance with general medical personnel standards. The Minister Park replied that he would operate the policy to accommodate all aspects. He said that it would be resolved by contracting with a manufacturer that produces 50,000 masks a week so medical staff can receive infection masks first, and early payment of medical benefit is also in progress and will be implemented soon. He also said, "We will also delay the screening schedule for medical institutions or reflect exceptions regarding the reduction of manpower in the standard of medical personnel to screening clinics".
- Policy
- MFDS reveals detailed clinical trial inspection plan
- by Lee, Tak-Sun Feb 20, 2020 06:35am
- Korea’s Ministry of Food and Drug Safety (MFDS) plans to conduct extensive inspection on clinical trial regarding pharmaceutical approval. The subjects are new drugs and drugs required to submit evidential data. Accordingly, pharmaceutical companies, CRO, and healthcare institutes would be investigated by Clinical Trial Management Division of MFDS. But, bioequivalence test covered under Good Clinical Practice (GCP) would be investigated by Pharmaceutical Equivalence Division and MFDS Regional Office as usual. As of Feb. 11, MFDS disclosed ‘Master Plan 2020 for Pharmaceutical Clinical Trial Audit and Inspection’ on its website. The plan specified ‘the authority would inspect clinical trial institute and sponsor (or CRO) to confirm their credibility of clinical trial and its outcome report.’ The plan stated, a sponsor or CRO who have been inspected in last two years would be exempted. And a clinical research institute would be exempted as well, if it has been inspected during a regular audit, or has been inspected more than three times in past one year. The research institute (principal investigator) would be inspected on followings; general details on clinical trial protocol approval and related contract; adequacy of clinical trial documented by principal investigator or research institute; adequacy of information exchange between principal investigator and institutional Review Board (IRB); adequacy of qualification and training of clinical trial related human resources; adequacy of principal investigator leading clinical trial; adequacy of consent by investigated subject; adequacy of recording and reporting data related to efficacy and safety evaluation; adequacy of managing pharmaceuticals used for clinical trial; and adequacy of laboratory information and human sample management. Sponsors (or CRO) would be inspected on followings; general details of clinical trial (schedule by each phase); adequacy of sponsor’s clinical trial document, standard operating procedure (SOP) system, documentation and management; adequacy of sponsor organization and human resources; adequacy of clinical trial development, protocol, and preparation stages; adequacy of sponsor conducting and managing clinical trial (CRO designation and supervising); adequacy of pharmaceutical quality control for clinical trial-use; adequacy of laboratory information and human body sample management (if applicable); adequacy of monitoring work; adequacy of data management; adequacy of analyzing statistics; adequacy of quality control system and audit task; adequacy of adverse reaction assessment system; and adequacy of protocol, final report and other medical writing. Some had expected that the extensive inspection would target all types of clinical trials executed for pharmaceutical approval, including bioequivalence test. But the Clinical Trial Management Division at MFDS confirmed it would only target new drugs and items required to submit documents. Bioequivalence test would not be a part of Clinical Trial Management Division’s inspection. Instead, MFDS Pharmaceutical Equivalence Division and Regional Offices would be in charge of post-management. Bioequivalence test has never been a part of clinical trial inspection. MFDS official explained, “Regular inspection on bioequivalence test has been discontinued, but it is conducted when needed. Healthcare institute, analytic institute and manufacturing company are all applicable for the inspection.” The industry, however, advises pharmaceutical companies, CRO and healthcare institutes running bioequivalence test should prepare for MFDS’ inspection, as it has been managed under Korea Good Clinical Practice (KGCP) from 2017, and the Bioequivalence Test Management Standard has been abolished from last October. An industry insider explained, “For previous bioequivalence test inspection, only the institute analyzing human body sample used be the subject. But as MFDS is tightening the regulation based on KGCP, pharmaceutical companies, CRO, and healthcare institute should also reinforce self-inspection capacity to generally improve clinical trial quality than only focusing on analysis.” The insider specifically suggested, “Small and medium pharmaceutical companies lacking inspection staff should also enhance audit capacity. Entrusting the inspection work to CRO could be a solution.”
- Policy
- If the MFDS followed the EMA instead of the FDA for Belviq
- by Lee, Tak-Sun Feb 19, 2020 06:33am
- Appetite suppressant At the time of approving Belviq, banned by the MFDS on the 14th, it would be regrettable that it had not been approved in accordance with the European EMA's decision. The European EMA disagreed with the approval due to side effects from animal testing, and the developer voluntarily withdrew the application. The US FDA, on the other hand, approved it in June 2012, subject to post-marketing studies on cardiovascular risk. Belviq was licensed in Korea through Ildong, an importer, in February 2015. In April of last year, Belviq XR was approved. Belviq was designated for re-examination at the time of domestic approval and was ordered for post-marketing investigation for six years from February 2015 to February 2021. Developed by the US Arena Pharmaceuticals, Eisai owns all rights in the United States, and Arena owns all rights in Europe and Asia. In 2012, Ildong gained copyright through a contract with Arena. The MFDS issued an order to suspend sales and recall in Korea on the 15th, referring to the US FDA's withdrawal order for Lorcaserin. U.S. distributor Eisai is reportedly withdrawing from the United States. As a result, Ildong Pharmaceutical, a domestic seller, is expected to exit the market by returning the permit. All items on the market will be recovered. Belviq's problem is the risk of developing cancer. The U.S. FDA reviewed CAMELLIA-TIMI 61, a clinical trial conducted by Eisai, and concluded that the longer the treatment period, the greater the incidence of cancer compared to the placebo group. In the past five years, over 12,000 patients with high cardiovascular risk were overweight or obese, and 520 cases of primary cancer were diagnosed in 462 patients (7.7%) in the Lorcaserin group and 470 cases, 423 patients (7.1%) in the placebo group. In particular, the incidence of some types of cancer, such as pancreatic cancer, colorectal cancer, and lung cancer, was higher in the Lorcaserin-administered group than in the placebo-administered group. In fact, Belviq's issue was whether it was safe in cardiovascular disease. This is because the obese drug Sibutramine has been withdrawn from the market due to side effects of 'cardiovascular disease'. Eisai also conducted a post-marketing investigation with an emphasis on cardiovascular safety. As a result of the 'CAMELLIA-TIMI 61' clinical trial, the annual incidence of cardiovascular events (MACE) was 2.0% in the Belviq group (Lorcaserin 10mg, twice daily), and 2.1% in the placebo group. The risk of adverse effects on the cardiovascular system was negligible. But because of the unexpected side effects of developing cancer, Belviq eventually got stuck. Earlier, the European EMA rejected Belvik's approval in an animal trial in late January 2013 for side effects such as tumor induction, heart valve disorders and mental illness. Although it was not related to the human test, it was the conclusion that the results of animal experiments were actively reviewed. On January 16, the FDA announced that it would review the issue of cancer, and the MFDS announced that it would distribute safety letters to review domestic and international permits and usage. In the meantime, information on cancer incidence increased in animal experiments is reflected in the permit, and the association with humans is unknown. However, the fact that the incidence of cancer has increased in animal experiments is not included in the Belviq permit, which was granted in February 2015, but in the Belviq XR, which was granted last year. This is why the MFDS has been actively aware of the issue at the time of its approval. If the agency had listened to the European EMA decision and not the US FDA, the risky drug would not have been used in the patient. Belviq was launched in Korea in the first quarter of 2015 and recorded sales of ₩13.6 billion in IQVIA, ₩15 billion in 2016, ₩12.2 billion in 2017, and ₩9.8 billion in 2018. While selling more than ₩50 billion, no measures were taken in Korea.
- Policy
- MOHW to require reimbursement negotiation for generic
- by Kim, Jung-Ju Feb 19, 2020 06:32am
- Even generic drugs, reimbursed pricing decided according to set formula, would have to negotiate with the insurer about the insurance benefit. The government is aiming to establish legal basis to prevent companies evading pricing reduction by listing the same drug as another, and also to require post-management. Basically, the revision is constructing legal foundation for further drug pricing system revision. Korea’s Ministry of Health and Welfare (MOHW) posted a draft of revised ‘Regulation on National Health Insurance Reimbursement Standard’ on Ministry of Government Legislation’s board. The draft has been more specified than the version unveiled at Health Insurance Policy Deliberation Committee’s (HIPDC) subcommittee meeting in last December, as a part of this year’s drug pricing system revision plan. MOHW would improve generic drug pricing system by mandating negotiation track for generics, currently exempted from pricing negotiation before reimbursement listing, to fine-tune contract terms, and by preventing companies to wiggling out of pricing reduction penalty. Also the revision would stipulate the government to authorize maximum reimbursed price as well. The draft focuses on four following issues; improving reimbursement decision-making principle with detailed pharmaceutical reimbursement deciding principles and prioritization system; stipulating rejection on reimbursement applicant evading drug pricing reduction penalty; unifying pharmaceutical reimbursement application procedure; and establishing government-authorized track and revising related procedure. First, the government plans to set detailed reimbursement deciding principles and implement pharmaceutical reimbursement prioritization system. With the changes, the government would be able to decide on listing items considering sustainability of limited National Health Insurance resources. At the same time, the changes in detailed principle and prioritization system would be stipulated on the regulation. Another new regulation would stipulate the government regulator rejecting pharmaceutical companies avoiding drug pricing reduction. When the change is finalized, the government regulator could legally shut off a company penalized to reduce drug pricing for providing illegal rebate but trying to evade it by applying for reimbursement as another item under company’s subsidiary. The pharmaceutical reimbursement listing procedure would be unified as well. All drugs that passed reimbursement feasibility review would have to complete negotiation within 60 days and decide on an outcome. This would legally require a generic item, or non-negotiated drug automatically priced by set formula, to negotiate with National Health Insurance Service (NHIS). NHIS not only negotiates reimbursed price of a new drug, but also handles contract regarding supplier’s responsibility, patient protection (accessibility) and financial stability. And the insurer would be able to include generic in their scope as well. A pre-negotiation with the president of NHIS could be conducted, for the manufacturer to flawlessly process the actual negotiation procedure. Also a new track would be available for pricing negotiation-exempted drug to expedite the negotiation procedure. Reporting to the Minister of Health and Welfare would follow after Drug Reimbursement Evaluation Committee (DREC) deliberation, and the result would be notified to the president of NHIS. The streamlined procedure seems to be the government’s solution to the new DREC changing the reimbursement listing procedure and requiring face-to-face briefing for DREC that slowed down the expedited non-negotiated track. The revision would touch up the government-authorized pricing calculation and listing procedure as well. The changes would apply for when reimbursement standard needs adjustment based on a change in label, overseas label and reimbursement status, and clinical evidence. This would also legally stipulate the listed drug reevaluation, the government is lately pushing on. In detail, the government could order a negotiation between NHIS and applicant company when it is needed for stable supply. But when the government authorizes the negotiation, the reimbursement decision would have to be made after it to properly reflect the amended listing procedure. Considering the drug pricing system revising plan the government has, the above changes would be specified and finalized before the second half of the year.
- Policy
- NSCLC targeted therapy Vizimpro approved in Korea
- by Lee, Tak-Sun Feb 18, 2020 06:35am
- Pfizer Pharmaceutical Korea’s non-small cell lung cancer (NSCLC) targeted therapy Vizimpro has been approved to market in Korea. The treatment is a second-generation targeted therapy like Boehringer Ingelheim’s Giotrif. On Feb. 14, Ministry of Food and Drug Safety (MFDS) has approved Pfizer Pharmaceutical Korea’s three Vizimpro tablets (dacomitinib) in 15 mg, 30 mg, and 45 mg doses. The treatment has been indicated as a first-line therapy for locally advanced or metastatic NSCLC patients with epidermal growth factor receptor (EGFR) gene deletion in exon 19 or exon 21 L858R substitution mutations. AstraZeneca’s Tagrisso also shares the same indication. Apparently, EGFR is overexpressed in more than 70 percent of NSCLC patients, which affects proliferation of cancer cells and metastasis. EGFR tyrosine kinase inhibitor (TKI) targeted therapy generally defines all treatments with mechanism of using a molecule to block EGFR in cells. The EGFR TKI even has third-generation targeted therapy that overcame the initial tolerance in earlier drugs. AstraZeneca’s Iressa (gefitinib), Roche’s Tarceva (erlotinib) are first-generations, Boehringer Ingelheim’s Giotrif (afatinib) is a second-generation. And AstraZeneca’s Tagrisso (osimertinib) is a third-generation. Lazertinib, currently in development by Yuhan, is also a third-generation EGFR TKI treatment. Newly approved Pfizer’s Vizimpro is in the same class of second-generation EGFR TKI as Giotrif. However, it would also compete straight against Tagrisso as well, because they share the same indication. But Tagrisso’s reimbursement has not been cleared for first-line treatment. In a transnational clinical study with 452 patients, Vizimpro demonstrated statistically meaningful improvement in progression-free survival, compared to that of gefitinib. Sub-analyzing Asian-region patient group treated with the second-generation targeted therapy, the median progression-free survival was recorded at 16.5 months, whereas the first-generation gefitinib group was at 9.3 months. The pharmaceutical industry predicts the follow-on EGFR TKI treatment Vizimpro would set lower pricing than predecessors to ease into the market. The targeted therapy has won the U.S. Food and Drug Administration’s approval in September 2018.
