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- 2026-05-21 00:08:30
- Company
- Boryeong’s copyright of anti-cancer drug,commercial value↑
- by An, Kyung-Jin Dec 27, 2019 06:28am
- The anti-cancer drug 'Zepsyre', which is owned by Boryeong in Korea, has entered the early stage of commercialization. PharmaMar, the original developer, is expected to secure the first FDA indication for small cell lung cancer by August next year. The company also won a large contract worth up to ₩640 billion to surpass the US copyright, which is expected to be released the fastest. Boryeong signed a domestic exclusive promotional license agreement for Zepsyre from PharmaMar in November 2017. In 2016, the company signed a monopoly on sales and development of a myeloma treatment drug, Aplidin, to build a strong partnership. According to the industry on the 26th, Borm Pharmaceutical's partner, Spanish PharmaMar, recently signed a monopoly license agreement with jazz pharmaceuticals’ Lurbinectedin. Lurbinectedin is the ingredient name of 'Zepsyre', an ovarian cancer drug introduced by Boryung in November 2017. It selectively exhibits anticancer activity by inhibiting the cause of cancer. It is a mechanism that selectively inhibits the oncogenic transcriptional processes activated in cancer cells and tumor-associated macrophages (TAM) and causes cell death by cutting DNA double strands. With the deal, PharmaMar secured a $200 million deposit (approximately ₩232.2 billion) from Jazz with no obligation to return. When Zepsyre is licensed to sell the US Food and Drug Administration (FDA), it will receive up to $250 million in additional technology charges (milestones). In the future, commercial milestones were guaranteed up to $550 million in technology fees and sales royalties ranging from late 10% to 30%. Jazz is a well-known company that is a partner of 'Sonosi (Solriamfetol)', a sleep disorder new drug exported by SK Biopharm. In the industry, Jazz has secured a huge short-term milestone from Zepsyre's US market potential. PharmaMar submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) on the 17th, based on the results of the second phase clinical trial of Zepsyre. According to PharmaMar's announcement of the American Society for Clinical Oncology (ASCO 2019) in June, patients with small cell lung cancer who received Zepsyre had a significant improvement in tumor response rate (ORR) of 35.2% compared to currently available Topotecan (16.9%). In addition to small cell lung cancer, various cancers including ovarian cancer, head and neck cancer, and BRCA mutation breast cancer are being actively researched. In recognition of this potential, the company signed a licensing agreement with Luye pharmaceutical of China (including Hong Kong and Macao) in April of this year. PharmaMar's executives are confident in the FDA's rapid approval. Small cell lung cancer monotherapy, a rare disease with high unmet demand, has secured positive clinical results. Zepsyre was designated by the FDA in August last year as a rare drug for small cell lung cancer. PharmaMar expects to receive the FDA's final approval in mid-August when the document is completed early next year and undergoes a six-month quick review process. Since then, the aim is to expand the indications to various carcinomas including ovarian cancer, head and neck cancer, and breast cancer. Bruce Cozadd, Chief Executive Officer of Jazz Pharmamaticals, said, “The treatment is limited in patients with advanced small cell lung cancer. The agreement is significant because it expands the jazz anticancer pipeline and later stage assets”.
- Company
- Discontinued sales of Champix generics
- by Kim, Min-Gun Dec 27, 2019 06:27am
- Anti-smoking drug Champix by Pfizer KoreaPfizer's Champix (Varenicline) salt-changing patent disputes have resulted in the loss of more than 20 domestic pharmaceutical companies, which has resulted in the suspension and recovery of generic drugs. According to the industry on the 24th, Hutecs Korea, C-tri, Danajen announced that they will be discontinued due to the result of a material patent evasion lawsuit by salt change of Champix This is because the patent court recently decided that “Champix generic anti-smoking drugs belong to products that differ from champix in the scope of the original material patent rights”. The ruling halted sales and prescriptions of generic products in response to a preliminary order to prohibit patent infringement. Increasingly, pharmaceutical companies are withdrawing from the market. Hutecs has discontinued its sales of 0.5mg (11 tablets, PTP packaging) and 1mg (28 tablets, PTP packaging) sold by the company. “It was due to the loss in the patent evasion litigation by changing the champix salt”, the company explained. In addition, Hutecs requested to block the code so that it is not sold to wholesale trade or nursing homes and to treat as a normal return although not subject to compulsory recall but due to discontinuation. C-tri has decided to discontinue the production of 0.5mg and 1mg of nicotine tablets. C-tri announced that there will be no future reproduction after the stock runs out and excluded from contract sales items. Danajen also stopped selling 0.5mg and 1mg of its Nicotine tablets on the 20th and began to collect all items. Danajen decided to complete the collection by the 15th of next month. In addition to coverage result of Dailypharm, the top domestic pharmaceutical companies that sell Champix generics have withdrawn from the market or are doing the same action. JW Shinyak, Chong Kun Dang, Daewoong Pharmaceutical, and Il Dong Pharmaceutical Co., Ltd ceased production and marketing. One of the pharmaceutical companies said, “We stopped prescribing and selling on the 23rd and will start returning products to pharmacies in the future, Other pharmaceutical companies also blocked both orders and sales”. An official from the PR team in Korea, who had completed the recall, said, “After the solicitation of Solifenacin, we finished preparations for the suspension and recovery early. Some pharmaceutical companies are quick to determine the profitability compared to marketing costs because they are unable to use the strategy to avoid salt changes”. On the other hand, there were some companies still watching the situation. A public relations executive at a mid-size pharmaceutical company said, “The sales department continues to sell, and we have not taken action yet”.
- Policy
- 'Brakes' on reimbursed drug’s listing process
- by Lee, Hye-Kyung Dec 27, 2019 06:27am
- This year, the insurance authorities were able to reorganize their drug price system to the organization of the person in charge of drug prices. Last year, The NHIS chairman Yong-ik Kim, who designed Moon Jae-in Care, was very active, and this year, there have been a number of institutional improvements that have been carried out by staff in charge of implementing the policy. In the drug sector alone, there were many big and small things happening, including the expansion of screening benefits and RSA drugs, and the creation of contracts that included supply obligations prior to drug price negotiations and patient protection and confidentiality. As the HIRA manages the health insurance finance, it has to focus on the income expansion to support the policy of strengthening security and the task of spending expenditure efficiency. If the focus has been on finding new drug-based follow-up management plans, next year, it will continue to seek ways to improve the 'price-volume agreement' that has been spinning the wheels with research services several years ago. The HIRA reviewed the revised economic evaluation guidelines and reference methods for foreign drug prices until the second half of this year to improve the drug listed system. In August, the RSA target was expanded from cancer and rare diseases to severe and intractable diseases, and the severe atopic dermatitis, Dupixent, will be paid from next January. ◆Enhancing Access to Medicines by Moon Jae-In Care= This year, the first case of drug screening benefits was released. In order to strengthen health insurance coverage, six types of anti-cancer drugs, which had no reimbursement standard or remained as 'baseline non reimbursement' at 100% of the copayment rate, were selected as a screening benefit. The protagonists of the first screening benefits include breast cancer treatments ‘Perjeta (Pertuzumab)’, ‘Halaven inj (Eribulin)’, Prostate Cancer Therapeutics, ‘Xtandi soft cap (Enzalutamide)’, and ‘Zytiga (Abiraterone)’. RSA targets for late-release drugs were also expanded. Dupixent, which was not an anticancer drug or a rare disease treatment drug, had difficulty in applying RSA expansion, but the health insurance policy review committee decided to complete the reimbursement registration process on the 23rd. The MOHW applies a special calculation to reduce the incurable cost of medical expenses (20~60% → 10%) for rare and incurable diseases, and expanded the target diseases. In January of this year, The MOHW identified 100 rare diseases and included them in the exception, and added 91 new rare diseases in the second half of this year. In the case of medicines, health insurance coverage is being expanded to focus on the treatment of serious diseases such as anticancer drugs and rare diseases. Compared to 2016, anti-cancer drug spending rose 41% from ₩1.47trillion to ₩1.46trillion in 2018, and rare disease treatment spending increased 81% from ₩235.2 billion to ₩4265 billion. During the same period, the drug cost growth rate exceeded 19%. This year, a new high-priced drug called Spinraza, which costs ₩560 million for the first year and ₩280 million from the next year, will cost ₩92.35 million per vial per patient. It is also a significant year for reimbursement listing under both total contracts system and RSA. ◆Reorganization of departments related to drug price in the HIRA=The organizational reform of the department in charge of drug prices in the HIRA, which was in charge of the implementation of Moon’s care, was an issue. The HIRA changed the existing insurance reimbursement division to the reimbursement strategy division from January 1 through amendment of the Order Regulations and the Enforcement Rules of the Order Regulations, and increased the departments related to drug prices from two to three. Dr. Jong-Heon Park, former researcher, was appointed as the head of the reimbursement strategy division. Since the establishment of the Drug Price System Division, it has also lowered the threshold of 'secret drug price negotiations' by opening a foreign drug price inquiry guidelines bulletin board and opening the drug price negotiation drug. In July, the glass ceiling of the 2nd level pharmacy occupation promotion of the HIRA broken. In order to guarantee the opportunity for promotion of pharmacy jobs, which was stopped at Level 3, the HIRA has been reorganizing its personnel and organizational regulations since 2017. As a result, Nam-sun Shin, the head of drug price negotiations, a second-level manager was produced from the pharmaceutical industry. ◆The HIRA, fix the drug price system= Last year, the Economic Evaluation System Improvement TFT was operated to revise the economic evaluation guidelines for medicines. TFT focused on the comparative drug, ICER, utility, and discount rate that the pharmaceutical industry has pointed out. Based on the TFT report, the HIRA is publishing commissioned research announcements to develop guidelines and conducting research. The economic evaluation system was created in 2007 following the introduction of a drug screening system. Over the past decade, the Economic Evaluation Subcommittee of the Committee on Drug Benefit Evaluation has reviewed data of approximately 190 ingredients (80 times) based on economic evaluation guidelines. However, since the guidelines used to evaluate the economic feasibility have been applied since the beginning of June 2006 and only one revision was made in December 2011, the pharmaceuticals complain that the reality is not reflected. At the Fifth Health Insurance Policy Review Committee held on April 3rd, there was a brake on the decision to skip negotiations. Another issue is the decision to delay negotiations to negotiate during the April 3 meeting of the Health Insurance Policy Review Committee. At the time of the face-to-face screening process, 90-100% of the weighted average price of alternative drugs was accepted and drug price negotiations were skipped. Among the drugs envisaged by the Health Insurance Policy Review Committee, there was a brake on reimbursement such as antidepressant Agotine tablet of Whanin, Faslodex of breast cancer treatment of AstraZeneca Korea, and Alunbrig tablet of non-small cell lung cancer treatment of Takeda. This is because members of the Health Insurance Policy and Deliberation Committee have put in place conditions for the drug price agreement. The conditional resolution was foreseen to some extent from the time the Ministry of Health and Welfare switched all the drugs proposed to the Health Policy Review Committee to face to face examination. The MOHW raised the CJ Healthcare's K-cap tablet for gastroesophageal reflux disease to the Health Insurance Policy Review Committee on February 26, and decided on an internal policy to turn the face-to-face examination of drugs that had been settled through price negotiations. From this point on, a subsidiary agreement on 'performance of supply obligations' will be drawn up for all drugs undergoing drug price negotiations with the HIRA, and the 'pre-counseling system' will be actively operated until the Minister of Health and Welfare 's order for drug price negotiations. The HIRA has signed and managed a contract containing the same provisions, including 'Supply Obligations and Patient Protection' on 172 drugs of 59 pharmaceutical companies by October this year. It is necessary to negotiate in advance whether there is a drug that can be replaced by itself and how the supply will proceed in the future. In the research process conducted by the HIRA, the foreign drug price standard referred to in the process of listing domestic drug benefits is added from A7 (USA, UK, Germany, France, Italy, Switzerland, Japan) to A10 (additially Taiwan, Canada, Australia). When the results of the study suggest that they should be expanded. The movement has begun to improve this. Recently, the HIRA also added 'Post-Pharmaceutical Evaluation' and 'Herbal Drugs' to the Subsidy Commission of the Pharmaceutical Benefits Evaluation Committee. The new Sub-Committee on Subsequent Drug Evaluation will conduct post-evaluation of those drugs that have extended their coverage by anticancer drugs, rare drugs, and clinical usefulness, which are expensive drugs. ◆Yang-ho Cho ’s issue=n last July, the prosecution filed a warrant for arrest of the chairman of Hanjin Group, Cho, Yang-ho, for fraud, embezzlement, and duties. He also illegally borrowed a pharmacist's license and ran a pharmacy to violate the pharmacist law, and retrieval process begins for ₩100 billion in insurance financing. Six criminal detectives at the Southern District Prosecutors' Office investigated Cho's suspicion of escaping the inheritance tax, and have been accused of running a pharmacy illegally as a nominee for over 20 years. But, on April 8, when President Cho suddenly passed away, the trial proceedings have been disrupted including violations of the Pharmaceutical Affairs Law. At present, Mr. Cho's illegal pharmacy trial continues against Mr. Won, a pharmacist Lee, and his spouse Mrs Ryu , who conspired to commit the crime. Sue was suspected of violating pharmacological law by opening a pharmacy on the first floor of the company's annex under the name of pharmacist Lee, through Mr. Won and Mrs Ryu. ◆Field survey=Since this year, the self-check system has been expanded. The autonomous check system was introduced to allow the reviewers to detect and report unfair claims by informing the appropriate nursing institution of the possibility of unfairness of the reimbursement expenses already paid before the on-site investigation. Trial project from December 2017 ▲ Temporary mandibular joint shooting (1st) ▲ Increase of claims after divided use of injection (2nd) ▲ Violation of breast biopsy calculation standard ▲Pharmacy differential index and night addition error claim based on the results of the autonomous inspections in turn, the autonomous inspection system was introduced in earnest from November 1, 2018. The HIRA noted that such a problem was also pointed out by the State Auditor last year. The HIRA feels the necessity of reviewing administrative measures for improvement based on the type and billing amount. On the other hand, the NHIS has argued that employees of the HIRA should have the special judicial police right to eradicate operated hospitals by office manager, not a doctor. ◆Bending of the first ₩1 trillion in history= The NHIS announced the average rate of increase in the conversion index for nursing institutions on the 1st of next year at 2.29% (bending ₩1.47 trillion). Although it was determined to be slightly lower than 2019 (2.37%) in consideration of the subscriber's ability, financial integrity, and medical expenses growth rate, it recorded the first ₩1 trillion in sales. Next year's budget is estimated at ₩1.4688 trillion, with ₩434.9 billion for hospitals, ₩93.5 billion for dentistry, ₩66.9 billion for oriental medicine, and ₩114.2 billion for pharmacies. The rate of increase was 3.5% in pharmacies, 3.1% in dentistry, 3% in oriental medicine, and 1.7% in hospital, but the order of the distribution of bending shares was reversed. ◆DUR Advancement Pilot Project=The Drug Utilization Review (DUR) Advancement Pilot Project, which has been in progress since August 1st, was completed this month. The HIRA conducted a pilot project for 20 medical institutions (2 senior general hospitals, 2 general hospitals, 1 hospital, 4 clinics, and 11 pharmacies) in the second half of this year. Based on the results of 2018 DUR Research Plan for Advancement of DUR, the pilot project was undertaken to establish a comprehensive management system before and after drug use as well as to establish a compensation system. And there are two types of systems in which pharmacies participate: aftercare, allergy, and adverse event monitoring. ◆Drug serial number system= From January 1, the serial number system has been implemented. The average reporting rate for the first half of all distributors released in August was 89.1%, at the time of shipment, 2591 companies (96.4%) had a serial number reporting rate of more than 50%, and 98 companies (3.6%) had less than 50%. The appeals of 18 wholesalers were cited as a result of the request by the HIRA to 98 companies for administrative disposal. 80 unappealed or rejected complaints were selected as the final administrative disposal request companies and notified to the public health center. In the second half of this year, the administrative reporting criteria for the distribution number serial number of distributors have been raised from 50% to 55%. From July to December this year, after the first half of this year's accounting period, requests for administrative disposal of manufacturing import companies are applied from the serial number reporting rate in the second half of this year.
- Policy
- Severe atopic drug Dupixent listed, first benefit from RSA
- by Kim, Jung-Ju Dec 26, 2019 06:34am
- Sanofi Aventis' treatment for severe atopic dermatitis, Dupixent PFS 300mg (Dupilumab), will be listed next month after all of its reimbursment hurdles. Although it was not an anticancer drug or a rare disease treatment agent, there was a difficulty in expanding the RSA, but the government and the health authorities were able to follow this track as they decided to expand the RSA disease. The MFDS held a Health Insurance Policy Deliberation Committee this afternoon, saying Dupixent's reimbursement was resolved. Dupixent was the first to be listed due to the expansion of RSA diseases. According to the resolution, the drug is listed on the first day of next month as an RSA with a combination of initial treatment refund type, refund type and total limit type. The reimubrsed price is ₩710,000 per syringe. The RSA initial treatment reimbursement type included in this drug contract is the reimbursement by the pharmaceutical company to the NHIS for the initial period of time. In addition, the refund type refers to the pharmaceutical company refunding a certain percentage of the drug bill to the NHIS, and the total limit contract is the mechanism by which a pharmaceutical company refunds a certain percentage of the amount to the NHIS if the actual amount exceeds the pre-set annual expected cap. Dupixent entered the domestic market in earnest with the approval of the MFDS on March 30 last year. Following the application for insurance registration on Feb 22 this year, the Pharmaceutical Benefits Evaluation Committee (Pharmaceutical Committee) was determined to be eligible for RSA on July 25. Later, on October 10, Formulary approval was recognized. The drug price negotiations with the NHIS were held from Oct 22 to Dec 17. At the time of deliberation, the textbook and clinical guidelines indicated clinical usefulness in severe atopic patients who were not adequately controlled or recommended by local or systemic immunosuppressants. Indeed, the cost of one-day administration is more expensive than alternative drugs, but the cost-effectiveness is considered to be acceptable through additional RSA and economic evaluation. Looking at the prices of major seven countries (A7) referring to the prices, they are listed in the United States, Italy, the United Kingdom, France, Germany, and Japan, and the A7 foreign drug prices (adjusted average price) are set at ₩ 971,661 per syringe. Meanwhile, the annual fiscal expenditures (estimated billings) presented during the drug price negotiations with the NHIS are about ₩76.2 billion.
- Policy
- Unpaid medical benefits “fully solved next month”
- by Kim, Jung-Ju Dec 26, 2019 06:31am
- The government reflected the unpaid medical benefits in the budget of ₩100 billion in next year's budget. Most of this year's unpaid payments have been resolved, and the unpaid payments of nursing institutions, which appeared at the beginning & the end of the year, are being resolved somewhat. However, dues are reflected in next year's budget, and may occur partially in some regions. The MFDS said in a recent question by the Professional Reporters Council that the unpaid medical benefits to be received by nursing homes this year have been resolved by supplementary budget, and the budget has been secured by reflecting the expected unpaid payments next year. The medical care budget for next year is about ₩7 trillion, an increase of ₩600 billion from ₩6.4 trillion this year. The reimbursement per capita has increased by more than 16%, the MFDS said that it was first reflected in the budget to prevent unpaid payments. Looking at the budget by year, it is increasing by ₩4.59 trillion in 2015, ₩4.81 trillion in 2016, ₩5.24 trillion in 2017, and ₩5.61 trillion in 2018. Nursing institutions, including pharmacies and other hospitals, have complained of difficulties in management due to the delayed payment of medical benefits for several months at the beginning & the end of the year. According to the MFDS, Ministry of Health and Welfare Committee Seung-Hee Kim's report presented at the National Audit, the unpaid medical benefit in 2018 was ₩869.5 billion, the highest ever. This is an increase of ₩430.9 billion (98%) compared to 2017, which is doubled compared to last year. As a result, the unpaid amount reflected in next year's medical benefit budget amounted to ₩108.7 billion. However, the MFDS explained that due to the portion reflected in next year's budget, the unpaid amount may be partially generated in some attempts. The Ministry of Health and Welfare said, “We expect little delay in payment every year, and the nursing institutions like pharmacies and hospitals would take a breather”.
- Product
- Oral treatment by Sanofi has the highest number of defects
- by Kim JiEun Dec 26, 2019 06:30am
- Ten defects were found in the same product of the same company a year The Seoul Pharmaceutical Society (Chairman Dong-ju Han), the pharmacy committee (Vice chairman Yong-seok Choi, Head Commissioner Woo-young Chang, Soo-hyun Byun, and Tae-seok Kang), and the Pharmacist Guidance Committee (Chairman Kyung-Jin Jeon and Soo-Yul Lim) announced the results of the submission of bad drugs this year. The Seoul Pharmaceutical Society has received reports from member pharmacies since this year by promoting the operation of the bad drugs report center. According to the Seoul Pharmaceutical Society, a total of 174 cases were received and processed at 70 member pharmacies in 24 Seoul branches. The most common types of defective drugs received were simple damages (33 cases), including ▲shortage of 17 cases, ▲poor PTP packaging, ▲12 poor tablets wear, ▲8 poor inspections, ▲8 poor tablet and poor coating, ▲ Seven PTP and bad inspection ▲4 bad inspection, ▲4 bad sealing, ▲4 bad containers, ▲Three poor granulation and bad tablets. In addition, there were discoloration and change of appearance, mixing of other products, mixing of foreign materials, poor filling, and excessive quantities. The Seoul Pharmaceutical Society received the most reports with 10 cases of oral infectious drugs by Sanofi. It recently announced that a recovery action was requested for the serial number and expiration date. In addition, a total of 136 items were reported. The Seoul Pharmaceutical Society receives a reception for defective drugs through text messages (Tel: 010-3568-5811), and the member pharmacy receives the name of the department, the name of the pharmacy, the name of the pharmaceutical company, the name of the drug, the manufacturing number/expiration date, and the bad drug picture. The pharmacy society asked for information from member pharmacies as it could be used as a basis for data accumulation even when pharmacies and pharmaceutical companies (wholesalers) provided their own drugs. They also pointed out that even though there are many cases of drug shortages in pharmacies, it is not easy to pass on because of lack of proof. In this case, they also asked for active reporting. Chairman Dong-ju Han said, “Defective drug notification serves as an important stepping stone to improve the quality and to ensure the safety of patients by identifying the cause and preventing recurrence and awaits the participation of member pharmacies”.
- Company
- Kyowa Kirin Korea appoints Lee Sang Heon as next CEO
- by Eo, Yun-Ho Dec 26, 2019 06:30am
- 이상헌 신임 사장 On Dec. 20, Kyowa Kirin Korea announced the promotion of current Chief Operating Officer Lee Sang Heon (54) as a Chief Executive Officer from Jan. 2, 2020. Graduated from Seoul High School and Yonsei University majoring in bioengineering, soon-to-be CEO Lee Sang Heon had experience in marketing and business alliance in Boryung Pharmaceutical and JW Pharmaceutical. Since April of 2010, Lee joined Kyowa Kirin Korea as a director of management and planning and successfully served his role in business management, project development, and compliance. After being promoted as an executive managing director in 2017, CEO Lee was later appointed as COO and contributed Kyowa Kirin to secure its market leadership in the special disease treatment sector like hemato-oncology and nephrology in Korea. The current CEO Na Jong Cheon is to resign at the end of 2019.
- Policy
- Moon Care on new drug and generic pricing in 2019
- by Kim, Jung-Ju Dec 26, 2019 06:29am
- The Moon Jae-in administration’s ambitious Moon Jae-in Care has directly affected the drug pricing system, essential to the insurance coverage. The healthcare coverage enhancement policy lowered the threshold of new drug listing standard, but further complicated the post-marketing drug pricing system. Also Ministry of Health and Welfare’s (MOHW) had its pharmaceutical benefit sector to concentrate their drug pricing capability on the designing of the technicalities of the healthcare policy. Lowered threshold, but complicated post-marketing evaluation for all-around management of generic and new drug The impact of the groundbreaking insurance coverage enhancement program by the Moon Care has struck down on the general drug pricing system this year. In the beginning of the year, the government, as previously notified, presented generic pricing and new drug listing system revision, listed drug reevaluation and pharmaceutical expense management all at once. For the bigger frame of enhancing healthcare coverage and reducing the people’s medical bills, the government has decided to progressively reinforce coverage on new drug while strictly managing already-listed new drugs and generics. To better manage quality of generic after the valsartan contamination issue, the government has decided to link approval and drug pricing system under the name of ‘3+1 System.’ Ministry of Food and Drug Safety (MFDS) revised the generic approval system and pricing system to gradually lower pricing of items depending on the number of listed items. In July, MOHW issued an administrative notice on partially revised regulation of ‘Pharmaceutical Affairs Decision Making and Approval Criteria’ with the said changes, and plans to finalize it by the end of the year. On the other hand, the barrier of new drug listing has been alleviated. The RSA eligibility and scope have been expanded for high-cost new drugs as constantly demanded by the industry. But for an item to choose the option, it has to pass the three following conditions; a drug used for treating cancer or disease either recognized by ‘Special Case Standard for Partial Copayment Benefit’ or ‘Special Case Benefit for Patients with Rare Disease and Chronic Disease’; drug with clinical efficacy proven to improve quality of life or recognized so by a related committee; drug recognized as Breakthrough Therapy Designation (BTD) or Priority Medicines (PRIME) by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), respectively, or recognized as equivalent by Drug Reimbursement Evaluation Committee (DREC). But some have raised an issue about the regulator turning Health Insurance Policy Deliberation Committee (HIPDC) on-paper reimbursement listing review into a face-to-face review for new drug exempted from negotiation. They claimed it would cripple the system’s effectiveness and accessibility. Meanwhile, the government plans to establish a listed drug reevaluation standard and to elaborate the post-marketing evaluation procedure. The three reevaluation types—external reference pricing, listing contract expired drug, and performance-based post-marketing evaluation—would be categorized by literature-based reevaluation and real world evidence (RWE)-based reevaluation. But the industry is firmly opposing on the notion of reevaluation, as the result of the reevaluations would eventually either reduce reimbursed price or adjust the general pricing lower. Reevaluation procedure on reimbursed drugs (summarized by Daily Pharm) The government also finalized the ‘7.7 Pricing System’, which raised both Korean and global pharmaceutical companies’ eyebrows, as its initial version and enforced it from this year. First it started from the KORUS FTA renegotiation agenda, but technically the government dropped both benefit for Korean-made new drug exporting to global markets and the U.S.-based multinational pharmaceutical companies’ demand for new drug pricing benefit. Considering the government had its agenda behind it, the industry reprehended the government last year for its concerning and unfair action. The Drug Pricing Benefit for companies states the manufacturer and suppliers of WHO-recommended essential drug or National Essential Drug as designated by Article 2 of the Pharmaceutical Affairs Act should be confirmed to manufacture and supply without an issue. And the government would strip the pricing benefit of the companies, if they have issues supplying drugs on the Reimbursed Drug List, or were imposed with administrative penalty or convicted by a court for providing illegal rebate, according to Paragraph 2 of Article 47 of the Pharmaceutical Affairs Act. But there are exceptions. A company that suspends the supply of the drug with following reasons would be exempted from the penalty; in case manufacturing plant is shut down or closed; manufacturing, import or sales approval is suspended or canceled; new issue of safety or effectiveness arises; manufactured or imported supply shortage occurs due to surged demand (except when the demanded amount is within the predicted billing amount); when the company is faced with inevitable natural disaster. The government is also continuing on with the rebate prevention policy. The so-called ‘K-Sunshine Act’ was enforced and required pharmaceutical companies to file, archive and submit financial profit provision record (within the allowed amount by Pharmaceutical Affairs Act), or the expenditure report. At the moment, the government is reviewing the submitted expenditure reports. The government is focusing on analyzing and investigating expenditure types to set the system down. However, the companies may undergo investigation by prosecution when correlation between their expenditure and rebate are clearly found. The insurance coverage enhancement policy implemented this year constructed with substance-by-substance reimbursement, expanded listing of high-cost drug, and listed drug reevaluation would base even more specified drug pricing policy for next year. The industry is expected to see the effect in the field. Moon Care ploughs on with coverage enhancement with selective reimbursement This year was the first year for the first National Health Insurance Comprehensive Plan. Last year the government was sketching out the technicality of the Moon Care, and this year it was busy executing the detailed policy actions in the set order. Starting from the first pilot program of primary healthcare-based chronic disease management (initiated from December 2018), the government gradually increased healthcare coverage on ultrasound scan, essential check up and treatment for lower abdomen (rectums and anal passage) and urinary system (kidney and bladder). Moreover, coverage on cavity treatment for children under 12, thoracoabdominal MRI scan and Korean medicine treatment has been granted this year. In addition, the government started the pilot program for Community Care that integrated healthcare and welfare, providing customized benefit by each region across the country. On July 2, President Moon Jae-In presented the importance of National Health Insurance, performance of coverage enhancement and prospective plan at the ‘Second Anniversary Briefing of NHI Coverage Enhancement Initiative Implementation’ convened at NHIS Ilsan Hospital. The healthcare coverage statistics presented by the government in July found the coverage rate in general hospital was increased from 62.6 percent in 2016 to 67.2 percent in 2018. But with the figure, the public is skeptical about the government raising the National Health Insurance premium by 3.2 percent. The skepticism is not only about the premium increase, but also about ultimately reducing the people’s medical bills by fixing insurance income source and increasing rate of the government funding. Both industrial organizations and civic groups are urging the National Assembly to push up the government funding rate up to 20 percent to keep the moderate balance of medical service fee and coverage rate. Currently, Ministry of Economy and Finance has promised MOHW to provide the government insurance funding of 14 percent for next year, which MOHW would utilize on reinforcing insurance coverage programs.
- Opinion
- [FOCUS] There is no reliability of cluless government policy
- by Chon, Seung-Hyun Dec 26, 2019 06:29am
- The impurity issues that started in Valsartan last summer led to Ranitidine and Nizatidine, and many drug products were discontinued. This year, the domestic pharmaceutical industry suffered greatly due to impurity risk all year round. Using a stigma called "carcinogen", a huge amount of medicines were recovered, and pharmaceutical companies suffered huge losses. So far, the government's follow-up on impurity drugs has been a fear to pharmaceutical companies. From the Valsartan to Nizatidine, the pharmaceutical industry continued to report that the domestic measures were strong. Valsartan immediately suspended the sale of products using the company's drug substance when recalls were received in Europe. Since January 2015, the Ministry of Food and Drug Safety has stopped selling all drug products that used the ingredients in question. It has been criticized that losses have increased and confusion has increased as the problem-free products have been recovered. It has been concluded that impurity-containing Valsartan medicines are not harmful to humans in both Korea and the United States. In Korea, Ranitidine has been inspected for the collection of finished drugs and drug substances, and all products of Ranitidine have been suspended. Not all Ranitidine has been removed from abroad. In the United States and Europe, companies made their own recovery. The US Food and Drug Administration (FDA) issued an official statement last month stating that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat". 13 products of Nizatidine was discontinued. No products have been issued a recall order in the US and Europe. Mainly older products were classified as subjects of recovery, and pharmaceutical companies complained that they were forced to sacrifice while stopping the sale of trouble-free products. The MFDS is currently investigating the presence of impurities in Metformin. Singapore's Ministry of Health (HSA) recently retrieved 46 items of Metformin sold locally and recovered three. N-nitrosodimethylamine (NDMA) was detected above the daily allowance. Unlike Valsartan, Ranitidine, and Nizatidine, Metformin investigations are cautious. The MFDS said they are investigating an Metformin, but has not yet conducted a collection test. The MFDS set out to conduct collection tests after Metformin's NDMA test was established this year. In this situation, the MFDS ordered pharmaceutical companies to submit data on the production of pharmaceuticals containing Metformin hydrochloride and the system of active drug substance investigation. Pharmaceutical companies are questioning whether “products using raw materials recovered from Singapore have been brought into the country”. Metformin's drug product recovered from Singapore has never been imported into Korea. However, the MFDS has not yet made an official position on whether the drug substance used in the product is imported into Korea. In the case of Valsartan, products that use the same raw material pharmaceuticals as those recovered as impurities from overseas must be discontinued in Korea. If it is confirmed that the same drug substance as Metformin recovered in Singapore is imported into Korea, it may be decided whether to discontinue the sale. In fact, it is reasonable to take follow-up measures through collection inspection even if the drug substance and the same manufactory that were recovered overseas are imported into Korea. It is reasonable to recover only the serial number in question even for the same product. This is a lesson already learned from the Valsartan issue. Rather, the bold policy to relieve the anxiety of the people encouraged anxiety. It caused a lot of social cost waste. It would be even more frustrating if they were reluctant to disclose transparent information because they were afraid of criticism that the MFDS would be in conflict with public insecurity or past policies. If they have experienced trial and error in the past, it is the government's role to honestly admit and implement an evolved policy. Then they should ask for understanding why it should have been. Only then they can gain trust. We want a "cool" government that can reflect on their mistakes.
- Company
- Roche sets sail for more trials on Xofluza
- by Eo, Yun-Ho Dec 24, 2019 06:13am
- Following the two decade-long heritage of Tamiflu, next generation flu treatment Xofluza is quickly taking next steps to secure its market position. According to the related industry source on Dec. 24, Roche is to soon present two Phase 3 trial results of Korean health regulator-approved Xofluza (baloxavir), and the company also is prepping for three other clinical trials. The completed trials have tested efficacy of the treatment in a post-exposure prophylaxis study and on high-risk children. The post-exposure prophylaxis study tested the rate of virus transmission from an influenza virus-infected household member to Xofluza-treated household. The result found an arm treated with Xofluza significantly reduced the risk of people developing flu by 86 percent. Clinical trial MINISTONE confirmed positive effect of Xofluza, evaluating virus titer and the time to alleviation of symptoms on pediatric patients aged one to 12 with treatment of the flu treatment. Moreover, Xofluza is also currently calling for clinical trial participants for three other trials. One of the three trials is to study the treatment effect on infant patients under the age of one, whereas the second one titled FLAGSTONE is to observe arms treated with either Xofluza only or Xofluza and the standard of care Tamiflu together as a combination on hospitalized patients. The FLAGSTONE trial is designed to administer Xofluza once on day 1, day 4, and day 7, respectively, for three times total. CENTERSTONE, the last one out of the three trials, is to evaluate preventive effect of Xofluza on patient’s virus transmission. Unlike the post-exposure prophylaxis study, the third trial is to administer the treatment on the patient only and observe not only the patient’s time to alleviation of symptoms, but also the virus transmission among the patient’s household members. When the three trials complete with satisfying results, indications for Xofluza would expand remarkably. Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”. Xofluza has been approved by Korea’s Ministry of Food and Drug Safety (MFDS) in November for treating adult and pediatric patients aged over 12 with Type A and B influenza infections.
