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- Policy
- Introduction-development-turn, and the price reduction
- by Kim, Jung-Ju Dec 06, 2019 09:46am
- The pharmaceutical industry's reaction to the ambitious post-evaluation of the high-priced drugs, ambitiously issued by the government and insurance authorities, is cold. The pharmaceutical community understood the big direction of follow-up of drugs for rational fiscal expenditure, coupled with enhanced security. At the same time, it is a matter of responding to various drugs and drug prices that are popping up around the market in a way that reduces prices At the site of ‘the Public Hearing for Establishment of Post-Drug Evaluation Criteria and Methods’ held by the HIRA on the 3rd, the officials of the pharmaceutical industry censure in the plan proposed by the HIRA and the MOHW. Pharmaceutical officials who came to the public hearing did not leave after the event and contacted the insurer. The biggest problem for the pharmaceutical industry is that the re-evaluation of effectiveness (clinical utility) planned by the HIRA is a repetition of the registered contract list maintenance project from 2007 to 2011. This is a problem of overlapping hurdles, namely safety effectiveness. For governments and insurers, the market entry for licensed items and the positive gateway for payroll entry are distinctly different, but this also leads to overlapping regulations in the industry of developing and selling drugs to patients. An official of a large pharmaceutical company who attended the audience complained of fatigue, saying, “I agree with the purpose of the reevaluation, but I don't understand the results and performance of the 2011 reimbursement item’s list, and am feeling of overlapping with the application of the business at that time”. The official also said, "If the MFDS reevaluates and revokes the revoked or revised permit, anyone can agree, but we have no choice but to argue against it." There was a continuation of the question of whether the government could cover the value of drugs with a revaluation to be introduced. Another official said, “If there is no difference from the evaluation made during the MFDS approval process, and if the level of clinical literature quality evaluation is uplifted, will separate the wheat from the chaff?” “We are qualitatively evaluating the effectiveness passed by the MFDS on a document-based basis. If we don't meet the criteria, we can be perceived as an ineffective drug”. This post-evaluation also voiced the need for a social consensus whether or not the policy was appropriate for the principle of insurance in terms of the so-called 'trade off', which the government explained earlier this year. An official of the pharmaceutical industry said, “Our country is already managing the drug price in the screening system. We have already passed the validity of MFDS before entering the reimbursement”. Eun-young Park, head of the Drug Management Division, in charge of improving the evaluation of the MFDS, said, “The reevaluation of MFDS is the least effective for safety, and what we see is the framework of randomized clinical trials.” "We've improved our standards, and we want to create a clinically useful environment for how cost-effective it is to patients on the reimbursement list after screening." The industry's doubts have not eased despite clarifications that pharmaceutical companies intend not to deny the safety efficacy of drugs that they have been working hard on, but rather to see their value and adequacy. Even after the public hearing, pharmaceutical workers were seen talking about the policy in the lobby. Concerns have also been raised about foreign policy prices. It is because the evaluation criteria can be completely changed according to the will of the government, and there are also controversies and risks about how to set the comparison method and the index. The Korea Pharmaceutical Bio Association said, "It is only a reference because the government and academia are not able to confirm the actual selling price of foreign countries when talking about the new drug price controversy." "Comparing prices in eight countries" is an unreasonable attempt. " KRPIA also criticized the government's direction to lower the price of medicines to solve various issues surrounding pharmaceuticals. An official of KRPIA stressed that “the factors that determine finances are price and usage, we should ignore the focus on usage and avoid the direction that leads to drug price-oriented policies”.
- Company
- Xolair reimbursed in China, Concerns over Korea Passing
- by Kim, Jin-Gu Dec 06, 2019 09:46am
- Novartis' Xolair is listed as a reimbursed drug in China. Analysts say that 'Korea Passing' is a reality in the industry Xolair, a chronic rash treatment drug, has been cited as one of the leading examples of Korea Passing, 'withholding or withdrawal of reimbursement in Korea to be listed in China and other countries'. China's National Health Insurance Corporation recently released the 'National Basic Medical Insurance Drug List', which is a list of Korea's health insurance benefits. Seventy new drugs are on the reimbusement list Since August, the Chinese government has held a 'medical insurance drug access negotiation', which corresponds to Korea's reimbursement adequacy evaluation and drug price negotiations. Negotiation targets were 119. In the end, 70 new drugs reached an agreement in the drug price negotiation. Xolair withdrew his reimbursement in Korea, finally on the Chinese reimbursement list The most noticeable item is Xolair. Novartis' Xolair passed the Drug Benefits Evaluation Committee in December last year. It was 11 years in Korea. However, Novartis abruptly withdrew from the drug negotiations with the National Health Insurance Corporation. The cause was China. China added Korea as one of its reimbursed reference countries, and Novartis headquarters decided to rule out 'a situation where the reimbursed price could be lowered' in the Chinese market, where purchasing power is 20 times that of Korea. The result was China's listing of reimbursemt. Xolair is listed as one of the 70 reimbusement items listed. However, the listed price of Xolair is not conveyed. The Chinese government has decided to keep the specific reimbursed price secret from this negotiation. Xolair's listing suggests much to Korea in that Korea's passing has become a reality. In Korea, concerns about Korea Passing have been growing over the past two years. An industry official said, "It was finally confirmed that global pharmaceutical companies withdrew from China or gave up their reimbursement in Korea, with the Chinese market in mind." He said, "If Novartis reapply for reimbursement in Korea, the damage is expected not to be small". China has finalized its reimbusement listing policy for 70 new drugs. Chinese Medical Insurance Bureau Website Captured Reimbursement entry including Humira, Lynparza, Forxiga, Zepatier The newly listed new drugs include 70 items, including 18 Chinese medicines. Anticancer agents, diabetes treatment agents, TNF alpha inhibitors, hepatitis C treatment agents, pulmonary arterial hypertension treatment agents, HIV treatment agents and the like. In case of anticancer drugs, ▲Roche's lung cancer treatment agent 'Alecensa' ▲ AstraZeneca's colorectal cancer treatment 'Tomudex' ▲ AstraZeneca's breast cancer and ovarian cancer treatment 'Lynparza' ▲ 'Jakavi' from Novartis, a treatment for myelofibrosis, a type of rare blood cancer entered the reimbursed list Chinese pharmaceutical companies named their own anticancer drugs. Daboshu ( Sinnatimab), a treatment for Hodgkin's lymphoma jointly developed by Innovent Biologics, in collaboration with Eli Lilly; Hutchison China MediTech's Colorectal Cancer Treatment 'Elunate' (Fruquintinib), The anti-pharmaceutical treatment for breast cancer 'Henrui'(Pyrotinib) is also on the list. Diabetes treatments have also entered the reimbursed list. The GLP-1 series includes AstraZeneca's Byetta and Sanofi's Lyxumia, and among the SGLT-2 lines, AstraZeneca's Forxiga, Boehringer Ingelheim’s Jadiance, Jansen’s Invokana. Etc. were included. Autoimmune disease treatment was also applied as a benefit. Abbvie's Humira, Jansen's 'Remicade', Pfizer's Xeljanes as JAK inhibitor, and , Novartis' 'Xolair' as IgE (immunoglobulin E) inhibitors, respectively are on the list. The hepatitis C treatments included MSD's Zepatier, Gilead's Eplusa and Harvoni. Two new HIV treatments were added, Gilead's Genvoya and Descovy. In addition, GSK's' Trelege Ellipta 'and Novartis' Ultibro' as a COPD therapy inhalation, Novartis' Entresto as a chronic heart failure treatment, Bayer's ‘Eylea 'as a treatment for macular degeneration, and retinal diseases Allegan's Ozurdex was included as a treatment. This is a list of major drugs listed. 8 Chinese-developed drugs have been listed on the reimbursement list, including 3 anticancer drugs in the red box. 70 New Drugs Cut Average Price by 61% "Hepatitis C pill, the world's lowest" This reimbursement update is shown in 'Drug cost reduction'. According to major Chinese media, including Xinhua News Agency, the average price cut of 70 new drugs is 61%. Like Korea, China is deeply concerned about the increase in reimbursement and drug costs. Since 2017, China has updated its list every year since 2017, and has been negotiating drug prices with global pharmaceutical companies. The high marketability of the population of more than 1.4 billion is the backdrop for the Chinese government to demand strong drug prices from pharmaceutical companies. In fact, most negotiated drug prices are among the lowest in the world. For example, three hepatitis C treatments reported that the average price was reduced by 85%. Existing hepatitis C treatment prices ranged from ¥ 30,000 to 70,000 (about ₩ 505 to 11.78 million). On the basis of this, it is possible to calculate ¥4500-4500 (about ₩760,000-17.7 million). The Chinese press describes it as "the lowest price in the world." Self developed anticancer drug surpasses Keytruda and Opdivo, listed Another point is the protection of homegrown medicines. Of the 70 drugs added, eight drugs, including Daboshu-Elunate, were developed by Chinese pharmaceutical companies. In particular, Daboshu attracts attention as it is the first to be paid for PD-L1 immunocancer drugs. Other PD-L1 immunocancer drugs, Keytruda and Opdivo, are not yet listed Daboshu is the result of the creation of a major drug, part of China's national science and technology project. After getting a marketing license in December last year, it quickly entered the reimbursement list. This year, the Chinese Society for Clinical Oncology (CSSO) revised its guidelines for lymphoma treatment and encouraged Dabosche's prescription. Elunate is similar. After getting a marketing license in September last year, it entered the reimbursed list relatively quickly. This is a part of the Chinese government's view of in-house developed medicine.
- Company
- High-risk osteoporosis should increase bone formation first
- by Eo, Yun-Ho Dec 06, 2019 09:43am
- KSBMR Chair Chung Ho-yeon “For a high-risk patient, it would be better to use effective bone-forming agent from the beginning.” Amgen Korea held a press conference held on Dec. 4 for the launch of Evenity (romosozumab-aqqg), where Chair Chung Ho-yeon of Korean Society for Bone and Mineral Research (KSBMR) stressed on the importance of top-down style prescription with the new option of osteoporosis treatment. He urged medical professions should choose prioritized option recommended as a medication strategy for patients at high risk and in need of urgent treatment effect. Particularly, Chung highlighted 12-month Evenity treatment showed increased bone formation effect in vertebral and hip fracture, more than with teriparatide. A number of clinical data confirmed Evenity, compared to single therapy with alendronate, notably reduces risk in new vertebral or non-vertebral fracture. “The prevalence rate of osteoporosis in age group over 50 has been constantly rising after 2008. More than anything, osteoporosis within a year results in hip fracture for one out of five patients, and in vertebral fracture for one out of ten patients, which can lead to possible deaths”, Chair Chung emphasized. Korean Ministry of Food and Drug Safety (MFDS) granted approval on Evenity in May 31. Now Evenity can be used on treating severe osteoporosis in postmenopausal women at a high risk of fracture, and to increase bone mineral density for men with osteoporosis at a high risk of fracture. A target therapy Evenity is the first dual-acting osteoporosis drug that increases bone growth by inhibiting the activity of sclerostin, a protein that regulates bone formation, and also inhibits bone resorption. The treatment is administered once-monthly in two separate subcutaneous injections (105 mg each, 210 mg in total) on different body parts. After administering full 12 doses, maintenance therapy with bone resorption inhibitor is needed. MFDS’ approval was based on Phase 3 FRAME and ARCH studies treating postmenopausal women with osteoporosis, and Phase 3 BRIDGE study treating men with osteoporosis. First, the Phase 3 FRAME trial compared Evenity with placebo in menopausal women with a T-score of -2.5 to -3.5 at the total hip or femoral neck. And the result showed that the treatment lowered risk of new vertebral fracture. Treated with Evenity for 12 months, the risk of new vertebral fracture was reduced by 73 percent compared with placebo. Patients who switched to Prolia for 12 months after 12-month Evenity treatment had a 75 percent lower risk of new vertebral fracture compared to patients who switched to Prolia from placebo. In the Phase 3 ARCH trial, comparing Evenity and alendronate, romosozumab showed outstanding preventive effect on postmenopausal women with osteoporosis and high risk of fracture by lowering incidence of both vertebral fracture and clinical fracture. A group of patients, who switched to alendronate after 12-month Evenity treatment, lowered risk of new vertebral fracture by 50 percent at 24-month compared to a group with alendronate treatment only. Also in BRIDGE trial comparing Evenity with placebo treating men with osteoporosis, 12 months of the treatment increased patient’s bone mineral density by 12.1 percent more than placebo, demonstrating a meaningful improvement in bone mineral density. “The U.S. Endocrine Society’s (ENDO) guideline revised in 2019 recommends bone formation agent as a first-line treatment for osteoporosis patient with fracture. With dual effect of increasing bone formation and reducing bone resorption, Evenity can be considered as a prioritized option recommended for treating osteoporosis at super high risk”.
- Policy
- Investing KRW 4 tn fostering Biohealth as ‘Post-semiconduct
- by Kang, Shin-Kook Dec 06, 2019 09:43am
- Until 2025, the Korean government is to assertively invest four trillion won on fostering biohealth industry as a ‘post-semiconductor industry.’ On Dec. 4, Deputy Prime Minister Hong Nam-ki led the fifth Innovative Growth Strategy meeting and the 28th Economic Ministerial meeting and discussed about next generation innovative growth engine, related validation process and additional plans. First, the government has decided to concentrate the state capability on developing biohealth industry, because new drug export volume was tripled from 1.4 trillion won in 2017 to 4.4 trillion in 2018, expanding the foundation of technology. Deputy Prime Minister Hong Nam-ki presiding at Innovative Growth Strategy meeting (middle) The government aims to grow biohealth industry as a next generation economic growth engine, or so-called ‘post-semiconductor industry’, by investing four trillion won on R&D until 2025 and developing and emerging technology. The government’s plans are to set a roadmap for biohealth regulation reform within this month to implement it from next year, and to establish human resources development center for biotechnology training two thousand experts at a time. Moreover, the government is also working on innovation strategy and plan for the service industry. The plan is to expand total service industry based on three major types of Manufacturing as a Service (MaaS), Healthcare as a Service (HaaS), and Financial Accounting Advisory Service (FAAS). MaaS is to be expanded centering a voucher program supporting companies in need of manufacturing service, whereas HaaS would develop pilot programs and validate and expand it in different regions. FAAS is to open encrypted big data of credit information provided by Korea Credit Information Services. However, the government officials expressed regret as the key regulatory reform plans for remote medicine, sharing economy and more are surrounded by fierce dispute between stakeholders and social conflicts. Specifically, the officials pointed sluggish process of revision of the three data protection laws essential for the growth of emerging industry, and that it is limiting the industries’ performance. The three information protection laws are; Personal Information Protection Act; Act on the Protection of Information and Communications Infrastructures; and Credit Information Use and Protection Act. Deputy Prime Minister stated “The government plans to foster biohealth as the next generation economic growth engine following the footsteps of semiconductor, and also it would set state-led artificial intelligence strategy, create data economy, and activate startup ecosystem for all product cycle.” “The Economic Policy Plan 2020 would contain policy focus and goals immediately in effect from next year and it would be presented to the public all together by the end of the month. To propel the innovative growth in stable and effective fashion, refining legal and regulatory foundation with legislation would be crucial,” the Deputy Prime Minister added.
- Company
- 3rd PARP inhibitor Talzenna readies for Korean market
- by Eo, Yun-Ho Dec 06, 2019 09:39am
- A pharmaceutical industry source reported on Dec. 6 that Pfizer Korea has recently submitted an application to Ministry of Food and Drug Safety (MFDS) for an approval on PARP inhibitor Talzenna (talazoparib). When it gets the green light from the ministry, it would be the third PARP inhibitor medicine in Korea to enter the market, following AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib). The application is for an approval on a single therapy indication to treat locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer in women with an inherited BRCA mutation. The treatment has been approved in Europe last June and the U.S. in October last year. Talzenna demonstrated its efficacy during EMBRACA trial with 431 patients. As a result, Talzenna arm well-surpassed the standard chemotherapy arm’s 5.6-month median progression-free survival (PFS) as it was extended to 8.6 months. Talzenna arm also demonstrated an objective response rate (ORR) of 62.6 percent, significantly higher than that in the standard chemotherapy arm with 27.2 percent. The most common adverse reactions of patients receiving Talzenna were fatigue, anemia, nausea, neutropenia, thrombocytopenia, headache, hair loss, diarrhea, and loss of appetite. In Korea, AstraZeneca’s Lynparza was the first PARP inhibitor to be listed for reimbursement. With the economic evaluation exemption system, Lynparza signed an expenditure cap type risk sharing agreement (RSA) in October 2017. Just recently, the treatment expanded approval on indication as a first-line maintenance therapy for advanced ovarian cancer, a first and second-line therapy on ovarian cancer with additional administration type (tablet), and a treatment for HER2-negative metastatic breast cancer. Meanwhile, another PARP inhibitor Zejula was granted with reimbursement starting from this month. The treatment can be prescribed as a single maintenance therapy for platinum-sensitive adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. However, Zejula’s first reimbursement scope is limited to patients with BRCA mutation.
- Policy
- “Providing as much clinical information for patients”
- by Lee, Tak-Sun Dec 05, 2019 06:23am
- Director Kim Jeong-mi of Clinical Trial Management Division Since the end of last October, the Korean Ministry of Food and Drug Safety (MFDS) has expanded scope of information on approved investigation new drug’s (IND) protocol uploaded on its website. Previously, only the names of clinical trial, sponsoring client, IND, targeting disease and clinical trial institute were publicly disclosed, but now more information, including comparison drug, contact information of the institute, subject selection and exemption standards are also uploaded online. Anyone can now check a company’s R&D progress in detail on the website, and patients can search information and actively participate in a clinical trial by contacting the clinical institute directly. At a press conference held on Dec. 3, Director Kim Jeong-mi of Clinical Trial Management Division at MFDS explained, “Although clinical trial information has been disclosed since 2007, we’ve been thinking that we are not meeting the patients’ expectation. We recognized the need to publicly provide similar level of information as other countries, so we formed a consultative body for clinical trial system development to specify expansion of the provided information.” “Our principle is to disclose as much information as the U.S. or EU. But the update has been slow as double-checking accurate information is taking more time than we expected,” Director Kim added. Expanding provided scope of clinical protocol information is expected to support patient’s right to know and their active participation in clinical trials. Revealing contact information of the healthcare institute was to meet the existing demands of patients seeking opportunities to participate. “These days, patients have gotten sophisticated so much to actively look for related information and to get highly knowledgeable in particular medicines. Naturally, they are curious about contact information of clinical institute and doctors in charge. Some are even eager to transfer the hospitals to participate in clinical studies”, Director Kim elaborated. Disclosed clinical protocol information has been expanded partially, but the website still lacks in system stability and promotion. Particularly because MFDS’ Drug Information System website (www.nedrug.mfds.go.kr) provides a vast amount of information on drugs, searching for IND approval status on the website takes a long time. Moreover, many people still do not realize the website provides IND information. The director said, “We still need to contemplate on how to provide the information with easier access. Also we are considering on making information search easier for IND developers and researchers.” In August, MFDS announced the Five-year Master Plan on Developing Clinical Trial System. The five-year plan aims to strengthen safety control over clinical trials and enhancing international competitiveness. Director Kim commented, “We have had a lot to ponder as transnational clinical trials have been stagnating recently and we want to create an advanced clinical environment and protocol review system in Korea attractive enough for Korean companies to develop global IND. The five-year plan has details of strengthening safety management and international competitiveness, communicating better of clinical trials and shifting public’s bias.” One of the highlights of the plan was making drug safety update report (DSUR) mandatory. The director explained, “Unlike late-phase clinical trials, earlier-stage trials have more prevalent risk of safety issue and adverse reaction. And to promote the earlier stages of trials, the ministry plans to tighten evaluation on trial sponsor and safety control on trial conductor. DSUR has been filed by multinational pharmaceutical companies, but we are also asking Korean companies to file them with the amendments.” Review on early phase clinical trials would be strengthened as well. By forming Innovative Early-phase Clinical Trial Review Team, MFDS plans to conduct overall review not only for INDs, but also on pharmacology test, quality, and statistics. “Without removing negative bias on clinical trials, Korea would struggle to acquire clinical competitiveness. We are planning to extend communication channel and to raise better awareness of clinical trials by working closely with Korea National Enterprise for Clinical Trials (KONECT) and consultative body for clinical protocol review,” Director Kim said. Nevertheless, the director stressed, “In other countries, clinical trial participation is considered as a ‘volunteer service’ with a side of treatment opportunity. But in Korea, clinical trials are regarded negatively rather than necessary. When the majority of the public can agree clinical trial is essential to the society, the need of new drug development and industrial benefit of drug development could be emphasized.”
- Policy
- Forxiga, solvate modifier applied for the first permit
- by Lee, Tak-Sun Dec 05, 2019 06:22am
- Diabetes treatment, Forxiga by AstrazenecaDomestic pharmaceutical companies have developed a solvate modified drug for the SGLT-2 inhibitory diabetic drug Forxiga (Dapagliflozin, AstraZeneca Korea) and has entered into the application process. Once approved, the market sale will be available from April 8 2023, when material patents will be terminated. According to the MFDS on 3rd, the first approval application for Forxiga's solvate modified drug was received on 26th, and the patent holder, Astrazeneca was notified according to the licensed patent linkage system. The formulations requested for approval are Dapagliflozin L-proline and Dapagliflozin citric acid. The solvate is different from the Dapagliflozin propanediol hydrate of Forxiga. In the meantime, Korean pharmaceutical companies have been trying to avoid patents by changing solvates. In particular, the efforts were made to advance the release date by avoiding the extended period of 917 days for material patents. However, the plan was out of order with the ruling that salt-modifying drugs could not circumvent material patents with extended duration. Pharmaceutical companies, except for material patents, have challenged to follow-up patents (substance 2, formulation) and received an invalid or evasion decision this year. As a result, after April 7 2023, when the patent of substance is terminated, it will be possible to market the late drug. The initial license applicants are unknown, but as many companies have been patent-challenged, concurrent licensed products are expected to be poured out through commissions. Forxiga, used for the treatment of type 2 diabetes, is the first drug to be developed as an SGLT-T inhibitor. SGLT-2 inhibitors have a mechanism that lowers blood sugar by inhibiting glucose resorption in the kidneys, thereby promoting the release of glucose through urine. Insulin-independent mechanism of action is not affected by beta cell dysfunction and insulin resistance, so it can be used in combination with existing oral hypoglycemic agents. In particular, releasing sugar through the urine has the effect of weight loss. In some cases, it is known as diabetes medication that lose weight. Because of these advantages, Forxiga is leading the new trend in the diabetic market with outpatient prescription of ₩27.4 billion last year. Currently, SGLT-2 inhibitors include Forxiga, Suglat, Jardiance, and Steglatro, all of which are new drugs. Generic drugs are blocked from market sales due to original patents.
- Opinion
- Both to blame of the rising Pharmaceuticals & Korea
- by Eo, Yun-Ho Dec 05, 2019 06:16am
- The pharmaceutical industry is a high value-added industry and Korea is now more interested in new drugs than ever before. As interest has increased, the names of pharmaceutical companies that have reported news such as clinical failures, discontinuations, or controversy about efficacy are very popular on the Internet. It is possible. Samsung and Celltrion's biosimilars are being recognized in the US and Europe, and the government is drawing blueprints for preferential treatment of new drug prices under the development policy of the pharmaceutical industry. But it should be clear. If success is easy, it is not a new drug in the first place. According to the analysis of 9,985 data performed or in progress by the US Food and Drug Administration (FDA) for 10 years from 2006 to 2015, the success rate of the phase I was 63.2%, the phase II was 30.7%, the phase III is 58.1%. If we calculate this and estimate the probability that a new drug will be commercialized, it is only 9.6%. Stopping development and failing clinical trials are strange not to happen. However, there is a herd effect and both to blame. It is also true that many pharmaceutical companies aimed at a bandwagon effect like striking while the iron is hot. The clinical entry and completion data of the developed materials and indiscriminately presented data of the development materials, which are distributed indiscriminately without any explanation of what the drug is, aims only at investor psychology. 'Excellent efficacy compared to OOO drugs', 'It is the first XXX cancer drug', 'Secured cardiovascular safety’. It is attractive but shows no evidence. As a result of how many patients were studied and how long the study was conducted, it is not known how the difference was shown in terms of efficacy and safety compared to the comparison group. There is even a case where a comment from a company official called 'Good Medicine' is all about the medicine. story of domestic drug development is encouraging. It should be duly evaluated. This is no time to care of IR (Investor Relations). Shouldn't the stigma of playing with stocks be free itself from restraints of rebates?
- Policy
- HIRA unveils listed drug reevaluation guideline
- by Kim, Jung-Ju Dec 05, 2019 06:14am
- Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team at HIRAThe government unveiled the details of the post-marketing reevaluation criteria and procedure of reimbursed drug. The scope of listed drug reevaluation mainly centers expensive drug items, such as anticancer and rare disease treatments, covered by insurance benefit despite their uncertainty in clinical efficacy. The evaluation borrows the previous reimbursed drug list adjustment procedure, but the criteria are to be set in more intricately to cover different kinds of pharmaceutical benefit provided now. Health Insurance Review and Assessment Service’ (HIRA) Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team under Pharmaceutical Department presented a post-marketing reevaluation plan on listed drug at a public hearing convened for the topic on Dec. 3 at the Ferrum Tower, Seoul. For the reevaluation, applicable items are to be selected from the pool of high-cost drugs treating cancer and rare disease with uncertainty in clinical efficacy. The selection procedure would take account of item’s insurance listing status in foreign countries, usage frequency, insurance billing ratio, namely pharmaceutical expenditure increase rate and billing amount. Also levels of pharmaceutical and medical importance and social interest could also affect the procedure. Initially selected list of drugs would then be evaluated by published literature, such as textbooks, guidelines and clinical literatures. Basically, the structure of the listed-drug post-evaluation is to follow the footsteps of the Moon Jae-in Care. Evaluation model the government used for adjusting reimbursed drug list from 2007 to 2011 ◆ Updating listed drug post-evaluation from 12 years back: Evaluation on clinical efficacy was a key evaluation model in the previous reimbursed drug list adjustment. Enforced from 2007 to 2011, the list adjustment procedure also made decisions on reimbursement listing cancellation or restriction based on literature review of related textbooks and guidelines, and verification of medically essential substances. The Level A clinical efficacy evaluation indicated an item is “clinically effective”, as long as it met at least one of criteria, including Health Technology Assessment (HTA), World Health Organization (WHO) Model List of Essential Medicines (EML), shortage prevention drug, orphan drug, basic parenteral solution, and other essential drug. Whereas, Level B evaluation indicated an item as “clinically effective” when it met all three criteria of confirming essential medicine recommendation by related academics, recognition by related committees, and usage status in foreign countries. In the past, the Korean government used to refer to the U.S. the U.K., France, Italy, Japan, Germany and Switzerland, also known as A7, for the status of reimbursement listing. For the evaluation, an item had to be listed in more than two countries from the list. A new drug developed from Korea or in Asia was considered ‘listed in two or more A7 countries.’ And now the government plans to apply the past experience in the reimbursed drug list adjustment procedure on to the new listed drug post-management. Considering the diversified pharmaceutical benefits since then, the new post-management system is expected to be segmentalized and tightened even more. New reimbursed drug post-marketing evaluation procedure model ◆ Evaluation details: From the overall list of reimbursed drug items, anticancer therapy, rare disease treatment and items with uncertainty in clinical efficacy would be selected as subjects for the evaluation. Further selection criteria consist of substances requiring clinical efficacy validation by reevaluating effectiveness, requiring tightened management due to change in population structure and increased usage volume, and requiring Post-marketing Drug Reevaluation Subcommittee’s evaluation considering impacts on the society and other healthcare issues. After the first phase of selection, HIRA would review foreign countries’ approval and reimbursement listing status on the subjects. Besides the list of seven foreign countries used for the past reimbursed drug list adjustment, Canada is newly added. Moreover, drug reimbursement billing amount, increased rate claims, billing frequency and its ratio are to be reviewed all around. Other factors like levels of pharmaceutical and medical importance and social interest would be added as the evaluation criteria. HIRA would then evaluate the filtered subjects with evenly chosen clinical literatures, such as related textbook, guidelines and HTA reports. The agency explained alternative treatment options and special property of substances would be considered as well. When choosing the textbooks and guidelines for the review, HIRA would extensively consider literature’s evidence basis, popularity, expertise, validity, publication period, language, and recognition based on academic society’s evidence evaluation. Currently, the government and HIRA have not finalized the detailed list of literatures, such as basic list of textbooks from major search database, list of basic guideline from foreign guideline search database, government-related or not-for-profit performance assessment report, and list of published Cochran Reviews and HTA report. In addition, HIRA is contemplating on taking account of substance demand from related academic societies, alternative feasibility based on available option with equivalent or different mechanisms, and special property of substance. Restrictive use for pediatric patient, treatment for special patients with HIV-like conditions, and emergent medicine are categorized as special property of substance. Clinical efficacy reevaluation procedure ◆ Procedure of clinical efficacy reevaluation: The government and HIRA are planning to select subject items with administrative review, Post-marketing Drug Reevaluation Subcommittee, and Drug Reimbursement Evaluation Committee (DREC), in the said order. The literature-based evaluation would follow the selection, and then the government agency is to officially notify respective pharmaceutical companies. The reevaluation can be repeated from the top, if need be, and the result is finalized after the second around. The government plans to subdivide the reevaluation procedure into finance-based and performance-based post-marketing evaluation, and further enhance the reevaluation procedure. Prospective plan for the reevaluation system
- InterView
- The key to drug development is not just safety and efficacy
- by Jung, Hye-Jin Dec 05, 2019 06:12am
- 박영준 대표“In short, it is an area that is easy to miss even though it is important enough to be the core of new drug development. Most of the domestic companies that have applied for a permit with the US FDA or the European EMA are asked to submit additional data. As more and more pharmaceutical companies are attempting to penetrate overseas, Korean companies are also beginning to recognize the importance of quality data”. The reporter met with Park Young-jun, Ph.D. (55, Seoul National University) who is a professor of Ajou University, to hear about CosmaxIMD, IMDpharm joins a venture founded by CosmaxPharma. However, Professor Park emphasized the importance of Chemistry, Manufacturing and Controls (CMC) in the new drug development process. Professor Park has been developing medicine at pharmaceutical companies since graduating from pharmacy. After 17 years as head of product development at Yuhan Research Institute, he worked as research director at Samil Pharmaceuticals and CJ Healthcare. Korea's No. 30 new drug 'K-Cap' is a product that he developed as a CJ research director.Professor Park then set up a new drug research institute. IMDfarm stands for 'Innovative Medicine & Drug Delivery'. ◆Overlooking the importance of CMC to ensure 'quality of material' IMDpharm is a company researching new innovative new drugs, ▲At the same time as developing new innovative medicine for intractable diseases, ▲Improving absorption of poorly soluble drug solubilization, a pharmaceutical formulation technology ▲Sustained Release Drugs ▲Persistent Injectable Technology ▲Disease Targeted Nanoparticle Technology ▲ It is a company that develops convergent new drugs by holding technologies in various formulations such as eye drops and external preparation technologies and applying them to new drugs. However, at present, IMDpharm's cash cow is quality management, or CMC, which is an essential element in the process of leading clinical trials. Venture companies that are engaged in new drug development are the main customers of IMD Pharm CMC service. According to Professor Park, there is no company in Korea that offers a full range of CMC services from nonclinical to clinical. Most of the nation's top pharmaceutical and venture companies, which spend ₩billions on new drug development, use CMC companies in China or India. This is the result of the CMC not receiving attention in the domestic pharmaceutical industry. But the mood has changed recently. This is because CMC, the quality control of the substance, is considered as important as the efficacy and safety of the drug. "The first thing to notice when developing a new drug is the effectiveness, because any substance has a 'pharmacological effect' to get started. The next thing to notice is safety. It is marketable as a drug, 'Quality Control' covers the whole process, from the beginning to the end, demonstrating that all experiments and tests are made of the same substance and keeping this process as records and data". A typical case is 'Rolontis' by Hanmi Pharmaceuticals, . In March, the US FDA requested additional data from Hanmi Pharmaceuticals for marketing approval, which is CMC data. Overseas, the quality control of substances has already been considered important, and more quality control data are required for companies attempting to obtain a marketing license. Professor Park said, "The reason we have to conduct CMC thoroughly from the beginning of new drug development is that we can't do the same clinical trial again." "Even if you already have finished the clinical trial and submitted the results, if you should prove that you have tested all the animals and humans with the same substances and without impurities, can companies that haven't left their data back in time?" "CMC is important for finished products as well as new drugs, increased impurity risk " "Controversial impurity management is also an important part of CMC. With the development of analytical techniques and tightening impurity regulations, this poses a greater risk for pharmaceutical companies. CMC will become even more important throughout the production and distribution of finished products, and Valsartan, Ranitidine, and Nizatidine are all about this. " In this atmosphere, IMDpharm has recently expanded its business. Established in 2016 and started full-fledged business from 2017, the company expanded non-clinical CMC to clinical CMC from August. In September, the company established a joint venture with CosmaxPharma. Cosmax Pharma, which has a finished mass production facility, produces the formulation developed by IMDpharm. “CosmaxPharma and IMDpharm have combined to provide full-service services for CMC, and this year, non-clinical and clinical CRO, Dt & CRO (DTI & CRO), will join us to ensure the safety of materials at all stages of drug development, from non-clinical and clinical. The ultimate goal is to increase the success rate of new drug development for domestic companies”. Professor Park would like to help create a new drug development foundation so that all the processes and technologies necessary for drug development can be solved in Korea".
