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- 2026-05-09 19:26:49
- Policy
- Generic exclusivity for ₩50 million Betmiga applied
- by Lee, Tak-Sun Jan 13, 2020 06:26am
- The first generic drug of 'Betmiga' (Mirabegron, Astellas), a potent overactive bladder treatment, coming soon in June this year applied for permission. The interest in the industry is amplified because generic exclusivity are given exclusive rights to the generic market based on who first applied for the permit. According to the MFDS and the industry on the 10th, the application for permission of the Betmiga was received on Dec 31. Since the re-examination period for the Betmiga was expired on Dec 30, the application for authorization was submitted the next day, Dec 31. However, the number of licensed items and company names have not been disclosed yet. Currently, 11 Korean companies have established the basis for early entry into the market, excluding the material patents of Betmiga, winning the decision to invalidate crystalline invalid patents. Accordingly, the first applicant of the 11 companies is likely to obtain a generic exclusivity, which is granted generic market monopoly for nine months. The 11 companies are Hanmi pharmaceutical, Chong Kun Dang, JW pharmaceutical corporation, Daewoong Pharmaceutical, Ildong Pharmaceutical, Intro biopharma, Alvogen Korea, Kyungdong pharmacetical, Shinil Pharm Ltd, Hanwha Pharma Co., LTD, and Shin Poong Pharm. Co., LTD. However, all 11 companies did not submit the application for permission last month. Some companies have reportedly failed to demonstrate bioequivalence with the original drug. As such, only a few companies are likely to win generic exclusivity. Generic exclusivity is expected to be granted for nine months from the day after May 3, 2020, when the Betmiga’s patent expires. During this period, the same ingredient generics will not be released, so it is highly likely that the rights holder will preoccupy the market. Accordingly, companies that have acquired generic exclusivity are expected to conduct aggressive marketing and marketing during that period. Betmiga is a large item of about ₩50 billion per year. In 2020, it is expected that Betmiga’s generics will struggle over the market.
- Policy
- Certican price reduced by ATP to KRW 5250 for 1mg
- by Kim, Jung-Ju Jan 13, 2020 06:22am
- The price of Novartis’ immunosuppressant Certican (everolimus) was lowered on Jan. 9, as a result of the recent actual transaction price (ATP) survey on reimbursed drugs. The price could be further adjusted when the final decision is made from the administrative litigation between the company and government about ex-officio adjustment of the drug pricing. On Jan. 8, Korea’s Ministry of Health and Welfare (MOHW) has issued the partially revised ‘List of Reimbursed Drugs and Maximum Reimbursement Price’ reflecting the price change. Last year, the government surveyed ATP of drugs supplied to healthcare institutes to calculate weighted average value, and lowered maximum reimbursed price of each drug item by no more than ten percent according to the survey result and calculation. Currently, Certican is in the midst of administrative litigation against the government’s decision to lower the drug pricing by 30 percent due to a first generic listing, but the company has requested for suspension on enforcement of the ex-officio adjustment. If the request had not been accepted by the court, the drug pricing would have been lowered by more than the ATP-based price reduction rate, which would not have been reflected. While the company is maintaining the original pricing with last year’s adjustment is suspended by the prolonged litigation, the government had to lower Certican’s pricing by ATP-based reduction rate like any other drugs. Accordingly, the new reimbursed maximum prices of Certican in different doses are 2,266 won for 0.25 mg, 3,617 won for 0.5 mg, 4,450 won for 0.75 mg and 5,250 won for 1.0 mg.
- Policy
- More rare diseases designated for special case NHI benefit
- by Lee, Hye-Kyung Jan 13, 2020 06:22am
- From Jan. 1 this year, the government expanded list of designated rare diseases and healthcare institutes examining rare disease eligible for the special case healthcare benefit. To reduce medical expense and to improve medical access for patients with ultra rare and unknown diseases, National Health Insurance Service (NHIS, President Kim Yong-ik) announced the extended list of rare disease and healthcare institute examining rare disease for special case National Health Insurance (NHI) benefit that came in effect from Jan. 1. The objective of the special case benefit system is to reduce patient’s copayment rate on expensive rare and severe disease treatment, which makes a rare disease patient to be responsible for 10 percent of inpatient and outpatient medical expense. Accordingly, the list of designated rare disease receiving special case benefit has been expanded to include 1,014 rare diseases, applying the benefit to around 270,000 patients. Before the change, it used to be approximately 265,000 patients receiving the benefit. Constantly listening to patients, their family, patient groups and related academic societies, NHIS increased the number of designated rare disease for the benefit after a series of deliberation by Rare Disease Management Committee (Korea Centers for Disease Control and Prevention) and Special Case Benefit Committee (NHIS). From last year, the government agency has opened a separate disease group dedicated for unspecified chromosome abnormalities, as patients with the condition could not receive any special benefit without a specific name of diagnosed disease. Rare disease patients with the designated special case disease are expected to access treatment with lessened financial burden, as supported by special case NHI benefit and Rare Disease Patient Medical Aid program. Also the NHIS has added more healthcare institutes to examine and diagnose rare disease. Since 2016, NHIS has appointed qualified healthcare institute to exam ultra rare disease and unspecified chromosome abnormalities to promptly but accurately provide special case benefit to the patients. In December, the agency called for a bidder among tertiary hospitals offering rare disease or genetics clinic, and selected seven more hospitals, making total of 28 hospitals available for rare disease examination from this year. The new appointment was to expedite examination procedure to diagnose increasing number of rare disease eligible for NHI special case benefit, and to resolve inconvenience of patients in regions without the designated institute, such as Jeonnam, Jeonbuk and Chungbuk. A NHIS official stated, “The agency would continue to improve rare disease patient’s access to treatment by providing special case benefit to growing number of newly diagnosed rare diseases found with fast-advancing technology, and by appointing more healthcare institutes capable of examining the diseases for the patients to receive adequate treatment.”
- Policy
- Choline alfoscerates, 82 generics were approved last year
- by Lee, Tak-Sun Jan 10, 2020 06:26am
- The most representative of choline alfosceratesDespite the controversy over last year's efficacy, choline alfoscerate formulations were found to have received 82 new licenses last year. Only 267 cumulative licensed items are available. On the 9th of last year, an investigation into the approved items of the same ingredient was conducted through MFDS' website. The choline alfoscerate formulation was found to have a validity issue during a national audit last October. In response, the Ministry of Health and Welfare announced plans to conduct a pay reevaluation by June this year, and the MFDS began validating in November. The industry believes that choline alfoscerate's reimbursement restrictions are strong. Nevertheless, pharmaceutical companies considered the high marketability of the formulation and continued to produce the product. Choline alfoscerate formulations form a large market with insurance claims amounting to about ₩300 billion. Irrespective of the size of hospitals and majors, the elderly are indiscriminately prescribed for the prevention of dementia. It is a perfect market for domestic pharmaceutical companies that do generic sales in the parliamentary market. In addition, consignment items poured out last year as new formulations such as liquid In hard capsules and syrups, which can be bottled, were released. Choline alfoscerate formulations, despite no original patent expiration issues last year, recorded a number of licensed items following Pregabalin (93) and Oseltamivir (87). Major generic drug licenses in 2019 Pregabalin and Oseltamivir formulations have recently expired. However, Pregabalin has three doses, and Oseltamivir is difficult to make an indirect comparison in that there are three capsule dosage forms and a suspension formulation. The MFDS is currently validating Choline alfoscerate preparations, but it is difficult to draw conclusions. Since it has already been validated through the 2018 update, it is difficult to conduct clinical reevaluation due to lack of literature data. However, the industry reports that reimbursement revaluation may result in reimbursement restrictions in order to reduce consumption.
- Policy
- 23 new drugs approved last year with no Korean-made
- by Lee, Tak-Sun Jan 10, 2020 06:25am
- Apparently, total 23 investigational new drugs have been approved in Korea last year. Compared to 2018, the number was increased by 14 but not one of them was made in Korea. Moreover, two incrementally modified drugs (IMDs) and three biosimilars have been cleared. According to Ministry of Food and Drug Safety (MFDS)’s pharmaceutical information website on Jan. 8, updated information of newly approved investigational drugs in 2019 found that total 23 drugs have been passed by MFDS last year. All of them were developed outside of Korea. Korean pharmaceutical companies JW Pharmaceutical, Jeil Pharm and SK Chemicals had their Hemlibra subcutaneous injection, Lonsurf tablet and Ongentis capsule approved, respectively, but all of them were developed from abroad. K-CAB tablet (tegoprazan, CJ Health Care), approved on July 5, 2018, is still the latest Korean-made new drug. 2019 new drugs Out of all drugs approved last year, five were biological drugs and 17 were synthetic drugs. MFDS has approved two IMDs last year, including; an amlodipine besylate-chlorthalidone-telmisartan triple combination drug, True Set tablet (Yuhan), and eight items of multiple combination drugs with pitavastatin calcium and fenobirate. Besides, three biosimilars—Samsung Bioepis’ Etolce 50 mg prefilled syringe (etanercept), Daewon Pharmaceutical’s Terosa cartridge injection and Pangen’s Panpotin prefilled syringe injection—were approved last year as well. Meanwhile, total 4,793 finished pharmaceutical products (661 OTC, 4,132 prescription drugs) have been approved last year. Compared to 2,056 products approved in 2018, year 2019 had significantly more finished products cleared. The surge in approved finished products could have been because of surge in number of CMO-manufactured generics with cosigned bioequivalence test. 4,207 generics have been cleared in 2019, which the number doubled from 1,754 in 2018. Sources analyze it was because many of the generics have applied for approval in a hurry before the cosigned bioequivalence test limiting policy came into effect.
- Policy
- Ibrutinib's Asian Standard Therapy Strategy Revealed
- by Lee, Jeong-Hwan Jan 10, 2020 06:24am
- A domestic study shows that allogeneic hematopoietic stem cell transplantation is the ultimate treatment strategy for patients who do not have treatment effect after 3 months after taking Imbruvica (Ibrutinib/Janssen), a kind of hematologic cancer. The researchers also found that the initial prognostic factors of mantle cell lymphoma and the failure to treat early Ibrutinib were a poor risk factor for refractory and recurrent mantle lymphoma. The Korean researchers have suggested a standardized treatment strategy for applying target anticancer drugs in mantle cell lymphoma disease. On the 8th, the research team of Professor Seok-gu Cho and Young-woo Jeon of the Lymphoma Center, Yeouido St. Mary's Hospital, Catholic University, Korea, released the findings. The new drug Ibrutinib is an oral capsule and is a special anticancer drug that kills only cancer cells. It is effective in some patients with lymphoma and attracts attention as a new treatment. Therapeutic research has been difficult for 'relapsed and non-refractory mantle cell lymphoma', which accounts for 6% of non-Hodgkin's lymphoma patients. In particular, the price of new drugs, such as Imbrica, was so expensive that accessibility to patients was low. This is why it is meaningful that a team of professors Seok-gu Cho and Young-woo Jeon at the Yeouido St. Mary's Hospital Lymphoma Center of Catholic University apply a single treatment at a single institution and analyze the Ibrutinib treatment response in the same patient. For four years (2013-2018), the researchers collected patient groups from the Lymphoma-myeloma center of the Seoul St. Mary's Hospital, and the Lymphoma Center of the Yeouido St. Mary's Hospital. Thirty-three patients who were prescribed Ibrutinib for recurrence of disease during the use of R-CHOP, a representative primary treatment, after the diagnosis of mantle cell lymphoma. The team analyzed the effects of Ibrutinib treatment and predictive outcomes. The disease-free survival of patients with refractory and recurrent mantle lymphoma with Ibrutinib was about 35 months, longer than the control group, 12 months. Based on the response for 3 months after taking Ibrutinib, the disease-free survival rate was also classified into ▲ early treatment response group and early treatment failure group. The disease-free survival rate was 82% in the early treatment responders with complete or partial remission and 18% in the early failure groups. The early treatment response group was found to maintain long-term survival while maintaining remission, but the early treatment failure group died within six months. The team found a risk factor that predicted a poor prognosis for patients with refractory and recurrent mantle cell lymphoma. ▲The initial prognostic factors of mantle cell lymphoma at first visit were poor, or ▲The initial treatment failed after taking Ibrutinib. It was also confirmed that allogeneic hematopoietic stem cell transplantation was the ultimate treatment for patients who had no therapeutic effect on Iburitinib. Professor Seok-gu Cho (corresponding author) said, "Cortic cell lymphoma is a disease with a very low incidence and a poor recurrence, and the new drug-targeted anticancer drug study is meaningful to patients who relapse during treatment with established and consistent treatments". Professor Cho added, "It also means that the analysis of prognostic factors and prognostic factors for the new drug-targeted anticancer drug is the initial analysis data published for Asians". Professor Jeon Young-woo, the first author, said, “New drug Ibrutinib is not a perfect treatment. Rapidity is most important in treating lymphoma when deciding and switching treatment, and the prognosis is extremely poor. A strategy to improve survival by allogeneic hematopoietic stem cell transplantation is important, and the study was published in the September 2019 issue of Cancer Medicin (IF = 3.35)”.
- Policy
- Exclusive rights such as Betmiga and Olosta expire
- by Lee, Tak-Sun Jan 09, 2020 06:43am
- In 2020, the generics market is likely to be generally calm, with a small number of large-scale items whose exclusive rights expire. Nevertheless,the exclusive right of blockbuster products like hypersensitivity bladder treatment ‘Betmiga’ (Mirabegron/Astellas), hypertension-hyperlipidemia treatment ‘Duowell’(Telmisartan, Rosuvastatin/Yuhan), anti-smoking ‘Champix’(Varenicline/Pfizer) is scheduled to expire, and fierce competition for the generic market is expected. On the 6th, after expiration of PMS and patent expiration items, a number of original items such as Duowell and Champix were captured. Generic drugs cannot be released until the original drug expires and the reexamination expires. Moreover, because there are many kinds of patents like substances, uses, and compositions, just because one patent is terminated doesn't mean you can make generic drugs. 'Duowell', a hypertension-hyperlipidemic drug, is not listed on the MFDS patent list. Generic applications can be applied after the re-examination expiration date which is October 30th. However, it is not attractive to the first generics because more than 10 drugs similar to Duowell have already been approved for sale as data submission drugs. Among the items whose PMS has expired, the substance patent of the anti-smoking drug 'Champix' expires in July. Dozens of companies have already obtained approval through salt-modified drugs, and have sold them for a limited time. But last month, the Patent Court raised the hands of the original drug, which prevented the sale of salt-modified drugs. However, sales will be possible after July. Although there is a follow-up patent, domestic pharmaceutical companies have already succeeded in avoiding patents. On May 3, the overactive bladder drug 'Betmiga' will expire. Although there is a follow-up patent like Champix, domestic pharmaceutical companies have been incapacitated through aggressive patent challenge, which is likely to release generic drugs within the year. The anti-depressant drug 'Pristiq' (Desvenlafaxine/Pfizer) is also likely to release generics this year. Pristiq's expiration date on February 5 has raised the possibility of early launch, with five domestic pharmaceuticals successfully evading patents last year. In addition, the patents on birth control pills 'Yaz', 'Yasmine' (Drospirenone/Ethinyl estradiol/Bayer) and Parkinson's treatment drug 'Stalevo'( Levodopa/Carbidopa/Entacapone) are completely expired. However, Stalevo has been selling products since 2015, with three companies including Jeil Pharmaceutical Co., Ltd, Myung In Pharmaceutical Co., Ltd., and Ilhwa gaining generic exclusivity permission through patent challenge. In addition, the hypertension-hyperlipidemia treatment drug 'Olostar' (Rosuvastatin Olmesatanmedoxomil/Daewoong Pharm. Co., Ltd) will be released this year based on the patent challenge of latecomers.
- Policy
- The MSI invests ₩420 billion to bio-based technologies
- by Lee, Jeong-Hwan Jan 09, 2020 06:42am
- The government will invest ₩420 billion to foster bio as a next-generation growth industry and invests ₩61.4 billion in finding and verifying new drugs. The budget increased by 10.1% compared to the previous year for the development of bio-based technologies. New drugs, medical devices, brain research, and bio-big data are the areas of intensive investment. On the 7th, the Ministry of Science and ICT said, "It will finalize the implementation plan of the original technology development project in the bio sector in 2020". The bio-innovation strategy established by the governmental department last year influenced the movement of the Ministry of Science and ICT. In particular, this year, we will strengthen our support to secure global technological competitiveness in bio-related core fields such as new drugs, medical devices, and brain research, while actively investing in future bio-convergence technologies such as biobig data, artificial intelligence drug development, and 3D biotissue chips. In accordance with the confirmed implementation plan, on the 8th, the government will announce new tasks in key areas such as new drugs and stem cells and start supporting them in earnest. The government selected the biohealth sector as one of the three new industries last year. Ministry of Science and ICT is fostering biotechnology by establishing an innovative strategy for the biohealth industry, and it is pointed out that SK Biopharm's epilepsy treatments are approved for marketing by the US Food and Drug Administration (FDA). First, the government plans to expand R&D investments to secure global technological competitiveness in biomedical core fields such as new drugs, medical devices, and precision medicine. In order to continue the performance of the new drug field, the government will invest ₩61.4 billion to secure new drug technologies, including new businesses to discover and verify new drug targets. In addition, AI and big data, which are the core engines of the Fourth Industrial Revolution, are expected to be used in the bio sector to transform the medical paradigm, thus supporting the convergence technology. Starting this year, the government plans to build a new 20,000 people scaled bio-data collection and utilization system for research with the relevant ministries (the Ministry of Science and ICT, the Ministry of Health and Welfare, Ministry of Trade and Industry). In addition, the government will continue to invest in the development of new drug technologies using artificial intelligence to drastically reduce the cost and time required for new drug development. New investments will also be made this year in building a next-generation drug evaluation platform. It also invests in the development of treatment technology to overcome diseases directly related to national health, such as dementia caused by aging and infectious diseases that are regularly problematic. From this year, the Ministry of Health and Welfare & the Ministry of Science and ICT will jointly support the cause of dementia, develop the pathogenesis, predict and diagnose early diagnosis, prevent and treat the development of treatment technology, and will also invest in the development and diagnosis of key brain diseases such as brain development disorders, emotional disorders such as depression, and damage to the nervous system. In order to strengthen its ability to respond to infectious diseases, it will invest ₩24.4 billion in developing technologies for preventing and treating infectious diseases, including developing new and emerging virus response technologies. Seo-gon Ko, a director of basic source research policy, said “Biofield is a technology-based industry, and securing core technology leads to the preoccupation of the market, there are also characteristics that new market is developed based on convergence technology, and the government will actively support the development of future medical technologies by combining R&D , artificial intelligence, and big data with bio to preoccupy the global core market”.
- Policy
- ATP-based reduction on immunosuppressant Certican
- by Kim, Jung-Ju Jan 09, 2020 06:24am
- Price of Novartis’ immunosuppressant Certican (everolimus), still in prolonged pricing reduction cancellation litigation with the government, would be reduced based on actual transaction price (ATP) survey result. The pricing reduction on Certican would be enforced after the ongoing litigation reaches its final decision as it still has administrative suspension order in effect. According to pharmaceutical industry sources on Jan. 6, Korea's Ministry of Health and Welfare (MOHW) is planning to announce amended Pharmaceutical Reimbursement Listing and Maximum Reimbursed Price on Jan. 9. The ATP-based pricing reduction refers to the government lowering price of drugs by a rate within ten percent of weighted average value calculated according to the recently surveyed ATP. Previously, the government has decided to alter Certican's pricing as Chong Geun Dang Pharmaceutical exclusively launched a generic, Certirobel, with Preferential Sales Approval. Accordingly, MOHW authorized pricing reduction of Certican in four different doses, based on the principle automatically lowering price of the original when a first generic is listed. Opposing on the government's decision, Novartis filed an administrative litigation and requested suspension of pricing reduction enforcement, which the court accepted and sustained the original pricing. The suspension request has been accepted on Mar. 15, May 31 and June 28 last year for three times, and currently the court's decision to suspend the pricing reduction until 30 days after the final decision on the appeal has been maintained. Certican's pricing has been kept unchanged with the repeated suspension order, but the government has to adjust the original maximum reimbursed price before with the ATP survey result. However, if the pricing reduction is enforced as planned, before the court’s order of suspension, the ATP-based pricing reduction would not be necessary as the first reduction rate is steeper than the ATP-based reduction rate. The government was first planning to lower the drug pricing down to 1,592 won for 0.25 mg, 2,546 won for 0.5 mg, 3,180 won for 0.75 mg and 3,714 won for 1.0 mg.
- Policy
- Reevaluation to first review underperforming drug
- by Kim, Jung-Ju Jan 08, 2020 06:19am
- The government reaffirmed the listed drug reevaluation subject would prioritize drugs with clinical efficacy underperforming than initially expected. Gradually conducted on all subjected drugs, actions following up the reevaluation, such as pricing reduction or reimbursed indication revocation or reduction on drug not reaching expected efficacy agreed on during listed pricing negotiation, would be decided after the result is out. On Jan. 7, Korea’s Ministry of Health and Welfare (MOHW) announced listed drug reevaluation principles, as a part of the National Health Insurance (NHI) Comprehensive Plan, and briefed current status of severe disease treatment-centered insurance coverage enhancement. First, the ministry plans to differentiate reevaluation type and conduct in phases to accommodate diverse properties of various drugs. The drug properties would mean new drug or drug with underperforming efficacy listed for NHI reimbursement through selective reimbursement, high-cost and severe disease treatment, conditional approval or pharmacoeconomic evaluation (PE) exemption tracks. MOHW explained, “The reevaluation would first review drugs not demonstrating expected level of clinical efficacy, while detailed evaluation procedure, criteria and schedule would be open as much as possible to keep them transparent.” And noting on the public’s concern about the objective of the reevaluation, the ministry official stressed “Follow-up actions like resetting reimbursement criteria and pricing, maintaining reimbursement and others would be decided depending on the evaluation outcome. So it does not mean definite revocation of reimbursement.” The official elaborated that each item has a number of indications and actual effectiveness in the field, patient demand and necessity could be different and affect the decision accordingly. The official also added the NHI coverage has been expanded since the announcement of NHI Coverage Enhancement Policy, centering anticancer and rare disease treatment. Total 421 items, including anticancer and rare disease treatments, were listed within a year from the government’s announcement in July 2018 to July last year. For an instance, Biogen’s spinal muscular atrophy (SMA) treatment Spinraza was originally priced at 92.35 million won per vial (5 ml), but the patient copayment went down significantly as it was listed for reimbursement in April last year. According to the government, the treatment is an expensive drug costing a patient approximately 300 million won to 600 million won annually. But NHI reimbursement was granted and copayment ceiling system was applied, which dropped patient copayment to around 5.8 million won a year. The government also cleared reimbursement for Sanofi-Aventis’ novel treatment for severe atopic dermatitis, ‘Dupixent Prefilled Syringe 300 mg’, and brought down copayment to around 5.8 million won like Spinraza. The patient copayment was decreased steeply as it was a first drug to sign newly expanded risk sharing agreement and was applied with copayment ceiling system. When it was still non-reimbursed, a patient had to pay 26 million won annually per patient. MOHW explained, “The NHI coverage would expand but selectively based on feasibility of NHI reimbursement depending on the improvement in clinical efficacy, reimbursement criteria and basic principle of moderate pricing evaluation. Focusing on severe disease treatments with high social demand, the government would continue to expand insurance coverage.”
