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- 2026-05-20 14:21:58
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- New anticancer drugs by Bayer have been approved in Korea
- by Eo, Yun-Ho Jun 02, 2020 06:09am
- Two new drugs of Bayer's anticancer drugs will enter the domestic market. Androgen Receptor Inhibitor (ARi), Nubeqa (Darolutamide), treatment for nmCRPC and Orbital Selective Tropomyosin Receptor Kinase (TRK) inhibitor, Vitrakvi (Larotretinib) was recently approved by the MFDS. Nubeqa is an androgen receptor inhibitor with a unique chemical structure. It binds to androgen receptors and suppresses the growth of prostate cells through strong antagonism. This domestic permit is based on ARAMIS, a phase III clinical study that compared and evaluated the effectiveness and safety of Nubeqa and placebo controls in combination with androgen deprivation therapy (ADT). The study's main evaluation item, Metastasis-free Survival Period (MFS), was 40.4 months in Nubeqa and ADT combination groups, and demonstrated a significant improvement compared to 18.4 months in the placebo and ADT combination groups. Death risk was found to have decreased by 31% In addition, Vitrakvi has a high probability of severe morbidity during local, metastatic, or surgical resection among adult and pediatric patients who have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquisition-resistant mutation, and proceeds after existing treatments (or treatment regimens). It can be used for the treatment of patients with solid cancer who do not have a suitable treatment available or are currently available. The efficacy effect of Vitrakvi was approved on the basis of the overall response rate, and no clinical trials have demonstrated clinical benefits such as increased survival. This domestic permit includes clinical trials for adult and pediatric NTRK gene fusion advanced solid cancer patients (Phase I for adults 18 years of age and older, NAVIGATE Phase II for adults and children over 12 years of age, and primary CNS tumors). It is based on SCOUT Phase I/II trial in pediatric patients from 1 month to 21 years of age). According to the efficacy evaluation of a total of 55 patients in which NTRK gene fusion was confirmed from three clinical studies, Vitrakvi achieved an objective response rate (ORR) of 75% and a partial response rate (PR) of 53% in various carcinomas (soft tissue sarcoma, infantile fibrosarcoma, salivary gland cancer, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor)
- Policy
- The emergency introduction of Remdesivir was confirmed
- by Lee, Tak-Sun Jun 02, 2020 06:09am
- 정은경 중앙방역대책본부장The government urgently introduced Gilead's 'Remdesivir' as a cure for COVID-19. Accordingly, the MFDS is planning to go through a special import procedure. Eun-kyung Jung, Head of the Central Disease Control Headquarters, said at the regular briefing on the 29th that the Central Clinical Committee on 28th suggested the need for the introduction of Remdesivir. Accordingly, the Central Disease Control Headquarters plans to apply for the special import (emergency introduction) of Remdesivir from the MFDS in response to the opinion of the Central Clinical Committee. The Committee evaluated that Remdesivir is safe and effective in the treatment of COVID-19 pneumonia, and that it is necessary to medically introduce Remdesivir in the absence of an alternative antiviral agent. In addition, it is said that the need for Remdesivir is given to patients with severe pneumonia from COVID-19 infection and who require oxygen treatment. The dosing period is about 5 days, and it is extended for 5 days depending on the patient's condition. However, the need for monitoring for effects or side effects is mentioned. Remdesivir is a drug that is currently undergoing clinical trials in Korea. The MFDS can import special drugs under the pharmaceutical affairs law at the request of the KCDC for drugs not approved for domestic use. If special import is recognized, it is possible to enter and use the imported items in Korea without the approval procedure. Pediatric Kaletra syrup, currently used to treat COVID-19, has also undergone this procedure. "Currently, there is not so much supply or production of drugs, so we plan to cooperate with related ministries as much as possible to secure drugs," said Jung. "It seems difficult to tell about the time now."
- Company
- Prescription drop amid COVID-19 finally emerges in April
- by Chon, Seung-Hyun Jun 02, 2020 06:09am
- The outpatient prescription volume in April has dropped by 10 percent against the same month last year. The outcome contrasts to this year’s first quarter prescription volume showing an increase against last year. Although the COVID-19 confirmed case curve in Korea seems to have gone down from April, the prescription volume shrunk even worse. As chronic disease patients have received long-term prescription in the first quarter to avoid visiting healthcare institutes amid COVID-19, a long break in prescription has seemingly occurred in the month of April. According to pharmaceutical market research firm UBIST on May 25, the total outpatient prescription volume in April was at 1.19 trillion won, which was brought down by 8.7 percent than in last year. In 2018 and 2019, the April prescription volumes have surged by 8.3 percent and 13.1 percent, respectively, compared to the previous year, but it bounced back down in last April. The April prescription volume this year has hit the lowest point in ten months since June last year. Monthly outpatient prescription trend (Unit: KRW 100 million) Source: UBIST The pharmaceutical industry experts evaluate that the COVID-19 impact on the prescription market has finally surfaced in the month of April. Since the first confirmed case of COVID-19 in Korea, the industry was deeply concerned that the prescription drug market would be shaken as pharmaceutical companies’ sales activities have been diminished and increasing number of outpatient refrained from visiting healthcare providers. But, the prescription volume up to March did not seem affected. Apparently, the prescription volume in the first quarter reached 3.70 trillion won, which was 2.7 percent higher than last year first quarter at 3.60 trillion won. The monthly prescription volume in January this year was dropped by 4.4 percent than last year by generating 1.22 trillion won. On the contrary, the February prescription volume this year was surged by 13.0 percent, generating 1.22 trillion. The industry experts analyze the number of business days in January and February have been affected by the early Lunar New Year holidays in Korea. This year’s January with less number of business days than last year had less prescription volume and February with more business days this year had increased volume. The total prescription volume in March was at 1.23 trillion won with 1.4 percent growth from last year. But the volume in April had the steepest fall so far in the year. In last year’s April, the prescription volume soared by 7.4 percent than the previous month, but this year’s April had a 3.2 percent dip from March. Many of chronic disease patients receiving long-term prescription to avoid visiting healthcare providers could have created a significant prescription drop in April. Apparently, the cases of patients receiving three to six months worth of prescription have skyrocketed when the confirmed case of COVID-19 peaked in Korea. The experts also suspect the postponed school semester, social distancing and better-managed personal hygiene could have reduced the disease prevalence in infants and children, which also affected the drop in the number of visit to healthcare institute. A majority of pharmaceutical companies in April had sluggish outcome in prescription volume. Among the top ten companies—Hanmi Pharmaceutical, Chong Kun Dang, Pifzer, Daewong Pharmaceutical, MSD, Novartis, Yuhan, Boehringer Ingelheim, HK inno.N and AstraZeneca—nine companies except for AstraZeneca had stagnating prescription volume in April than the year before. Top April outpatient prescription volume in 2020 by companies (Unit: KRW 100 million) Source: UBIST Hanmi Pharmaceutical recording the highest volume of prescription has made 52.9 billion won in April, falling down 8.7 percent than in last year. The Korean company’s first quarter volume was increased by 6.2 percent than in last year, but the volume was pulled back down in April. Chong Kun Dang and Pfizer’s April prescription volumes also had significant drop of 10.5 percent and 8.8 percent, respectively. Chong Kun Dang had a 1.7 percent growth in the first quarter, but the company took a steep fall in April. Pfizer’s first quarter prescription volume was dropped by 4.1 percent, and the figure got worse in April. The companies with the highest prescription volume, such as Daewoong Pharmaceutical, MSD, Novartis, Yuhan, Boehringer Ingelheim and HK inno.N, all performed worse than last year. Meanwhile, AstraZeneca made 9.3 percent more in this year’s April than last year. The multinational company’s first quarter prescription volume also grew by 9.7 percent from the year before. The pharmaceutical industry expects the prescription drug market would take a sharp upturn soon, as the number of confirmed COVID-19 cases has been dropping and the social distancing has been shifted to distancing in daily life.
- Policy
- Pfizer's non-steroidal eczema, under phase III in Korea
- by Lee, Tak-Sun Jun 01, 2020 06:20am
- A non-steroidal ointment that can be used for eczema in children is under clinical trial for domestic introduction. Pfizer's Crisaborole is a drug sold in the United States under the name of 'Eucrisa' after it was approved by the US in 2016. The MFDS approved a multinational clinical trial phase III for Pfizer’s Crisaborole on the 29th of last month. This clinical trial is aimed at verifying the efficacy and safety of 2% of Crisaborole ointment in Asian children and adult subjects (over 2 years of age) with mild to moderate eczema. Of the 510 subjects, the total number of domestic patients is 120. If safety and effectiveness are proved through this clinical trial, it is expected that the drug approval process will be conducted in Asia, including Korea. Eczema is a symptom of itching and dry skin, which usually starts in early childhood. the cause of the disease is still unknown, but it is said to be affected by genetic factors and environmental factors. Topical steroid ointments are used to moisturize the skin and suppress itching. However, the side effects of steroids are thinning the skin and there is a risk of infection, so long-term use should be avoided. Crisaborole is a non-steroid, and is a new ointment that can be used for eczema in the PDE-4 (phosphodiesteras). PDE-4 drugs that maintain immune homeostasis by increasing the release of inflammatory mediators include CDPD treatment, Daxas and psoriasis treatment, Otezlar, the first ointment to treat pediatric eczema. Accordingly, it is expected that the release of Crisaborole will act as an alternative to steroid ointments. Crisaborole was approved by the United States FDA in December 2016 for children over 2 years of age and adults with eczema. Recently, clinical trials have been conducted to lower the age group so that it can be used by children over 3 months of age. It is reported that there are about 950 thousand eczema patients in Korea, which is increasing every year. Treatment for non-steroidal eczema exists in Korea, but it is likely that attention will be focused on the introduction of Crisaborole in that it is rare for ointments that can be used in children.
- Policy
- Mabthera coverage extended and Strensiq newly listed
- by Kim, Jung-Ju Jun 01, 2020 06:20am
- Healthcare reimbursement would be granted on AbbVie Korea’s adult psoriasis treatment Skyrizi prefilled syringe (risankizumab) and Handok’s rare disease treatment Strensiq Injection (asfotase alfa) with new reimbursement standards. Korea’s Ministry of Health and Welfare (MOHW) announced the finalized changes in the revised Healthcare Reimbursement Standard and Method would be effective from June 1. ◆Skyrizi prefilled syringe: A new detailed standard of healthcare reimbursement would be established for the risankizumab injection based on the existing biological therapy options for psoriasis treatment. The coverage on the treatment would be granted to patients (age over 18) with chronic (expressed for over six months) psoriasis at a severe level, who qualify all following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface area; scoring 10 or higher on Psoriasis Area and Severity Index (PASI); and demonstrating no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. However, those patients who cannot receive both photochemotherapy (PUVA) and UVB phototherapy should qualify following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface; scoring 10 or higher on PASI; and demonstrating no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine, or cannot maintain the therapy due to adverse reaction. If the patient shows reduction of PASI by 75 percent or more after taking the treatment for 16 weeks (three doses), the coverage status is maintained for another six months. The PASI would be evaluated every six months and the coverage would be maintained if the patient shows the initial evaluation result. Risankizumab was added as an alternative option of TNF-α inhibitors like adalimumab, etanercept and infliximab or guselkumab, ixekizumab, secukinumab and ustekinumab have added risankizumab with the new reimbursement approval. ◆ Strensiq 40 mg/ mL injection and other: Handok’s Strensiq injection (asfotase alfa), the only enzyme replacement therapy indicated to treat infantile- and juvenile-onset hypophosphatasia (HPP). The injection would also be listed from June 1 for patients with infantile- and juvenile-onset HPP, who started treatment before the age of 19. Accordingly, provisional approval procedure and other reimbursement standards were added to manage careful use of the treatment with standard of initial administration and suspension. A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19. The evaluation has to be conducted prior to the initial treatment, three and six months into the therapy, and clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) should be followed every six months from then on. The treatment has to be administered at a healthcare institute by principle, but self-administration would be allowed only when a properly trained patient demonstrates stable disease activity and no sign of adverse reaction. For a long-term prescription, a single dose is for maximum of four weeks. The patient also has to document ‘medication log’ to keep track of administration period and management for the responsible healthcare institute to follow. ◆ Lemtrada injection: Sanofi-Aventis Korea’s Lemtrada injection (alemtuzumab) indicated to treat relapsing remitting multiple sclerosis (RRMS) in adult patients is extending its reimbursement to cover third cycle for patients qualifying acceptable disease activity level after the second cycle. Patients, who have relapsed at least once, are eligible for the coverage if they meet two conditions out of following three; brain or spinal MRI detects new or enlarged T2 lesion, or new Gadolinium-enhanced lesion. ◆ Cyclosporine oral and injection and mycophenolate mofetil: The reimbursed indications are expanding for Cipol-N soft capsule and Sandimmun injection (cyclosporine), Cellcept capsule (mycophenolate mofetil), cyclophosphamides, Mabthera Injection (rituximab) and IV-Globulin SN injection (human immunoglobulin G). Specifically, the healthcare reimbursement would be granted for the off-label use of the drugs in immune tolerance induction as immunosuppressant to treat hemophilia A or B patients, if pre-approved by Health Insurance Review and Assessment Service (HIRA). The President of HIRA is stipulated to decide prerequisite conditions of the pre-approval, such as forming a committee, standard, procedure and method of the pre-approval. But the reimbursed off-label use of Pfizer Pharmaceutical Korea’s Benefix injection (Recombinant Blood Coagulation Factor Ⅸ) cleared is only for hemophilia B patients. ◆Desmopressin acetate and mirabegron: As Ferring Korea’s Nocdurna 25 μg sublingual tablet is to get listed, desmopressin acetate items exempted from reimbursement due to the revised standard would be stipulated. Also, the reimbursement standard for mirabegron would be revised with the listing of overactive bladder treatment by Hanmi Pharmaceutical, Mirabeg 50 mg SR tablet.
- Company
- Ilyang’s Supect were approved for phase III in Russia
- by Lee, Seok-Jun Jun 01, 2020 06:19am
- Ilyang announced on the 28th that its domestically developed new drug, Supect, will be conducting phase III clinical trials in Russia for the purpose of treating COVID-19. According to the company, Supect received phase III approval of 'COVID-19 treatment' from the Russian government under the supervision of R-Pharm, the No. 1 company in the Russian pharmaceutical industry. R-Pharm pays all costs for the phase III, and Ilyang provides the clinical drug Supect. Clinical trials are conducted in 145 mild and severe COVID-19 confirmed patients from 11 institutions in Russia and neighboring Belarus. After two weeks of dosing, Supect’s significance of treatment effect will be confirmed. An official from Ilyang said that Supect is a domestically proven new drug that is the first clinical trial among domestic pharmaceutical companies, and is likely to be commercialized as a therapeutic agent faster than other candidates.
- Policy
- Hanmi, applied for permission for Xoterna's generic drug
- by Lee, Tak-Sun Jun 01, 2020 06:19am
- HanmiHanmi is expanding its inhaler business for respiratory diseases such as bronchial asthma and chronic obstructive pulmonary disease (COPD). In 2014, Fluterol, generic for GSK's asthma treatment was first introduced in Korea, and recently, the COPD treatment Xoterna (Korea Sandos) is also targeting the market. According to the industry on the 27th, Hanmi applied for the same ingredient as Indacaterol/Glycopyrronium on the 25th. This drug is a bronchodilator and is used as a maintenance therapy to relieve symptoms of chronic obstructive pulmonary disease. The inhalation method is to inhale by attaching a capsule-type inhalant once a day to a separate inhaler (Hanmi Heller). The original is Xoterna by Sandos under Novartis. Xoterna was licensed in May 2014. Based on IQVIA last year, sales amounted to ₩6.4 billion. Hanmi had earlier attempted a patent challenge. Last year, an invalidation trial was filed in a patent that is due to expire . Whether to enter the market will be determined based on the result of the request for the trial. So far, there have been few domestic inhalants. There are still many imported items in the market. Hanmi continues to challenge its domestic products. In 2014, it was the first domestic company to introduce Fluterol, a generic for the asthma treatment Seretide, and in 2015, it was granted Tiropium, generic for COPD treatment Spiriva. An inhaler device called 'Hanmi Heller' was also developed. However, the market performance is lower than that of the original drug compared to expectations. In the case of Fluterol, last year's sales amounted to about ₩1 billion. On the other hand, the original Seretide diskus recorded ₩12 billion. The size of global inhaler market is estimated at 40 trillion. Korea is also not small, with a size of 300 billion. According to the analysis, if localization is established in the market, which is one of the imported products, it can be a 'goose that lays golden eggs'.
- Policy
- Novartis filed a lawsuit for Galvus’ salt-altering drug
- by Lee, Tak-Sun May 29, 2020 06:17am
- It was confirmed that Novartis has filed a lawsuit against the MFDS regarding the approval process of 'Vildagle 50mg' (Vildagliptin HCl), a DPP-4 series diabetes treatment drug that was approved in January. Unlike the Novartis’ Galvus (Vildagliptin), Hanmi's Vildagle is a salt-altering drug with HCl. In addition, Vildagle's indication doesn’t include co-administration with Sulfonylurea or Metformin or Thiazolidinedione monotherapy if blood sugar control is not available. According to the industry on the 28th, Novartis recently filed a lawsuit against the MFDS for request for suspension of execution and cancellation of item permission, saying that Hanmi was granted permission in violation of the obligation to notify the application for permission under the drug patent linkage system. According to the licensing patent linkage system introduced in 2012, generic companies must notify the patent holder of the application for permission. The patent holder may dispute this, and the manufacture and marketing of generics may be suspended for nine months. Novartis claims, however, that Hanmi failed to comply properly even though it was obliged to notify generic licenses. However, Hanmi argues that Vildagle was not obliged to notify, as he was granted permission without an indication that the patent is currently in existence. The MFDS also said that there was no obligation to notify Vildagle as it is not related to the patent rights that exist. Currently, Hanmi has been requesting a judgment to confirm the passive scope of rights that Vildagle has evaded Galvus’ patent rights (expired on March 4, 2022). The judge is expected to come to trial in June as soon as possible. Novartis said that the MFDS and Hanmi went through the permitting process, assuming Vildagle’s patent evasion, before the trial of the Judge was issued. Novartis has also filed a disposition to prohibit the sale of Vildagle to Hanmi. Vildagle 50mg received a price of ₩403 per tablet in April, so it was ready for release. If the court accepts the Novartis’ claim and cites the suspension of the item license for Vildagle, it is expected that the rights such as market sales will be deprived for a certain period of time. In addition, if Novartis wins the main lawsuit, it is expected to cancel the item license. However, as the MFDS claims that the item approval process was normal, the final ruling is expected to take a long time.
- Company
- KRPIA-MOHW talk negotiation, prioritized lisiting and PVA
- by Eo, Yun-Ho May 29, 2020 06:16am
- “Nothing was clarified, but we could somewhat feel out their approach.” For the first time since new Director Yang Yoon Seok was appointed, the Division of Pharmaceutical Benefits at Ministry of Health and Welfare (MOHW) met with a couple of dozen Korean Research-based Pharmaceutical Industry Association (KRPIA) officials and multinational pharmaceutical company market access (MA) representatives on May 28. Along with Director Yang, Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho joined the meeting, where the organization officials and various pharmaceutical company representatives freely asked questions and spoke of their recommendations. Of all topics addressed, three main issues were discussed in-depth. Is pricing negotiation required for all drugs seeking for reimbursed pricing? The Korean government has notified earlier of implementing unified drug listing procedure. For all drugs evaluated to be appropriate for health insurance reimbursement, the government has mandated negotiation to finalize the listing decision. The change is crucial for Korean pharmaceutical companies and their generic products. But for multinational pharmaceutical companies, the change is a concerning issue for the drugs taking the negotiation-exempted track with pricing lower than weighted average price. The point of negotiation exemption system is speed. Technically, companies aiming to swiftly proceed with reimbursement listing take the negotiation exemption track and choose to price the drug on the level of negotiated price. But now the mandatory negotiation procedure could slow down the listing procedure. Regarding the concern, MOWH implied its intention to operate a flexible system. MOHW official said, “The government is also aware that not all drugs seeking for reimbursement would be fit for negotiation on projected claim amount. Depending on the circumstances, the negotiation condition may vary.” Is reimbursement listing prioritization making a leeway to neglect some drugs? The new drug pricing system also stipulates the Minister of Health and Welfare to decide the prioritized order of drug reimbursement listing. Currently, the reimbursement listing review by relevant committees like Drug Reimbursement Evaluation Committee has a limited period of 150 days. But the new prioritized reimbursement review would remove the time limit. The pharmaceutical industry is clearly worried about the amendment. Basically, the reimbursement listing procedure for a drug simply pursuing the benefit could be delayed indefinitely based on the prioritized order. The government seems to be aware of the concern. MOHW explained, “Only because a drug is expensive, or in other words, the drug has a significant financial impact, it would not be ruled out from the priority order. Some drugs could start the listing procedure fast, if need be. We are always pondering on how to improve new drug access.” Price-volume agreement system and labeled price A company representative also spoke of applying the ‘labeled price’ notion, used in the risk sharing agreement (RSA) system, for drugs lowering price due to price-volume agreement (PVA) system. In fact, the government already allows PVA drugs to apply refund rate. However, the benefit is only given to the companies certified as an innovative pharmaceutical company. And the multinational company official proposed the benefit should be extended. The government officials apparently answered with a positive note. The ministry official urged, “The recommendation is plausible and we would review the matter in detail. But, as you would be aware, changes in regulations cannot be rushed in a short span of time.”
- Policy
- KAPO-HIRA on Lutathera coverage “Shooting for September”
- by Lee, Jeong-Hwan May 29, 2020 06:16am
- A patient group announced a meeting was convened with Health Insurance Review and Assessment Service (HIRA) Pharmaceutical Management Department to talk about granting healthcare reimbursement on Neuro Endocrine Tumor (NET) treatment Lutathera. The group is demanding the Korean government to take into consideration of the patients reluctantly travelling afar to receive treatment in Malaysia amid COVID-19 pandemic for more reasonably priced option. HIRA plans to accept the patient group’s demand as much as possible and to issue revised Lutathera coverage status notice on Sept. 1. On May 27, Korea Alliance of Patients Organization (KAPO) disclosed the outcome of their meeting with HIRA Pharmaceutical Management Department. KAPO official reported HIRA is fully aware of patients’ agony of inevitably paying for expensive Lutathera as COVID-19 pandemic has blocked them from the overseas treatment the patients received despite the reported cases of medication misadventure. The officials elaborated Novartis is not applying for reimbursement listing, although Ministry of Food and Drug Safety (MFDS) has asked for Novartis Korea’s listing application through approval-reimbursed pricing evaluation linkage system after completing Lutathera’s safety and efficacy review. Moreover, HIRA is currently reviewing National Health Insurance (NHI) reimbursement standard on Lutathera. However, HIRA has reportedly expressed concern over pharmaceutical companies abusing the NHI reimbursement exceptionally granted on urgently approved orphan drug. But as a conclusion, HIRA said the agency would strive to issue the revised Lutathera reimbursement notice on Sept. 1. KAPO pointed out, “HIRA and Novartis should promptly proceed with the reimbursement listing procedure to lessen the burden of NET patients struggling with overseas treatment and high-cost drugs.”
