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- 2025-12-27 15:35:01
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- Terramycin out again, Pfizer says February next year
- by Jung, Hye-Jin Dec 09, 2019 06:26am
- Pfizer Korea’s Terramycin ophthalmic ointment (3.5 g) is out of stock yet again. Pharmacies are expecting to fall into confusion as the versatile ointment is used vastly with affordable reimbursed price for various conditions. Pfizer Korea notified distributors and pharmacies recently that the production schedule of Terramycin ophthalmic ointment has been delayed and accordingly the supply would be suspended temporarily. The company expects drug supply would resume in around February next year. The ointment was experiencing a long-term shortage for 18 months from 2016 to 2017, and gained the title of ‘problematic out-of-stock drug.’ At the time, Korean Pharmaceutical Association (KPA) demanded Ministry of Food and Drug Safety (MFDS) for a countermeasure as hospitals and clinics continued to prescribe Terramycin ointment despite the shortage. Terramycin ophthalmic ointment is popular among patients as it is used to treat a wide variety of superficial ocular infections, such as corneal ulcer and conjectivitis, and also because of its affordable price. The usage volume has surged lately as increasing number of pet owners started applying the ointment on their pets Besides, the reimbursed price of 385 won is another attractive factor of the product. The prescribed ointment sold about 180 million won, or about 470,000 units in the first half of the year alone. Even before Pfizer Korea disseminated an official notice, online shops and major distributor have gone out of stock. A number of major online shops have out-of-stock notice on their websites, and distributors are doing their best to find leftover stock. A drug distributor source explained, “When the rumor about the shortage spread, the stock level had already plummeted since the beginning of November. The shortage seems to have begun earlier as some concerned pharmacies have ordered excessive amount than usual”.
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- 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.
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- 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”.
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- 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.
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- Ildong exclusively sells 9 kinds of GSK generic drugs
- by Chon, Seung-Hyun Dec 04, 2019 06:41am
- Ildong Pharmaceuticals announced on the 2nd that it has signed 9 co-promotional contracts with GlaxoSmithKline Consumer Healthcare Korea, including general medicines. With this agreement, Ildong Pharmaceuticals is a comprehensive cold medicine ‘ theraflu’, an ophthalmic drug ‘Otrivin’, a non-smoking supplement ‘Nicotinell’, a hyperhidrosis cure, ‘Driclor soln’, an external anti-inflammatory analgesic ‘ Voltaren’, a denture attachment ‘Polident’, toothpaste ‘Sensodyne’, ‘Paradontax’, and band medical expander,‘Breathlite’. Last year, domestic sales of nine products stood at about ₩46 billion. It is equivalent to 9% of last year's consolidated revenue. Ildong Pharmaceuticals will be in charge of distribution, sales and marketing of co-promotional products to the pharmacy market from next year. GSK Consumer Healthcare Korea will support brand marketing and customer service related tasks. Dong-wha Pharmaceticals was in charge of distribution and sales of products that Ildong Pharmaceutical decided to sell. Dong-wha Pharmaceutials entered into a copyright agreement with GSK until 2020, but due to the merger of GSK and Pfizer Healthcare, the company was terminated and decided to terminate the contract by the end of this year. Ildong Pharmaceutical anticipated that, starting next year, the company will be able to achieve annual sales of more than ₩200 billion only through the OTC pharmaceutical business. Ildong Pharmaceuticals is known to have differentiated competitiveness in the field of OTC and consumer healthcare by possessing a number of well-known brands such as Aronamin, the No.1 best selling drug in Korea, and specialized sales and marketing organizations and human resources. The company explained that the company's online drug store 'Ildong Shop' was able to increase profitability as well as sales through efficient distribution and inventory management. A representative of Ildong Pharmaceutical said, “We have expanded our cooperation with GSK Consumer Healthcare Korea and OTC / Consumer Healthcare after co-promotion of flu medicine, Relenza with GSK Korea. We will continue to look for partnerships that will allow us to work together and grow together in the medium to long term”.
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- Narcolepsy treatment, Nuvigil settled down in Big 5 hospital
- by Eo, Yun-Ho Dec 04, 2019 06:41am
- Narcolepsy treatment, Nuvigil are facing the entry in Big 5 hospitals. According to the industry, Handokteva's Nuvigil (Amordafinil) has passed the SNUH, Severance Hospital, SMC, and ASAN Medical Center's drug commitee (DC). In addition, prescription code was generated at St. Vincent's Hospital of Catholic University. The system of St. Mary's Hospitals is centralized, and must be approved by the Seoul St. Mary's Hospital before the code is applied to the entire St. Mary's Hospital. It has entered into an unusual case. Nuvigil was released last September in the health insurance reimbursement list in June last year for the treatment of hypersomnia related to adult narcolepsy. Narcolepsy is a symptom controlled through drug treatment. Currently, there are few treatments, so the choice is very limited. Nuvigil is an R-isomer of Amordafinil, which is currently used as a treatment for narcolepsy, and is characterized by an improved drug convenience by improving the duration of drug efficacy. Nuvigil, the active isomer of sleep seizure treatment Provigil (Modafinil), is a blockbuster drug with sales of about $80 million (about ₩94.8 billion). Teva acquired Nuvigil in 2011 by taking over Cephalon inc, the original developer. In Korea, it was approved as an indication for 'excessive drowsiness related to narcolepsy'. Nuvigil is prescribed for sleep attacks, obstructive sleep apnea, and shift work sleep disorder. In particular, a study comparing Nuvigil and placebo in 245 patients with shift work sleep disorder was noted. In this study, the proportion of patients whose sleep latency was more than 5 minutes, measured by multiple sleep latency tests, was 38% in the Nuvigil’s group, 17% above placebo. An official of the Sleep Society said, "Nuvigil is a drug that improves waking conditions without interfering with the sleeping state. Although there is a late entry into Korea, it is expected to be used in various ways".
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- 8 multinational companies name new CEOs in Korea
- by Eo, Yun-Ho Dec 03, 2019 03:21pm
- From top left; Vice-chair Lee Youngshin, CEO Moon Hee-seok, CEO Shin Jung-beom, President Alberto Riva, CEO Kang So Young, CEO Lee Hye-young, CEO Kim Jinyoung, and CEO Kang Sangwook Sources report eight global pharmaceutical companies have appointed new CEOs of Korean affiliates this year only. Daily Pharm surveyed a roster of major 30 multinational companies’ Korean affiliate CEOs as of Dec. 4, and found about 28 percent of the companies have either replaced or newly appointed the top executive personnel. While several companies had a regular personnel reshuffle, others had a new personnel this year for specific reasons like merger, corporate split, and disciplinary dismissal. Roster of Korean affiliate CEOs of multinational pharmaceutical companies (as of Dec. 2019) First, Takeda Pharmaceutical and Bristol-Myers Squibb completed their acquisitions of Shire and Celgene, respectively, and welcomed new CEOs to their merged organizations. As for Takeda Pharmaceutical Korea, when the former CEO Mahender Nayak left the position it was vacant until the former CEO of merged company Shire Korea, Moon Hee-seok took over. With such development, the pharmaceutical industry had their eyes on the recently merged Bristol-Myers Squibb (BMS) and Celgene Korea’s CEO. BMS ultimately chose a promotion from within. BMS also had a vacant CEO position for a while as the former CEO Park Hye-sun left suddenly before her term ended in May. And the former CEO of Celgene, Ham Tae-jin was re-elected for another term. Although the BMS headquarters interviewed number of major candidates from Korean pharmaceutical industry, including CEO Ham Tae-jin, it appointed then acting CEO and former head of Legal and Compliance division of BMS Korea as an official CEO of the merged company. Some top executives, who served their company for a long term, left the position. A former general manager of Abbvie Korea, Yoo Hong-Ki had his retirement ceremony in last March after leading the company for over a decade, even before Abbvie was split from Abbott. As he left the company, he appointed former vice-president Kang So Young as a new general manager of the Korean branch. Menarini Korea also saw the former president Albert Kim leave last year, who served the company since before Invida was acquired by Menarini. The position was replaced by Park Hyeyoung. Pfizer Upjohn Korea, established with the recent Pfizer split, appointed Lee Hye-young as the first head of the company. Before she was appointed as a CEO, Lee used to lead Pfizer Korea’s off-patent product division. In addition, Lilly Korea appointed Alberto Riva, LEO Pharma Korea appointed former Roche personnel Shin Jung-beom, and GSK Consumer Healthcare invited former L'Oréal personnel Kang Sangwook as the new heads of their Korean affiliates. The Korea Research-based Pharmaceutical Industry Association (KRPIA) also welcomed a new CEO, Youngshin Lee. Meanwhile, this year’s ratio of Korean personnel, as a CEO of Korean affiliate of multinational pharmaceutical company, soared to 66 percent from 50 percent last year. And overall female CEO ratio in the multinational companies reached 30 percent.
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- Counterattack of Valsartan’s Pharmaceuticals
- by Chon, Seung-Hyun Dec 03, 2019 05:54am
- Pharmaceuticals filed an alleged class action lawsuit against health authorities. A lawsuit was filed preemptively that the government can not accept the Valsartan claim. Cost liability for follow-up of impurity drugs has been determined in court. According to the industry, 36 pharmaceutical companies recently filed a lawsuit to confirm the absence of debt against the National Health Insurance Service in the Seoul Central District Court. It is a lawsuit stating that it is not responsible for the valsartan damages claimed by the National Health Insurance Service. The NHIS asked to pay a donation of ₩2.03 billion to 69 pharmaceutical companies in last October. It is a follow-up to the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies after exchanging impurity valsartan for the remainder of their prescriptions last year. It is unprecedented that pharmaceutical companies filed a lawsuit against the government in a group. In 2012, the government made a move to file a lawsuit against the collective price cuts of health authorities, but did not lead to a legal workshop. In 2013, the NHIS and pharmaceutical companies filed a lawsuit for damages related to drug substance preferential treatment. However, at this time, the NHIS filed a lawsuit. Originally, pharmaceutical companies considered the joint response to the NHIS 'lawsuit. However, they agreed to take a hard-line response by preemptively bringing up class action. The number of companies participating in litigation is also on the rise. Pharmaceutical companies were the first to discuss whether they would co-operate for the first time immediately after receiving a bill from the NHIS in early October, at that time, 20 companies showed a positive position. When it decided to file a lawsuit last month, it increased to 35 companies, and it was reported that one large pharmaceutical company was willing to join an additional company immediately after submitting the complaint. Most companies with large damages have refused to pay. According to the data submitted to the Democratic Party's member, Nam In-sun, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. The pharmaceuticals refused to pay about 80% of the recourse amount. Pharmaceutical companies are claiming no responsibility for the government-claimed Valsartan damages. The NHIS has proposed a product liability law on the grounds of valsartan compensation. It is judged that there is a defect in the manufacturer's product and safety, and according to the product liability law, it is possible to claim for damages due to the product defect. It is based on Article 3 of the Product Liability Act, which states that 'manufacturers shall reimburse those who suffer damages to life, body or property due to defects of the product'. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan’s issue, is a hazardous substance in the valsartan raw material that has no standard. Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages. After the valsartan’s issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards. The MFDS set the NDMA standard for Valsartan to 0.3 ppm or less by reviewing the guidelines recommended by the International Pharmaceutical Regulatory Coordination Committee (ICH M7), domestic and international data, and expert advice. Moreover, the hazard of impurity Valsartan was not revealed. The MFDS said, “ in last December, based on individual doses and duration of patients actually taking NHA-detected drugs using Valsartan by Huahai , the possibility of additional cancer was negligibly low“ Pharmaceutical companies argue that the National Health Insurance Service does not include claims for damages. The NHIS has charged Valsartan medical fees and dispensing fees, but pharmaceutical companies are not liable for compensation under the Product Liability Act. An official of a pharmaceutical company said, “We took huge losses from the recovery and disposal of products that are not exposed to human hazards, and it is unfair to pay for represription fee and redispensing costs. Following Valsartan, sales of Ranitidine and Nizatidine were stopped, and we decided we need to weigh the injustices of the government action”.
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- ECCK “Revised Pricing Negotiation Guideline Violates FTA"
- by Kim, Jin-Gu Dec 03, 2019 05:53am
- Chair Julien Samson of ECCK Healthcare Committee (VP& General Manager of GSK Korea, fourth from the right) and other ECCK members presented White Paper 2019 and presented recommendations to Korean government. Europe-based global pharmaceutical companies with offshoots in Korea have filed official complaints on ‘additional requirements under side agreement’ added to drug pricing negotiation procedure in Korea. They claim the new changes could violate the principles of Korea-EU Free Trade Agreement (FTA). European Chamber of Commerce in Korea (ECCK) convened a press conference on Nov. 29 at Four Seasons Hotel Seoul, and addressed issues regarding each industry sector and 180 recommendations to the Korean government. ECCK’s Healthcare Committee (Chair Julien Samson, VP & General Manager of GSK Korea) also contributed 34 recommendations. The highlight of the recommendations was the ‘Revising the New Requirements Imposed through Drug Price Agreement.’ National Health Insurance Service (NHIS) imposed several ‘side agreement’, or ‘additional requirements’ to the pharmaceutical companies during the price negotiation since last year and regulated them in June, 2019. ECCK official warned the additional requirements were “regulated without any public comment period. Some of them are overly strict with little relevance to pricing negotiation. This could violate the principles of Korea-EU FTA”. The committee argues Korea-EU FTA stipulates when revising regulation or guideline regarding pharmaceutical pricing or insurance reimbursement, both government bodies should communicate with industry. “It is recommended to consult with the industry stakeholders on any new requirements or revisions in line with the principles of the Korea-EU FTA”, ECCK officially advised. In fact, the side agreement requirements have become the most talked about issue of recent drug pricing negotiation cases. Lipiodol incident was the critical point triggered the Korean government. The change is interpreted as the government’s effort to prevent any other already-listed item refusing to supply products to Korean market. The new requirements impose penalty on pharmaceutical company not fulfilling obligation to supply drug products, and stipulate the companies to provide compensation for patient when suspending supply. Also the side agreement requires both negotiating parties to keep negotiation details non-disclosed. Biogen’s Spinraza, Janssen’s Darzalex, Amgen’s Prolia and other items that completed pricing negotiation this year had to meet the additional requirements. Although it had the negotiation last year, CJ Healthcare’s K-Cab had to fill out the side agreement as well. And three new drug items exempted from negotiation were denied from the last reimbursement review procedure in April, because they were “missing side agreement”. It was unexpected as reimbursement used to be granted usually without an issue for an item passed by Health Insurance Policy Deliberation Committee (HIPDC). At the end, Whanin Pharm’s Agotin, AstraZeneca’s Faslodex and Takeda’s Alunbrig were successfully listed after compiling side agreement. But the happening reaffirmed the gravity of side agreement in the negotiation procedure. In June, the side agreement submission was regulated as a law. NHIS’ revised drug pricing negotiation guideline now requires pharmaceutical companies to submit an agreement about supply obligation, patient protection measures, and confidentiality when negotiating drug pricing. The Article 9 of Drug Pricing Negotiation Guideline was revised and now imposes new requirements to pharmaceutical companies to protect Korean patient, to provide compensation for patient damage, and keep negotiation confidential. The pharmaceutical industry is mainly complaining about the government omitting the industry comment period. For an instance, a global pharmaceutical company organization, or Korean Research-based Pharma Industry Association (KRPIA), submitted an official statement claiming “Imposing of additional requirement or obligation for drug pricing negotiation should come with an administrative notice according to the Administrative Procedure Act”. The organization also reprehended the new requirements are considered as ‘side agreement’, but it actually puts NHIS on an authoritative position for it to unilaterally impose obligations to pharmaceutical companies. The ECCK’s complaint is basically an extension of the criticism. Established in 2012, ECCK has headquarters in Europe and it consists of 360 active member companies. Every year the Chamber represents the voice of European businesses by collecting recommendations and relaying them to the Korean government. Last year, the Chamber has presented ECCK White Paper 2018 with 123 recommendations, and almost 40 percent of the recommendations received positive feedbacks from the Korean Ministry of Trade, Industry and Energy (MOTIE).
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- Drug Committees pass oral Fabry treatment Galafold
- by Eo, Yun-Ho Dec 02, 2019 05:57am
- Galfold (migalastat) The world’s first orally taken Fabry disease treatment ‘Galafold’ is landing its code on tertiary hospital drug list. According to pharmaceutical industry, Handok’s Galafold (migalastat) has been passed by drug committees (DC) in specialized healthcare institutes for rare disease care, like Seoul Asan Medical Center, Ajou University Hospital, and Pusan National University Yangsan Hospital. Other major general hospitals and Big 5 hospitals are also processing the drug code. Galafold is prescribed to patients aged 16 years or older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. The treatment should be taken one capsule every other day. Galafold’s Phase 3 ATTRACT study switched therapy for 57 Fabry disease patients, who had enzyme replacement therapy (ERT) for at least 12 months, with Galafold. The investigational treatment demonstrated statistically equivalent annual change of estimated glomerular filtration rate (eGFR) with 18-month of ERT. While the group who remained on ERT had a decline of left ventricular mass index (LVMi) by -2.0 g/m2 over 18 months, the group who switched from ERT to migalistat had a significant decline in LVMI by -6.6 g/m2 over the same period. Developed by an U.S.-based Amicus Therapeutics, Galafold was approved by the U.S. Food and Drug Administration (FDA) in October, 2018, and it is now available in the U.S., EU, Australian, Canadian, Swiss, Israeli, and Japanese markets. The treatment has been designated as an investigational orphan drug to meet urgent medical needs, and received approval from Korean Ministry of Food and Drug Safety (MFDS) in 2017. Its insurance reimbursement was also granted from last March. Currently, Galafold’s competitive medicine are Sanofi Genzyme’s Fabrazyme (agalsidase beta) and Shire’s Replagal (agalsidase alfa). The two competitors are ERT sharing a similar mechanism in injection formulation. Replagal is injected once every other week into intravenous line with dose of 0.2 mg per kg body weight, whereas Fabrazyme is injected once every other week into intravenous line with dose of 1.0 mg per kg body weight. Fabrazyme is comparatively a high-dose treatment. Another notable difference is that Replagal is produced in a human cell line, and Fabrazyme is produced in Chinese hamster ovary cell line. An official from Korean Society of Medical Genetics and Genomics commented, “Rare disease like Fabry disease has small patient size to begin with, which makes conducting a credible clinical trial quite difficult. Therefore, medical professions are more likely to be loyal to older treatments. However, having more treatment option for the disease is good news”.
