- LOGIN
- MemberShip
- 2020-02-22 02:29
Dailypharm Korea will be available without login access until the end of December 2019.
Membership login access would be required from February 2020 to access more news and website services.
Membership login access would be required from February 2020 to access more news and website services.
Top Head
Headline
- InterView
- I'm happy to introduce Spinraza to patients.
- by Eo, Yun-Ho Feb 21, 2020 06:36am
- Biogen, a bioventure company in the US and a smaller company in Korea. Last year, Biogen Korea, which has about 10 employees, registered and launched insurance benefits for its famous spinal muscular atrophy (SMA) treatment Spinraza (Nusinersen). Prior to listing, Biogen Korea's employees had only five employees. Spinraza, a high-priced new drug for rare diseases, did not go well due to its price. Hwang was the only representative of Biogen and introduced the only but necessary new drug, Spinraza. From the approval stage to the reimbursement adequacy evaluation by the HIRA and negotiations with the NHIS, the CEO of the corporation directly persuaded the government. . After approval from the MFDS in December 2017, the company went through two reimbursement-based subcommittees and was also presented twice to the pharmaceutical benefits advisory committee. After a long discussion, It was able to pass a deliberation by accepting the pre-approval system in the form of a refund/expenditure cap of risk sharing agreement (RSA) in last April. Dailypharm met with the CEO of Biogen, Se-eun Hwang who launched a new drug in Korea to hear about the company's future. -For the general public, Biogen is a unfamiliar company so far. Please introduce briefly Biogen is a global biotechnology company founded in 1978 by five scientists, including Nobel laureates Walter Gilbert and Philip Sharp. Although it is a young company with low recognition in Korea, it is widely known as a neuroscience specialist company with over 40 years of history in the United States. The mission of the company is 'At Biogen, our mission is clear, we are pioneers in neuroscience'. In particular, the aim is to provide solutions in areas where therapeutics have not yet been developed and where more effective therapeutics are still needed. Until now, we have been developing and supplying therapeutic drugs in a wide range of neuroscience fields such as rare diseases and multiple sclerosis, Lou Gehrig's disease, and Parkinson's disease, which are equivalent to the field of neuroscience. -What is Biogen's goal in Korea and its short-term and long-term goals? The first purpose of the Korean subsidiary was to allow for the rapid introduction of SMA therapeutic Spinraza into Korea. A Korean subsidiary was established after FDA approval in the United States in 2016, and the goal was to focus on creating an environment in which spinal muscular atrophy patients could have treatment as soon as possible. The short term goal is to improve the environment so that patients can be diagnosed early and begin treatment. Although Spinraza was released in April last year, it is a rare disease treatment, so I think there are a lot of patients who are not aware of the disease. It is also important for medical staff to provide accurate information with more opportunities for Spinraza. The long-term goal is to build and promote a foundation for providing patients with new drugs that can be introduced into the country in the future. To provide Korean patients with as many clinical opportunities as possible and to expand their investment in domestic clinical research to create a win-win environment. -It has been 40 years since its establishment. It's not short, but the only drug introduced in Korea is Spinraza. Companies basically aim to bring together many talented people to achieve business goals and grow together. Biogen Korea is pursuing an efficient structure. The currently approved drug is Spinraza, which has an optimized staffing structure. In the future, the introduction of new drugs will expand the scope as well as human resources. -Even if there aren't many drugs yet, Isn't the size of the corporation quite small? Biogen pursues a small but strong organization. Biogen Korea was established with the initial goal of supplying Spinraza to Korea. And Biogen is an organization where the best people are agile in many situations. This spirit of bioventure is what makes Biogen a success for 40 years. -What corporate culture do you want to build as a CEO, and how do you want to run it? Biogen aims to be a 'Matrix Organization' as a way of collaborating organically with employees in different departments while maintaining existing departmental systems. The Korean subsidiary is also a horizontal organization, where employees work in a way that reports directly to their line manager, instead of going through a number of procedures for each area of &8203;&8203;expertise. Each employee is an expert in his field. Last week's employee workshops also highlighted the importance of collaborating with experts in each field. -Are there any preparations after Spinaza? It is difficult to know exactly which drugs will be introduced first (including next year and the future). Rare diseases are difficult to develop therapeutics and predict the clinical outcome. Biogen is currently in phase 1 to 3 clinical trials of more than 20 pipelines worldwide. Although it may not be decided immediately, Biogen Korea's role is to make it possible to provide domestic patients as soon as possible when new drugs are introduced. -Listing and launching Spinraza was not an easy process. Please give your impressions. There were various discussions before insurance coverage was applied. I think it's too early to say it's because I think it's on the reimbursed list but it's not over yet. However, compared to the first time I decided to join Biogen Korea and wondered whether I can introduce Spinraza to Korea, It is a pleasure to be able to apply the benefits quickly and to be able to receive treatment. -What was the hardest part of the listing process? Personally, I think it was the hardest thing to solve one by one with everything uncertain. Spinraza, in particular, had to start reimbursement process right after I joined Biogen as the first employee, but it was the most difficult to predict because I had never had a big role in the reimbursement process before, so the prediction of the possibilities was the hardest. -I wonder what the process of coordination with the head office was like. I think it was the first branch of Korea and the process of coordinating with the head office was not easy. How much does Biogen headquarters consider the situation in Korea? Until I joined Biogen, I was primarily responsible for commercial work, and I was not directly responsible for Market Access. However, in the light of industry stories and personal experiences, the support is clearly a big boost. Biogen understands the domestic situation at a high level. In particular, close negotiations between the government and the company are very important in drug price negotiations, and in the process, the head office supported a large portion of them, which led to a successful reimbursement listing. It is also a reason to feel proud as a member of the company and to thank the company. -You have marketing experience in 'Soliris' in Handok, and Spinraza in Biogen. The two types of pipelines that represent careers are rare diseases. Is there any reason to be particularly interested in the field of rare diseases? I have been in the pharmaceutical industry for over 20 years, but until I worked in Handok, my major was chronic disease. At that time, I was proud of all my medications and worked with the conviction that patients taking medications were much more useful than their competitors. After joining Handok, I was responsible for treating rare diseases for the first time. Unlike in the chronic disease market, which was judged by market share, I was able to feel and think more closely about the changes in patients' lives than in the market for rare diseases.
- Policy
- NHIS fully inspects 1479 nursing facilities for COVID-19
- by Lee, Hye-Kyung Feb 21, 2020 06:36am
- National Health Insurance Service (NHIS, President Kim Yong Ik) has announced a plan to inspect all 1,479 nursing facilities and long-term care institutes to prevent spreading of COVID-19. From Feb. 17 to 18, NHIS has inspected all nursing facilities related to status of inpatient with pneumonia from unknown cause, staff and nurse with travel history of (visiting China, Hong Kong and Macau) removed from wards, and other compliance regarding COVID-19 prevention. As a follow-up measure of the long-term care institute safety control guideline, the complete inspection would be conducted on 312 institutes with foreign workers, and 754 long-term care institutes with workers who have traveled overseas in February. The long-term care institute inspection would focus on pre-training on related workers and inpatient and preventive rule compliance, management of foreign workers or local workers with travel history, testing and care for inpatient with pneumonia, and visitation control. President Kim Yong Ik stated, “As a preemptive measure to shut off spreading of COVID-19, the agency would fully inspect long-term care institute and nursing facilities to further secure patients’ safety.”
- Policy
- Stivarga renews RSA and Azilect lowers pricing by 30%
- by Kim, Jung-Ju Feb 21, 2020 06:36am
- By renewing an expiring risk sharing agreement (RSA) with National Health Insurance Service (NHIS), Bayer Korea has decided to lower the maximum reimbursed price for metastatic colorectal cancer and gastrointestinal stromal tumor (GIST) treatment Stivarga 40 mg tablet (regorafenib) by 7 percent. And the health regulator has authorized pricing reduction on idiopathic Parkinson’s disease treatment Azilect tablet (rasagiline msylate) by 30 percent. Korea’s Ministry of Health and Welfare (MOHW) plans to reflect the changes on the List of Reimbursed Drugs and Maximum Reimbursed Price. Although most of the changes would come in effect from Mar. 1, some changes would be enforced from different dates due to individual issues. ◆ RSA-renewed drug: Bayer’s Stivarga has successfully renewed soon-to-be expiring RSA with NHIS on the 40 mg tablet, indicated to treat metastatic colorectal cancer, GIST, and hepatocellular carcinoma (HCC). Stivarga 40 mg tablet took the refund type RSA track from June 1, 2016, and received reimbursement in Korea. The original RSA, typically lasting for four years, was expected to expire on coming May 31. The current reimbursed price is at 36,608 won, and the company has agreed to lower it by 7 percent to 34,045 won after renewing the negotiation. The lowered pricing would be applied from June 1, when the renewed agreement comes in effect. Accordingly, Korea now has three RSA-renewed drugs including Stivarga. Merck’s metastatic colorectal cancer treatment Erbitux (cetuximab) and Astellas Pharma’s metastatic prostate cancer treatment Xtandi (enzalutamide) have also renewed their agreements. ◆ Pricing reduction by increased volume: The maximum reimbursed pricea for Betmiga (migabegron) 50 mg and 25 mg tablets would be lowered as they are now subject for Price-volume Agreement (PVA) negotiated with NHIS. The government manages post-marketing pricing with PVA for drugs exceeding initially estimated volume and claimed amount. Under the PVA system, their prices are renegotiated and brought down. The tablet took the Type Na (나) PVA for the negotiation. Type Ga (가) PVA applies to a new drug listed with pricing negotiation, but had claimed volume over 30 percent higher than the estimated volume. For the agreement, the item has to have same company name, administration method, substance, and formulation as when it was first listed. The Type Na PVA, applied to Betmiga, is for new drug either price adjusted by Type Ga or four years passed since listing date, and accumulated claimed volume surpassed the estimation by 30 percent. It also applies when a drug’s accumulated claimed volume in a year is surged by 60 percent from the previous year, or is increased by 10 percent but the increased amount is over 5 billion won. The negotiated pricing each lowered the original prices by 5.9 percent. The maximum prices of 50 mg tablet and 20 mg tablet was dropped from 757 won to 712 won, and from 505 won to 475 won, respectively. . The new pricing would take in effect from Mar. 1. Meanwhile, another drug’s pricing would be lowered early due to expanded indication. Based on analysis of estimated additional claimed volume and the increase rate, Takeda Pharmaceuticals Korea has agreed to reduce the pricing of Adcetris (brentuximab). Coming in effect from March, the current price of 3,262,400 won would be reduced by 3.6 percent to 3,144,953 won. ◆ Government-authorized changes: Due to generic’s reimbursement listing, total ten originals or drugs with same administration method, ingredients and formulation as an original would have their maximum price brought down by the government from Mar. 1. When a first generic is listed for reimbursement, the government applies so-called ‘half-price,’ or 53.55 percent of the original’s price, on the generic. But it applies weighted pricing of 70 percent of the original’s for the first year from the point of listing. And the weighted pricing is sustained, even after a year, when there are less than three companies supplying items in the same class. The pricing is kept until the number of companies reaches over four. The prices of Lundbeck Korea’s Azilect 1 mg tablet and 0.5 mg tablet would fall by 30 percent from 3,501 won and 2,348 won to 2,451 won and 1,643 won, respectively. And the price of Lily Korea’s osteoporosis treatment Forsteo (teriparatide) has also dropped by 30 percent from 326,358 won to 228,451 won. Dong-A ST’s osteoporosis treatment Teribone SC injection 56.5 μg (teriparatide acetate) would be priced 22.2 percent lower from 73,287 to 57,001 won. Except for Forsteo, other drugs’ weighted pricing would be eliminated from next Feb. 1. The ‘half-price’ would be applied from then on. ◆ Raised maximum price and voluntarily-reduced drug pricing: Prices of seven items, designated as radiopharmaceuticals, would be significantly raised from Mar. 1 to secure consistent supply in Korean market. The government either accepts raised maximum pricing of radiopharmaceuticals and National Essential Drugs, or compensates for the raised pricing by negotiating with NHIS. The price of Korea Atomic Energy Research Institute’s Kaeri MIBG (1311) injection (2-iodobenzyguanidine (1311)) would be raised slight or exponentially by 0.4 percent of 120.6 percent, depending on the dose. Some other items are voluntarily lowering their prices to better compete in the market. The following six items are the case; Dong Kook Pharmaceutical’s antidepressant Dulcerin capsule (duloxetine hydrocholoride) in two doses, Dong Wha Pharm’s severe hand eczema treatment alitno soft capsule (alitretinoin) in two doses, Pharmbio Korea’s chronic pancreatitis quick symptom reliever Foichol 100 mg tablet (camostat mesilate), Hanmi Pharmaceutical’s HIV-1 infection and chronic hepatitis B virus treatment Tefovir tablet (tenofovir disoproxil phosphate). Dulcerin 30 mg and 60 mg capsules’ would be lowered by 4 percent and 6.7 percent, respectively. Hanmi Pharmaceutical’s Tefovir tablet price would be lowered by 17.5 percent from 2,910 won to 2,400 won.
- Company
- SCD Pharm confirms Eylea's US partner
- by Lee, Seok-Jun Feb 21, 2020 06:35am
- In-seok Jeon, SCD Pharm’s CEO, said on the 18th that he had selected US and European partners for Eylea’s Biosimilar (SCD411). Only Senju Pharmaceutical in Japan contracted SCD411. According to CEO Jeon’s remarks, additional export announcements (disclosures, etc.) are imminent. SCD411 is about to launch its global phase III study in the first half of this year. In addition to SCD411, Jeon said, "We are developing oral diabetes drugs (insulin, GLP-1) and anticancer drugs (Enbrel and Herceptin) as oral drugs". The reason why global pharmaceutical companies are having their eye on SCD411? The CEO mentioned five things about SCD411 competitiveness. Those five things are △ original formulation patents and overseas applications (US, JP, EU, etc.) △2000L CMO production line construction Completed pre-verification regarding IND △development of the same product line as the original △completed pre-validation of IND-related products such as quality, non-clinical, clinical, etc. with each country's permit holders (outside Japan, Europe, and the US) △ development of the same product line as the original. Jeon said, “The meaning of certification and securing the 2000L production facility is that it lowered the risk of quality equality during the scale-up process. The cost competitiveness is more than three times cheaper than 500L, and That's the capacity to cover global demand. Non-clinical studies were conducted with the global CRO Cobans, but some of them were delayed due to Cobans issues. However, the delayed part was replaced with a three-phase preparation process, which minimized time leakage. In particular, he emphasized the same product development sector as the original. The CEO analyzed that the same vials products as Eylea and PFS (Pre-filled Syringe, Pre-filled Syringe) have been developed, 24 weeks long-acting (long-lasting) products are also under development and SCD Pharm is the only company with this lineup. Following Japan, the US and European partners have been confirmed, and Eylea’s Biosimilar of the existing formulations is expected to start sales in U.S.A & Japan in 2023 and Europe in 2024. 'S-Pass Application', Injection → Oral Development 'Hidden Card' CEO Jeon also unveiled their future strategic projects for the first time. The projects are about the non invasive glucose monitor, S-CHECK, oral development of injectable diabetes treatments such as insulin and GLP-1, and No Needle platform Biz development of injectable anticancer drugs such as Enbrel and Herceptin. The CEO explained that S-CHECK proved similar to the blood glucose meter Roche’s Accu-Check. There was no difference between the blood glucose meter and S-CHECK, non invasive glucose monitor. He said that S-CHECK is 100% blood free, no additional calibration, no need to replace sensors and cartridges and will quickly replace the glucose meter market in the future. It also shared the S-Pass platform, which converts injections into oral ones. S-Pass platform is Nano Micelle + Protein Complex and the Advantages are △GI (gastrointestinal + small intestine) absorption (Quick Acting → Quick Onset) △ encapsulation (permeability and absorption increase) ) △digestion inhibition/high bioavailability(cost reduction and price competitiveness) △Avoiding FDA approved excipients and oils(Ease/permit and minimize side effects) △No antacids and surfactants (Minor side effects for long-term chronic patients) A related advantage is the lack of features for companies looking to develop oral injections. SCD Pharm has filed a patent application for S-Pass last August. The CEO Jeon said, "We are developing Diabetes treatment such as insulin and GLP-1 as well as anti-cancer drugs such as Enbrel and Herceptin as oral drugs using the S-Pass platform. After that, it will be the cornerstone of growth of SCD Pharm after Eylea’s Biosimilar".
- Policy
- Generic drug for Lipiodol was approved
- by Lee, Tak-Sun Feb 21, 2020 06:35am
- The generic drug of Lipiodol, a special contrast agent which was controversial due to a demand for price increase by the seller, received an item license. Lipiodol may not be able to treat patients in the event of a supply disruption, since there have been no drugs of the same composition so far. With the approval of the generic drug, it is expected that the anxiety problem will be solved. The Ministry of Food and Drug Safety approved the Dongkook’s generic for Lipiodol (Iodized oil; ethyl esters of the iodised fatty acids of poppy seed) on 11th. This product was made by Dongkook Pharmaceutical, which has a high market share in the contrast medium market. Similar to Lipiodol, it is used for lymphography, salivary gland imaging and transarterial chemoembolization (TACE) in liver cancer. Lipiodol's supply disruption happened in 2018. At that time, Guerbet Korea, which sells Lipiodol, applied for drug price adjustments that said supply could be stopped if price increases were not premised due to a surge in overseas demand. At that time, the patient groups condemned Guerbet Korea for proceeding with drug price negotiations by taking patients as hostages, and the MFDS reviewed the emergency introduction (import through Korea Orphan & Essential Drug center without permission) in preparation for the supply disruption. In the end, however, the government raised the price of Lipiodol. The drug price was set at &8361;190,000/10mL, which was more than three times higher than the previous August (&8361;52,560/10mL). There was no drug to replace Lipiodol, and It was essential medicine for patients with liver cancer. Yong-ik Kim, chairman of the NHIS, who concluded the drug price negotiations at the time, said, “We set the price at a much lower level than that suggested by the pharmaceutical company. Supply is also expected not to be difficult in the next few years”. Contrary to government evaluations, some criticized the fact that some raised their hands on the domineering of pharmaceutical companies that dominate the market. Lipiodol currently has no patents registered with the MFDS. As such, Dongkuk Pharm has no hurdles in selling generic drugs after the listing.
more articles
- Pharmacist's role during COVID-19 outbreak
- Expert column | President Yoo Chang-shik of New Wave Pharmacist Association
MOST READ
