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- 2026-03-19 08:09:25
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- Yuhan and Eisai ink co-marketing deal for PPI Pariet
- by Eo, Yun-Ho Feb 12, 2020 06:31am
- Yuhan is to join the effort to market PPI medication Pariet in Korea. According to pharmaceutical industry sources, Pariet supplier Eisai Korea and Yuhan have signed a co-marketing contract on marketing and sales in Korea for proton pump inhibitor (PPI) medication Pariet (rabeprazole sodium) 5 mg as it has been listed for reimbursement since last September. Currently, the co-marketing deal is limited to low-dose (5 mg) tablet of Pariet, and the two companies are reportedly in discussion to expand the contract to cover all doses (10 mg and 20 mg) of the Pariet brand. With Yuhan’s powerful sales capacity, Pariet could further consolidate its position in the PPI market in Korea. UBIST reported, Pariet has generated 10.4 billion won and 12.5 billion won in 2017 and 2018, respectively, and recorded up to 20 percent of growth so far. The newly launched Pariet 5 mg is the lowest dose of PPI or rabeprazole medication available in Korea. Pariet 5 mg, the only rabeprazole medication indicated for low-dose aspirin in Korea, differentiates itself from high-dose PPI mediation as lowest-dose PPI medication, and it was released in Korea following the first global release in Japan. Randomized, double-blind, multicenter PLANETARIUM study confirmed the efficacy and safety of Pariet 5 mg. Over 24 weeks, 472 patients receiving low-dose aspirin for cardiovascular or cerebrovascular protection, but also has a history of peptic ulcers, were divided into three groups each treating them with Pariet 5 mg, Pariet 10 mg, and mucosal protective agent teprenone 50 mg. As a result, Pariet 5 mg, Pariet 10 mg, and teprenone 50 mg patient groups showed cumulative recurrence rates of 2.8 percent, 1.4 percent, and 21.7 percent, respectively, and confirmed meaningful treatment effect in Pariet patient groups. In the extension phase of PLANETARIUM, teprenone-treated patient group was randomly switched to rabeprazole for 28 weeks to maximum 52 weeks. The group administered with 5 mg of Pariet demonstrated cumulative recurrence rate of peptic ulcers of 3.7 percent, showing continuous peptic ulcer preventive effect. No bleeding ulcers were reported during the trial period.
- Company
- Baxter-Boryung shake hands on comarketing PN in Korea
- by Eo, Yun-Ho Feb 12, 2020 06:28am
- GM Hyun Dong-wook of Baxter (left) and CEO Lee Sam-soo of Boryung Pharmaceutical Boryung Pharmaceutical is to reinforce the sales capacity in Korea for Baxter’s nutrition solution pipeline. Baxter (GM Hyun Dong-wook) announced on Feb. 10 of signing a business partnership agreement with Boryung Pharmaceutical (Co-CEO Ahn Jae-hyun, Lee Sam-soo) on co-marketing the company’s Olimer and two other major nutrition solution products in Korea. Under the agreement, Boryung Pharmaceutical would be in charge of the marketing Olimel and Periolimel, Clinoleic, and Primene in Korean hospitals and clinics from January. Baxter’s star intravenous nutrition solution Olimel is parenteral nutrition in triple-chamber bag providing fluid, electrolytes, amino acids and calories to adult and infant patient age under two, who needs parenteral nutrition due to issues in gastrointestinal tract. In particular, the solution provides sufficient amount of protein to patients wasting nutrition, due to burn, blood poisoning, severe injury or cancer, for them to recover and sustain life with balanced nutrition. Clinoleic provides calories and essential fatty acid to premature or low birth-weight infant, pediatric and adult patients in need of parenteral nutrition. Primene provides parenteral nutrition to normal or low birth-weight infant, premature infant or infant and pediatric patients who cannot sufficiently consume nutrition orally or enterally. General Manager of Baxter, Hyun Dong-wook stated, “By signing the business partnership agreement with Boryung Pharmaceutical, we hope to stabilize supply of Baxter’s top nutrition solution line-ups to patients in Korea.” CEO Lee Sam-soo of Boryung Pharmaceutical said, “We expect to create good synergy effect between Baxter’s outstanding products and Boryung Pharmaceutical’s excellent sales infrastructure in Korea.”
- Company
- Lipitor won the market in the 2010s
- by An, Kyung-Jin Feb 12, 2020 06:27am
- In the past decade, Lipitor, the hyperlipidemia drug, recorded the most outpatient prescriptions. Lipitor has been prescribed a total of ₩1.31 trillion since 2010. After the patent expiration in 2009, even in the offensive of generic drugs, Lipitor showed that it never fell below the second place in prescriptions. The hepatitis B drug 'Baraclude' has been priscribed an average of more than ₩100 billion per year from 2010 to last year and has been at the leading position for the longest time. In 2010, hepatitis B treatment drug Viread and hyperlipidemia medicine Crestor had accumulated over ₩800 billion in prescriptions. Pfizer's Lipitor(Atorvastatin), ranked first in 2010-2019 with a total prescription of ₩1.31 trillion. Pfizer Korea introduced Lipitor to the domestic market in 1999. In the 20 years since its launch, more than 130 generic products have poured into the market for Atorvastatin-based hyperlipidemia. The drug price of Lipitor 10mg was cut in half from ₩1,241 in 2007 to ₩644. Nevertheless, Lipitor's outpatient prescriptions increased by nearly 80% from 2010's ₩98.3 billion. In the past decade, the overall prescription drug ranking has never fallen below second place. Pfizer Pharmaceuticals has self-diagnosed that the prescription amount could be continuously increased by conducting a large-scale clinical study of Koreans and carrying out active marketing activities such as social contribution activities. It is also analyzed that co-selling with Jeil, which has been established for a long time, has generated synergies. Outpatient prescription performance by year for the top three products in 2010-2019 (Unit: ₩100 million, Source: UBIST) BMS's Baraclude has accumulated over ₩1.23 trillion in the past 10 years. This means that the company has recorded more than ₩100 billion in prescriptions over the past 10 years. There are only two products, Lipitor and Baraclude, that have recorded prescriptions worth ₩ one trillion over 10 years. Baraclude has been the leader in prescriptions for the longest period of 2010, with outpatient prescriptions soaring from ₩ 88.8 billion in 2010 to ₩193.1 billion in 2014. However, after the emergence of competitive drugs and generic patent expiration, it fell to ₩71.4 billion in 2019 due to the entry of generics. Outpatient prescriptions decreased 63% QoQ. The rival drug Viread has been ranked 3rd in terms of cumulative prescriptions, with prescriptions worth ₩847 billion for the past 10 years. Viread, which appeared in the domestic market in 2013, led the year with a record of ₩166 billion in 2017, but fell to ₩106.8 billion last year. Since the entry into the generics market, drug prices have dropped sharply. Baraclude and Viread, along with Lipitor, dominated the prescription drug market in the 2010s, but suffered the upswing in generics after the patent expiration. During the decade of the 2010s, the top spot for prescriptions was granted to only three items: Lipitor, Baraclude, and Viread. After Lipitor took the top spot in 2010, Baraclude took the lead for five years from 2011 to 2015. In 2016, Lipitor recaptured the first place in six years, but in 2017, gave the lead. Since then, due to drug price cuts and the general offensive, Viread's prescription performance has slowed down. In 2018, Lipitor returned to the top position and remained the number one for two consecutive years until last year. AstraZeneca's hyperlipidemia treatment, Crestor recorded a total prescription amount of ₩803.3 billion over the last 10 years. Sanofi's anti-thrombotic drug Plavix has accumulated cumulative prescriptions of ₩721.9 billion since 2010. Boehringer Ingelheim's Twynstar (Telmisartan/Amlodipine) has been prescribed for ₩711.8 billion over the last 10 years. Antihypertensive drugs, Exforge & Amosartan, Norvasc, and prostatic hyperplasia treatment, Harnal have been listed in the top 10 items with the highest prescription rates in the last decade. Over the past decade, the trend in prescription drug sales has been clear. Multinational pharmaceutical companies with patent-expired drugs implemented their market defense strategy by strengthening their sales force through joint sales agreements with domestic pharmaceutical companies. Crestor's outpatient prescriptions peaked at ₩100.8 billion in 2014 from ₩66.8 billion in 2010 and then turned downward. However, the company has continued its uptrend for the second straight year, reaching ₩74.1 billion in 2018 and ₩84 billion in 2019. AstraZeneca has been co-selling Crestor with Daewoong Pharmaceutical since 2016. Last year, prescription sales for Plavix increased by 17.3% year-on-year to ₩88.9 billion. In 2013, it fell to ₩46.4 billion in 2013 from ₩95.8 billion in 2010, but recovered ₩60 billion in the following year, up 48.2% in five years. Two years after launching joint sales with Dong-wha in 2017, the prescription performance jumped 28.1%, which is considered to be an effective defense against the generic offensive. More than 100 generic products for Twynsta have been poured to the market since its patent expiration in 2013, but there has been no change in prescription performance. After peaking at ₩97.7 billion in 2016, the market faltered to ₩81.2 billion in 2017 and ₩80.3 billion in 2018, but rebounded to ₩84.7 billion last year. Twynsta is co-sold by Yuhan. (Clockwise from top left) Lipitor, Baraclude, Viread, Albis, Stillen, & Hepsera The top prescriptions in 2010 and 2019 were also changed significantly. Dong-A ST's gastritis treatment Stillen, which was ranked fourth in 2010 with a prescription amount of ₩88.3 billion, disappeared from the top of 2019. In 2011, the prescription amount of Stillen, jumped to ₩93.3 billion, but its market position has declined significantly since the emergence of generics. In 2017, the reimbursement for prevention of gastritis was deleted, and even reimbursement benefit was cut in half. Last year, outpatient prescriptions amounted to ₩9.3 billion, which was only about one tenth of 2010. Chong Kun Dang's high blood pressure treatment, Dilatrend, Pfizer's Norvasc, Daewoong's brain function improver Gliatilin, and MSD's asthma treatment, Singulair disappeared from the top of 2019. On the other hand, Daewoong Bio's brain function improver Gliatamin, Boehringer Ingelheim's Twynsta, Hanmi's Rosuzet, Eisai's brain function improver Aricept, Hanmi’s Amosartan have newly ranked at the top.Top 10 Outpatient Prescription Products in 2010 and 2019 (Unit: ₩100 million, Source: UBIST)
- Company
- JAK-inhibiting oral antirheumatic drug market getting fuller
- by Eo, Yun-Ho Feb 11, 2020 06:31am
- Orally taken antirheumatic treatment, JAK inhibitor drug market in Korea would be soon led by four competitors. According to pharmaceutical industry, the close competition between Pfizer’s Xeljanz (tofacitinib) and Lilly’s Olumiant (baricitinib) would get even intensified as Astellas Pharma’s Smyraf (peficitinib) entered the competition last month and AbbVie’s upadacitinib is awaiting Ministry of Food and Drug Safety’s nod at the moment. Janus kinase (JAK) inhibitor has gotten the industry’s attention since its release, because it was first oral therapeutic option for autoimmune disease with equivalent treatment level as anti-TNF medicine. However, its position in the market is not as influential as other biologics. While anti-TNF drug and anti-interleukin drug have consolidated their positions in the market, JAK inhibitors’ indications have been too narrow except for rheumatoid arthritis. Global Sales Volume of Anti-TNF Drugs and JAK Inhibitor Drugs (Unit: KRW 100 million) In other words, JAK inhibitor still has much more potential. The first JAK inhibitor, Xeljanz was additionally indicated for treating ulcerative colitis and psoriatic arthritis, and other following drugs have ongoing trials to expand indications treating autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylsoing spondylitis. Once Smyraf and upadacitinib enter the market, and Gilead Sciences’ filgotinib, currently under review in the U.S. and Europe, is commercialized in Korea, JAK inhibitor market with convenience of oral administration option would naturally grow. But also there is a drawback. JAK inhibitor recently had an adverse reaction issue regarding cardiovascular system safety when administering high dose. Although direct relationship of cause-and-effect has not been fully confirmed, warning has been labeled on the high-dose prescription of the three drugs. High-dose of the drugs is prescribed for rheumatoid arthritis and other major indications. JAK inhibitors block inflammatory cytokine cell’s family of Janus kinase enzymes (JAK1, JAK2, JAK3, and TYK2). Different kinds of JAK inhibitors share the same mechanism of actions but with some intricate differences. Xeljanz inhibits JAK1 and JAK3, Olumiant blocks JAK1 and JAK2, whereas Smyraf blocks JAK1, JAK2, JAK3 and TYK2. Upadacitinib and filgotinib interferes activity of JAK1.
- Company
- Pfizer recalling Lipitor and Caduet in defective packaging
- by Jung, Hye-Jin Feb 11, 2020 06:29am
- Pfizer Korea is recalling some of Lipitor and Caduet stocks, not because of the drug itself but because of defective packaging. On Feb. 6, Pfizer Korea disseminated official notice to vendors and requested them to suspend shipping of Lipitor and Caduet. The shipping is halted for Lipitor 10 mg in 90-tablet packaging with manufacturer’s serial number DA1448 (expired by Apr. 15, 2022), CY0992 (expired by Apr. 15, 2022), and DA0505 (expired by Oct. 24, 2021), and Caduet 5/ 20 mg in 30-tablet packaging with serial number CR4181 (expired by Aug. 5, 2022). Pfizer Korea explained the company has found potential risk on product quality, and said it would voluntarily recall the products. The official notice stated, “Any healthcare institute or distributor with the said packaging in the stock should suspend shipping, and return the products to supplier when the recall is initiated.” Currently, Pfizer is discussing about the recall with Ministry of Food and Drug Safety (MFDS), and is also planning to notify related vendors and healthcare institutes about the recall method as soon as possible when it is decided. Pfizer Upjohn Korea official said, “The shipping suspension has been decided, because we found some bottled products with a crack on the rim of bottle opening. However, the ratio of products with the crack among the to-be-recalled products is estimated to quite low.” The company elaborated the potential risk on patient is low, but the preemptive steps are taken voluntarily to ensure safety of the patients.” Lipitor is hypertension-treating drug with atorvastatin that made 176.2 billion won in Korea last year. Caduet is a combination drug treating hypertension and dyslipidemia with atorvastatin and amlodipine. It has raised 24.1 billion won last year from prescription.
- Company
- MSD’s Spin off completes within this year
- by An, Kyung-Jin Feb 10, 2020 06:31am
- Employees of Korean subsidiaries had begun to stir as Merck (US MSD) declares a division of business. Anxiety over future behaviors is heightening as the company announces the launch of an independent corporation to manage women's health-related products, patent expired drugs, and biosimilars within the year. #Decision to split MSD business, Transfer women's health and biosimilar products to a new corporation MSD held a conference call on the 5th and formulated a spin-off plan. The company plans to split the existing pharmaceutical division into two and set up a separate independent corporation (tentatively named NewCo) to focus on women's health-related products, cardiovascular diseases, respiratory and pain products, and biosimilar products. MSD has decided to focus its research and development (R&D) capabilities on remaining drugs, including anticancer drugs, vaccines, specialty products, and animal health. By item, About 90 patent-expired drugs such as ▲Biosimilars distributed by MSD headquarters such as Renflexis, Brenzys and Ontruzant through a contract with Samsung Bioepis ▲Etonogestrel implant Nexplanon franchise, birth control pills, maternity products, etc. ▲Hyperlipidemia drug, Zetia, Vytorin, respiratory disease drug Singulair, skin disease drugs, pain medicine, etc. will be transferred to the new corporation. Business split plan announced by MSD (Source: Merck Conference Call) Ken Frazier, CEO of Merck, said he decided to split the company to build a business model that fits the portfolio and expects both companies to focus on investment and growth in the first half of 2021. The company announced that it will proceed with the process of establishing a new corporation in the coming months. Based on the contraceptive and infertility related products currently owned by MSD, the goal is to foster new corporations as global leaders in women's health. The company also said it would seek opportunities for active partnerships with other pharmaceutical bio companies to maximize the value of cardiovascular and skin diseases, respiratory diseases, pain, and biosimilar products and to increase patient access. MSD plans to split the company within this fourth quarter, reorganization is imminent According to the headquarters policy, reorganization is inevitable even for a Korean corporation with 700 employees. MSD Korea held a town hall meeting for all employees on the 6th afternoon to share information on corporate division and had a Q&A time. According to officials who attended the Town Hall meeting, the management of the Korea MSD on the day set the standard that the employee's affiliation will follow the business unit to which the dedicated product portfolio belongs. Of the four divisions under the MSD of Korea, more than 100 employees from the DB (Diverse Brand) division dealing with respiratory and skin diseases such as Propecia and Singulair and some employees in the PC(Primary Care) with diabetes and cardiovascular diseases are influential. Since the new corporation is a completely independent company, the office will be operated separately after the spin-off. For example, sales marketing staff currently in charge of vaccine products such as Gardasil work at MSD, while sales marketing staff dedicated to DB business products such as Singulare are moved to a new corporation. The distribution criteria for employees who were in charge of both company's products or internal departments other than sales marketing department have not been specified yet. Since the company's affiliation may vary depending on the division's operating model, the company said that it would provide individual guidance on whether or not it belongs to the third quarter. The management of Korea MSD said, “It is expected that it will complete the spin-off within the fourth quarter of this year, regardless of the schedule of the headquarters. It is difficult to predict the number of employees who will be moving to a new corporation, except for clinical departments. Next week's departmental session will provide details”. Korean subsidiary's confusion aggravated, "no ERP implementation plan" by company Sudden decision adds confusion among employees. Employees attending the town hall are said to have asked questions about the succession of consecutive years of service and salary, benefits, and conditions of succession when they move to a new corporation. There is also anxiety that the ERP(Early Retirement Program) may be activated if the service years are not inherited or if the settlement of severance pay in the middle of business split. In this regard, a Korean MSD official said, “the company does not currently plan to settle interim severance pay or implement ERP. Years of service remain the same. Since the establishment of the new corporation, the company has not received any information from the headquarters regarding the sale and merger and acquisition plan”. He stressed, "It is not a cost reduction but a decision for long-term growth, so we plan to actively support the growth and career development of our employees after the division".
- Company
- AstraZeneca, decided to withdrawal from the KDPU
- by Kim, Jin-Gu Feb 10, 2020 06:31am
- AstraZeneca Korea decided to withdraw from the KDPU(Korea Democratic Pharmaceutical Union). The branches of the KDPU have been reduced to 18, including 17 multinationals and 1 domestic. According to the pharmaceutical industry on the 6th, the Branch of AstraZeneca Korea under the KDPU has voted for members whether or not to withdraw from the end of this January. As a result of the voting, More members were in favor of the withdrawal. After the withdrawal process, the union of AstraZeneka Korea will conduct collective bargaining with the company as an industrial union. AstraZeneca Korea's withdrawal from the KDPU is the third after Janssen Korea and Novonordisk. Prior to AstraZeneca Korea, the majority of members withdrew from the MSD Branch of Korea, but it did not lead to a complete withdrawal yet. At the end of last year, MSD Korea withdrew 300 members out of 380 members of the KDPU. There are currently two unions in the MSD Korea. Reasons for withdrawal include unequal voting rights and an increase in union costs. The KDPU are currently entitled to one vote per company regardless of the number of members. As a result, large companies continue to complain. It is reported that the union's executive department recently decided to raise union costs. In the case of large companies, the right to vote is limited and union costs have increased, which is a double burden. After the withdrawal of Jansen Korea, AstraZeneca Korea was the second largest after Novartis Korea. The KDPU was launched in 2012 by multinational companies under the Federation of Korean chemical Workers’ Unions. At the time, 8 companies including ▲Novartis Korea ▲Takeda Korea▲Sanofi-Pasteur ▲AstraZeneca Korea ▲Wyeth Korea ▲Zuellig Pharma Korea ▲ Bristol-Myers Squibb Korea and ▲Janssen Korea participated as founding members. Since then, ▲Baxter Korea ▲Merck KGaA ▲Ferring Pharmaceuticals, Korea ▲Allergan Korea ▲Fresenius Kabi Korea ▲Fresenius Medical Care ▲Abbvie Korea ▲Astellas ▲MDS Korea ▲Mundipharma Korea ▲Galderma Korea ▲Zuelligpharma services Korea joined as a new union branch. Among domestic companies, Kolon pharma has attracted attention by joining the union. Among them, Janssen Korea, Novonordisk and AstraZeneca Korea withdrew, and currently, there are 18 branches under the KDPU.
- Company
- Ilyang's Supect, good effect on leukemia cells reduction
- by Jung, Hye-Jin Feb 10, 2020 06:30am
- Ilyang announced that its phase III clinical trial of 'Supect', a leukemia treatment drug developed by the company, outperformed than Glivec. Ilyang Pharmaceutical (President Kim Dong-yeon) announced on the 6th that the clinical results were published in British journal of Hematology. In this trial, 241 patients with chronic myelogenous leukemia were administered to 24 hospitals in Asia (Korea, Thailand, Philippines, and Indonesia) for four years, and the results were followed by the administration of Supect, brand for Radotinib and the first generation of anticancer drugs 'Glivec'. According to the results, 86% of Supect administration group & 75% of Glivec administration group were the patients who received the major gene response who estimated to have reduced leukemia cells by more than 1000 times, and The complete gene response rate was 58% in the Supect-treated group and 49% in the Glivec group. According to Ilyang Pharmaceuticals, the treatment failure rate was 6% in the 300mg twice daily dose of SUPECT, more than three times less and 19% in the Glivec group. Kim Dong-Wook, Hematology Professor of Seoul St. Mary's Hospital, who led the clinical study and participated in the paper, said, “At 3 months after treatment, predicted long-term good genetic response rate was 86% in the Supect group and 71% in the Glivec group. The use of Supect is expected to result in a long-term treatment effect in a larger number of patients faster and significantly increase the number of patients who can stop drug treatment after using SUPECT for a period of time. Targeted anticancer drugs prescribed for patients with chronic myelogenous leukemia for the first time were Glivec, a first-generation anticancer drug, and a second-generation target anticancer drug, such as Supect from Ilyang Pharmaceutical, Tasigna by Novartis Switzerland, and Sprycel by Bristol Myers Squibb. Ilyang said, “The first diagnosis of chronic myelogenous leukemia patients showed faster and higher gene response rates in the 'Supect' group, and there was no new serious adverse reaction even after long-term follow-up, It was confirmed that the repair treatment could increase the possibility of Treatment Free Remission. And, the second generation of targeted anticancer drugs has been selected as the first treatment in many countries because of its superior efficacy than Glivec". In addition, "Supect, the second-generation targeted anticancer drug, is the inexpensive treatment cost, which can reduce the financial burden on patients and contribute greatly to the financial stability of national health insurance". A total of 20 researchers participated in the trial, including Professor Do Young-rok (first author), Department of Hematology and Oncology, Keimyung University Dongsan Medical Center and Professor, Dong-Wook Kim(corresponding author), Seoul St. Mary's Hospital.
- Company
- MFDS to clear Forxiga’s heart failure indication soon
- by Eo, Yun-Ho Feb 10, 2020 12:17am
- Anti-diabetic treatment Forxiga is ready to be reintroduced as a heart failure drug in Korean market as well. According to pharmaceutical industry on Feb. 7, AstraZeneca’s sodium-glucose cotransporter 2 (SGLT-2) inhibitor Forxiga (dapagliflozin) would be soon indicated for reducing the risk of hospitalization by heart failure in patients with type 2 diabetes. Korea’s Ministry of Food and Drug Safety (MFDS) is expected to conclude the review within this month at earliest. AstraZeneca started the additional indication approval procedure immediately after the U.S. Food and Drug Administration (FDA) has cleared of the indication in back October 2019. The company also aims to quickly process expanding an indication to reduce the risk of heart failure in patients with reduced ejection fraction, with and without type 2 diabetes, the FDA has processed under Priority Review. Forxiga’s efficacy to reduce the risk of hospitalization of diabetic patients with heart failure was confirmed during Phase III DECLARE-TIMI 58 trial. The large-scale trial observed 17,000 patients around the world with co-morbid type 2 diabetes and either cardiovascular-related risk or heart failure to study the effect of the SGLT-2 inhibitor on cardiovascular conditions. The outcome found Forxiga lowering the risk of hospitalization or death from heart failure by 17 percent and, specifically, the risk of hospitalization was lowered by 27 percent. The tendency of reduced risk of hospitalization by heart failure or death by cardio vascular disease was consistently prevalent in patient groups with cardiovascular risk factors (hypertension, dyslipidemia, smoking), and previous record of cardiovascular disease. Executive Director Chae In Ho of Korean Society of Interventional Cardiology (Professor at Seoul National University Bundang Hospital) stated, “Although heart failure treatment options are available, its medical need is still highly unmet. The use of SGLT-2 inhibitor for treating heart failure would be significantly popular in Korea.” Another SGLT-2 inhibitor, Boehringer Ingelheim’s Jardiance (empagliflozin) also has ongoing clinical trials to test indication to treat heart failure. The drug is simultaneously conducting EMPEROR-Preserved trial on patients with preserved ejection fraction and EMPEROR-Reduced trial on patients with reduced ejection fraction. Based on EMPEROR and EMPERIAL studies particularly testing efficacy on heart failure, FDA has reportedly granted fast track status on Jardiance’ heart failure indication.
- Company
- Opdivo retries expanding reimbursement without NSCLC
- by Eo, Yun-Ho Feb 06, 2020 06:31am
- Seemingly have given up on expanding reimbursement, Opdivo has turned around and started taking actions again. Nevertheless, its health coverage application excluded indication for lung cancer. According to industry sources, Ono Pharmaceutical and BMS have recently applied for expanding reimbursement on PD-1 inhibitor-based immunotherapy Opdivo (nivolumab). The application is for the use as second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN), and second-line treatment for typical Hodgkin’s disease. The issue-making indication treating non-small cell lung cancer (NSCLC) regardless of expressed PD-L1 was dropped from the new application. Although the companies may have left the NSCLC indication behind, they are determined to continue improving access to Opdivo. Since early 2019, the government has been negotiating with respective pharmaceutical companies on Opdivo, Roche’s Tecentriq (atezolizumab), and MSD’s Keytruda (pembrolizumab) all together for expanded reimbursement. In the process, Ministry of Health and Welfare (MOHW) engaged in preliminary negotiation with the companies and laid a condition to limit reimbursement only to patients showing response and the ‘trade-off’ initiative, which would reduce off-patent drug’s pricing as a compensation for recognizing value of new drug. The preliminary negotiation is a type of special procedure, not a part of regular deliberation process for reimbursement expansion, such as Cancer Disease Deliberation Committee, Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) or drug pricing negotiation with National Health Insurance Service (NHIS). Immunotherapy has been a game changer that shifted the paradigm of anticancer therapy. However, it is extremely expensive and its indication can expand out indefinitely. Preliminary negotiation is a unique tool the Korean government has established to discuss easing reimbursement criteria for drugs necessary for treatment but comes with significant financial burden. The purpose of the tool is to expedite the procedure with DREC and NHIS by reaching an agreement on financial issues and reimbursement criteria prior to the regular procedure. But, only Roche reached an agreement with the government. Although the second round of negotiation fell through, MSD applied for reimbursement expansion again with another indication approved at the end of last year and is now waiting for Cancer Disease Deliberation Committee’s decision. Whereas, Ono Pharmaceutical and BMS have not taken any other actions after the first negotiation ruptured last May. Many suspected the companies have basically ‘given up’ on Korean market. For now, the industry is keeping close eyes on Opdivo putting aside the discrepancy experienced last year and yet again applying for expanding reimbursement without the NSCLC indication. Initially, Opdivo was indicated ‘regardless of expressed PD-L1,’ but it was listed in August 2017 with a set expression rate of PD-L1 under refund and expenditure cap type risk sharing agreement.
