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- 2026-05-15 21:38:32
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- The first oral GLP-1 Novonodisc's Rybelsus was approved
- by May 04, 2022 06:03am
- The world's first oral GLP-1 analog has landed in Korea. Novonodisk announced on the 3rd that it has obtained an item license from the MFDS for oral GLP-1 analog-based type 2 diabetes treatment Rybelsus (Semaglutide). Rybelsus is used as a dietary and exercise therapy supplement to improve blood sugar control in adults who do not have sufficient control of type 2 diabetes. It is taken once a day, and there is no need to control the dosage of drugs in patients with renal or hepatic dysfunction or in the elderly. Rybelsus demonstrated its validity and safety in eight global clinical studies PIONEER. In particular, it showed a superior blood glucose drop effect than the SGLT-2 inhibitor-based Empagliflozin and DPP-4 inhibitor-based Sitagliflozin, which are representative oral treatments. The advantage of weight control compared to Sitagliptin was also confirmed. In a PIONEER2 study of patients whose blood sugar is not controlled by Metformin, the Rybelsus group confirmed a 1.3% decrease in glycated hemoglobin level compared to the baseline, which is superior to -0.9% of the Empagliflozin group. PIONEER9 and PIONEER10 studies have demonstrated efficacy in Asians. This is a clinical trial conducted on 458 patients with type 2 diabetes whose blood sugar is not controlled by administration of oral hypoglycemia alone. In the change in glycated hemoglobin levels at week 52, the Rybelsus-administered group was -1.7%, which was superior to the Dulaglutide-administered group of -1.4%. Rana Azfar Zafar, president of Novonodisk, said, "Rybelsus is expected to establish itself as an innovative treatment option for adult diabetes patients with type 2 based on the incidental benefits of excellent blood sugar drop and weight control identified through large-scale clinical trials."
- Company
- When will the discussion on Dupixent's benefit be concluded?
- by Eo, Yun-Ho May 03, 2022 06:09am
- It does not seem easy for Dupixent, an atopic dermatitis treatment, to expand insurance benefits for children and adolescents. According to related industries, Standard of Sanofi-Aventis Korea's Dupixent 200mg was recently set. It is the first time in about a year since the application for expansion of benefits in March 2021. Dupixent's expansion of atopic dermatitis benefits for children and adolescents took seven months to start consulting experts last year. As it is an expensive new drug and it was not easy to register for the first time, it is judged that discussions on expansion are also difficult. Although detailed indications are different, there is a clear difference in speed compared to JAK inhibitors such as Lilly Korea's Olumiant and Abbvie Korea's Rinvoq, which belatedly submitted applications for expanding atopic benefits. JAK inhibitors are also relatively inexpensive. Both drugs have been paid since this month. Since it is a RSA drug and a separate dose of Dupixent 200mg has been added, it is necessary to go through the cost-effectiveness review process of the HIRA in the future as well as negotiations with the NHIS. It remains to be seen whether Dupixent will be able to reach an agreement with the government and expand child benefits. A company official said, "In the case of patients with severe childhood atopic dermatitis, treatment options with effects and safety information that can be used after local treatments are practically limited. Sanofi will do its best to administer Dupixent to pediatric and adolescent patients as soon as possible." The current standard for Dupixent's health insurance coverage is when all patients with chronic severe atopic dermatitis aged 18 or older with a history of more than 3 years fall under the EASI (Extension Severity Evaluation Index) 23 or higher ▲even after 4 weeks of primary local treatment, the symptoms were not controlled, ▲ if a full-body immunosuppressant is administered for more than 3 months but has no response (more than 50% reduction in EASI) or cannot be used due to side effects, or ▲ before the start of Dupixent administration. This includes the Dupixent 300 mg dose.
- Company
- Cephalosporin CMOs discontinue or downsize business
- by Kim, Jin-Gu May 03, 2022 06:09am
- CMO companies that have been manufacturing cephalosporin antibiotics upon consignment are either shutting down or reducing their business one after another. Given the limited number of domestic manufacturers, existing consignors are in a rush to find new consignees. Due to this, industry concerns are rising over how this breakaway among consignees may accelerate due to the increased production cost and lead to an antibiotic crisis in the second half of the year. ◆3 CMOs discontinue or reduce manufacture in 6 months According to industry sources on the 3rd, A mid-sized pharmaceutical company, Company A, recently delivered its plan to discontinue the manufacture of cephalosporin to its consignees. The company had agreements to contract manufacture 4-5 cephalosporins. By product, 4 to 10 pharmaceutical companies had entrusted the manufacture of their products to this company. An official from Company A said, “We haven’t officially decided to withdraw the business, but are considering up to withdrawal in our final review.” Other companies are also discontinuing or reducing contract manufacture of cephalosporins one after another. A large pharmaceutical company, Company B, had reduced its CMO business for cephalosporin last year. Recently, another large pharmaceutical company, Company C, decided to discontinue its cephalosporin CMO business. An official from Company C said, “We are not planning to completely close down the cephalosporin business. We plan to continue selling our products but change our directly-manufactured products to contract manufacturing products.” In the case of the mid-sized pharmaceutical company, Company D, their contract manufacture of cephalosporins on consignment has been temporarily suspended due to its factory relocation process for the past 2 years. Consequently, all the consignors that hired the CMOs above for their cephalosporin products now have to find new CMOs. Among the 10 companies in Korea that manufacture cephalosporin antibiotics upon consignment, currently, the manufacture of cephalosporins in at least 4 companies is disrupted. The industry estimates that there will be more companies planning to discontinue or reduce the manufacture of cephalosporins. An official from a cephalosporin CMO said, “With many major CMOs leaving the field, not many CMOs that manufacture cephalosporin antibiotics are left in Korea now. This is why there has been a significant increase in the number of inquiries about the consignment production of cephalosporins. We are asking some pharmaceutical companies for their understanding as we cannot accept all the manufacturing requests.” he explained. ◆Triple distress due to ’surge in raw material prices+fixed supply price+reduced prescriptions' CMO companies that are considering market withdrawals say that ‘it is not profitable' to continue the business. The increased price of raw materials and despite the fixed supply price maintained by national insurance have deteriorated profitability. Most of the major raw materials used to manufacture cephalosporin antibiotics are imported from China and India. The price of such raw materials has increased 10-20% going through the COVID-19 crisis. And the recent rapid changes in the major exporter China’s internal situation have left companies with difficulty obtaining even these materials. An official from a CMO said, "The Chinese government stopped the operation of raw material factories for 3-4 months earlier this year due to their hosting of the Winter Olympics. Also, the lockdown of major cities in China has due to the resurge of COVID-19 cases, further decreasing the supply of raw materials.” He added, “Meanwhile the price of the products has not changed at all as they are listed for reimbursement in the National Health Insurance. Labor costs have also increased significantly recently. We cannot even attempt to maximize profit by increasing production due to the 52-hour workweek rule.” Another CMO official said, “The is almost no profit in manufacturing first or second-generation cephalosporins. Their profitability has worsened with the significantly reduced use of such antibiotics. Our company has discontinued contract manufacture the first and second-generation antibiotics, and will continue to manufacture the other third and fourth generation antibiotics.” The industry expressed rising concerns that if prolonged, the situation may worsen and result in a shortage of cephalosporin supply in Korea after this fall. An official from the pharmaceutical industry said, “With the existing CMOs increasing manufacturing of cephalosporin antibiotics, I believe no issue will rise for now. However, after the COVID-19 crisis subsides and the number of respiratory infections increases to the level recorded in the average year, there is a possibility that a supply shortage of cephalosporin antibiotics will arise.” Cephalosporins, or cepha-class antibiotics, are widely used to treat respiratory conditions including pneumonia, pharyngitis, tonsillitis, and bronchitis. Since the Ministry of Health and Welfare has mandated the separation of its manufacturing facilities since 2012, it has been produced only in plants equipped with dedicated lines for the manufacture of cephalosporins.
- Company
- GSK Consumer Healthcare Korea appoints Dongwoo Shin as CEO
- by May 03, 2022 06:09am
- Dongwoo Shin, General Manager of GSK Consumer Healthcare Korea GSK Consumer Healthcare Korea announced that it has appointed Dongwoo Shin (55) as the new head of its Korean subsidiary. The new General Manager has graduated from Hanyang University with a BA in Philosophy and a MA in Philosophy from the University of Rochester. After serving in various companies including Coca-Cola Korea, 20th Century Fox Home Entertainment Korea, and the Consumer Healthcare division of L'Oreal Korea, Shin was appointed Head of Consumer Healthcare Business at Sanofi Korea. Since then, Shin has severed as the head of various other pharmaceutical companies, including as the General Manager of Consumer Healthcare at Pfizer Korea and the General Manager of GSK Consumer Healthcare Hong Kong. The new GM Shin owns expertise in leading the consumer business with company and brand growth strategy development, innovative driving force, and optimized organizational operations, and is known to have a high understanding of the consumer health business as he had led the consumer health care business of major global pharmaceutical companies such as Pfizer and Sanofi from their initial establishment. While serving as the GM of GSK Consumer Healthcare Hong Kong, Shin had successfully merged with Pfizer Consumer Healthcare and achieved a successful business turnaround in just 2 years through stable organization and innovative management. As the General Manager of GSK Consumer Healthcare Korea, Shin will complete the company’s spin-off from GSK and drive the company’s transformation and launch as Haleon. Meanwhile, GSK Consumer Healthcare had globally announced its new official name as ‘Haleon’ in February and is preparing its spin-off from GSK mid-year. In consideration of the time required for preparations and changing product packaging, the company will retain its current company name (GSK Consumer Healthcare Korea) for the time being.
- Company
- COVID-19 vaccine SKYCovione has been applied
- by Kim, Jin-Gu May 03, 2022 06:08am
- SKYCovione, a coronavirus vaccine developed by SK Bioscience SK Bioscience announced on the 29th that it has applied for an item permit for the COVID-19 vaccine candidate GBP510. SK Bioscience predicted that it will be able to commercialize it in the second half of the year after obtaining approval from the MFDS. The name of the vaccine applied through item approval was SKYCovione Multi Injection. If the MFDS approves the item license, SKYCovione will be the first COVID-19 vaccine in Korea. SKYCovione's item approval is carried out through a rapid approval process for official item approval, not EUA. If approval is completed, it is expected to be commercialized during the second half of the year. In March, SK Bioscience signed a domestic supply contract with KDCA and SKYCovione for a total of 10 million doses. SKYCovione is immunogenic with only one inoculation. SKYCovione will be supplied around the world through COVAX Facility after obtaining a domestic item license. In addition, SK Bioscience plans to register SKYCovione on the WHO Emergency Use List (EUL) and acquire EUA by foreign countries such as Europe. SKYCovione is a synthetic antigen-type COVID-19 vaccine developed in collaboration with global organizations and companies centered on SK Bioscience. Institute for Protein Design (IPD) and SK Bioscience jointly developed it. From the early stages of development, it received funding from the Bill & Melinda Gates Foundation (BMGF) and the Infectious Disease Prevention Vaccine Union (CEPI). In addition, GSK's Adjuvant (Adjuvant) AS03 was applied to increase the immune response and induce a high level of neutralizing antibodies. SK Bioscience announced that it has confirmed excellent immunogenicity and safety in the recently completed phase 3 clinical trials. Phase 3 clinical trials were conducted on 4,037 adults aged 18 or older in six countries, including Korea, Thailand, Vietnam, New Zealand, Ukraine, and the Philippines. Vaxzevria, AstraZeneca's COVID-19 vaccine, was examined for the immunogenicity and safety of SKYCovione as a control vaccine. As a result, it was found that all of them had superior immunogenicity and safety compared to Vaxzevria. At the time of SKYCovione's second inoculation, neutralizing antibodies were formed 2.93 times higher than that of the control vaccine. SKYCovione's antibody conversion rate (subjects with a quadruple increase in neutralizing antibodies after inoculation) was 98%, which was more than 10% higher than the antibody conversion rate of 87% of the control vaccine, showing a statistically significant difference. Even in the elderly aged 65 or older, the antibody conversion rate of those who were vaccinated with SKYCovione exceeded 95%, showing a significant difference compared to the control vaccine (79% of the elderly antibody conversion rate). The cellular immune response, which plays an important role in lowering the severity of COVID-19 infection, was also at the level of equal to or higher than that of the control vaccine. In the case of safety, SKYCovione showed an abnormal response rate similar to that of the control vaccine. It was confirmed that no special safety problems were reported during the clinical trial period. SK Bioscience expects SKYCovione to give new vaccine options to some classes who refused to vaccinate the existing COVID-19 vaccine. Unlike the existing COVID-19 vaccine with new technology, the synthetic antigen method has been widely used in various vaccines so far, proving its safety. In addition, unlike existing mRNA vaccines that require ultra-low temperature storage, refrigerated distribution and long-term storage of 2-8 degrees will contribute to increasing vaccination rates in underdeveloped countries that do not have expensive ultra-low temperature facilities. SK Bioscience plans to conduct additional clinical trials so that SKYCovione can be widely used in quarantine in the endemic era. These include booster shot clinical trials for existing COVID-19 vaccinations, cross-vaccination booster shot clinical trials, clinical trials for adolescents, and extended clinical trials for mutant viruses such as omicrons. In particular, phase 3 clinical trials for those aged 12 to 17 are expected to enter within the first half of the year. Roger Connor, CEO of GSK's Global Vaccine Business Department, said, "As COVID-19 endemics are predicted, demand for vaccines that are easy to distribute is expected to continue to increase." He said, "SKYCovione, which combines GSK immune enhancers, will play a very important role in the prevention of the endemic era." Ahn Jae-yong, president of SK Bioscience, said, "It is a new feeling that the first COVID-19 vaccine in Korea has reached the final stage for release." He said, "We will do our best to continue to cooperate with global organizations and companies to become an innovative bio company that competes on the global stage without being complacent."
- Company
- Generics for Xarelto with sales of ₩60 billion are com
- by Kim, Jin-Gu May 03, 2022 06:08am
- Competition of generic products is in full swing in the new oral anticoagulant (NOAC) market of Rivaroxaban ingredients worth 60 billion won a year. With more than 20 companies' generics pouring in in earnest since the fourth quarter of last year, Chong Kun Dang seems to be one step ahead. In the pharmaceutical industry, it is analyzed that this is the result of Chong Kun Dang's preoccupation with the market by pushing ahead with the release of generic before the patent expires. ◆Expanding the influence of generics for Xarelto According to UBIST, a pharmaceutical market research firm, on the 23rd, the market size of outpatient prescriptions for Rivaroxaban-based anticoagulants in the first quarter is estimated to be 16.8 billion won. It increased by 13% compared to 14.8 billion won in the first quarter of last year. It is analyzed that the overall market size has also expanded with the addition of generic. During the period, the prescription amount of Xarelto, an original product, fell 4% from 14.8 billion won to 14.2 billion won. Analysts say that growth has decreased due to the release of generic. Bayer has delayed the reduction of drug prices due to generic registration through administrative litigation. Generic posted a total of 2.6 billion won in prescription performance in the first quarter of this year. Since the first generics came out in the second quarter of last year, they are gradually increasing their influence. As of the first quarter of this year, the market share of Rivaroxaban reached 16%. ◆Chong Kun Dang's Rivaroxaban ranked first among generics While generic is gradually expanding its influence, Chong Kun Dang's Rivaroxaban is located at the highest position among generic products. The first quarter prescription is 600 million won. This is interpreted as the result of Chong Kun Dang's preoccupation with the market by pushing ahead with the release of generic before the patent expires. Chong Kun Dang released Riroxia as generics for Xarelto in May last year. At that time, it was five months before the expiration of the Xarelto patent (October 2021). In the pharmaceutical industry, it is interpreted as Chong Kun Dang's winning move to dominate the Xarelto's generic market. Based on the victory of the Eliquis patent dispute, domestic companies have sold generics for Eliquis since July 2019. Sales of generics for Eliquis were suspended in April last year when the Supreme Court overturned the first and second trials and sided with the original company. Chong Kun Dang was the most active in promoting generics for Eliquis, causing great damage. In this situation, it was quickly replaced by generics for Xarelto, which has only a few days left before the expiration of the patent. Chong Kun Dang's winning move is somewhat correct. The cumulative prescription recorded by Chong Kun Dang over the past 11 months is 1.8 billion won. It is higher than the prescription performance (1 billion won) for 11 months after the release of generics for Eliquis. ◆ Since October last year, market competition is expected to heat up The pharmaceutical industry predicts that competition between generics for Xarelto will intensify in the future. Except for Chong Kun Dang, other generic companies joined the market in earnest in the fourth quarter of last year. Since October last year, when the Xarelto patent expired, 22 companies, including Samjin Pharmaceutical and Hanmi Pharmaceutical, have poured out 66 items of generics for Xarelto. It was five months after Chong Kun Dang entered the market. They are rapidly expanding their influence. Excluding Riroxia, the total prescription amount of generic for Xarelto increased 2.5 times from 400 million won in the fourth quarter of last year to 1 billion won in the first quarter of this year. After the second quarter, competition for generic is expected to intensify. This is because more than 20 companies have yet to officially release their products after receiving Xarelto permission and benefits. Generics are predicting aggressive promotions with price competitiveness. Based on Rivaroxaban 10mg, the upper limit price of Riroxia is 1,312 won. Most of the remaining companies listed at 1,115 won. Samjin Pharmaceutical's generic costs 770 won, and Ildong Pharmaceutical's generic costs 760 won.
- Company
- Nerlynx reattempts at reimb after failing CDDC review
- by Eo, Yun-Ho May 02, 2022 06:03am
- An adjuvant therapy drug for breast cancer, Nerlynx, that failed to receive reimbursement in its first attempt is reattempting reimbursement in Korea. According to industry sources, Bixink Therapeutics plans to apply for insurance benefits for its oral HER2 inhibitor Nerlynx (neratinib) in the second half of this year. The drug reached deliberations by the Cancer Disease Deliberation Committee in February, but the committee did not reimbursement standards for the drug. Nerlynx, which was originally developed by the US-based Puma Biotechnology, was first approved FDA approval as an extended adjuvant treatment for early-stage HER2-positive breast cancer in July 2017. Its indication in the US had been extended to the treatment of metastatic HER2-positive breast cancer in February 2020. Bixink introduced Nerlynx to Korea in October last year as ‘extended adjuvant therapy for patients with early-stage HER2 receptor-positive and hormone receptor-positive breast cancer who have completed adjuvant(postoperative) trastuzumab-based therapy less than one year ago.’ Nerlynx has received attention for being effective in brain metastasis by penetrating the blood-brain barrier (BBB), which had been considered a limitation among existing drugs. In fact, Nerlynx has been recommended in the US 2022 NCCN guidelines and the 2022 Korean clinical practice guideline for the treatment of early-sate breast cancer and metastatic breast cancer. However, as Korea’s reimbursement system is conservative towards accepting maintenance therapies, whether Nerlynx may pass the tight barrier and be listed for reimbursement remains to be seen. Joohyuk Sohn, Professor of Medical Oncology at Shinchon Severance Hospital said, “Recurrent or metastatic breast cancer cases that occur from relapse in patients with early-stage breast cancer lead to serious life-or-death situations. I hope that the addition of Nerlynx to the existing standard of care will help increase the number of cured patients in the field of high-risk HER2-positive breast cancer.” Meanwhile, Nerlynx reduced the risk of recurrence or death by 42% and the risk of brain metastasis or death by 59% in women with early-stage HER2-positive breast cancer in the long term in a 5-year follow-up study.
- Company
- Will the flu vaccine market rebound?
- by May 02, 2022 06:03am
- As the obligation to wear outdoor masks is lifted from today, attention is being paid to whether there will be a new change in the influenza vaccine market this year. This is because the importance of flu vaccination increases as the possibility of flu infection, especially COVID-19, increases if taking off the mask. Prime Minister Kim Bu-gyeom announced a change in the guidelines for wearing masks at a meeting of the COVID-19 Central Disaster and Safety Countermeasure Headquarters on the 29th of last month. According to the announcement, the obligation to wear a mask outdoors will be lifted from May 2. More than 50 people who are at high risk of infection do not have to wear masks except when watching rallies, events, performances, and sports games. The lifting of the obligation to wear outdoor masks is also expected to change the flu vaccine market. Recently, the flu vaccine market has drawn a sharp inflection line with COVID-19. According to the MFDS, the flu vaccine, which was approved for national shipment in 2020, reached 30.4 million doses, up 20% from the previous year, but decreased to 28.56 million doses last year. The industry expects that the return rate of flu vaccines will also increase by more than 10% this year. This is because the number of consumers looking for a flu vaccine decreased as the flu incidence rate fell during the COVID-19 pandemic. According to the KDCA, the vaccination rate for the elderly was 73.0% last season (2020-2021), 12.0%p lower than the target vaccination rate of 85.0%. The infant vaccination rate was 73.4% and 50.4% respectively for the first and second subjects, which were 6.6%p and 9.6%p lower than the target vaccination rate. Experts predict that the possibility of catching the flu will increase if both social distancing and wearing masks are lifted this year. If COVID-19 becomes an endemic disease, there will be more cases of both flu and COVID-19. Kim Yoon-kyung, a professor of pediatrics at Korea University Ansan Hospital, said, "The probability of simultaneous infection will inevitably increase if the COVID-19 virus spreads again in a situation where there is a risk of infection because the influenza vaccine is not inoculated. Currently, in the case of RS virus without a vaccine, cases of simultaneous infection with COVID-19 are quite confirmed, he said. "In the case of simultaneous infection, not only the severity of the disease increases, but treatment can be very difficult due to quarantine problems." In a survey of 500 domestic medical staff conducted by Seqirus Korea, a specialized flu vaccine developer, 7 out of 10 respondents (69.4%) would become more important after the COVID-19 pandemic, and 94% recommended flu vaccinations to visiting patients. Distrust of vaccines in general is pointed out as a decrease in the inoculation rate. This is because the public's view of the entire vaccine has changed negatively as side effects of the COVID-19 vaccine have been reported. Professor Kim said, "When concerns about certain vaccines grow, the other vaccines are avoided. However, since the influenza vaccine has been safely inoculated for so long, the society is also emphasizing this point and finding ways to overcome concerns. As influenza is a virus that can be as powerful as COVID-19 if antigenic mutations occur at any time, it is very important to prevent it with continuous vaccination."
- Company
- Rozlytrek can be prescribed with reimb in Korea
- by Eo, Yun-Ho May 02, 2022 06:02am
- The tumor-agnostic drug Rozlytrek may now be prescribed at general hospitals in Korea. According to industry sources, Roche Korea’s NTRK(Neurotrophic tyrosine receptor kinase) targeted anticancer therapy Rozyltrek (entrectinib) has passed the drug committees of medical institutions including the Seoul National University Hospital, Severance Hospital, and Chungnam National University Hospital. With its competitor, Bayer Korea’s Vitrakvi (Larotrectinib) also being prescribed in SNUH since Q1 this year and both drugs being applied insurance benefit from this month, prescriptions for the drugs are expected to start in earnest in the field. The two drugs may be used in most tumor types with identified NTRK gene fusions. However, reimbursement for the drugs is limited to types of tumors mentioned in the NCCN guidelines. Rozlytrek, which was approved as an orphan drug in April last year may be prescribed for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation and for adult patients with locally advanced ROS1-positive or metastatic NSCLC. Rozlytrek was approved based on Phase I/II STARTRK-NG trial on pediatric patients, as well as the pivotal Phase II STARTRK-2 and Phase I STARTRK-1 and ALKA-372-001 trials. In the Phase II STARTRK-2 study, Rozlytrek reduced tumors in more than half (objective response rate [ORR] = 56.9%) of people with NTRK fusion-positive solid tumors. Objective responses to Rozlytrek were seen across 10 different solid tumor types with a median duration of response (DoR) of 10.4 months. Also, the sub-analysis results of Rozlytrek in Asians presented at the ESMO Asia 2020 that was held last year gained much attention. The sub-analysis results in Asians showed that the ORR was 69.2%, the median DoR 10.4 months, and the median progression-free survival (PFS) 14.9 months in 13 patients with NTRK gene fusion-positive solid tumor who received Rozlytrek. However, the overall survival rate was not provided. The median ORR was 69.9% and median DoR 14.9% in ROS1-positive NSCLC patients, with a median OS of 28.3 months and median PFS of 13.6 months. Ahn Myung-Ju, professor of Hemato-Oncology at Samsung Medical Center said, “I hope the introduction of Rozlytrek in Korea and the clinical evidence that confirmed the drug’s potential in Asians will aid the establishment of a virtuous cycle of precision medicine in Korea, a cycle which provides personalized treatment according to the patients’ genetic characteristics for rare cancer patients who had no therapeutic alternatives and their treatment information leading back to research and development.”.
- Policy
- New cost of Tecentriq is 2,271,109 won
- by Kim, Jung-Ju May 02, 2022 06:02am
- Tecentriq, an immuno-cancer drug from Roche Korea, will be expanded from next month due to a combination treatment with Avastin. The new insurance drug price is 2,271,109 won per 20mL for Tecentriq, 218,782 won per 100mg for Avastin, and 712,098 won for Avastin 400mg. The MOHW announced that the "Amendment to the Pharmaceutical Benefit List," which aims to expand the standard for immuno-cancer drugs, was passed after presenting it as a resolution by the 10th Health Insurance Policy Review Committee today (29th). These drugs were listed in January 2018 as the current NSCLC secondary therapy and urinary tract epithelial cancer treatment, and have also been receiving benefits for small cell lung cancer since August 2020. The benefit expansion this time is ▲ a case for primary treatment of progressive non-small cell lung cancer without PD-L1 gene expression and specific gene (EGFR or ALK gene) mutations, and ▲combination therapy with Avastin as a treatment for patients with irreversible hepatocellular carcinoma who had not previously undergone systemic therapy. Alternative drugs include Nexavar (Sorafenib) and Lenvima (Lenvatinib) in hepatocellular carcinoma, and Keytruda (Pembrolizumab) is a representative alternative to non-small cell lung cancer. Janssen Korea applied for the expansion of benefit standards for hepatocellular carcinoma in October 2020 and non-small cell lung cancer in April 2021. In response, the board held a cancer disease review committee in February and July 2021, respectively, and passed it in January this year. It considered that in the case of hepatocellular carcinoma, the quality of life improved in terms of side effects compared to the existing alternative therapy, but since it is expensive with Bevacizumab, the drug benefit evaluation committee needs to discuss the cost effectiveness. In the case of non-small cell lung cancer, it was judged that it was necessary to set salary standards in consideration of clinical literature, but to proceed with follow-up procedures simultaneously with the competitive drug Keytruda. As a result of the committee's deliberation, hepatocyte cancer is at a level that can accept the economic evaluation result (ICER) in terms of cost effectiveness, and in the case of non-small cell lung cancer, the cost is low compared to Keytruda, an alternative drug. The drug is listed in all A7 countries. The company moved to the NHIS and negotiated the new insurance drug price and the expected amount of claims from the end of January to the end of last month. As a result of the negotiations, Tecentriq agreed to 2,271,109 won, down 1.1% from the previous price, with Refund and Expenditure Cap, which the pharmaceutical company refunds to the NHIS for a certain percentage of initial drug treatment and a certain percentage of the cap excess. Avastin also succeeded in agreeing to 218,782 won per 100 mg and 712,098 won for 400 mg, down 5.4% from the previous one, considering the upper limit adjustment criteria and insurance financial impact as the range of use was expanded as a combination therapy. The MOHW and the HIRA set the scope of insurance benefits in consideration of the MFDS' permits, textbooks, guidelines, and academic opinions, and set the recognition period up to two years by applying the same standards as other immuno-cancer drugs.
