- LOGIN
- MemberShip
- 2026-04-08 13:42:23
- Product
- KPA, “to discuss ingredient prescribing in upcoming FAPA"
- by Kim JiEun Mar 05, 2024 05:49am
- The Korean Pharmaceutical Association (KPA) held ‘The 70th General Meeting of Senior Representatives’ for 2024. Kwang-Hoon Choi, President of the Korean Pharmaceutical Association (KPA), has announced that he would assign the proposal for active ingredient prescribing as the priority agenda for the Federation of Asian Pharmaceutical Associations (FAPA) Congress, which is scheduled to be held in October this year. Choi aims to convince the Korean citizens and the government to support active ingredient prescribing. In preparation for this proposal, the KPA is discussing with the government to simplify the substitute drug post-notification procedures. During ‘The 70th General Meeting of Senior Representatives’ on the 28th, KPA (President: Kwang-Hoon Choi) voted to partially revise last year’s KPA presidential election rules. Moreover, a Q&A session was held with the senior representatives and the executive branch to discuss current issues involving pharmacists During the meeting, KPA reviewed seven items, including ‘Revising the election rules for President of KPA and head of branch office,’ and reached decisions. The election rules were decided during last year’s meeting for senior representatives, but the rules were partially revised and finalized during this year’s meeting. In addition, KPA finalized the following matters: ▲2023 audits, and the approval of annual revenue and annual expenditure budget ▲Voting rights for the review of the 2024 business plan ▲Voting rights for the review of the 2024 approval of annual revenue and annual expenditure budget ▲Confirmation of the vice president’s position ▲Approval of a new member of the board of directors ▲Consideration of suggestions from the regional branch. Moreover, the management reports and audits of 2023 regarding KPA’s affiliated agencies, including K-Pharm news, Korea Institute for Pharmaceutical Policy Affairs (KIPPA), and Korea Pharmaceutical Information Center (KPIC), have been reported. During the meeting, the senior representatives voiced many questions about the welfare of the pharmacist society and current policies. The questions were mainly about resolving drug shortages, the system for transferring prescriptions, a system crash during the public transfer of prescriptions, and KPA’s support for introducing active ingredient prescribing. Furthermore, several representatives expressed their concerns regarding KPA’s affiliated agencies, such as KPIC and KIPPA, and ongoing businesses. Regarding KIPPA, there were concerns raised about the malfunctioning KIPPA website and the lack of research on current issues faced by pharmacists. Several senior representatives raised concerns about KPIC’s ongoing business for developing a cloud-based PSP system, which aims to be accomplished by the end of this year. Upon receiving questions and comments from the senior representative regarding the issue, Choi stepped forward and explained KPA’s stand and the association’s strategy. “With the expansion of telemedicine prescribing, there has been an increasing need for active ingredient prescribing. The KPA executive branch continues to support this proposal,” Kwang-Hoon Choi, President of the KPA, stated. “KPA regards simplifying the substitute drug post-notification procedures as a stepping stone for the next step and is discussing this issue with the government. During the FAPA Seoul congress, we aim to prioritize the proposal for active ingredient prescribing as an agenda and gain support from the Korean citizens and the government,” Choi added.
- Company
- Kolon Life Science appeals to the Supreme Court for Invossa
- by Nho, Byung Chul Mar 05, 2024 05:49am
- On the 28th, Kolon Life Sciences decided to appeal to the Supreme Court against the manufacturing and sales license revocation ruling that had been made for its knee osteoarthritis cell gene therapy Invossa-K Inj (“Invossa”). In its appeal to the court, Kolon Life Sciences explained, "While we respect the court's decision, we will strive to restore the scientific achievements and value of Invossa, the world's first gene therapy for osteoarthritis, by correcting the misunderstandings that arose regarding the product’s legal principles and safety at the appellate court.” In 2019, Kolon Life Sciences filed an administrative suit to seek the court’s ruling on the illegality and injustice of the MFDS’s decision to revoke Invossa’s marketing authorization but lost both the first and second trials. Kolon Life Sciences acknowledged that there was an error in indicating the origin of the cells for the 2nd liquid, which was the main substance at the time of the application and approval of Invossa. However, since all non-clinical and clinical trials were conducted with the same cells in all stages before its authorization, the company believes the safety and efficacy of Invossa have been verified by the MFDS, and based on which the company plans to continue its vigorous defense in the final appeals following the first and second appeals. Kolon Life Sciences emphasized that the outcome of the administrative proceedings is completely unrelated to the Phase III clinical trial being conducted by Kolon TissueGene in the U.S. and that it decided to proceed with the final trial to correct the misinformation related to Invossa and restore its scientific value. Accordingly, regardless of the outcome of the administrative proceedings, Kolon TissueGene's Phase III clinical trial on TG-C (formerly known as Invossa) in the U.S. is proceeding according to plan. The company is enrolling and dosing 1,020 patients in the U.S., with the last 150 patients enrolled as of January 2024. In addition, TG-C was approved by the U.S. Food and Drug Administration (FDA) in December 2023 to expand its indication to Degenerative Disc Disease (DDD), in addition to being evaluated in Phase II clinical trials for knee osteoarthritis. In October 2023, Kolon Life Sciences was acquitted on appeal in the second trial of a criminal case against company executives who were charged with obstruction of justice against the Ministry of Food and Drug Safety (MFDS), resolving allegations that the company engaged in intentional manipulation and concealment. Long-term follow-up of patients from 2019 to the present has also shown no direct causal relationship between tumor development and treatment with Invossa.
- Company
- Hugel receives FDA approval for its botulinum toxin Letybo
- by Nho, Byung Chul Mar 05, 2024 05:48am
- On the 4th, Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration (FDA) on February 29th for 50 units and 100 units of its botulinum toxin Letybo (Korean brand name: Botulax). The FDA approval of Letybo represents a strong affirmation of Hugel's product quality and credibility, as it has met the rigorous standards of one of the world's leading regulatory authorities. It also further underscores the company’s global leadership position. With the approval, Hugel has become the first and only Korean company and one of the top 3 players globally that have obtained market approvals in the 3 major global aesthetic markets—the United States, China, and Europe. To date, it has received marketing approvals in a total of 63 countries and has continued to expand its global coverage. The United States is the world's largest medical aesthetic market, accounting for over 50% of the total market. According to data from global research firms Decision Resource Group and the Boston Consulting Group, the market is expected to continue to grow, by nearly twofold from KRW 3.25 trillion in 2023 to KRW 46.36 trillion by 2031. Hugel is currently in the process of finalizing its market penetration strategy, aiming to commercially launch the product by the middle of this year. The launch of Letybo in Canada last year laid a solid foundation for the company’s entry into the North American market, setting the stage for accelerated penetration into the U.S. market. A Hugel official said, “As a leading global medical aesthetic company, we are delighted to be able to release Letybo in the United States, the world's largest and yet still fast-growing market. We will build on our unparalleled performance and leadership in Korea, as well as our comprehensive academic programs, to add value and differentiate ourselves in the industry."
- Company
- New multiple myeloma Ab ‘Elrexfio’ expects to enter KOR
- by Eo, Yun-Ho Mar 05, 2024 05:48am
- Pfizer Korea ‘Elrexfio,’ a new bispecific antibody to treat multiple myeloma, is expected to become commercially available soon. Pfizer Korea has applied for approval of Elrexfio (elranatamab) last year, and it is currently under review by the Ministry of Food and Drug Safety (MFDS), according to industry sources. Elrexfio is expected to be commercially available in the first half of this year. Last August, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Elrexfio. Elrexfio indication is now approved for patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Elrexfio binds bispecific B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells and activates T cells by engaging the cells, resulting in myeloma cell death. It is a BCMA-directed agent that can be administered subcutaneously, with once-weekly dosing and biweekly long-term dosing after 24 weeks of initial treatment. The phase 2 MagnetisMM-3 clinical study demonstrated efficacy of Elrexfio. In the clinical study, Elrexfio showed significant responses as the first BCMA-targeted treatment for patients with relapsed or refractory multiple myeloma who had received many prior therapies. The overall response rate (ORR) of 97 patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy before Elrexfio administration was 58%, and approximately 82% of the patients maintained the response for at least nine months. The median first response time was 1.2 months. Furthermore, the FDA has granted ‘Breakthrough Therapy Designation’ and ‘Orphan Drug Designation’ to Elrexfio. It has received conditional approval from the European Medicines Agency (EMA) and is currently under review for approval in South Korea and Japan.
- Policy
- Will Ferinject be reimbursed this time?
- by Lee, Tak-Sun Mar 05, 2024 05:48am
- Reimbursement for JW Pharmaceutical’s high-dose iron injection ‘Ferinject Inj’ is imminent in Korea. Although the company failed to pass the pricing negotiation stage once in 2020, analysts are seeing a true possibility for its reimbursement this time, as the company's willingness for its reimbursement is stronger than ever. According to industry sources on the 4th, the reimbursement application for Ferinject passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting in January and is currently in the drug pricing negotiation stage with the National Health Insurance Service. The 60-day drug pricing negotiation period will end at the end of this month. Therefore, depending on the speed of the negotiations, Ferinject can be reimbursed in Korea as early as next month. However, given the short period left to report to the Health Insurance Policy Review Committee this month, it is likely that the drug will be included in the reimbursement list in May. The drug, which was introduced by JW Pharmaceuticals from the Swiss company Vifor and released in Korea in 2011, is a high-dose iron injection that has the advantage of supplementing iron with just a single injection. On January 11, the Ministry of Food and Drug Safety determined that the drug was adequate for reimbursement in treating iron deficiency. This is the 4th time the company attempted reimbursement listing for Ferinject. In 2014 and 2018, the drug failed to pass the DREC review, and in 2020, the drug was recognized as adequate for reimbursement at the DREC level but filed to complete negotiations. Despite such setbacks, the company has been posting strong sales in the non-reimbursement market. In 2022, the company's consolidated annual sales reached KRW 20.5 billion. While conventional intravenous iron injections take more than 40 minutes per dose and require multiple hospital visits, Ferinject can quickly replenish iron in the body with up to 1,000 mg of iron per day in 15 minutes, making it an effective alternative to blood transfusions for surgical patients who need to raise their hemoglobin levels in a short period of time, and for mothers who experience hemorrhage due to childbirth. Its high efficacy and convenience have made it popular in the non-reimbursement market, and its market has been growing strongly every year. However, its cost, which is around KRW250,000 per injection, is posing a financial burden for the patients. According to the company, it needs to be reimbursed to make it more affordable for more patients. The problem is if the drug is reimbursed, its price has to become lower than its non-reimbursed price. Therefore, JW Pharmaceuticals is expected to struggle over the change in profit margin and balance the increased usage and price difference during drug price negotiations. However, as it is the second drug price negotiation, the industry believes that there is a higher chance of the NHIS and the company reaching an agreement than in the last negotiation in 2020. This is because if the negotiations fall through again, it will be difficult to attempt reimbursement again. An industry official said, “The deadline for negotiations is the end of March, but it will take a while for the two to reach an agreement. Depending on the progress, the drug may be listed in April, but I don't think the company will deliberately speed up the process."
- Company
- Intensifying competition in ulcerative colitis drug market
- by Son, Hyung-Min Mar 04, 2024 05:53am
- New drug development for conquering ulcerative colitis drives competition among global pharmaceutical companies. Competition in the market will likely intensify due to the efficacy shown by new drugs, including JAK inhibitors Rinvoq and Xeljanz, anti-integrin drugs, and S1P receptor modulators, in clinical trials, in addition to biological medicine Omvoh, a recently approved drug. While TNF-alpha inhibitors such as Humira and Remicade currently dominate the market for ulcerative colitis, the market landscape is forecasted to change. Omvoh, Eli Lily’s interleukin (IL)-23 inhibitor, has been approved in Korea, the industry said on the 27th. Omvoh can treat patients with ulcerative colitis who have previously had failed response to corticosteroids or immunomodulators. Omvoh selectively binds to the p19 subunit of IL-23 and offers a targeted treatment mechanism for the disease. The efficacy of Omvoh was confirmed in Phase 3 LUCENT-1 and 2 clinical trials that included patients with moderately active ulcerative colitis. The clinical trials enrolled patients who had inadequate response to corticosteroids, immunomodulators, or one or more biological medicines. The patients were randomized to receive Omvoh or placebo, starting with a 12-week intravenous administration followed by a 40-week maintenance therapy through subcutaneous injection. The clinical results have shown that the Omvoh group demonstrated a clinical remission rate of 24.2% compared to 13.3% in the placebo group. The Omvoh group achieved 27.1% in histologic-endoscopic mucosal improvement (HEMI), a significant improvement compared to 13.9% in the placebo group. Based on the results after evaluating 544 patients who underwent a 40-week maintenance therapy, 49.9% of patients in the Omvoh group achieved clinical remission, compared to 25.1% of the placebo group, demonstrating Omvoh’s efficacy. Regarding the safety of Omvoh, the most common adverse reactions associated with Omvoh were respiratory infections (7.9%), headaches (3.3%), and rash (1.1%). Omvoh will likely compete with Janssen’s Stelara, an IL-12 and IL-23 inhibitor. Stelara is indicated for Crohn’s disease, besides ulcerative colitis. Eli Lily, the company responsible for developing Omvoh, is currently evaluating Omvoh for Crohn’s disease in clinical trials. Skyrizi, an interleukin-23(IL-23) inhibitor.In addition to Omvoh, the company is also working on securing indications of interleukin inhibitors for treating ulcerative colitis. Abbvie is also developing Skyrizi, an interleukin-23(IL-23) inhibitor like Omvoh, for the treatment of ulcerative colitis. Skyrizi received approval in Korea only for Crohn’s disease. Both the INSPIRE study, which evaluated the effectiveness of induction therapy at 12 weeks, and the Phase 3 COMMAND clinical study, which evaluated maintenance therapy at 52 weeks, demonstrated Skyrizi’s effectiveness compared to the placebo group. Janssen is developing Tremfya, an IL-23 inhibitor, for the treatment of ulcerative colitis. In the Phase 2 clinical study, Tremfya’s clinical response was achieved in 80% of Tremfya-treated patients. Janssen is conducting a multinational Phase 3 clinical study in patients with active ulcerative colitis. S1P receptor modulators have also proven effective, in addition to JAK inhibitors and anti-integrin drugs In addition to interleukin inhibitors, JAK inhibitors, and anti-integrin drugs have secured indications for ulcerative colitis. JAK inhibitors work by blocking the activity of JAK, a kinase that regulates immunity and inflammation. This mechanism of action is effective in reducing inflammation. JAK inhibitors are used to treat autoimmune diseases such as ulcerative colitis, rheumatoid arthritis, atopic dermatitis, and inflammatory bowel disease. Eisai’s Jyseleca, Pfizer’s Xeljanz, and Abbvie’s Rinvoq. Among the JAK inhibitors that have received approval in Korea, the medicines that have secured indications for ulcerative colitis are Abbvie’s Rinvoq, Eisai’s Jyseleca, and Pfizer’s Xeljanz. These drugs are undergoing clinical trials to evaluate their effectiveness as maintenance therapy for ulcerative colitis. Takeda’s Kynteles, an anti-integrin drug, has secured an indication for ulcerative colitis. Kynteles inhibits the migration of lymphocytes, which causes inflammation, into the gastrointestinal tract. Recently, the sphingosine-1-phosphate (S1P) receptor modulator has entered the market. Pfizer’s Velsipity recently received approval in Europe after securing approval in the United States last year. Inhibition of the S1P receptor can reduce the leakage of lymphocytes circulating in the lymph nodes, thereby diminishing inflammatory responses. Velsipity demonstrated efficacy in patients with ulcerative colitis who have previously had a failed response or intolerance to one or more treatments. Velsipity has shown effectiveness in patients who have had an inadequate response to at least one or more biologic or Janus kinase JAK inhibitor therapy compared to the placebo. It has been shown that there are improvements in endoscopic outcomes, alleviation of symptoms, and a restoration of the intestinal barrier. Velsipity aims to compete with BMS’s similar S1P receptor modulator, Zeposia. Zeposia, which received approval in Korea last year, secured reimbursement this year and launched in the market. It has landed in general hospitals, where prescriptions are being actively written.
- Policy
- Guideline to be revised to prevent unintentional impurities
- by Lee, Hye-Kyung Mar 04, 2024 05:52am
- Amid the recent recall of sitagliptin combination products due to excess detection of impurities, the Ministry of Food and Drug Safety appears to be busy preparing a system to manage unintentional impurities at all times. The MFDS aims to revise the 'Guideline for Safety Management of Impurities in Drug Products’ within June to establish and advance a permanent pharmaceutical industry-led system for managing unintentional impurities in drugs. The revised guidelines will reflect the latest advances in Korea and abroad such as new impurity tolerance standards, causes, and reduction strategies, and measures such as information collection, risk assessment, testing, and reduction. Unintentional impurities have continued to occur, including those in the hypertension drug valsartan in 2018, gastrointestinal drugs ranitidine and nizatidine in 2019, and the diabetes drug metformin in 2020. In addition, last year, due to the detection of nitrosamine impurities, the government implemented safety measures such as submission of test results and recalls were implemented on domestically distributed drugs such as ‘perindopril,’ ‘tamsulosin,’ ‘nortriptyline,’ and ‘sitagliptin’ based on the evaluation results. In particular, in the case of sitagliptin, a number of sales recalls have recently been carried out by the companies as a precautionary measure due to concerns over the detection of excess impurities (NTTP). In January, Kyung Dong Pharma’s anti-ulcer drug ‘Zanitin Tab 150mg' was recalled due to concern over the detection of impurities, and in February, Alvogen Korea's ‘Genxiga S Tab 10/100mg', Hutecs Korea Pharmaceutical's ‘Nanudangxiga Tablet 10/100mg', KyungBo Pharmaceutical's ‘Janustin Duo Tab 10/100mg', Ahn-Gook Pharm’s ‘Adapasita Duo Tablet 10/100mg', and Nex Pharm Korea's 'Flosita Tab 10/100mg' were also recalled. An MFDS official, said, “We will strengthen drug quality control and contribute to public safety through preemptive management of impurities that may be unintentionally mixed into drugs."
- Company
- Generics of ‘Opsumit’ face tough competition in KOR
- by Kim, Jin-Gu Mar 04, 2024 05:52am
- The product photos of Opsumit (left) and Masiten (right). In the market for the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan, the period of priority of sale given to the first generic drugs is set to expire on the first of next month. While Janssen’s ‘Opsumit’ competes with Samjin Pharm’s ‘Masiten’ in the market, Daewoong Pharmaceutical’s newly launched ‘Macimit’ is expected to join the competition. As the generic’s market share is insignificant at below 1%, Daewoong’s introduction into the market draws the pharmaceutical industry’s attention related to potential market expansion in the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan. The sales of Opsumit 13%↓ in a year due to drug pricing decreases following the generic launch. The market size for the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan totaled 15.2 billion won last year, according to a pharmaceutical market research company IQVIA on the 29th. This figure represents a 13% decrease from 17.4 billion won in 2022. The market has gradually expanded, with 11.9 billion won in 2019, 16.3 billion won in 202, 16.0 billion won in 2021, and 17.4 billion won in 2022. However, the sales decreased by over 10% last year. The decrease in sales is likely due to the drug pricing decrease of the original medicine following the generic launch. Samjin Pharm filed a claim for passive trials to confirm the scope of a right involving the active ingredient patent of Opsumit against Janssen in May 2022. Samjin Pharm won the first trial in April of the following year. Last May, Samjin Pharm launched Masiten Tab after receiving the trial results. During the same period, the price of Opsumit, Janssen’s original medicine, decreased by 30%. The Ministry of Health and Welfare (MOHW) issued a decrease in Opsumit price following the reimbursement listing of the drugs with the same active ingredient. Janssen has appealed to the patent court in response to the first trial judgement. However, the company did not file a suspension of execution related to the drug pricing reduction. While accepting the government’s measure of drug pricing reduction, Janssen has decided to continue with the patent dispute with Samjin Pharm to protect the patent right. The quarterly sales of the treatments Opsumit, the original drug for treating pulmonary arterial hypertension (PAH) with the active ingredient macitentan, and its generic, Masiten. The quarterly sales of Opsumit steadily recorded 4.0 to 4.6 billion won until the second quarter of last year, then rapidly dropped to around 3 billion won after the third quarter. The decrease is due to a reduction in drug pricing that took effect after the third quarter of last year, following the generic launch in May of last year. Masiten had a market share of 0.5% in Q4 last year. Will Daewoong’s introduction lead to an expansion of the generics market? Samjin received a right for priority of sale after successfully challenging the Opsumit patent. Daewoong also challenged the same patent for Opsumit, but Samjin was a step ahead in obtaining the approval for its generic version. Therefore, Samjin obtained the priority of sale for the Opsumit generic alone. The priority of sale was granted from April 21st of last year until March 1st of this year. Although Samjin sold the generic without competition, Masiten’s impact on the market is insignificant. Last year, Masiten generated cumulative sales of merely over 20 million won. After the priority of sale ends, another generic is expected to enter the market on the 1st of next month. Daewoong Pharmaceutical obtained approval for their Macimit, as a generic version of Opsumit, in May of last year. It is anticipated that Daewoong Pharmaceutical will launch the product after next month. Daewoong’s introduction draws the pharmaceutical industry’s attention regarding the potential market expansion of generics containing the active ingredient macitentan. In the market of the treatment of pulmonary arterial hypertension (PAH) with the active ingredient macitentan, Masiten had a market share of 0.5% in the fourth quarter of last year.
- Company
- Bayer releases 2 new CVD drugs with reimb in KOR
- by Eo, Yun-Ho Mar 04, 2024 05:52am
- Bayer Korea, which has been slow to launch new drugs, is making a comeback, recently succeeding in reimbursing two of its cardiovascular drugs in Korea. According to industry sources, Bayer Korea launched its heart failure drug ‘Verquvo (vericiguat)’ with reimbursement on September 1 last year and its kidney disease drug ‘Kerendia (finerenone)’ on February 1 this year. The addition of the two drugs is expected to revitalize Bayer's cardiovascular division, which did not have a prominent pipeline since the launch of its novel oral anticoagulant (NOAC) ‘Xarelto (rivaroxaban).’ Verquvo, the first sGC stimulator for heart failure Verquvo was approved in December 2021 as a combination therapy in Korea as a treatment to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient intravenous (iv) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Conventional heart failure treatments work by blocking the harmful effects of the natural neurohormonal system that is activated by myocardial and vascular dysfunction. In contrast, Verquvo is a soluble sGC stimulator that has a novel mechanism of action to improve myocardial and vascular function by catalyzing the synthesis of intracellular cyclic guanosine monophosphate (cGMP), which regulates cardiac contractility, vascular tone, and cardiac remodeling. It is the first-in-class sGC stimulator approved for the treatment of chronic heart failure. The Phase III VICTORIA trial, which became the basis for Verquvo’s approval, was shown to reduce the risk of hospitalization in patients with heart failure. A total of 5,050 patients were enrolled in the study, including 1,132 Asian patients. Study results showed that at a median of 10.8 months of follow-up, the risk of death from cardiovascular disease or first hospitalization due to heart failure was about 10% lower in the Verquvo group than that of the placebo group, and the trial met its primary efficacy endpoint with an annual absolute risk reduction of 4.2%. Kerendia, the first kidney failure drug introduced in 20 years Kerendia was approved in Korea in May 2022 by the KFDA for the treatment of adult patients with chronic kidney disease (CKD) and Type 2 diabetes to reduce the risk of end-stage kidney disease (ESKD) and a sustained decline in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. Until now, only treatments that target hemodynamic changes and metabolic abnormalities, 2 of the 3 causes that worsen chronic kidney disease in type 2 diabetes, had existed, but the introduction of Kerendia made available a treatment that inhibits inflammation and fibrosis in the kidneys. Kerendia’s reimbursement approval was based on the reduction in kidney disease progression, cardiovascular benefit, and safety that was demonstrated through the Phase III trials FIDELIO-DKD and FIGARO-DKD. In the FIDELIO-DKD study, Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo.
- Policy
- Will the novel anticancer drug Enhertu be reimb in April?
- by Lee, Tak-Sun Mar 04, 2024 05:52am
- After going through two Cancer Disease Deliberation Committee meetings and two Drug Reimbursement Evaluation Committee meetings, the anticancer drug ‘Enhertu’ has finally started drug pricing negotiations with the National Health Insurance Service. As the drug has passed drug evaluations after repeated revisions, the negotiations are expected to go smoothly. In particular, it will be interesting to see if the government grants reimbursement within April, as there are analysts who believe that the government is using the scenario of coverage before the parliamentary election. According to the industry on the 28th, the Health and Welfare Ministry recently issued a drug pricing negotiation order to the NHIS for Enhertu, after which the NHIS has begun full-scale negotiations. Enhertu 100mg Inj (fam-trastuzumab deruxtecan-nxki, Daiichi Sankyo Korea) was granted marketing approval in Korea in September 2022. The company applied for reimbursement coverage in December of the same year. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. .As a HER2-targeted antibody-drug conjugate (ADC), Enhertu demonstrated clinical efficacy over existing agents .HER2-targeted antibody-drug conjugate (ADC) Enhertu reduced the risk of disease progression or death by nearly 50% compared with conventional chemotherapy, with an mOS of 23.4 months, which was a 6.6-month extension from the 16.8 months in the chemotherapy group .However, this high effect rather posed a hurdle during drug pricing evaluations .Due to the high survival rate, the duration of its use was expected to increase, making it difficult for the drug to pass the economic evaluation threshold .If the ICER value (incremental cost-effectiveness ratio) of a drug, which is used as an indicator for economic evaluation, exceeds the threshold, it makes it difficult for reviewers to recognize the adequacy of the drug’s reimbursement .Due to this, the Cancer Disease Deliberation Committee was held twice last year to set the reimbursement standard for the drug, and the Drug Reimbursement Evaluation Committee meeting, which makes the final judgment on the adequacy of reimbursements appropriateness of drugs, was held twice in January and February this year .Although the ICER value of Enhertu exceeded the threshold of KRW 50 million set for anticancer drugs, the threshold was reportedly lowered to a reasonable level after discussion with the authorities .The company is analyzed to have conceded a lot in terms of drug price .As the drug price and financial sharing have been somewhat clarified during the evaluation process, negotiations are expected to go more smoothly .This raises the possibility that the deal could be finalized earlier than the 60-day negotiation period and listed in April .As there is talk that the government may list Enhertu and promote it as an innovative new drug listing achievement before the general elections, this is expected to speed up the negotiation process .However, there is also an analysis that the MOHW’s negotiation order came later than expected, leaving insufficient physical time to complete negotiations before the Health Insurance Policy Review Committee meeting commences in March.
