- LOGIN
- MemberShip
- 2026-04-09 04:47:31
- Company
- Public petition filed for the reimb of Verzenio
- by Eo, Yun-Ho Nov 02, 2023 05:35am
- A public petition imploring the government to reimburse Verzenio for early breast cancer has been posted online for review. On October 31st, a petition was posted on Cheong Wa Dae’s National Petition Bulletin Board entitled ‘Petition requesting reimbursement for Verzenio (abemaciclip), a targeted treatment for early breast cancer.’ The petitioner introduced himself as a person whose wife is suffering from HR+/HER2- breast cancer and asked the government to promptly list Verzenio, which is virtually the only treatment option available for her condition, for reimbursement. Accordingly, attention is focused on whether the CDK4/6 inhibitor Verzenio, which recently reapplied for reimbursement after a failure, will be able to successfully be reimbursed. Apart from letrozole generics that are used as endocrine therapy, Verzenio is the only new drug for the HR+/HER2- subtype of breast cancer. The drug was first approved on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, a very limited range of patients with ▲ 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and a tumor size of 5 cm or larger, or ▲histological grade 3 disease, can receive treatment with Verzenio. Lilly applied for reimbursement immediately upon Verzenio‘s approval. However, the drug struggled from the first step to its reimbursement at HIRA's Cancer Disease Review Committee level. After a long wait of 6 months after submitting the application, the agenda was finally reviewed at the 3rd CDDC meeting that was held on May 3rd. However, Verzenio had unfortunately many contestants. A total of 9 items were reviewed in the 3rd CDDC meeting. This was the largest amount of subjects among the 7 cancer screening meetings held this year. Five months after the first CDDC review, Lilly filed for reimbursement again on October 4th to the Health Insurance Review and Assessment Services. The company was equipped with new supporting data presented at the 2023 ESMO Congress that had been held in Madrid, Spain recently. The 5-year morachE data that was released was a follow-up study of the 4-year data released at the San Antonio Breast Cancer Symposium published in Lancet Oncology in December 2022. Study results showed that the differences in the major clinical indicators - invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) rates – widened more distinctively between the Verzenio arm and the control arm (endocrine therapy alone) at 5 years compared to 4 years. At 5 years, the primary efficacy endpoint IDFS differed by 8%. This means that even after completing Verzenio treatment during the limited period of 2 years after surgery, its treatment effect continued until the 5th year. This data is even more significant as the term, ‘cure,’ is generally used 5 years after cancer treatment.
- Policy
- Complete deletion of Ranitidine from the list of benefits
- by Lee, Tak-Sun Nov 01, 2023 05:40am
- Most ranitidine products, which were suspended due to adulteration in September 2019, will be removed from the reimbursement list as of November. This is because there has been no production performance over the past three years or no insurance benefit claims over the past two years. There are only three Ranitidine products remaining on the November list. According to the industry on the 30th, unclaimed medicines were deleted and unproduced, and expired medicines were deleted from the November benefit list, leading to the expulsion of the majority of ranitidine preparations. Ranitidine preparations were suspended on September 26, 2019, after the impurity NDMA (N-nitrosodimethylamine) was detected. Although it has been on the benefits list with benefits suspended, it has been completely removed from the list due to the recent overhaul of unclaimed and unproduced medicines. In order to normalize the benefits, there is no choice but to apply for benefits again, but as it is analyzed that it will be difficult to maintain the license through renewal, it appears that it will virtually be permanently excluded from the market. Unclaimed medicines are those that have not been claimed for insurance benefits over the past two years (July 1, 2021 - June 30, 2023) and are subject to deletion from the benefits list. 125 items were deleted from the November list. Unproduced or expired medicines are medicines that have not been produced or imported for the past three years (January 1, 2020, to December 31, 2022) and are deleted from the benefit list if their expiration date or expiration date has expired. This time, 961 items were deleted. Ildong Pharmaceutical's Curan (5 products), which was the flagship product of a single ranitidine drug, was deleted due to non-production and expired expiration dates. Daewoong Pharmaceutical's Albis Tablet, which had the highest performance among combination drugs, was also removed from the benefits list due to non-production and expiration date. This time, 46 items identical to Alvis disappeared from the benefit list. Now, there are only three ranitidine products remaining on the payroll list. The combination drug is Anacid from Aju Pharmaceutical, and the single drug is Genupharma Latini Tablet and SCD Ranitidine 150mg. The three items were also suspended as of September 26, 2019.
- Company
- Daewoong-Merck pursues full-cycle AI-based new drug dev
- by Lee, Seok-Jun Nov 01, 2023 05:40am
- Daewoong Pharmaceutical announced on the 31st that it had signed a memorandum of understanding (MOU) with Merck Life Science for the ‘establishment of an AI-based new drug development platform and full-cycle technical support of new drug development.’ The companies will work together to improve the efficiency and productivity of the new development process. Under the MOU, Merck will provide the data and programs necessary for the drug development process, and Daewoong will incorporate them into its web-based modeling platform for drug candidate discovery, verification, and monitoring. Merck will become the first in the industry to use AI (artificial intelligence) to support the technology necessary for the ‘entire cycle’ of new drug development. Daewoong Pharmaceutical will utilize Merck’s ‘SYNTHIA™’ and 'AMS(Aldrich Market Select)’ to improve the efficiency of its drug development process. Daewoong Pharmaceutical has demonstrated its R&D capabilities by developing new homegrown drugs for 2 consecutive years, including the gastroesophageal reflux disease treatment 'Fexuclue' and the SGLT-2 inhibitor antidiabetic ‘Envlo.’ Through the MOU, the company plans to strengthen its competitiveness in R&D and spur the development of first-in-class global blockbuster drugs. Joon-Seok Park, Park Chief of Daewoong Pharmaceutical's Drug Discovery Center, said, “We expect the MOU to increase our efficiency in new drug research and lay the foundation for our growth into a global big pharma by widening the gap in our new drug R&D capabilities with other domestic competitors. Ji Young Chung, Head of Science and Lab Solutions at Merck Life Science, said, “Our MOU with Daewoong Pharmaceutica holds significance as it marks the first partnership in Korea forged to support AI-based drug development throughout its entire lifecycle.”
- Policy
- Hanmi recieves 1st approval for aspirin+rabeprazole combo
- by Lee, Hye-Kyung Nov 01, 2023 05:40am
- With the development of aspirin and rabeprazole sodium combinations in active progress, Hanmi Pharmaceutical successfully obtained the first marketing authorization for its combination drug. The Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's Raspirin Cap. 100/5mg (aspirin/rabeprazole) on the 30th. The combination of aspirin and rabeprazole is considered a way to minimize the side effects of aspirin and is proposed as an alternative to the combined use of low-dose PPI agents. The Ministry of Food and Drug Safety included the aspirin+rabeprazole combination as a subject for the new drug development support it provides for Korean incrementally modified drugs, which is expected to lead to continued approvals of such combinations in the future. The rabeprazole combination was developed to prevent the side effects of bleeding that follow the long-term use of aspirin in patients with gastric and duodenal ulcers who take aspirin to inhibit blood clot formation. Aspirin is indicated for patients with a history of gastric or duodenal ulcers who need to inhibit thrombus formation in myocardial infarction, cerebral infarction, and unstable angina; or inhibition of thrombus formation after coronary artery bypass graft (CABG) or percutaneous coronary coronary angioplasty (PTCA); or reduction of cardiovascular risk in high-risk patients (patients with complex risk factors such as family history of ischemic heart disease, hypertension, hypercholesterolemia, obesity, and diabetes) Rabeprazole is a proton pump inhibitor (PPI) that has a mechanism to suppress gastric acid secretion. The ingredient comes in various doses ranging from the lowest dose of 5 mg to 10-20 mg. Adults take 1 Raspirin capsule (aspirin/rabeprazole sodium 100/5mg) once a day. The total market for aspirin is worth about KRW 46 billion based on UBIST’s outpatient prescriptions last year. In addition to Hanmi Pharmaceutical, which received approval for the combination of aspirin and rabeprazole, domestic developers such as Youngjin Pharm and GL Pharm Tcch are preparing to receive approval for their drugs.
- Company
- 5th JAK inhibitor released…heats up competition
- by Kim, Jin-Gu Nov 01, 2023 05:40am
- (clockwise from the upper left) Jyseleca, Cibinqo, Rinvoq, Olumiant, Xeljan The fifth product was released in the market for JAK inhibitors, an oral autoimmune disease treatment drug. The JAK inhibitor market, which has continued rapid growth recently, is expected to grow more rapidly due to the addition of the new product. Competition among products is also expected to intensify. While Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are competing for the lead, the new entrants, Cibinqo (abrocitinib) and Jyseleca (filgotinib), are also heralding their pursuit. Quarterly prescriptions exceed KRW 10 billion… Olumiant, Xeljanz, Rinvoq in a fierce battle for the lead Industry sources revealed that Eisai Korea released Jyseleca on the 1st. With the addition of Jyseleca, a total of 5 JAK inhibitors are currently available in the Korean market. Following the release of Pfizer Xeljanz in 2015, Lilly’s Olumiant was released in 2019, and AbbVie’s Rinvoq in 2021. In July this year, Pfizer's second JAK inhibitor, Cibinqo, was launched, and then Eisai’s Jyseleca. JAK inhibitors are used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. Its mechanism of action blocks inflammation, pain, and cell activation by suppressing inflammatory cytokines. The domestic JAK inhibitor market has been expanding rapidly. According to the pharmaceutical market research institution UBIST, outpatient prescriptions of domestic JAK inhibitors in Q3 this year reached KRW 10.7 billion, a 24% increase in a single year compared to the KRW 8.6 billion made in the same period last year. In particular, quarterly prescriptions exceeded KRW 10 billion for the first time in Q3. At this pace, the total outpatient prescriptions this year are expected to expand and exceed KRW 40 billion. Quarterly outpatient prescription of JAK inhibitors (Unit: KRW 100 million, Data: UBIST) The battle for the lead is also fierce. While sales of Xeljanz, which has kept the lead for a long time, have slowed down somewhat, Olumiant has jumped to the lead since Q2 this year. In Q3, Olumiant posted prescriptions worth KRW 3.7 billion. This is a 28% increase from the KRW 2.9 billion in Q3 last year. During the same period, Xeljanz’s prescriptions increased by 2% from KRW 3.6 billion to KRW 3.7 billion. However, the difference between Olumiant and Xeljanz prescriptions is less than KRW 40 million in Q3, making it unclear which will rise to the top again. On top of that, the third entrant Rinvoq, has also quickly increased its prescription performance and joined in the leading competition. In the third quarter, Rinvoq posted prescriptions worth KRW 3.1 billion. This is a 45% YoY increase from the KRW 2.1 billion posted in Q3 last year. fifth drug ‘Jyseleca’ is released…JAK inhibitor market expected to continue to grow The addition of Cibinqo and Jyseleca to the market is expected to further intensify competition in the JAK inhibitor market. Cibinqo was released with reimbursement in July to treat atopic dermatitis. In the first 3 months of its launch, prescription sales amounted to approximately KRW 260 million. Jyseleca was newly released on the 1st of this month. It is an adenosine triphosphate (ATP)-competitive and reversible inhibitor that selectively inhibits JAK1. Quarterly major JAK inhibitor prescriptions (Unit: KRW 100 million, Data: UBIST) The JAK inhibitor market is expected to continue its high growth for some time due to the expansion of indications and the addition of new products. After first receiving approval as a treatment for rheumatoid arthritis, Xeljanz additionally received indications for psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Olumiant first received approval as a treatment for rheumatoid arthritis, then added indications for atopic dermatitis and alopecia areata. Rinvoq was also first approved for rheumatoid arthritis and then added indications for psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. Cibinqo indicates atopic dermatitis. However, unlike other products, it can be used not only by adults but also by teenagers over the age of 12. The fifth product, Jyseleca, has indications for rheumatoid arthritis and ulcerative colitis.
- Company
- Gilead aims for reimbursement of COVID-19 tx Veklury
- by Eo, Yun-Ho Nov 01, 2023 05:40am
- COVID-19 treatment Veklury is aiming to be listed on insurance benefits. According to related industry sources, Gilead Sciences Korea submitted an application for Veklury's benefit last month. As with Pfizer Korea's Paxlovid, the government plans to end the current free support system from the first half of next year, so it is believed that the reimbursement registration process will be followed accordingly. The government announced that it will pursue the registration of Paxlovid insurance benefits within the first half of 2024 in accordance with the plan to ease the COVID-19 crisis level adjustment roadmap. This measure is due to the fact that COVID-19 treatments, which are currently being supplied free of charge, are about to be converted to being supplied for a fee like general medicines. When stage 2 of the COVID-19 crisis level adjustment roadmap, which further relaxes the quarantine system, is implemented next month, COVID-19 will transform into a level 4 infectious disease like influenza (flu). In other words, the incorporation of medicines such as Veklury and Paxlovid into the general medical system becomes inevitable. The government said that even if the second stage roadmap is implemented, it will provide oral COVID-19 treatments free of charge for the time being, but it is unclear how long the free provision will last. Meanwhile, Veklury has a wider range of indications than Paxlovid. This drug was first approved in Korea in July 2020, and based on the current indications, it can be prescribed for children and adults, from mild to moderate patients at high risk of progressing to severe disease to patients with severe pneumonia requiring supplemental oxygen treatment. do. Gilead's application for reimbursement was also made for all currently approved indications for Remdesivir.
- Policy
- HIRA ‘Will advance CDDC result disclosure within the year'
- by Lee, Jeong-Hwan Oct 31, 2023 05:35am
- The Health Insurance Review and Assessment Service announced that it will pursue systemic advancement within the year so people can gain access to details such as the reasons for the evaluations made by the Cancer Disease Review Committee. HIRA also revealed plans to review the scope, method, and timing of disclosure of the details of the meeting results, on how they will only be disclosed when it has a ingsingificant impact on the Ministry of Health and Welfare's reimbursement policy or reimbursement order. In addition, the authorities announced that they will include experts recommended by consumer and patient groups as members in the next committee composition stage set for the end of the year. On the 27th, HIRA responded so to the criticism raised by the National Assembly’s Health and Welfare Committee at the NA audit. Rep. Jeoung-ae Han of the Democratic Party of Korea urged the committee to disclose the results of the CDDC meeting in more detail and prepare ways to better reflect patient opinion in the committee's decision-making process. HIRA responded that CDDC, which reviews the standards and methods to apply reimbursement to anticancer drugs prescribed and administered to seriously ill patients, has been disclosing the deliberation results on its website immediately after its meeting since 2021 in response to the rising social interest. However, the authorities also added that specific details are not being disclosed due to regulations that restrict their disclosure, including sensitive information such as the pharmaceutical company’s trade secrets or when follow-up procedures are in progress. Instead, HIRA promised to advance the system within the year to broaden the disclosed details such as specific evaluation stages and reasons for evaluation of applicants to improve the predictability of CDDC's review results. After advancing the system, HIRA will consult the MOHW to review ways to expand the disclosure of cancer information and improve it so that experts recommended by patient groups can participate in the committee. Regarding the composition of the committee, 4 experts recommended by consumer and patient groups can be added out of the total quota of 45, but only 1 expert is currently participating in the committee due to the insufficient number of recommendations made from related organizations when composing the current committee in 2021. So the improved system will seek to address this problem as well. HIRA said, “We will review the scope, method, and timing of disclosure of the meeting details, but only for those whose reimbursement standards have not been set, and their disclosure is met with a high level of social interest and has relatively little impact on the Ministry of Health and Welfare’s reimbursement policy or order. We will fill the quota of recommended experts by allowing consumer and patient groups to recommend cancer-related experts regardless of the relevant cancer type to fill the quota of recommended experts when forming the next committee.”
- Policy
- Roche Lunsumio, domestic approval imminent
- by Lee, Hye-Kyung Oct 31, 2023 05:35am
- According to the pharmaceutical industry on the 30th, the Ministry of Food and Drug Safety completed the safety and effectiveness review of Lunsumio. Completing this review means that the product approval process will soon begin. Lunsumio was designated as a GIFT item as the urgency of its introduction to expand patient treatment opportunities was recognized as the target disease is relapsed or refractory follicular lymphoma and is a drug for which there is no existing treatment. When designated as a GITF target, the review period is shortened by at least 25% (e.g. 120 → 90 working days), the rolling review is applied to review prepared materials first, close communication between reviewers and developers through product briefing sessions and supplementary briefing sessions, and regulatory-related expertise. You will receive a variety of support for rapid productization, including consulting. Lunsumio was designated as a GITF on November 29th of last year, and it is understood that it would take about 11 months from review to approval if the approval announcement is made as early as the end of this month or at the latest in early November. The Ministry of Food and Drug Safety emphasized that the time taken may vary from pharmaceutical company to pharmaceutical company when requesting supplementary data as the reason why it took longer than the originally targeted shortened review period. There are a total of 17 items designated as GIFT targets, and GIFT approvals are expected to continue one after another, starting with the first, Lunsumio. Lunsumio was approved by the U.S. FDA in December last year as a treatment for adult patients with relapsed or refractory follicular lymphoma (FL) after receiving two or more systemic treatments. This drug is a bispecific antibody that engages CD20xCD3 T cells and has a mechanism to connect immune cells and cancer cells by selectively binding to T cells and malignant B cells, which are immune cells that attack cancer cells. Lunsumio confirmed its potential through Lunsumio's phase 2 clinical trial GO29781 study conducted on patients with follicular lymphoma. The study found that Lunsumio's ORR was 80% (72/90), with the majority (57%) having responses that lasted at least 18 months. The proportion of patients who achieved a complete response was 60% (54/90), and the mDOR of response for patients who responded to treatment was 22.8 months.
- Company
- Global biosimilar market worth KRW 3.9 tril…Pfizer vs Amgen
- by Kim, Jin-Gu Oct 31, 2023 05:35am
- Prospects of the global biosimilar market have shown that the global biosimilar market, which is currently worth USD 28.62 billion (about KRW 39 trillion), will expand rapidly to reach USD 76.51 billion (about KRW 102 trillion) by 2028. On the 30th, the Korea Biotechnology Industry Organization made the forecast, citing biosimilar market data from global market research firm Frost & Sullivan (F&S). According to KoreaBIO, the global biosimilar market is expected to grow 17.8% a year until 2028. In particular, market size is expected to grow in earnest with the release of Humira (adalimumab) biosimilars this year. The global market size is expected to expand to USD 42 billion by next year, to USD 50 billion in 2025, to USD 60 billion in 2027, then to USD 70 billion in 2028. This is because the patents of global blockbuster drugs will be successively expiring during the period. The patents for Eylea, Stelara, Victoza, and Humira will expire this year, the patents for Xolair and Simponi in 2024, the patents for Prolia, Soliris, and Yervoy in 2025, the patents for Perjeta and Cyramza in 2026, then the patents for Trulicity in 2027. In 2028, patents for Keytruda, Opdivo, and Cosentyx are also set to expire. Currently, more than 400 companies are competing in the global biosimilar market. As of last year, the top 5 companies' share in the global biosimilar market reached 22.1%. Pfizer accounts for 8.4%, Amgen 4.9%, Eli Lilly 3.6%, Biogen 2.7%, and Teva 2.6%. In addition, Merck, Boehringer Ingelheim, Fresenius Kabi, Sandoz, Mylan, Biocon, Novo Nordisk, Celltrion, and Samsung Bioepis are competing with the top 5 companies in the North American and European markets. In the largest markets - the US and Europe - 40 and 64 biosimilars were approved, respectively, as of last year. In the case of Humira biosimilars that are attracting attention, 9 of the 10 companies that received approval released their biosimilar products in the U.S. market. In Europe, 10 companies have received approval for their Humira biosimilars. In Europe, in addition to Humira, biosimilar competition is fierce for Avastin (bevacizumab), Neulasta (pegfilgrastim), and Neupogen (filgrastim). 8 companies were approved for their Avastin and Neulasta biosimilars, and 7 companies were approved for their Neupogen biosimilars. Korea and Japan are leading the biosimilar approval and manufacturing in the Asian market, with India and China rapidly catching up. India has the most number of approved biosimilars in the world, with the count currently at 127. This surpasses the number of those approved in Germany and the United States. China has also emerged as a major country in biosimilar R&D recently. Currently, more than 60 pharmaceutical companies in China are developing biosimilars.
- Company
- Public opinion grows on if PO kidney tx should be covered
- by Nho, Byung Chul Oct 31, 2023 05:35am
- Bayer chronic kidney disease treatment Kerendia. This drug is a disease-related disease that has emerged for the first time in 20 years As first-in classes related to kidney disease are blocked by insurance registration review barriers, it seems urgent to improve the system through social consensus. A drug related to this is Kerendia, Bayer's chronic renal failure treatment that was newly introduced for the first time in 20 years. Renal anemia that occurs due to abnormal kidney function can be mentioned, including the recently approved AstraZeneca Evrenzo (2021), JW Pharmaceutical Eronai (2022), and Mitsubishi Danabe Vadanem (2023). The reasons why a rapid registration process for innovative new drugs related to kidney disease is required are to expand patient treatment options and reduce health insurance finances. According to the NHIS data, the number of chronic kidney disease patients in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021, and in particular, those in their 80s surged by 82.8%. The number of hemodialysis patients is also showing an exponential increase, and the health insurance budget currently spent on approximately 100,000 patients is close to 3 trillion won. Compared to existing renal anemia treatments that are distributed only as injections, it is expected that patient compliance will also significantly increase because it is in the form of an oral pill. The news that Kerendia has been submitted to the pharmaceutical review committee provides some hope for the insurance listing of these drugs related to comprehensive kidney disease. This is a result of approximately one and a half years after approval (May 2022) due to the expression of opinions from all directions, including not only the developer, but also the nephrology society, the National Assembly, and patient groups. Therefore, discussions on drug price negotiation for Kerendia, which was recognized as appropriate for coverage of chronic kidney disease with type 2 diabetes at the 11th pharmaceutical reimbursement evaluation committee, are gaining momentum, giving strength to the justification for listing renal anemia treatment drugs. The reason why health authorities actively reviewed the adequacy of Kerendia's benefits was to reduce social costs. When chronic kidney disease progresses to end-stage renal failure, treatment progresses to hemodialysis, peritoneal dialysis, kidney transplantation, and surgery, which costs around 30 million won per year, which goes against public opinion to overcome this by actively intervening in drug therapy in the process. We are doing it together. AstraZeneca, JW Pharmaceutical, and Mitsubishidanabe obtained approval from the Ministry of Food and Drug Safety for tablet-type renal anemia treatments Evrenzo, Eronai Tablet, and Badanem in 2021, 2022, and 2023, respectively. These drugs are expected to have equivalent effects compared to injectable drugs and contribute to reducing health insurance costs but are still pending HIRA review As can be seen in the Kerendia case, tablet-type renal anemia treatments also require an emphasis on drug efficacy and cost-effectiveness and a quick reimbursement process is required. It is known that tablet-type renal anemia treatment drugs can achieve financial savings of about 10 to 20% compared to existing injection drugs, based on clinical data on anemia treatment in dialysis patients, even if patients with general kidney disease are excluded. Some are concerned about issues related to blood clots, but according to the industry, existing drugs appear to be in a similar situation, so it is almost a logical contradiction to use this as an issue to put a brake on drug price negotiations. The only treatment for renal anemia is EPO, which was developed about 30 years ago, and recently, even third-generation injectable drugs with extended administration intervals have been released. As the number of patients who do not respond to existing medications is gradually increasing, new treatment mechanisms are required due to side effects such as blood pressure changes and nausea and vomiting. It is understood that JW Pharmaceutical's Eronai and Mitsubishi Badanem are attempting to be listed at the average price among alternative drugs. AstraZeneca Evrenzo appears to have virtually suspended all proposals for PE and alternative drug weighted average prices based on the headquarters' high orphan drug price policy.
