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- 2026-05-18 10:21:17
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- Novartis applies for another gene therapy, Luxturna
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- Novartis has applied for the registration of insurance benefits for another new one-shot gene therapy drug. According to related industries, Novartis Korea recently submitted an application for benefits for the Inherited Retinal Dystrophy (IRD) treatment "Luxturna (Voregenene Neparvovec). Luxturna restores its function by replacing the deficiency and defective RPE65 gene, one of the causes of IRD, with a normal gene with just one administration. In other words, fundamental treatment of diseases is possible. The drug was designated by the U.S. FDA as a target for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained rapid approval in 2017. IRD is a rare refractory disease that causes visual loss due to mutations in genes responsible for retinal optic cell structures and functions. It contains more than 20 various eye diseases and has about 300 causative genes. IRD, caused by RPE65 gene mutation, causes abnormalities in the visual cycle in the retina that converts visual information into neural signals and transmits it to the brain. The RPE65 gene mutation can reduce the RPE65 protein essential for visual circuits and gradually narrow the field of view as retinal cells are destroyed, which can eventually lead to blindness. Kang Se-woong, chairman of The Korean Retina Society (Professor of Ophthalmology at Samsung Medical Center), said, "Luxturna can expect recovery to the extent that independent walking is possible without the help of a guardian with a single injection." Luxturna proved its effectiveness through phase 3 clinical trials conducted in patients with hereditary retinal disease whose double confrontational trait mutation of the RPE65 gene was confirmed. Clinical results show that the patient group who received Luxurna treatment at 1 year of treatment had statistically functional vision than the control group who did not receive treatment. It has improved significantly. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT) at the time of 1 year of treatment as a primary evaluation variable, the score change of the Luxturna treatment group was 1.8 points, 1.6 points higher than the control group's score change of 0.2 points. In the darkest 1lux (Lux), 65% (n=13/20) of the Luxturna treatment group reported the maximum improvement in MLMT scores, while none of the controls passed.
- Policy
- Keytruda·Tagrisso is in the process of expanding benefits
- by Lee, Hye-Kyung Oct 18, 2021 05:54am
- There was an opinion calling for expediting the expansion of the benefit standard for tumor-agnostic therapy. Independent lawmaker Lee Yong-ho said in a parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, "Benefits of Keytruda & Tagrisso have not expanded and are causing pain to patients," adding, "Keytruda's first lung cancer benefit has not been expanded for four years. I think many patients would have lived during that period." Han Hyun-ho, a clinical assistant professor at Yonsei University's urology department, who attended as a reference at the request of lawmaker Lee, demanded the urology benefit of Keytruda. Professor Han said, "Keytruda is an anticancer drug approved for tumor-agnostic therapy overseas," adding, "It can be used in patients with bladder cancer and prostate cancer in urology." In response to such criticism, Kim Sun-min, director of the HIRA said, "Keytruda is expensive and takes a lot of finance," adding, "We are also considering the cost-effectiveness of clinical sites." Director Kim said, "The HIRA is also being reviewed, and the term-agnostic therapy has set benefit standards and is in the process of follow-up procedures," adding, "We will quickly strengthen the coverage of cancer patients." However, he added that kidney cancer and bladder cancer have not yet received clear evidence based on the HIRA, so review will be conducted after clinical research is conducted.
- Policy
- “Impartiality of reimbursement review system undermined"
- by Lee, Jeong-Hwan Oct 18, 2021 05:54am
- HIRA president Sun-Min Kim (left) is answering to People Power Party member Jung-sook Suh’s inquiry (Pic provided by National Assembly Press Corps)The principal investigator of the clinical trial of lung cancer drug B participated in lung cancer A drug’s reimbursement assessment meeting. Isn’t this a conflict of interest and cause for the member’s exclusion from the committee?” (People Power Party Jung-sook Suh) “There are operational regulations set for the Cancer Disease Deliberation Committee, however, it is difficult to regulate the members’ participation in competitor drug’s clinical trials” (HIRA president Sun-Min Kim) Controversy over the fairness and expertise of the Health Insurance Review and Assessment Service and its Cancer Disease Deliberation Committee has risen in the course of providing health insurance benefits for non-small cell lung cancer treatments. The issue was that a professor of a medical school who is in charge of the clinical trial of lung cancer drug B, a competitor drug, had participated in the reimbursement review of the lung cancer drug A, which is a conflict of interest that undermines the impartiality of HIRA and the expertise of CDDC. On the criticism, HIRA’s president Sun-Min Kim expressed the service’s position that it would be difficult to exclude all professors who participated in clinical trials of competitors' drugs from the reimbursement reviews. NA member Jung-sook Suh of the People Power Party had inquired so to HIRA president Sun-Min Kim at the NHIS·HIRA’s NA audit on the 15th. Suh had pointed out that it is inappropriate for the principal investigator of a competing company to participate in the drug reimbursement review of its competitor drug. Suh's point of view was affected by the appeal made by a lung cancer patient group that visited the National Assembly to ask for the extended reimbursement of the lung cancer drug A. With lung cancer drug A failing to receive reimbursement for several years, some have been criticizing that this was an infringement of the patients’ right to accessibility. Currently, the lung cancer drug A has been approved for reimbursement as a second-line treatment and applied to extend its reimbursement to first-line. The competitor drug B is currently conducting clinical trials to assess its efficacy in the first line. Suh said that professor K, principal investigator of the clinical trial of lung cancer drug B, participating in lung cancer drug A’s reimbursement review raises the issue of fairness. The professor had participated in the Cancer Disease Deliberation Committee meeting in April that reviewed the reimbursement of lung cancer drug A as first line. Suh used the committee’s exclusion, recusal, and avoidance regulations to point out that the situation has greatly undermined the objectivity of the reimbursement review for lung cancer drug A. According to Article 13-2 of the Operating Regulations of the Cancer Disease Deliberation Committee, if a person who attends the committee and makes a statement is deemed not to be fair or objective due to family relations or personal and economic interest under the civil law, the committee shall refuse the participation and statement of the committee member. Seo said, “It is very inappropriate for the principal investigator of the competitor lung cancer drug B’s clinical trial, professor K, to participate and deliberate on lung cancer drug A’s first-line reimbursement. According to the Operating Regulations of the Cancer Disease Deliberation Committee, professor K should have refused to participate or provide an opinion on the matter. A serious and clear flaw in the committee’s operations have been revealed, and HIRA should explain why this has happened and come up with measures to prevent recurrence “ While expressing some agreement to Suh’s argument, HIRA president Sun-min Kim expressed the service’s position that it would be difficult to regulate the member’s participation in other drugs’ clinical trials as exclusion criteria in the operating regulations. Kim said, “Operating Regulations for the Cancer Disease Deliberation Committee does exist, however, it is difficult to regulate the members’ participation in competitor drug’s clinical trials.”
- Policy
- Introduction of CDF for Zolgensma was proposed
- by Lee, Hye-Kyung Oct 18, 2021 05:54am
- When the National Assembly proposed the introduction of the Cancer Drugs Fund (CDF) for Zolgensma, the NHIS accepted the beginning of the discussion. Rep. Kim Sung-joo of the Democratic Party of Korea said in a parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, "There was a story of a new drug worth 2.5 billion won per time, but patients are losing valuable time because of pharmaceutical companies and the government trying to cut drug prices." "An alternative approach is needed to this issue," he said. Rep. Kim said, "I think a new fund is needed if there is no agreement between the parties." He said, "I want to propose an anticancer drug fund like the UK. I also know that a bill has been proposed for pharmaceutical companies, the government, and private foundations to pay for treatments that have been proven cost-effective in health insurance. "I want to ask what the chairman thinks," he asked. In this regard, Chairman Kim Yong-ik said, "CDF seems to be an important proposal," adding, "As of now, there is no discussion, so there is nothing good or bad about it." "I will say that we should open the beginning of the discussion," he said.
- Company
- Bayer·Viatris·Pfizer settles in new locations
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- News of multinational pharmaceutical companies’ relocations continue. According to industry sources, Korean subsidiaries of multinational pharmaceutical companies including Bayer, Viatris, and Pfizer have decided on their new offices and are working on relocation projects. Bayer Korea, which had been located in Boramae, Dongjak-Ku for a long period of time, will move to Yeouido next month (in November). Bayer’s new company building will be located in Yeoido’s hot place, Parc1 Tower. With the relocation, the company’s new headquarters will become a smart office with improved transport access, which was one of the disadvantages of the existing office building. Yeoido has risen as a strategic core in the pharmaceutical industry since 2018 when Novartis Korea has moved into the IFC building. With Bayer’s relocation, a total of 4 pharmaceutical companies – Bayer Korea, Biogen Korea, Alvogen Korea, and Novartis Korea – will be in Yeoido. Viatris Korea, a spinoff of Pfizer Korea, has confirmed its relocation to the Grand Central Tower near the Seoul Station earlier next year. Viatris had been using the shared office ‘FAST FIVE Myeong-dong’ as a temporary office from August until the end of this year. Viatris plans to actively reflect the various experiences it accumulated in the shared office to establish a smart working environment in the new headquarters so that employees can work at ease. At FAST FIVE Myeong-dong, employees were able to choose from the open space where they can perform individual tasks, one-person independent space for virtual meetings, and meeting space for 2-3 to 10 or more people, to meet the employee’s individual needs. After selling Myeongdong’s landmark Pfizer Tower at ₩112 billion, Pfizer opted to maintain its geographic legacy. The company sold its building to GRE Partners 15 months after the building was put on sale. After discussing various options, the company had decided on Namsan State Tower as its new home and plans to move in next year. The new office is located within a walking distance of the existing Pfizer Tower and will be moving into the new building in the second half of next year. Meanwhile, new Korean subsidies of multinational pharmaceutical companies are being established this year. The promising Chinese pharmaceutical company ‘BeiGene’ established a new subsidiary in Korea, and Moderna, one of the COVID-19 vaccine developers, has also registered its corporation and is awaiting launch in Korea.
- Policy
- The HIRA also decided to disclose the results of Kymriah
- by Lee, Hye-Kyung Oct 15, 2021 05:58am
- The HIRA has decided to disclose the results of the drug benefit assessment. Although the entire evaluation process required by citizens, patient organizations, and the pharmaceutical industry is not disclosed in detail, it has decided to clearly disclose the establishment of benefit standards and appropriateness of benefits. The HIRA released the "7th Severe Cancer Drugs Benefit Appraisal Committee's deliberation results" at 6:23 p.m. on the 13th, and distributed a press reference to Kymriah deliberated at the Cancer Drugs Benefit Appraisal Committee at 10:46 p.m. The results of the Cancer Drugs Benefit Appraisal Committee deliberation include the items applied for the medical care benefit decision, pharmaceutical companies, efficacy and effect, deliberation results and expanded benefit standards. It is similar to the scope of disclosure of the results of the Drug Reimbursement Evaluation Committee review, which has been released since June 2017. Following the Drug Reimbursement Evaluation Committee, the HIRA decided to distribute the results of the Cancer Drugs Benefit Appraisal Committee deliberation on the media and website in the form of press references after the end of each month's meeting. Kim Ae-ryeon, head of the drug management office, said, "There have been demands for disclosure of the results of the Severe Cancer Drugs Benefit Appraisal Committee, and some unwanted pharmaceutical companies have been curious about expensive drugs and discussed with the Cancer Drugs Benefit Appraisal Committee." Regarding the press reference related to Kymriah, she said, "In addition to setting the benefit standard, Kymriah's reference data were exceptionally released." She said, "It was also dealt with in this parliamentary audit, and there were several issues. It won't come out continuously." The HIRA is considering the timing of distribution of press reference materials. Like the Drug Reimbursement Evaluation Committee, it was also scheduled to distribute press references the morning after the meeting. However, due to the issue drugs such as Kymriah, it announced that it would be distributed after 6 p.m. on the 13th, shortly after the end of the meeting, and distributed to reporters immediately after the monthly meeting. In this regard, Director Kim said, "We will need to consider the timing of distributing the press reference materials of the Drug Reimbursement Evaluation Committee and the Cancer Drugs Benefit Appraisal Committee," and added, "We will review the timing after the parliamentary audit and finalize it."
- Policy
- Requests for confirmation of medical expenses, disclosed
- by Lee, Hye-Kyung Oct 15, 2021 05:57am
- After Avastin receiving the indication of macular degeneration, a patient who paid at his own expense requested confirmation of medical expenses, but the non-reimubrsed cases was justified. The HIRA released a case of requesting confirmation of non-reimbursed medical expenses in the third quarter. Patients can check the details of medical expenses on the HIRA's website and request confirmation of medical expenses if they pay for the benefits as non-reimbursement. In the case of Avastin, as a result of the HIRA confirmation, it was confirmed that the medical institution applied for approval for non-reimbursement use after IRB deliberation. When prescribed and administered to patients beyond the scope of the MFDS' permission, non-reimbursement can be used after IRB deliberation. In the case of Leuplin, it was decided that there was no refund for calculating the full amount of patient copayment. According to the MOHW's notice, medical benefits are recognized when ▲ girls are 9 years old (8 years and 365 days), and boys are 10 years old (9 years and 365 days), ▲ secondary puberty stage 2 or higher and bone age increases from that age, and ▲ the maximum concentration is 5 IU/L or more as the sulfur-forming hormone (LH) increases 2-3 times the basal value in the stimulation test of GnRH (renewal gland stimulation hormone). However, in the case of patients who received a request for confirmation of medical expenses, it was decided that pt would pay the full amount beyond the benefit standard because she was a 10-year-old girl. A refund decision was made on antibody tests to confirm antibody production after COVID-19 vaccination. The COVID-19 antibody test conducted for health examination purposes was paid as non-reimbursement to confirm medical expenses, because the COVID-19 antibody test conducted without an application for a new medical technology decision cannot be collected as non-reimbursement cannot be applied. Request was made to confirm medical expenses for emergency medical management fees, sedation endoscopy patient management fees, human tube locks, synthetic gauze dressing, ultrasonography, MRI, breast surgery, and liposuction.
- Company
- Rediscovery of Clopidogrel brings back generic boom
- by Kim, Jin-Gu Oct 15, 2021 05:57am
- Picture of Plavix, a clopidogrel original Development of generics using ‘clopidogrel,’ an antiplatelet drug, is regaining momentum. A company that already owned a clopidogrel generic has released a new dose product in 16 years. And the generic companies have been showing positive responses after the effect of clopidogrel was reilluminated in a study on stent-inserted patients, raising expectations that competition in clopidogrel will intensify again in the future. According to industry sources on the 13th, 13 bioequivalence tests on clopidogrel were approved just this year, 9 of which were approved after May this year. Compared to the average of 4.3 cases that were approved in the 3 years from 2018 to 2020, the number of tests increased significantly. Currently, 145 single compound clopidogrel products are approved in Korea. Most of the approvals were concentrated between 2005 and 2007. Around 40 products including Handok’s ‘Plavix,’ and Samjin’s ‘Platless’ were approved in this period. Since then, approvals continued sporadically until the second wave of approvals rushed in 2012-2013. A total of 35 items were approved during the period. And the atrial fibrillation prevention indication was added at the end of 2011, and the release of the aspirin combination has also increased approval of the single-ingredient clopidogrel. In addition, one of the reasons why bioequivalence tests are increasing for clopidogrel this year is because of the study results that were released last May. In May, Hyo-Soo Kim, Professor of Cardiology at the Seoul National University Hospital, presented the results of his study on patients who had undergone percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) comparing aspirin vs. clopidogrel as an antiplatelet agent. Professor Kim had directly compared the effect of clopidogrel and aspirin as a long-term maintenance therapy on patients who underwent PCI with a dual antiplatelet therapy (DAPT) regimen for 6 to 18 months. The study was conducted for 2 years in 37 hospitals in Korea, on 5,500 patients who underwent PCI. The results, which confirmed that clopidogrel is superior to aspirin, gained attention as all existing major treatment guidelines recommended aspirin as maintenance therapy after PCI. Professor Kim announced the results above at ACC 2021. As around 70,000-80,000 patients receive PCIs every year, and clopidogrel demonstrated a superior effect in Korean patients compared with aspirin, the front-line pharmaceutical companies have been positively responding to the study results. In fact, 9 of the 13 clopidogrel bioequivalence tests newly approved this year were submitted after the study was presented. And industry sources believe Samjin Pharmaceutical’s recent release of the high-dose product is not unrelated to the study results as well. Samjin Pharmaceutical was the first to release a 300mg clopidogrel product on the 12th. This was the first product line extension made by the company, 16 years after the 75mg dose was approved. Only 75mg products including the original are currently approved in Korea. However, the inconvenience of the ACS patients needing to take 4 tablets as the initial loading dose before receiving PCI was pointed out. The high-dose Platless that was released recently has improved this convenience with a single tablet, once-daily dose. An industry official said, “The clopidogrel ingredient treatment market has been continuously growing for the 20 years since its release with the popularization of PCIs. Also, with the latest study results demonstrating that clopidogrel is superior to aspirin as a long-term maintenance therapy, the competition in the clopidogrel treatment market will continue to intensify in the future.” According to the market research institution UBIST, the clopidogrel market last year sold ₩360 billion. In the market, the original Plavix was prescribed the most with ₩91.6 billion. Among the generics, Samjin’s Platless sold ₩61.2 billion, and Chong Kun Dang’s Pregrel sold ₩25.8 billion last year.
- Policy
- A new drug preferential law will be promoted
- by Lee, Jeong-Hwan Oct 15, 2021 05:57am
- The MOHW announced that it will start enacting subordinate laws to substantially implement and secure the effectiveness of the "clause for preferential treatment of new domestic drugs" developed by innovative pharmaceutical companies under the Special Act on the Pharmaceutical Industry. The "upper limit price preferential treatment of drugs" stipulated in Article 17-2 of the Special Act on the Pharmaceutical Industry was newly established on December 11, 2018, but criticism has been raised as the Presidential Decree and enforcement regulations have not been created for nearly three years. On the 12th, the MOHW responded to individual written inquiries from Rep. Nam In-soon of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee. Rep. Nam asked why, background, and cause sub-laws related to the preferential provisions for new drugs developed in Korea, including Article 17-2 of the Pharmaceutical Industry Act, have not been made for years. The pharmaceutical preferential provisions in the Pharmaceutical Industry Act are of great interest not only in the National Assembly but also in the domestic pharmaceutical industry. Domestic pharmaceutical companies say that they need a system that recognizes drug prices higher when pharmaceutical companies selected as innovative pharmaceutical companies make new drugs in Korea to promote their willingness to develop new drugs in Korea. Domestic companies are calling for the MOHW to show some preferential treatment in terms of follow-up management of drug prices if it fails to create subordinate laws due to concerns over trade friction with foreign countries such as the United States. The intention is that the introduction of measures such as delaying the start of PVA negotiations or limiting the number of times will provide an environment that actually favors the price of new domestic drugs without having to think about ordinary problems. An official from pharmaceutical company A, which owns a new domestic drug, said, "The drug price depends on the first registration after development and post-marketing follow-up management.""If it is difficult to give preferential treatment to drugs when registering as a normal problem, if we give preferential treatment to new domestic drugs during follow-up management such as PVA, the system will be effective without any problems," he said. An official from Company A added, "If the start of follow-up management such as PVA is delayed further, the follow-up price will be applied after the new domestic drug has sufficiently established itself in the Korean market. I think it is one of the ways to realize the system's goals without ordinary friction. Rep. Nam In-soon, who sympathized with the domestic pharmaceutical industry's position, also pointed out the responsibility for the situation to the MOHW and urged for improvement. In particular, Rep. Nam presented an example in which foreign countries provide drug preferential treatment for locally approved new drugs. According to data submitted by the MOHW to Rep. Nam, in Japan, 10-20% is applied to new drugs that were first approved prior to other countries. In addition, in Japan, 5-20% of new drugs that explicitly contain dosages for children are subject to additional calculation. However, if there is no clinical result that includes Japanese children in the country, the relevant addition is excluded. Taiwan is applying an additional 10% to new drugs that have conducted clinical trials on a certain scale or larger that have proven their effectiveness in the country. The MOHW plans to consult with related agencies such as the KPBMA regarding the absence of subordinate laws and regulations under the Pharmaceutical Industry Act. Regarding the reason for not enacting subordinate laws for more than two years, the MOHW explained that it had no choice but to be cautious because it could lead to trade disputes with foreign countries. In addition, the MOHW says that some preferential measures are already being implemented for generics and biosimilars made by innovative pharmaceutical companies.The MOHW adds the first one-year drug price to innovative pharmaceutical companies when applying insurance after developing generic products based on "drug decision and adjustment standards." An additional rate of 68% for innovative pharmaceutical companies and 59.5% for other pharmaceutical companies were set. The MOHW said, "On December 11, 2018, a provision for preferential drug treatment for innovative pharmaceutical companies was prepared under the Special Act on the Pharmaceutical Industry." It said, "However, drug treatment for certain companies can lead to trade disputes with foreign countries, so careful review is necessary." It said, "The global innovative drug preferential system, which favored drug prices developed by innovative pharmaceutical companies, has been excluded from the FTA revision negotiations between Korea and the U.S.," adding, "There are no sub-laws for domestic new drugs, but some preferential treatment such as generic and biosimilars are being implemented." The MOHW then promised, "We will consult with related agencies to review drug support measures, including the enactment of subordinate laws, so that innovative pharmaceutical companies can be supported while avoiding trade friction in the future."
- Company
- ‘Ibrance’ opens new horizon as the lead CDK4/6 inhibitor
- by Oct 14, 2021 05:38am
- The breast cancer treatment ‘Ibrance (palbociclib)’ was what established Pfizer Korea as the ‘anticancer drug power’ in Korea. The company had other excellent anticancer drugs such as ‘Xalkori,’ and ‘Sutene,’ but none had received as much spotlight as Ibrance. As the ‘first CDK4/6 inhibitor,’ and ‘the first new breast cancer drug in 50 years,’ Ibrance had quickly rose to the ranks and became a blockbuster drug. ◆ The first CDK4/6 inhibitor, unrivaled status despite controversy Ibrance selectively inhibits Cyclin-dependent kinases (CDK) 4/6 that regulate cell division and cell growth to block the proliferation of tumor cells. Lilly’s Verzenio (abemaciclib),’ and Novartis’s ‘Kisqali (ribociclib)’ belong to CDK4/6 inhibitor class drugs. Among these drugs, Ibrance is the first drug in its class, the ‘first-in-class’ CDK 4/6 inhibitor. Ibrance is indicated for the treatment of breast cancer in combination with an aromatase inhibitor as first-line endocrine therapy in postmenopausal women or combination with fulvestrant in pre-and post-menopausal women with disease progression following endocrine therapy. For a year Ibrance was launched in Korea in August 2016, the field was full of expectations, disappointment, longing, and appeals. The introduction of a new drug with a new mechanism of action was blissful news. In particular, the patient population for Ibrance was wider than other drugs, as it targeted f hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. These patients had to use anti-hormonal drugs such as aromatase inhibitors or chemotherapy, which had many systemic side effects if not managed until Ibrance appeared. Before the introduction of Ibrance, this patient group had to use antihormonal therapy such as aromatase inhibitors, and if their condition was not managed with such therapies, use chemotherapy, which had many systemic side effects Korea was the fifth country to approve the drug. In December of the same year, the drug's efficacy and safety in Asian patients were verified through a clinical trial and rose as the drug that could change the breast cancer treatment paradigm. The National Comprehensive Cancer Network’s ‘Category 1’ recommendation of CDK4/6 inhibitors as combination therapy for the treatment of HR+/HER2- advanced/metastatic breast cancer had also contributed greatly to establishing the drug as standard care in breast cancer. However, Ibrance did not immediately rise and become the star after its release. The drug had suffered receiving reimbursement due to its high drug price, costing over ₩5 million per month. In particular, 2017 was the time when many high-price anticancer drugs were introduced and rejected reimbursement, and Pfizer Korea was put at a difficult price due to its difficulty in demonstrating cost-effectiveness, and the issue that Ibrance was more expensive in Korea than abroad. The Health Insurance Review and Assessment Service recognized Ibrance’s feasibility of reimbursement in July 2017, after rounds of review. However, the approval left much to be desired among patients because the reimbursement was only allowed as first-line endocrine therapy in postmenopausal women in combination with letrozole. Its use as second-line therapy in combination with fulvestrant was non-reimbursed, and premenopausal patients, which are much more prevalent in the East than in the West, were unable to receive the reimbursement benefit at all. The 2nd-line reimbursement of Ibrance+fulvestrant was only approved last July, 4 years after Ibrance’s approval. In addition, the fact that the drug was reimbursed at the same time with the CDK4/6 class latecomer Verzenio, left much to be desired for Ibrance. However still, Ibrance is fully exerting its strength as the ‘first’ introduced to its market. Among the three products in the CDK4/6 market, Ibrance has been dominating the market as the second drug, Verzenio, was approved in Korea three years later than Ibrance, in May 2019. The third CDK4/6 inhibitor Kisqali was approved 5 months after Verzenio, in October 2019 and listed for reimbursement in November last year. 자료: 아이큐비아 Ibrance raised annual sales of ₩40 billion in three years in the competitor-free market. According to the market research institution IQVIA, sales of Ibrance, which was ₩6.6 billion in 2017, surged 283% in 2018 to reach ₩25.3 billion after being listed for reimbursement. Then, sales rose 73% again to record ₩43.7 billion in 2019. Last year, Ibrance sold around ₩60 billion and is expected to sell near ₩70 billion this year. Compared to Ibrance’s quarterly sales, which is around ₩15 billion, Verzenio’s sold ₩3 billion, and Kisqali sold mid-₩1 billion range. ◆Three-way competition starts now… data will decide the winner With all three products now approved for reimbursement, the competition is finally in full pace. Of course, the other two drugs have a long way to go because they need to break down the solid position held by Ibrance in the market. Therefore, the latecomer drugs are betting in areas where Ibrance has not reached, as preoccupying new areas is easier than breaking down Ibrance's established position. The attempt will also support the expansion of the overall CDK4/6 inhibitor market amid the increased introduction of new-class drugs. One of the areas being targeted is early breast cancer. Despite its strength in metastatic breast cancer, Ibrance did not show as a good result in early breast cancer. In both the PALLAS study that tested Ibrance+endoctrine therapy as adjuvant therapy in hormone receptor-positive (HR+)/HER-2 negative (HER2-) metastatic breast cancer and the PENELOPE-B study that tested Ibrance+endoctrine therapy after neoadjuvant chemotherapy, Ibrance did not show a difference in invasive disease-free survival (iDFS) compared to placebo (primary endpoint). Pfizer believed the high early discontinuation rate due to the strict dose restriction and the short period of administration had an effect. On the other hand, Verzenio achieved its primary endpoint in a median follow-up period of 15.5 months as adjuvant therapy, suggesting the potential for scope expansion. Of course, whether using CDK4/6 inhibitor as adjuvant therapy in early breast cancer patients is more beneficial, remains a question that needs to be addressed. Kisqali can be used in combination with an aromatase inhibitor as first-line endocrine therapy in pre/perimenopausal women that cannot use Ibrance, and therefore may resolve the unmet needs of Ibrance. Also, Kisqali has demonstrated the longest overall survival period among all drugs, threatening Ibrance’s sole lead in the market.
