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- 2026-05-08 04:16:54
- Opinion
- [Reporter's view] When will Enhertu's benefit be available?
- by Jul 31, 2023 05:29am
- Daiichi Sankyo and AstraZeneca's Enhertu are continuing their unstoppable moves. Enhertu, which has achieved remarkable results in breast cancer, has expanded the types of carcinoma to include gastric cancer and lung cancer and is expected to be used in a number of solid cancers that show HER2 expression, such as cervical cancer, endometrial cancer, and ovarian cancer. Several ADCs have been approved, but none have been as scalable as Enhertu. Indeed, Enhertu is writing ADC history. The phase 2 results for Enhertu announced at ASCO 2023 in June were very positive. Although it was not at a stage that deserved a standing ovation like last year's announcement of low-expression breast cancer of HER2, this announcement raises the possibility that Enhertu will be reborn as an anti-cancer drug regardless of cancer type. The Enhertu DESTINY-PanTumor02 clinical trial announced at ASCO was a study that examined the effects of Enhertu by forming a cohort of cervical cancer, endometrial cancer, ovarian cancer, bile duct cancer, pancreatic cancer, bladder cancer, and other solid cancers without a control group. For each cohort, 40 patients were recruited and Enhertu was administered. ORR was set as the primary evaluation index, and DOR, DCR, PFS, OS, and safety were established as secondary evaluation indexes. What is noteworthy is the response rate that Enhertu showed. It recorded a response rate of 50% or more in cervical cancer and endometrial cancer. In particular, the response rate for endometrial cancer reached 57.5%. Seven out of 40 endometrial cancer patients (17.5%) showed complete remission (CR) and 16 (40%) showed partial response (PR). At 12 weeks, 80% (32 patients) of endometrial cancer patients had their disease under control. In conclusion, Enhertu recorded a response rate of 30% or more in all cancer types studied, except for pancreatic cancer, which had a response rate of only 4%, and biliary tract cancer, which had a relatively low response rate of 22%. About a month later, on the 27th, additional analysis results of DESTINY-PanTumor02 were announced. In summary, Enhertu demonstrated improvement in PFS and OS, which were set as secondary evaluation indicators. Follow-up clinical trials should be supported, but it is clear that Enhertu is rapidly taking off as an anti-cancer drug regardless of cancer type. Domestic patients looking at Enhertu's rapid development were very distressed. Although approved, access to treatment is low due to non-reimbursement. Enhertu is an oasis for patients not only in breast cancer but also in gastric cancer where new drug options are limited. Daiichi Sankyo's commitment to Enhertu's fast benefit was also quite large. It is known that several measures were prepared, such as offering the drug price at the lowest price in the world and considering additional RSA. Patients urged Enhertu's speedy reimbursement listing. The national consent petition for this was so supportive that it obtained the consent of 50,000 people last February. The health authorities seem to be paying attention to Enhertu's benefit, as if conscious of public opinion. It can be seen from the fact that even when the review committee was first eliminated, it was concluded through a re-examination rather than not setting a standard. Considering the time it takes for a new drug to be registered for reimbursement in Korea, Enhertu's reimbursement process is fast. Currently, Enhertu has passed the cancer disease review committee after re-examination and is undergoing a PE review. However, it is unclear when it will be presented to the pharmaceutical reimbursement evaluation committee, which is in the final stage. Patients are anxiously awaiting news of the assumption. In about two months, it will be a year since Enhertu was approved in Korea. Even after passing the Drug Evaluation Committee, all procedures for insurance coverage are completed only after drug price negotiations with the NHIS and the health insurance policy deliberation committee of the Ministry of Health and Welfare. By the end of the year, after Enhertu's first global launch, it will take 48 months to receive benefits in Korea, exceeding the OECD average of 45 months. We hope that patients' wait for Enhertu will not be too long.
- Policy
- Bill proposed to allow Kymriah’s use at transplant hospital
- by Kim, Jung-Ju Jul 31, 2023 05:28am
- A bill was proposed to amend the law and improve patient access to Novartis’s Kymirah, the ultra-high-priced ‘one-shot drug,’ by realistically amending the requirements for institutions that use the drug. The main point of the amendment is to allow hematopoietic stem cell transplant institutions designated as transplant hospitals to provide Kymriah treatment. Rep. Young Woo Lee of the Democratic Party of Korea proposed the bill for the ‘Partial Amendment to the Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products’ that contained the proposal above on the 27th. Kymriah was approved in March 2021 as the world’s first chimeric antigen receptor T-cell (CAR-T) therapy and the first advanced biopharmaceutical under the ‘Advanced Regenerative Bio Act.' With the enactment of the Act, the Ministry of Food and Drug Safety classified Kymriah as a biodrug and stipulated the medical institutions that seek to use Kymriah to receive a permit for a human cell management business under the newly implemented ‘Advanced Regenerative Bio Act.’ However, to receive the permit, the law requires the institution to be equipped with a GMP facility that meets the pharmaceutical manufacturing management standards. Rep. Lee pointed out that the irony lies in how medical institutions that seek to use Kymriah for treatment only ‘draw, extract, and freeze’ the patient’s blood to send to Novartis. Lee criticized that requiring treatment institutions to have pharmaceutical manufacturing facilities is wasteful and unnecessary as the institutions are not in charge of making the drug itself. Due to such limitations, only the 5 large hospitals in Seoul - the ‘Big 5 Hospitals’ of Korea - were permitted to use Kymriah. Due to this restriction, patients living in rural areas had to come all the way to Seoul to receive treatment. The amendment aims to reduce the patient's suffering and waste and alleviate the concentration of medical care in the metropolitan area by allowing hematopoietic stem cell transplantation institutions designated as ‘transplant hospitals’ under Article 25 of the Organs Transplant Act to use Kymriah for treatment. In addition to Rep. Young Woo Lee, the bill was jointly proposed by Rep. Young In Ko, Ju Young Kim, Gab Seok Song, Soo Jin Lee, Sung Ho Jung, Il Young Chung, Pil Mo Jung, Oseop Jo, and Jung Min Hong.
- Company
- Equipped with two new drugs this year alone
- by Jul 31, 2023 05:28am
- Janssen challenges with a new mechanism, BMS widening the gap with maintenance therapy Janssen has added a new drug for multiple myeloma in Korea. This is the second permit this year. It is noteworthy whether Janssen will change the multiple myeloma market where BMS dominates with Celgene. On the 26th, the Ministry of Food and Drug Safety approved Janssen’s Tecvayli as a fourth or higher treatment. Tecvayli is indicated for use as monotherapy in adult patients with relapsed or refractory multiple myeloma who have received at least three lines of therapy, including proteasome inhibitors, immunosuppressants, and anti-CD38 monoclonal antibodies. Tecvayli is Korea's first multiple myeloma bispecific antibody. It double-targets the B-cell maturation antigen (BCMA), which is overexpressed on multiple myeloma cells, and the CD3 receptor, which is expressed on the surface of T cells. When this antibody binds to BCMA and CD3, lysis and death of BCMA-expressing myeloma cells are induced by activated T cells. The study that served as the basis for Tecvayli's approval was the MajesTEC-1 study, a phase 1/2 clinical trial. As a result of evaluating efficacy in 165 patients, Tecvayli recorded an ORR of 63% in patients who failed 3 or more treatments. 32.7% of patients presented with sCR. The number of patients with CR and VGPR was also 6.7% and 19.4%, respectively. The average time from the administration of Tecvayli to the first response was 1.2 months. The response lasted 18.4 months. Janssen's aggressive move in multiple myeloma continues. Following the CAR-T treatment Kavicty in March, Tecvayli was installed with two new drugs this year alone. Kavicty is the second CAR-T treatment to appear in Korea. This is the first CAR-T with multiple myeloma as an indication. Unlike existing multiple myeloma treatments, Kavicty inserts genetic information capable of recognizing BCMA into the patient's immune cells and then injects these T cells back into the patient's body. Initially, Kavicty was approved for use as a fifth-line or higher treatment, and the number of patients for which it could be used was very limited. Recently, a new clinical presentation prepared the basis for expanding the scope. These are the results of the phase 3 clinical CARTITUDE-4 study presented at ASCO 2023 held in June. In this clinical trial, standard therapy PVd (Pomalidomide + Bortezomib + Dexamethasone) or DPd (Daratumumab + Pomalidomide + Dexamethasone) was administered to 419 patients with relapsed/Lenalidomide-refractory multiple myeloma who had previously received first- or third-line treatment. Compared to Kavicty. Clinical results showed that Kavicty lowered the risk of disease progression or death by 74% compared to standard therapy. In the primary endpoint, progression-free survival, the Cavikti group recorded 76%. The control group was 49%. The control group's median PFS was recorded at 11.8 months, whereas the Kavicty group had not yet reached the median. As a result of the sub-analysis according to the treatment order, Kavicty proved its potential as a second to fourth-line treatment by improving progression-free survival regardless of the treatment order. Tecvayli, approved this month, is considered a promising global blockbuster. Clarivate, a global academic information service company, predicted earlier this year that Tecvayli will record estimated sales of $1.8 billion (2.2363 trillion won) in 2031. However, as competition in the multiple myeloma treatment market is fierce, the report said that Tecvayli needs to think about ways to increase its utilization if it wants to become a blockbuster new drug. Accordingly, Janssen is seeking a new combination therapy using Tecvayli. It is a method of using it in combination with Talquetamab, a new bispecific antibody drug that has not yet been approved in Korea. Unlike Tecvayli, which simultaneously targets BCMA and CD3, Talquetamab is a novel mechanism that inhibits both GPRC5D protein and CD3 expressed on the surface of specific cancer cells. At the last ASCO, data from phase 1b clinical trials evaluating the combination therapy of the two drugs were also announced. Janssen is trying to transform the multiple myeloma market by adding two new drugs with new mechanisms following the existing drugs, Darzalex and Velcade. Several pharmaceutical companies in Korea are selling multiple myeloma treatments, but BMS is by far the strongest player at this point. BMS has significantly strengthened its multiple myeloma pipeline by acquiring Celgene, which owns Velcade and Pomalyst. The BMS-Celgene acquisition, which took place in 2019, was of an unprecedented scale and was considered the most significant M&A case in the global pharmaceutical industry. At that time, the amount invested by BMS to acquire Celgene amounted to about 83 trillion won. According to IQVIA, a pharmaceutical market research institute, Revlimide has the highest annual sales of 38.6 billion won among domestic multiple myeloma treatments. Amgen's Kyprolis ranked second with 34.5 billion won in sales. Sales of Janssen's Darzalex and Velcade recorded 21.2 billion won and 10.4 billion won, respectively. Darzalex is showing rapid growth but remains in third place. Janssen plans to change the treatment landscape with a new drug with a new mechanism. To this end, efforts are in full swing to raise the treatment order of new drugs to the front stage. The variable is the maintenance regimen of Revlimide. Revlimide, which was the first-line treatment, is widening the gap by moving to maintenance therapy, which is a more advanced treatment. In January of this year, maintenance therapy was also listed on the list of insurance benefits, showing a growing trend. Revlimide sales in the first quarter were 10.4 billion won, up 14% from the previous year.
- Company
- Handok will sell original insulin drug Lantus
- by Lee, Tak-Sun Jul 31, 2023 05:28am
- Handok, which had previously stopped selling the insulin biosimilar ‘Glarzia (insulin glargine)', will be marketing and distributing the original insulin 'Lantus' from the 1st of next month. Whether the company will be able to expand its presence in the diabetes treatment market with the original product based on the know-how in insulin sales it had accumulated selling Glarzia is gaining attention. According to industry sources on the 28th, Handok will be in charge of the marketing and sales of Lantus Injection Solostar and Lantus Injection Vial that is being imported and marketed by Sanofi-Aventis Korea from August 1st. Lantus is a long-acting insulin injected once a day. As the current leading product in Korea, the product posted sales of KRW 20.2 billion last year (IQVIA). However, the drug has come down from its unrivaled position after the introduction of its biosimilars in 2016. Currently, the Lantus biosimilars Lilly's ‘Basaglar Kwik Pen’ and GC Biopharma’s ‘Glarzia Prefilled Pen' are available in Korea. Among the two biosimilars, Glarzia, which was developed by Indian drugmaker Biocon, has been sold by Handok in Korea in co-partnership with GC Biopharma since its release in 2018. The company’s agreement with GC Biopharma ended in June, leaving a gap in its sales of insulin products. Since then, Dongkook Pharmaceutical has been in charge of sales and distribution of Glarzia. However, the company closed its sales gap in only 2 months. Handok will start selling the original Lantus from August 1st and is expected to further increase the company's presence in the insulin market. Handok has a strong presence in the diabetes market selling diabetes treatments and consumables such as Amaryl and Tenelia. The industry expects the addition of the original Lantus to the lineup to further strengthen the company’s position in the field. Even though Lantus biosimilars were introduced to the market, their sales are not high yet. Based on the IQVIA report, Glarzia sold KRW 1.1 billion, Basaglar KRW 0.4 billion last year.
- Company
- Reimb of Bayer’s new heart failure drug Verquvo imminent
- by Eo, Yun-Ho Jul 31, 2023 05:28am
- The new heart failure drug ‘Verquvo’ is expected to be reimbursed in Korea soon. According to industry sources, Bayer Korea’s soluble Guanylate Cyclase (sGC) stimulator ‘Verquvo (Vericiguat)’ has essentially completed drug pricing negotiations with the National Health Insurance Service. Therefore, the drug is expected to be listed for reimbursement in Korea soon. Verquvo was approved in December 2021 as a combination therapy used to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The efficacy of the drug was demonstrated through the Phase III VICTORIA trial. The trial was conducted on a total of 5,050 adult patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) and left ventricular ejection fraction (LVEF) less than 45%, following a worsening heart failure event were enrolled in the trial. A worsening heart failure event was defined as heart failure hospitalization or the use of outpatient IV diuretics for heart failure prior to randomization. 59.7% of the participants had been receiving 3-drug combination therapy, and 41% were severe patients - NYHA Class III or NYHA Class IV. In the trial, patients received up to the target maintenance dose of Verquovo 10 mg or a matching placebo combination with another heart failure therapy. 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 than that of the placebo group, and the trial met its primary efficacy endpoint with an annual absolute risk reduction of 4.2%. The annual absolute risk reduction of hospitalization from heart failure was 3.2%, and compared with placebo, it delivered a 10% relative risk reduction in composite cardiovascular-related death and heart failure hospitalization. Previous heart failure treatments worked by blocking harmful effects caused by natural neurohormones that were activated by myocardial and vascular dysfunction. Unlike these existing options, Verquovo is a sGC stimulator that catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP) that modulates heart contraction, vascular tension, cardiac remodeling, etc. The drug is a first-in-class drug, the first sGC stimulator in the world that was approved as a treatment for chronic heart failure.
- Policy
- Re-evaluation of the upper limit amt, scheduled for August
- by Lee, Tak-Sun Jul 31, 2023 05:27am
- The final result of the re-evaluation of the upper limit amount standard requirement will be presented as an agenda for the Pharmaceutical Reimbursement Evaluation Committee to be held on August 3. It is expected that negotiations with NHIS will proceed in earnest after the submission of the committee. The results of the re-evaluation of the adequacy of this year's benefits are expected to be presented in September. According to HIRA and the industry on the 28th, the committee meeting on the 3rd of next month will review the final result of the re-evaluation of the upper limit amount standard. This is the final review following the first review in May. HIRA notified pharmaceutical companies of the results after the first review by the review committee in May. After that, the final result will go to the committee on the 3rd of next month after the appeal. This is about two months behind the original plan to reflect drug price adjustment through re-evaluation in July. This is because data submissions were rushed all at once in February, and more than 1,000 objections came out after the first evaluation. After this committee is over, the NHIS is expected to hold negotiations with pharmaceutical companies regarding supply for the month of August. It is expected that the re-evaluation results will be reported to the health policy review committee in August, and the drug price adjustment plan will be reflected in the reimbursement list on September 1. The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the drug has met its own BA test and DMF listing criteria for already-listed drugs. The upper limit is maintained if both BA and DMF requirements are met, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%. Currently, the first evaluation of 14,000 items is underway, and the second round of about 5,000 drugs will begin in earnest after submitting data in July. The re-evaluation of the adequacy of wages this year is expected to be somewhat delayed due to the re-evaluation of the maximum amount. The original plan was to submit the re-evaluation results to the Drug Evaluation Committee in August, but it is likely to be presented in September at the earliest. This year, the target item for re-evaluation of benefit adequacy is peptic ulcer medicine Rebamipide, a drug for the circulatory system Limaprost Alfadex, an antipyretic, analgesic, anti-inflammatory drug Loxoprofen Sodium, a drug for the digestive system Levosulpiride, a drug for allergy Epinastine Hydrochloride, an ophthalmic hyaluronic acid eye drop. Among them, hyaluronic acid eye drops are the largest with a market size of 231.5 billion won (3-year average billing amount). Next, the pharmaceutical industry is paying attention to the results of the re-evaluation of the adequacy of reimbursement for these drugs.
- Company
- Erleada can be prescribed at tertiary hospitals in KOR
- by Eo, Yun-Ho Jul 28, 2023 05:30am
- The new prostate cancer drug Erleada has landed in general hospitals in Korea. According to industry sources, Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) has passed the drug committee (DC) review at the Big 5 tertiary hospitals in Korea, - Samsung Medical Center, Seoul National University Hospital, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, and Sinchon Severance Hospital – and its prescription code has been already inserted into 60 medical institutions nationwide. The drug has seemingly quickly settled in the prescription market after it was listed for reimbursement in April. Erleada is an androgen receptor-targeted agent (ARTA) that is in the same class and a follow-up to ‘Zytiga (abiraterone)’ and ‘Xtandi (enzalutamide).’ The drug demonstrated its safety and efficacy in the Phase III TITAN trial in 1,052 patients with mHSPC. Despite the fact that about 40% of the patients assigned to the placebo group continued treatment with Erleada during the study, the risk of death in the Erleada group was 35% lower than that of the placebo group. Overall survival (OS) at 48 months was 65% in the Erleada group and 52% in the placebo group. Also, when excluding the effect of patients who switched medication from the placebo group to Erleada, the risk of death in the Erleada group was 48% lower than that of the placebo group. Meanwhile, according to the National Cancer Registration Statistics Program, the number of patients diagnosed with prostate cancer in 2020 was 16,815, ranking third in men following lung cancer (19,657) and stomach cancer in (17,869). The number surpassed that of colorectal cancer (16,485). In addition, among the 5 major male cancers (lung cancer, stomach cancer, prostate cancer, colorectal cancer, and liver cancer), only the rate of prostate cancer has been increasing, and at an annual average rate of over 5%.
- Policy
- Janssen’s MM drug Tecvayli Inj is approved in KOR
- by Lee, Hye-Kyung Jul 28, 2023 05:30am
- On the 26th, the Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) approved ‘Tecvayli Inj (teclistamab),’ a rare disease drug used to treat multiple myeloma. Tecvayli is used in adult patients with relapsed and refractory multiple myeloma who have received at least three previous lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Tecvayli is a bispecific antibody that binds to the B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells. Tecvayli binds to BCMA and CD3 and induces myeloma cell death via activation of T cells. BCMA is a cell surface protein that is selectively induced during plasma cell differentiation. It is an ideal target for plasma cell cancer (multiple myeloma). The MFDS stressed that it will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.
- InterView
- ‘Leclaza can occupy 50% of mkt if used as combination'
- by Jung, Sae-Im Jul 28, 2023 05:30am
- Yuhan Corp’s Leclaza (lazertinib) was the first homegrown new drug to be approved as a first-line treatment for EGFR mutation-positive non-small-cell lung cancer. The industry’s eyes are now on how the drug will fare in the global market. Will Leclaza be able to rise as a new contender to AstraZeneca’s ‘Tagrisso (osimertinib)’ that is dominating the global market? The key lies in the clinical results of 'MARIPOSA', which is being conducted by Janssen. The Phase III MARIPOSA study directly targets the current first-line standard-of-care Tagrisso with Janssen’s ‘Rybrevant (amivantamab)’ and Leclaza combination. If the Rybrevant+Leclaza combination demonstrates a progression-free survival (PFS) superior to that of Tagrisso, this could bring major change to the current treatment environment. The interim results of MARIPOSA phase 3 are expected to be presented at the European Society for Oncology (ESMO) Congress 2023 which will be held in October. “If the MARIPOSA trial ends a success, third-generation options for the first-line treatment of EGFR-mutation-positive NSCLC will increase to 3 (Tagrisso, Rybrevant+Leclaza, Leclaza). I think it's very significant that two-thirds of the options include the use of Leclaza." Professor Byoung-Chul Cho (Medical Oncology, Yonsei Cancer Center) and Professor Ki Hyeong Lee (Hemato-Oncology, Chungbuk National University Hospital) Professor Byoung-Chul Cho (Medical Oncology, Yonsei Cancer Center) and Professor Ki Hyeong Lee (Hemato-Oncology, Chungbuk National University Hospital) met with the reporter at the LASER Symposium that was held on the 22nd for medical oncologists and relayed their anticipation on Leclaza’s potential as a global new drug. According to clinicaltrials.gov, a registry and results database of clinical studies, the MARIPOSA study divided 1,074 patients around the world into three treatment arms. Treatment Arm A will receive Rybrevant+Leclaza and Arm B and C will each receive Tagrisso and Leclaza as monotherapy. The study seeks to demonstrate that the Rybrevant+Leclaza combination therapy is superior to Tagrisso. Tagrisso has settled as the global standard of care with progression-free survival (PFS) of 19 months when used in the first-line. Therefore, achieving a statistically significant superiority will be very difficult. Conversely, if the clinical trial produces good results, it would also be that much of a game-changer. Professor Cho said, “The standard for statistical significance was set quite high in the clinical trial that compared Rybrevant+Leclaza and Tagrisso. I have high expectations for the study because I believe the cancer treatment paradigm will shift from the use of monotherapy to combination therapies. After the results of the MARIPOS clinical trial are presented, the company will sequentially start its approval process in the US. If approved, two of the three options in the field will include the use of Leclaza, and simple arithmetic can tell us that the drug can occupy up to 70% of the market share. "This will have a significant impact on prescriptions," he predicted. Although it is not the main point of the trial, the study may also serve as an opportunity to recognize the effect of Leclaza once again as it also evaluates Leclaza and Tagrisso as monotherapy in one trial. Leclaza demonstrated a long progression-free survival of 20.6 months in the global Phase III LASER301 trial that was presented last year. Although this is longer than what Tagrisso had achieved in its Phase III trial, the two are not directly comparable due to the different patient groups enrolled in each study. The MARIPOSA study includes Tagrisso and Leclaza monotherapy arms, which allows for the efficacy between the two to be examined. Professor Lee said, “I want to know if the results from the LASER301 clinical trial and its subgroup analysis will show consistently in the MARIPOSA study. If we see positive results in that trial, it would be an opportunity for HCPs to recognize the efficacy of Leclaza. If successful, I believe Leclaza would be able to take over 50% of the market.” Tagrisso is also seeking to expand its indication through the FLAURA2 trial, which examined Tagrisso’s use in combination with chemotherapy. The combination obtained statistically significant top-line results recently and will announce the results in the second half of the year. However, the professors believe the FLAURA2 trial will not cause a major change in the current treatment landscape. Professor Cho held the 1st generation gefitinib+chemotherapy combination in the past as an example. The combination had shown a significant improvement in overall survival (OS), and a related paper was published in the Journal of Clinical Oncology (JCO) published by the American Society of Clinical Oncology (ASCO) and also listed in international guidelines. However, no one has been actually prescribing this combination on-site. Cho added, “Those who have experience dealing with a lot of EGFR mutations are confident that they can achieve the same results with monotherapy without adding chemotherapy. Adding chemotherapy is effective with immunotherapy, but the situation is different in EGFR-mutation-positive NSCLC, as we are already achieving high response rates with targeted therapies alone. The MARIPOSA trial is at another level compared with the FLAURA2 trial.” Professor Lee said, “Chemotherapy not only brings side effects, but I'm just personally not sure if it works. I think chemotherapy will disappear from the market in the future. With the advent of targeted therapy, there is no reason for us to go back and use chemotherapy, so it is difficult to understand why we should consider using it again even as a combination.”
- Policy
- Maintenance of grounds for original drug price
- by Kim, Jung-Ju Jul 27, 2023 05:40am
- The government will establish a legal basis so that the insurance price of the original drug can be reduced ex officio when a generic of an original drug whose patent has expired is listed on the drug reimbursement list. It is interpreted that they are trying to respond to pharmaceutical companies by preparing a clear basis for the ex officio adjustment drug price lawsuits that arise every time. The Ministry of Health and Welfare made a legislative announcement on the 26th and announced the implementation date of the 'Partial Amendment Decree of the Rules on the Standards of National Health Insurance Medical Care Benefit' with this content. The government is lowering the price of the original drug through an ex officio adjustment when the patent of the original drug expires and generic drugs are to receive insurance benefits to compete with it. However, as patent disputes with generic development companies heated up, there were many cases where lawsuits for suspension of execution, which neutralized the government's ex officio coordination, were filed together, so there was a need to prepare a legal basis. In response, the government decided to clearly establish the basis for 'whether a drug is eligible for medical care benefit and the disposition of ex officio adjustment of the upper limit amount' determined and announced by the Minister of Health and Welfare under the Health Insurance Act. This will have the effect of strengthening the legal basis for pharmaceutical companies to respond head-on when they file a drug price lawsuit against the Ministry of Health and Welfare in the future. This amendment is a follow-up measure to reorganize detailed regulations as Article 41-3 (5) of the Health Insurance Act was prepared. The government plans to implement both the detailed revision of the Health Insurance Act and sub-statutes related to this from November 20th.
