- LOGIN
- MemberShip
- 2026-05-19 03:41:38
- Company
- Will BMS's 'Revlimid' be reimbursed as RVd therapy?
- by Eo, Yun-Ho Nov 11, 2021 06:01am
- Whether the multiple myeloma treatment ‘Revlimid’ will succeed in expanding reimbursement to its use in RVd therapy is gaining attention. According to industry sources, reimbursement of Revlimid (lenalidomide) for RVd therapy (Lenalidomide + bortezomib + dexamethasone) passed the Health Insurance Review and Assessment Services’ Cancer Disease Deliberation Committee review in September and is awaiting deliberation by the Pharmaceutical Benefits Appraisal Committee. The agenda is expected to be presented for PBAC deliberation in December. In Korea, the standard first-line therapy for multiple myeloma under reimbursement includes VMP (bortezomib+ melphalan+ prednisolone) and Rd (lenalidomie+dexamethasone) in patients who are not eligible for stem cell transplants, and VTd (bortezomib+thalidomide+dexamethasone) for patients eligible for stem cell transplants. However, the 5-year relative survival rate of multiple myeloma patients in Korea remains in the 40% range. RVD therapy is recommended as a priority in the first-line treatment of multiple myeloma in the US NCCN guidelines and EHA-ESMO guidelines. According to HIRA, among the 8,929 patients in Korea who were treated for multiple myeloma in 2020 (diagnosis code: C90, multiple myeloma, and malignant plasma cell neoplasms), 47% were over the age of 70 and were ineligible for transplant under the reimbursement standards. Elderly patients over the age of 70 have limited treatment options as they have difficulty receiving stem cell transplants, raising the demand for RVd reimbursement. Seok-Jin Kim, Professor of Hematology-Oncology at the Samsung Medical Center, said, “Treatment of multiple myeloma requires multiple considerations from the medical aspect as well as in the patient’s condition, treatment sequence, reimbursement conditions, etc. Both the patients and us HCPs will welcome a treatment option with a promising prognosis that can be used freely without reimbursement restrictions." He added, “I hope reimbursement for multiple myeloma treatments is extended to cover RVd therapy, maintenance therapy after autologous hematopoietic stem cell transplant, and R2 in follicular lymphoma to benefit more patients.” In a Phase III clinical trial, RVd therapy significantly extended PFS (progression-free survival) and OS (overall survival) compared to Rd therapy in patients with newly diagnosed multiple myeloma that are ineligible for stem cell transplant. In a network meta-analysis that assessed the relative efficacy of MM drugs used in newly diagnosed patients that are ineligible for stem cell transplant, RVd demonstrated significant extension in PFS and OS over Rd, and Rd over VMP.
- Product
- Claiming a more expensive drug than a generic
- by Kim JiEun Nov 11, 2021 06:00am
- Pharmacist A, who did not give a follow-up notice of general submission and charged for a drug that was more expensive than an alternative drug, filed a lawsuit claiming that it was an unfair disposition, but the court refused to accept it. The Seoul Northern District Court recently dismissed a claim filed by pharmacist A against the NHIS for the return of unfair gains. Pharmacist A did not notify the doctor after generic substitution of the drug from the MOHW in 2016, and was suspended for 50 days, claiming that the NHIS was unfairly paid about 34 million won. Afterwards, the NHIS disposed of the collection of about 34 million won in unfair claims through notification of the results of the on-site investigation by the MOHW. Since then, it has been executed in a way that deducts medical care benefits to be paid to pharmacies operated by pharmacist A. After the disposition, pharmacist A filed a lawsuit with the Seoul Administrative Court, and in 2018, the pharmacist won the case. For this reason, the court explained, "Some of the periods under investigation lack proof of the reasons for disposition, but the illegal parts of the disposition cannot be clearly distinguished, and some of the facts that were the basis for discretionary judgment are not recognized, forcing cancellation of all relevant dispositions." Immediately after that, the MOHW appealed to the Seoul High Court, but the pharmacist's victory was confirmed. Based on the ruling, the pharmacist filed a lawsuit against the corporation to recover unfair profits. Since the related disposition of the MOHW was canceled through administrative litigation, the disposition of the corporation, which recovered 34 million won in the name of unfair claims based on the same reason, is also illegal, so the recovered amount must be returned. However, the court did not accept it. It noted the reason why the court, which ruled in the previous ruling to cancel the administrative disposition of the MOHW, revealed it. The court explained that just because the MOHW's disposition was canceled, there was no reason to cancel the separate disposition, the NHIS' redemption measure, saying it was unfair. The court said, "The reason for canceling the disposition in an administrative lawsuit against the cancellation of the disposition of the MOHW is that there is a lack of proof of facts regarding 'part' of the reasons for the disposition." As a lack of proof of some of the reasons for disposition, it falls under the case where the presence or absence of the defect is revealed only when the facts are accurately investigated. It is difficult to say that the defect in the disposition of this case has reached a significant and obvious degree, it said. He then said, "It is a separate and independent disposition based on a separate provision of the (former) National Health Insurance Act, even though the facts and the previous disposition of the MOHW are common." The court said, "Even if the related disposition is canceled, the NHIS cannot be ordered to return the disposition because the degree of defect in separate disposition has not naturally reached invalidity. The pharmacist's claim is dismissed for no reason, it said.
- Policy
- Controversy rise over standards used in pricing negotiations
- by Moon, sung-ho Nov 11, 2021 06:00am
- “It may seem cruel for the smaller pharmaceutical companies, but it is important.” The National Health Insurance Services is expected to consider the ‘marketing and sales’ ability of pharmaceutical companies as a major criterion in estimating the ‘expected claims amount’ of the companies, which is an essential part in drug pricing negotiations. In other words, such abilities will be a major consideration in judging the ‘market share rate’ of drugs subject to negotiations. As marketing and sales abilities inevitably correspond to the size of the companies, controversy over this criterion will be inevitable in the future. # The NHIS held an online briefing session on ‘Guidelines for setting the expected claims amount’ for front-line pharmaceutical companies and explained the specifics of its implementation. The NHIS guideline could be considered as the standard used by the NHIS in setting the expected claims amount of a drug during pricing negotiations, a process that is mostly conducted for new drugs. The guideline will serve as a guide that shows what data is used to calculate the expected market size, growth, and share of a drug, depending on whether the drug has an alternative available, and how the expected claims amount is set. In the drug negotiation process, the NHIS had been continuously criticized for conducting ‘negotiations in the dark.’ The guideline is interpreted as the authorities’ groundwork to dispel such concerns and conduct transparent negotiations. The key item of focus among pharmaceutical companies was the method NHIS used to estimate the ‘market share’ of the drug subject to negotiation. This is because the NHIS will be estimating the market size and growth rate with predictable data such as the NHI claims data, claims amount, and the number of patients, but will reflect the characteristics of pharmaceutical companies to estimate the market share of the drug subject to negotiations. The ‘characteristics’ part of the pharmaceutical companies was designed so that the marketing and sales power of the companies will affect the results. In other words, marketing for the subject drugs and the number of sales representatives will be used to judge the expected market share of the drug, and this number could influence the drug pricing negotiations. Therefore, the NHIS said that the pharmaceutical companies will have to submit data on doctor surveys, hospital drug committee (DC) approval status, number of client clinics and hospitals, major pipeline, number of sales representatives, number of marketing PMs, and whether a domestic trial was conducted in the process of drug pricing negotiations. Se Rim Oh, Head of Team in the NHIS’s New Drug Management Division, said, “It may seem brutal for the smaller pharmaceutical companies, but new drug development requires more than just will. We need to be level in this aspect. Developing a new drug and future occupation of the market both require money.” Oh said, “Submitting a survey on doctors or data on the number of PMs or sales representatives at your company will help estimate the claims amount during the negotiation process. Even a small pharmaceutical company that has an excellent pipeline in its field and has enough clients, the aspects will be fully considered in our estimates.” In addition, the NHIS said that data from domestic claims companies may be used as a reference when the authorities estimate the total market size of the drug subject to pricing negotiations. However, this only applies when domestic or foreign data on the drug is virtually nonexistent. Some pharmaceutical companies have been submitting claims data from domestic pharmaceutical research institutions for support during the negotiation process, however, such data is not expected to be much help. Oh said, “NHIS’s claims data is more accurate than UBIST and IQVIA combined. However, we will consider using such data when identifying the market size. We may consider using the data if the domestic data or the NHIS claims data we have is limited.”
- Company
- What do scholars refer to as effective tx for myeloma?
- by Nov 11, 2021 06:00am
- With the release of various new drugs over the past decade, treatment results for multiple myeloma have been gradually improving. This is because as options vary, opportunities for "customized treatment" to select drugs depending on patients expand. Professor Eom Hyun-seok (left) and Professor Kwee Yong (right) who are conducting video talks Medical staff's attention is focused on which patients should be used to maximize the effectiveness. In particular, third-drug therapy centered on second-generation proteasome inhibitors (PI) is a trend in patients with first recurrence. As KRd therapy (Carfilzomib+ Revlimid +Dexamethasone) centered on Kyprolis and IRd therapy (Ixazomib+Revlimid+Dexamethason) centered on Ninlaro compete, the process of identifying appropriate drug choices considering drug characteristics and patient conditions continues. Takeda held an academic conference between British and Korean medical staff on the treatment of recurrent and refractory multiple myeloma according to patient characteristics such as disease risk and cytogenetic high-risk groups. Eom Hyun-seok, director of the National Cancer Center Hospital (Professor of Hematology and Oncology), an authority in the field of blood cancer, and Kwee Yong, a professor at University College London, participated in the meeting. Professor Eom Hyun-seok: What are the guidelines for selecting IRd and KRd as secondary therapies for patients with recurrent and refractory multiple myeloma? Professor Kwee Yong: Proteasome inhibitor and Lenalidomide combination therapy are very good methods in secondary treatment. Most patients will reach a therapeutic response with this combination therapy. The issue is which one to choose between IRd and KRd. The risk of the disease is first identified, and then whether it recurred early or aggressive. If the disease is aggressive and recurs early, has extra-bone marrow lesions, has high M protein levels, and the disease progresses quickly, KRd should be selected. However, patients should be young and able to visit the hospital every week. It is a very intensive treatment. On the contrary, if the condition is not aggressive and recurrence is not carried out early, so the progressive survival period (PFS) is at least 18 to 24 months, IRd will be selected. It is a fairly comfortable treatment for patients in many aspects. The side effects of KRd's Kyprolis require more careful attention. In particular, they have a history of heart disease or kidney damage. Professor Eom Hyun-seok: If so, can high-risk groups be classified into KRd according to the patient's risk and IRd if it is a general risk? Professor Kwee Yong: There is no clear standard. This is because IRd responses are very good even in patients who are genetically at high risk. If we have to make a distinction, the aggression of the disease, the pace of disease progression, and the burden of the disease will be more consistent. Professor Eom Hyun-seok: How do you see the use of IRd in multiple myeloma with advanced extra-bone marrow lesions? Professor Kwee Yong: Treatment is very difficult when extra-bone marrow lesions have progressed. In terms of experience, even if the reaction appeared, it did not last very long. I will choose a combination treatment based on proteasome inhibitors and IMiD, an immunomodulatory anticancer drug. Even when extra-bone marrow lesions progressed, there were cases in which the response was very good with IRd treatment. Professor Eom Hyun-seok: In the case of early recurrence, there may be characteristics of high-risk groups, and if the response appears slowly while presenting the case, the duration of the reaction will be extended. Is there anything additional to say about the reaction time and timing of recurrence? Professor Kwee Yong: First of all, I would like to tell you that there is not only one type of high risk of disease. Some high-risk factors speed up disease progression and respond quickly. Some patients with chromosome defects 17 are thought to have a single opposing genetic effect. The important thing is that treatment should be maintained. If treatment is stopped, it does not work. In some high-risk patients, such as chromosome 1 acquisition or chromosome 17 defect, it takes a long time to respond, but if treatment continues, it will be maintained well. Professor Eom Hyun-seok: In the case of the high-risk patients, it is important to continue treatment. Professor Kwee Yong: So the advantage of IRd is that it can continue to treat proteasomes inhibitors. It is difficult in VRd or KRd. Professor Eom Hyun-seok: Another part is about clinical practice. There are a variety of important clinical trials related to secondary treatment, which are slightly different from real world data, so you should be careful in interpreting these data. Professor Kwee Yong: There are several clinical trials and the number of previous treatments varies from one to three. However, most of the large-scale clinical trials were conducted before Lenalidomide was widely used. These clinical trials are not very useful these days because the proportion of patients exposed to lenalidomide was small and they were not refractory to lenalidomide. This is especially true if the patient has already received lenalidomide treatment. Clinical trials have shown good results for Renalidomide three-drug therapy such as Daratumab-Lenalidomide-Dexamethason, KRd, and IRd. However, when looking at the meta-analysis data, the margin benefit is similar. In addition, these clinical trials exclude many patients with poor performance data, patients with renal dysfunction, and patients with low platelet levels that we meet at the clinic every day. Professor Eom Hyun-seok: In Real World, it is very important whether the drug resistance or treatment continues. For patients, discontinuation of treatment is not the best, but I think excellent drug resistance is one of the biggest advantages of IRd.
- Policy
- RWD & RWE will be important means of use in post-evaluation
- by Kim, Jung-Ju Nov 11, 2021 06:00am
- Limited replacement is appropriate as a means of supplementing proven RC The quality of the site, which will be the standard, such as standardization of medical records at hospitals where data will be calculated. The task of government insurance authorities and the private sector is to increase patient access to very expensive and innovative new drugs, in other words, to make benefit entry smoother and faster. The government, the National Assembly, and the pharmaceutical community continue to consider revitalizing related systems such as the "the approval-benefit linkage system" and "post-registration evaluation," but the emergence of ultra-high-priced drugs cannot be covered by our evidence-based insurance system. The RWD and the work of processing it as RWE, and the movement and discussion to further systematize the evaluation area after the approach by reflecting the results in the policy are important. However, when this mechanism is actively used, there are many tasks to be prepared in the future, such as eliminating concerns about other harsh regulations or affecting all new drugs in the current system with RCT, and standardizing detailed standards in domestic clinical sites, which are one of private medical institutions. Several panels participated in the Innovation Research Symposium hosted by the HIRA on the 4th. Standards should be prepared at the level of field practice such as detailed standards, and guidelines. Like Kymriah, the emergence of ultra-high-priced drugs makes it possible to predict the future trend direction of new drug development and insurance-listed drugs. Therefore, it is clear that RWD and RWE will be important means of use in post-evaluation to enhance patient access and coverage when second, third, and fourth drugs challenge benefits one after another. On the premise of this justification, panels agree that detailed practical standards such as qualitative standardization and data collection at the current level and different medical records of private medical institutions should be established. Taking the case of Kymriah as an example, Bang Young-joo, an honorary professor at Seoul National University (CEO of Bang & Ock Consulting), said, "Kymriah is a drug that cannot be waited until 1,000 clinical patients are recruited. Since clinical characteristics and recruitment limits are different for each drug, we need to prepare a sample size setting standard. Park Jong-heon, head of the big data operation office at the NHIS, also mentioned the importance of setting practical standards through cases. When the corporation conducted a post-evaluation study of immuno-cancer drugs in the past, it conducted a study by linking health insurance-clinical data, and each hospital had different methods of providing data and doctors. Director Park said, "There are enough laws in place. However, he said, "I think it is necessary to form a sufficient consensus on the importance of RWD and RWE," and emphasized, "Since related guidelines have not been made, micro-linked methods and practical discussions such as standardization are needed." "Another regulation following RCT, limited use" vs "flexibility to enter benefits may be secured" The industry and the government's position on RWD and RWE was quite different. This could be an opportunity to make the hurdle barrier more flexible in the long run, as it is essential for the post-evaluation of ultra-high-priced drugs with high uncertainty, and questions about whether the new drug must be reevaluated as RWD's base production even after entering the benefit. First, Kim Joon-soo, chairman of the KRPIA Policy Committee, mentioned the case that Nice in the UK also prefers RCT and uses RWD limitedly if additional data are required when uncertainty is high in terms of cost effectiveness, such as anticancer drugs and rare disease treatments. Chairman Kim also stressed, "RCT is designed under the condition of pre-blocking for intermediate variables, so RWE is based on daily data, so it is not high in terms of reliability and low in level of evidence due to various environmental conditions and influencing variables." Lee Eun-young, director of Korea alliance of patients organization, said, "RCT is designed to be licensed and registered with data, but I know that RWE has emerged because the design and clinical results do not match at the clinical site. In addition, the government emphasized the justification for application. The government, which has introduced high-priced drugs into salaries, needs to look back on whether they were of appropriate value and reasonable cost afterwards. Choi Kyung-ho, an insurance drug officer at the MOHW, said, "Even if RCT is appropriate, I think RWE is necessary when registering ultra-high-priced drugs like Kymriah."
- Policy
- The MFDS consulted on Expedite Approval of COVID-19 PO
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- The MFDS announced that it is conducting consultations with the company for rapid domestic approval on overseas developed COVID-19 oral treatments on the verge of commercialization. In the case of Molnupiravir, an oral treatment for MSD, the government plans to gradually introduce 404,000 people through a pre-purchase contract in February next year, which is expected to speed up discussions on the introduction of overseas COVID-19 treatments in Korea. Kim Mi-jung, head of the pharmaceutical standards division at the MFDS, briefly met with reporters at Osong on the afternoon of the 9th and made the announcement. Kim said, "In the case of oral treatments of MSD and Pfizer, we are conducting consultations on the scope and schedule of data submission for Expedite Approval," and explained, "However, actual data are not received." Kim added, "In principle, we plan to conduct safety, effectiveness, and quality screening for COVID-19 treatments," adding, "We plan to review them quickly when data are received." Prior to this, Kang Sung-sik, vice president of Pfizer Pharmaceutical's medical department, said at the 2021 Pfizer Press University held online on the 8th, "We are in close consultation with regulatory authorities including the MFDS." Paxlovid is expected to show that the hospitalization and death rate decreased by 89% compared to placebo when taken within three days of symptom onset as a result of interim analysis of phase 2 and 3 released on the 5th. MSD's oral treatment, which the government declared in February next year, also reduced the risk of hospitalization and death by about 50% as a result of a phase 3 interim analysis. Britain approved Molnupiravir, for the first time in the world on the 4th. As Korea promised to introduce it in February, it is expected to speed up its approval review. However, if the submission of data is delayed, it is highly likely to be introduced in Korea through procedures such as Expedite Approval. Kim said at a briefing that day, "Since the enforcement of the Data Limitation Act in July, the submission of a biological equivalence test plan has increased 2.5 times more than usual." Kim said, "If next year's result report is submitted, the MFDS will have more work." In addition, Kim said that she established a "comprehensive evaluation team for constant evaluation of impurities" consisting of about 20 people to prepare impurity evaluation technologies through information sharing with overseas regulators, as well as determine the cause. However, she added that there are no additional impurity issues other than the three Sartan types, which were decided to be recovered due to impurities in Azido in September. She is also considering recruiting about 50 people due to the expansion of overall permit screening work.
- Opinion
- [Reporter’s View] Verify the oral COVID-19 treatments
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- Following COVID-19 vaccines, oral COVID-19 treatments are also expected to enter the market soon as the government plans to phase in 404,000 courses of COVID-19 oral antivirals from next February. If oral treatments for COVID-19 are introduced, Korea will have laid the groundwork for managing the COVID-19 virus like influenza. Also, clinical results for COVID-19 treatment candidates are being announced one after another. MSD's 'molnupiravir' was found to reduce the risk of hospitalization and death by 50% if taken within 5 days of symptom onset. Pfizer also released clinical results showing that ‘Paxlovid’ reduces the risk of hospitalization and death by 89% if taken within 3 days of symptom onset, and by 85% if taken within 5 days of symptom onset. The movement to introduce the drugs has also been speeding up abroad. On the 4th, the UK became the world’s first country to approve molnupiravir. The US FDA also plans to review the use of molnupiravir at the end of this month. The treatment is also set to be introduced in Korea from February through an advance purchase agreement. The faster the treatments are introduced the better, considering how late we were in introducing and commercializing vaccines compared to other countries at the end of last year. With legislation such as the Emergency Use Authorization established for the prompt introduction of such treatments, we will need to thoroughly prepare so that the oral antivirals developed abroad can promptly be imported for use in Korea. In addition to such prompt introduction, we would also need to pay close attention to and verify the oral treatments in advance so that the drugs may be safely used in Korean patients. This is a task for the Ministry of Food and Drug Safety. As the government announced that it will introduce COVId-19 treatments in February, the MFDS does not have much time for review. Therefore, MFDS would need to independently conduct its review and thoroughly verify the safety of the treatment in the limited time provided rather than rely on news of approvals from agencies abroad to reassure the public. In other words, now is the time for the government to take initiative. The government should proactively search for and persuade pharmaceutical companies to promptly introduce their COVID-19 treatments to Korea even if they have no plan to introduce the drugs to Korea yet. The reality is that Korea will have to depend on COVID-19 treatments developed overseas, just like the case was for the vaccines. Rather than focus on the commercialization of domestic COVID-19 treatments, the government should fully mobilize its administrative power to promptly introduce new COVID-19 treatments developed overseas.
- Company
- Expectations rise for Rinvoq in treating severe AD
- by Nov 10, 2021 05:55am
- A second JAK inhibitor has been introduced to the field of moderate-to-severe atopic dermatitis treatment. Abbvie’s ‘Rinvoq (upadacitinib),’ with its double advantage in improved convenience and effect, is heralding new change in the field of AD treatment. Rinvoq was additionally approved for the atopic dermatitis indication on the 6th last month by the Ministry of Food and Drug Safety. With the approval, Rinvoq is now approved for patients with moderate-to-severe atopic dermatitis in adults and adolescents over the age of 12. Rinvoq became the second JAK inhibitor after ‘Olumiant’ to be approved for atopic dermatitis. Also, the addition of Rinvoq increased the number of options for AD to three – the biological drug ‘Dupixent,’ and JAK inhibitors Rinvoq and Olumiant – in an area where no new drug had been introduced for a long period of time. ◆Dupixent’ targets specific cytokines – ‘Rinvoq’ provides broader inhibition Numerous inflammatory mediators are entangled like a web in atopic dermatitis, and Dupixent and the JAK inhibitor Rinvoq treat atopic dermatitis with different mechanisms of action. Dupixent selectively and potently inhibits IL-4 and IL-13, the key and central drivers of the type 2 inflammation that causes atopic dermatitis. It provides a higher effect by targeting specific cytokines, but also may not be effective in some patients. On the other hand, JAK inhibitors including Rinvoq provide broader cytokine inhibition. Cytokines bind to the cell surface receptors to deliver signals through the JAK-STAT and other signaling pathways, and JAK inhibitors target the JAK enzymes that command the protein that plays a pivotal role in immune/inflammatory regulation. Among the JAK enzymes, Rinvoq specifically targets JAK1, which not only includes IL-4 and IL-13, but also is involved in various other cytokines including the itch-specific cytokine IL-31, keratin-involved TSLP, IL-22 that thickens the skin, and interferon-gamma. ▲ Yong-hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine This mechanism of action is how RInvoq was able to show immediate effect in such a short period of time. At the RInvoq press conference that was held on the 9th, Yong-Hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine, said, “Inhibiting only IL-4 and IL-13 cannot be a complete solution to atopic dermatitis, as the immunopathological mechanism of atopic dermatitis is very complex, and manifests differently by race or age. The introduction of Rinvoq has resolved this unmet need.” Also, another difference between the two drugs that arise from the differences in mechanisms is in their method of administration. The biologic Dupixent is an injection and JAK inhibitors like RInovq are small molecule inhibitors that can be taken orally. Rinvoq can be a more convenient option for patients who have difficulty making regular visits to hospitals for injections. Oral drugs also have the advantage of allowing easier dosage adjustments fit for each patients’ condition. ◆Rises among JAK inhibitors with its superior data… achieves convenience in administration and effect Another advantage of Rinvoq is its excellent clinical data. In Phase III studies that compared RInvoq with placebo (Measure Up1, Measure Up2, AD Up), 60~70% of patients who received Rinvoq achieved EASI75 (at least a 75% improvement in the Eczema Area Severity Index) at Week 16. The proportion was 70-80% in patients who receive a higher dose (30mg). Also, 42-53% (higher dose 58-66%) achieved EASI90 (at least 90% improvement). Also, RInvoq significantly reduced itching, the symptom patients find most difficult to bear, in about half of the patients. 42~53% (Worst Pruritus improvement≥4) The results were more positive than the data from Olumiant, where about half of phase 3 participants reached EASI75. In addition, Rinvoq also demonstrated superior efficacy and safety in a head-to-head trial compared to Dupixent, which has the sole lead in treating moderate-to-severe atopic dermatitis. In the 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group ▲ Dong-hoon Lee, Professor of Dermatology at Seoul National University HospitalAlso, recently updated analysis data shows that switching from dupilumab to RInvoq had shown significant improvement. Dong-hoon Lee, Lee of Dermatology at Seoul National University Hospital, said, “Both the patients who showed response or no response to dupilumab showed significant improvement when switching from dupilumab to Rinvoq at Week 24 or later. And the effect continued until Week 52. The significant improvement in skin clearance and itching reduction even after switching was notable.”
- Policy
- The National Assembly speeds up the telemedicine bill
- by Lee, Jeong-Hwan Nov 10, 2021 05:55am
- With the government declaring a phased COVID-19, the National Assembly's Health and Welfare Committee is speeding up its review of amendments to the medical law, which temporarily introduces non-face-to-face treatment. The Welfare Committee plans to propose two amendments to the medical law aimed at legislating telemedicine at the plenary session to be held on the 11th and discuss whether to review the bill subcommittee. There are a total of two telemedicine bills proposed by the National Assembly: Kang Byeongwon of the Democratic Party of Korea and Choi Hye-young of the Democratic Party of Korea. Kang proposed the bill that telemedicine between doctors and patients is not allowed, but indirect medical practices such as non-face-to-face counseling are allowed through remote monitoring. Rep. Choi proposed a plan to allow telemedicine and non-face-to-face prescriptions and preparations only for vulnerable medical sites and vulnerable patients. The Welfare Committee is expected to complete the review of next year's budget by the MOHW, the MFDS, and the KCDA by the middle of this month, and immediately hold a subcommittee to review telemedicine bills. As the National Assembly speeds up telemedicine and non-face-to-face prescription and dispensing bills, related expert groups such as The KMA and the Korean Pharmaceutical Association are also paying keen attention to legislative trends. The KMA has formed a telemedicine response TF to start preparing countermeasures. The pharmaceutical society, which is set to hold the next pharmaceutical presidency election next month, has not formed a TF like the KMA, but is opposed to the legislation of telemedicine and non-face-to-face-to-face dispensing. The KMA, the KDA, and the Korean Pharmaceutical Association issued a joint statement last month and expressed regret over the revision of Kang Byeongwon and Choi Hye-young's medical bill. From the perspective of the pharmaceutical society, telemedicine legislation is a sensitive agenda in that it can promote the generalization of drug delivery and delivery platforms based on the activation of non-face-to-face dispensing. Kim Min-seok, chairman of the Welfare Committee, Kim Sung-joo, secretary of the Democratic Party, and Kang Ki-yoon, secretary of the People's Power, are coordinating the agenda of the subcommittee on bills.
- Company
- Ono's BTK inhibitor Velexbru was approved for sale
- by Nov 10, 2021 05:55am
- Onopharm (CEO Choi Ho-jin) announced on the 9th that it has received approval from the MFDS to sell BTK inhibitor Velexbrew as a monotherapy for patients with B cell-induced PCNSL. The first BTK inhibitor has emerged as a PCNSL treatment that has not yet been established. The basis for approval is the results of phase 1/2 clinical trials (ONO-4059-02) evaluating the efficacy and stability of Velexbrew in patients with recurrent or refractory PCNSL in Japan. The first efficacy evaluation index was ORR according to BICR. In this study, the ORR of the Velexbrew administered group was 52.9% (9/17 patients). The main side effects of grades 3 and 4 included neutropenia, leukopenia, and hyperneutral lipidemia, respectively, and 11.8% (2/17 patients).
