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- 2026-05-08 01:10:32
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- Bridge Biotherapeutics applies to FDA for the phase 1/2 plan
- by Mar 29, 2023 06:02am
- Bridge BiotherapeuticsBridge Biotherapeutics announced on the 27th that it had applied to the FDA for a phase 1/2 clinical trial plan for 'BBT-207', a 4th generation non-small cell lung cancer drug candidate. BBT207 is a new drug candidate that targets the C797S mutation that can occur after using third-generation non-small cell lung cancer treatments such as Tagrisso. Bridge Biotherapeutics plans to conduct clinical trials at 15 to 20 institutions in the US and Korea when the phase 1/2 clinical trial plan is approved. This clinical trial is a study to evaluate the safety, pharmacokinetic/pharmacodynamic properties, and efficacy of BBT-207 in patients with advanced non-small cell lung cancer with EGFR mutation after EGFR TKI treatment. The dosage will be increased through a phase 1/2 study targeting 112 patients, and an appropriate phase 2 dose will be explored. Capacity expansion will follow. Bridge Biotherapeutics plans to attend AACR on the 18th (local time) and present the preclinical data of BBT-207 as a poster. Based on the results of additional animal experiments, the company plans to publish data related to antitumor efficacy, survival rate improvement in brain metastasis animal models, and brain metastasis inhibitory activity, which study the potential of BBT-207 for targeted treatment for C797S-positive mutations.
- Company
- TB treatment Dovprela lands in general hospitals in Korea
- by Eo, Yun-Ho Mar 29, 2023 06:02am
- ‘Dovprela,’ the first new drug introduced in the field of tuberculosis in half a century can now be prescribed at general hospitals in Korea. Viatris Korea's multidrug-resistant tuberculosis treatment Dobprela (pretomanid) passed the Drug Committees (DCs) of Seoul National University Hospital and Seoul Asan Medical Center. Dovprela, which was first approved in September 2019 in the US and in October 2021 in Korea, is indicated in combination with bedaquiline and linezolid to treat adult patients with extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). Pretomanid is the first new drug introduced in the field in 50 years. The field of TB has been neglected by front-line pharmaceutical companies due to its lack of economic feasibility. In fact, Viatris developed the drug in collaboration with a non-profit organization, ‘TB Alliance,’ rather than a general pharmaceutical company. Multi-drug resistant tuberculosis is a type of TB that cannot be treated with two or more TB treatments due to intolerance including isoniazid and rifampicin, the two most effective anti-TB treatments. Its cause can be divided into primary resistance and acquired resistance. Primary resistance develops when a patient is infected with drug-resistant MTB or during the course of treatment due to arbitrary discontinuation of treatment or irregular administration, etc. The treatment success rate of multi-drug resistant tuberculosis is around 50%, therefore, the condition's treatment efficiency is low, and an increased number of adverse events occur with their use in the second-line compared to first-line drugs. Moreover, due to its longer treatment period of 18 to 24 months, its cost burden is high and may even require surgical operations to remove lesions. Also, the seven-drug combination therapy that includes bedaquiline (Bdq) that is used as the current standard treatment for multidrug-resistant tuberculosis is not well used in Korea due to its high drug resistance rate and long treatment period of 9 to 12 months. Due to the long treatment period, the 7-drug combination is difficult to manage and has a high failure rate. Meanwhile, Dovprela demonstrated its efficacy through the Phase III Nix-TB trial. Dovprela, in combination with bedaquiline and linezolid (BPaL), demonstrated 92% effect in patients with treatment-intolerant or nonresponsive multidrug-resistant TB and an 89% effect in patients with extensively drug-resistant TB within 6 months and demonstrated its potential as a new short-term combination therapy in the field. Also, it reduced the treatment period from 18-24 months to 6 months, and almost all patients with treatment-intolerant or nonresponsive multidrug-resistant TB and extensively drug-resistant TB were found to be sputum culture-negative within 16 weeks. As the first ready-to-use combination that consists solely of oral treatments, the BPaL regimen reported a 90% cure rate in patients with extensively drug-resistant tuberculosis when used for 6 months compared to the standard treatment that recommends the use of at least 4 drugs in the initial intensive phase.
- Company
- Daewoong succeeds in Entresto's unregistered patent
- by Kim, Jin-Gu Mar 28, 2023 05:56am
- A generic company succeeded in invalidating the unregistered patent of Novartis' heart failure treatment 'Entresto'. This patent was one of the hurdles that must be overcome for the early release of generics. As such, it is analyzed that generic companies are one step closer to the release of generic for Entresto. According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board made a ruling on the invalidation of the Entresto salt/hydrate patent recently filed by Daewoong Pharmaceutical against Novartis. This patent is not listed in the Ministry of Food and Drug Safety patent catalog. However, from the perspective of generic companies, it was a patent that must be overcome in order to release later drugs early. Novartis obtained approval for the crystalline form of sacubitril/valsartan, the main ingredient of Entresto, as '2.5 hydrates'. In the patent catalog, only 2.5 hydrates, which are directly related, are listed. Generic companies supplied crystalline raw materials as 'trihydrate' and 'tetrahydrate' instead of 2.5 hydrates. The problem is that Novartis did not register it in the patent catalog, but separately registered the trihydrate patent with the Korean Intellectual Property Office. From the perspective of a generic company, the unregistered patent trihydrate patent must be avoided or invalidated in order to release a trihydrate-based generic. In response, Daewoong Pharmaceutical filed an invalidation trial on this unregistered patent in April 2021. Afterwards, Erison Pharmaceuticals and Hanmi Pharmaceuticals joined by requesting the same judgment. The Intellectual Property Tribunal sided with Daewoong Pharmaceutical. It is expected that the same result will come out in the judgment of Hanmi Pharmaceutical and Erison Pharmaceutical, which has not yet been concluded. As a result, generic companies have succeeded in overcoming 5 out of 6 patents related to Entresto. The remaining patent that has not yet been overcome is 'Use Patent 2' related to heart failure, which preserves the ejection fraction, which Novartis registered after generic companies applied for product approval. Since Novartis registered the patent a step later, it does not have a big impact on the early release of generics by patent challengers. Generic companies have already applied for Entresto generic product approval since April of last year. In addition, in December of last year, Novartis' request for an injunction to ban the sale of generics was also rejected by the court. The remaining risk factor is the second trial of the patent dispute with Novartis. Novartis appealed to the Patent Court in December 2021 after a first-instance defeat for the crystalline patent. Then, in July of last year, after losing in the first trial related to patents, the case was similarly brought to the second trial. No conclusion has been reached yet. If generic companies win the second trial following the first trial, the timing of the release of Entresto's generics is expected to accelerate. According to UBIST, a pharmaceutical market research institute, Entresto's outpatient prescription performance last year was 40.6 billion won. Since its launch in 2017, Entresto's prescription performance has soared from 6.3 billion won in 2018 to 15 billion won in 2019, 23.5 billion won in 2020, and 32.3 billion won in 2021.
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- Sam Chun Dang Pharm’s biosimilar equivalent to Eylea
- by Nho, Byung Chul Mar 28, 2023 05:56am
- On the 27th, Sam Chun Dang Pharm announced that it had received the final result report for its Phase III trial for SCD411 (Eylea biosimilar). The results are from a global phase III clinical trial that had been conducted on 576 patients at 132 hospitals in 14 countries from September 2020 to September 2022. Through the global Phase III trial, the company demonstrated the equivalence of SCD411 to the original Eylea in terms of efficacy (primary endpoint & secondary endpoint), safety, tolerance, effectiveness, and immunogenicity. The primary outcome measure, change from baseline in BCVA (best corrected visual acuity) measured from baseline to Week 8, fell within the equivalence limit interval set by the US FDA (Food and Drug Administration), EMA (European Medicines Agency), and Japan’s PDMA (Pharmaceuticals and Medical Devices Agency) compared to the original. UF FDA set the equivalence limit interval as a confidence interval of 90% with a treatment difference with the original between -3.0 to 3.0 characters, Europe’s EMA and Japan’s PMDA as a confidence interval of 95%, and a difference between -3.8 to 3.8 characters. The results of the primary outcome measure analysis showed that the differences in effect were between -1.6 to 0.9 characters under the US standards, and between -1.8 to 1.1 characters under the European and Japanese standards. Based on the results, Sam Chun Dang Pharm plans to apply for marketing approval of SCD411 in major countries such as the United States, Europe, and Japan and will supply and market the products through its partners as soon as it receives authorization.
- Company
- Erleada's reimb and lower coinsurance rate raise issue
- by Eo, Yun-Ho Mar 28, 2023 05:56am
- Most latecomer drugs are priced at a lower level than first-comer. This is an essential element in Korea's reimbursement listing system. However, a rare occasion occurred where patients are complaining over the lower price set for a latecomer drug. The drugs that arose as an issue were Janssen Korea’s prostate cancer treatment ‘Erleada (apalutamide),’ and Astellas Korea’s ‘Xtandi (enzalutamide)’ which was listed for reimbursement before Erleada. The situation goes as follows. The price difference (list price) between the two drugs is not large. However, the problem lies in the listing registration system the two drug companies selected and the patient's coinsurance. In August of last year, reimbursement for Xtandi was extended through a selective reimbursement system. Xtandi was first listed in 2014 as a treatment for metastatic castration-resistant prostate cancer (mCRPC). The selective reimbursement system is a system for listed drugs that authorities determine is urgent to expand coverage. To rapidly extend the scope of reimbursement for such drugs, the authorities waive the economic feasibility evaluation process but differentiate the copayment rate for the drug. Xtandi met the purpose of the system for the 'metastatic hormone-sensitive prostate cancer (mHSPC)' indication, which was why Astellas chose to receive reimbursement through the system. However, the situation was different for Erleada. As a newly listed new drug, Erleada did not have the option to choose selective reimbursement, therefore, it had to undergo the essential reimbursement processes, including the pharmacoeconomic evaluation process. This was why the time to the listing of the two drugs differed significantly. The two drugs passed review by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February last year, but Erleada is only being listed for reimbursement starting next month. Applying selective reimbursement to new drugs has remained a long-cherished desire in the industry. The different reimbursement tracks taken by the two companies led to the difference in the amount paid by patients as coinsurance. Xtandi’s coinsurance rate under the selective reimbursement system is 30%, whereas the rate is a mere 5% for Erleada which is applied essential reimbursement and special calculation of exemptions. If so, it would seem that existing patients can opt to use the cheaper Erleada, but it is impossible for patients taking Xtandi to switch to Erleada under the current reimbursement standards. In other words, dissatisfaction is arising among patients as existing patients could not benefit from the use of a cheaper drug option that became available. However, no one is to blame for the situation. Aside from the company's strategy, Astellas quickly offered a reimbursed treatment option in mHSPC through the selective benefit system. Janssen also has no fault. The prevailing view had been that it would be difficult for anticancer drugs with the mHSPC indication to be listed for reimbursement in Korea. This was why the news that Janssen completed final negotiations and successfully receive reimbursement after receiving pharmacoeconomic evaluations was received with surprise in the industry. Also, a solution does exist. The gap caused by the difference in coinsurance rates can be resolved if Xtandi also receives pharmacoeconomic evaluations and switches to an essential reimbursement like Erleada. However, it is unclear whether such a decision can be made quickly due to the nature of multinational pharmaceutical companies. A pricing official in the industry said, “Although it is uncommon, we should not overlook the fact that this can happen again in the future. Institutional improvement is needed to resolve the out-of-pocket burden that occurs with the entry of latecomers for selective benefit-applied items.”
- Company
- Pfizer Korea dividend KRW 12.48M, net profit KRW 119.5B
- by Chon, Seung-Hyun Mar 27, 2023 05:56am
- Despite posting record-breaking performance last year, Pfizer Korea’s dividend was set at only KRW 12.48 million. The company adhered to its dividend policy of ’20% preferred stock’ regardless of its performance. According to the Financial Supervisory Service (FSS), Pfizer Korea set its dividend payout for the last year as KRW 12.48 million. With the decision, the company’s dividend payout has now remained the same at 12.48 million for five consecutive years. # i1 The dividend was calculated at the same level as before even though Pfizer Korea’s performance improved significantly due to sales of COVID-19 drugs last year. Pfizer Korea’s sales increased 90.4 YoY from KRW 1.694 trillion to KRW 3.225 trillion last year. Its operating profit more than doubled from the previous year to reach KRW 120.1 billion. Sales of its COVID-19 vaccines and treatments raised the company’s sales performance. Its sales had risen over fourfold in two years from KRW 391.9 billion in 2020, and profitability also improved significantly from its operating loss of KRW 7.2 billion in 2020. The company’s net profit also increased 24.0% YoY to reach KRW 119.5 billion. In general, companies pay out dividends to shareholders proportionate to their increase in net profit. However, Pfizer’s dividend remained the same at KRW 12.48 million as in the previous year, and its dividend payout ratio was a mere 0.01%. Pfizer Korea calculated its dividend by applying a 20% dividend rate to its preferred stock capital. Pfizer Korea’s total capital is KRW 922.92 million. Among them, the common stock capital (172,104 shares) is KRW 860.52 million, and the preferred stock capital (12,480 shares) is KRW 62.4 million. Therefore, with a 20% preferred stock, the dividend was set at 20% of the KRW 62.40 million, at KRW 12.48 million. Pfizer Korea’s largest shareholder is Pfizer’s Dutch subsidiary, 'PF OFG South Korea 1 B.V,’ which owns 99.99% of the shares. Therefore, PF OFG South Korea 1 B.V., which owns all of the company’s preferred stock, will be receiving a dividend of KRW 12.8 million. Pfizer Korea had paid dividends of KRW 12.48 million based on the same standard of '20% preferred stock' for all but two occasions over the past 20 years since 2003. In 2017, its dividends were set at KRW 79.79 billion, which was higher than its net profit. At that time, the dividend rate was set at 660% of the face value of KRW 5,000 for both its common stocks (2,455,520 shares) and preferred stocks (12,480 shares), increasing dividends. In 2008, the dividend was set at KRW 190 billion. Even though the company recorded a deficit of KRW 600 million at the time, the high dividend was determined based on a dividend rate of 3045% compared to face value. Over the past 20 years, these two were the only occasions the company set high dividends, and it upheld its small dividend policy of KRW 12.48 million during the rest of the period.
- Company
- SGLT-2 combo Qtern awaits release in Korea
- by Eo, Yun-Ho Mar 27, 2023 05:56am
- With reimbursement extensions to combination therapies that use SGLT-2 inhibitors imminent, the combination drug ‘Qtern’ is rapidly landing at general hospitals in Korea. According to industry sources, AstraZeneca’s DPP-4i+SGLT-2i Qtern (saxagliptin+dapagliflozin) which is being solely distributed by Ildong Pharmaceutical in Korea, has passed the drug committee (DC) reviews in tertiary hospitals such as Seoul National University Hospital, Seoul St. Mary’s Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, and other general hospitals including Gangwon National University Hospital, Korea Anam University Hospital, Nowon Eulji Medical Center, Ewha Womans University Medical Center, Inje University Ilsan Paik Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University Hospital, and Hanyang University Guri Hospital. Although the drug had been approved in March 2017, it was not released in Korea due to the non-resolution of the reimbursement issue for antidiabetic combination therapies in Korea. However, However, Qtern may finally be released in line with the progress made regarding the government’s discussions on antidiabetic combination drugs and the reimbursement standards being expanded for antidiabetic combination therapies from next month (April). Qtern is currently undergoing reimbursement listing in Korea. Other DPP-4+SGLT-2 combination drugs that are approved in Korea include Boehringer Ingelheim’s ‘Esglito (linagliptin+empagliflozin)’ and MSD’s ‘Stegluzan (sitagliptin+ertogliflozin).’ These drugs are also awaiting the revitalization of the combination market that will come with the resolution of the reimbursement issue. Generic versions of antidiabetic combos are also awaiting entry into the market. The post-marketing surveillance period for DPP-4i+SGLT-2i combos is soon to expire, until which application for generic drugs is blocked. Meanwhile, in a Phase III trial that studied adding dapagliflozin or placebo to the saxagliptin+metformin two-drug combination therapy for 52 weeks, results showed that patients that used the three-drug combination showed an improvement in terms of lowering blood sugar level and achieving glycosylated hemoglobin (HbA1c) target level over the two-drug combination therapy. No hypoglycemia side effects were additionally observed in the study.
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- Discussion of reimbursement for Vyndamax is running in place
- by Eo, Yun-Ho Mar 24, 2023 05:48am
- It seems that discussions on registration of transthyretin (TTR) amyloid cardiomyopathy drug 'Vindamax' for insurance benefits are at a standstill again. As a result of the coverage, Pfizer Korea's ATTR-CM (ATTR amyloidosis with cardiomyopathy) treatment Vyndamax, (Tafamidis 61mg) passed the HIRA last year, but the schedule for presentation to the Pharmaceutical Reimbursement Evaluation Committee has not yet been set. there is. In fact, it is judged that the discussion has ceased. The passage of the standard subcommittee itself was the result of only the fourth challenge, but it disproves that the gap between the government and pharmaceutical companies remains. Vyndamax failed to designate an essential drug in its first reimbursement challenge in early 2021. Afterward, an economic evaluation was conducted in the first half of the same year and a second challenge was reached through a Risk Sharing Agreement, but the results were the same. And in April of last year, it failed to exceed the standard subcommittee again, but in the second half of last year, it barely made a step forward. However, it is judged that there were still difficulties in finding a point of agreement in terms of financial sharing. It remains to be seen whether Vyndamax will be able to supplement the data again and continue discussions on salary listing. Meanwhile, Vyndamax is virtually the only ATTR-CM treatment option. ATTR-CM has been regarded as a disease with poor treatment results because it is misdiagnosed as simple heart failure or has no treatment, even though it is fatal enough that the survival period is only 2 to 3.5 years if not treated appropriately. In this situation, Vyndamax is a drug that has been shown to reduce the occurrence of cardiovascular events in CM patients through the phase 3 ATTR-ACT study and to improve the 6-minute walking test. In the ATTR-ACT study, 441 patients have randomized to Tafamidis 80 mg, Tafamidis 20 mg, and placebo in a 2:1:2 ratio. The main secondary endpoints of the study were the change in the 6-minute walk test from baseline to 30 months, the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the KCCQ-OS score, where higher scores mean better health. As a result of the study, the Tafamidis-administered group showed a statistically significantly lower risk of all-cause death and cardiovascular-related hospitalization compared to the placebo-treated group.
- Company
- 5th time the charm for Tagrisso’s reimbursement extension?
- by Jung, Sae-Im Mar 24, 2023 05:48am
- After five attempts, the EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment ‘Tagrisso (osimertinib)’ finally crossed the first hurdle to receiving reimbursement as a first-line treatment. Although other procedures such as deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee remain, the fact that it had overcome the highest barrier to reimbursement, the Cancer Disease Deliberation Committee review, 4 years after its indication was expanded to the first line, is regarded an achievement. HIRA’s CDDC held its second 2023 Reimbursement Standard Deliberation Meeting for Anticancer Drugs on the 22nd and established reimbursement standards for Tagrisso. The CDDC determined it was appropriate to set reimbursement standards for Tagrisso as a ‘first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.’ With the decision, the drug was able to pass the first gateway for third-generation EGFR-targeted anti-cancer therapies to receive reimbursement as a first-line treatment. ◆Passes CDDC review after 5 attempts...sees fruition 4 years after indication expansion Tagrisso is a third-generation targeted anticancer therapy that targets the EGFR mutation. It inhibits both the EGFR mutation and T790M mutation that are represented by L858R and Exon 19 deletions. As the drug has a high blood-brain barrier (BBB) permeability than first and second-generation EGFR-targeted therapies, Tagrisso has shown a superior effect in patients with brain metastasis. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, the drug was unable to receive reimbursement as a first-line treatment for over 4 years. AstraZeneca had attempted reimbursement for Tagrisso at the CDDC level 4 times since 2019 and failed every attempt. When Tagrisso’s reimbursement to the first line first emerged as an agenda in the second half of 2018, the government had been in favor of extending reimbursement. However, the favorable stance faltered with the release of the Asian subgroup analysis results from a global Phase III trial in 2019. The FLAURA trial assessed the efficacy and safety of Tagrisso in the first line, and the Asian subgroup analysis results of this global trial had risen as a barrier to its reimbursement as its hazard ratio (HR) was 0.995. An HR of 0.995 indicates that the difference between Tagrisso and the control group is 0.005, which could be interpreted as the difference being insignificantly small. After such results were disclosed, the CDDC in October 2019 decided to defer its decision until the full data from the Phase 3 FLAURA trial was released. The company made its second attempt, submitting the overall OS data of FLAURA in 2020. However, due to the rapid spread of COVID-19, the CDDC meeting that was set for February of the year had been pushed back and canceled several times and finally held at the end of April. The reimbursement standards for the drug had not been set then either. Although AstraZeneca expressed their will to accept most of the cost-sharing plan proposed by the government in consideration of the Asian subgroup data, the reimbursement fell through due to strong opposition from committee members that raised the issue of the drug’s clinical efficacy. In September of the same year, the company made its third attempt powered by results from the FLAURA China study that confirmed improved OS in Asians. The FLAURA China trial data analyzed a cohort of 136 Chinese patients that included 19 Chinese patients from the global FLAURA trial as well as 117 patients from a trial that had been separately conducted. Results showed that the median PFS of the Tagrisso group was 17.8 months, which was comparable to the results from the global study. Median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. This is a higher OS improvement than the 6.8 months identified in the global trial. The third reimbursement extension discussions for Tagrisso were made in April 2021. The third attempt also resulted in failure. At the time, CDDC members concluded that the OS value from the FLAURA China trial lacked statistical significance. After the third attempt failed, patient groups rose to the occasion. After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent a joint statement to the government imploring the government to extend Tagrisso’s reimbursement to the first line as in many major countries. Academic societies also criticized how only Tagrisso is not being reimbursed as first-line treatment in Korea. 3 months after its third setback, AstraZeneca applied for the 4th time to extend reimbursement. This time, the company adopted a strategy of narrowing part of its reimbursement standards. The company excluded Exon 21 mutation from the 'EGFR exon 19 deletion or exon 21 (L858R) mutation NSCLC’ it had been indicated for. The company narrowed the criteria to 'first-line treatment for patients with EGFR exon 19 deletion and brain metastases' and reapplied for reimbursement. The plan was to increase the clinical value of the drug by excluding the patient group that showed a relatively small difference in efficacy from the control group. However, Tagrisso’s reimbursement extension was rejected at the CDDC meeting that was held in November 2021. Real-world study on first-line Tagrisso use in Japan. OS results according to gene mutation status (Data: ESMO) This reluctant sentiment on Tagrisso’s reimbursement extension was reversed at the end of last year with the release of large-scale real-world data on Tagrisso’s use in the first line in Asia and Europe. Analysis of real-world data on 660 Japanese patients confirmed a longer progression-free survival period (20.0 months) and an overall survival period of more than 3 years (40.9 months) than those identified in the Phase III trial. With this data, the company put an end to Tagrisso’s efficacy controversy in Asia. AstraZeneca took on its 5th challenge with this new data and a plan to lower drug prices as supplements. The patient organizations’ petition requestion reimbursement extension also added support. The 'Petition regarding the request for first-line treatment of the lung cancer treatment Tagrisso’ that was uploaded to the e-People website in February was sent to the National Assembly Health and Welfare Committee for deliberation after receiving over 50,000 consents. As a result, after 5 attempts in the course of the past 4 years, Tagrisso finally made it through the first barrier to its reimbursement and passed the CDDC review. ◆Can it be reimbursed within the year? Depends on DREC progress Although it has passed the high barrier of CDDC review, many procedures still remain for its reimbursement extension. For anticancer drugs, CDDC review is only the first step of many. The agenda has to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC), and then undergo pricing negotiation with the NHIS, then pass MOHW’s Health Insurance Policy Deliberation Committee (HIPDC) review to complete all the procedures required to extend benefits. Tagrisso is subject to the risk-sharing agreement (RSA) scheme and must pass the pharmacoeconomic evaluation. HIRA’s statuary evaluation period is set to 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data. After completing discussions with HIRA and passing DREC review, the company has to conduct drug pricing negotiations with NHIS for up to 60 days. Within 30 days from the period, MOHW’s HIPCD will deliberate and then issue a notification on the new drug price and then list the drug for extended reimbursement. In other words, at maximum, Tagrisso’s reimbursement extension is set to be made by the end of this year. The decisive step in advancing or delaying this timing of Tagrisso's reimbursement is expected to depend on DREC’s stage, where the pharmacoeconomic evaluation takes place. If DREC requests supplementary data repeatedly, reimbursement listing may be delayed indefinitely. In fact, several anticancer drugs have not been deliberated for over a year at the DREC level after passing the CDDC review. In the case of MSD's Keytruda, which succeeded in extending reimbursement to the first-line treatment of NSCLC after 4 years, Keytruda’s reimbursement agenda was presented to DREC 6 months after passing the CDDC review in July 2021. Although the company showed a high willingness to negotiate the reimbursement of Keytruda, the process was only completed eight months after passing the CDDC review due to a delay in its schedule, such as an unsuccessful submission for the DREC review in November 2021. AstraZeneca plans to make the best efforts to extend Tagrisso's reimbursement within the year. The company said, "We welcome the CDDC’s decision and would like to express our thanks to the government and committee members for making efforts to enable this. We will continue to do our best to complete the procedures that remain and receive the reimbursement decision”
- Company
- Neurofibromatosis Tx Koselugo makes progress for reimb
- by Eo, Yun-Ho Mar 23, 2023 04:45am
- Finally, reimbursement discussions for the new neurofibromatosis drug ‘Koselugo’ has made some progress. Results showed that AstraZeneca Korea’s new neurofibromatosis drug has passed the review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee recently. Therefore, its reimbursement can now be deliberated by the Drug Reimbursement Evaluation Committee. After the drug received a non-reimbursement decision from DREC in March, the company worked promptly and prepared the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo, and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. In contrast to the non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
