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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.”
Opinion
[Reporter's view] The goal of global new drug development
by
Hwang, Jin-joon
Mar 28, 2023 05:54am
When the government announced the 'Third Five-Year Comprehensive Plan to Foster and Support the Pharmaceutical Bio Industry', it was emphasized that it would create three new blockbuster drugs that record global sales of more than 1 trillion won by 2030. For this purpose, strategic R&D investment was selected as a key task. In the development of new drugs, it is planned to significantly increase public and private R&D investment. Looking at the detailed support measures, the government plans to promote R&D investment of a total of 25 trillion won jointly with the private sector for 5 years with 10 global new drug development goals. The government also expects to invest 4 trillion won in government R&D and 21 trillion won in private R&D from this year to 2027. Based on the national new drug development project that inherited the results of the pan-governmental new drug development project from 2011 to 2020, a joint public-private investment of 2.2 trillion won was invested to develop one new blockbuster drug and three new drugs by 2035. A plan for development was also established. The government's will to foster the industry is positive, but the problem with new drug development is that speed is not important. As of last year, there were zero blockbuster new drugs recognized by the government. The government expects to secure two by 2027. Under the current circumstances, only Yuhan's non-small cell lung cancer drug Leclaza and SK Biopharmaceuticals' epilepsy drug Xcopri appear to be the only drugs developed by domestic biopharmaceutical companies by 2027 that have the potential to become global blockbusters. Leclaza was transferred from Genosco/Oscotec to Yuhan Corporation in July 2015 when preclinical development was underway. In November 2018, the technology was transferred from Yuhan to Janssen, a subsidiary of J&J, a global pharmaceutical company. Yuhan received conditional approval for Leclaza as a treatment for secondary mutations in non-small cell lung cancer in Korea in 2021. In other words, it took five and a half years from preclinical trials to conditional approval. It seems that it will take more time for Leclaza to rise to prominence as a global blockbuster. Janssen, which holds the global copyright, is conducting a phase 3 trial of Leclaza alone and Rybrevant as an indication for non-small cell lung cancer. Cenobamate started with basic research in 2001, went through clinical trials and licensing, and was approved by the U.S. Food and Drug Administration (FDA) in 2019. It took 18 years from the first research to enter the large-scale US pharmaceutical market. Last year, US sales of Cenobamate more than doubled from the previous year to 169.2 billion won, but it will take more time to get on the list of global blockbuster new drugs. Moderna's Corona 19 mRNA vaccine, which recorded $18.4 billion in sales last year, was praised for succeeding in developing it in about a year, but the actual situation is different. Moderna's COVID-19 mRNA vaccine is the product of 30 years of RNA research, 20 years of LNP development that protects mRNA, and 10 years of Moderna's own research and development. The government recognized the biopharmaceutical industry as a 'future food in a low-growth period', a 'key field for securing jobs', and an 'essential national strategic industry for overcoming infectious diseases and other diseases and guaranteeing public health'. In order to realize this, not only R&D support measures such as active support for global clinical trials but also support measures for basic research fields such as chemistry and biotechnology from a long-term perspective must be prepared.
Opinion
[Reporter's view] Tagrisso's first benefit
by
Mar 27, 2023 05:56am
AstraZeneca's lung cancer drug Tagrisso has begun receiving benefits for first-line treatment. After 5 challenges, he passed the HIRA Cancer Disease Review Board. After adding the first treatment indication in December 2018, Tagrisso actively tried to expand benefits but was rejected by the review committee every time. The reason was that looking at the data of the phase 3 sub-analysis, the effect of improving overall survival in Asians could not be confirmed. The controversy over the efficacy of Tagrisso was started by Japan and ended by Japan. In the phase 3 FLAURA clinical trial, Japan had the greatest impact in making the OS values of Asians insignificantly different from those of the control group. The medical environment where drug switching is free is a crazy aftermath. The real damage was seen by Korean patients. In Japan, the first benefit is applied regardless of the results of the sub-analysis, but in Korea, because of this data, they had to receive treatment without benefit for more than 4 years. It is also Japan that has quelled OS doubts in Asia. Last year, Japan's large-scale real-world data came out. Real-world data is not clinical in a controlled environment, so it is generally less effective than data from clinical practice. However, Tagrisso showed a longer progression-free survival period and an overall survival period of more than 3 years compared to the phase 3 trial in the Japanese real world. There is no longer any need to argue over phase 3 sub-data. Already, the first-line Tagrisso therapy has fully established itself as a global trend for EGFR-mutated non-small cell lung cancer. A German professor of hemato-oncology whom I met in an interview last year expressed some disapproval at the reporter's question, "What do you think of the sequential treatment that uses the first and second generations first and then the third generation?" This is because I had never thought about sequential therapy after Tagrisso. His answer was, "I heard that even in Germany, a small number of hospitals choose sequential treatment. However, since Tagrisso has already become the clear first-line standard treatment, to be honest, I have never thought about sequential treatment. I'm sorry I couldn't give you an answer. it was" It will take a little longer for Tagrisso to become the standard first-line therapy in Korea. Concern about cancer is just the beginning of reimbursement for anticancer drugs, and in the future, drug price negotiations with the HIRA and the NHIS, and the Ministry of Health and Welfare must all pass. Now it's a speed battle. Depending on how long it stays on the drug rating, the Tagrisso benefit expansion could be over the year or within the year. First of all, AstraZeneca has a very high will to cooperate with the government as much as possible and expedite the process. The HIRA also has many new drugs to review for reimbursement adequacy. But it's only 4 years. The fact that the first petition for Tagrisso's salary exceeded 50,000 people can be said to have reached its maximum level of desperation. I hope that their wait will not exceed 5 years.
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.
Policy
Jeil Pharmaceutical discontinued Actos co-promotion
by
Lee, Tak-Sun
Mar 27, 2023 05:56am
Actozon 15mgJeil, which has already launched sales of the generic drug Actozone 15mg and the combination drug Actozonemet 15/850mg from 4Q last year, is expected to launch Actozon 30mg in the reimbursement market in April. According to the industry on the 26th, Actozon 30mg will be listed at the upper limit of 940 won from April 1st. There are still fewer than 19 generic drugs listed, and Jeil Pharmaceutical succeeded in calculating the same price as the highest price by meeting all the standard requirements. Previously, when Actozon 15mg was re-listed in January of last year, it was difficult to calculate the highest price as there were more than 20 generics. Accordingly, Actozon 15mg has been listed at the lowest price of 359 won for the same product. Actozonemet was also listed at the highest price of 714 won when it was re-listed in August of last year, as fewer than 19 identical drugs were listed. In terms of drug price, apart from 15mg, single drugs 30mg, and combination drugs maintain the highest price, and it is evaluated that they did well even though they entered the generic market belatedly. Jeil entered the generic market belatedly because the co-promotion of the original Actos and Actos met, which had been sold since the second half of last year, was discontinued. Best has sold Actos since 2013. At the time, it signed a co-promotional contract with Takeda. Jeil had to end 9 years of original sales as Celltrion Pharm took over the Asia-Taeyang region rights for Takeda products including Actos last year and started selling them alone from the second half of the year. Jeil immediately put generics into the market. In January of last year, Actozon 15mg, which had been removed from reimbursement, was listed again on the list of benefits, and in August of that year, Actozonemet was also listed again. Then, from the fourth quarter of last year, generic drugs were sold in earnest. Actozon 30mg was additionally approved in January. From April, it is expected to enter the market in earnest with a full lineup of pioglitazone capacities. As Jeil secured a large number of customers by selling the original Actos, it is expected that the relationship with customers lost due to the suspension of product sales in the generic business will be restored in the short term. The three-drug regimen including Metformin + SGLT2 will be covered from April for Glitazone drugs, which is also positive for sales recovery. An official in the pharmaceutical industry said, “As Jeil has a long experience in selling Actos, it is highly likely that it will quickly settle into the market as a generic drug.” He explained, "Therefore, other generic companies are also watching Jeil's movements."
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.
Policy
Dupixent 200mg, newly listed
by
Kim, Jung-Ju
Mar 27, 2023 05:55am
Sanofi-Aventis Korea's severe atopic dermatitis treatment Dupixent PFS 300mg has expanded insurance coverage to pediatric and adolescent patients, and products with 200mg content will be newly listed next month with an expanded range. Taking this as an opportunity, the government is planning to expand the scope of benefits for special calculations based on eliminating blind spots in existing treatments for severe atopic dermatitis. Janssen Korea Erleada, which is used for the treatment of metastatic prostate cancer (mHSPC), will be newly listed as a risk-sharing contract (RSA) reimbursement type at around 20,000 won. According to the industry on the 21st, the Ministry of Health and Welfare plans to revise the 'drug reimbursement list and reimbursement upper limit table' and is pushing to apply it on the 1st of next month. There are a total of 4 new drugs being promoted, 1 drug that has been expanded in the scope of use (benefit), and 4 items that are under contract renewal negotiations with the NHIS due to the expiration of the RSA period. ◆Newly listed item = Erleada is newly listed next month at 20,045 won so that it can be applied for health insurance. This drug is used in combination with androgen deprivation therapy (ADT) for the treatment of patients with hormone-responsive metastatic prostate cancer. Currently, A7 is registered in a total of seven countries, including the United States, Japan, France, Germany, Italy, Switzerland, and the United Kingdom. The company applied for insurance listing to the Review and Assessment Service on November 30, 2021, a year later. proceeded. At the time, the committee judged that the cost-effectiveness ratio was included in the acceptable range as a result of the economic evaluation, but the reimbursement was appropriate when the drug price was lowered in consideration of the financial impact such as the possibility of an increase in market share. As the company accepted this result, the drug was put on the negotiating table of the NHIS, and immediately entered into negotiations on the drug price and expected billing amount, and was successfully registered in April. The corporation expects that this drug will be cheaper than alternative treatments, and actual additional finance will be insignificant when considering the RSA refund rate in the future. Dupixent, which is used for severe atopic skin disease in adults, is also listed as a 200mg product with reduced content. Similar to the 300mg content product already registered and covered by insurance, RSA refund type, total amount limit type, and initial treatment cost refund type were applied to this content product in combination. In addition, Bukwang Pharmaceutical's Zaledeep 5mg and 10mg content products, which have stepped on the track of skipping drug price negotiations with the NHIS, are also listed at 102 won and 153 won per capsule, respectively. ◆ Expansion of scope of use = The scope of reimbursement for Dupixent 200mg, which is already registered, will be expanded from adults currently applied to children and adolescents in the future. Currently, it is estimated that 5,000 Korean adults with atopic dermatitis are receiving benefits. The government plans to broaden the reimbursement standard so that the drug can be widely used for children (6-11 years old) and adolescents (12-17 years old) with atopic dermatitis. The number of these patients is estimated to be 2550. The drug's benefit for children and adolescents is being applied to all A7 countries, and it is also being applied to adults in Korea, so its clinical usefulness has already been proven. Following the increase in benefits this time, the company negotiated with the NHIS again and set the price at 696,852 won per share, a 1.5% cut. At the same time, the government expands the scope of application of special calculations accordingly. It is to adjust the benefit standard while expanding the benefit from the existing adult target to children and adolescents. This is because if the current registration standards for calculation special cases are maintained, pediatric patients fall under the pharmaceutical reimbursement standards, but cannot meet the registration standards for calculation special cases, creating a blind spot where special cases are not applied. ◆ RSA Expiration Evaluation Items = Negotiations were made to renew contracts for 4 items of drugs covered by insurance through RSA. The target is Cabometyx, a renal cell cancer drug from Ipsen Korea, and Erbitux Inj. 5mg/mL (cetuximab), colorectal cancer, and head and neck cancer treatment from Merck. Before the contract period of the RSA drug expires, the government has the Pharmaceutical Review Committee evaluate the drug's clinical usefulness and cost-effectiveness, and proceed with contract renewal negotiations with the NHIS. The types of negotiations include lower drug prices, expected billing amounts, reimbursement rates, and caps. The target drugs for this time were contracts with Cabometyx or Erbitux, which limit the amount of use per patient, and as the companies expressed their intention to renew the contract, the procedure was followed. As a result of the negotiations, Cabometyx will be cut by 2.5% for each content, and Erbitux will be cut by 8.5%. In the case of Erbitux, the new drug price will be applied as of May 1 due to the renewal of the contract.
Policy
Forxiga patent is about to expire
by
Kim, Jung-Ju
Mar 24, 2023 05:48am
As the patent for Dapagliflozin, the original drug (Forxiga), is about to expire, domestic generics of this drug will be released early next month. Accordingly, the government is swiftly proceeding with the process of calculating the drug price and additional negotiations so that the drug can be listed immediately. According to the industry on the 21st, the Ministry of Health and Welfare is planning a revision of the drug reimbursement list and the maximum reimbursement amount table and is pushing to apply it on the 1st of next month. The application date is April 8, the day after the patent expiry date of Forxiga. Forxiga is an antidiabetic drug, and its price dropped to 734 won, or 3.4%, after negotiations with the NHIS for PVA type "Na" was concluded on the 13th. Domestic generics, which are taking a breather to secure market share, are 89 single drugs and 78 combination drugs. The Ministry of Health and Welfare has calculated generic drug prices based on 734 won, which was set as a result of PVA negotiations, in order to quickly register these drugs. If the original drug expires, the generics are automatically given a price calculation of 53.55%. Currently, companies ahead of the launch of Forxiga's generics are currently in the process of negotiating with the NHIS for stable supply and quality control while preparing for enlistment on the 8th. The deadline for negotiations is the 30th of this month. Governments and authorities expect generics to quickly capture half of the claims once they hit the reimbursement market. The estimated size of fiscal savings is expected to be around 1.1 billion won per month. Estimated on an annual basis, it is about 13.2 billion won. As the share of domestic products increases, the reduction in health insurance finances is proportional to that amount, so the government has no choice but to be busy.
Policy
Dual punishment for CSO rebates passes NA committee
by
Lee, Jeong-Hwan
Mar 24, 2023 05:48am
A provision that stipulates the prohibition of doctors from receiving rebates offered by contract sales organizations (CSOs) and a plan to amend the Medical Service Act to advance regulations on medical advertisements and allow the Ministry of Health and Welfare to intervene in the Medical Advertisement Deliberation Committee passed the plenary meeting of National Assembly’s Health and Welfare Committee. Also, a proposal to amend the Pharmaceutical Affairs Act, which includes a clause prohibiting illegal hospital subsidies in exchange for prescriptions between hospitals and pharmacies that are preparing to open, and a clause that allows pharmacists to refuse to dispense poor or counterfeit narcotics prescriptions was passed in the same the plenary meeting. Also, the bill to manage the harm from cigarettes, which was merged as an alternative by the NA Chair after the bill was separately presented by NA Rep. Hye-Young Choi of the Democratic Party of Korea and Ki-Yoon Kang of the People Power Party, also crossed the threshold set by the Health and Welfare Committee. On the 23rd, the NA Health and Welfare Committee. held a plenary session and voted on the bills that were reviewed by the 1st and 2nd legislation subcommittees. A bill that adds drug CSOs to the scope of rebates such as money and valuables that doctors should not receive and obligates the medical device CSOs to report to the government and local governments passed the Health and Welfare Committee deliberations. Therefore, these agendas will go through legislative procedures with the drug CSO reporting system that had been pending at the Legislation and Judiciary Committee level. Changes are expected in the review of medical advertisement deliberations in the future as the Medical Advertisement Deliberation Committee, which consists of functional groups of medical professionals such as those from the Korean Medical Association, passed the bill to improve MDAC deliberations and allows the Ministry of Health and Welfare the right to intervene. Also, the Pharmaceutical Affairs Act, which prohibits prospective hospitals and pharmacies from exchanging hospital subsidies for prescriptions, is subject to review by the NA’s Legislation and Judiciary Committee. Furthermore, legislation of the Tobacco Hazard Control Act, which includes disclosure of the types and amounts of harmful substances contained in e-cigarettes as well as leaf tobacco is expected to accelerate progress. Also, an amendment to the Narcotics Control Act that stipulates that pharmacists at pharmacies may refuse to dispense drug prescriptions issued by medical institutions that poorly entered patient information or are suspected a forgery also passed the Health and Welfare Committee. Whether to present the bills at the plenary session will be determined by the Legislation and Judiciary Committee after considering the agenda seriatim.
Company
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.
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