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- 2026-04-14 03:36:12
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- The Effects and Challenges of Vitrakvi
- by Jul 20, 2021 05:46am
- Bayer's "Vitrakvi" has been able to treat cancer patients who are positive for NTRK gene fusion, regardless of cancer type. The NTRK gene plays an essential role in the physiology, development and function of the nervous system through the TRK protein, which causes problems when unrelated genes are combined. This phenomenon, called NTRK gene fusion, produces a fusion TRK protein that transmits abnormal signals. Eventually, the downstream pathway becomes hyperactive, causing problems in cell growth and survival, leading to cancer. All cancers can be caused by NTRK gene fusion, but they vary in frequency from cancer to cancer. There are very few cases of NTRK gene fusion in commonly known small cell lung cancer (SCLC) or direct colorectal cancer. On the other hand, NTRK gene fusion is frequently found mainly in rare cancers such as secretive salivary gland cancer, secretive breast cancer, and infant-type fibrous sarcoma. So far, there have been no treatments targeting NTRK gene fusion. In May last year, Bayer's "Vitrakvi (Larotectinib)" was approved, paving the way for treatment of patients positive for NTRK gene fusion in Korea. Vitrakvi is a targeted anti-cancer drug developed exclusively for NTRK gene fusion. It is also an anti-cancer drug that can be used in patients who are positive for NTRK gene fusion. In Korea, less than 50 cancer patients are known to show NTRK fusion-positive casers every year. Vitrakvi demonstrated superior effectiveness in NTRK gene fusion positive patients. Clinical results for 159 patients published in the international journal Lancet last year showed an objective response rate (ORR) of 79%, and a median response period of 35.2 months (mDoR). It has shown therapeutic effects for about three years. There were also 24 cases (16 per cent). At the time of announcement, the median value of the overall survival period (mOS) was 44.4 months and the median value of the progressive survival period (mPFS) was 28.3 months. Vitrakvi has been effective not only in adults but also in pediatric patients. Twenty-four patients under the age of one were also included in the clinical trial, which showed equal efficacy without difference from adults. Vitrakvi is therefore licensed for use regardless of adults or children. Oh Do-yeon, a professor of oncology at Seoul National University Hospital, said, "As a result of prescribing Vitrakvi in a 6-year-old pediatric patient with thyroid cancer, the cancer mass spread to the lungs was so good that video findings showed few feared side effects." The professor said, "I've been taking medicine for four years, and it's been working well so far." The challenge for Vitrakvi is data. For now, medical staff are not aware of NTRK fusion-positive casers. It is also unknown whether there will be a consistent effect on each type of cancer. Professor Oh Do-yeon also said, "If you look at each type of cancer, the number of patients is very small, so it is difficult to determine whether 80% of ORR can be maintained for each type of cancer." The professor explained, "If there are more parameters over time, the answer will come out." Professor Oh said, "There is a lot of controversy over when to treat Vitrakvi among the standard treatments established for each cancer species." If NTRK fusion-positive casers are found, they will use Vitrakvi before other treatments, but different medical staff members have different ideas. "If data accumulates more and medical staff's perception of NTRK gene fusion improves, we expect to use Vitrakvi in the early stages." Another stumbling block for Vitrakvi is whether to register pay.Vitrakvi passed the first stage of the HIRA's Cancer Drugs Benefit Appraisal Committee in May with the same NTRK targeted drug Roche's Rozlytrek. Bayer is pushing for a quick listing as a pharmacoeconomic study and PE study exemption track. Attention is focusing on Vitrakvi's move as there have been no cases of anti-cancer drugs being registered as salaries regardless of cancer.
- Company
- ‘Tagrisso’ tenaciously attempts reimb. for 1st line NSCLC
- by Eo, Yun-Ho Jul 19, 2021 10:34am
- AstraZeneca Korea is attempting to receive insurance benefits for ‘Tagrisso’ once again after modifying its reimbursement standards. Industry officials said that AstraZeneca Korea had recently reapplied for expansion of insurance benefit for its 3rd generation EGFR TKI Tagrisso (osimertinib) to first-line treatment in non-small cell lung cancer (NSCLC). The key strategy for the approval of insurance benefits this round is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to provide the benefit to those who have a high treatment need rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would also naturally allow for a broader discussion on its fiscal impact. Thus, whether the agenda will be put up for deliberation at the Health Insurance Review and Assessment service’s Review Committee for Cancer Disease meeting planned in September is gaining attention. If reviewed, this will be the fourth time the agenda is discussed by the Review Committee for Cancer Disease As the committee passed MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ for the first-line treatment of lung cancer at the meeting in July after 4 years of deliberation, attention is focused on the committee’s decision for Tagrisso as well. Tagrisso, which added its indication for first-line treatment of lung cancer in Korea in December 2018, aimed to expand its reimbursement to the indication in 2019. However, after deliberation by the Review Committee for Cancer Disease in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in first-line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) that there was an issue with the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the first-line reimbursement of Tagrisso.”
- Company
- Prolonged Galvus patent dispute… results to come next year?
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- The patent dispute surrounding Novartis’ anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ may be prolonged and not be concluded within this year. With the substance patent of the said product to expire in March of next year, the benefits of early release will disappear for generic companies if the ruling comes after then. However, generic companies plan to continue the legal dispute to the end in consideration of the impact this case will have on future pharmaceutical patent strategies set by the industry in general. ◆4 years of legal dispute over invalidation of the extended period for a substance patent deepens Supreme Court’s concerns Pic of Galvus1According to the pharmaceutical industry, the legal dispute between the original drugmaker Novartis and generic companies centered around Ahn-Gook Pharmaceutical is ongoing for 4 years now. The case is currently pending in the Supreme Court. In November last year, Novartis filed an appeal to the Supreme Court despite the partial win it received in the second trial. The period for the dismissal of appeal to the Supreme Court had passed, and the Supreme Court will now officially review the legal dispute. However, negative prospects on whether the Supreme Court will make a final decision soon are being raised, as the court will have to carefully examine this new type of legal dispute that had not existed in the past. A legal official said, “Many legal suits to invalidate the extended period of substance patents for pharmaceuticals had been filed; however, the claims had never been recognized in the first or second trial. The Galvus case was the first ruling by the court that accepted the invalidation claim to shorten the extended term of a patent.” “Due to these issues that require careful consideration, the Supreme Court seems to be seriously contemplating on the case. Even the parties in dispute will not be able to predict the date of the Supreme Court's ruling, and there is a possibility that a final decision will not be reached within this year," he added. ◆Despite substance patent expiry in March 2022, generic companies are 'in for the whole fight' The key is whether the Supreme Court will make its ruling before March 4th of next year. March 4th is the date when the substance patent for Galvus expires. If the court’s ruling comes after May 4th, the generic companies will not be able to reap the benefits of overcoming Galvus’s patent or from the early release of its generic. According to UBIST, Galvus and Galvusmet sold 8.1 billion and 36.4 billion won in outpatient prescriptions last year. If the ruling comes after March, the generic companies will lose the opportunity to acquire the right to exclusive marketing approval of their generic in the prescription market that amounts to 40 billion won per year. Despite the risks, the generic companies plan to fight the full battle, as the results of this legal dispute may set a new milestone for generic companies in establishing patent strategies for generics in the future. If the generic companies succeed in invalidating even just one day of the extended patent term, this will may start a series of challenges on substance patents of original drugs, an area that had been considered impregnable. ◆187 days vs 55 days vs 0 days… What will the Supreme court’s judgment be? The Supreme Court‘s ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid. The conflict began 4 years ago in July 2018 when Ahn-Gook Pharmaceutical requested a trial claiming that part of the term extended for the substance patent of Galvus is invalid. Hanmi Pharmaceutical later joined in the fight. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the protection term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Ahn-Gook Pharmaceutical claimed that the 187 days of the extended term for Galvus’s substance patent was invalid. IPTAB accepted Ahn-Gook claim and ruled the 187 days invalid. Novartis appealed, and the case went to the hands of the Patent Court of Korea. Intellectual Property Trial and Appeal Board had overturned the first instance judgment to take Novartis’ side. However, the court ruled that only 55 of the 187 days are invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. As a result, Novartis once again appealed, and the case is not being reviewed by the Supreme Court.
- Company
- Emtuen became the largest shareholder of SillaJen
- by An, Kyung-Jin Jul 19, 2021 05:56am
- SillaJen said that Emtuen paid ￦60 billion for 18.75 million shares. Emtuen will become SillaJen's new largest shareholder starting with the payment, seeking to normalize its management and strengthen its expertise in bio-industry companies. On the 13th of next month, SillaJen will hold an extraordinary shareholders' meeting at the Korea Broadcasting Center in Yangcheon-gu, Seoul and appoint new board members. According to SillaJen, the new board consists of people who can normalize management and develop bio expertise. GreenFireBio.LLC personnel, a U.S. drug development company with Emtuen as the largest shareholder, are also expected to join the board of directors of SillaJen. "We will do our best to become a pioneer in the bio industry as well as responsible management as the new largest shareholder," an Emtuen official said. "We will make efforts to establish a virtuous cycle model for the bio industry that leads to Emtuen, Sillazen and GFB." "With capital and expertise, Emtuen is truly pleased to be the new largest shareholder," said SillaJen. "We will do our best in research and development as SillaJen is able to make a new leap forward." Emtuen sets the entire new shares to lock-up period for three years to advocate responsible management as the largest shareholder and guarantee minority shareholders rights.
- Company
- ↑38% of drug exports in the first half
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- In the first half of the year, Korea's pharmaceutical exports recorded about ￦4.5 trillion. There is a possibility that it will surpass ￦10 trillion within this year. In particular, exports of medicines to Germany have increased significantly. In the first half of this year alone, more than ￦1.5 trillion was exported to Germany. Germany's share of domestic pharmaceutical exports exceeded one-third of the total. According to the Korea Customs Service on the 15th, Korea's pharmaceutical exports in the first half of this year are estimated at $3,915.86 million. The figure rose 38% from $2843 million in the first half of last year. Due to the prolonged corona crisis, it is observed that it is consistently performing well in drug exports. Semi-annual drug exports were in the mid- to late $1 billion by the second half of 2019, but have been in the middle of more than $2 billion since the first half of last year when the corona crisis began in earnest. In the first half of the year, imports of drugs amounted to $3.989 billion. The trade balance of drugs, which deducted imports from exports, was $6.92 million. It turned from a deficit of $847.22 million in the first half of last year to a surplus. This is the second consecutive surplus since second half of last year. Attention is focusing on whether it will change its record-high export performance recorded last year. Semi-annual drug exports since 2017 (Unit: $billion, Korea Customs Service) Total exports of drugs last year amounted to $6.89355 billion, the highest ever. In particular, more than $4 billion was concentrated in the second half of the year. Assuming that it will produce export performance similar to last year in second half of this year, it is predicted that it will be able to surpass ￦10 trillion by end of this year. Top 10 countries in drug exports in the first half of 2020 and the first half of 2021 (Unit: $billion, Korea Customs Service) By country, exports of medicines to Germany were high. In the first half of the year, $1.352.63 billion of medicines were exported to Germany. It accounted for more than one-third (34%) of domestic pharmaceutical exports. Last year, exports to Germany accounted for 22%. Exports of drugs to the United States, the largest exporter of drugs, have declined significantly. It was $46.72 million in the first half of last year, but fell 32% to $274.83 million in the first half of this year. Exports to Japan rose 30% ($168.23 million → $219.38 million dollars), the Netherlands 345% ($45.1 million → $288 million), and China 14% ($119.27 million → $136.47 million). Exports to Turkey fell 54% ( $327.31 million → $149.83 million), while Brazil also fell 9% ( $96.37 million → $87.32 million).
- Policy
- Aduhel has been applied for permission in Korea
- by Lee, Tak-Sun Jul 19, 2021 05:56am
- Recently, Aduhel (Aducanumab), a new drug for Alzheimer's disease approved by the U.S. Food and Drug Administration (FDA), has applied for permission in Korea. Aduhel is a new drug for Alzheimer's disease approved by the U.S. FDA in 18 years, the first drug to target the amino acid peptide β-amyloid known to be involved in the disease. The FDA approved after much meandering last month, but controversy still persists. According to industry sources on the 15th, Biogen Korea recently applied for Aduhel's approval from the MFDS. Aduhel was approved by the U.S. Food and Drug Administration on the 7th (local time) on condition that a post-marketing investigation would prove its effectiveness. The FDA determined that Aduhel's therapeutic benefits over risk for Alzheimer's patients. Aduhel did not meet the primary evaluation variables in EMERGE and ENGAGE clinical trial studies. Accordingly, in November last year, the FDA advisory committee decided that there was insufficient evidence to prove its effectiveness. However, Biogen further analyzed the clinical data and applied for approval from the FDA based on validation in the high dose group. Aduhel was approved, but the controversy continues. Three FDA advisors who opposed Aduhel's approval resigned, raising controversy over the appropriateness of the permit. The FDA recently asked the Office of Independent Inspectors (OIG) to investigate Aduhel's approval. Some say that indications may have been reduced as the FDA suggested prescription guidelines and added that patients with mild cognitive impairment or early Alzheimer's should start using Aduhel. The MFDS has been reviewing new drugs approved by the U.S. FDA and European EMA by applying advantage. Therefore, most of them were granted without difficulty. It is expected that Aduhel will not be able to gather consensus during the screening process as controversy continues even after approval. However, it is believed that the demand for new drugs for Alzheimer's disease will be actively reflected in the licensing review. In June last year, Aduhel was approved for clinical 3b in Korea and tested its efficacy on 41 patients.
- Company
- Onivyde is expected to be eligible for insurance coverage
- by Eo, Yun-Ho Jul 16, 2021 05:54am
- The new pancreatic cancer drug Onivyde is expected to be listed on the insurance benefit. According to the industry, Servier recently concluded a negotiation with the NHIS for the listing of Onivyde(Irinotecan HCl). As a result, it is expected that new insurance benefits will be available in pancreatic cancer treatment. Onivyde is eligible for the benefit if it passes the final procedure, the Health Insurance Policy Committee. It is the first achievement in about four years since domestic approval was made in August 2017. The drug has passed the DC of major medical institutions, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. Combination of Onivyde and 5-FU/LV are available for patients who fail primary treatment based on Gemcitabine. Through a global NAPOLI-1 study, Onivyde significantly improved treatment performance by combining with the existing secondary treatment option 5-FU/LV in patients who failed Gemcitabine based primary treatment. It has become a reminder of the importance of sequential treatment strategies in treating metastatic pancreatic cancer. If Gemcitabine-based chemotherapy is used as a secondary chemotherapy for metastatic pancreatic cancer, it is the only treatment recommended by NCCN to be Category 1. Onivyde was approved by the Food and Drug Administration (FDA) in October 2015. Since then, Baxalta has acquired permission in Europe in October last year, and Shire has taken over development and sales rights in the global market except for the United States and Taiwan. Servier took over Shire's anti-cancer drug division and was granted permission from 2019.
- Policy
- Once 'out of stock' Bayer Aspirin 100mg to be discontinued
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- Bayer decided to discontinue domestic supply of its antipyretic analgesic, ‘Bayer Aspirin 100mg.’ Despite the company’s explanation that the decision was made due to poor sales, the pharmacys’ eyes are not so kind on the company's decision as they have suffered shortages of stock issues regarding the product. According to the Ministry of Food and Drug Safety on the 15th, Bayer has decided to discontinue the supply of its Bayer Aspirin 100mg tablet on the 31st of this month. Bayer Korea explained, “We made the difficult decision to discontinue import of the product due to a decline in sales. We will discontinue supply with the last import of the product on December 29th last year." However, the company will continue to import and sell the Bayer Aspirin 500mg tablet. The company plans to inform wholesalers and HCPs with an official notice at the time of discontinuation. As the indication, effect, dosage, and regimen of the 100mg and 500mg doses are identical, it seems unlikely that the market withdrawal of the 100mg dose will cause a supply shortage. Bayer Asprin tablets are used to reduce and relieve mild to moderate pain from the common cold and other conditions such as headaches, toothaches, sore throats, menstrual pain, muscle and joint pain, backache, and minor arthritis pain. Patients aged 15 and over may take 500mg~1000mg orally once every 4 hours. As the starting dose is 500mg, it is true that the 100mg tablets are sold less. However, as the dose is increased or reduced according to the patient's age, condition, and symptoms, and a lower dose is required for pediatric patients without an indication, the 100mg tablet does have its use. The Aspirin Protect tab. is also a 100mg product but it has a totally different indication as it is used for the prevention of cardiovascular diseases. Pharmacies have been less trusting of Bayer Aspirin products due to their frequent out-of-stock issues. In particular, in 2017, the company's relocation of its manufacturing plant from Germany from Indonesia had halted sales of the drug for over a year. The company resumed sales in November 2018, but the instability in supply and demand continued with the 100mg product later becoming temporarily out-of-stock. A pharmaceutical industry official said, “The Bayer Aspirin 100mg tablet was out of stock in June, but I didn’t expect the company to stop importing the drug completely. Due to the long-term out-of-stock issue of the 500mg product, I have lingering distrust in the company’s ability to provide a stable supply.” Bayer Aspirin was made by chemist Felix Hoffman in 1897 using acetylsalicylic acid based on a willow bark extract. The product, which has been sold for over 120 years, was released in Korea in 1980. According to IQVIA, the Bayer Aspirin tablet sold around 1.7 billion won in sales in Korea last year.
- Policy
- 2nd AZ·Pfizer·Moderna shot prevents variants by 80%
- by Lee, Hye-Kyung Jul 16, 2021 05:54am
- Study results on the preventive effect of the AstraZeneca, Pfizer, and Moderna vaccine against variants showed that the vaccines had a preventive effect of over 80% after completing the two-dose regimen. The prevention effect was greater against the Alpha variant than the Delta. In preventing symptomatic infections, the vaccines had a similar prevention effect against variants and the original virus. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine and the systemic reaction was at an acceptable level. The National Evidence-based Healthcare Collaborating Agency (NECA, President: Kwang-hyub Han) and the Korean Academy of Medical Sciences (KAMS, President:Ji-Tae Choung) jointly presented the results of the "Rapid review on issues regarding COVID-19 vaccines" study on the 15th. On the preventive effect of the current COVID-19 vaccines against variant strains such as the Alpha, Beta, Gamma, and Delta strains, the vaccines demonstrated a clinically significant effect (prevention of symptomatic infections, hospitalizations, and death). Regarding the preventive effect of the vaccines against variants, the vaccines were slightly less effective against the variants compared to the original virus, but still, the vaccine had a preventive effect of over 80% when subjects completed the two-dose regimen. The vaccines had a stronger preventive effect against the Alpha variant than the Delta. In preventing symptomatic infections, the preventive effect was of the vaccines was at a similar level for variants and the original virus. When completing a single shot of vaccination, the risk of hospitalization and deaths from variant infection was reduced by 78-96%, and after the second shot, by 86-96%. Also, the vaccines' effect on reducing hospitalization and deaths was not largely different against different types of variants, however, the data available as of now were insufficient to discern the severity of the events. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine. Systemic reactions increased after the use of mixed vaccines, but at an acceptable level. On the immunogenicity after receiving mixed vaccinations, the study showed that receiving mixed vaccinations also elicited a neutralizing antibody response against the COVID-19 virus. In general, immune response increased after mixed vaccinations compared to two doses of the AstraZeneca vaccine, and was similar or higher than that measured after two doses of an mRNA vaccine (Pfizer, Moderna). The mixed vaccination had increased systemic response compared to two doses of the same vaccine, but was tolerable and at an acceptable level. However, as only short-term safety studies existed on mixed vaccination, it was difficult to evaluate the adverse events that have a low incidence using studies based on the current scale. The mixed vaccination regimen had increased immune response against the variants compared to two shots of the AstraZeneca vaccine and had an increased or reduced effect compared to two shots of the Pfizer vaccine, depending on the type of variant. But the limitation was that only small-scale studies with limited results existed for review. No direct studies on preventing infections were available and only studies with immunogenicity results existed for review. Mi-young Choi, head of Clinical Evidence Research Team at NECA said, “This study was the first systemic literature review conducted on the use of mixed dose vaccinations and activities against the variant strains. As most of the reviewed literature were studies in progress or unpublished, quantitative and qualitative limitations do exist in our study.” KAMS Policy Director Ho-kee Yum (Chair of the Expert Committee for COVID-19 Response, Korean Medical Association) said, "We can predict and respond to new infectious diseases to a certain extent by studying existing clinical data. I believe the release of reliable study results from a medical society and the government like this will contribute greatly to reducing the public anxiety that has been rising recently and in overcoming the pandemic.”
- Company
- SMA tx Evrysdi has been applied for insurance benefits
- by Jul 16, 2021 05:54am
- Roche's Evrysdi, the second treatment for spinal muscular atrophy (SMA) in Korea, began the process of registering insurance benefits eight months after approval. According to the pharmaceutical industry on the 15th, Roche Korea applied to the HIRA earlier this month for the registration of the oral SMA treatment Evrysdi(Risdiplam). Evrysdi is the second domestically licensed treatment for spinal muscular dystrophy after Biogen's Spinraza. Although it was approved in November of last year, it has not been officially released in markets yet. A third treatment for spinal muscular dystrophy, Novartis' Zolgensma, has been approved. Novartis completed the application last month using the evaluation linkage system. Evrysdi was approved first, but Zolgensma's reimbursement was faster. Evrysdi is expected to be easy to register because it is cheaper than the previously listed Spinraza. Zolgensma are most expensive, so there are many concerns about which pay model to apply. Spinraza was also not easy to register at a high cost of nearly ₩100 million per vial at the time of the process. It took months before it was presented to the Pharmaceutical Benefits Advisory Committee. The final price of Spinraza is ₩9,2359,131. It costs ₩554.15 million per person in the first year, and ₩277.07 million from the following year. Patient's copayment is 10% of the total cost. Since Spinraza, which is already more expensive, has been reimbursed, it is not difficult to register if Evrysdi's drug price negotiation goes well. Evrysdi is also likely to follow the Expenditure Cap (RSA) applied to Spinraza. Zolgensma is a "one-shot treatment" that is only taken once in a lifetime, but the price is about ₩2.5 billion (based on the U.S.), the most expensive drug in Korea. The government and the company are considering ways to reduce the financial burden of health insurance. The company proposed a value-based RSA. The government are reviewing the Amortized Payment model. However, the only drug listed as Value-based RSA is "Evoltra," an acute lymphocytic leukemia treatment, and the Amortized Payment model is a new model that is attempted for the first time. It is expected to take some time to set detailed items such as standards and evaluation methods. Meanwhile, Evrysdi met the criteria for 'sitting without help' in BSID-III 12 months after treatment in the FIREFISH clinical trial of 41 infants from 2.2 to 6.9 months of age. 88% of patients on Evrysdi over two years survived without respirators for two years. In addition, the SUNFISH study of 180 patients aged 2-25 demonstrated improvement in motor function evaluation scale MFM-32 of Evrysdi in the 12th month of treatment.
