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- 2026-04-08 06:56:15
- Policy
- Pfizer starts trial for its RSV drug sisunatovir on adults
- by Lee, Hye-Kyung Mar 08, 2024 05:19am
- Pfizer will initiate a clinical trial for its respiratory syncytial virus (RSV) infection drug sisunatovir in adults in Korea. The company had previously initiated a trial for the drug on pediatric patients in Korea. On the 7th, the Ministry of Food and Drug Safety (MFDS) approved Pfizer's "interventional Phase II/III, adaptive, multicenter, randomized, double-blind clinical trial to compare the efficacy and safety of oral sisunatovir with placebo in non-hospitalized adults with symptomatic respiratory syncytial virus infection at risk of progression to severe disease.” The trial will be conducted in Chungnam National University Hospital, Korea University Medicine, Chilgok Kyungpook National University Medical Center, Gachon University Gil Hospital, Konkuk University Medical Center, Chonnam National University Hospital, Ewha Womans University Mokdong Hospital, Gangnam Severance Hospital, Wonju Severance Christian Hospital, Ajou University Hospital, Korea University Ansan Hospital, Kangdong Sacred Heart Hospital, Seoul Asan Medical Center, Jeonbuk National University Hospital, Hallym University Gangnam Medical Center, Eunpyeong Saint Mary's Hospital, Seoul Saint Mary's Hospital, and Korea University Guro Hospital. The company acquired the new drug candidate in 2022 when it acquired the UK-based antiviral drug developer ReViral. At the time, Pfizer paid up to USD 525 million to ReViral, which included an upfront payment and future development milestone payments. If successful, Pfizer expected ReViral’s programs to generate annual sales of over USD 1.5 billion. Reviral had received a Fast Track designation for sisunatovir from the US. FDA in August 2020 and initiated two international multi-phase clinical studies in pediatric and high-risk adult patients. RSV is a respiratory pathogen that can cause severe and fatal lower respiratory tract infections (LRTIs) in high-risk populations, including infants, immunocompromised individuals, and the elderly. Approximately 64 million people are infected each year, resulting in 160,000 deaths. Developing preventive treatments for RSV is an area that has been receiving much interest from global big pharmaceutical companies, and last year, RSV vaccines GSK's Arexvy and Pfizer's Abrysvo were approved by the US FDA. Also, AstraZeneca and Sanofi’s preventive antibody RSV treatment ‘Beyfortus’ was approved last year. Currently, there is no vaccine or antiviral drug available for the RSV virus, and AstraZeneca's Synagis is used in Korea to prevent severe lower respiratory tract diseases in children who require hospitalization due to RSV. Among Korean companies, SK Bioscience is working to discover an RSV vaccine candidate, and EUGiologics is preparing preclinical trials.
- Policy
- Pharmas impacted by ‘minoxidil’ bioequivalence test result
- by Lee, Hye-Kyung Mar 08, 2024 05:18am
- The bioequivalence re-evaluation of the active ingredient ‘minoxidil’ in comparison to Hyundai Pharm’s Bioequivalence test outcomes result in different paths for prescription drugs containing the active ingredient ‘minoxidil,’ which was first introduced as a hypertension drug but is now commonly used as a hair-loss drug. The Ministry of Food and Drug Safety (MFDS) recently issued a two-month sales suspension order on Binex’s ‘Bimo Tab 5mg.’ Binex received a notice for ‘Failing to submit the required documents for the 2023 bioequivalence re-evaluation of medicines.’ As a result, the company is banned from selling the item in question from March 11th to May 10th. Although Bimo Tab received a drug suspension settlement, Binex continues attempting bioequivalence test. Binex received approval from the MFDS on February 6th to conduct a bioequivalence study to re-evaluate Bimo Tab and Hyundai Pharm’s 'Minoxidil Tab Hyundai' and has completed patient recruitment. Due to a late start, the company’s submission of equivalence test report may have been delayed. “The delay in the bioequivalence study was due to protocol issues during the preparation process for the equivalence re-evaluation,” a Binex official stated. “Patient recruitment has been completed, and the first phase of blood sampling has been conducted.” The eight products containing the active ingredient minoxidil underwent a re-evaluation for equivalence. These products include Union Korea Pharm’s 'Uni-Minoxidil Tab,' TheU Pharmaceuticals' 'Momosidil Tab,' Medica Korea’s 'Medica-Minoxidil Tab,' Binex’s 'Bimo Tab 5mg,' Auskorea Pharm’s 'Minoxion Tab,' Biopharma’s 'Introminoxidil Tab,' Dae Han New Pharm’s 'DHNP Minoxidil Tab,' and Dongkwang Pharm’s 'Minoxidil Tab 5mg Dongkwang.' DHNP Minoxidil Tab and Medica-Minoxidil Tab were voluntarily withdrawn. Meanwhile, Minoxion Tab and Introminoxidil Tab are currently not in production. Therefore, the four products subjected to equivalence re-evaluation included Minoxidil Tab 5mg Dongkwang, Bimo Tab, Uni-Minoxidil Tab, and Momosidil Tab. Among these, Uni-Minoxidil Tab and Momosidil Tab showed inequivalent compared to Hyundai Pharm’s 'Minoxidil Tab Hyundai' in the bioequivalence test, leading to a recall order for companies on February 7th. Also, Bimo Tab is currently under a suspension of sales order. The only re-evaluated product currently approved for marketing is Minoxidil Tab Dongkwang. The MFDS is reviewing the submitted bioequivalence results report. However, the bioequivalence test for Bimo Tab, which received administrative order, is ongoing. Additionally, Union Korea Pharm is conducting new bioequivalence test for Uni-Minoxidil Tab after a recall, the results of which are currently unknown. Union Korea Pharm received approval from the MFDS on February 21st to conduct bioequivalence test for the Uni-Minoxidil Tab. "After reviewing the bioequivalence report submitted for Uni-Minoxidil, it was found that the drug was not equivalent and had to be recalled. The company revised its bioequivalence test plan and obtained re-approval," an MFDS official stated. The official added, "The bioequivalence re-evaluation will maintain the product's approval status intact, limiting the recall of products already distributed in the market. As the re-evaluation continues, Union Korea Pharm has amended its test plan to conduct bioequivalence test again."
- Policy
- CSL Behring’s hemophilia B Tx Idelvion reattempts reimb
- by Lee, Tak-Sun Mar 08, 2024 05:18am
- CSL Behring, a subsidiary of Australian multinational pharmaceutical giant CSL, is reattempting to receive reimbursement benefits for its hemophilia treatment in Korea. CSL Behring holds the domestic marketing authorization and reimbursement rights for the hemophilia drug Afstyla Inj which was developed by SK Chemicals. According to industry sources on the 7th, the reimbursement adequacy of CSL Behring’s hemophilia B treatment ‘Idelvion Inj’ was discussed at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that was held on the 7th. The drug had previously been reviewed by the committee in July 2021. At the time, the committee determined that Idelvion’s reimbursement was adequate if the company accepted a price below the assessed value, but there had been no news of progress being made since then. So it is understood that the company did not accept a lower assessed price. And more than 3 years later, the company has reapplied for reimbursement. The drug is indicated for the ▲control and prevention of bleeding episodes, ▲ control and prevention of bleeding in the perioperative setting, and ▲ routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency). In Korea’s hemophilia B treatment market, Pfizer’s ‘BeneFIX Inj’ owns the top market share. If reimbursed, Idelvion is expected to rise and become a viable competitor to BeneFX, fueled by its more convenient dosing frequency, as it can be administered once every 1 to 3 weeks. On the other hand, BeneFIX is administered once or twice weekly. In the PROLONG-9FP trial, patients who were administered Idelvion maintained mean Factor IX activity by over 5% for over 14 days with a single 75 IU/kg administration and a median annualized spontaneous bleeding rate (AsBR) of 0.00. Also, in a clinical trial that reviewed the long-term effect of Idelvion, patients who received 100 IU/kg every 21 days showed FIX activity levels in the 7.6% range. AsBR in the 14-day and 21-day regimen were all similar to the 7-day regimen. Based on these findings, Idelvion was approved by the US FDA and in Europe, Japan, and Canada in 2016. In Korea, the drug was approved in March 2020.
- Company
- Anemia drug ‘Vadanem’ makes 2nd attempt at reimb listing
- by Nho, Byung Chul Mar 08, 2024 05:18am
- Mitsubishi Tanabe Pharma Vadanem, Mitsubishi Tanabe Pharma’s new tablet anemia drug, will likely receive approval from the U.S. Food and Drug Administration by early April and make a second attempt at getting a reimbursement listing in Korea. If the company gets the drug reasonably priced comparable to a weighted average price of the substitute during drug pricing negotiation with the Health Insurance Review and Assessment Service (HIRA), the drug will be recorded as the first new anemia drug in tablet form to be commercialized in Korea. According to the pharmaceutical industry, Vadanem (vadadustat) has been re-submitted for U.S. approval for the indication of ‘Treating anemia in adult patients with chronic kidney disease who are receiving dialysis.’ The FDA is conducting a positive review of the submission. Furthermore, listing Vadanem, which received European approval in May 2023, for EU drug pricing is proceeding smoothly. Considering its ongoing FDA approval and European listing schedule, Mitsubishi Tanabe Pharma aims to negotiate with the HIRA for drug pricing within May. However, insurance reimbursement will be available for its known original efficacy in treating anemia in dialysis patients but not in non-dialysis patients. EPO ingredient, developed 30 years ago, is the only new anemia drug available. The products are available as third-generation injection forms with longer administration duration. Increasing demand for new mechanism-based treatments arose due to patients' unresponsiveness to conventional drugs and side effects such as changes in blood pressure and vomiting. Vadanem, which acquired the BLA from the Ministry of Food and Drug Safety (MFDS), is an anemia drug for treating adult patients with chronic kidney disease who are receiving dialysis. It inhibits Hypoxia-inducible factor (HIF) prolyl hydroxylase and promotes Erythropoiesis. HIF is a protein that responds to decreased oxygen supply in cells. When starting Vadanem treatment, patients must have sufficient storage ions and be checked for levels of transferrin saturation (TSAT) and ferritin. The starting reference dose is below 10 g/dL hemoglobin (Hb) for patients who had not previously been treated with erythropoiesis-stimulating agents (ESA). It is possible to switch patients who are receiving ESA to this medication. Vadadustat is orally administered at an initial dose of 300 mg once daily, and after treatment, the dose can be gradually increased depending on the patient's condition. The maximum dose is 600 mg once daily. The need for expedited approval processes for innovative drugs related to kidney disease is driven by the necessity to expand treatment options for patients and reduce health insurance expenses. The number of chronic kidney disease patients in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021, according to data from the National Health Insurance Service (NHIS). Particularly noteworthy is the 82.8% surge among individuals in their 80s during the same period. The number of patients undergoing dialysis is increasing exponentially. The NHIS spends nearly KRW 3 trillion on approximately 100,000 patients. Moreover, patient adherence is expected to increase as Vadanem is an oral tablet, unlike conventional erythropoiesis-stimulating agents that are administered only via injection. Another oral formulation erythropoiesis-stimulating agent similar to Vadanem is JW Pharmaceutical's Enaroy Tab (enarodustat, approved in Korea in 2022). Enaroy Tab is scheduled to undergo reimbursement listing based on the weighted average price of the substitute drug. AstraZeneca's new erythropoiesis-stimulating agent Evrenzo Tab, containing the active ingredient roxadustat, received approval in Korea in 2021. However, due to the company's policy of pricing orphan drugs at a high cost, it seems they have stopped conducting economic evaluations and proposals for a weighted average price of the substitute drug.
- Policy
- 2yr use restriction lifted for Alimta+Keytruda combo reimb
- by Lee, Tak-Sun Mar 08, 2024 05:18am
- The reimbursement period for the Alimta+Keytruda+platinum-based chemotherapy is set to be extended. Previously, the 3-drug combination was covered for up to 2 years, but the Cancer Disease Deliberation Committee decided to remove this restriction from the reimbursement standards. The Health Insurance Review and Assessment Service announced that it had made the decision above at the 2nd 2024 Cancer Disease Review Committee meeting that was held on March 6. After deliberations, the CDDC decided to remove the maximum 2-year coverage restriction set for pemetrexed drugs such as Alimta Inj used in combination with pembrolizumab and platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous NSCLC without EGFR or ALK mutations. This is expected to reduce the financial burden borne by patients who use the regimen for a longer period of time. The reimbursement standards for Clinigen Korea’s Erwinase Inj will also be changed, and its use as ‘a component of a chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase’ that was allowed for patients with level 3 or higher allergic reactions will be changed to level 2. Reimbursement standards for Zavedos Inj (idarubicin), which Pfizer Korea applied to extend reimbursement as an idarubicin monotherapy for transarterial chemoembolization (TACE) in liver cancer, were not set, however, off-label use with partial copayment 5/100 was approved. Also, reimbursement extension requests for Lonquex Pre-filled Inj (lipegfilgrastim, Teva-Handok), Taxotere 1 Vial Inj (docetaxel trihydrate, Sanofi), Verzenio Tab (abemaciclib, Lilly) were not accepted, and were not set. Also, all 3 drugs that applied for new reimbursement listings - Tepmetko Tab (tepotinib, Merck), Pemazyre Tab (pemigatinib, Handok), and Tevimbra (tiselizumab, Beigene) – were unable to pass the CDDC stage. For the second year, the reimbursement progress for Tepmetko Tab has remained stalled at the CDDC stage.
- Policy
- DPK urges doctors to return to work
- by Lee, Jeong-Hwan Mar 07, 2024 07:16am
- Rep. Kim Min-seok, the head of the Democratic Party’s situation room. The Democratic Party of Korea (DPK) urged trainee doctors who walked off the job en masse to return to their medical sectors. Furthermore, the DPK suggested that medical community negotiate a reasonable capacity of medical school admissions. The ruling party has temporarily allowed non-face-to-face medical treatment to address the current absence of trainee doctors in hospitals. In response, the DPK has officially requested the government allow additional supportive systems, including active ingredient prescribing and prescription refills, also temporarily. “We understand the concerns regarding the medical crisis. In response, the Democratic Party has established an emergency situation team, affiliated with the party’s situation room, for medical crisis,” Rep. Kim Min-seok, the head of the Democratic Party’s situation room, announced on the 3rd during the press conference at the National Assembly’s communication building. The DPK has acknowledged that expanding medical school quotas is a timely issue for the medical community. They suggest that the reasonable capacity of expansion should be determined through dialogue. "With my expereince serving as the chair of the Ministry of Health and Welfare (MOHW), I will personally oversee the development of measures by communicating with medical community," Kim added, "I am already communicating with various medical professional organizations, including not only doctors but also nurses and pharmacists," Kim said. "We must be cautious about expanding the medical school enrollment quota, as it might increase non-insured doctors in the metropolitan area. Therefore, we should consider implementing supportive systems like regional doctor quotas," Kim said. "The government should also discuss with the medical community, including the possibility of introducing regional doctors quotas along with the issue of medical school." The DPK proposed the temporary allowance of active ingredient prescribing and prescription refills in order to reorganisze the non-face-to-face medical treatment pilot project, which is being implemented without legal basis. "The government has announced measures to temporarily allow non-face-to-face medical treatment without legal basis, unrelated to the current crisis," Kim emphasized. He added, "If such measures are necessary, implementing supportive systems like active ingredient prescribing and prescription refills, even temporarily, will ensure integrity." Kim also argued, "The government's proposal to allow Physician Assistants (PAs), which is currently illegal under existing laws, citing medical crises and treatment disruptions, would ultimately shift responsibility onto medical institutions and nurses, resulting in irresponsible consequences." "The government must clearly outline the legal basis for implementing nursing law," Kim said. "If the Nursing Act, promoted in the National Assembly, had been passed earlier without the president's veto, it would have helped deal with the PA issue more stably in the current situation. I hope that the government takes note of this," Kim added. Kim continued, "There is a need to reconsider the government's stance of not communicating with the Korean Medical Association as a channel for dialogue and communication." "The DPK will do its best to alleviate the damage to patients and the anxiety of the public due to the confusion in the medical field," Kim added.
- Policy
- High-strength Ebixa generics start receiving approval again
- by Lee, Hye-Kyung Mar 07, 2024 07:16am
- Approvals for generic versions of the high-strength Ebixa 20mg (memantine hydrochloride), a treatment for severe Alzheimer's, that had been slowing down lately, have begun to gain momentum again. On March 5, the Ministry of Food and Drug Safety approved Dongkook Pharmaceuticals 'Memantine Tab 20mg.' Eighteen years after the 10mg formulation of the original memantine drug Ebixa (company: Lundbeck Korea) was approved in September 2003, the 20mg formulation that offers improved patient convenience had been released in November 2021. Unlike how patients had to take the 10mg formulation twice daily, the higher-strength 20mg tablet formulation can be taken only once a day, significantly improving dosing convenience. In particular, the release of such high-strength products by the market leader Eisai Korea’s ‘Aricept (donepezil hydrochloride)’ and the runner-up Ebixa has attracted the attention of domestic pharmaceutical companies. According to UBIST, outpatient prescription sales of Aricept were KRW 86.1 billion and Ebixa KRW 16.9 billion in 2021. Eleven months after the approval of Ebixa 20mg, Hyundai Pharm’s ‘Dimantine Tab’ became the first high-strength generic to receive approval in Korea. Launching the first 20mg generic version in addition to the existing Dimantine 5mg and 10mg, the company promoted the release of a new treatment option. Last year, 3 Korean pharmaceutical companies made a bid into the high-strength Ebixa market: Myung In Pharmaceutical’s ‘Fello OD Tab,’ Korean Drug Co’s ‘Admed Tab,’ and Huons’ ‘Easymantine Tab.’ In particular, only Whan In Pharm and Myung In Pharmaceutical had approvals for low-strength oral disintegrating tablet formulations of Ebixa. Orally disintegrating tablets are more convenient than capsules or tablets, and in the case of memantine, which is used to treat dementia, it was evaluated to be more effective as many patients have swallowing disorders. Due to this, Myung In Pharmaceutical first gained competitiveness with its high-strength Fello OD. With Dongkook Pharmaceutical also waiting to enter Ebixa’s high-strength generic market, which has been sluggish since Huons received approval for its Easymantine Tab 20mg in October last year, 6 companies are set to compete in the market from now on. Use of high-dose memantine must be initiated by a physician experienced in the diagnosis and treatment of Alzheimer's disease, and only if a caregiver is available to regularly check the patient's compliance with the medication. The drug is administered orally once daily, and the recommended dose is 20 mg per day in elderly patients over the age of 65.
- Policy
- Once-weekly growth hormone Sogroya is approved in Korea
- by Lee, Hye-Kyung Mar 07, 2024 07:16am
- A growth hormone that can be administered once weekly was approved in Korea. The Ministry of Food and Drug Safety approved Novo Nordisk’s ‘Sogroya Prefilled Pen (somapacitan-beco)’ 5mg, 10mg, and 15mg on June 6. Sogroya is a once-weekly treatment for adult hormone deficiency and is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and in adults with growth hormone deficiency (adult GHD) in Korea. As a type of human growth hormone analogue that is injected subcutaneously once a week, Sogroya offers better dosage convenience over existing growth hormone formulations that require daily dosing. The drug was approved by the US FDA in 2020 based on results from a comprehensive clinical development program, including those from the REAL 1 trial. The Real 1 trial was a Phase III, randomized, parallel-group, double-blind, placebo-controlled trial that was conducted on treatment-naïve patients with adult GHD for 35 weeks. In the trial, a total of 300 adult patients with adult GHD were recruited and randomized to treatment with once-weekly Sogroya, once-weekly placebo, or once-daily somatropin. Results showed that patients treated with Sogroya demonstrated a mean reduction of 1.06% in truncal fat at week 34, a significant difference compared with the 0.47% increase found with the use of placebo. Patients treated with daily somatropin achieved a change in truncal fat % of -2.23% after 34 weeks. Sogroya was approved and released in Japan in 2021, at a price of JPY 26,107 for the 5mg vial and JPY 52,214 for the 10mg vial.
- Company
- Oral PNH drug Fabhalta to soon be released in Korea
- by Eo, Yun-Ho Mar 07, 2024 07:15am
- Novartis' new PNH drug Fabhalta is set to land in Korea. According to industry sources, Novartis Korea has submitted an application for the marketing authorization of its Paroxysmal Nocturnal Hemoglobinuria (PNH) drug Fabhalta (iptacopan) to the Ministry of Food and Drug Safety. Therefore, the drug is expected to be approved within this year. After receiving approval from the US Food and Drug Administration (FDA) at the end of the past year, the company is also undergoing review processes for Fabhalta’s approval in Europe and Japan. Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). As an oral formulation, the drug offers better dosing convenience over existing intravenous formulations like Soliris and Ultomiris. The drug’s efficacy was confirmed through the Phase III APPLY-PNH trial in patients with residual anemia despite prior anti-C5 treatment who switched to Fabhalta and the Phase III APPOINT-PNH study in complement inhibitor-naïve patients. During the 24-week core treatment periods in the APPLY-PNH and APPOINT-PNH trials 82.3% of anti-C5-experienced Fabhalta patients, 0% of anti-C5-treated patients, and 77.5% of complement inhibitor-naïve patients showed sustained increase of hemoglobin levels of 2 g/dLa or higher from baseline in the absence of transfusions. Also, 67.7% of anti-C5-experienced Fabhalta patients and 0% of anti-C5 patients sustained a hemoglobin level of 12 g/dLa or higher without transfusion. The rate of patients avoiding transfusion was 95.2% for anti-C5-experienced Fabhalta patients and 45.7% for anti-C5-treated patients. The most commonly reported adverse reactions with Fabhalta were headache, diarrhea, abdominal pain, viral infection, and nasopharyngitis. However, a black box warning was included on the risk of serious infections caused by encapsulated bacteria. Meanwhile, competition in the PNH market is expected to intensify in the coming years. AstraZeneca launched Ultomiris (ravulizumab) as a follow-on to Soliris (eculizumab), and Soliris’s patent is due to expire in Europe in 2023 and in the US in 2027. Ultomiris is given intravenously every 2 weeks whereas Soliris is administered every 8 weeks. Roche is also preparing to commercialize crovalimab, which has shown promise in a head-to-head trial with Soliris. The drug recently received the first approval in China and has been designated an orphan drug in Korea. In addition, Samsung Bioepis's Soliris biosimilar ‘Episcli’ recently received approval in Korea. This is the first Soliris biosimilar approved in Korea, and Samsung Bioepis also received approval for the drug in Europe last year.
- Policy
- The RSA track to include drugs for chronic diseases, asthma
- by Lee, Tak-Sun Mar 07, 2024 07:15am
- The Risk Sharing Agreement (RSA) will cover chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. It was announced last year as part of ‘The drug pricing system to ensure fair-value compensation for innovative new drugs.’ Since the announcement, the RSA has covered several drugs to treat chronic and severe disorders. The committee will now develop detailed guidelines to ensure the implementation of these measures. The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) will hold a meeting on the 7th to review the guidelines, according to the industry sources on the 6th. The current RSA only applies to anticancer and orphan drugs treating life-threatening severe diseases without substitute drugs. However, there were cases where the RSA covered other severe diseases besides orphan drugs. For instance, ‘Dupixent inj,’ a drug used to treat severe atopic dermatitis, and the severe asthma drug ‘Nucala’ have been covered by health insurance reimbursement via RSA. The government will additionally apply RSA to drugs treating chronic and severe diseases to provide better patient insurance benefits. The government will promptly implement this measure because RSA has already covered several drugs for treating severe diseases, and the administrative work only includes developing detailed guidelines. This is the first measure to implement ‘The drug pricing system to ensure fair-value compensation for innovative new drugs,’ announced last year. Therefore, once the DREC reaches an agreement, it is expected that drugs for treating chronic and severe diseases causing irreversible deterioration in the quality of life, including generalized pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma, will be covered by RSA and later, those drugs will likely be reimbursement listed. The DREC, which will be held on the 7th, will also review the reimbursement appropriateness of Fasenra Pre-filled Syringe Inj. (benralizumab, AZ), used for treating severe eosinophilic asthma. Fasenra Pre-filled Syringe Inj. received a reimbursement status via RSA at the DREC last September. However, it did not receive a non-reimbursement decision. On the other hand, Nucala (mepolizumab, GSK), a severe eosinophilic asthma treatment similar to Fasenra, was successfully listed for reimbursement via RSA. Whether Fasenra will clear the reimbursement appropriateness and the expansion of the RSA measure is to be watched.
