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- 2026-04-08 13:42:22
- 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.
- Opinion
- [Reporter’s View] On MFDS’s new drug management team
- by Lee, Hye-Kyung Mar 06, 2024 06:03am
- A new drug management support team will be established under the Ministry of Food and Drug Safety’s Pharmaceutical Safety Bureau. According to the 'Partial Amendment of the Enforcement Rules of the Ministry of Food and Drug Safety and its Affiliated Institutions' that was released by the MFDS on February 7, the MFDS will newly establish a drug safety management team using the total payroll costs system. As such, the MFDS is expected to reorganize and make personnel appointments to reflect the amendments in the near future. The role of the Pharmaceutical Management Support Team will focus on managing items with unstable supply and demand. The duties of the head of the Pharmaceutical Management Support Team include overseeing the procurement policies for medical products in response to public health crises, operating the Safety Management and Supply Committee, establishing and operating information systems, approving emergency use of drugs, designating, managing, and stabilizing the supply of national essential medicines, operating the drug supply forecast system, managing the targets for reporting production and supply interruptions, and managing Korea Orphan & Essential Drug Center projects. The Pharmaceutical Management Support Team will also take over some of the tasks currently handled by the Pharmaceutical Policy Division. The team will also represent the MFDS at the public-private consultative meetings held to respond to unstable drug supply and demand, which have been held 13 times so far. The imbalance in the supply and demand of medicines has intensified since COVID-19, and through the public-private consultative meeting, measures for distribution management and administration are being explored. The MFDS monitors the unstable supply and demand items and simultaneously requests pharmaceutical companies to cooperate with production while seeking measures to support drugs that have supply disruptions due to problems such as unavailability. As such, there is consensus on the need to separately manage drug supply and demand instabilities. It is a positive sign that the MFDS plans to separate the Pharmaceutical Management Support Team from the Pharmaceutical Policy Division to manage items with unstable supply and demand. However, unlike the Narcotics Prevention and Rehabilitation Team, whose team leader is appointed from 4th Grade or above, the head of the Pharmaceutical Management Support Team can be a 5th Grade official. The team is supposed to be in charge of encouraging pharmaceutical companies to manufacture and provide administrative support to stabilize the supply of medical products to respond to public crises, but instead of a Director with a Grade 4 clearance or higher, a Grade 5 Deputy Director would be in charge. Although they can manage, it would have been nice to have a Deputy Director take charge of the team and make viable promises to pharmaceutical companies. In addition, the Pharmaceutical Management Support Team will have a set term and will end on January 31, 2027. After the term, the team’s tasks will be reassigned to the Pharmaceutical Policy Division. However, when looking at the roles taken by the Pharmaceutical Management Support Team, the team seems to be an indispensable department that has a close relationship with medical institutions, pharmacies, and pharmaceutical companies. The MFDS’s decision to reorganize its structure to manage the unstable supply and demand of drugs is laudable, but thoughts are required on whether a 3-year temporary team with a team leader at the level of a 5th-grade official will be able to function as intended.
- Company
- Rare drug Ultomiris posts KRW 40 billion in sales in 3 yrs
- by Nho, Byung Chul Mar 06, 2024 06:03am
- Becoming a KRW 40 billion blockbuster in just 3 years since its launch, the growth potential of AstraZeneca’s Ultomiris Inj (ravulizumab) is gaining industry-wide attention. The biological orphan drug Ultomiris Inj. is considered to be the successor to Soliris Inj. (eculizumab) with significant improvements in dosing convenience. The drug was approved in June 2021 at a reimbursed price of KRW 5,598,942 for the 30 ml vial and is indicated for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. By Q3 2021, 2022, 2023, Ultomiris has generated sales of KRW 19.5 billion, KRW 43.1 billion, and KRW 37.8 billion, respectively. Ultomiris is administered every 8 weeks as a maintenance dose (through intravenous infusion 2 weeks after administering a loading dose based on body weight). In contrast, Soliris is dosed with weekly intravenous infusions for the first 4 weeks, followed by a 5th dose 7 days after the fourth dose, and then every 2 weeks thereafter. While Ultomiris is a follow-on to Soliris, it is notable that Soliris still maintains sales as a blockbuster drug that posts sales in the KRW 10 billion range, by securing indications such as systemic myasthenia gravis and neuromyelitis optica spectrum disorder. Soliris had generated KRW 43.8 billion to KRW 43.9 billion in sales in 2019-2020 before the launch of Ultomiris. Since then, it has maintained sales of KRW 31 billion, KRW 10.1 billion, and KRW 6.4 billion through Q3 in 2021, 2022, and 2023, respectively. In addition, Soliris has undergone two drug price cuts from KRW 6,138,844 in February 2017 and is currently priced at KRW 5,132,364 per 30ml vial. PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system. Without treatment, 4 out of 10 patients die within 5 years after diagnosis. In Korea, around 200 patients suffer from PNH. Until Ultomiris’s launch in Korea in 2012, Soliris was the only treatment for PNH and was shown to improve the 5-year survival rate by 95.5%. Meanwhile, Ultomiris’s efficacy was demonstrated through 2 prospective studies (Study 301 and Study 302) that were conducted on PNH patients. In both studies, Ultomiris demonstrated non-inferiority compared to Soliris in the primary efficacy endpoints of avoidance of the need for transfusions, LDH normalization, and LDH change rate, as well as in the secondary endpoints of LDH change rate, change in the quality of life (FACIT-Fatigue), breakthrough hemolysis, and proportion of patients with stabilized hemoglobin. In addition, a preference assessment study that was conducted as an extension study in patients with paroxysmal nocturnal hemoglobinuria who were previously treated with both Soliris and Ultomiris showed that 93% of patients preferred Ultomiris.
- Company
- Reimb for Verzenio in early breast cancer undergoes review
- by Eo, Yun-Ho Mar 06, 2024 06:03am
- Verzenio, the first CDK4/6 inhibitor to apply for insurance reimbursement in early breast cancer, is taking the second step to extend its reimbursement coverage. According to a report, the agenda of reimbursing Lilly Korea’s Verzenio (abemaciclib) will be presented to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee today (March 6). Therefore, the industry’s attention is on whether Verzenio will succeed in its second reimbursement attempt. The company had difficulty reaching the CDDC stage during its first attempt for reimbursement in early breast cancer. After a long 6-month wait after submitting the application, the case reached the CDDC deliberation stage in May last year, but no standards were set. The company resubmitted the reimbursement application 5 months later to HIRA in October. The same month, a petition was posted on the Cheong Wa Dae National Petition Board, “Petition requesting reimbursement for the targeted therapy Verzenio in early breast cancer.” Also, the application was backed by additional clinical evidence.: 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress. This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium Annual and Lancet Oncology in December 2022. Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4. At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms. This suggests that even after completing treatment with Verzenio for a limited period of time, 2 years after the surgery, the treatment benefit continued to year 5. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer. The drug’s indication was expanded on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, the drug is indicated for a very limited range of patients with ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and tumor size of 5 cm or larger, or ▲histological grade 3 disease. Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio and endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”
- Company
- Cash cow ‘bepotastine’ to face reimb re-evaluation
- by Chon, Seung-Hyun Mar 06, 2024 06:02am
- In facing re-evaluation of ‘bepotastine’ for reimbursement in the upcoming year, pharmaceutical companies fear its impact. The market size for bepotastine has increased by more than 50% in just two years during the pandemic and endemic, labeling bepotastine as a new cash cow. However, there are concerns that the companies may face financial loss if drugs containing bepotastine as an active ingredient receive negative results from the re-evaluation, such as reduced reimbursement or removal. According to industry on the 6th, the Ministry of Health and Welfare (MOHW) recently held the Health Insurance Policy Review Committee, where they reported on drugs that will be re-evaluated for reimbursement appropriateness in 2025. Next year, the reimbursement appropriateness of eight active ingredients, including olopatadine, clematis radix plus trichosanthes root plus prunella spike, bepotastine, spherical adsorptive carbon, artemisia Herb extract, L-ornithine- L-aspartate, and chenodeoxycholic acid-ursodeoxycholic acid, will be determined through the re-evaluation. The MOHW explained, “We have selected eight active ingredients. Five active ingredients have been listed for an extended time, and three active ingredients are currently under clinical re-evaluation by the Ministry of Food and Drug Safety (MFDS)." The MOHW will perform a comprehensive analysis and evaluation of drugs based on clinical research article results, clinical usefulness, cost-effectiveness compared to substitute drugs, and the overall increase in insurance benefits for society. The compiled data will be reviewed by experts, and the MOHW will decide whether to maintain, reduce, or remove reimbursement. The industry is particularly interested in hearing results from the MOHW’s re-evaluation of the appropriateness of reimbursement for bepotastine because the market has expanded significantly recently. Pharmaceutical companies may face financial loss if the drugs containing bepotastine receive negative results from the re-evaluation, such as reduced reimbursement or removal of indication. Annual outpatient prescription sales for bepotastine (unit: 100 million won, source: UBIST). Bepotastine is a drug used to treat perennial allergic rhinitis, chronic hives, and pruritus accompanied by skin disorders. The prescription market for bepotastine experienced rapid growth during COVID-19 and endemic. According to UBIST, a pharmaceutical market research agency, the out-patient prescription market size for bepotastine was 70.2 billion won last year, an increase of 17.7% from the previous year. The prescription market size for bepotastine stayed mainly the same between 2018 and 2021, generating 45.3 billion won and 45.3 billion, respectively. However, it reached 59.7 billion won in 2022, showing a growth of 31.8%, and even greater last year. The prescription market size for bepotastine expanded to 55.2% in the past two years. Since the end of 2021, there has been a significant surge in demand for nasal discharge treatment, which is one of the remedies to alleviate symptoms of COVID-19. This is due to the increasing number of people testing positive for COVID-19, with hundreds of thousands of new cases daily. Even after the pandemic, there are still many COVID-19-positive patients and growing patients with influenza or the common cold, leading to even greater demand for bepotastine. Dong-A Pharmaceutical’s Twolion dominates the prescription market for bepotastine. Twolion’s prescription sales were 10.7 billion won, up 11.7% from the previous year. In two years, it has increased 33.1% from 8.1 billion won in 2021. Mitsubishi Tanabe Pharma’s Talion is the original medicine with bepotastine as an active ingredient. Initially, Dong-A ST marketed Talion, but Mitsubishi Tanabe Pharma withdrew from the Korean market after its patent expired at the end of July. Since then, Dong-A Pharmaceutical received approval for Twolion, a generic version of Talion, and Dong-A ST is responsible for its marketing. Daewon Pharm’s Bepostarbi recorded 4.9 billion won in prescription sales last year, a 29.1% increase in just two years since making 3.8 billion in 2021. Dong Kook Pharmaceutical’s Bepotan accumulated 3.7 billion won in prescription sales, up 47.0% from two years ago. The prescription sales for Medica Korea’s Galion were merely 1.4 billion in 2021 but recorded 3.3 billion won last year, more than doubling the size. Only two of the eight active ingredients survived the reimbursement re-evaluation conducted last year by the MOHW. The MOHW conducted re-evaluation of reimbursement on eight ingredients, including rebamipide, levosulpiride, loxoprofen sodium, limaprost alfadex, epinastine hydrochloride, oxiracetam, acetyl-L-carnitine hydrochloride, and hyaluronic acid (HA) eye drops. Only two of the ingredients, rebamipide and levosulpiride, maintained their reimbursement prices since the drugs proved clinical usefulness. Loxoprofen sodium, limaprost alfadex, and epinastine hydrochloride are the three active ingredients receiving reimbursement cuts. Loxoprofen sodium’s indication, ‘Reducing fever and pain relief for acute upper respiratory inflammation,’ will be excluded from receiving the reimbursement. For limaprost alfadex, the reimbursement will not cover its indication, one of the two, for ‘Improving ischemic symptoms such as ulcer, pain, and cold sensation that are associated with thromboangitis obliterans.’ Oxiracetam and acetyl-L-carnitine hydrochloride were excluded from the current re-evaluation because the MOHW had already stopped allowing reimbursement for those two ingredients due to inadequate demonstration of their effectiveness based on the MFDS’s clinical re-assessment. The decision for hyaluronic acid (HA) eye drops has been postponed until reimbursement criteria for all disposable eye drops are established.
- Company
- Dupixent, 1st biologic approved for pruritic rash indication
- by Son, Hyung-Min Mar 05, 2024 05:49am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center. As Dupixent is approved to treat prurigo nodularis (nodular itchy rash), the drug emerged as the only available treatment option among biologic agents. Previously, there were limited treatment options for treating prurigo nodularis, a condition that causes extreme itchiness. Sanofi hosted a press conference at Novotel Ambassador Seoul Gangnam on the 28th to commemorate the company’s expansion of Dupixent indications to treat prurigo nodularis. Dupixent is a biological agent designed to target interleukin (IL)-4 and IL-13 signaling pathway, biomarkers of type 2 inflammation, and regulates the symptoms. The drug has shown effects in inflammatory diseases such as atopic dermatitis and eosinophilic esophagitis. Moreover, Dupixent secured an expanded indication for prurigo nodularis. Last December, Dupixent was approved in Korea for treating moderate to severe prurigo nodularis in patients aged 18 years and older who had inadequate responses to or were not recommended for a topical treatment. Prurigo nodularis is a chronic dermatitis associated with type 2 inflammation. It is known to significantly impact a patient’s quality of life more than any other inflammatory skin disease due to extreme itchiness. High-dosage topical steroids are commonly prescribed for the treatment, but their long-term use can pose safety risks. These risks include dermal atrophy, infection, blurry vision, and vision deterioration. The introduction of Dupixent, which has confirmed efficacy and safety, may improve patient’s quality of life. This approval was based on the PRIME and PRIM2 Phase 3 clinical studies. The studies included 311 patients aged 18 and older with prurigo nodularis. The primary endpoint was the proportion of patients who achieved scores of 4 points or greater reduction in the Worst-Itch Numeric Rating Scale (WI-NRS) at 12 weeks and 24 weeks. In PRIME clinical results, the patients who received Dupixent showed nodule reduction at 12 weeks and 24 weeks. At 24 weeks, 48% of patients with Dupixent showed an improvement in their condition measured by a WI-NRS score of 4 points and a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S). Therefore, the improvement by Dupixent treatment was significantly greater than the 18% observed in the placebo group. Furthermore, the PRIME2 clinical study also demonstrated that 45% of patients who received Dupixent showed an improvement by a WI-NRS score of 4 points or more and a score of 0 or 1 point in the IGA PN-S, a significantly higher proportion of patients with improvements compared to the 16% in the placebo group. Throughout the first 24 weeks, Dupixent displayed a consistent safety profile that is similar to what is known from other indications. “Prurigo nodularis is often associated with type 2 inflammatory diseases such as atopic dermatitis and asthma. Almost half of the patients with prurigo nodularis also have atopic disease. Dupixent is the only biologic agent available for targeting this disease,” Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center, said. “Over 60% of patients suffer from sleep-related deterioration due to chronic itch, which is often linked to psychological disorders such as depression or anxiety,” Ahn added. “The previous treatment options for prurigo nodularis were limited. Therefore, the introduction of biologic agent that is effective and has fewer side effects can improve the quality of life of the patients,” Ahn emphasized.
