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Luxturna, Kerendia, & Raspirin will get new reimb standards
by Lee, Jeong-Hwan Jan 22, 2024 05:49am
On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notification on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements.” New reimbursement standards will be established for Novartis’s Luxturna, a one-shot retinal dystrophy treatment, Hanmi Pharmaceutical’s Raspirin Cap, and Bayer’s Kerendia Tab 10 mg, as they are set to be listed for reimbursement. Reimbursement standards will be set for Takeda’s Obizur, a treatment for acquired hemophilia A, and Pfizer’s Zavicefta Inj, a new antibiotics drug, as they are in the process of reimbursement listing. On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notice on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements” and will collect opinions by the 29th. ◆Luxturna Inj= an ophthalmic drug Luxturna will be eligible for reimbursement for pediatric and adult patients with inherited retinal dystrophy caused by biallelic RPE65 mutations who meet all of the following conditions and have sufficient surviving retinal cells. Patients must have a genetic diagnosis of biallelic pathogenic or likely pathogenic RPE65 mutations. Reimbursement will be approved for patients who are aged four years or older but younger than 65 years at the time of administration. The maximum corrected visual acuity in both eyes should be 0.3 or less, or the visual field in both eyes should be less than 20 degrees. In addition, there must be enough surviving retinal cells, and all the following conditions must be met. The thickness of the posterior part of the retina in optical coherence tomography findings should exceed 100 μm. Based on fundus examination, the area in the posterior part of the retina without atrophy or pigment degeneration should be at least three times the size of the optic disk. The visual field measured with Goldmann III4e isopter or its equivalent should remain within the central 30 degrees of vision. Patients who have undergone intraocular surgery within the past six months or have had infections in or around the eyes will be excluded from the treatment group. Luxturna, a gene replacement therapy given as a single dose, is eligible for reimbursement once in a lifetime. It should be administered exclusively by a retinal specialist experienced in macular surgery. According to the revised standards for managing reimbursement of high-cost drugs, patients receiving Luxturna must provide reimbursement information on the reimbursement statement for four years, adhering to the specified reimbursement claim procedure, assessment claim form, statement format, and preparation guidelines. ◆Raspirin Cap= Reimbursement will be approved for patients who are being treated with a combination therapy of Aspirin and rabeprazole, meeting reimbursement standards. ◆Kerendia 10 mg= Reimbursement will be approved for adult patients with chronic kidney disease associated with type 2 diabetes who are receiving the drug in combination with a standard therapy (ACE inhibitor or angiotensin II receptor blocker) and meet all conditions, even if they have been stably treated with the maximum tolerated labeled dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker for more than four weeks. However, patients in NYHA class II~IV with consistent symptoms will be excluded from reimbursement eligibility. ◆Obizur= Reimbursement for Obizur will be applied for the treatment of bleeding episodes in adults with acquired hemophilia A. The treatment is intended for patients who meet one of the following conditions: who have an antibody titer of greater than 5 Bethesda Units (BU), who have antibody titer of less than 5BU and a lack of clinical response to high doses of antihemophilic factor, or who have a recent history of an antibody titer of less than 5BU and who had a clinical response to Obizur after having a lack of clinical response to high doses of antihemophilic factor. Obizur can be administered to hospitalized patients and outpatients in hospitals. Treatment costs can be reimbursed when the drug is used according to the recommended methods of administration and dosage. Patients should also refer to precautions, including warnings, adverse reactions, and general precautions. Patients should be diagnosed and receive prescriptions by hematologists specializing in hematology-oncology in the department of internal medicine or hematology-oncology specialists in the department of pediatrics. ◆Zavicefta Inj= Reimbursement will be approved for patients with documented cases of complicated intra-abdominal infections, complicated urinary tract infections, or when carbapenem antibiotics have failed in treating hospital-acquired and ventilator-acquired pneumonia, or when multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria are present. Additionally, a prescription recommendation must be attached. ◆Forxiga and Jardiance= Reimbursement for Forxiga (ingredient: dapagliflozin) 10 mg and Jardiance Tab (ingredient: empagliflozin) 100 mg, which are SGLT-2 inhibitor-mediated diabetes treatments, will be expanded for patients undergoing treatment for chronic heart failure. Specifically, reimbursement will be approved for patients having chronic heart failure with reduced left ventricular ejection function, falling into NYHA class Ⅱ∼Ⅳ, having a Left Ventricular Ejection Fraction (LVEF) of ≤ 40%, and undergoing a standard treatment with a stable dose.