Nefecon Included in the Reimbursement Drug List of “Beijing Puhui Health Insurance Program” as a First-in-Disease Therapy for IgA Nephropathy
Shanghai, China—May 12, 2023—An imported version of Nefecon (budesonide) delayed release capsule has been added to the 2023 New Reimbursement Drug List of Specialized Medicines of the “Beijing Puhui Health Insurance Program.” Nefecon is a first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN). Nefecon has been approved by the United States Food and Drug Administration under accelerated approval under the trademark “TARPEYO®” to reduce proteinuria in adults with IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. Coverage by this and other local insurance plans will help increase patient access to Nefecon, listed in the Beijing Puhui Health Insurance Program as “TARPEYO.”
The Beijing Puhui Health Insurance Program is under the supervision of both the Beijing Municipal Medical Insurance Bureau and Beijing Municipal Bureau of Financial Regulation and Supervision, and is an important part of Beijing's multi-tier medical insurance system. In the two years since launch, more than 6 million people have signed up for the program. Beijing Puhui Health Insurance covers 100 specialized drugs that are not listed in the National Reimbursement Drug List and some imported drugs from overseas, including those newly marketed abroad and those that can be prescribed only in designated medical institutions in Boao Lecheng. The maximum insurance coverage for each person is 1 million yuan a year. The updated list, which includes Nefecon, went into effect on May 5, 2023.
“The inclusion of Nefecon into the drug reimbursement list of the Beijing Puhui Health Insurance Program enables patients insured in Beijing to receive reimbursement for up to 60% of the drug costs. This inclusion can help alleviate the financial burden for patients and improve patient adherence to the treatment,” said Rogers Luo, Chief Executive Officer of Everest Medicines. “Nefecon was made available for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary in April, and we expect that our application for a marketing approval for Nefecon will receive nationwide approval in the second half of this year. In addition to Beijing, Nefecon has also been included in other local insurance programs, such as those in Kunming city and Shanxi Province. Diversified payment models allow more IgAN patients in China to benefit from this first-in-disease medicine, meeting significant unmet medical needs.”
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories.
Nefecon was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders.. For more information, please visit its website at www.everestmedicines.com.
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