Approximately five months after launch, the inclusion of neffy on these three additional formularies has expanded access to half of all patients and caregivers managing Type 1 allergic reactions, bringing the total number of formulary platforms covering neffy to 30
Feb. 20, 2025 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that Cigna Healthcare, Navitus Health Systems and OptumRx, through their Group Purchasing Organization (GPO) Emisar, have added neffy® (epinephrine nasal spray) to their National Formularies.
“Millions of patients nationwide now have improved access to neffy through their commercial insurance, thanks to coverage from leading pharmaceutical benefit managers and health plans. neffy will also be available at the lowest branded copay for patients insured by OptumRx, Cigna Healthcare, and Navitus Health Systems - without the need for prior authorizations or restrictive step therapies,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “As a result, more patients will qualify for the low copay price of $25 for neffy, when they apply the ARS Pharma copay assistance, and healthcare providers can prescribe it without the need for additional paperwork.”
“This announcement also underscores the critical demand for a nasal spray epinephrine option within the severe allergy community and we remain committed to ensuring continued access for as many patients and caregivers as possible. While Emisar represents both OptumRx and UnitedHealthcare as their GPO at this time only OptumRx has agreed to the Emisar terms. ARS Pharma is working closely with UnitedHealthcare, as one of the country’s largest healthcare providers, to add neffy to their formulary as soon as possible,” said Lowenthal.
The addition of neffy to these formularies improves coverage for the approximately 20 million people who have been diagnosed and treated for the more severe Type I allergic reactions that may lead to anaphylaxis and need epinephrine therapy to protect themselves in their daily lives. To assist patients in navigating coverage and affordability challenges, ARS Pharma offers a number of programs for patients and caregivers. For more information, visit www.neffy.com/savings.
neffy 2 mg is for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). It is the first and only FDA-approved epinephrine nasal spray that provides a needle-free alternative to traditional injectable epinephrine. It’s simple and intuitive design enables rapid administration, helping patients and caregivers act quickly and confidently, and the small size is easy to carry. Additionally, neffy has a shelf-life of 30 months and temperature exclusions up to 122 degrees Fahrenheit.
The supplemental NDA for neffy 1 mg, for children over four years of age who weigh 15 to 30 kg, has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025. Based on review timelines and subject to approval, product availability of neffy 1 mg is expected by the end of May 2025. ARS Pharma anticipates that by the epinephrine prescription renewal period, which occurs over the summer for many children in the United States, that school age children who meet the weight and age criteria will have access to neffy.
neffy is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis.
Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.
ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.
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