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A Parkinson’s therapy, a treatment for seizures, a drug used in the treatment of heart failure, and a therapy for a rare disease have been removed from Prime’s Medicare formularies.
Prime Therapeutics has removed four products from its Medicare formularies. Three have been removed because generics are now available. The fourth therapy has been discontinued by the manufacturer.
The first is Apolyn (apomorphine) cartridge, 30 mg/3mL, which is marketed by Supernus Pharmaceuticals to treat hypomobility, “off” episodes associated with advanced Parkinson’s disease. The first generic for this medication was approved in February 2022. The approval was for Sage Chemical’s drug cartridge only, which is compatible for use with the Apokyn pen. Patients first have to get a prescription for the pen through a specialty pharmacy.
The second product removed is Samsca (tolvaptan) tablet, 15 mg, developed by Otsuka America Pharmaceutical. It is used to treat low levels of sodium in the blood in patients who have heart failure. First generics were launched in May 2020 by Alkem/Ascend and Apotex.
The product removed is UCB’s Vimpat (lacosamide) tablets, 50 mg, 100 mg, 150 mg, 200 mg, which is approved to treat patients with epilepsy. Generics are now available from Camber Pharmaceuticals, Glenmark Pharma and Vista Pharm.
The fourth product removed is Ruzurgi (amifampridine) tablets 10 mg, which was been discontinued by the manufacturer, Jacobus Pharmaceutical. The company had been involved in a lawsuit with Catalyst Pharmaceuticals regarding Ruzurgi, and in February 2022, a District Court ruled that the FDA approval of Ruzurgi for the treatment pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) violated Catalyst’s exclusivity for Firdapse (amifampridine) under the Orphan Drug Act.
Firdapse was approved in 2018 to treat adults with LEMS, and the company is about to submit a new drug application for the pediatric indication.
For the three products with generics now available, the formularies impacted by the change include Ideal, Value, Value Plus & Essential Formularies, and Center of Excellence Formularies. Ruzurgi has been removed from all of Prime’s formularies.