Generics are now available for the three therapies: Cystadane, Selzentry, and AmBisome.
Prime Therapeutics has removed three therapies from its Medicare formulary because generics are now available.
The first is Recordati Rare Disease’s Cystadane (betaine anhydrous) powder for oral solution, which is used to treat treatment of homocystinuria, a genetic disorder that affects the metabolism of methionine, an amino acid. Cystadane helps to decrease elevated homocysteine blood levels. High levels of homocysteine and abnormal levels of methionine can lead to chronic, serious, and potentially life-threatening health issues.
In February 2022, the FDA approved the first generic of Cystadane, developed by Oakrum Pharma in collaboration with Ani Pharmaceuticals. The regulatory agency also granted the manufacturers competitive generic therapy of 180 days of exclusivity.
The second therapy removed from Prime’s Medicare formularies is Viiv Healthcare’s Selzentry (maraviroc) tablets, 150 mg and 300 mg, which is used to treat HIV. In February 2022, Camber Pharmaceuticals launched a generic version for both dosage forms.
The third product removed from Prime’s Medicare formularies is Gilead’s AmBisome (amphotericin B) liposome for injection, which is used to treat fungal infections. In December 2021, the FDA approved Sun Pharma’s generic, the first generic available for AmBiosome. Sun Pharma was granted competitive generic therapy designation by FDA.
Prime’s move for all of these products impacts several of its formularies, including Ideal, Value, Value Plus, Essential Formularies, and Center of Excellence formularies. Several health plan formularies are impacted as well, including Alignment, Asuris, Capital Blue Cross, HCSC, Horizon, and Regence.