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The first generic equivalent of the HIV therapeutic is now available.
Prime Therapeutics has removed Janssen’s Intelence (etravirine) from its Medicare Part D formularies effective July 15, 2021. A generic therapy is now available and will be covered instead.
This will impact several Medicare Part D formularies, including Ideal Formularies, Value & Essential Formularies, Client Specific Formularies (Alignment, Asuris, Capital Blue Cross, HCSC, Horizon, Regence).
Intelence has been available since 2008, when the FDA granted accelerated approval for use in combination with antiretroviral (ARV) medications for treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents. n November 2009, the FDA granted Intelence traditional FDA approval based on 48-week data from the two studies, DUET 1 and DUET 2.
The FDA also approved Intelence in March 2012 for use in pediatric patients 6 years to 18 years of age.
The FDA approved Amneal Pharmaceutical’s generic in June 2021, and the company has already made the therapy available. Etravirine is the first generic equivalent for Intelence.