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    Controversy surrounds Exondys 51 approval: What to know


    Anthem says ‘no’

    Lori McLaughlin, an Anthem spokesperson, says that the FDA label cites that a “clinical benefit” of Exondys 51 has not been established.

    “In reviewing the medical literature, Anthem’s Medical Policy & Technology Assessment Committee (MPTAC), a majority of whom are external physicians, determined that Exondys 51 failed to show it improves health outcomes, and therefore it is not a covered benefit for member and employer-sponsored plans and other plans that follow our medical policy,” she says.

    She says that Anthem will continue to review new clinical information, which Sarepta recently provided, at its next quarterly MPTAC meeting. 

    Approval with conditions

    Humana and UnitedHealthcare chose to include Exondys 51 on their formularies but with strings attached.


    Humana’s Pharmacy and Therapeutics (P&T) Committee determined that Exondys 51 meets an unmet medical need because there is a lack of effective alternative therapy for the treatment of DMD. The drug requires approval on a member-by-member basis, at which time the insurer looks for appropriateness of the treatment per the FDA label.

    Maria Renneke, a spokesperson for Humana, says that the P&T Committee meets often to evaluate all drug coverage polices as new evidence becomes available. Exondys 51, like all drugs, is subject to re-evaluation based on new data.

    At UnitedHealthcare, commercial health plan members who are ambulatory and meet other clinical coverage requirements will be able to receive Exondys 51 for treating DMD under the medical benefit. “This prior authorization will help ensure appropriate coverage, given the limited clinical evidence supporting the effectiveness of this treatment,” says a spokesperson.


    Mari Edlin, a frequent contributor to Managed Healthcare Executive, is based in Sonoma, California. 

    Mari Edlin
    Mari Edlin is a frequent contributor to Managed Healthcare Executive. She is based in Sonoma, California.


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