UnitedHealthcare’s March 1, 2026 update to MDC 07 narrows hepatic exclusion criteria for Elevidys by defining preexisting hepatic impairment as GGT >2× the upper limit of normal or total bilirubin >ULN (unless due to Gilbert’s syndrome), and continues to exclude acute hepatic viral infection. Prescribers must attest to weekly GGT and total bilirubin testing and clinical exam for the first 3 months after administration, and weekly troponin‑I monitoring for the first month, with subsequent monitoring per FDA labeling. Eligibility remains limited to ambulatory patients aged 4–5 years with LVEF ≥40% and anti‑AAVrh74 titers <1:400; recent vaccination or active/recent infection within 4 weeks are additional exclusions. The revision aligns monitoring language with FDA labeling and archives the prior policy version.
March 2026 Revision: Clarified Hepatic Impairment Definition and FDA-Aligned Monitoring
The policy revision dated 03/01/2026 replaced and clarified prior coverage criteria related to hepatic impairment and monitoring for Elevidys. Specifically, the prior criterion that excluded patients with “preexisting hepatic impairment, acute liver disease (e.g., acute hepatic viral infection), chronic hepatic condition, or elevated GGT” was revised to a more specific exclusion: patients with preexisting hepatic impairment defined as gamma-glutamyl transferase (GGT) > 2 times the upper limit of normal or total bilirubin > the upper limit of normal not due to Gilbert’s syndrome, or acute liver disease (e.g., acute hepatic viral infection) are not eligible.
Additionally, language about cardiac monitoring was updated to specify that the prescriber attests to monitoring troponin-I weekly for the first month following Elevidys administration “in accordance with the FDA approved labeling,” replacing the prior phrasing that required monitoring “per recommendations in the prescribing information.” The revision also notes an update to the FDA section to reflect the most current information and archives the previous policy version IEXD00126.06.
Eligibility Criteria: Age, Ambulation, Laboratory and Cardiac Requirements for Elevidys
The coverage criteria require that the patient be aged 4 or 5 years and ambulatory without an assistive device, with submission of medical records (e.g., chart notes) confirming ambulatory status. The policy enumerates several explicit exclusion criteria tied to safety monitoring and baseline status: patients with (as defined by GGT or total bilirubin thresholds) or , those with left ventricular ejection fraction () < 40%, and those with an elevated anti-AAVrh74 total binding antibody titer ≥ are not eligible.
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