Premera‑Blue Cross updated MDC 05 to incorporate FDA approval of Rezdiffra (resmetirom) for MASH (approved March 14, 2024) and limits dosing to 100 mg daily. Rezdiffra must be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist; non‑formulary exception approvals may be granted up to 12 months for initial authorization. The policy designates Iqirvo (elafibranor), Livdelzi (seladelpar), and Rezdiffra as investigational when used outside the policy’s specified indications and ties coverage to FDA dosing/labeling. It also aligns PBC coverage with cardiometabolic management: age ≥30, exclude Wilson disease and cirrhosis (F4), require A1c <9% if type 2 diabetes, BMI ≥30 requires documented diet and activity, and concurrent treatment of CVD, diabetes, dyslipidemia, and hypertension is expected.
Premera-bluecross: Inclusion of Rezdiffra (resmetirom) Following FDA Approval
This revision documents the incorporation of the FDA approval of Rezdiffra (resmetirom) for Metabolic Dysfunction-Associated Steatohepatitis (MASH) into the coverage criteria. The policy explicitly notes that resmetirom was FDA‑approved on March 14, 2024 and establishes conditions for medical necessity when Rezdiffra is prescribed: the medication must be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist, and dosing is limited to 100 mg daily. The policy also clarifies that non‑formulary exception reviews for drugs listed in the policy may be approved up to 12 months for initial authorization.
In addition, the document identifies three agents—Iqirvo (elafibranor), Livdelzi (seladelpar), and Rezdiffra (resmetirom)—and designates investigational status for these drugs where their use is not consistent with indications or criteria outlined in this policy. The policy ties the listed medications to their FDA dosage and administration prescribing information, indicating that approved uses must follow the product labeling.
Specified Medical Necessity Criteria for Primary Biliary Cholangitis and Comorbidities
The policy defines specific medical necessity criteria for primary biliary cholangitis (PBC) that intersect with MASH management in patients with metabolic comorbidities. For PBC, coverage requires that the individual be 30 years of age or older and not have a diagnosis of Wilson's disease. When type 2 diabetes mellitus is present, the person must have an A1c less than 9%. For individuals with BMI ≥30, documentation of adherence to a dietary plan and increased physical activity is required. The policy also excludes individuals with cirrhosis (F4 fibrosis) from coverage under these criteria.
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