Ocaliva Removed; Iqirvo/Livdelzi/Rezdiffra Combo Edits Updated (Mar 2026)

Effective March 1, 2026, Premera removed coverage criteria for Ocaliva (obeticholic acid) following product withdrawal for liver safety risks and eliminated prior combination-use exclusions that referenced Ocaliva for Iqirvo, Livdelzi, and Rezdiffra. Iqirvo (elafibranor) and Livdelzi (seladelpar) remain covered for adults with PBC (including compensated cirrhosis) after ≥1 year of UDCA with inadequate response or UDCA intolerance, with dose and prescriber limits and mutual exclusion of combined use. Rezdiffra (resmetirom) remains covered for adults with biopsy- or test-confirmed MASH and stage F2–F3 fibrosis, with specified alcohol limits, comorbidity control, prescriber requirements, and a 100 mg daily dose limit. Authorizations may be approved up to 12 months with reauthorization contingent on documented clinical benefit; safety warnings and ongoing confirmatory trial requirements are noted for these agents.

The 2026 update (effective Mar. 1, 2026) removes coverage criteria for Ocaliva (obeticholic acid) because the product was withdrawn from the market due to liver-related safety risks. The policy text notes a contemporaneous review of the prescribing information for Iqirvo (elafibranor), Livdelzi (seladelpar), and Rezdiffra (resmetirom) and specifically states the removal of the previous requirement to exclude combination use with Ocaliva for those three agents.

Other historical changes summarized in the policy record include prior additions and edits: Iqirvo coverage was added in 2024; Livdelzi coverage criteria were added in 2025; and Rezdiffra (resmetirom) was moved into this policy in 2025 from a different policy number. The 2026 change is limited to removing Ocaliva criteria and updating combination-exclusion language to reflect the product withdrawal.

This policy addresses pharmacologic treatments for chronic non-infectious liver diseases, focusing on primary biliary cholangitis (PBC) and metabolic dysfunction-associated steatohepatitis (MASH) (also referenced as and the broader spectrum). It establishes when three specific oral agents may be considered medically necessary: and for PBC, and for stage F2–F3 fibrosis due to MASH.

For PBC, both Iqirvo (elafibranor) and Livdelzi (seladelpar) are covered when prescribed for adults (≥18 years) who have either PBC without cirrhosis or PBC with compensated cirrhosis (Child–Pugh A) without portal hypertension. Diagnosis must be supported by at least 6 months of elevated alkaline phosphatase (ALP) and either a positive antimitochondrial antibody (AMA), PBC-specific autoantibodies (sp100 or gp210) when AMA negative, or liver biopsy consistent with PBC. The diagnosis must not be attributable to cholestatic drug reaction, complete biliary obstruction, sarcoidosis, or primary sclerosing cholangitis.

Both agents require prior trial of ursodeoxycholic acid (UDCA) for at least 1 year with inadequate response or documented UDCA intolerance. Iqirvo must be prescribed by or in consultation with a gastroenterologist or hepatologist, is limited to 80 mg once daily, and cannot be used in combination with Livdelzi. Livdelzi has the same prescriber requirement and is limited to 10 mg once daily, with mutual exclusion for combination use with Iqirvo.

Rezdiffra (resmetirom) is listed as medically necessary for adults (≥18 years) with biopsy- or test-confirmed hepatic steatohepatitis and stage F2 or F3 fibrosis due to MASH, with the dose limited to 100 mg daily. Required elements include alcohol consumption limits (≤15 standard drinks/week for males; ≤10/week for females), hepatitis C viral load control (negative/undetectable or suppressed for 12 weeks prior), and exclusion of hemochromatosis (transferrin saturation ≥45% with elevated ferritin). Additional stipulations include age-related exclusion of Wilson disease for patients <30 years, diabetes control if present (A1c <9%), and lifestyle measures for obesity (BMI ≥30).

Rezdiffra must be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist. The policy requires concurrent treatment of comorbid conditions (cardiovascular disease, diabetes, dyslipidemia, hypertension) and notes that approvals for Rezdiffra (as with other agents) are contingent on continued demonstration of clinical benefit on re-authorization.

Authorization and duration language notes that non-formulary exception reviews and other reviews for Iqirvo, Livdelzi, and Rezdiffra may be approved for up to 12 months. Re-authorization for Iqirvo and Livdelzi may be granted up to 12 months if drug-specific criteria are met and chart notes show continued reduction in ALP from baseline. For Rezdiffra, re-authorization may be approved up to 12 months if criteria are met and chart notes document a continued positive clinical response to therapy.

The policy also flags that the FDA accelerated approval pathway applied to Iqirvo (based on ALP reduction as a surrogate endpoint) and that confirmatory trials (e.g., ELFIDENCE) are ongoing. Warnings and common adverse reactions for each drug are summarized in the policy narrative (e.g., myopathy and liver injury warnings for Iqirvo; liver test abnormalities and biliary obstruction warnings for Livdelzi; gastrointestinal adverse effects for Rezdiffra).

OpenPayer

Mar 2026 Revision: Removal of Ocaliva and Combination-Use Edits

Scope: Indications and Drugs Covered for PBC and MASH

PBC-Specific Coverage Criteria for `Iqirvo` and `Livdelzi`

MASH Coverage Criteria for `Rezdiffra (resmetirom)`

Authorization Durations, Re-authorization Requirements, and Safety Summaries