UnitedHealthcare notes Intercept’s voluntary market withdrawal of Ocaliva (obeticholic acid) on Sept 11, 2025, following an FDA request. The policy retains historical coverage criteria that limited Ocaliva to patients with a documented diagnosis of primary biliary cholangitis who have failed or had an inadequate response to at least 12 consecutive months of ursodeoxycholic acid. Because the product is withdrawn, the stated approval pathway may no longer be operational or available for dispensing, creating a divergence between formal criteria and real‑world access. No alternative agents, replacement pathways, or updated prior authorization instructions are provided in this excerpt; the entry functions mainly as a record of prior criteria and the withdrawal notice.
September 11, 2025: `Ocaliva` Voluntary Market Withdrawal Noted
This revision documents a critical supply and regulatory event: on September 11, 2025, Intercept Pharmaceuticals announced the voluntary market withdrawal of Ocaliva (obeticholic acid) following a request from the US Food and Drug Administration. The policy text retains the prior step-therapy requirement that sought failure of ursodeoxycholic acid (e.g., Urso, ursodiol) before approving Ocaliva for primary biliary cholangitis, but the withdrawal notice changes the practical availability and potential coverage considerations for this agent.
Because the product has a voluntary market withdrawal, this policy revision signals a change in the clinical and coverage landscape for Ocaliva. The document continues to state the historical coverage criteria for approval, but the withdrawal effectively means the drug may no longer be available for dispensing, which impacts the operational relevance of the stated criteria.
Coverage Indication: `Primary biliary cholangitis` Requirement
The policy specifies that Ocaliva will be approved for the indication of primary biliary cholangitis only when all enumerated criteria are met. The first mandatory criterion listed is an explicit diagnosis of primary biliary cholangitis.
The document frames approval as conditional upon meeting the diagnosis requirement and additional step-therapy related criteria, indicating a narrow, indication-specific approval pathway within the payer's clinical pharmacy program.
Step Therapy Requirement: 12-Month `ursodeoxycholic acid` Trial
A step-therapy requirement is described: one of the approval pathways requires that the patient has not achieved an adequate response to an appropriate dosage of ursodeoxycholic acid (e.g., Urso, ursodiol) after at least 12 consecutive months of therapy. This is presented as an AND condition paired with the diagnosis criterion for primary biliary cholangitis.
The policy frames this as an attempt to encourage use of lower-cost alternatives before authorizing Ocaliva, consistent with step therapy program goals. The 12-month therapy duration for ursodeoxycholic acid is explicitly stated as the minimum timeframe to establish inadequate response under the policy.
Implication of Withdrawal on Coverage Criteria and Availability
The policy text demonstrates a tension between formal coverage rules and real-world product availability: while it lays out specific approval criteria for Ocaliva, the voluntary market withdrawal announced by the manufacturer and requested by the FDA alters the operational ability to fulfill these criteria. The document preserves the historical criteria but notes the withdrawal, which may require downstream administrative or clinical adjustments not detailed in this text.
No alternative therapies, replacement agents, prior authorization codes, or updated coverage pathways are specified in this excerpt. The policy therefore functions as a record of prior criteria and the withdrawal notice rather than presenting a newly available therapeutic option.
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