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Prior Authorization Protocol

OCALIVATM (obeticholic acid)

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of primary biliary cholangitis

    AND

    • Used in combination with ursodeoxycholic acid (unless there is intolerance or unresponsiveness to ursodeoxycholic acid)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Ocaliva is being evaluated for the treatment of non-alcoholic steatohepatitis (NASH). Results of a phase II trial are available. A Phase III trial is ongoing. Based on an ICER (Institute for Clinical and Economic Review) review, obeticholic acid as an off-label treatment for adults with NASH with fibrosis is not currently recommended. The limited evidence was deemed insufficient based on uncertainty regarding the long-term clinical effects of changes in surrogate endpoints and conflicting physiological outcomes while taking the drug (e.g., insulin resistance in one trial versus another trial).
    • According to the AASLD Primary Biliary Cirrhosis 2009 practice guidelines, UDCA dosed at 13-15 mg/kg/day orally is recommended for all patients with PBC who have abnormal liver enzyme values regardless of histological stage. Improvement in liver tests will be seen within a matter of a few weeks and 90% of the improvement usually occurs within 6-9 months. The eligibility criteria in the Ocaliva efficacy trial required enrolled patients to have a minimum 12 month history of taking UDCA.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    UrsodiolR (ursodeoxycholic acid)

    13  15 mg/kg per day PO given BID to QID

    45 mg/kg per day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Ocaliva

    5 to 10 mg PO QD

    Length of Benefit

  7. Product Availability:

    Ocaliva tablets: 5 mg and 10 mg

  8. References:

    1. Ocaliva [Prescribing Information]. New York, NY: Intercept Pharmaceuticals, Inc.; May 2016.
    2. Institute for Clinical and Economic Review. Obeticholic Acid for the Treatment of  Nonalcoholic Steatohepatitis: Comparative Clinical Effectiveness and Value. Draft Evidence Report: May 25, 2016. Available at: http://icer-review.org/meeting/obeticholic-acid/. Lindor KD, Gershwin ME, Poupon R, et al. AASLD Practice Guidelines: Primary Biliary Cirrhosis. Hepatology, July 2009

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.
Draft Prepared: 31-MAY-16 SA
Approved By Health Net National P&T: 24-AUG-16
Revised: 19-OCT-16 NN