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Prior Authorization Protocol
OFEVR (nintedanib)

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:
    • The treatment of idiopathic pulmonary fibrosis (IPF)
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of idiopathic pulmonary fibrosis
  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:
    • Ofev is a tyrosine kinase inhibitor, others of which have been used for non-small cell lung cancer (NSCLC). Existing data for the use of Ofev for NSCLC as a second-line agent show statistically significant improvement in progression free survival, but the clinical significance of the improvement (0.7 months) is questionable. Additionally, there is no significant difference in overall survival in patients treated with Ofev. National Comprehensive Cancer Network (NCCN) guidelines do not currently mention Ofev as a treatment alternative for NSCLC.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    EsbrietR (pirfenidone)
    801 mg (three capsules) PO TID with food

    2403 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    OfevR (nintedanib)

    150 mg PO BID approximately 12 hours apart, taken with food
    Maximum Dose:
    300 mg/day

    Length of Benefit

  7. Product Availability:
    Capsules: 100 mg, 150 mg
  8. References:
    1. Ofev [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2014.
    2. Richeldi L, du Bois R.M., Raghu G., et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 2014;370:2071-82.
    3. Richeldi L, Costabel U., Selman M., et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med 2011;365:1079-87.
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: 30-OCT-14 AM
Approved By Health Net National P&T: 18-FEB-15, 18-NOV-15
Revised: 28-MAY-15 SL