VA Criteria for Use Formulary Advisor Reference
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NINTEDANIB CAP,ORAL

Generic Name
NINTEDANIB CAP
Brand Names
NINTEDANIB ESYLATE, OFEV
Drug Class
RESPIRATORY AGENTS,OTHER
Formulary Status
Non-Formulary Requires prior authorization
Copay Tier
2
Last Updated
April 1, 2026

Clinical Criteria Summary

Exclusion Criteria

  • Moderate to severe hepatic impairment (Child Pugh B or C)
  • Current smoker (reduced drug exposure)
  • End stage renal disease (eGFR less than 15 ml/min/1.73 m2)
  • Concurrent treatment with pirfenidone (no evidence of benefit with combination)
  • Pregnancy
  • Lactating

General Inclusion Criteria

  • Care provided by VA/VA Community Care pulmonologist experienced in the management of interstitial lung disease (ILD)
  • Confirmed interstitial pulmonary fibrosis (IPF) or non-IPF ILD with progression using clinical, radiologic and if applicable, histopathologic information
  • Baseline liver function testing (aspart aminotransferase [AST], alanine aminotransferase [ALT], bilirubin)

Progression Criteria for Non-IPF ILD

  • One of the following must be met in the past 24 months:
  • Relative decline in forced vital capacity (FVC) of at least 10% of predicted and worsening of respiratory symptoms
  • Relative decline in FVC of 5% to less than 10% of predicted with either worsening of respiratory symptoms or increased extent of fibrotic changes on imaging
  • Worsening of respiratory symptoms and increased extent of fibrotic changes on imaging

Reproductive & Pregnancy Requirements

  • Pregnancy must be excluded prior to receiving nintedanib
  • Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 3 months after stopping treatment required for patients who can become pregnant

Diagnostic & Monitoring Requirements

  • IPF confirmation requires exclusion of other identifiable causes of ILD, high resolution CT scan showing usual interstitial pneumonia (UIP) pattern or probable UIP pattern, or indeterminate pattern for UIP with histologic confirmation of IPF
  • Progressive pulmonary fibrosis (PPF) is a pattern of disease progression requiring markers for progression in addition to the non-IPF ILD diagnosis
  • Baseline, monthly, and periodic monitoring of AST, ALT, and bilirubin required due to association with elevated liver enzymes and drug induced liver injury (DILI); dose modifications or avoidance may be recommended depending on severity of elevations and/or presence of symptoms

Source Documents

Download CFU PDF: Nintedanib OFEV in IPF and PPF CFU