Ofev (nintedanib) — United Healthcare
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Initial criteria
- Diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) as documented by all of the following:
- One of the following:
- Skin thickening of the fingers of both hands extending proximal to the metacarpophalangeal joints
- At least two of the following:
- Skin thickening of the fingers (e.g., puffy fingers, sclerodactyly of the fingers)
- Fingertip lesions (e.g., digital tip ulcers, fingertip pitting scars)
- Telangiectasia
- Abnormal nailfold capillaries
- Pulmonary arterial hypertension
- Raynaud’s phenomenon
- SSc-related autoantibodies (e.g., anticentromere, anti-topoisomerase I, anti-RNA polymerase III)
- Presence of interstitial lung disease as determined by evidence of pulmonary fibrosis on HRCT involving at least 10% of the lungs
- Ofev is not used in combination with Esbriet
- Prescriber is a pulmonologist
Reauthorization criteria
- Documentation of positive clinical response to Ofev therapy
- Ofev is not used in combination with Esbriet
Approval duration
12 months