Northera — Blue Cross Blue Shield of Illinois

Initial criteria

• Diagnosis of neurogenic orthostatic hypotension (nOH) AND ALL of the following:
• - Prescriber has performed baseline blood pressure readings while sitting or supine and within 3 minutes of standing
• - Patient has decrease of ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes of standing
• - Patient has persistent and consistent symptoms of nOH caused by ONE of: primary autonomic failure (Parkinson’s disease, multiple system atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy
• - Prescriber has assessed severity of baseline symptoms (dizziness, lightheadedness, presyncope, etc.)
• - Prescriber has assessed and adjusted medications known to exacerbate orthostatic hypotension (e.g., diuretics, vasodilators, beta-blockers)
• - ONE of the following regarding midodrine or special circumstances:
• • Patient has stage four advanced, metastatic cancer and agent is used for cancer or related condition per supportive documentation
• • Patient currently treated with and stable on requested agent
• • Tried and had inadequate response to midodrine
• • Midodrine discontinued due to lack of efficacy, adverse event, or diminished effect
• • Intolerance, hypersensitivity, or labeled contraindication to midodrine
• • Midodrine expected to be ineffective, harmful, or clinically inappropriate based on patient characteristics (with documentation)
• • Midodrine not in best interest of patient based on medical necessity
• • Tried another agent in same pharmacologic class/mechanism as midodrine which was ineffective or not tolerated
• OR patient has another FDA labeled indication for droxidopa and:
• - Age is within or supported for FDA labeling for indication
• If brand Northera requested when generic droxidopa available, ONE of the following:
• • Same stage 4 metastatic cancer criteria as above
• • Patient stable on requested brand agent
• • Tried and failed generic equivalent droxidopa
• • Generic discontinued for lack of efficacy or adverse event
• • Intolerance, hypersensitivity or contraindication to generic not expected with brand
• • Generic expected to be ineffective, harmful, or not in patient’s best interest
• • Tried other drug in same class as generic droxidopa and failed
• • Support for use of brand over generic provided
• Prescriber is a specialist in the diagnosis area (e.g., cardiologist, neurologist) or has consulted with one
• Patient has no FDA labeled contraindications to requested agent

Reauthorization criteria

• Patient previously approved for agent through prior authorization process
• ONE of the following:
• - Diagnosis of neurogenic orthostatic hypotension (nOH) AND BOTH:
• • Improvement in baseline symptoms (dizziness, lightheadedness, fainting) documented
• • Increase in systolic BP ≥10 mmHg upon standing from supine position
• OR
• - Patient has another FDA labeled indication AND has had clinical benefit with agent
• If brand Northera requested when generic droxidopa available, ONE of the following:
• • Same metastatic cancer documentation as initial
• • Patient currently treated with and stable on brand agent
• • Tried and failed generic equivalent; or discontinued due to lack of efficacy/adverse event
• • Intolerance, hypersensitivity, or contraindication to generic not expected with brand
• • Generic expected to be ineffective, harmful, or not medically necessary
• • Tried another similar agent which was ineffective or not tolerated
• • Support for continued use of brand over generic provided

Approval duration

BCBSIL: 12 months; BCBSMT and BCBSNM: 3 months; all other plans: 1 month