Northera — Blue Cross Blue Shield of Texas

Preferred products

• midodrine
• droxidopa (generic)

Initial criteria

• Diagnosis of neurogenic orthostatic hypotension (nOH) AND ALL of the following:
• - Baseline blood pressure readings recorded while sitting/supine and within 3 minutes of standing
• - Decrease ≥ 20 mmHg systolic or ≥ 10 mmHg diastolic within 3 minutes of standing
• - Persistent symptoms of nOH caused by primary autonomic failure, dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy
• - Prescriber assessed baseline severity of dizziness/lightheadedness/feeling faint/feeling like blacking out
• - Prescriber assessed and adjusted medications that exacerbate orthostatic hypotension (e.g., diuretics, vasodilators, beta-blockers)
• - ONE of the following:
• • Stage 4 advanced metastatic cancer and use consistent with best practices and FDA approval, OR
• • Currently stable and being treated with requested agent, OR
• • Tried and inadequate response to midodrine, OR
• • Midodrine discontinued due to lack of efficacy/effectiveness/adverse event, OR
• • Intolerance or hypersensitivity to midodrine, OR
• • FDA labeled contraindication to midodrine, OR
• • Midodrine expected to be ineffective, worsen comorbid condition, impair function, cause adverse reaction, or not in patient’s best interest, OR
• • Tried another agent in same pharmacologic class as midodrine and discontinued due to efficacy or adverse event.
• OR Patient has another FDA labeled indication for requested agent and route AND
• - Patient’s age within FDA labeling or supported by evidence for requested indication.
• If request is for brand Northera when generic droxidopa available, ONE of:
• • Stage 4 advanced metastatic cancer use consistent with best practices, OR
• • Patient stable on requested brand, OR
• • Tried and failed or intolerant to droxidopa generic, OR
• • Contraindicated or not in best interest to use generic as documented.
• Prescriber is a cardiologist, neurologist, or consulted with such specialist.
• Patient has no FDA labeled contraindications to requested agent.

Reauthorization criteria

• Patient previously approved through plan PA process AND
• ONE of the following:
• - Diagnosis of nOH AND BOTH:
• • Improvement in baseline symptoms (dizziness, lightheadedness, faintness, etc.) AND
• • Increase in systolic BP from baseline ≥ 10 mmHg upon standing
• OR BOTH of the following:
• • Another FDA labeled indication AND
• • Clinical benefit observed with requested agent.
• If brand Northera requested when droxidopa generic available, then one of:
• • Stage 4 metastatic cancer use as above, OR
• • Stable on requested brand, OR
• • Generic not tolerated, ineffective, or contraindicated, or not in best interest.

Approval duration

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