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droxidopa — Blue Cross Blue Shield of Oklahoma

neurogenic orthostatic hypotension (nOH)

Preferred products

  • midodrine
  • generic droxidopa

Initial criteria

  • 1. ONE of the following:
  • A. The patient has a diagnosis of neurogenic orthostatic hypotension (nOH) AND ALL of the following:
  • 1. Baseline blood pressure readings obtained while sitting or supine and within 3 minutes of standing from a supine position
  • 2. Decrease of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes after standing
  • 3. Persistent and consistent symptoms of nOH caused by ONE of the following: primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure) OR dopamine beta-hydroxylase deficiency OR non-diabetic autonomic neuropathy
  • 4. The prescriber has assessed severity of baseline symptoms of dizziness, lightheadedness, feeling faint, or feeling like patient may black out
  • 5. The prescriber has assessed and adjusted any medications known to exacerbate orthostatic hypotension (e.g., diuretics, vasodilators, beta-blockers)
  • 6. ONE of the following regarding prior or concurrent treatments:
  • A. Stage four advanced metastatic cancer use consistent with FDA and supported literature, OR
  • B. Patient is currently stable on requested agent [chart notes required], OR
  • C. Patient has tried and had inadequate response to midodrine [chart notes required], OR
  • D. Midodrine discontinued due to lack of efficacy or adverse event [chart notes required], OR
  • E. Patient has intolerance or hypersensitivity to midodrine [chart notes required], OR
  • F. Patient has FDA labeled contraindication to midodrine [chart notes required], OR
  • G. Midodrine expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease functional ability, cause adverse reaction or harm [chart notes required], OR
  • H. Midodrine not in best interest of patient based on medical necessity [chart notes required], OR
  • I. Patient has tried another drug in same pharmacologic class or with same mechanism as midodrine and it was discontinued due to lack of efficacy or adverse event [chart notes required]
  • B. Patient has another FDA labeled indication for droxidopa AND
  • 2. If patient has FDA labeled indication, then ONE of the following: age within FDA labeling OR supported use for age
  • 3. If request is for brand Northera with available generic equivalent droxidopa, then ONE of the following applies:
  • A. Stage four metastatic cancer scenario consistent with FDA and supported literature, OR
  • B. Patient is currently stable on Northera [chart notes required], OR
  • C. Patient has tried and inadequate response to generic droxidopa [chart notes required], OR
  • D. Generic equivalent discontinued due to lack of efficacy or adverse event [chart notes required], OR
  • E. Intolerance or hypersensitivity to generic not expected with brand [chart notes required], OR
  • F. FDA labeled contraindication to generic not expected with brand [chart notes required], OR
  • G. Generic expected ineffective, causes adherence barrier, worsens comorbidity, decreases functional ability, or causes adverse effects [chart notes required], OR
  • H. Generic not in best interest of patient based on medical necessity [chart notes required], OR
  • I. Patient tried another drug in same class or mechanism as generic and discontinued due to ineffectiveness or adverse event [chart notes required], OR
  • J. There is support for brand use over generic
  • 4. Prescriber is a specialist in the diagnosis area (e.g., cardiologist, neurologist) or has consulted with one
  • 5. Patient does NOT have any FDA labeled contraindications to Northera

Reauthorization criteria

  • 1. Patient previously approved through plan prior authorization
  • 2. ONE of the following:
  • A. Patient has diagnosis of nOH AND BOTH:
  • 1. Improvement in severity from baseline symptoms (dizziness, lightheadedness, faint) [chart notes required]
  • 2. Increase in systolic blood pressure at least 10 mmHg upon standing from supine position
  • B. BOTH of the following: patient has another FDA labeled indication AND has had clinical benefit with requested agent
  • 3. If request is for brand Northera with available generic droxidopa, then apply same criteria as initial: either stable use, failed generic, intolerance, contraindication, or justified brand medical necessity as outlined

Approval duration

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