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droxidopa — Blue Cross Blue Shield of Montana

other FDA labeled indications for droxidopa

Preferred products

  • midodrine
  • droxidopa (generic)

Initial criteria

  • 1. Patient has a diagnosis of neurogenic orthostatic hypotension (nOH) AND ALL of the following:
  • • Baseline blood pressure recorded while sitting or supine and within 3 minutes of standing.
  • • Decrease ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes after standing.
  • • Persistent symptoms of nOH due to ONE of: primary autonomic failure (Parkinson’s disease, multiple system atrophy, or pure autonomic failure), dopamine beta‑hydroxylase deficiency, or non‑diabetic autonomic neuropathy.
  • • Prescriber has assessed severity of baseline dizziness/lightheadedness/fainting symptoms.
  • • Prescriber has assessed and adjusted medications known to exacerbate orthostatic hypotension (e.g., diuretics, vasodilators, beta‑blockers).
  • • ONE of the following:
  • – Patient has stage IV advanced metastatic cancer and use is consistent with best practices; OR
  • – Patient is currently stable on requested agent; OR
  • – Patient has tried and had inadequate response to midodrine; OR
  • – Midodrine discontinued due to lack of efficacy or adverse event; OR
  • – Intolerance, hypersensitivity, or FDA labeled contraindication to midodrine; OR
  • – Midodrine expected to be ineffective, cause adherence barrier, worsen comorbidity, or harm; OR
  • – Midodrine not in best interest of patient based on medical necessity; OR
  • – Tried another agent in same pharmacologic class as midodrine with inadequate result.
  • OR
  • 1B. Patient has another FDA labeled indication for droxidopa AND
  • • Patient’s age is within FDA labeling for that indication OR age use is adequately supported.
  • AND
  • If brand Northera is requested and generic droxidopa available, ONE of the following applies:
  • • Same cancer or stability exceptions as above; OR
  • • Tried and failed generic equivalent; OR
  • • Discontinued generic for lack of efficacy or adverse event; OR
  • • Intolerance/hypersensitivity or contraindication to generic not expected with brand; OR
  • • Generic expected to be ineffective or unsafe; OR
  • • Generic not in patient’s best interest; OR
  • • Tried another drug in same class as generic with failure; OR
  • • Support noted for use of brand over generic.
  • AND prescriber is a specialist (cardiologist, neurologist) or consulted with one.
  • AND patient does NOT have FDA labeled contraindications to droxidopa.

Reauthorization criteria

  • 1. Patient previously approved for droxidopa and ONE of the following:
  • A. Has nOH AND BOTH:
  • • Improvement in severity of baseline symptoms (dizziness, lightheadedness, faintness).
  • • Increase in systolic BP from baseline by at least 10 mmHg upon standing.
  • OR
  • B. Has another FDA labeled indication AND demonstrated clinical benefit.
  • If brand Northera requested and generic available, ONE of the following applies:
  • • Same cancer exceptions; OR
  • • Patient stable on requested agent; OR
  • • Tried and failed generic; OR
  • • Discontinued generic due to lack of efficacy or adverse event; OR
  • • Intolerance/hypersensitivity or contraindication to generic not expected with brand; OR
  • • Generic expected to be ineffective or unsafe; OR
  • • Generic not in best interest; OR
  • • Tried another drug in same class as generic with failure; OR
  • • Support for brand over generic.

Approval duration

3 months