Northera — Blue Cross Blue Shield of New Mexico

Preferred products

• droxidopa (generic)

Initial criteria

• Diagnosis of neurogenic orthostatic hypotension (nOH) AND ALL of the following:
• - Baseline blood pressure readings performed while sitting/supine and within 3 minutes of standing
• - Decrease of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes after standing
• - Persistent and consistent symptoms of nOH caused by primary autonomic failure (Parkinson’s disease, multiple system atrophy, or pure autonomic failure) OR dopamine beta-hydroxylase deficiency OR non-diabetic autonomic neuropathy
• - Prescriber has assessed severity of baseline symptoms (dizziness, lightheadedness, feeling faint, or feeling like may black out)
• - Prescriber has assessed and adjusted any medications that exacerbate orthostatic hypotension
• - ONE of the following regarding therapy options:
• • Patient has stage four advanced, metastatic cancer and use is for treatment or associated condition per best practices and FDA labeling
• • Patient is currently being treated and stable on requested agent
• • Patient has tried and had inadequate response to midodrine
• • Midodrine was discontinued due to lack of efficacy, diminished effect, or adverse event
• • Patient has intolerance, hypersensitivity, or FDA labeled contraindication to midodrine
• • Midodrine is expected to be ineffective, cause adherence barriers, worsen comorbid condition, or cause harm
• • Midodrine is not in best interest of patient based on medical necessity
• • Patient has tried another prescription drug in same pharmacologic class or with same mechanism of action and discontinued due to lack of efficacy or adverse event
• OR patient has another FDA labeled indication for requested agent AND patient’s age is within FDA labeling or supported for use at that age
• If request is for brand Northera with available generic droxidopa, then ONE of the following:
• - Patient with stage four advanced, metastatic cancer use as above
• - Patient currently treated and stable on requested brand
• - Patient tried and had inadequate response to generic droxidopa
• - Generic droxidopa discontinued due to lack of efficacy, diminished effect, or adverse event
• - Patient has intolerance, hypersensitivity, or FDA labeled contraindication to generic droxidopa
• - Generic equivalent expected to be ineffective, cause adherence barriers, worsen comorbid condition, or cause harm
• - Generic equivalent is not in best interest based on medical necessity
• - Patient has tried another drug in same class as generic equivalent and discontinued due to lack of efficacy or adverse event
• - There is support for use of brand over generic
• Prescriber is a specialist (e.g., cardiologist, neurologist) or has consulted with one
• Patient does NOT have any FDA labeled contraindications to Northera

Reauthorization criteria

• Patient previously approved for Northera through plan’s PA process
• ONE of the following:
• - Diagnosis of neurogenic orthostatic hypotension (nOH) AND BOTH of:
• • Improvement in baseline symptoms (dizziness, lightheadedness, feeling faint, or feeling like may black out)
• • Increase in systolic blood pressure of ≥10 mmHg upon standing from supine position
• OR BOTH of the following:
• • Patient has another FDA labeled indication for droxidopa
• • Patient has had clinical benefit with requested agent
• If request is for Northera brand with available generic droxidopa, same brand-vs-generic criteria from initial evaluation apply

Approval duration

3 months