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Prior Authorization Protocol
NORTHERATM (droxidopa)


HNCA
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For use in the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure [Parkinson's disease (PD), multiple system atrophy and pure autonomic failure], dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of symptomatic neurogenic orthostatic hypotension
    AND
    • Failure or clinically significant adverse effects to midodrine OR fludrocortisone
  3. Coverage is Not Authorized For:
    • BLACK BOX WARNING: Supine Hypertension
      • Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses. Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measure in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA.
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
  4. General Information:
    • Effectiveness beyond two weeks of treatment has not been established. Per package labeling for Northera, continued effectiveness of Northera should be assessed periodically.
    • Includes a boxed warning for reduction or discontinuation of Northera if supine hypertension cannot be managed by elevation of the head of the bed with any increase in dose.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    midodrine (ProAmatineR)

    10 mg PO TID
    At 3 to 4 hour intervals (during daytime hours)

    30 mg per day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Northera

    100 mg PO TID

    Titrate to symptomatic response,
    in increments of 100 mg TID every 24-48 hours up
    to a maximum dose of 600 mg TID.

    Length of Benefit

  7. Product Availability:
    Capsule: 100 mg, 200 mg, 300 mg
  8. References:
    1. Northera [Prescribing Information]. Charlotte, NC: Chelsea Therapeutics, Inc.; February 2014.
    2. Lanier JB, et al. Evaluation and management of orthostatic hypotension. Am Fam Physician. 2011;84(5):527-536.
    3. MicromedexR Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed: June 18, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.