Subject: droxidopa-Northera SGM 2020-A P2026

Drug

NORTHERA  (droxidopa)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications^1,2

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. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Northera (droxidopa) should be assessed periodically.

All other indications are considered experimental/investigational and not medically necessary.

Prescriber Specialties

This medication must be prescribed by or in consultation with a cardiologist, neurologist, or a specialist in the treatment of neurogenic orthostatic hypotension.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: blood pressure measurements demonstrating a persistent, consistent decrease in systolic blood pressure (SBP) of at least 20 mmHg or decrease in diastolic blood pressure (DBP) of at least 10 mmHg within 3 minutes of standing or head-up tilt test.

Coverage Criteria

Neurogenic Orthostatic Hypotension^1-3

Authorization of 3 months may be granted for treatment of neurogenic orthostatic hypotension in adult members when both of the following criteria are met:

·        Member has a persistent, consistent decrease in SBP of at least 20 mmHg or decrease in DBP of at least 10 mmHg within 3 minutes of standing or head-up tilt test.

·        Member has neurogenic orthostatic hypotension due to any of the following diagnoses:

§  Primary autonomic failure due to Parkinson’s disease, multiple system atrophy, or pure autonomic failure

§  Dopamine beta hydroxylase deficiency

§  Non-diabetic autonomic neuropathy

Continuation of Therapy

Neurogenic orthostatic hypotension^1,2,4

Authorization of 12 months may be granted for treatment of neurogenic orthostatic hypotension in adult members when both of the following criteria are met:

·        Member has experienced a sustained decrease in symptoms of neurogenic orthostatic hypotension (e.g., dizziness, lightheadedness, “feeling that you are about to black out”)

·        Member has neurogenic orthostatic hypotension due to any of the following diagnoses:

§  Primary autonomic failure due to Parkinson’s disease, multiple system atrophy, or pure autonomic failure

§  Dopamine beta hydroxylase deficiency

§  Non-diabetic autonomic neuropathy

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Northera [package insert]. Deerfield, IL: Lundbeck; July 2019.

2.     Droxidopa [package insert]. Bedminster, NJ: Ascend Laboratories, LLC; January 2025.

3.     Gibbons CH, Schmidt P, Biaggioni I, et al. The recommendations of a consensus panel for the screening, diagnosis, and treatment of neurogenic orthostatic hypotension and associated supine hypertension. J Neurol. 2017;264:1567-1582.

4.     Isaacson S, Shill HA, Vernino, S, et al. Safety and durability of effect with long-term, open-label droxidopa treatment in patients with symptomatic neurogenic orthostatic hypotension (NOH303). J Parkinsons Dis. 2016;6:751-759.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 03, 2026