Subject: droxidopa-Northera 2020-A SGM P2023

Drug

NORTHERA  (droxidopa)

droxidopa

Policy:

      I.  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 Indication
          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 should be
          assessed periodically.

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


    II.  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.


  III.  CRITERIA FOR INITIAL APPROVAL

          Neurogenic orthostatic hypotension
          Authorization of 3 months may be granted for treatment of
          neurogenic orthostatic hypotension when all of the following
          criteria are met:
          A.  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.
          B.  Member has neurogenic orthostatic hypotension due to ONE
               of the following diagnoses:
               1.  Primary autonomic failure due to Parkinson’s disease,
                    multiple system atrophy, or pure autonomic failure, OR
               2.  Dopamine beta hydroxylase deficiency, OR
               3.  Non-diabetic autonomic neuropathy


   IV.  CONTINUATION OF THERAPY

          Neurogenic orthostatic hypotension
          Authorization of 6 months may be granted for treatment of
          neurogenic orthostatic hypotension when all of the following
          criteria are met:
          A.  Member has experienced a sustained decrease in dizziness
          B.  Member has neurogenic orthostatic hypotension due to ONE
               of the following diagnoses:
               1.  Primary autonomic failure due to Parkinson’s disease,
                    multiple system atrophy, or pure autonomic failure, OR
               2.  Dopamine beta hydroxylase deficiency, OR
               3.  Non-diabetic autonomic neuropathy

Place of Service:

Outpatient

The above policy is based on the following references:

1. Northera [package insert]. Deerfield, IL: Lundbeck Inc.; July 2019.
2. AHFS Drug Information. http://online.lexi.com/lco. Accessed March 6, 2023.
3. Palma JA, & Kaufmann H. Epidemiology, Diagnosis, and Management of Neurogenic Orthostatic Hypotension. Movement Disorders Clinical Practice. 2017 May-Jun;4(3):298-308.
4. droxidopa [package insert]. Baltimore, MD: Lupin Pharmaceuticals, Inc.; March 2021.

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.

August 13, 2023