Northera (droxidopa)
Indications for Prior Authorization
Northera (droxidopa)
-
For diagnosis of Neurogenic orthostatic hypotension (NOH)
Indicated for 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. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Northera should be assessed periodically.
Criteria
Brand Northera, Generic droxidopa
Prior Authorization (Initial Authorization)
Length of Approval: 1 Month(s)
- Diagnosis of symptomatic neurogenic orthostatic hypotension (NOH) AND
- NOH is caused by one of the following conditions:
- Primary autonomic failure (e.g., Parkinson's disease, multiple system atrophy, pure autonomic failure)
- Dopamine beta-hydroxylase deficiency
- Non-diabetic autonomic neuropathy
- Prescribed by or in consultation with one of the following specialists: [2, A]
- Cardiologist
- Neurologist
- Nephrologist
- Attempt has been made to manage NOH through at least one non-pharmacologic intervention (e.g., use of compression stockings/abdominal binder, increasing salt/fluid intake, patient participates in regular exercise, discontinue or reduce hypotensive or antihypertensive medications) [2, 4, 5, B] AND
- Trial and failure, contraindication, or intolerance to one of the following agents:
- Fludrocortisone acetate [2, 3]
- Midodrine [2, 3]
Brand Northera, Generic droxidopa
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient demonstrates positive clinical response to therapy.
P & T Revisions
2024-04-03, 2023-11-02, 2023-04-11, 2022-03-08, 2021-04-09
References
- Northera Prescribing Information. Lundbeck. Deerfield, IL. July 2019
- Berger MJ, Kimpinski K. A practical guide to the treatment of neurogenic orthostatic hypotension. Can J Neurol Sci. 2014;41:156-163.
- DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Accessed March 7, 2022
- Per Clinical Consultation with a Neurologist. July 7, 2014.
- Freeman R. Neurogenic orthostatic hypotension. N Engl J Med. 2008; 358:615-24.
End Notes
- Per consultant recommendation, prescribers who are best able to manage blood pressure or neurological conditions, like NOH, include cardiologists, neurologists, and nephrologists. [4]
- According to international treatment guidelines, as well as per consultant recommendation, NOH should be managed non-pharmacologically before using medications, such as fludrocortisone, midodrine, or droxidopa, to treat NOH directly. This requirement of non-pharmacologic intervention is not possible for Medicare due to benefit design, and will therefore be applicable to Commercial plans only. [2, 4, 5]
Revision History
- 2024-04-03: 2024 Annual Review. No criteria changes.
- 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-04-11: Annual review
- 2022-03-08: Annual Review
- 2021-04-09: Annual Review and GPI Add