WHA

NORTHERA (droxidopa)

Self-Administration – oral 

Diagnosis considered for coverage:
  • 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 droxidopa capsules should be assessed periodically.
Coverage Criteria:

For diagnosis of symptomatic neurogenic orthostatic hypotension (NOH):

  • Dose does not exceed FDA label maximum of 600 mg three times daily; AND
  • Patient is 18 years of age or older; AND
  • Neurogenic orthostatic hypotension (NOH) must be 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; AND
  • Prescribed by or in consultation with a cardiologist, neurologist, or nephrologist; AND
  • 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); AND
  • Patients must have tried and failed treatment with midodrine
Reauthorization Criteria:

For diagnosis of symptomatic neurogenic orthostatic hypotension (NOH):

  • Dose does not exceed FDA label maximum of 600 mg three times daily; AND
  • Documentation supporting that the patient has experienced a positive clinical response to therapy.
Coverage Duration: 
  • Initial: 1 month
  • Reauthorization: 1 year
Authorization is not covered for the following:


The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 
  • Use of DOPA decarboxylase inhibitors may require dose adjustments for Northera
  • Patients with renal impairment: Dosing recommendations cannot be provided for patients with a GFR < 30 mL/min
  • BBW: 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 measured in this position. If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue Northera
  • Dosing
    • Starting dose: 100 mg three times daily during the day
    • Titrate by 100 mg three times daily, every 24-48 hours to symptomatic response. 
    • Maximum dose: 600 mg three times daily (1800 mg/day)
Policy Updates:
  • 9/1/2014 – New policy approved by P&T.
  • 8/16/2022 – Updated criteria to include maximum dosing, age limitations, specialist involvement, use of non-pharmacologic interventions, and changed trial and failure to midodrine only; also added reauthorization criteria and updated coverage duration.
References:


1.    Northera Prescribing Information. Lundbeck. Deerfield, IL. July 2019 
2.    Berger MJ, Kimpinski K. A practical guide to the treatment of neurogenic orthostatic hypotension. Can J Neurol Sci. 2014;41:156-163. 
3.    DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Accessed March 7, 2022 
4.    Freeman R. Neurogenic orthostatic hypotension. N Engl J Med. 2008; 358:615-24.
5.    Eschlböck, S., Wenning, G., & Fanciulli, A. (2017). Evidence-based treatment of neurogenic orthostatic hypotension and related symptoms. Journal of neural transmission (Vienna, Austria : 1996), 124(12), 1567–1605. https://doi.org/10.1007/s00702-017-1791-y
6.    Goldstein, D. S., Sharabi, Y. Neurogenic Orthostatic Hypotension. Circulation. January 2009; doi: 10.1161/circulationaha.108.805887
7.    Palma, J. A., & Kaufmann, H. (2020). Management of Orthostatic Hypotension. Continuum (Minneapolis, Minn.), 26(1), 154–177. https://doi.org/10.1212/CON.0000000000000816

Last review date: August 16, 2022