INBRIJA (levodopa)

INBRIJA (levodopa) 

SELF ADMINISTRATION – inhalation

Indication for Prior Authorization:

• Intermittent treatment of “OFF” episodes in patients with Parkinson’s disease (PD) treated with carbidopa-levodopa.

Coverage Criteria:

Treatment of PD “off” episodes:

• Diagnosis of PD confirmed by chart note documentation; AND
• Prescribed by or in consultation with a neurologist; AND
• Patient is currently taking carbidopa-levodopa; AND
• Patient has previously tried one of the following for treatment of “off” episodes: entacapone (Comtan), rasagiline (Azilect), pramipexole (Mirapex), ropinirole (Requip), tolcapone (Tasmar), apomorphine (Apokyn), cabergoline (Dostinex), selegiline (Eldepryl, Zelapar, EMSAM), safinamide (Xadago); AND
• Patient does not have asthma, chronic obstructive pulmonary disease (COPD), or any other chronic underlying lung disease.

Dosing:

• Oral inhalation of the contents of two 42 mg capsules (84 mg) as needed, up to 5 times a day.
  • Load 1 capsule (42 mg levodopa) into the inhaler and breathe in (inhale). A complete dose is 2 capsules. Do not load 2 capsules at the same time.
  • The maximum dose per “OFF” period is 84 mg.
• The maximum recommended daily dosage of Inbrija is 420 mg (10 capsules per day).

Coverage Duration:

• 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 Committee.

Additional Information:

• The on-time period is when levodopa is working and reduces PD symptoms (e.g. tremors, difficulty walking, etc.). An "OFF" episode occurs when the medication stops working well, resulting in a recurrence of PD symptoms.
• For oral inhalation only. DO NOT swallow Inbrija capsules. Only use Inbrija capsules with the Inbrija inhaler.
• Inbrija is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor or who have recently (within 2 weeks) taken a nonselective MAO inhibitor (e.g. phenelzine [Nardil], isocarboxazid [Marplan], tranylcypromine [Parnate]).

Review History:

• 05/06/2020 – Annual review.
• 01/20/2021 – Annual review; updated format.

References:

• INBRIJA® (levodopa inhalation powder), for oral inhalation use [package insert]. Ardsley, NY: Acorda Therapeutics, Inc; August 2020.
• Miyasaki JM, Martin W, Suchowersky O, Weiner WJ, Lang AE. Practice parameter: initiation of treatment for Parkinson’s disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2002 Jan 8;58(1):11-7.