WHA

Nourianz (istradefylline)

Indications for Prior Authorization

Nourianz (istradefylline)
  • For diagnosis of Parkinson's Disease
    Indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off' episodes.

Criteria

Nourianz

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of Parkinson's disease
    • AND
  • Patient is experiencing "off" episodes
    • AND
  • Used in combination with carbidopa/levodopa at a maximally tolerated dose [A,1,2]
    • AND
  • Trial and failure, contraindication or intolerance to two of the following [A,B,1-4]:
    • MAO-B Inhibitor (e.g., rasagiline, selegiline)
    • Dopamine Agonist (e.g., pramipexole, ropinirole)
    • COMT Inhibitor (e.g., entacapone)
    AND
  • Prescribed by or in consultation with a neurologist
Nourianz

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient demonstrates positive clinical response to therapy
    • AND
  • Used in combination with carbidopa/levodopa [A,1,2]

  • Guideline ID
    GL-158377

  • Formulary
    premium

  • Effective date
    Jan 1, 2025

  • P&T approval date
    Nov 21, 2024

P & T Revisions

2024-11-01, 2023-10-09, 2022-11-03, 2021-10-27, 2020-10-26, 2019-11-14

  1. Nourianz Prescribing Information. Kyowa Kirin, Inc. Bedminster, NJ. May 2020.
  2. Isaacson SH, Bette S, Pahwa R. Istradefylline for off episodes in Parkinson’s disease: A US perspective of common clinical scenarios. Degenerative Neurological and Neuromuscular Disease. 2023;12:97-109.
  3. Masood N, Jimenez-Shahed J. Effective management of “off” episodes in Parkinson’s disease: Emerging treatment strategies and unmet clinical needs. Neuropsychiatric Disease and Treatment. 2023;19:247-66.
  4. Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and Movement Disorder Society evidence-based medicine review: update on treatments for the motor symptoms of Parkinson’s disease. Movement Disorders. 2018;33(8):1248-66.
  1. Patients included in the pivotal trials continued levodopa/carbidopa treatment throughout study duration, with or without other adjunctive agents, including COMT inhibitors, MAO-B inhibitors, and dopamine agonists. Of the 195 patients of a North American phase IIb trial, 86% of patients were on adjunct dopamine agonists and 41% were on adjunct COMT inhibitors. Similarly, amongst the combined 967 patients enrolled in the other 3 trials (1 North American, 2 Japanese), about 90% were on adjunctive treatment regimens. [1, 2]
  2. Management of “off” episodes is individualized to patient response and presentation, which fluctuate and change with disease progression. A 2018 evidence-based medicine review on the treatment of motor fluctuations in Parkinson’s disease recommended MAO-B inhibitors, dopamine agonists, and COMT inhibitors as clinically useful and efficacious, whereas Nourianz was recommended as possibly useful and only likely efficacious. [3, 4]
  • 2024-11-01: Annual review - no criteria changes
  • 2023-10-09: Annual review - update to reauth verbiage without change to clinical intent
  • 2022-11-03: Annual Review - no criteria changes
  • 2021-10-27: Annual Review
  • 2020-10-26: Annual review, no changes
  • 2019-11-14: New guideline created.