WHA

Isturisa (osilodrostat)

Indications for Prior Authorization

Isturisa (osilodrostat)
  • For diagnosis of Cushing's Syndrome
    Indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s Syndrome for whom surgery is not an option or has not been curative

Criteria

Isturisa

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of Cushing's syndrome
    • AND
  • Used for treatment of endogenous hypercortisolemia
    • AND
  • One of the following:
    • Patient is not a candidate for surgery (e.g., adrenalectomy, transsphenoidal surgery)
    • Surgery has not been curative for the patient
    AND
  • Trial and failure for a minimum of 90 days, contraindication or intolerance to oral ketoconazole [A]
    • AND
  • Prescribed by or in consultation with an endocrinologist
Isturisa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient demonstrates positive clinical response to therapy (e.g., a clinically meaningful reduction in 24-hour urinary free cortisol levels, improvement in signs or symptoms of the disease)

  • Guideline ID
    GL-486431

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Jun 17, 2020

P & T Revisions

1970-01-01, 2025-12-18, 2025-06-04, 2025-05-09, 2024-07-03, 2023-10-10, 2021-06-02, 2020-09-08, 2020-05-29

  1. Isturisa prescribing information. Recordati Rare Diseases Inc. Lebanon, NJ. April 2025.
  2. Pivonello R, Fleseriu M, Newell-Price J, et al. Osilodrostat provides clinical benefit over 48 weeks in patients with Cushing disease: results from the LINC 3 study. Endocr Abstr. 2019. https://doi.org/10.1530/endoabs.63.OC3.1. Accessed May 14, 2021.
  3. Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): IBM Corporation.; Updated periodically. Available by subscription at: https://www.micromedexsolutions.com/. Accessed May 14, 2021.
  4. Per clinical consult with endocrinologist, July 13, 2020.
  5. I Bancos, E B Geer, F Castinetti, R Feelders, M Fleseriu, R Pivonello, M Reincke, A Tabarin, J Le Mouhaër, J Stermenska, M Maldonado, B M Biller, 7790 A Non-interventional, Multinational, Phase IV Study to Evaluate the Long-Term Safety and Efficacy of Osilodrostat in Patients with Endogenous Cushing's Syndrome (LINC 6): 1-Year Real-World Interim Analysis, Journal of the Endocrine Society, Volume 8, Issue Supplement_1, October-November 2024.
  1. Per feedback from consultant, determining efficacy of ketoconazole therapy is difficult to determine as multiple dose adjustments often need to be made depending on patient's response. Consultant recommends failure to respond to therapy be defined as requiring more than 3-4 dose adjustments or no response after 4 months. [4]
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-06-04: Annual review - No changes to criteria
  • 2025-05-09: Guideline update with revised indication.
  • 2024-07-03: 2024 Annual Review - No changes to criteria
  • 2023-10-10: Program update to standard reauthorization language. No changes to clinical intent.
  • 2021-06-02: 2021 Annual Review, no changes to criteria.
  • 2020-09-08: Updated to include step through ketoconazole
  • 2020-05-29: New Program