Pharmacy Prior Authorization Criteria

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

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

AND

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

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)

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

Isturisa prescribing information. Recordati Rare Diseases Inc. Lebanon, NJ. April 2025.
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.
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.
Per clinical consult with endocrinologist, July 13, 2020.
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.

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]

2025-06-04: 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