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L.5.01.563
Isturisa (osilodrostat)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Isturisa (osilodrostat) is a cortisol synthesis inhibitor which inhibits 11β-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. Isturisa (osilodrostat) is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
First-line treatment for Cushing’s disease is surgical intervention. If surgery is not an option or is completed and fails, treatment is based on current status at time of retreatment (i.e., tumor resection, medication, etc.).
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Isturisa (osilodrostat) is considered not medically necessary as there are other treatment options covered by the Plan for the treatment of hypercortisolemia.
Services related to delivery and/or administration of a medication which have not been approved through BCBSMS PA review process will be considered not medically necessary.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
appropriate with regard to standards of good medical practice; and
not solely for the convenience of the Member, his or her Provider; and
the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
08/06/2020: New policy added. Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to state that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Revised policy statement to state that Isturisa (osilodrostat) is considered not medically necessary as there are other treatment options covered by the Plan which are recognized in current guidelines. Added statement that services related to delivery and/or administration of a medication which have not been approved through BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records. Removed investigative definition. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy language updated to change "member" to "individual." Sources updated.
09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Isturisa (osilodrostat). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Revised statement to state that Isturisa (osilodrostat) is considered not medically necessary as there are other treatment options covered by the Plan for the treatment of hypercortisolemia. Sources updated.
Isturisa prescribing information. Recordati Rare Diseases, Inc. April 2025. Last accessed June 2025.
Lynnette K. Nieman, Beverly M. K. Biller, James W. Findling, et al. Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 8, 1 August 2015, Pages 2807–2831, https://doi.org/10.1210/jc.2015-1818
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