CurrentAvMedPolicy N/A

Isturisa (osilodrostat) pharmacy prior authorization

Defines clinical prior authorization and reauthorization criteria for coverage of Isturisa (osilodrostat) for treatment of endogenous Cushing's syndrome/Cushing's disease for AvMed members; applies to prescriptions processed through pharmacy/specialty pharmacy.

Policy Summary

PayerAvMed

PolicyIsturisa (osilodrostat) pharmacy prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form with provider signature plus chart notes, labs (including current mUFC or 24-hour UFC), diagnostics, and pharmacy paid claims to document prior therapy failures, surgical history/contraindication, and safety assessments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120/30dQuantity limit (1 mg & 5 mg tabs)

6 moInitial authorization duration

12 moReauthorization duration

>3xmUFC threshold for initiation

Clinical Prior Authorization Criteria

Policy Summary

PayerAvMed

PolicyIsturisa (osilodrostat) pharmacy prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

ALL of the following

Member must be 18 years of age or older
Prescribing provider is an endocrinologist or neurosurgeon
Diagnosis (ONE of the following)
- Endogenous Cushing's Syndrome
- Cushing's Disease
Surgical candidacy / history (at least ONE)
- Member is NOT a candidate for surgery or surgery has NOT been curative
- Member is awaiting surgery for endogenous Cushing's syndrome
Prior medication failure (must have failed 90 days of ONE of the following)
- ketoconazole
  Failure verified by chart notes or pharmacy paid claims; 90 days required
- metyrapone
  Failure verified by chart notes or pharmacy paid claims; 90 days required
- mitotane
  Failure verified by chart notes or pharmacy paid claims; 90 days required
Member must have current mean urine free cortisol (mUFC) > 3 times the upper limit of normal (ULN)> 3 x ULN
Labs must be submitted
Member will NOT use concurrent Cushing's disease treatment with Isturisa (e.g., ketoconazole, metyrapone, mifepristone, mitotane)
No concurrent pharmacologic treatments for Cushing's
Member has been assessed for QTc prolongation/Torsade de Pointes, hepatic and renal impairment
Assessment documentation required
Member is NOT taking glucocorticoids (e.g., prednisone, hydrocortisone)
For members with diabetes and/or hypertension, disease is adequately controlled
Documentation required
No history of specified cardiovascular conditions
- Congestive Heart Failure (CHF)
- Unstable angina
- Sustained ventricular tachycardia
- Clinically significant bradycardia
- Advanced heart block
- Acute myocardial infarction <1 year prior to starting Isturisa
- Clinically significant impairment in cardiovascular disease

Reauthorization (all criteria required)

All criteria must be met for approval of reauthorization. Documentation including labs and chart notes must be provided.

ALL of the following

Member's current 24-hour urinary free cortisol level is below the upper limit of normal (labs must be submitted)
Improvements in quality of life have been maintained while on Isturisa therapy
Chart notes or clinical documentation required
Member will continue to be monitored for QTc prolongation, hepatic and renal impairment
Ongoing monitoring documentation required

Prior Authorization & Documentation Requirements

Prior Authorization

Submit completed prior authorization form

Prescribing physician must sign and clearly print name on the prior authorization request (preprinted stamps not valid). Submit the completed PA form along with supporting chart notes, laboratory results, diagnostics, and pharmacy paid claims as applicable to support each checked criterion.

Prescriber signature and printed name required (no preprinted stamps).
Include chart notes, labs, diagnostics, and pharmacy paid claims as applicable.

Documentation Required

Provide lab and diagnostic evidence

Provide laboratory and diagnostic evidence to support initiation or reauthorization: current mean urinary free cortisol (mUFC) >3×ULN for initiation or current 24‑hour UFC below ULN for reauthorization, documentation of 90‑day prior therapy failures, surgical history or contraindication, assessments for QTc prolongation/hepatic/renal function, and cardiovascular history.

Current mUFC > 3 × ULN for initiation (labs must be submitted).
Current 24‑hour UFC below ULN for reauthorization (labs must be submitted).
Documentation of 90 days failure of ketoconazole, metyrapone, or mitotane (chart notes or pharmacy paid claims).
Surgical history/contraindication to surgery documentation.
Assessment documentation for QTc prolongation/Torsade de Pointes, hepatic and renal impairment.
Documentation of cardiovascular history (no specified adverse conditions).

Denial Risk

Incomplete documentation may delay or deny authorization

If requested information is not complete, correct, or legible, the authorization process can be delayed or denied.

Missing, incorrect, or illegible information may cause processing delays or denial of the request.

Step Therapy

Prior medication therapy required

Member must have failed at least 90 days of therapy with one of the following—ketoconazole, metyrapone, or mitotane—verified by chart notes or pharmacy paid claims prior to approval.

Failure of 90 days of one agent is required (ketoconazole, metyrapone, or mitotane).
Verification can be via chart notes or pharmacy paid claims.

Billing Rule

Specialty pharmacy dispensing

Isturisa is dispensed through the Specialty Pharmacy (Proprium Rx); use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Medication provided by Specialty Pharmacy - Proprium Rx.
Samples do not meet PA/step‑edit criteria.

Clinical Thresholds and Monitoring Requirements

Thresholds

Mean urinary free cortisol (mUFC) for initiation> 3 x ULN

24-hour urinary free cortisol for reauthorizationbelow ULN

Isturisa (osilodrostat) is an oral adrenal steroidogenesis inhibitor indicated for treatment of endogenous Cushing's syndrome/Cushing's disease and is dispensed via Specialty Pharmacy (Proprium Rx). Prior authorization requires documentation that the member meets disease severity and treatment prerequisites and that safety monitoring has been performed. For initiation the policy requires a current mean urinary free cortisol (mUFC) > 3 x ULN, verification of prior surgical candidacy or outcome, and evidence of failure of at least one steroidogenesis inhibitor (ketoconazole, metyrapone, or mitotane) for at least 90 days (chart notes or pharmacy paid claims required).

Because osilodrostat can affect cardiac conduction and organ function, the policy mandates baseline and ongoing safety assessments. The prescriber must document assessment for QTc prolongation/Torsade de Pointes, as well as evaluation of hepatic and renal function prior to and during therapy. Reauthorization requires submission of a current 24-hour urinary free cortisol that is below the ULN and documentation that quality of life improvements have been maintained while continuing monitoring for QTc, hepatic, and renal safety concerns.

The prior authorization form and supporting documentation (signed prescriber form, chart notes, labs, diagnostics, and pharmacy paid claims as applicable) must be submitted; incomplete, incorrect, or illegible information may delay or result in denial of the request. Quantity limits and durations are specified on the form (initial authorization: 6 months; reauthorization: 12 months; quantity limit: 120 tablets/30 days for 1 mg & 5 mg tablets).

OpenPayer

Isturisa (osilodrostat) pharmacy prior authorization

Clinical Prior Authorization Criteria

Required Diagnosis Coding

Prior Authorization & Documentation Requirements

Clinical Thresholds and Monitoring Requirements

Terms Used in This Policy