How to Get Isturisa (Osilodrostat) Covered by UnitedHealthcare in Ohio: Complete Prior Authorization Guide
Answer Box: Getting Isturisa Covered by UnitedHealthcare in Ohio
Fastest path to approval: UnitedHealthcare requires prior authorization for Isturisa (osilodrostat) with documented Cushing's disease and proof that surgery isn't an option or wasn't curative. No step therapy is required if these criteria are met.
Three steps to start today:
- Gather your UFC, salivary cortisol, and dexamethasone suppression test results
- Have your endocrinologist submit a prior authorization through the UnitedHealthcare provider portal
- Include surgical history documentation (why surgery wasn't done or why it failed)
If denied: You have two levels of internal appeals, then external review through Ohio's Department of Insurance within 180 days.
Table of Contents
- Who Should Use This Guide
- Member & Plan Basics
- Clinical Criteria for Approval
- Coding and Billing Requirements
- Documentation Packet Checklist
- Submission Process
- Specialty Pharmacy Network
- After Submission: What to Expect
- Common Denial Reasons & How to Fix Them
- Appeals Process in Ohio
- Costs & Financial Assistance
- FAQ
Who Should Use This Guide
This guide is for Ohio residents with UnitedHealthcare coverage who need Isturisa (osilodrostat) for Cushing's disease. You'll find this most helpful if you:
- Have been diagnosed with Cushing's disease by an endocrinologist
- Are not a candidate for pituitary surgery, or surgery wasn't successful
- Have received a prior authorization denial from UnitedHealthcare
- Need to understand the appeals process in Ohio
Expected outcome: With proper documentation, most medically appropriate requests get approved either initially or on appeal. The key is having complete lab evidence and surgical history documentation.
Member & Plan Basics
Coverage Requirements
Active UnitedHealthcare coverage: Verify your plan is active and includes prescription drug benefits through OptumRx. Check your member ID card for "OptumRx" or similar pharmacy benefit manager information.
Plan types that cover Isturisa:
- UnitedHealthcare commercial plans
- UnitedHealthcare Medicare Advantage
- UnitedHealthcare Medicaid (Community Plan)
Note: Self-funded employer plans follow federal ERISA rules but typically use similar prior authorization processes.
Deductible and Authorization Requirements
Isturisa requires prior authorization regardless of your deductible status. Once approved, your copay depends on your plan's specialty drug tier—typically 20-40% coinsurance after deductible.
Clinical Criteria for Approval
UnitedHealthcare's OptumRx requires these specific criteria for Isturisa approval:
Primary Requirements
- Documented Cushing's disease diagnosis
- One of the following:
- Patient is not a candidate for pituitary surgery, OR
- Pituitary surgery has not been curative
- Age 18 or older
- Prescriber must be an endocrinologist (or have endocrinology consultation documented)
No Step Therapy Required
Unlike many specialty drugs, UnitedHealthcare does not require you to try and fail other medications before Isturisa if you meet the surgical criteria above.
Lab Evidence Needed
Your endocrinologist must document hypercortisolism with:
- Elevated 24-hour urinary free cortisol (UFC) with reference ranges
- Abnormal late-night salivary cortisol levels
- Abnormal dexamethasone suppression test (DST) results
Coding and Billing Requirements
NDC and Billing Information
Component | Details |
---|---|
NDC Number | 55292-320-60 (11-digit: 55292-0320-60) |
Billing Unit | Each (EA) - 60 tablets per package |
ICD-10 Code | E24.0 (Pituitary-dependent Cushing's disease) |
J-Code | None assigned (oral medication) |
Important Billing Notes
- Specialty pharmacies bill using the NDC number on pharmacy claims
- No HCPCS J-code exists for Isturisa as it's an oral medication
- Always include the specific ICD-10 code E24.0 for Cushing's disease
Documentation Packet Checklist
Provider Letter of Medical Necessity
Your endocrinologist's letter must include:
Patient Information:
- Full name, date of birth
- UnitedHealthcare policy and group number
- Clear statement of Cushing's disease diagnosis
Clinical Documentation:
- Detailed disease history and symptoms
- Lab results: UFC, salivary cortisol, DST with reference ranges and dates
- Prior surgical history or explanation why surgery isn't an option
- Requested dose and frequency per FDA labeling
- What happens if treatment is denied (medical consequences)
Supporting Attachments:
- All relevant lab reports
- Clinic notes from endocrinology visits
- Surgical consultation notes (if applicable)
- Prior authorization form (completed)
Tip: Recordati Rare Diseases provides a letter of medical necessity template that can be customized for your specific case.
Submission Process
Electronic Submission (Required as of June 2025)
For providers: Submit through the UnitedHealthcare provider portal or OptumRx provider interface.
Required fields that commonly cause rejections:
- Complete member ID and group number
- Specific ICD-10 code (E24.0)
- Prescriber NPI number
- Exact medication name and NDC
- Requested quantity and days supply
Timeline Expectations
- Standard review: 15 business days
- Expedited review: 72 hours (if delay could seriously jeopardize health)
- Automated approval: Under 30 seconds if all criteria are clearly met through OptumRx PreCheck system
Specialty Pharmacy Network
Required Network Pharmacies
Isturisa must be filled at a UnitedHealthcare-approved specialty pharmacy, typically:
- Optum Specialty Pharmacy (primary)
- Other contracted specialty pharmacies (verify at optumrx.com)
Shipment Process
Once approved:
- Optum Specialty Pharmacy contacts you to confirm delivery address
- Medication ships with tracking and signature requirement
- Clinical support team provides ongoing refill coordination
- Reauthorization managed automatically when renewal is due
After Submission: What to Expect
Confirmation and Tracking
- Save your confirmation number from the provider portal submission
- Check status every 3-5 business days through the portal
- Document all communications with dates and reference numbers
Approval Duration
- Initial approval: 12 months
- Reauthorization: Requires documented positive clinical response (normalized UFC levels)
Common Denial Reasons & How to Fix Them
Denial Reason | How to Fix | Required Documentation |
---|---|---|
Diagnosis not documented | Submit complete lab workup | UFC, salivary cortisol, DST results with dates |
Missing surgical history | Provide surgical consultation | Notes explaining why surgery isn't suitable or wasn't curative |
Non-endocrinology prescriber | Get endocrinologist involved | Consultation note or prescription from endocrinologist |
Incomplete prior authorization | Resubmit with all fields | Complete form with member ID, NPI, ICD-10, NDC |
Medical necessity unclear | Strengthen clinical rationale | Detailed letter explaining consequences of denial |
Appeals Process in Ohio
Internal Appeals (UnitedHealthcare)
Level 1: Reconsideration
- Deadline: 21 calendar days from denial for outpatient
- Method: Electronic submission required (as of June 2025)
- Timeline: 15 business days for standard, 72 hours for expedited
Level 2: Formal Appeal
- Deadline: Within 12 months of original denial
- Additional evidence: Can include new clinical documentation
- Peer-to-peer option: Request within 24 hours of denial for urgent cases
External Review (Ohio Department of Insurance)
After exhausting internal appeals:
Timeline: Submit within 180 days of final internal denial Process: File with Ohio Department of Insurance, which assigns an Independent Review Organization Decision timeline: 30 days standard, 72 hours expedited Binding: Decision is final and binding on UnitedHealthcare
Ohio Department of Insurance Contact:
- Consumer hotline: 1-800-686-1526
- External review information
From our advocates: We've seen cases where initial denials were overturned simply by including the surgical consultation note that explained why the patient wasn't a surgical candidate. The external reviewer specifically noted that this documentation was missing from the original submission, highlighting how important complete records are for these complex cases.
Costs & Financial Assistance
Manufacturer Support
Recordati Rare Diseases Patient Support Program:
- Copay assistance for eligible patients
- Prior authorization support
- Reimbursement navigation
Additional Resources
- Ohio Patient Advocate Foundation: Financial assistance for specialty drugs
- NeedyMeds: Database of patient assistance programs
- GoodRx: Limited utility for specialty drugs but worth checking
FAQ
Q: How long does UnitedHealthcare prior authorization take for Isturisa in Ohio? A: Standard review is 15 business days, but expedited review (72 hours) is available if delay could harm your health.
Q: What if Isturisa is non-formulary on my plan? A: Non-formulary medications can still be covered with prior authorization and medical necessity documentation. The clinical criteria remain the same.
Q: Can I request an expedited appeal in Ohio? A: Yes, both internal appeals and external review can be expedited if delay would seriously jeopardize your health.
Q: Does step therapy apply if I've tried other treatments outside Ohio? A: UnitedHealthcare's criteria don't require step therapy for Isturisa if you meet the surgical criteria, regardless of where previous treatments occurred.
Q: What happens if my endocrinologist isn't in UnitedHealthcare's network? A: Out-of-network specialists can still prescribe Isturisa, but you may face higher costs. The prior authorization process remains the same.
Q: How often do I need reauthorization? A: Initial approval is for 12 months. Renewal requires documentation of positive response (typically normalized UFC levels).
About Counterforce Health: Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals that align with payers' own rules, significantly improving approval rates for specialty medications like Isturisa.
If you're facing a denial or need help navigating the appeals process, Counterforce Health can provide the specialized support you need to get your medication covered.
Sources & Further Reading
- UnitedHealthcare Isturisa Prior Authorization Notification
- Recordati Rare Diseases Letter of Medical Necessity Template
- UnitedHealthcare Provider Appeals Process
- Ohio Department of Insurance External Review Guide
- OptumRx Prior Authorization Process
- FDA Isturisa Prescribing Information
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and requirements may change—verify current information with UnitedHealthcare and your healthcare team.
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