By Counterforce Health Team in Isturisa (osilodrostat) —

How to Get Isturisa (Osilodrostat) Covered by Humana in Ohio: Appeals, Forms, and Medical Necessity Criteria

Answer Box: Getting Isturisa (Osilodrostat) Covered by Humana in Ohio

Humana requires prior authorization for Isturisa (osilodrostat) in Ohio, with coverage based on confirmed Cushing's disease diagnosis and documented surgical contraindication or failure. Your fastest path to approval:

  1. Gather documentation: 24-hour urine free cortisol (UFC) results, late-night salivary cortisol, or dexamethasone suppression test showing hypercortisolism, plus endocrinologist consultation notes
  2. Submit prior authorization through Humana's provider portal with surgical contraindication or failure documentation
  3. If denied, file internal appeal within 65 days, then external review through Ohio Department of Insurance within 180 days

Start today by calling Humana at the number on your insurance card to confirm current prior authorization requirements.

Table of Contents

Coverage Requirements Overview

Humana covers Isturisa (osilodrostat) as a specialty medication, typically placed on Tier 4 or 5 of their formulary. All Humana Medicare Advantage and commercial plans require prior authorization for this high-cost Cushing's disease treatment, with coverage decisions based on FDA-approved indications and medical necessity criteria.

Plan Types and Coverage:

  • Medicare Advantage: Prior authorization required; appeals follow Medicare timelines (65 days for internal, then external review)
  • Commercial plans: Prior authorization required; appeals follow Ohio state regulations (180 days for external review)
  • Medicaid: Coverage varies by state Medicaid formulary; check with Ohio Medicaid for specific requirements
Note: If you're starting Isturisa before enrolling in a new Humana plan, prior authorization typically isn't required for the first 90 days, but coverage will be reviewed against criteria afterward.

Medical Necessity Criteria

FDA-Approved Indication Requirements

Humana covers Isturisa for adult Cushing's disease when pituitary surgery is not an option or has not been curative. Your endocrinologist must document:

Biochemical Diagnosis (at least one required):

  • 24-hour urine free cortisol (UFC): Two elevated results with proper collection documentation
  • Late-night salivary cortisol: Two elevated results between 11 PM-midnight
  • Low-dose dexamethasone suppression test: Morning cortisol >1.8 μg/dL after 1 mg dexamethasone at 11 PM

Surgical Documentation:

  • Contraindication to pituitary surgery (acute sphenoid sinusitis, significant suprasellar extension, anatomic barriers)
  • OR failed prior pituitary surgery with persistent hypercortisolism
  • OR surgical evaluation declining to proceed due to risk factors

Prescriber Requirements:

  • Prescription from or consultation with endocrinology specialist
  • Patient age ≥18 years
  • Proper ICD-10 coding (E24.0 for Cushing's disease)

Dosing and Quantity Limits

Isturisa is dosed twice daily starting at 2 mg BID, titrated up to maximum 30 mg BID based on cortisol response. Humana typically approves quantities supporting:

  • Initial dose: 60 tablets per month (2 mg BID)
  • Maintenance dose: Variable based on titrated dose (commonly 2-7 mg BID)
  • Maximum: 1,800 tablets per month (30 mg BID)

Hepatic impairment adjustments:

  • Moderate (Child-Pugh B): 1 mg BID
  • Severe (Child-Pugh C): 1 mg once daily

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis Documentation

Who: Your endocrinologist What: Gather biochemical test results showing hypercortisolism Timeline: Before prescription submission Source: Endocrine Society Cushing's Guidelines

2. Document Surgical Status

Who: Endocrinologist with neurosurgery consultation if needed What: Clear documentation of surgical contraindication or failure Timeline: Include in initial prior authorization Source: Medical chart notes and imaging reports

3. Submit Prior Authorization

Who: Prescribing physician or staff What: Complete prior authorization through Humana provider portal Timeline: Before prescription fill to avoid coverage denial Source: Humana Prior Authorization Search Tool

4. Coordinate Specialty Pharmacy

Who: Patient and clinic What: Isturisa requires specialty pharmacy distribution Timeline: After prior authorization approval Source: Contact Recordati Rare Diseases patient support

5. Monitor and Document Response

Who: Endocrinologist What: Cortisol levels every 1-2 weeks during titration Timeline: Ongoing for reauthorization Source: FDA prescribing information

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Insufficient diagnosis documentation Submit complete biochemical testing Two abnormal UFC, salivary cortisol, or DST results
Missing surgical evaluation Provide surgical consultation Neurosurgery notes documenting contraindication/failure
Non-endocrinology prescriber Obtain specialist consultation Endocrinology consultation note and prescription
Incomplete prior therapy documentation Document medical history Chart notes showing treatment timeline
Quantity limit exceeded Justify dosing requirements Cortisol monitoring results supporting dose titration
From our advocates: We've seen patients succeed by ensuring their endocrinologist includes specific language about surgical contraindications in the prior authorization letter. Generic statements like "not a surgical candidate" often get denied, while detailed explanations referencing imaging findings or specific anatomic barriers typically get approved on first submission.

Appeals Process in Ohio

If Humana denies your Isturisa prior authorization, Ohio law provides a structured appeals process with specific timelines and protections.

Internal Appeals with Humana

Timeline: 65 days from denial notice for Medicare Advantage; check plan documents for commercial timelines How to file:

  • Online: Humana member portal
  • Phone: Number on your insurance card
  • Mail: Address on denial letter

Required information:

  • Member ID and claim/reference number
  • Reason for disagreement with denial
  • Additional medical documentation
  • Prescriber support letter

External Review Through Ohio Department of Insurance

If Humana upholds their denial, you can request an independent external review through the Ohio Department of Insurance.

Timeline: Within 180 days of final internal denial How to file:

Review process:

  • Independent Review Organization (IRO) assigned randomly
  • Standard review: 30 days for decision
  • Expedited review: 72 hours for urgent medical needs
  • No cost to patient
  • Decision is binding on Humana

Required documentation:

  • Humana's final denial letter
  • All medical records supporting medical necessity
  • Provider letters explaining why Isturisa is essential
  • Any additional clinical information

Costs & Patient Support Programs

Typical costs without insurance: $15,000-$25,000+ per month depending on dose With Humana coverage: Varies by plan; specialty tier typically requires 20-40% coinsurance

Financial assistance options:

  • Recordati Rare Diseases Patient Support: Contact manufacturer for copay assistance and patient access programs
  • Chronic Disease Fund: Provides copay assistance for qualifying patients
  • HealthWell Foundation: Grants for rare disease treatments
  • Ohio pharmaceutical assistance programs: Contact Ohio Department of Commerce for state programs
Tip: Even with insurance coverage, specialty medications like Isturisa often have high out-of-pocket costs. Apply for manufacturer copay assistance before your first fill to potentially reduce costs to $10-$25 per month.

When to Get Professional Help

Consider working with a healthcare coverage specialist like Counterforce Health if you're facing repeated denials or complex appeals. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.

Their platform identifies the exact denial basis—whether it's prior authorization criteria, step therapy, non-formulary status, or "not medically necessary" determinations—and pulls the right evidence from FDA labeling, peer-reviewed studies, and recognized drug compendia to build compelling appeals that meet procedural requirements and track deadlines.

FAQ

How long does Humana prior authorization take for Isturisa in Ohio? Standard prior authorization decisions are typically made within 14 days for commercial plans and up to 30 days for Medicare Advantage. Expedited requests (when delay could seriously harm your health) must be decided within 72 hours.

What if Isturisa is not on Humana's formulary? You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are ineffective or contraindicated. This requires detailed documentation from your endocrinologist.

Can I get an expedited appeal in Ohio? Yes, if waiting for a standard appeal timeline would seriously endanger your health, you can request expedited review. Both Humana internal appeals and Ohio external reviews offer expedited options with 72-hour decision timelines.

Does step therapy apply to Isturisa? Humana may require trial of other Cushing's disease treatments first, but exceptions are available if you have contraindications, intolerances, or if other treatments have failed. Document these clearly in your prior authorization.

What happens if I move from another state to Ohio? If you were already taking Isturisa under another insurance plan, Humana typically provides transition coverage while processing your prior authorization. Contact Humana immediately when changing plans to avoid treatment interruptions.

How do I find an endocrinologist who treats Cushing's disease in Ohio? Use Humana's provider directory to find in-network endocrinologists, then call to confirm they treat Cushing's disease. Academic medical centers like Cleveland Clinic and Ohio State University often have specialists experienced with rare endocrine disorders.

What if my doctor isn't familiar with prior authorization requirements? Share this guide with your healthcare team and consider asking them to contact Counterforce Health for assistance with complex prior authorization submissions. Many practices benefit from specialized support for rare disease treatments.

Can I appeal if I disagree with quantity limits? Yes, if your endocrinologist determines you need a higher dose than Humana's quantity limits allow, you can appeal with documentation showing medical necessity for the higher dosing based on cortisol monitoring and clinical response.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about your specific medical situation and contact your insurance company directly to confirm current coverage requirements and procedures. Coverage policies and appeal processes may change; verify current information with official sources.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.