By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (Inotuzumab Ozogamicin) Covered by Humana in Ohio: Complete Prior Authorization and Appeal Guide

Quick Answer: Getting Besponsa Covered by Humana in Ohio

Eligibility: Adults with relapsed/refractory CD22-positive B-cell ALL requiring prior authorization through Humana's specialty oncology vendor, Evolent. Fastest path: Submit complete documentation package including CD22-positive pathology reports, prior therapy failures, and hepatic monitoring plan via Humana's provider portal. Start today: Contact your oncologist to gather pathology reports confirming CD22-positive status and complete treatment history. Appeals available through Ohio's external review process within 180 days if denied.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Documentation Package
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in Ohio
  6. Costs & Patient Assistance
  7. When to Escalate
  8. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory through Evolent (specialty vendor) Humana provider portal Humana PA Lists
CD22-Positive Status Must confirm via pathology report Hospital/lab records Multiple payer policies
Diagnosis Code C91.00 (B-cell precursor ALL) Medical records Aetna Policy
Age Requirement 18+ years (adult ALL indication) Patient demographics FDA labeling
Hepatic Monitoring VOD risk assessment protocol Oncology notes FDA boxed warning
Appeals Deadline 65 days for Medicare Advantage Denial notice Humana Appeals
External Review 180 days from final denial Ohio Department of Insurance Ohio insurance law

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility Requirements

Who does it: Oncology team
Document needed: Recent pathology report with CD22-positive confirmation
Timeline: 1-2 days to obtain records
Source: Multiple insurance policies require CD22+ status

2. Gather Prior Treatment Documentation

Who does it: Patient and clinic staff
Documents needed: Complete therapy history with dates, regimens, and failure reasons
Timeline: 2-3 days for comprehensive records
Source: Standard PA requirements across payers

3. Obtain Baseline Laboratory Values

Who does it: Oncology team
Documents needed: Complete metabolic panel, liver function tests, hepatitis screening
Timeline: Same day if recent labs available
Source: FDA prescribing information (hepatotoxicity monitoring)

4. Submit Prior Authorization Request

Who does it: Provider's office
How to submit: Humana provider portal or through Evolent
Timeline: Submit within 2-3 days of gathering documentation
Expected response: 7 days for standard, 24 hours for expedited

5. Follow Up on Decision

Who does it: Patient or clinic
Action: Check portal or call member services
Timeline: Day 5-7 after submission
Next step: If denied, immediately begin appeal process

6. File Appeal if Denied

Who does it: Patient, provider, or authorized representative
How to file: Written request to Humana within 65 days
Documents: Original denial letter plus new supporting evidence
Source: Humana appeals process

7. Request External Review (if needed)

Who does it: Patient
Timeline: Within 180 days of final Humana denial
How to file: Submit request form to Ohio Department of Insurance
Contact: Ohio DOI Consumer Services: 1-800-686-1526

Required Documentation Package

Core Clinical Documentation

  • Pathology report explicitly stating CD22-positive B-cell lineage
  • Oncology consultation notes with complete diagnosis (ICD-10: C91.00)
  • Prior treatment history including specific regimens, duration, and reasons for discontinuation
  • Current disease status with recent imaging or bone marrow biopsy results
  • Baseline laboratory values including liver function tests

Medical Necessity Letter Checklist

Your oncologist should include:

  • Patient age verification (18+ for adult ALL indication)
  • Confirmation of relapsed or refractory disease status
  • Documentation that CD22-positive status has been confirmed
  • Previous therapy failures with specific details
  • Clinical rationale for Besponsa based on FDA labeling
  • Hepatic monitoring plan addressing VOD risk
  • References to NCCN guidelines for ALL treatment
Clinician Corner: When drafting medical necessity letters, reference the specific FDA indication for "adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia" and include the boxed warning acknowledgment regarding hepatotoxicity and veno-occlusive disease monitoring.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
CD22 status not documented Submit official pathology report Lab report with CD22-positive confirmation
Insufficient prior therapy Provide detailed treatment timeline Complete regimen history with dates/outcomes
Hepatic risk not addressed Include monitoring protocol VOD screening plan and baseline LFTs
Not relapsed/refractory Document disease progression Recent imaging or bone marrow results
Age criteria not met Verify adult indication Patient demographics showing 18+ years

Appeals Process in Ohio

Internal Appeal with Humana

  • Deadline: 65 days from denial notice
  • How to file: Written request via member portal or mail
  • Required: Original denial letter and new supporting evidence
  • Timeline: 30 days for standard, 72 hours for expedited
  • Source: Humana member appeals

Ohio External Review

Ohio provides a consumer-friendly external review process for denied treatments:

  • Eligibility: Available after exhausting Humana's internal appeals
  • Timeline: 180 days from final denial to request external review
  • Process: Independent Review Organization (IRO) with medical experts
  • Decision timeframe: 30 days standard, 72 hours expedited
  • Binding: IRO decisions are binding on Humana if overturned

To file: Contact Ohio Department of Insurance at 1-800-686-1526 or submit the External Review Request Form through their website.

Note: Self-funded employer plans follow federal ERISA rules rather than Ohio's external review, but many voluntarily provide similar processes.

Costs & Patient Assistance

Manufacturer Support

  • Pfizer Oncology Together: Patient assistance program for eligible patients
  • Contact: Visit Besponsa support resources (verify current availability)
  • Eligibility: Based on income and insurance status

Financial Assistance Options

  • Copay assistance cards for commercially insured patients
  • Foundation grants through organizations like CancerCare or Leukemia & Lymphoma Society
  • Hospital charity care programs
  • Medicare Extra Help program for Part D costs
Cost Context: Besponsa's wholesale acquisition cost is approximately $8,700 per 0.9-mg vial, though actual costs vary by treatment protocol and insurance coverage.

When to Escalate

Contact Ohio regulators if you experience:

  • Unreasonable delays in prior authorization processing
  • Repeated denials despite meeting clinical criteria
  • Procedural violations in the appeals process

Ohio Department of Insurance Consumer Services

  • Phone: 1-800-686-1526
  • Website: insurance.ohio.gov
  • Services: Appeals guidance, complaint filing, external review coordination

Additional Resources

  • UHCAN Ohio (Universal Health Care Action Network): Consumer advocacy
  • OSHIIP (Ohio Senior Health Insurance Information Program): Medicare-specific assistance

FAQ

How long does Humana's prior authorization take for Besponsa in Ohio? Standard decisions within 7 days; expedited decisions within 24 hours if your prescriber documents that delays could seriously harm your health.

What if Besponsa isn't on Humana's formulary? Request a formulary exception by submitting the "Request for Medicare Prescription Drug Coverage Determination" form with supporting clinical documentation. Humana formulary exception process allows coverage for medically necessary non-formulary drugs.

Can I request an expedited appeal in Ohio? Yes, if your prescriber certifies that standard timeframes could seriously jeopardize your health. Mark the expedited box on appeal forms and include prescriber documentation.

Does step therapy apply to Besponsa? Most payers require documentation of prior therapy failures rather than formal step therapy, but you must show previous treatments were inadequate or caused intolerable side effects.

What happens if Ohio's external review denies my appeal? The IRO decision is final for the administrative process, but you retain rights to seek legal remedies or file regulatory complaints if procedural violations occurred.

How do I prove CD22-positive status if my original pathology report doesn't mention it? Request flow cytometry or immunohistochemistry testing from your pathologist to specifically identify CD22 expression on B-cells.

Can family members help with the appeals process? Yes, but you'll need to complete authorization forms allowing them to act as your representative with Humana and Ohio regulators.

What if I have both Medicare and Medicaid in Ohio? Dual-eligible patients may have additional appeal rights through Ohio Medicaid managed care plans. Contact Ohio Department of Medicaid for dual-coverage appeals guidance.

Navigating insurance approvals for specialty cancer treatments shouldn't add stress to your journey. At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific basis for denial, and drafts point-by-point rebuttals aligned with each payer's own policies—streamlining the path to approval for medications like Besponsa.

When dealing with complex prior authorizations like Besponsa, having the right documentation and understanding payer-specific workflows can make the difference between approval and denial. Counterforce Health's approach of matching clinical evidence to each plan's specific criteria helps reduce the back-and-forth that often delays treatment access.

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 and insurance company for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with official sources before making decisions.

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