By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

Humana's Coverage Criteria for Besponsa (Inotuzumab Ozogamicin) in Illinois: What Counts as "Medically Necessary"?

Answer Box: Getting Besponsa (Inotuzumab Ozogamicin) Covered by Humana in Illinois

Humana Medicare Advantage requires prior authorization for Besponsa through their specialty oncology vendor Evolent Health. Medical necessity requires: CD22-positive B-cell precursor ALL, relapsed/refractory status, prior therapy failures documented, and hepatic monitoring plan. Submit PA via Evolent portal or call 844-926-4528. Standard decisions in 7 days, expedited in 72 hours. New members get 90-day temporary coverage. If denied, appeal within 60 days via Humana member portal or 800-867-6601.

Table of Contents

  1. Policy Overview: How Humana Covers Besponsa in Illinois
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Required Diagnostics and Documentation
  5. Site of Care and Specialty Pharmacy Requirements
  6. Evidence to Support Medical Necessity
  7. Sample Medical Necessity Narrative
  8. Appeals Process for Illinois Patients
  9. Common Denial Reasons and Solutions
  10. Quick Reference Table

Policy Overview: How Humana Covers Besponsa in Illinois

Humana covers Besponsa (inotuzumab ozogamicin) under their Medicare Advantage plans in Illinois, but it requires prior authorization through their specialty oncology management vendor, Evolent Health (formerly New Century Health). This applies to all Humana Medicare Advantage plans statewide, including their dual Medicare-Medicaid plans like Gold Plus Integrated.

The drug is covered under Medicare Part B (medical benefit) when administered in healthcare facilities, not Part D (prescription drug benefit). Humana's 2025 prior authorization list specifically includes oncology injectables like Besponsa, with policies effective through 2026.

For new Humana members already receiving Besponsa, there's a 90-day grace period where prior authorization isn't required for ongoing treatment courses, though Humana may conduct retrospective review to ensure the treatment meets their coverage criteria.

Medical Necessity Requirements

Humana's medical necessity criteria for Besponsa align with FDA labeling and focus on specific clinical documentation requirements:

Primary Diagnosis Requirements

  • B-cell precursor acute lymphoblastic leukemia (ALL) confirmed by pathology/hematopathology report
  • CD22-positive disease documented by flow cytometry or immunophenotyping showing ≥70% CD22 expression
  • Adult or older adolescent population (consistent with FDA approval)
  • Appropriate ICD-10 coding: C91.02 (acute lymphoblastic leukemia in relapse) for B-cell lineage

Disease Status Documentation

  • Relapsed or refractory B-cell precursor ALL after at least one prior line of therapy
  • Clear documentation of:
    • First or subsequent relapse with dates, or
    • Refractory to initial induction or salvage therapy
  • Performance status (ECOG) documentation

Treatment History Requirements

Comprehensive documentation of all prior chemotherapy and targeted therapies including:

  • Start/stop dates for each regimen
  • Best response achieved (complete remission/CR, complete remission with incomplete recovery/CRi, partial response/PR, or no response)
  • Reason for discontinuation (progression, intolerance, or toxicity)

For Philadelphia chromosome-positive (Ph+) ALL, Humana specifically requires documentation of tyrosine kinase inhibitor (TKI) use and failure or intolerance before approving Besponsa.

Step Therapy and Exceptions

Unlike many specialty medications, Besponsa typically doesn't require formal step therapy protocols since it's indicated for relapsed/refractory disease—meaning patients have already failed prior treatments. However, Humana does expect documentation that standard first-line therapies have been attempted and failed.

Common Prior Therapies Expected

  • Standard induction chemotherapy regimens (e.g., Hyper-CVAD)
  • For Ph+ disease: TKI therapy (imatinib, dasatinib, or similar)
  • Other salvage therapies may include blinatumomab or investigational agents

Medical Exceptions

Exceptions to typical sequencing may be granted when:

  • Patient has contraindications to standard therapies
  • Severe toxicity from prior treatments
  • Rapid disease progression requiring immediate targeted therapy

Document these circumstances clearly in the prior authorization request with specific clinical rationale.

Required Diagnostics and Documentation

Humana requires comprehensive clinical documentation to establish medical necessity:

Laboratory Requirements

  • Baseline liver function tests: total bilirubin, AST, ALT, alkaline phosphatase
  • Complete blood count with differential
  • Renal function tests
  • CD22 expression analysis (flow cytometry report showing percentage of CD22-positive cells)

Clinical Documentation

  • Oncology consultation notes documenting:
    • Disease stage and molecular characteristics
    • Treatment history and responses
    • Current disease status
    • Treatment goals (bridge to transplant vs. palliative care)
  • Pathology reports confirming B-cell precursor ALL
  • Philadelphia chromosome/BCR-ABL status testing results
  • Prior treatment summary with dates, regimens, and outcomes

Safety Monitoring Plan

Given Besponsa's boxed warning for hepatotoxicity and veno-occlusive disease (VOD), Humana requires:

  • Baseline hepatic function assessment
  • Plan for monitoring liver tests before and after each dose
  • VOD risk assessment and monitoring strategy
  • For patients proceeding to stem cell transplant: plan to limit treatment to 2 cycles and avoid alkylating conditioning regimens

Site of Care and Specialty Pharmacy Requirements

Besponsa must be:

  • Dispensed through Humana-designated specialty pharmacies managed by Evolent Health
  • Administered at network oncology infusion centers that accept Humana Medicare Advantage terms

Verify approved sites through the Humana provider directory or contact Customer Care at 1-800-787-3311 (TTY 711). Out-of-network administration may be covered if no in-network options are available within a reasonable distance, particularly for dual Medicare-Medicaid plan members.

Evidence to Support Medical Necessity

When submitting prior authorization requests, include references to established treatment guidelines and evidence:

Clinical Guidelines

  • NCCN Guidelines for Acute Lymphoblastic Leukemia (cite current version)
  • FDA prescribing information for Besponsa
  • Institutional protocols if applicable

Supporting Literature

Reference peer-reviewed studies demonstrating efficacy in relapsed/refractory B-cell ALL, particularly:

  • Pivotal clinical trials leading to FDA approval
  • Real-world evidence studies
  • Comparative effectiveness data vs. other salvage therapies

Institutional Support

Include letters from:

  • Treating oncologist explaining medical necessity
  • Tumor board recommendations if applicable
  • Transplant team coordination if bridging to stem cell transplant

Sample Medical Necessity Narrative

From our advocates: We've found that clear, structured narratives addressing each coverage criterion significantly improve approval rates. One composite case involved a 45-year-old with relapsed B-cell ALL where the initial PA was denied for "insufficient CD22 documentation." After resubmission with the flow cytometry report clearly highlighted and a point-by-point response to coverage criteria, approval was granted within 48 hours.

Here's a template structure for medical necessity letters:

Patient: [Age]-year-old with relapsed B-cell precursor acute lymphoblastic leukemia (ICD-10: C91.02)

Clinical Situation: Patient has CD22-positive disease (flow cytometry showing [X]% expression) that has relapsed [X] months after achieving complete remission with [prior regimen]. Prior treatments include [list with dates and responses].

Medical Necessity: Besponsa is FDA-approved for this exact indication. Patient meets all coverage criteria: confirmed CD22+ B-cell ALL, documented relapse/refractory status, and appropriate prior therapy trials. Treatment plan includes [X] cycles with hepatic monitoring per protocol.

Treatment Goals: [Bridge to allogeneic stem cell transplant / palliative care / other specific goal]

Monitoring Plan: Liver function tests before each dose, VOD surveillance, [other relevant monitoring]

Appeals Process for Illinois Patients

If Humana denies coverage for Besponsa, Illinois patients have robust appeal rights:

Internal Appeals (Level 1)

  • Timeline: 60 days from denial notice to file
  • Decision timeframe: 7 calendar days (standard) or 72 hours (expedited)
  • How to submit:
    • Phone: 800-867-6601
    • Online: Humana member portal
    • Mail: Use Humana's appeal form

Expedited Appeals

For urgent situations where delay could jeopardize health:

  • Criteria: Prescriber statement that standard timeline would seriously harm patient
  • Decision time: 24 hours with prescriber documentation
  • Best practice: Call Humana immediately and follow up with written request

External Review (Level 2)

If internal appeal is denied, Illinois patients can request independent external review:

  • Timeline: 30 days from final internal denial (shorter than many states)
  • Process: Illinois Department of Insurance coordinates Independent Review Organization
  • Decision: Binding on Humana if overturned
  • Cost: Free to consumers
Note: Illinois' 30-day external review deadline is stricter than the 4-month window in many states, so act promptly after an appeal denial.

Common Denial Reasons and Solutions

Denial Reason Documentation to Include Where to Find It
"CD22 status not documented" Flow cytometry report showing CD22 expression percentage Pathology lab or treating facility
"Not relapsed/refractory" Clear timeline of prior treatments, dates, responses Oncology notes, treatment summaries
"Insufficient prior therapy" Complete treatment history with regimen names, dates, outcomes Medical records, pharmacy records
"Hepatic risk not addressed" Baseline LFTs, VOD monitoring plan, transplant coordination Lab results, treatment protocol
"Dosing outside label" FDA prescribing information, dosing rationale Package insert, oncology consultation

Quick Reference Table

Requirement Details Documentation Needed
Prior Authorization Required for all Humana MA plans Submit via Evolent portal
Diagnosis CD22+ B-cell precursor ALL Flow cytometry, pathology report
Disease Status Relapsed/refractory Treatment timeline, response documentation
Prior Therapy ≥1 failed regimen (+ TKI if Ph+) Complete treatment history
Safety Monitoring Hepatic function, VOD surveillance LFTs, monitoring protocol
Decision Timeline 7 days standard, 72 hours expedited N/A
Appeal Deadline 60 days (internal), 30 days (external) Denial notice date

About Counterforce Health: Counterforce Health helps patients and clinicians navigate insurance denials by creating evidence-backed appeals tailored to each payer's specific requirements. Our platform analyzes denial letters and plan policies to draft targeted rebuttals that address coverage criteria point-by-point, significantly improving approval rates for complex specialty medications like Besponsa.

For additional support with Humana appeals in Illinois, contact the Illinois Department of Insurance Consumer Helpline at 877-527-9431 or the Illinois Attorney General's Health Care Helpline at 1-877-305-5145.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with Humana and consult with your healthcare provider about treatment decisions. For personalized assistance with appeals, consider consulting with Counterforce Health or other patient advocacy services.

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