By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (Inotuzumab Ozogamicin) Covered by Cigna in Michigan: Complete Approval Guide

Quick Answer: Getting Besponsa Covered by Cigna in Michigan

To get Besponsa (inotuzumab ozogamicin) covered by Cigna in Michigan, you need prior authorization with documentation of CD22-positive B-cell precursor ALL that's relapsed or refractory. Submit Cigna's Besponsa CCRD form with pathology confirming CD22 expression, prior therapy records, and baseline liver function tests. If denied, you have 180 days for internal appeals, then 127 days for Michigan's external review through DIFS. Start today by calling Cigna to verify if Accredo specialty pharmacy is required and requesting the PA form.

Table of Contents

Cigna's Coverage Policy for Besponsa

Besponsa is classified as a high-cost specialty oncology drug requiring prior authorization across Cigna's commercial, Medicare, and marketplace plans in Michigan. The medication is typically covered under the medical benefit (not pharmacy) since it's administered by IV infusion.

Plan Types and Coverage

  • Commercial HMO/PPO: Prior authorization required; may mandate Accredo specialty pharmacy
  • Cigna Medicare: PA required with CMS-aligned criteria for relapsed/refractory B-cell ALL
  • Marketplace plans: Follow commercial PA requirements with potential formulary restrictions
Note: Coverage specifics can vary by employer group. Always verify your exact plan requirements by calling the member services number on your ID card.

Indication Requirements & FDA Status

FDA-Approved Use

Besponsa is FDA-approved for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Cigna's coverage aligns strictly with this indication.

What Cigna Requires for Approval

According to Cigna's Besponsa PA form:

  1. Diagnosis: B-cell precursor ALL with appropriate ICD-10 code (C91.00 or specific subcode)
  2. Disease status: Must check "Yes" for relapsed or refractory disease
  3. CD22 expression: Must confirm CD22-positive disease with pathology report
  4. Age appropriateness: FDA approval is for adults; pediatric use requires additional justification

Off-Label Considerations

Cigna generally does not cover off-label uses unless supported by major compendia (NCCN, AHFS-DI) or peer-reviewed literature demonstrating standard of care.

Step Therapy & Medical Exceptions

Required Prior Treatments

Besponsa is never approved as first-line therapy. Cigna requires documentation of:

  • Prior standard chemotherapy (e.g., Hyper-CVAD, pediatric-inspired regimens)
  • Treatment failure, relapse, or intolerance to initial therapy
  • Reason why other salvage options (blinatumomab, CAR-T therapy) are not appropriate

Medical Exception Pathways

If you haven't tried all typical salvage therapies, document why alternatives aren't suitable:

  • Blinatumomab contraindicated: CNS involvement, prior seizure history
  • CAR-T not feasible: Age, comorbidities, lack of centers, insurance barriers
  • Intensive salvage inappropriate: Performance status, organ dysfunction

Required Diagnostics & Documentation

Laboratory Requirements

Before starting Besponsa, Cigna expects baseline monitoring due to the boxed warning for hepatotoxicity:

Test Requirement Timing Documentation
Liver function tests ALT, AST, bilirubin, alkaline phosphatase Baseline and before each dose Must be within normal limits or explained
CD22 expression Flow cytometry or immunohistochemistry At diagnosis or relapse Pathology report required
Performance status ECOG 0-2 preferred Current assessment Clinic note documentation
Hepatitis screening HBV, HCV testing Within 3 months Negative results preferred

Clinical Documentation Checklist

  • Problem list with B-cell precursor ALL diagnosis
  • Pathology report confirming CD22 positivity
  • Treatment history with dates, regimens, and responses
  • Current disease status (bone marrow results, imaging)
  • Contraindications to alternative therapies

Specialty Pharmacy & Site of Care Rules

Accredo Requirement

Many Cigna plans in Michigan require specialty medications to be filled through Accredo Specialty Pharmacy. Check your specific plan by:

  • Logging into myCigna online
  • Calling the member services number on your ID card
  • Asking your oncologist's office to verify during PA submission

Approved Sites of Care

Cigna's PA form allows administration at:

  • Physician office (often preferred for cost)
  • Hospital outpatient department
  • Ambulatory infusion center
  • Home infusion (with appropriate monitoring)
  • Hospital inpatient (for complications)
Tip: Cigna may prefer lower-cost settings. If using hospital outpatient, document medical necessity (monitoring needs, comorbidities).

Evidence to Support Medical Necessity

Guidelines and References

When appealing denials or submitting PA requests, cite these authoritative sources:

  1. FDA prescribing information: Besponsa label
  2. NCCN Guidelines: Acute Lymphoblastic Leukemia (subscription required for full text)
  3. Clinical trials: INO-VATE study demonstrating efficacy in R/R B-cell ALL

Sample Medical Necessity Statement

"This 45-year-old patient has CD22-positive B-cell precursor ALL that relapsed 8 months after achieving CR1 with Hyper-CVAD. Bone marrow biopsy shows 65% blasts with confirmed CD22 expression by flow cytometry. Besponsa is FDA-approved and NCCN-recommended for this indication, offering superior MRD-negative remission rates compared to conventional salvage chemotherapy. Patient is planned for allogeneic transplant and requires effective cytoreduction."

Fastest Path to Approval (Step-by-Step)

Step 1: Verify Benefits and Requirements

Who: Patient or clinic staff
Action: Call Cigna member services to confirm:

  • Prior authorization requirements
  • Accredo specialty pharmacy mandate
  • In-network oncology providers Timeline: Same day

Step 2: Gather Required Documentation

Who: Clinic staff and patient
Documents needed:

  • Insurance card and photo ID
  • Complete treatment history
  • Pathology reports with CD22 status
  • Recent bone marrow or imaging results
  • Baseline liver function tests Timeline: 1-3 days

Step 3: Complete Cigna's PA Form

Who: Prescribing oncologist
Form: Besponsa CCRD form
Submission: CoverMyMeds portal or fax to 855-840-1678
Timeline: Same day once complete

Step 4: Submit Supporting Documentation

Who: Clinic staff
Include:

  • Medical necessity letter
  • Pathology reports
  • Treatment history summary
  • Baseline labs Timeline: Same day as PA form

Step 5: Follow Up on Decision

Who: Patient and clinic
Action: Track PA status through Cigna provider portal
Timeline: Cigna responds within 5 business days for standard requests

Step 6: Appeal if Denied

Who: Patient with clinic support
Action: File internal appeal within 180 days
Timeline: Start immediately upon denial receipt

Step 7: External Review if Needed

Who: Patient
Action: File with Michigan DIFS within 127 days of final denial
Timeline: DIFS decides within 60 days (72 hours if expedited)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
CD22 status not documented Submit pathology report Flow cytometry or IHC results showing CD22+
Not relapsed/refractory Clarify disease timeline Bone marrow results, treatment dates, relapse documentation
First-line use Emphasize salvage setting Prior therapy summary, failure/intolerance notes
Alternative not tried Medical contraindication Explain why blinatumomab/CAR-T inappropriate
Hepatic risk concerns Safety monitoring plan Baseline LFTs, hepatitis screening, monitoring protocol
Non-formulary Request formulary exception Medical necessity letter, lack of therapeutic alternatives

Appeals Playbook for Michigan

Internal Appeals (Cigna)

  • First level: 180 days from denial to file
  • Standard timeline: 30 days for Cigna decision
  • Expedited: 72 hours if urgent medical need
  • How to file: Member portal, phone, or written request

Michigan External Review

Michigan offers one of the most patient-friendly external review processes in the country through the Department of Insurance and Financial Services (DIFS).

Eligibility Requirements

  • Completed Cigna's internal appeals process
  • Involves medical necessity or clinical appropriateness
  • Filed within 127 days of final denial
  • Concerns a covered benefit under your policy

How to File

  1. Online: DIFS External Review portal
  2. Mail/Fax: Request for External Review form (FIS 0018)
  3. Required documents:
    • All denial letters
    • Medical records
    • Physician letter supporting necessity
    • Plan coverage documents

Timelines

  • Standard review: Up to 60 days
  • Expedited review: 72 hours (requires physician attestation of serious jeopardy)
  • Judicial review: 60 days after DIFS decision if still unsatisfied
From our advocates: We've seen Michigan external reviews frequently overturn specialty drug denials when patients provide comprehensive clinical documentation. One composite case involved a leukemia patient whose Cigna denial was reversed by DIFS within 45 days after submitting detailed treatment history and expert guidelines. The key was demonstrating that standard alternatives had been tried and failed.

Costs & Patient Assistance

Manufacturer Support

Pfizer Oncology Together: Provides financial assistance for eligible patients

  • Copay assistance: May reduce out-of-pocket costs
  • Patient assistance program: For uninsured or underinsured
  • Contact: Visit Pfizer Oncology Together website or call patient support

Michigan-Specific Resources

  • Michigan Department of Health and Human Services: Medicaid coverage for eligible patients
  • University of Michigan Rogel Cancer Center: Financial counseling services
  • Henry Ford Cancer Institute: Patient assistance programs

Frequently Asked Questions

How long does Cigna prior authorization take in Michigan?

Cigna has 5 business days for standard PA decisions and 72 hours for urgent requests. Complex cases may take longer if additional information is needed.

What if Besponsa is non-formulary on my plan?

Request a formulary exception by documenting medical necessity and lack of formulary alternatives. Include clinical guidelines supporting use.

Can I request an expedited appeal?

Yes, if delay would seriously jeopardize your health. Your physician must provide written attestation of urgent medical need.

Does step therapy apply if I've failed treatments outside Michigan?

Yes, document all prior treatments regardless of where received. Out-of-state treatment records are valid for step therapy requirements.

What happens if I miss the 127-day deadline for external review?

Unfortunately, Michigan DIFS cannot accept late external review requests. The 127-day deadline is strictly enforced.

How much does Besponsa cost without insurance?

Wholesale acquisition cost is approximately $8,700 per 0.9 mg vial, with total treatment costs varying by number of cycles and dosing.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Besponsa. Our platform helps patients and clinicians navigate prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to craft compelling appeals that align with payer-specific criteria. If you're facing coverage challenges with specialty cancer drugs, Counterforce Health can help streamline the approval process.

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 plan for specific coverage determinations. Coverage policies and requirements may change. For personalized assistance with insurance appeals in Michigan, contact Counterforce Health or consult with a healthcare advocate.

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