By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

The Complete Requirements Checklist to Get Besponsa (Inotuzumab Ozogamicin) Covered by UnitedHealthcare in Pennsylvania

Quick Answer: Getting Besponsa Covered by UnitedHealthcare in Pennsylvania

Besponsa (inotuzumab ozogamicin) requires prior authorization from UnitedHealthcare for all plan types. Your fastest path to approval: 1) Gather documentation proving CD22-positive relapsed/refractory B-cell ALL and failed prior therapies, 2) Submit PA request through UnitedHealthcare Provider Portal with complete clinical justification, 3) If denied, file internal appeal within 180 days, then request Pennsylvania's external review within 4 months. Pennsylvania's new external review program has overturned roughly 50% of denials in 2024.

First step today: Contact your oncologist to initiate the prior authorization request with complete hepatic monitoring protocols documented.

Table of Contents

Who Should Use This Checklist

This comprehensive requirements checklist is designed for:

  • Patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) who need Besponsa coverage
  • Oncologists and healthcare providers submitting prior authorization requests
  • Caregivers and patient advocates navigating the approval process
  • Specialty pharmacy coordinators ensuring proper documentation

Expected outcome: Following this checklist significantly improves your chances of first-time approval and reduces delays. If denied, you'll have the complete documentation needed for a successful appeal through Pennsylvania's external review process.

Member & Plan Basics

Coverage Verification Requirements

Before starting your prior authorization request, confirm these essential details:

✓ Active UnitedHealthcare coverage with current member ID
✓ Plan type identification (Commercial, Medicare Advantage, or Medicaid)
✓ Deductible status and specialty pharmacy benefit details
✓ Prior authorization requirement confirmed (Besponsa requires PA for all UnitedHealthcare plans)

Note: UnitedHealthcare processes Besponsa exclusively through OptumRx Specialty Pharmacy for covered members.

Clinical Criteria Requirements

Primary Indication Documentation

Required diagnosis: Adults (≥18 years) with relapsed or refractory CD22-positive B-cell precursor ALL

Essential clinical documentation:

  • ✓ Pathology reports confirming CD22-positive status and B-cell lineage
  • ✓ Disease status documentation showing relapsed or refractory disease
  • ✓ Prior therapy history with specific regimens, durations, and outcomes
  • ✓ Baseline laboratory values including complete hepatic function panel
  • ✓ Treatment plan aligned with FDA labeling and NCCN guidelines

Step Therapy Requirements

UnitedHealthcare typically requires documentation of:

  • Failed or contraindicated standard first-line ALL therapies
  • Specific reasons for treatment failure (progression, intolerance, contraindications)
  • Clinical rationale for why alternatives like blinatumomab or CAR-T therapy are not appropriate

Hepatotoxicity Risk Assessment

Critical requirement: Due to Besponsa's boxed warning for hepatotoxicity and veno-occlusive disease (VOD), your submission must include:

  • ✓ Baseline liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
  • ✓ Hepatitis screening results
  • ✓ VOD risk assessment especially if stem cell transplant is planned
  • ✓ Detailed monitoring protocol for hepatic function throughout treatment

Coding and Billing Requirements

Essential Billing Codes

Code Type Code Description Units
HCPCS/J-Code J9229 Injection, inotuzumab ozogamicin, 0.1 mg Per 0.1 mg
ICD-10-CM C91.00 Acute lymphoblastic leukemia, not having achieved remission Primary diagnosis
CPT Administration 96413 Chemotherapy administration, IV, up to 1 hour Per infusion
CPT Add-on 96415 Each additional hour As needed

Required Modifiers

  • JW modifier: Required for Medicare to document discarded drug amounts
  • TB modifier: For 340B hospitals on Medicare claims

NDC Information

  • NDC: 00008-0100-01 (Besponsa, 0.9 mg single-dose vial)

Documentation Packet Essentials

Medical Necessity Letter Components

Your physician's letter of medical necessity must include:

  1. Patient identification (name, DOB, member ID)
  2. Confirmed diagnosis with ICD-10 code (C91.00)
  3. Clinical history detailing prior treatments and outcomes
  4. Rationale for Besponsa citing FDA labeling and clinical guidelines
  5. Hepatotoxicity management plan addressing VOD risk
  6. Treatment goals and expected outcomes
  7. Supporting references from peer-reviewed literature

Required Attachments Checklist

  • ✓ Recent oncology consultation notes
  • ✓ Pathology reports confirming CD22+ B-cell ALL
  • ✓ Laboratory results (CBC, comprehensive metabolic panel, LFTs)
  • ✓ Prior treatment records and response documentation
  • ✓ Hepatitis screening results
  • ✓ Insurance authorization forms (plan-specific)

Submission Process

Primary Submission Methods

Preferred method: UnitedHealthcare Provider Portal

  • Faster processing (5-15 business days standard)
  • Real-time status tracking
  • Electronic document upload capability

Alternative methods:

  • Phone: Provider services line for urgent cases
  • Fax: Use plan-specific fax numbers (verify current numbers)

Required Form Fields

Ensure these fields are complete to avoid automatic rejections:

  • Member ID and group number
  • Prescriber NPI and DEA numbers
  • Specific diagnosis codes
  • Detailed clinical justification
  • Proposed treatment duration and dosing schedule
Tip: Incomplete submissions are the leading cause of delays. Double-check all required fields before submission.

Specialty Pharmacy Coordination

OptumRx Specialty Pharmacy Process

Once approved, UnitedHealthcare routes Besponsa through OptumRx Specialty Pharmacy:

  1. Prescription transfer from prescribing physician
  2. Patient enrollment and benefits verification
  3. Coordination with infusion center for delivery timing
  4. Patient counseling on administration and side effects
  5. Ongoing refill coordination throughout treatment

Infusion Site Requirements

Besponsa must be administered in qualified healthcare facilities with:

  • Appropriate infusion capabilities
  • Emergency management protocols
  • Hepatic monitoring capabilities

After Submission: What to Expect

Timeline Expectations

Review Type Timeline When to Use
Standard Review 5-15 business days Routine cases
Expedited Review Within 72 hours Urgent medical need
Peer-to-Peer Review 1-3 business days After initial denial

Status Tracking

  • Confirmation number: Record immediately after submission
  • Status checks: Monitor through provider portal every 2-3 business days
  • Documentation: Keep records of all communications and reference numbers

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Insufficient CD22 documentation: Always include specific pathology reports confirming CD22-positive status
  2. Missing hepatic monitoring plan: Detail your VOD risk assessment and monitoring protocols
  3. Inadequate prior therapy documentation: Provide specific regimens, dates, and outcomes for all previous treatments
  4. Generic clinical justification: Reference specific NCCN guidelines and FDA labeling language
  5. Incomplete safety protocols: Address contraindications and drug interactions explicitly

Documentation Best Practices

  • Use specific medical terminology from FDA labeling
  • Include quantitative lab values, not just "normal" or "abnormal"
  • Reference current clinical guidelines by name and version
  • Provide clear treatment timelines and monitoring schedules

Pennsylvania Appeals Process

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial notice
Method: Provider portal, phone, or written appeal
Required: Original denial letter, additional clinical documentation, updated medical necessity letter

Pennsylvania External Review

Pennsylvania's Independent External Review Program offers significant advantages:

Success rate: Approximately 50% of appeals overturned in 2024
Timeline: 45 days for standard review, 72 hours for expedited
Cost: Free for Pennsylvania residents
Filing window: 4 months after final internal denial

How to request external review:

  1. Complete UnitedHealthcare's internal appeal process
  2. Obtain Final Adverse Benefit Determination letter
  3. Submit external review request through Pennsylvania Insurance Department portal
  4. Provide additional supporting documentation within 15 days
From our advocates: "We've seen Pennsylvania's new external review process make a real difference for patients. One family fighting a Besponsa denial gathered all their documentation, submitted a thorough external review request with updated clinical notes, and received approval within 30 days. The key was having complete hepatic monitoring protocols documented upfront."

State Resources for Help

  • Pennsylvania Insurance Department Consumer Services: Available for guidance on appeals process
  • Pennsylvania Health Law Project: Free advocacy assistance for complex cases
  • Pennie Consumer Hotline: Support for marketplace plan issues

Quick Reference Checklist

Before You Start

  • Verify active UnitedHealthcare coverage
  • Confirm CD22-positive B-cell ALL diagnosis
  • Gather complete prior treatment history
  • Obtain baseline liver function tests
  • Identify appropriate infusion facility

For Prior Authorization

  • Complete medical necessity letter with hepatic monitoring plan
  • Attach all required clinical documentation
  • Use correct billing codes (J9229, C91.00)
  • Submit through UnitedHealthcare Provider Portal
  • Record confirmation number and track status

If Denied

  • Request peer-to-peer review within 24 hours
  • File internal appeal within 180 days
  • Gather additional supporting evidence
  • Consider Pennsylvania external review if internal appeal fails
  • Contact state consumer assistance if needed

Need help navigating complex prior authorization requirements? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals that align with payer-specific requirements, helping patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Besponsa in Pennsylvania?
Standard review typically takes 5-15 business days. Expedited review for urgent cases can be completed within 72 hours.

What if Besponsa is not on my UnitedHealthcare formulary?
Request a formulary exception with your prior authorization. Include clinical documentation showing why formulary alternatives are inappropriate.

Can I request an expedited appeal in Pennsylvania?
Yes, both UnitedHealthcare internal appeals and Pennsylvania external reviews offer expedited processing for urgent medical situations requiring physician certification.

Does step therapy apply if I failed treatments in another state?
Yes, prior treatment failures from any location count toward step therapy requirements. Ensure you have complete documentation from all treating facilities.

What happens if Pennsylvania's external review approves my appeal?
The decision is binding. UnitedHealthcare must provide coverage immediately, including retroactive payment for any out-of-pocket expenses during the appeal.

How much does Besponsa cost with UnitedHealthcare coverage?
As a specialty tier medication, expect 25-50% coinsurance. Copay assistance may be available through Pfizer's patient support programs.

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 the most current requirements and procedures. Coverage policies and appeal processes may change. For personalized assistance with complex cases, consider working with Counterforce Health or other qualified patient advocacy services.

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