By Counterforce Health Team in Stelara (ustekinumab) —

How to Get Stelara (Ustekinumab) Covered by UnitedHealthcare in Florida: Complete Guide to Prior Authorization, Appeals, and Specialty Pharmacy Requirements

Answer Box: Getting Stelara Covered by UnitedHealthcare in Florida

UnitedHealthcare now requires biosimilar ustekinumab (Steqeyma or Yesintek) instead of brand Stelara for most commercial plans as of September 2024. To get coverage: 1) Have your doctor submit prior authorization through the UHC Provider Portal documenting moderate-to-severe disease and failure of conventional therapies, 2) Expect step therapy requiring biosimilar trial first unless you have documented contraindications, 3) Use OptumRx specialty pharmacy for dispensing. If denied, Florida residents have 180 days to file internal appeals and can request external review through the Florida Department of Financial Services within 4 months of final denial.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Clinical Criteria
  5. Cost and Copay Assistance
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Florida-Specific Appeal Rights
  10. Troubleshooting Common Issues

Coverage Basics

Is Stelara Covered by UnitedHealthcare in Florida?

UnitedHealthcare has significantly changed its ustekinumab coverage as of September 2024. Brand Stelara is excluded from most commercial formularies, with coverage shifted to biosimilar alternatives like Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce).

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all ustekinumab products UHC Provider Portal
Formulary Status Biosimilars preferred; brand excluded UHC Commercial PDL
Step Therapy Must try biosimilars first Ustekinumab Medical Policy
Specialty Pharmacy OptumRx specialty required UHC Member Services
Age Limits Per FDA labeling by indication FDA Prescribing Information

Which Plans Are Affected?

  • Commercial plans: Brand Stelara removed September 1, 2024
  • Medicare Advantage: Subject to similar biosimilar preferences
  • Exchange/ACA plans: Follow commercial formulary rules
  • Medicaid (Community Plan): Electronic appeals required starting June 2025

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician must submit the PA through the UnitedHealthcare Provider Portal or by calling OptumRx at 888-397-8129. Patients cannot submit PAs directly.

Step-by-Step: Fastest Path to Approval

  1. Verify plan coverage - Check if your specific UHC plan covers ustekinumab products
  2. Gather documentation - Collect diagnosis codes, severity scores, and prior treatment history
  3. Submit PA request - Provider submits through UHC portal with clinical justification
  4. Address biosimilar requirement - Document why Steqeyma/Yesintek aren't appropriate if requesting brand Stelara
  5. Include safety screening - TB testing, hepatitis panel, CBC as required
  6. Monitor status - Track approval through provider portal
  7. Coordinate with specialty pharmacy - Arrange dispensing once approved

Timing and Deadlines

How Long Does Prior Authorization Take?

  • Standard requests: Up to 72 hours for most states
  • Urgent/expedited: Within 24 hours with physician documentation of urgency
  • Post-service appeals: Up to 60 days depending on plan type

When to Request Expedited Review

Request expedited review if delay could:

  • Cause serious deterioration of psoriasis (erythrodermic, disabling disease)
  • Lead to IBD complications or hospitalization
  • Result in inability to function or work

Clinical Criteria

What Counts as Medical Necessity for Stelara?

UnitedHealthcare requires documentation of:

For Psoriasis/Psoriatic Arthritis:

  • Moderate-to-severe disease (PASI ≥10 or BSA ≥10%)
  • Failed conventional therapy (topicals, phototherapy, systemic agents)
  • Trial/failure of preferred biologics or documented contraindications

For Crohn's Disease:

  • Active inflammation on endoscopy or imaging
  • CDAI scores showing moderate-to-severe disease
  • Failed steroids, immunomodulators, and often one biologic

For Ulcerative Colitis:

  • Mayo score or SCCAI indicating active disease
  • Objective markers (CRP, fecal calprotectin, endoscopy)
  • Prior therapy failures per step-therapy requirements

Required Laboratory Tests

  • Tuberculosis screening (IGRA or PPD)
  • Hepatitis B and C panel
  • Complete blood count
  • Liver function tests
  • Recent inflammatory markers (CRP, ESR)

Cost and Copay Assistance

UnitedHealthcare Specialty Drug Costs

Stelara/ustekinumab is classified as a specialty medication with:

  • 1-month supply limits per prescription
  • Tier 4 or 5 copays (typically $50-$500+ per month)
  • Coinsurance often 20-50% after deductible

Manufacturer Support Programs

Janssen CarePath offers:

  • Commercial copay cards reducing costs to as low as $5 per injection
  • Patient assistance programs for uninsured/underinsured patients
  • Delay and denial support to help with appeals
Important: Copay cards cannot be used with Medicare, Medicaid, or other government programs due to federal anti-kickback rules.

Copay Accumulator Programs

Many UHC plans use copay maximizer programs where manufacturer copay assistance doesn't count toward your deductible or out-of-pocket maximum. Ask UHC member services: "Do you apply copay accumulator rules to Stelara?"

Denials and Appeals

Common Denial Reasons

Denial Reason How to Overturn
Brand Stelara not on formulary Request biosimilar coverage or document medical necessity for brand
No trial of biosimilars Provide documentation of Steqeyma/Yesintek failure or contraindication
Insufficient disease severity Submit objective scores (PASI, CDAI, Mayo) and specialist notes
Missing step therapy Document failure/intolerance of required conventional and biologic therapies
Wrong benefit (pharmacy vs medical) Clarify IV induction (medical) vs SC maintenance (pharmacy) billing

Internal Appeal Process

Timeline: 180 days from denial date to file appeal

Required Documents:

  • Detailed physician letter addressing specific denial reason
  • Clinical notes with diagnosis and severity scores
  • Prior medication list with start/stop dates and outcomes
  • Lab results and procedure reports
  • Clear explanation why alternatives aren't appropriate

Florida-Specific Appeal Rights

External Review Process

After exhausting UHC's internal appeals, Florida residents can request independent external review through the Florida Department of Financial Services.

Key Features:

  • 4-month deadline from final internal denial
  • No cost to consumers
  • Binding decision if reviewer overturns denial
  • Expedited review available for urgent cases (72 hours)

2025 Florida Appeal Enhancements

Florida's new appeal laws provide stronger protections:

  • 30-day maximum for standard appeal decisions
  • Specialist-to-specialist review requirement
  • 7-day-a-week processing by insurers
  • Consumer hotline: 1-800-FL-HEALTH for timeline violations
From our advocates: We've seen Florida's specialist-to-specialist review requirement significantly improve approval rates for complex biologics. When appealing a rheumatology or dermatology drug denial, specifically request that the reviewer be a board-certified specialist currently practicing in that field. This simple request has helped overturn denials that were initially reviewed by general practitioners.

How to Request External Review

  1. Complete external review form from Florida DFS
  2. Attach final internal denial letters and medical records
  3. Include clinical guidelines supporting the medication
  4. Submit within 4-month deadline
  5. Request expedited review if urgent

Specialty Pharmacy Requirements

Why Was My Prescription Transferred?

UnitedHealthcare requires most specialty medications, including ustekinumab, to be dispensed through OptumRx specialty pharmacy or other approved specialty networks.

Specialty Pharmacy Rules

  • 1-month supply limits for SC maintenance doses
  • Home delivery preferred over retail pickup
  • Clinical monitoring and adherence support included
  • Prior authorization must be on file before dispensing

Site of Care Considerations

  • IV induction (IBD): Billed under medical benefit in office/infusion center
  • SC maintenance: Usually pharmacy benefit through specialty pharmacy
  • Self-administration: UHC may require documentation if patient cannot self-inject

Renewal Requirements

When to Reauthorize

Most ustekinumab approvals are granted for 12 months and require renewal with:

  • Documentation of clinical response (PASI improvement, symptom reduction)
  • Objective markers showing benefit (labs, endoscopy, imaging)
  • Continued moderate-to-severe disease if dose escalation needed
  • Absence of serious adverse events

What Changes in 2025?

  • Electronic appeals required for Florida Medicaid starting June 2025
  • Continued biosimilar preference enforcement
  • Enhanced appeal monitoring by Florida regulators

Troubleshooting Common Issues

Provider Portal Problems

If the UHC provider portal is down or forms are missing:

  • Call OptumRx PA line: 888-397-8129
  • Use backup fax numbers provided in denial letters
  • Submit urgent requests by phone with written follow-up

Missing Documentation

Common missing items that delay approval:

  • ICD-10 diagnosis codes
  • Objective severity scores
  • Complete prior therapy history with dates and outcomes
  • Required laboratory results
  • Specialist consultation notes

Peer-to-Peer Review Requests

If your PA is denied, request a peer-to-peer review where your prescriber can speak directly with UHC's medical director. This often resolves denials based on misunderstood clinical circumstances.

Frequently Asked Questions

Q: How long does UnitedHealthcare PA take in Florida? A: Standard requests typically take up to 72 hours, while urgent requests are decided within 24 hours.

Q: What if Stelara is non-formulary on my plan? A: You can request a formulary exception with strong medical necessity documentation, or consider covered biosimilar alternatives.

Q: Can I request an expedited appeal? A: Yes, if delay could seriously jeopardize your health. Your physician must document the urgency in writing.

Q: Does step therapy apply if I failed treatments outside Florida? A: Yes, UHC recognizes prior therapy failures from other states if properly documented in medical records.

Q: What's the difference between internal and external appeals? A: Internal appeals are reviewed by UHC; external appeals are reviewed by independent medical experts contracted by Florida DFS.

Q: Can I use manufacturer copay cards with UHC? A: Yes for commercial plans, but not with Medicare, Medicaid, or other government programs.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address payers' specific criteria. Whether you're facing a UnitedHealthcare denial for Stelara or another specialty medication, we provide the clinical documentation and appeal strategies that improve approval rates.

When dealing with complex prior authorization requirements and biosimilar preferences, having the right documentation and appeal strategy makes all the difference. Counterforce Health specializes in navigating these challenging coverage decisions, helping patients access the medications they need while reducing the administrative burden on healthcare providers.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan documents and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals and coverage issues, contact the Florida Department of Financial Services at 1-877-MY-FL-CFO.

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