By Counterforce Health Team in Stelara (ustekinumab) —

Renewing Stelara (Ustekinumab) Coverage with UnitedHealthcare in Michigan: 2025 Timeline, Forms, and Appeal Options

Quick Answer: Renewing Stelara Coverage with UnitedHealthcare in Michigan

Important Update: UnitedHealthcare no longer covers brand-name Stelara as of September 2024. You must switch to preferred biosimilars (Steqeyma or Yesintek) or meet strict medical exception criteria. For renewals: submit documentation 30 days before current authorization expires, include clinical response evidence, and prepare for potential transition to biosimilars. Michigan residents have strong external review rights through DIFS if denied.

First step today: Contact your prescriber to discuss biosimilar transition options and gather renewal documentation including recent clinical notes showing treatment response.

Table of Contents

Renewal Triggers: When to Start the Process

UnitedHealthcare typically requires Stelara (ustekinumab) renewal every 12 months, but several factors can trigger an earlier renewal need:

Standard renewal triggers:

  • Annual authorization expiration (check your approval letter for exact dates)
  • Plan year changes (January 1st for most commercial plans)
  • Formulary updates that affect coverage status

Early renewal situations:

  • Dosing changes or frequency adjustments
  • New indication added (e.g., switching from psoriasis to Crohn's disease treatment)
  • Insurance plan changes or employer switches
  • Move between UnitedHealthcare plan types (commercial to Medicare Advantage)
Critical 2025 Update: UnitedHealthcare has excluded brand-name Stelara from most formularies effective September 2024. Current users must transition to preferred biosimilars Steqeyma (ustekinumab-stba) or Yesintek (ustekinumab-kfce) unless they meet strict medical exception criteria.

Signs you should start early:

  • Receiving formulary change notifications from UnitedHealthcare
  • Pharmacy alerts about coverage issues
  • Prior authorization expiring within 60 days
  • Changes in your clinical status or treatment response

Evidence Update: What UnitedHealthcare Needs

For successful Stelara renewal (or biosimilar transition), UnitedHealthcare requires updated clinical evidence demonstrating:

Treatment Response Documentation

For Psoriasis:

  • Current PASI (Psoriasis Area and Severity Index) score or body surface area (BSA) percentage
  • Physician Global Assessment (IGA) scores
  • Before/after photos if available
  • Patient-reported outcome measures

For Crohn's Disease:

  • Crohn's Disease Activity Index (CDAI) scores
  • Patient-Reported Outcome-2 (PRO-2) assessments
  • Recent colonoscopy or imaging results showing mucosal healing
  • Inflammatory markers (CRP, ESR, fecal calprotectin)

For Ulcerative Colitis:

  • Mayo Score or Simple Clinical Colitis Activity Index (SCCAI)
  • Recent colonoscopy findings
  • Stool frequency and bleeding assessments
  • Laboratory markers of inflammation

Safety Monitoring Results

UnitedHealthcare requires documentation of ongoing safety monitoring, including:

  • Infection screening: Recent TB testing, hepatitis B/C status, complete blood count
  • Malignancy surveillance: Skin cancer screening for dermatology patients
  • Neurologic assessment: Screening for posterior reversible encephalopathy syndrome (PRES) symptoms
  • Pregnancy status: For women of childbearing potential
Note: Routine ustekinumab drug level monitoring is not standard but may be considered for patients with secondary loss of response.

Renewal Packet: Must-Include Documents

Your renewal submission should include:

Required Clinical Documentation

  1. Updated medical necessity letter from prescribing physician
  2. Recent progress notes (within 3 months) showing:
    • Current disease activity assessment
    • Treatment response evaluation
    • Absence of serious adverse events
    • Adherence to therapy
  3. Laboratory results confirming safety parameters
  4. Prior authorization renewal form (available through OptumRx provider portal)

Medical Necessity Letter Structure

Your physician's letter should address:

Clinical Problem:

  • Specific diagnosis with ICD-10 codes
  • Disease severity and impact on quality of life
  • Previous treatment history and outcomes

Current Treatment Rationale:

  • Why ustekinumab remains appropriate
  • Evidence of continued clinical benefit
  • Absence of alternative effective treatments

Monitoring and Safety:

  • Recent safety assessments completed
  • Plan for ongoing monitoring
  • Patient compliance with treatment protocol
Counterforce Health can help streamline this process by automatically generating evidence-backed renewal letters that align with UnitedHealthcare's specific criteria, pulling the right clinical citations and formatting requirements to reduce back-and-forth with your insurer.

Timeline: When to Submit and Decision Windows

Optimal Submission Timeline

Action Timing Responsibility
Begin gathering documents 45-60 days before expiration Patient/Provider
Submit complete renewal packet 30 days before expiration Provider
Follow up if no response 15 days before expiration Provider/Patient
Prepare appeal if denied Within 7 days of denial Provider/Patient

UnitedHealthcare Decision Windows

Standard Review: Up to 15 calendar days for non-urgent renewals Expedited Review: 24-72 hours for urgent medical situations Appeal Response: 30 days for internal appeals, up to 60 days for external review in Michigan

Submit renewals through:

If Coverage Lapses: Bridge Options

If your Stelara authorization expires before renewal approval:

Immediate Actions

  1. Contact specialty pharmacy to request emergency fill (typically 30-day supply)
  2. Have prescriber submit urgent prior authorization with clinical justification for continuity
  3. Request expedited review if treatment interruption poses health risks

Temporary Coverage Options

Manufacturer Support:

  • Contact Janssen CarePath at 1-877-227-3728
  • May provide temporary supply during coverage gaps
  • Income-based eligibility requirements apply

State Protections: Michigan law may require temporary continuation during formulary changes—reference this when requesting bridge therapy from UnitedHealthcare.

Biosimilar Transition Support

If transitioning to Steqeyma or Yesintek:

Annual Changes: Formulary and Plan Updates

What to Monitor Annually

Formulary Changes:

  • Review UnitedHealthcare's annual formulary updates (typically released in October for following year)
  • Check for tier changes or new restrictions
  • Verify preferred pharmacy network participation

Plan Design Shifts:

  • Copayment or coinsurance changes
  • Deductible modifications
  • Specialty pharmacy requirements

Clinical Criteria Updates:

  • New step therapy requirements
  • Updated medical necessity criteria
  • Changes in quantity limits or dosing restrictions

2025 Specific Changes

UnitedHealthcare has implemented significant changes affecting ustekinumab coverage:

  • Brand exclusion: Stelara no longer covered on most commercial plans
  • Preferred alternatives: Only Steqeyma and Yesintek biosimilars covered
  • Exception criteria: Strict medical necessity requirements for continued Stelara use

Michigan Appeals Process

If UnitedHealthcare denies your Stelara renewal, Michigan provides robust external review rights:

Internal Appeals (Required First Step)

Timeline: Must file within 180 days of denial Process: Submit through UnitedHealthcare member portal or by mail Decision: Typically within 30 days (72 hours for expedited)

External Review Through Michigan DIFS

Filing Deadline: 127 days from final internal denial Standard Review: Decision within 56-84 days Expedited Review: Decision within 72 hours with physician urgency letter

How to File:

Tip: Michigan's external review process is binding on insurers and has strong consumer protections. Don't hesitate to use this option if your renewal is inappropriately denied.

Personal Tracker Template

Use this template to track your Stelara renewal progress:

Current Authorization Details:

  • Approval date: ___________
  • Expiration date: ___________
  • Authorized quantity: ___________
  • Next renewal due: ___________

Clinical Monitoring Schedule:

  • Last PASI/disease activity score: ___________
  • Date: ___________
  • Next assessment due: ___________
  • Recent lab work completed: ___________

Renewal Submission Tracking:

  • Documents gathered: ___________
  • Submission date: ___________
  • Confirmation number: ___________
  • Expected decision date: ___________

Backup Planning:

  • Emergency fill available: ___________
  • Biosimilar discussed with provider: ___________
  • Appeal preparation: ___________

FAQ

Q: How long does UnitedHealthcare prior authorization renewal take in Michigan? A: Standard renewals take up to 15 days. Expedited reviews for urgent medical situations are completed within 24-72 hours.

Q: What if Stelara is no longer on my UnitedHealthcare formulary? A: As of September 2024, brand-name Stelara is excluded from most UnitedHealthcare formularies. You must switch to preferred biosimilars Steqeyma or Yesintek, or meet strict medical exception criteria.

Q: Can I request an expedited appeal in Michigan? A: Yes, Michigan offers expedited external review within 72 hours if your physician certifies that waiting would seriously jeopardize your health.

Q: Does step therapy apply if I've been on Stelara for years? A: Existing users may be grandfathered, but formulary changes can trigger new step therapy requirements. Current UnitedHealthcare policy requires biosimilar use unless medical exceptions apply.

Q: What counts as medical necessity for continued Stelara use? A: UnitedHealthcare requires documented failure, intolerance, or adverse response to both preferred biosimilars, with detailed physician documentation of clinical superiority.

Q: How much does Stelara cost with UnitedHealthcare coverage? A: Costs vary by plan, but specialty biologics typically fall under the highest tier with significant copayments or coinsurance. Biosimilars may have lower cost-sharing.

Counterforce Health helps patients and providers navigate complex insurance approvals for specialty medications like Stelara. Our platform automatically generates evidence-backed appeals and renewal letters tailored to specific payer requirements, reducing approval times and improving success rates. Learn more about our coverage advocacy services.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions and insurance coverage options. Coverage policies and requirements may change; verify current information with your insurer and healthcare team.

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