By Counterforce Health Team in Ultomiris (ravulizumab) —

If Ultomiris (Ravulizumab) Isn't Approved by UnitedHealthcare in Michigan: Formulary Alternatives & Exception Strategies

Quick Answer: Your Options When Ultomiris Is Denied

If UnitedHealthcare denies Ultomiris (ravulizumab) in Michigan, you have three main paths: try a formulary alternative like Soliris (eculizumab), request a formulary exception with medical necessity documentation, or pursue a formal appeal. Your fastest option is often requesting a peer-to-peer review where your doctor speaks directly with UnitedHealthcare's medical director. Start by calling UnitedHealthcare member services at the number on your insurance card to confirm your plan's specific formulary status and initiate the exception process.

Table of Contents

When Alternatives Make Sense

UnitedHealthcare often requires step therapy for complement inhibitors, meaning you'll need to try a preferred alternative before Ultomiris gets approved. This isn't necessarily bad news—many patients do well on formulary alternatives.

Consider alternatives when:

  • Your condition is newly diagnosed and you haven't tried first-line complement therapy
  • Cost is a major concern (formulary drugs typically have lower copays)
  • Your doctor believes an alternative could be equally effective
  • You want to start treatment quickly without waiting for appeals

Push for Ultomiris specifically when:

  • You've failed or can't tolerate Soliris (eculizumab)
  • The 8-week dosing schedule would significantly improve your quality of life
  • Your doctor has specific clinical reasons why Ultomiris is preferred
  • You're switching from another complement inhibitor and want to maintain stability
Note: According to UnitedHealthcare's complement inhibitor policy, step therapy requirements vary by indication and may have built-in exception pathways.

Formulary Alternatives by Condition

For PNH (Paroxysmal Nocturnal Hemoglobinuria)

Soliris (eculizumab) remains the most common formulary alternative. It's typically preferred on UnitedHealthcare plans and requires dosing every two weeks after an initial loading period.

Empaveli (pegcetacoplan) may also be available as a C3 complement inhibitor option, given twice weekly by subcutaneous injection.

Emerging options: Biosimilar eculizumab products are becoming available and may be preferred on some OptumRx formularies as of 2024.

For aHUS (Atypical Hemolytic Uremic Syndrome)

Soliris (eculizumab) is typically the first-line formulary option, with the same every-two-week maintenance dosing.

For Generalized Myasthenia Gravis (gMG)

Before any complement inhibitor, UnitedHealthcare requires documentation of failure with at least two immunosuppressive agents (like azathioprine, corticosteroids, cyclosporine) over 12 months, or failure of one immunosuppressant plus four or more courses of plasmapheresis/IVIG.

Soliris (eculizumab) would be the typical formulary alternative to Ultomiris for gMG patients meeting these criteria.

For NMOSD (Neuromyelitis Optica Spectrum Disorder)

Soliris (eculizumab) may be available as a formulary alternative, though first-line immunosuppressive therapy failure must be documented first.

Pros and Cons of Each Option

Soliris (Eculizumab) - Most Common Alternative

Pros:

  • Usually preferred on UnitedHealthcare formularies
  • Extensive clinical data and experience
  • Same mechanism of action as Ultomiris (C5 complement inhibition)
  • Lower copays as a preferred drug

Cons:

  • Requires dosing every 2 weeks vs. every 8 weeks for Ultomiris
  • More frequent infusion center visits
  • May have higher treatment burden for patients

Empaveli (Pegcetacoplan) - For PNH Only

Pros:

  • Self-administered subcutaneous injection
  • Different mechanism (C3 inhibition) may help some patients who don't respond fully to C5 inhibitors

Cons:

  • Twice-weekly injections
  • May not be preferred on all formularies
  • Different side effect profile to consider

Biosimilar Eculizumab Options

Pros:

  • Often preferred by payers for cost reasons
  • Same clinical efficacy as reference Soliris
  • May have lower copays

Cons:

  • Limited long-term data compared to reference product
  • Switching between products requires medical supervision
Coverage Tip: OptumRx formularies for 2024 show varying preferences for complement inhibitors. Always verify your specific plan's formulary status before assuming coverage.

Exception Strategy: When to Push for Ultomiris

Strong Medical Necessity Arguments

Document these scenarios for the best exception chances:

  1. Soliris intolerance or failure: Include specific adverse events, lab values showing inadequate response, or quality of life impacts
  2. Dosing schedule medical necessity: Document how 8-week intervals would improve adherence, reduce infection risk, or address specific patient circumstances
  3. Clinical stability concerns: If switching from another complement inhibitor, emphasize maintaining therapeutic response

Required Documentation

Your doctor should submit:

  • Detailed medical necessity letter addressing UnitedHealthcare's specific criteria
  • Lab results showing current disease activity
  • Documentation of prior therapy trials and outcomes
  • Specialist consultation notes supporting the request

From our advocates: We've seen the strongest exception approvals when providers include both the clinical rationale and specific quality-of-life factors—like how frequent infusions impact work, school, or family caregiving responsibilities. The key is connecting medical need to real-world patient outcomes.

Peer-to-Peer Review Process

Request a peer-to-peer review where your doctor speaks directly with UnitedHealthcare's medical director. This often resolves denials faster than written appeals.

How to request:

  • Call the prior authorization number on your denial letter
  • Ask specifically for a "peer-to-peer review"
  • Your doctor should be prepared to discuss clinical rationale in detail

Switching Logistics and Coordination

If Starting an Alternative First

Coordinate with your care team:

  1. Verify vaccination status: All complement inhibitors require meningococcal vaccination at least 2 weeks before starting
  2. Schedule appropriately: Plan your first infusion timing based on the new drug's schedule
  3. Monitor closely: Track the same lab parameters you would with Ultomiris

Transitioning Between Complement Inhibitors

Key safety considerations:

  • Never stop one complement inhibitor without immediately starting another
  • Switching protocols exist for moving from Soliris to Ultomiris when approved
  • Maintain consistent monitoring for breakthrough hemolysis or disease activity

Insurance coordination:

  • Get prior authorization for the new drug before stopping the current one
  • Coordinate with your specialty pharmacy for seamless transition
  • Keep detailed records of response to support future Ultomiris requests

Re-trying for Ultomiris Later

What to Document During Alternative Therapy

Keep detailed records of:

  • Efficacy measures: Lab values, symptom scores, transfusion requirements
  • Quality of life impacts: Missed work/school, caregiver burden, treatment-related stress
  • Side effects or tolerability issues: Even minor ones that affect daily life
  • Adherence challenges: Difficulty with frequent dosing or infusion schedules

When to Resubmit for Ultomiris

Strong timing for a new request:

  • After 3-6 months of alternative therapy with documented suboptimal response
  • When quality of life impacts become well-documented
  • If new clinical evidence emerges supporting Ultomiris for your specific situation
  • At plan renewal when formulary changes might occur

Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify exactly why coverage was denied, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. Learn more about our coverage advocacy services.

Appeals Playbook for Michigan

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial to file internal appeal

How to file:

  • Online through UnitedHealthcare member portal
  • Mail to address on your denial letter
  • Fax using number provided in denial letter

What to include:

  • Completed appeal form
  • Updated medical necessity letter from your doctor
  • Supporting clinical documentation
  • Any new evidence since initial request

External Review Through Michigan DIFS

If UnitedHealthcare upholds the denial after internal appeals:

Timeline: 127 days from final internal denial

How to file:

Expedited review available: 72 hours for urgent medical needs with physician support letter

Contact: Michigan DIFS at 877-999-6442 for assistance

Important: Michigan's external review decisions are binding on insurers. If approved, UnitedHealthcare must provide coverage as directed.

When to Escalate Further

Contact Michigan DIFS for complaints about:

  • Delayed appeal responses
  • Procedural violations
  • Pattern of inappropriate denials

For Medicaid plans, different appeal processes may apply through Michigan Department of Health and Human Services.

FAQ

How long does UnitedHealthcare prior authorization take in Michigan? Standard requests: 72 hours for non-urgent, 24 hours for urgent. If no response within these timeframes, the request may be automatically approved.

What if Ultomiris is completely non-formulary on my plan? You can still request a formulary exception. Provide strong medical necessity documentation and consider peer-to-peer review to discuss alternatives.

Can I request expedited appeal if I'm currently on Soliris? Yes, if switching is medically urgent. Your doctor must provide documentation that delay would jeopardize your health.

Does step therapy apply if I failed similar drugs outside Michigan? Yes, document prior failures thoroughly. UnitedHealthcare should accept out-of-state treatment history with proper documentation.

What's the difference between formulary exception and prior authorization? Prior authorization is required for covered drugs; formulary exception requests coverage for non-covered drugs. Both use similar documentation requirements.

How do I find my specific UnitedHealthcare formulary? Check your plan documents or call member services. OptumRx manages most UnitedHealthcare drug benefits, and formularies vary by specific plan type.

What if my doctor won't do a peer-to-peer review? Some practices have policies limiting these calls. Ask if another provider in the practice or a specialist can participate, or consider getting a second opinion.

Can I appeal if I'm switching from employer to individual coverage? Yes, but formularies may differ between plan types. Start the process early during open enrollment periods when possible.

Sources & Further Reading

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 decisions. For personalized help with insurance appeals and coverage advocacy, visit Counterforce Health.

Disclaimer: Coverage policies change frequently. Verify all information with current UnitedHealthcare policies and Michigan regulations before making coverage decisions.

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