By Counterforce Health Team in Ultomiris (ravulizumab) —

Getting Ultomiris (ravulizumab) Covered by Humana in Michigan: Complete Coverage Guide with Forms and Appeal Process

Answer Box: Getting Ultomiris Covered by Humana in Michigan

Eligibility: Ultomiris requires prior authorization from Humana for FDA-approved conditions (PNH, aHUS, gMG, NMOSD). Fastest path: Your doctor submits a PA request with diagnosis confirmation, lab results, and medical necessity documentation through Humana's provider portal. Start today: Contact your prescriber to initiate the PA process and gather required documentation. If denied, you have 60 days for internal appeal, then 127 days for Michigan DIFS external review.

Table of Contents

  1. Humana's Coverage Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy and Medical Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Lab Values
  6. Site of Care and Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Documentation
  9. Appeals Process in Michigan
  10. Common Denial Reasons and Solutions
  11. Costs and Patient Assistance
  12. FAQ

Policy Overview

Humana covers Ultomiris (ravulizumab) under Medicare Part B (for Medicare Advantage members) and commercial plans, but prior authorization is mandatory for all indications. The drug is classified as a specialty medication requiring administration through Humana's contracted specialty pharmacy network.

Plan Types and Coverage

  • Medicare Advantage: Covered under Part B with PA requirements
  • Commercial Plans: Subject to medical policy and formulary placement
  • Part D Plans: May require formulary exception process for non-formulary coverage
Note: Coverage policies are updated regularly. Always verify current requirements through Humana's prior authorization lists.

FDA Indication Requirements

Humana covers Ultomiris for these FDA-approved conditions:

Indication Key Requirements Documentation Needed
Paroxysmal Nocturnal Hemoglobinuria (PNH) Flow cytometry showing ≥5% PNH cells Lab results, LDH levels, transfusion history
Atypical Hemolytic Uremic Syndrome (aHUS) Platelet count ≤150 × 10⁹/L, evidence of hemolysis CBC, creatinine, complement studies
Generalized Myasthenia Gravis (gMG) AChR-antibody positive Antibody testing, clinical severity scores
Neuromyelitis Optica Spectrum Disorder (NMOSD) AQP4-antibody positive Antibody results, MRI findings, relapse history

Important: STEC-HUS (Shiga toxin-producing E. coli hemolytic uremic syndrome) is specifically excluded from coverage.

Step Therapy and Medical Exceptions

Standard Step Therapy Requirements

For most indications, Humana may require trial of:

  1. Soliris (eculizumab) first-line for complement-mediated conditions
  2. Biosimilar eculizumab where available
  3. Other condition-specific therapies as outlined in medical policies

Medical Exception Pathways

You can bypass step therapy if your doctor documents:

  • Previous trial and failure of required medications
  • Medical contraindication to step therapy drugs
  • Intolerance or adverse reactions to alternatives
  • Clinical urgency requiring immediate Ultomiris therapy
Tip: When switching from eculizumab to Ultomiris, no washout period is typically required. Schedule the first Ultomiris dose within 2 weeks of the last eculizumab infusion.

Quantity and Frequency Limits

Dosing Parameters

  • Loading dose: Weight-based calculation per FDA labeling
  • Maintenance dosing: Every 8 weeks for IV; weekly for subcutaneous (where approved)
  • Dose adjustments: Must be clinically justified and within FDA parameters

Renewal Requirements

Humana typically requires reauthorization every 6-12 months with documentation of:

  • Clinical response (e.g., LDH normalization for PNH, reduced relapses for NMOSD)
  • Continued medical necessity
  • Updated lab monitoring results

Required Diagnostics and Lab Values

Pre-Treatment Requirements

  • Meningococcal vaccination (mandatory due to REMS program)
  • Baseline complement studies (C3, C4, AH50)
  • Condition-specific labs as outlined above

Ongoing Monitoring

  • Trough ravulizumab levels: Target >175 mcg/mL for efficacy
  • Free C5 levels: <0.5 mcg/mL indicates optimal complement inhibition
  • AH50 activity: Should be undetectable at therapeutic levels
  • Safety monitoring: CBC, liver function, infection screening
Clinical Tip: The Mayo Clinic offers ravulizumab level testing with reference ranges to support coverage documentation.

Site of Care and Specialty Pharmacy Requirements

Approved Administration Sites

  • Physician's office (POS 11)
  • Outpatient hospital (POS 22)
  • Ambulatory surgical center (POS 24)
  • Home infusion (POS 33) - requires additional medical necessity documentation

Specialty Pharmacy Network

Ultomiris must be dispensed through Humana-contracted specialty pharmacies. Contact Humana's specialty pharmacy team to coordinate drug supply and administration logistics.

Evidence to Support Medical Necessity

Required Clinical Documentation

  1. Diagnosis confirmation with appropriate lab/imaging studies
  2. Treatment history including prior therapies, doses, duration, and outcomes
  3. Clinical rationale for Ultomiris specifically
  4. Monitoring plan and expected outcomes

Supporting Literature

  • FDA prescribing information for indication-specific guidance
  • Clinical practice guidelines from relevant specialty societies
  • Peer-reviewed studies demonstrating efficacy for your patient's condition
  • Drug compendia (e.g., Micromedex, Lexicomp) for off-label uses if applicable

Sample Medical Necessity Documentation

Medical Necessity Letter Template

"[Patient] is a [age]-year-old with [diagnosis] confirmed by [specific test results]. Previous treatments including [list prior therapies with dates, doses, outcomes] have been [inadequate/contraindicated/caused adverse effects]. Ultomiris is medically necessary because [specific clinical rationale]. The patient meets FDA-approved indication criteria as evidenced by [lab values, clinical findings]. Expected outcomes include [specific measurable goals]. Monitoring will include [lab schedule, clinical assessments]."

From our advocates: We've seen the strongest approvals when providers include specific lab values that meet FDA criteria, document previous complement inhibitor experience (if applicable), and clearly state measurable treatment goals. Keep the letter focused and include recent test results rather than historical summaries.

Appeals Process in Michigan

Internal Appeals with Humana

  • Timeline: 60 days from denial date
  • Standard review: Up to 30 days for decision
  • Expedited review: 72 hours for urgent cases
  • Submission: Via Humana member portal or provider portal

Michigan External Review (DIFS)

If Humana's internal appeal is unsuccessful:

  • Timeline: 127 days from final denial to request external review
  • Expedited option: 72 hours for urgent cases with physician support
  • Cost: Free to patients
  • Contact: Michigan DIFS at 877-999-6442
  • Forms: Available at michigan.gov/difs

Required Documentation for Appeals

  • Final denial letter from Humana
  • All previous appeal materials
  • Updated medical records
  • Physician letter supporting medical necessity
  • For expedited appeals: physician certification of urgency

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
"Not medically necessary" Submit detailed clinical rationale Treatment history, clinical guidelines, expected outcomes
"Step therapy not completed" Request medical exception Contraindications, prior failures, clinical urgency
"Experimental/investigational" Demonstrate FDA approval FDA labeling, indication-specific studies
"Quantity exceeds limits" Justify dosing requirements Weight-based calculations, clinical response data
"Non-formulary drug" File formulary exception Medical necessity for this specific agent vs. alternatives

Costs and Patient Assistance

Financial Support Options

  • Alexion Access Navigator: Patient support program offering copay assistance and case management
  • Manufacturer copay cards: May reduce out-of-pocket costs for eligible patients
  • Foundation grants: Various rare disease foundations offer financial assistance
  • State programs: Michigan may have additional assistance for rare disease medications
Note: Annual costs for Ultomiris often range in the high-$400k range, making patient assistance programs crucial for many families.

For patients and clinicians navigating complex coverage denials, Counterforce Health provides specialized support in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with each payer's specific requirements, helping families access critical treatments like Ultomiris more efficiently.

FAQ

How long does Humana's prior authorization take? Standard PA requests are typically processed within 5-7 business days. Humana aims to respond to 85% of requests within one business day as of 2025.

What if Ultomiris is non-formulary on my plan? You can request a formulary exception by having your doctor submit documentation that all covered alternatives would be less effective or cause adverse effects.

Can I get an expedited appeal in Michigan? Yes, both Humana (72 hours) and Michigan DIFS (72 hours) offer expedited appeals for urgent medical situations with physician certification.

Do I need to try Soliris first? Not necessarily. If you have medical contraindications, previous intolerance, or clinical urgency, your doctor can request a step therapy exception.

How often do I need reauthorization? Typically every 6-12 months, depending on your plan. Your doctor will need to document continued medical necessity and clinical response.

What happens if my appeal is denied? You can escalate to Michigan's external review process through DIFS, which provides an independent medical review at no cost to you.

When to Escalate

Contact Michigan DIFS at 877-999-6442 if:

  • Humana doesn't respond within required timeframes
  • You believe the denial violates state insurance laws
  • You need assistance navigating the external review process

For urgent situations where delays could harm your health, request expedited reviews at every level and ensure your physician provides supporting documentation of medical urgency.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always consult current official sources and work with your healthcare provider for personalized guidance.

Sources & Further Reading

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