By Counterforce Health Team in Ultomiris (ravulizumab) —

Getting Ultomiris (Ravulizumab) Covered by Aetna CVS Health in California: Forms, Appeals, and Alternative Options

Answer Box: Fast Track to Ultomiris Coverage

To get Ultomiris (ravulizumab) covered by Aetna CVS Health in California: Submit the Ultomiris Precertification Request form with complete clinical documentation showing FDA-approved indication, failed alternatives, and vaccination records. If denied, file internal appeal within 60 days, then request California Independent Medical Review (IMR) through DMHC. Success rates for well-documented rare disease appeals in California often exceed 50%. Start today: Call Aetna at 1-800-872-3862 to confirm your plan's specific requirements and download the PA form.

Table of Contents

  1. When Alternatives Make Sense
  2. Typical Formulary Alternatives
  3. Pros and Cons Overview
  4. Exception Strategy
  5. Switching Logistics
  6. Re-trying for Ultomiris Later
  7. California Appeal Process
  8. Coverage Requirements at a Glance
  9. Common Denial Reasons & Solutions
  10. FAQ

When Alternatives Make Sense

Aetna CVS Health typically requires patients to try less expensive complement inhibitors before approving Ultomiris (ravulizumab). This step therapy approach makes clinical and financial sense in many cases, but there are important exceptions.

When alternatives are appropriate:

  • You're newly diagnosed with PNH or aHUS and haven't tried other complement inhibitors
  • Your current treatment isn't working optimally but you haven't documented failure
  • Cost is a significant concern and alternatives offer similar efficacy

When to skip alternatives and go straight to Ultomiris:

  • You've already failed or can't tolerate Soliris (eculizumab) or its biosimilars
  • Frequent infusions create significant logistical barriers (work, distance to infusion center, caregiver availability)
  • You're switching from Soliris due to adherence issues with the every-2-week schedule
Note: California law protects your right to request exceptions to step therapy when your doctor determines an alternative isn't appropriate for your specific situation.

Typical Formulary Alternatives

Based on current Aetna formulary patterns, here are the complement inhibitors your plan likely prefers before Ultomiris:

For PNH (Paroxysmal Nocturnal Hemoglobinuria)

Primary alternatives:

  • Soliris (eculizumab) - The original C5 inhibitor; every 2 weeks IV
  • Bkemv (eculizumab-aeeb) - Interchangeable biosimilar to Soliris (launching March 2025)
  • Empaveli (pegcetacoplan) - C3 inhibitor; subcutaneous twice weekly

For aHUS (Atypical Hemolytic Uremic Syndrome)

Primary alternative:

  • Soliris (eculizumab) or Bkemv - Only other FDA-approved complement inhibitors for aHUS

For Generalized Myasthenia Gravis (gMG)

Step therapy sequence typically required:

  1. Standard immunosuppressants (azathioprine, mycophenolate, corticosteroids)
  2. IVIG or plasmapheresis
  3. Soliris as first complement inhibitor
  4. Ultomiris only after Soliris failure/intolerance

For NMOSD (Neuromyelitis Optica Spectrum Disorder)

Step therapy sequence:

  1. First-line immunosuppressants (azathioprine, mycophenolate, rituximab)
  2. Soliris as preferred complement inhibitor
  3. Ultomiris for Soliris failures

Pros and Cons Overview

Soliris (Eculizumab) vs. Ultomiris

Factor Soliris Ultomiris
Dosing frequency Every 2 weeks Every 8 weeks
Typical approval time 7-14 days 14-30 days
Cost to plan Lower (biosimilars available) Higher
Infusion burden Higher Lower
Clinical efficacy Established Equivalent
REMS requirements Yes Yes

Empaveli (for PNH only)

Advantages:

  • Subcutaneous self-injection at home
  • No infusion center visits required
  • Different mechanism (C3 vs C5 inhibition)

Considerations:

  • Injection site reactions common
  • Requires twice-weekly injections
  • More complex monitoring initially
From our advocates: We've seen patients successfully argue for Ultomiris when they can document specific barriers to frequent infusions - such as living 2+ hours from an infusion center or having inflexible work schedules that make every-2-week appointments unsustainable. The key is quantifying the real-world impact on adherence.

Exception Strategy

Building Your Medical Necessity Case

Your specialist should document these key elements in the prior authorization request:

1. Confirmed diagnosis with supporting labs

  • Flow cytometry results (PNH)
  • ADAMTS13 levels >5% and negative Shiga toxin (aHUS)
  • Antibody testing (AChR+ for gMG, AQP4+ for NMOSD)

2. Disease severity and impact

  • Baseline LDH levels, transfusion requirements
  • Functional scores (MG-ADL for myasthenia gravis)
  • Relapse history (NMOSD)

3. Prior treatment failures or contraindications

  • Specific medications tried, doses, duration
  • Documented adverse effects or inadequate response
  • Reasons why preferred alternatives aren't suitable

4. Safety requirements met

  • Meningococcal vaccination completed
  • REMS program enrollment confirmed

Strengthening Your Request

Include these supporting elements:

  • Recent lab results showing disease activity
  • Specialist letter explaining why Ultomiris is specifically needed
  • Documentation of adherence challenges with alternatives
  • Quality of life impact statements

At Counterforce Health, we help patients and clinicians transform insurance denials into successful appeals by identifying the specific denial reasons and crafting targeted, evidence-backed responses that align with each plan's own coverage criteria.

Switching Logistics

If Starting Soliris First

Coordination steps:

  1. Specialty pharmacy setup - Both drugs require specialty pharmacy dispensing
  2. Infusion center scheduling - Confirm they can handle both medications
  3. Monitoring plan - Lab schedules for efficacy and safety
  4. Documentation strategy - Track response and any issues for future Ultomiris request

Transition Timeline

Week Activity Responsible Party
1-2 Initial Soliris loading doses Infusion center
4-8 Assess initial response Specialist
12-16 Full efficacy evaluation Specialist
16+ Document for Ultomiris switch if needed Specialist
Tip: Keep detailed records of every infusion appointment, including scheduling difficulties, travel time, and any missed work. This documentation becomes crucial if you later need to justify switching to Ultomiris.

Re-trying for Ultomiris Later

Documentation During Alternative Trials

Track these metrics:

  • Efficacy measures: LDH levels, transfusion needs, symptom scores
  • Tolerability issues: Infusion reactions, injection site problems
  • Adherence barriers: Missed appointments, scheduling conflicts
  • Quality of life impact: Work missed, caregiver burden

When to Request Switch

Consider requesting Ultomiris after:

  • 3-6 months of suboptimal response to alternatives
  • Documented adherence problems with frequent dosing
  • Significant quality of life impact from treatment schedule
  • New contraindications to current therapy

Building the Switch Case

Your specialist should document:

  • Objective measures showing inadequate response
  • Specific barriers to continuing current therapy
  • How Ultomiris addresses these limitations
  • Expected benefits of extended dosing interval

California Appeal Process

Internal Appeal with Aetna

Timeline: 30 days for standard, 72 hours for expedited How to file: Member portal, phone (1-800-872-3862), or written request Required: Denial letter, supporting clinical documentation, specialist letter

Independent Medical Review (IMR)

California offers one of the strongest external review processes in the nation. For DMHC-regulated Aetna plans:

Eligibility: Available after internal appeal or if Aetna doesn't respond in 30 days Success rates: Historical data shows 50-80% of medical necessity denials overturned Timeline: 30 days standard, 3 days expedited Cost: Free to patients

How to file IMR:

  1. Complete DMHC IMR application
  2. Include all medical records and specialist letters
  3. Submit denial letters and internal appeal responses
  4. DMHC assigns independent medical experts for review
Note: IMR decisions are binding on Aetna - if approved, they must provide coverage.

Coverage Requirements at a Glance

Requirement Details Source
Prior authorization Required for all indications Aetna CPB 0946
Formulary status Specialty tier, non-preferred Plan-specific
Age limits ≥1 month (PNH, aHUS); Adults (gMG, NMOSD) FDA label
Specialist required Hematologist, nephrologist, neurologist Aetna policy
Vaccination Meningococcal required REMS program
Site of care Specialty infusion center preferred Utilization management
Appeal deadline 60 days from denial California law

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Not medically necessary" Provide detailed specialist letter with lab values, prior treatments, and guideline citations
"Step therapy not completed" Document specific failures/contraindications to required alternatives
"Experimental/investigational" Emphasize FDA approval for your specific indication
"Not on formulary" Request formulary exception with medical necessity justification
"Quantity/frequency limits" Justify dosing based on weight and FDA labeling

For each denial, Counterforce Health helps identify the specific coverage criteria that weren't met and develops targeted responses that directly address the plan's concerns using their own policy language.

FAQ

How long does Aetna prior authorization take in California? Standard PA decisions: 14 business days. Expedited (urgent): 72 hours. Extensions possible if additional information needed.

What if Ultomiris isn't on my formulary? Request a formulary exception with medical necessity documentation. California law requires plans to cover medically necessary treatments even if not on formulary.

Can I get expedited review? Yes, if delay poses serious health risks. Your doctor must certify urgency. Both Aetna internal appeals and DMHC IMR offer expedited timelines.

Does step therapy apply if I failed treatments in another state? Yes, document all prior treatments regardless of location. Complete medical records transfer to your California specialist.

What's the cost without insurance approval? Ultomiris typically costs $400,000-500,000+ annually. Check manufacturer patient assistance programs and foundation grants while pursuing coverage.

How do I find a specialist familiar with these appeals? Contact major medical centers with rare disease programs. Hematology/oncology, nephrology, and neurology departments typically have experience with complement inhibitor coverage.

What if my Aetna plan is through my employer? Self-funded employer plans may not be subject to California IMR. Check your plan documents or contact HR to determine if it's DMHC-regulated.

Can I switch from Soliris to Ultomiris mid-treatment? Yes, with proper medical justification. The switch requires specific timing - Ultomiris loading dose at your next scheduled Soliris appointment.

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 additional help with California health insurance appeals, contact the DMHC Help Center at 1-888-466-2219.

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