By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (Eculizumab) Covered by Aetna CVS Health in Michigan: Complete Prior Authorization Guide

Answer Box: Getting Soliris Covered by Aetna CVS Health in Michigan

Fastest path to approval: Submit prior authorization with diagnosis-specific lab values (flow cytometry for PNH, anti-AChR antibodies for myasthenia gravis), proof of meningococcal vaccination, and documentation of failed therapies. First step today: Call Aetna at (866) 752-7021 to initiate precertification. If denied, you have 180 days for internal appeals and 127 days for Michigan DIFS external review. Success rates: 40-60% of external reviews overturn specialty drug denials.

Table of Contents

  1. Aetna CVS Health Policy Overview
  2. Medical Necessity Requirements by Indication
  3. Step Therapy and Exception Pathways
  4. Required Diagnostics and Lab Values
  5. Safety Requirements and REMS Program
  6. Appeals Process in Michigan
  7. Common Denial Reasons and Solutions
  8. Cost Assistance and Resources
  9. FAQ

Policy Overview

Aetna CVS Health requires precertification for all eculizumab products, including Soliris, Bkemv (biosimilar), and Epysqli (biosimilar). This applies across HMO, PPO, and Medicaid managed care plans in Michigan.

Key Contact Information:

  • Prior Authorization: (866) 752-7021
  • Fax: (888) 267-3277
  • CVS Specialty Pharmacy handles most infusions
Note: Self-funded employer plans may have different policies. Check your specific plan documents or call the member services number on your insurance card.

Coverage at a Glance

Requirement Details Timeline Source
Prior Authorization Required for all plans 30-45 days standard Aetna Precert List
Step Therapy May require Empaveli first for PNH Varies by plan Blue Cross Alert
Meningococcal Vaccination Mandatory ≥2 weeks before first dose Before treatment FDA Label
Appeals Deadline (Internal) 180 days from denial - Standard Aetna policy
External Review (Michigan) 127 days from final denial 60 days max decision Michigan DIFS

Medical Necessity Requirements by Indication

Aetna's approval criteria vary significantly by diagnosis. Each indication requires specific lab values and clinical documentation.

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Required Documentation:

  • Flow cytometry results showing GPI-deficient cells
  • Elevated lactate dehydrogenase (LDH) levels
  • Evidence of hemolysis (low haptoglobin, elevated indirect bilirubin)
  • Transfusion history or hemoglobinuria episodes

Authorization Period: 12 months for continuing therapy with demonstrated clinical benefit

Atypical Hemolytic Uremic Syndrome (aHUS)

Required Documentation:

  • Confirmation of complement-mediated thrombotic microangiopathy
  • Critical: Tests confirming absence of Shiga toxin (to rule out STEC-HUS)
  • Platelet count and LDH normalization on therapy
  • Kidney function monitoring

Generalized Myasthenia Gravis (gMG)

Required Documentation:

Eligible immunosuppressives: azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus, or rituximab

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Required Documentation:

  • Anti-aquaporin-4 (AQP4) antibody positive
  • Core clinical characteristics documented
  • Reduction in relapse frequency on therapy

Authorization Period: 6 months (shorter than other indications)

Step Therapy and Exception Pathways

Some Aetna plans now require step therapy with Empaveli (pegcetacoplan) before approving Soliris for PNH. However, medical exceptions are available.

Step Therapy Exception Criteria

Automatic exceptions may apply for:

  • Contraindication to first-line therapy
  • Previous trial and failure of required medication
  • Drug interaction with patient's current medications
  • Adverse reaction history

Documentation needed:

  • Specific contraindication or intolerance details
  • Previous trial duration and outcome
  • Clinical rationale for Soliris over alternatives
Tip: Include specific adverse events and dates when documenting previous failures. Generic statements like "patient couldn't tolerate" rarely succeed.

Required Diagnostics and Lab Values

PNH Diagnostic Requirements

Flow Cytometry (Gold Standard):

  • Must show GPI-deficient granulocytes >20% for treatment consideration
  • Uses FLAER (fluorescent aerolysin) and CD55/CD59 markers
  • High-sensitivity flow cytometry preferred

Supporting Labs:

  • LDH: Typically elevated >225 U/L (normal: 80-225 U/L)
  • Haptoglobin: Often low <83 mg/dL (normal: 83-267 mg/dL)
  • Indirect bilirubin: Elevated >1.0 mg/dL (normal: 0.3-1.0 mg/dL)
  • Coombs test: Must be negative to rule out autoimmune hemolysis

Lab Monitoring on Therapy

Treatment response indicators:

  • LDH normalization or significant reduction
  • Hemoglobin stabilization or improvement
  • Reduced transfusion requirements
  • Platelet count improvement (for aHUS)

Safety Requirements and REMS Program

Soliris carries a boxed warning for life-threatening meningococcal infections. Patients have a 1,000-2,000 fold increased risk compared to the general population.

Mandatory Vaccination Protocol

Required vaccines (both needed):

  • MenACWY (covering serogroups A, C, W, Y)
  • MenB (covering serogroup B)

Timeline: Must be completed ≥2 weeks before first Soliris dose

Urgent therapy exception: If treatment can't be delayed, provide 2 weeks of antibacterial prophylaxis while completing vaccination

REMS Certification Requirements

  • Prescribers must be certified in the Soliris REMS program
  • Pharmacies (including CVS Specialty) must be certified
  • Healthcare settings dispensing Soliris must participate
Important: Even with vaccination, meningococcal protection is incomplete. Maintain high suspicion for meningococcal disease symptoms.

Appeals Process in Michigan

Michigan offers robust patient protection through the Department of Insurance and Financial Services (DIFS) external review process.

Step-by-Step Appeals Timeline

1. Internal Appeal with Aetna (Required First)

  • Deadline: 180 days from denial notice
  • Timeline: 30-45 days for standard; 72 hours for expedited
  • How to file: Submit written appeal addressing specific denial reasons

2. Michigan DIFS External Review

  • Deadline: 127 days from Aetna's final denial
  • Timeline: Up to 60 days for decision; 72 hours if expedited
  • Cost: Free to patients
  • How to file: Online form or FIS 0018 form

3. Expedited Review Criteria

  • Medical urgency documented by physician
  • Standard timeline would jeopardize health
  • Request within 10 days of final denial

Required Documentation for Appeals

  • Copy of Aetna's denial letter
  • Prescription records and dosing rationale
  • Lab results supporting diagnosis
  • Documentation of failed prior therapies
  • Physician letter of medical necessity

DIFS Contact Information:

  • Phone: (877) 999-6442
  • Hours: 8 AM - 5 PM, Monday-Friday
  • Online: Michigan DIFS PRIRA website

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
"Not medically necessary" Submit diagnosis-specific lab values Flow cytometry, antibody titers, LDH levels
Missing vaccination Complete meningococcal vaccines Vaccination records with dates
Step therapy not met Request medical exception Previous trial failures, contraindications
"Experimental/investigational" Cite FDA approval FDA label, indication-specific guidelines
Insufficient diagnostic proof Provide complete lab panel All required tests with reference ranges
Non-qualified prescriber Obtain specialist consultation Hematology/neurology/nephrology referral

From Our Advocates

"We've seen the strongest appeals include exact lab values referenced against the plan's own policy criteria. For example, instead of writing 'patient has PNH,' specify 'flow cytometry shows 45% GPI-deficient granulocytes, exceeding Aetna's 20% threshold per policy 0807.' This precision-targeting approach has helped overturn denials that generic medical necessity letters couldn't address."

Cost Assistance and Resources

Manufacturer Support:

  • Alexion OneSource provides vaccination support and patient assistance
  • Financial assistance programs available based on income

Specialty Pharmacy Options:

  • CVS Specialty Pharmacy (primary for Aetna members)
  • Accredo Specialty Pharmacy
  • AlexionPharma (manufacturer's pharmacy)

Foundation Grants:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)
Note: Copay assistance may not apply to government-funded plans (Medicare, Medicaid).

When Coverage Gets Complex

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Soliris. Their platform analyzes denial letters and plan policies to identify specific coverage gaps and draft point-by-point rebuttals using the right clinical evidence and procedural requirements.

For patients facing repeated denials or complex coverage scenarios, professional advocacy services can help navigate Aetna's specific requirements while ensuring all Michigan appeal deadlines are met. The platform tracks payer-specific workflows and produces letters that meet both clinical and procedural standards.

FAQ

How long does Aetna prior authorization take for Soliris in Michigan? Standard decisions take 30-45 days. Expedited reviews (for urgent medical need) are completed within 72 hours.

What if Soliris is non-formulary on my Aetna plan? Request a formulary exception with documentation of medical necessity and failed alternatives. Non-formulary doesn't mean uncoverable.

Can I get an expedited appeal in Michigan? Yes, if your physician documents that standard timelines would jeopardize your health. Submit within 10 days of denial with physician letter.

Does step therapy apply if I've tried other treatments outside Michigan? Yes, document all previous therapies regardless of where they occurred. Include specific medications, duration, and outcomes.

What happens if DIFS external review is denied? DIFS decisions are typically final for state-regulated plans. Consider working with Counterforce Health to identify any procedural issues that could support a new request.

How do I know if my Aetna plan is self-funded vs. state-regulated? Self-funded employer plans may not be subject to Michigan DIFS review. Check your plan documents or call member services to confirm your appeal rights.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may vary by specific plan. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. For official Michigan insurance appeal assistance, contact DIFS at (877) 999-6442.

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