By Counterforce Health Team in Ultomiris (ravulizumab) —

Aetna (CVS Health) Coverage Criteria for Ultomiris (ravulizumab) in New York: What Counts as "Medically Necessary"?

Answer Box: Getting Ultomiris Covered by Aetna (CVS Health) in New York

Ultomiris (ravulizumab) requires prior authorization from Aetna (CVS Health) for all FDA-approved indications (PNH, aHUS, anti-AChR+ generalized myasthenia gravis, and NMOSD). Coverage requires meeting diagnosis-specific criteria, meningococcal vaccination, and documentation of clinical necessity. Quick start: 1) Verify your plan's specialty pharmacy benefit, 2) Gather required lab results and prior therapy records, 3) Submit PA through Aetna's provider portal. If denied, New York residents have strong appeal rights through the Department of Financial Services external review program.

Table of Contents

Policy Overview

Aetna (CVS Health) treats Ultomiris as a high-cost specialty drug requiring precertification for both the medication and site of care. This applies across commercial, Medicare Advantage, and Medicaid managed care plans in New York.

Plan Types and Coverage Pathway

  • Commercial/Employer Plans: Generally covered under medical benefit (J1303) with CVS Specialty Pharmacy handling distribution
  • Medicare Advantage: Subject to Part B coverage rules with additional Aetna-specific criteria
  • Medicaid Managed Care: Must meet both state Medicaid and Aetna's medical necessity standards

All Aetna plans in New York follow the same core medical policy framework for complement inhibitors, with specific criteria varying by indication.

FDA-Approved Indications & Requirements

Aetna covers Ultomiris only for FDA-labeled indications when medical necessity criteria are met:

Coverage at a Glance

Indication Key Requirement Lab/Clinical Threshold Authorization Period
PNH Flow cytometry showing ≥5% PNH clone LDH ≥1.5× ULN + clinical symptoms 6 months initial, 12 months renewal
aHUS TMA with exclusion of STEC-HUS Negative Shiga toxin test required 6 months initial, 12 months renewal
Anti-AChR+ gMG Positive AChR antibodies MG-ADL score ≥5, MGFA Class II-IV 12 months
AQP4+ NMOSD Positive AQP4 antibodies Clinical attack history documented 12 months

Universal Requirements (All Indications)

Before starting Ultomiris, patients must have:

  • Meningococcal vaccination ≥2 weeks before first dose (MenACWY and MenB per CDC guidelines)
  • No concurrent complement inhibitor use (e.g., Soliris, Zilbrysq)
  • Documentation of FDA-approved diagnosis with appropriate specialist evaluation

Step Therapy & Medical Exceptions

While Aetna's published policies don't explicitly require step therapy for Ultomiris, many commercial plans prioritize eculizumab (Soliris) or its biosimilars as first-line therapy. This varies by contract and region.

Medical Exception Pathways

If step therapy applies to your plan, exceptions are granted for:

  • Prior eculizumab failure or intolerance (documented adverse events, inadequate response after adequate trial)
  • Contraindication to eculizumab (medical reasons preventing use)
  • Access barriers (geographic distance to infusion centers, scheduling conflicts with bi-weekly dosing)
Tip: Document specific reasons why eculizumab is inappropriate. "Patient preference" alone typically doesn't qualify for medical exceptions.

Required Diagnostics & Laboratory Values

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Essential Documentation:

  • High-sensitivity flow cytometry showing ≥5% PNH clone on ≥2 cell lineages
  • LDH ≥1.5× upper limit of normal
  • Evidence of clinically significant hemolysis:
    • Symptomatic anemia (Hb <10 g/dL with symptoms)
    • History of thrombosis or major adverse vascular events
    • Transfusion dependence (≥2 units in 12 months)
    • Organ dysfunction from chronic hemolysis

Atypical Hemolytic Uremic Syndrome (aHUS)

Required Tests:

  • Negative Shiga toxin (essential to exclude STEC-HUS)
  • Evidence of thrombotic microangiopathy:
    • Thrombocytopenia
    • Microangiopathic hemolytic anemia (elevated LDH, schistocytes)
    • Renal impairment (elevated creatinine/decreased eGFR)
  • ADAMTS13 activity (to exclude TTP)

Generalized Myasthenia Gravis (Anti-AChR+)

Diagnostic Requirements:

  • Positive anti-acetylcholine receptor antibodies
  • MG-ADL total score ≥5
  • MGFA Class II-IV severity
  • Prior treatment with ≥2 immunosuppressive therapies for ≥12 months OR use of IVIG/plasmapheresis

NMOSD (AQP4-Antibody Positive)

Clinical Documentation:

  • Positive AQP4-IgG via cell-based assay
  • ≥1 core clinical characteristic (optic neuritis, acute myelitis, area postrema syndrome)
  • MRI findings consistent with NMOSD
  • History of relapse despite prior therapy

Site of Care & Specialty Pharmacy Requirements

Aetna requires precertification for both drug and administration site. CVS Specialty Pharmacy typically handles distribution.

Preferred Administration Sites

  1. Physician offices (most preferred)
  2. Ambulatory infusion centers
  3. Home infusion (if available and medically appropriate)
  4. Hospital outpatient departments (requires additional justification)

Hospital Outpatient Exceptions

HOPD administration is approved for:

  • First 2 infusions or re-initiation after ≥6 months
  • Complex monitoring needs per clinical guidelines
  • Patient safety concerns requiring hospital-level care

Evidence to Support Medical Necessity

Clinical Guidelines and Literature

When submitting prior authorization requests, include references to:

  • FDA prescribing information for Ultomiris
  • International consensus guidelines for the specific condition
  • Peer-reviewed studies demonstrating efficacy in the patient's indication
  • Professional society recommendations (e.g., American Society of Hematology, Myasthenia Gravis Foundation)

Sample Medical Necessity Narrative

"This 34-year-old patient with confirmed PNH (flow cytometry showing 78% PNH clone) presents with symptomatic hemolysis (LDH 2.3× ULN, Hb 7.2 g/dL) and history of portal vein thrombosis. Despite optimal supportive care, patient requires monthly transfusions. Ultomiris is FDA-approved for PNH and offers extended dosing intervals (every 8 weeks vs. every 2 weeks for eculizumab), improving quality of life while maintaining complement inhibition. Patient has completed MenACWY and MenB vaccination series."

Appeals Playbook for New York

New York residents have exceptionally strong appeal rights through the Department of Financial Services.

Internal Appeals (First Step)

Timeline: File within 180 days of denial Process: Submit through Aetna member portal or provider services Decision: Standard appeals decided within 30-45 days; expedited within 72 hours

External Review (New York DFS)

If internal appeals fail, New York's External Appeal Program provides independent review:

Who's Eligible: All New York residents with fully-insured plans Timeline: File within 4 months of final internal denial Cost: $25 fee (waived for financial hardship/Medicaid) Decision: Binding on the insurer

Note: Search the External Appeals Database for prior Ultomiris decisions to strengthen your appeal with precedent.

Step-by-Step: Filing an External Appeal

  1. Gather documentation: Final denial letter, medical records, supporting literature
  2. Complete DFS External Appeal Application (Form EA 04/23)
  3. Obtain specialist attestation for rare disease appeals
  4. Submit within deadline via mail or fax to DFS
  5. Track decision through DFS portal

For urgent cases, expedited external appeals provide decisions within 72 hours (24 hours for drug denials).

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Experimental/Investigational" Emphasize FDA approval and labeled indication FDA prescribing information, approval date
"Not medically necessary" Provide clinical evidence of disease severity Lab values, symptom documentation, prior therapy failures
"Step therapy not completed" Request medical exception Document eculizumab contraindication/intolerance
"Quantity limits exceeded" Justify weight-based dosing Patient weight, FDA dosing guidelines
"Site of care not approved" Document medical necessity for setting Clinical complexity, monitoring needs

Counterforce Health specializes in turning these denials into successful appeals by analyzing payer policies and crafting targeted, evidence-based responses that align with each plan's specific coverage criteria.

FAQ

How long does Aetna prior authorization take in New York? Standard decisions within 14 business days; expedited reviews within 72 hours for urgent medical needs.

What if Ultomiris is non-formulary on my plan? Request a formulary exception with clinical justification. Include documentation of medical necessity and lack of therapeutic alternatives.

Can I appeal if I've been stable on Soliris? Yes, if switching to Ultomiris provides clinical benefits (reduced infusion frequency, improved quality of life). Document stability and rationale for change.

Does Aetna require specialty pharmacy for Ultomiris? Yes, typically through CVS Specialty Pharmacy. The drug is then shipped to your approved infusion site.

What vaccination requirements apply? MenACWY and MenB vaccines ≥2 weeks before starting therapy. If urgent treatment needed, prophylactic antibiotics may be substituted initially.

How do I request an expedited appeal in New York? Check the expedited box on your appeal form and call DFS at the expedited number. Must demonstrate that delay would seriously jeopardize health.

For personalized guidance on navigating Aetna's coverage requirements, Counterforce Health's platform analyzes your specific denial and creates targeted appeals using payer-specific language and evidence standards.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Aetna plan and consult healthcare providers for medical decisions. For additional support with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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