By Counterforce Health Team in Ultomiris (ravulizumab) —

How to Get Ultomiris (Ravulizumab) Approved by Cigna in New York: Complete Guide to Coverage and Appeals

Answer Box: Getting Ultomiris Covered by Cigna in New York

Cigna requires prior authorization for Ultomiris (ravulizumab) in New York for all FDA-approved conditions: PNH, aHUS, generalized myasthenia gravis, and NMOSD. The fastest path to approval: Have your specialist complete Cigna's Ultomiris PA form with complete diagnosis documentation, prior treatment history, and lab results. Submit via CoverMyMeds or fax. Start today by requesting your medical records and scheduling a visit with your specialist to review Cigna's specific clinical criteria. If denied, New York's external appeal process through the Department of Financial Services provides strong patient protections.

Table of Contents

  1. Understanding Cigna's Ultomiris Requirements
  2. Preparing for Your Provider Visit
  3. Building Your Evidence Kit
  4. Working with Your Doctor on the Medical Necessity Letter
  5. Supporting Your Provider During Peer-to-Peer Review
  6. After Your Visit: Staying Organized
  7. When to Escalate and Appeal in New York
  8. Cost Assistance and Support Programs
  9. FAQ

Understanding Cigna's Ultomiris Requirements

Ultomiris (ravulizumab) is a long-acting complement inhibitor that requires prior authorization from Cigna for all FDA-approved uses. The drug costs approximately $474,000-$569,000 annually, making thorough documentation essential for approval.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all indications Cigna PA form needed Cigna Ultomiris Policy
Specialist Requirement Must be prescribed by or with specialist Hematologist (PNH), nephrologist (aHUS), neurologist (gMG/NMOSD) Cigna Coverage Criteria
Diagnosis Documentation Lab confirmation required Flow cytometry (PNH), AChR antibodies (gMG), AQP4 antibodies (NMOSD) Cigna PA Form
Step Therapy May apply Prior treatment failures documented Formulary Exception Process
REMS Program Mandatory enrollment Meningococcal vaccination required FDA Label

Key FDA-Approved Indications

Paroxysmal Nocturnal Hemoglobinuria (PNH): Adults and pediatric patients ≥1 month with confirmed diagnosis and ongoing hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS): Patients ≥1 month, excluding STEC-HUS cases.

Generalized Myasthenia Gravis (gMG): Adult patients with anti-AChR antibody-positive disease.

Neuromyelitis Optica Spectrum Disorder (NMOSD): Adult patients with anti-AQP4 antibody-positive disease.

Preparing for Your Provider Visit

Success starts with thorough preparation. Your specialist needs comprehensive information to craft a compelling prior authorization request.

Step-by-Step: Pre-Visit Checklist

  1. Gather Your Insurance Information
    • Cigna member ID and group number
    • Current formulary tier for Ultomiris
    • Any previous denial letters or EOBs
  2. Document Your Symptom Timeline
    • When symptoms began
    • How they've progressed
    • Impact on daily activities and work
    • Emergency room visits or hospitalizations
  3. Compile Treatment History
    • All medications tried for your condition
    • Dosages and duration of each treatment
    • Specific reasons for discontinuation (side effects, ineffectiveness, contraindications)
    • Documentation of failures or intolerances
  4. Prepare Functional Impact Notes
    • Specific activities you can't perform
    • Work limitations or missed days
    • Need for assistance with daily tasks
    • Quality of life impacts
Tip: Keep a daily symptom diary for 2-3 weeks before your appointment. Include specific examples of functional limitations that your doctor can reference in the medical necessity letter.

Building Your Evidence Kit

Your provider will need comprehensive documentation to support the prior authorization. Help them gather this evidence systematically.

Essential Documentation Components

Laboratory Results

  • Flow cytometry results (for PNH)
  • Complement levels and activity
  • AChR antibody titers (for myasthenia gravis)
  • AQP4 antibody results (for NMOSD)
  • Complete blood count, LDH, bilirubin levels

Imaging and Diagnostic Tests

  • Relevant imaging studies
  • Electromyography results (for myasthenia gravis)
  • MRI findings (for NMOSD)
  • Any genetic testing results

Treatment Documentation

  • Pharmacy records showing prior medications
  • Hospital discharge summaries
  • Infusion center records
  • Documentation of adverse events or treatment failures

Clinician Corner: Medical Necessity Letter Essentials

Your doctor's medical necessity letter should include:

  • Clear diagnosis with ICD-10 codes and supporting lab values
  • Clinical rationale explaining why Ultomiris is appropriate for your specific case
  • Prior treatment history with specific reasons for failure or discontinuation
  • Functional impact describing how your condition affects daily life
  • Treatment goals with measurable outcomes expected
  • Safety considerations including REMS compliance and monitoring plans
  • Guideline citations from FDA labeling and relevant medical societies

Working with Your Doctor on the Medical Necessity Letter

The medical necessity letter is often the most critical component of your prior authorization. Work with your provider to ensure it addresses Cigna's specific requirements.

Key Elements to Discuss

Condition-Specific Requirements

For PNH Patients:

  • Document ongoing hemolysis with elevated LDH levels
  • Include transfusion history and frequency
  • Explain how Ultomiris' extended dosing interval (every 8 weeks vs. every 2 weeks for Soliris) benefits your specific situation

For aHUS Patients:

  • Confirm exclusion of STEC-HUS
  • Document thrombotic microangiopathy markers
  • Include baseline creatinine, platelet count, and LDH values

For Myasthenia Gravis Patients:

  • Confirm anti-AChR antibody-positive status
  • Document MG-ADL and QMG scores
  • Include history of pyridostigmine and immunosuppressant trials

For NMOSD Patients:

  • Confirm anti-AQP4 antibody-positive status
  • Document relapse history and current disability level
  • Include prior treatment failures with other therapies

Safety Documentation Requirements

Your provider must document:

  • Current meningococcal vaccination status
  • Plans for ongoing monitoring for infections
  • Understanding of boxed warning risks
  • REMS program enrollment

Supporting Your Provider During Peer-to-Peer Review

If Cigna requests a peer-to-peer review, you can help your provider prepare for this crucial conversation.

Preparation Strategy

Create a Concise Case Summary

  • One-page overview of your diagnosis, treatment history, and current status
  • Bullet points highlighting key clinical criteria met
  • Specific functional limitations and treatment goals

Offer Availability Windows

  • Provide your provider with times you're available for urgent follow-up
  • Ensure they have updated contact information
  • Be prepared to provide additional documentation quickly

Key Talking Points for Your Provider

  • Emphasize condition-specific clinical criteria fulfillment
  • Highlight functional impact and quality of life considerations
  • Reference FDA labeling and relevant clinical guidelines
  • Address any formulary preference issues (e.g., vs. Soliris or biosimilars)

Scripts for Provider Support

For Clinic Staff Requesting Peer-to-Peer: "I'm calling to request a peer-to-peer review for [patient name]'s Ultomiris prior authorization. The patient has [condition] with documented [key clinical criteria]. We have comprehensive clinical documentation available and can schedule the review at your earliest convenience."

After Your Visit: Staying Organized

Maintain organized records to support your case and prepare for potential appeals.

Documentation to Save

  • Copy of completed prior authorization form
  • Medical necessity letter
  • All supporting lab results and imaging
  • Submission confirmation (fax confirmation or portal screenshot)
  • Any correspondence from Cigna

Follow-Up Protocol

  • Contact your provider's office 3-5 business days after submission
  • Check Cigna member portal for status updates
  • Keep a log of all phone calls and reference numbers

When to Escalate and Appeal in New York

New York provides strong patient protections for insurance appeals, including robust external review rights.

Cigna Appeal Timeline

Level Deadline to File Decision Timeline Next Step
Internal Appeal 180 days from denial 30 days (standard), 72 hours (urgent) Level 2 or External
Level 2 Internal 60 days from Level 1 denial 30 days (standard), 72 hours (urgent) External Review
NY External Review 4 months from final denial 30 days (standard), 72 hours (urgent) Binding decision

New York External Appeal Process

New York's external appeal system through the Department of Financial Services provides independent medical review of insurance denials.

Key Benefits:

  • Independent medical experts review your case
  • Decisions are binding on Cigna
  • Expedited reviews available for urgent cases
  • Searchable database of past decisions for reference

How to File:

  1. Complete internal appeals with Cigna first
  2. Submit external appeal application to DFS within 4 months
  3. Include all medical documentation and Cigna's final denial
  4. Pay $25 fee (waived for financial hardship or Medicaid)
Note: You can search the DFS External Appeals Database for similar cases involving Ultomiris or other complement inhibitors to strengthen your appeal.

When to Contact Community Health Advocates

Community Health Advocates provides free assistance to New York residents with insurance appeals. Call 888-614-5400 if you need help:

  • Understanding your appeal rights
  • Filing external appeals
  • Gathering supporting documentation
  • Navigating the DFS process

Cost Assistance and Support Programs

Even with insurance coverage, Ultomiris can have significant out-of-pocket costs. Several programs may help reduce your financial burden.

Manufacturer Support

  • Alexion Access Navigator: Provides coverage support and patient assistance programs
  • Copay assistance: May be available for eligible commercially insured patients
  • Patient assistance programs: For uninsured or underinsured patients

Foundation Support

  • Various rare disease foundations offer grants for complement inhibitor therapies
  • State pharmaceutical assistance programs may provide additional support

FAQ

How long does Cigna prior authorization take for Ultomiris in New York? Standard reviews typically take 5-7 business days. Urgent requests are processed within 72 hours if medical urgency is documented.

What if Ultomiris is not on Cigna's formulary? You can request a formulary exception with clinical justification. Standard reviews are completed within 1-2 business days.

Can I request an expedited appeal in New York? Yes, both Cigna and New York's external review process offer expedited reviews when delay would jeopardize your health. Decisions are made within 72 hours.

Does step therapy apply if I've failed treatments outside New York? Yes, documented treatment failures from any location count toward step therapy requirements. Ensure your new provider has complete records.

What counts as medical necessity for Ultomiris? Medical necessity includes FDA-approved indications, appropriate clinical criteria, specialist involvement, and documentation that the drug is the most appropriate treatment for your specific condition.

How much does Ultomiris cost without insurance? Annual costs typically range from $474,000-$569,000, varying by weight and dosing requirements. Insurance coverage is essential for accessing this therapy.

Can I switch from Soliris to Ultomiris? Yes, if you meet clinical criteria and your provider documents medical necessity for the switch (such as improved adherence with less frequent dosing).

What happens if my external appeal is denied? New York's external appeal decisions are final and binding. However, you may have additional options through federal programs or if new clinical information becomes available.

How Counterforce Health Can Help

Counterforce Health specializes in turning insurance denials into successful appeals for complex specialty medications like Ultomiris. Their platform helps patients, clinicians, and pharmacies navigate prior authorization requirements by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed appeals that align with payer policies. For New York patients facing Cigna denials, Counterforce Health can help ensure your appeal includes the right clinical documentation, meets procedural requirements, and leverages New York's strong external appeal protections.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage policies may change, and individual circumstances vary. For the most current information about your specific Cigna plan, contact Cigna directly or consult your member handbook.

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