By Counterforce Health Team in Ultomiris (ravulizumab) —

How to Get Ultomiris (Ravulizumab) Approved by UnitedHealthcare in New York: Timeline, Requirements & Appeals

Quick Answer: Getting Ultomiris Approved by UnitedHealthcare in New York

UnitedHealthcare requires prior authorization for Ultomiris (ravulizumab) with standard review taking up to 7 calendar days, expedited requests within 2 business days. Starting January 1, 2025, new patients may face step therapy requirements through OptumRx. If denied, New York residents have strong appeal rights including external review through the Department of Financial Services within 4 months of final denial.

First steps: Submit PA through the UnitedHealthcare Provider Portal with complete REMS vaccination documentation, diagnosis codes, and prior therapy records.

Table of Contents

What Affects Ultomiris Approval Timing

Several factors influence how quickly UnitedHealthcare approves Ultomiris coverage in New York:

Benefit Type & Plan Structure

  • Commercial plans through OptumRx (as of January 2025)
  • Medicare Advantage with new step therapy requirements
  • Medicaid managed care plans

Clinical Complexity Your specific indication affects review time:

  • PNH (Paroxysmal Nocturnal Hemoglobinuria): Requires flow cytometry results, LDH levels
  • aHUS (atypical Hemolytic Uremic Syndrome): Must exclude STEC-HUS, document kidney function
  • Generalized Myasthenia Gravis: AChR antibody status, MG-ADL scores needed
  • NMOSD (Neuromyelitis Optica Spectrum Disorder): AQP4 antibody confirmation required

Documentation Completeness Missing any required element triggers delays:

  • REMS program compliance and meningococcal vaccination proof
  • Prior therapy failures or contraindications
  • Weight-based dosing calculations
  • Site of care justification
Note: UnitedHealthcare's PreCheck Prior Authorization system can approve eligible requests in as little as 29 seconds when all criteria are met automatically.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Patient Information

  • UnitedHealthcare member ID and policy details
  • Complete diagnosis with ICD-10 codes
  • Current weight and body surface area
  • Insurance card front and back copies

Clinical Records

  • Diagnostic test results (flow cytometry for PNH, complement levels for aHUS)
  • Recent lab work (LDH, hemoglobin, platelet count, creatinine)
  • Prior therapy documentation showing failures or contraindications
  • Current medication list and dosing history

REMS Compliance

  • Meningococcal vaccination records (ACWY and B vaccines)
  • Vaccination timeline (must be ≥2 weeks before first dose)
  • If urgent: documentation of antibiotic prophylaxis plan

Provider Requirements

  • Medical necessity letter with clinical rationale
  • Treatment plan including monitoring schedule
  • Site of care justification (infusion center vs. home)

Submission to Initial Review (1-5 Days)

How to Submit

Electronic Submission (Fastest)

  1. Log into the UnitedHealthcare Provider Portal with One Healthcare ID
  2. Navigate to "Specialty Pharmacy Transactions" tile
  3. Complete PA request form with all required fields
  4. Upload supporting documentation as PDFs
  5. Submit and save confirmation number

Manual Submission If electronic submission isn't available, fax completed forms to OptumRx (confirm current fax number through provider portal).

What Reviewers Check First

UnitedHealthcare's initial review focuses on:

  • Plan eligibility and benefit coverage
  • REMS program compliance documentation
  • Diagnosis alignment with FDA-approved indications
  • Step therapy compliance (for new patients starting January 2025)

Step Therapy Requirements New UnitedHealthcare Medicare Advantage members must try preferred complement inhibitors first unless:

  • Previous therapy documented in last 365 days
  • Medical contraindication to preferred agents
  • Clinical emergency requiring immediate treatment

Additional Information Requests (1-7 Days)

If UnitedHealthcare requests additional information, respond within the specified timeframe (typically 7-14 days) to avoid automatic denial.

Common Information Requests

  • Updated lab results if submitted values are >6 months old
  • Clarification on prior therapy timeline and outcomes
  • Additional vaccination documentation
  • Peer-to-peer review request

How to Respond Quickly

  • Use the same submission method as original request
  • Reference original PA confirmation number
  • Include cover letter summarizing new information provided
  • Follow up via phone to OptumRx at 888-397-8129
Tip: Counterforce Health helps patients and providers navigate complex prior authorization requirements by analyzing denial patterns and crafting targeted appeals with the right clinical evidence and payer-specific documentation.

Decision Window & Outcomes

Standard Timeline

  • Standard requests: Up to 7 calendar days (effective January 1, 2025)
  • Expedited requests: Within 2 business days
  • Urgent clinical need: Within 24-72 hours

Reading Your Approval Letter

Full Approval

  • Coverage duration (typically 12 months)
  • Approved dosing and frequency
  • Site of care authorization
  • Renewal requirements

Partial Approval

  • Modified dosing or frequency
  • Limited duration (3-6 months)
  • Additional monitoring requirements

Denial

  • Specific reason codes
  • Required documentation for appeal
  • Internal appeal deadline (typically 180 days)

If Denied: New York Appeal Process

New York residents have robust appeal rights when UnitedHealthcare denies Ultomiris coverage.

Internal Appeals (First Step)

Timeline: Must file within 180 days of denial Process:

  1. Submit appeal through UnitedHealthcare member portal or by mail
  2. Include additional clinical documentation addressing denial reasons
  3. Request peer-to-peer review if appropriate
  4. Await decision within 30 days (expedited: 72 hours)

External Appeals Through New York DFS

If internal appeals fail, New York's Department of Financial Services offers independent review.

Eligibility: Available for denials based on medical necessity, experimental/investigational determinations, or out-of-network issues Timeline: File within 4 months of final internal denial Cost: $25 fee (refunded if appeal succeeds; waived for Medicaid/hardship) Process: Independent medical experts review case with binding decision

Note: New York's External Appeals Database is searchable by drug name and can provide supporting medical literature for your appeal.

Expedited External Appeals For urgent cases where health is at serious risk:

  • Decision within 72 hours
  • 24-hour turnaround for urgent drug denials
  • No waiting for internal appeal completion required

Getting Help

  • Community Health Advocates: Free assistance at 888-614-5400
  • Consumer Assistance Program: State-funded counseling on appeals
  • DFS Consumer Hotline: Direct support for external appeal filing

Annual Renewal Cycles

UnitedHealthcare requires annual reauthorization for Ultomiris with robust documentation of continued medical necessity.

Renewal Documentation Requirements

Updated Clinical Data (within 3-6 months)

  • Recent lab results showing treatment response
  • Functional assessment scores (MG-ADL for myasthenia gravis)
  • Relapse history and MRI findings (for NMOSD)
  • Transfusion requirements and LDH trends (for PNH)

Physician Letter of Medical Necessity Must address:

  • Continued diagnosis confirmation
  • Objective treatment response data
  • Absence of unacceptable toxicity
  • Contraindications to alternative therapies
  • Ongoing monitoring plan

REMS Compliance Update

  • Current vaccination status
  • Any changes to risk factors
  • Updated safety monitoring results

Renewal Timeline Strategy

90 days before expiration: Begin gathering updated documentation 60 days before expiration: Submit complete renewal request 30 days before expiration: Follow up if no decision received 7 days before expiration: Request expedited review if needed

Timeline Overview

Phase Standard Timeline Expedited Timeline Key Actions
Pre-submission prep 0-2 days Same Gather all documentation
Initial submission 1 day Same Submit via provider portal
UnitedHealthcare review Up to 7 days 2 business days Await decision or info request
Additional info response 1-7 days Same Respond to any requests promptly
Internal appeal (if denied) 30 days 72 hours Submit with new evidence
External appeal (NY DFS) 30 days 72 hours Independent medical review

Time-Saving Tips

Portal Optimization

  • Use UnitedHealthcare Provider Portal for fastest processing
  • Enable automated notifications for status updates
  • Save template documentation for similar future requests

Bundled Evidence Strategy

Submit comprehensive documentation upfront including:

  • All required clinical data in single submission
  • Anticipate common questions with preemptive answers
  • Include guideline citations supporting off-label use if applicable

Direct Specialty Routing

  • Specify "specialty pharmacy" in submission routing
  • Include NDC/J-codes for proper classification
  • Flag as complement inhibitor therapy for appropriate reviewer assignment

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Incomplete REMS documentation Submit vaccination records and safety plan Meningococcal vaccine dates, prophylaxis plan
Step therapy not met Document prior therapy failures or contraindications Treatment history, intolerance records
Diagnosis not established Provide definitive diagnostic testing Flow cytometry (PNH), complement levels (aHUS)
Dosing exceeds guidelines Justify weight-based or response-based dosing BSA calculations, clinical response data
Site of care not approved Document medical necessity for specific setting Infusion center requirements, patient factors

Costs & Patient Assistance

With annual costs often exceeding $450,000, financial assistance is crucial.

Manufacturer Support

  • Alexion Access Navigator: Coverage and reimbursement assistance
  • Patient assistance programs: For eligible uninsured/underinsured patients
  • Copay assistance: May reduce out-of-pocket costs for commercially insured patients

Foundation Grants

  • National Organization for Rare Disorders (NORD): Emergency financial assistance
  • HealthWell Foundation: Disease-specific grant programs
  • Patient Advocate Foundation: Copay relief programs

State Resources

  • New York State of Health: Marketplace plan comparisons
  • Medicaid: Comprehensive coverage for eligible residents
  • Essential Plan: Low-cost coverage for moderate-income New Yorkers

FAQ

How long does UnitedHealthcare prior authorization take for Ultomiris in New York? Standard requests take up to 7 calendar days, while expedited requests are processed within 2 business days as of January 2025.

Does step therapy apply to Ultomiris coverage? Yes, for new UnitedHealthcare Medicare Advantage members starting January 1, 2025. Existing patients with documented recent use are exempt.

Can I appeal a UnitedHealthcare denial in New York? Yes, New York residents have internal appeals through UnitedHealthcare (180 days) and external appeals through the Department of Financial Services (4 months from final denial).

What vaccination is required for Ultomiris? Meningococcal ACWY and B vaccines must be completed at least 2 weeks before starting therapy, or antibiotic prophylaxis must be provided for urgent cases.

How often does UnitedHealthcare require reauthorization? Annual reauthorization is required with updated clinical documentation demonstrating continued medical necessity and treatment response.

What if my doctor isn't in UnitedHealthcare's network? You may request an out-of-network exception if no in-network specialists are available for your rare condition, or seek external appeal through New York DFS.

This article provides general information about insurance coverage and is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations.

Need help navigating complex prior authorization requirements? Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial patterns and crafting evidence-backed rebuttals tailored to each payer's specific requirements.

Sources & Further Reading

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