By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (Eculizumab) Covered by UnitedHealthcare in New Jersey: Complete Guide to Prior Authorization, Appeals, and State Protections

Quick Answer: Getting Soliris Covered in New Jersey

Eligibility: UnitedHealthcare requires prior authorization for Soliris (eculizumab) with strict documentation of approved conditions (PNH, aHUS, gMG, NMOSD), meningococcal vaccination records, and REMS compliance. Fastest path: Submit PA through UnitedHealthcare provider portal with complete vaccination records and specialist prescription. First step today: Confirm your diagnosis meets FDA-approved indications and schedule meningococcal vaccination if not current. New Jersey's step therapy protections (effective 2026) and IHCAP external review provide strong appeal rights if initially denied.

Table of Contents

  1. Why New Jersey State Rules Matter
  2. UnitedHealthcare Prior Authorization Requirements
  3. New Jersey Step Therapy Protections
  4. Continuity of Care Safeguards
  5. External Review Through IHCAP
  6. Appeals Playbook for UnitedHealthcare
  7. Common Denial Reasons & Solutions
  8. When to Escalate to State Regulators

Why New Jersey State Rules Matter

New Jersey's healthcare regulations provide important protections that work alongside UnitedHealthcare's policies. The state's step therapy reform law (A1825), effective January 1, 2026, establishes clear medical exception criteria for specialty drugs like Soliris. Additionally, New Jersey's Independent Health Care Appeals Program (IHCAP) offers external review when internal appeals fail.

These protections apply to fully insured commercial plans and NJ FamilyCare (Medicaid), but not to self-funded employer plans, which follow federal ERISA rules. You can identify your plan type by checking your insurance card or calling member services.

UnitedHealthcare Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all Soliris prescriptions PA form through provider portal UHC Complement Inhibitors Policy
Specialist Prescriber Must be prescribed by qualified specialist Hematologist or appropriate specialist UHC Policy
REMS Compliance FDA safety program enrollment required Provider attestation of REMS training FDA REMS Program
Meningococcal Vaccination Required ≥2 weeks before first dose Vaccination records or prophylaxis plan UHC Policy
Approved Indications Must meet FDA-approved uses Lab confirmation of diagnosis Soliris FDA Label

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis (Patient & Clinic): Ensure you have lab-confirmed PNH, aHUS, gMG with AChR antibodies, or NMOSD with AQP4 antibodies
  2. Complete Vaccination (Patient): Get meningococcal vaccines at least 2 weeks before treatment or arrange prophylaxis
  3. Provider REMS Enrollment (Clinic): Prescriber must complete Soliris REMS training
  4. Submit Prior Authorization (Clinic): Use UnitedHealthcare provider portal with complete documentation
  5. Track Decision (Patient & Clinic): Standard decisions within 72 hours, expedited within 24 hours
  6. Appeal if Denied (Patient & Clinic): File internal appeal within 180 days with additional clinical evidence
  7. External Review (Patient): If internal appeals fail, file with NJ IHCAP within 4 months
Tip: UnitedHealthcare's 72-hour standard timeline can be expedited to 24 hours if your doctor documents urgent medical need.

New Jersey Step Therapy Protections

New Jersey's Assembly Bill A1825, effective January 1, 2026, provides strong protections against inappropriate step therapy requirements. Under this law, you can override step therapy if:

  • The step-therapy drug is contraindicated or likely to cause harm
  • The step-therapy drug is expected to be less effective due to your specific clinical characteristics
  • All formulary alternatives have been tried and were ineffective or caused adverse reactions
  • You're stable on current therapy and changing would be medically inadvisable

Documentation for Medical Exceptions

Your provider must submit clinical documentation supporting the exception request, including:

  • Medical records showing prior therapy failures or adverse reactions
  • Lab results confirming diagnosis and treatment necessity
  • Clinical rationale explaining why step therapy is inappropriate
  • Evidence of contraindications to preferred alternatives

Timeline for Exception Reviews:

  • Urgent requests: 24-hour response required
  • Standard requests: 72-hour response required
  • Exception duration: Minimum 180 days when approved

Continuity of Care Safeguards

If you're already receiving Soliris and UnitedHealthcare changes its formulary or coverage policies, New Jersey regulations require transition protections. These include:

  • Grace periods for ongoing therapy during formulary changes
  • Transition plans when coverage is discontinued
  • Advance notification of coverage changes affecting specialty medications

For managed long-term services (MLTSS) programs, New Jersey regulations specifically prohibit involuntary relocations and require continuity of services during transitions.

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program, managed by Maximus, provides external review when UnitedHealthcare denies coverage. This process is available after completing internal appeals (or if UnitedHealthcare fails to comply with appeal requirements).

IHCAP Process Overview

Eligibility: Fully insured commercial plans and NJ FamilyCare/Medicaid (not self-funded employer plans)

Filing: Submit through the Maximus NJ IHCAP portal within 4 months of final internal denial

Timeline:

  • Standard review: Decision within approximately 45 days
  • Expedited review: Decision within 72 hours for urgent cases
  • Preliminary review: 5 business days to determine eligibility

Cost: No charge to patients (insurers pay all review costs)

Binding Effect: IHCAP decisions are binding on UnitedHealthcare

Note: External appeals have shown success rates of 38-55% overall, with higher rates for well-documented rare disease cases.

Appeals Playbook for UnitedHealthcare

Internal Appeals Process

Appeal Level Timeline to File Decision Deadline How to Submit
First Level 180 days from denial 30 days (72 hours expedited) UHC member portal or written request
Second Level 60 days from first denial 30 days (72 hours expedited) Same as first level
External Review 4 months from final denial 45 days (72 hours expedited) NJ IHCAP portal

Required Documentation for Appeals

  • Original denial letter with specific denial reasons
  • Complete medical records supporting medical necessity
  • Provider letter addressing each denial reason point-by-point
  • Clinical literature supporting off-label use (if applicable)
  • Prior therapy documentation showing failures or contraindications

Clinician Corner: Medical Necessity Letter Checklist

When writing appeals for Soliris denials, include:

✓ Patient's specific diagnosis with ICD-10 codes and lab confirmation
✓ Prior treatment history including failures, intolerances, or contraindications
✓ Clinical rationale explaining why Soliris is medically necessary
✓ Dosing and monitoring plan with administration details
✓ Guideline citations from FDA labeling or peer-reviewed literature
✓ REMS compliance confirmation and vaccination status

Key references to cite:

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documentation Needed
Missing vaccination records Submit proof of meningococcal vaccination Immunization records showing completion ≥2 weeks prior
Non-specialist prescriber Transfer prescription to qualified specialist New prescription from hematologist or appropriate specialist
Insufficient diagnosis documentation Provide complete lab workup Disease-specific lab results (LDH for PNH, antibody tests for gMG/NMOSD)
Step therapy not attempted Request medical exception Clinical documentation of contraindications or prior failures
REMS non-compliance Complete provider enrollment REMS training certificate and attestation

Patient Phone Script for UnitedHealthcare

"I'm calling about a prior authorization denial for Soliris, eculizumab, for [condition]. The denial letter dated [date] cited [specific reason]. I have [vaccination records/specialist prescription/lab results] that address this concern. Can you help me understand what additional documentation is needed, and can we request an expedited review given the urgent nature of this rare disease treatment?"

When to Escalate to State Regulators

Contact New Jersey regulators if UnitedHealthcare:

  • Fails to respond within required timelines
  • Requests inappropriate documentation
  • Denies coverage despite meeting all criteria
  • Violates step therapy protections (after January 2026)

New Jersey Department of Banking and Insurance
Consumer Hotline: 1-800-446-7467
IHCAP Questions: 1-888-393-1062
File complaints online

When filing complaints, include:

  • All correspondence with UnitedHealthcare
  • Denial letters and appeal responses
  • Medical documentation supporting necessity
  • Timeline of events showing regulatory violations

Getting Additional Support

For patients struggling with prior authorization denials and appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to identify specific denial reasons and draft point-by-point rebuttals aligned to each payer's own rules, potentially improving your chances of approval.

From Our Advocates: We've seen cases where initial Soliris denials were overturned after submitting vaccination records that were missing from the original PA request, along with detailed lab results confirming the diagnosis. The key is addressing each specific denial reason with targeted documentation rather than submitting generic medical records.

FAQ

How long does UnitedHealthcare prior authorization take for Soliris in New Jersey?
Standard decisions within 72 hours, expedited decisions within 24 hours for urgent cases. Appeals must be decided within 30 days (72 hours if expedited).

What if Soliris is non-formulary on my UnitedHealthcare plan?
You can request a formulary exception with medical necessity documentation. New Jersey's step therapy protections (effective 2026) strengthen your ability to override preferred alternatives.

Can I request an expedited appeal for Soliris?
Yes, if delaying treatment would seriously jeopardize your health. Your doctor must provide clinical documentation of the urgent medical need.

Does step therapy apply if I failed treatments outside New Jersey?
Yes, prior therapy failures from any location count toward step therapy requirements. Provide documentation of all previous treatments and outcomes.

What's the difference between internal and external appeals?
Internal appeals are reviewed by UnitedHealthcare. External appeals through NJ IHCAP use independent medical reviewers and have higher success rates for complex cases.

How much does Soliris cost without insurance coverage?
Annual costs can exceed $500,000 depending on dosing and indication. Manufacturer assistance programs and state resources may help with costs during appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan terms. Always consult with your healthcare provider and insurance plan for specific guidance about your situation. For personalized assistance with appeals and prior authorization challenges, consider consulting with coverage advocacy services like Counterforce Health.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.