By Counterforce Health Team in Soliris (eculizumab) —

Cigna's Coverage Criteria for Soliris (Eculizumab) in Pennsylvania: What Counts as "Medically Necessary"?

Answer Box: Getting Soliris Covered by Cigna in Pennsylvania

Cigna requires prior authorization for Soliris (eculizumab) with specific diagnostic tests, meningococcal vaccinations ≥2 weeks before treatment, and prescriber REMS enrollment. For PNH, you need flow cytometry showing GPI-anchored protein deficiency; for myasthenia gravis, positive anti-AChR antibodies; for NMOSD, positive anti-AQP4 antibodies. Submit via Cigna provider portal or CoverMyMeds with complete lab results and vaccination records. If denied, Pennsylvania's new Independent External Review program overturns ~50% of appeals.

First step today: Contact your prescriber to confirm your diagnosis meets Cigna's criteria and schedule required vaccinations.

Table of Contents

  1. Policy Overview: How Cigna Manages Soliris Coverage
  2. Indication Requirements by Condition
  3. Step Therapy & Medical Exceptions
  4. Quantity Limits and Dosing Rules
  5. Required Diagnostic Testing
  6. Site of Care and Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Documentation
  9. Common Denial Reasons & How to Fix Them
  10. Pennsylvania Appeals Process
  11. Frequently Asked Questions

Policy Overview: How Cigna Manages Soliris Coverage

Cigna classifies Soliris as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug is typically managed through Express Scripts or Accredo specialty pharmacy, with infusions coordinated at certified sites.

Key policy details:

  • Coverage policy: IP_0549 (updated July 1, 2024)
  • HCPCS codes: J1300 through March 31, 2025; J1299 beginning April 1, 2025
  • Approval duration: 6 months initial, 1 year continuation with documented benefit
  • Plan types covered: Commercial, Medicare Advantage (verify self-funded plan exclusions)

The latest policy updates removed previous requirements for rituximab or systematic therapy trials, streamlining approval for patients who meet diagnostic criteria.

Indication Requirements by Condition

Cigna covers Soliris for four FDA-approved indications, each with specific clinical criteria:

Coverage at a Glance

Condition Age Requirement Key Diagnostic Test Specialist Required Approval Duration
PNH ≥6 years Flow cytometry (GPI-anchored proteins) Hematologist 6 months initial
Atypical HUS ≥6 years Exclude Shiga toxin E. coli Nephrologist 1 year
Myasthenia Gravis ≥6 years (MG-ADL ≥6 if ≥18) Anti-AChR antibodies Neurologist 6 months initial
NMOSD ≥18 years Anti-AQP4 antibodies Neurologist 1 year

Source: Cigna Policy IP_0549

Step Therapy & Medical Exceptions

Good news for Pennsylvania patients: Cigna's July 2024 policy update removed most step therapy requirements for Soliris. Previously, patients had to fail rituximab or other systemic therapies first.

Current requirements:

  • PNH/aHUS: No step therapy required
  • Myasthenia gravis: Must show inadequate response to pyridostigmine (standard first-line treatment)
  • NMOSD: No step therapy required

If your plan still requires step therapy, document previous treatment failures with specific details about lack of efficacy, intolerance, or contraindications.

Quantity Limits and Dosing Rules

Cigna follows FDA-approved dosing schedules with some flexibility for weight-based adjustments:

Standard dosing patterns:

  • Loading phase: Weekly infusions for 4 weeks
  • Maintenance: Every 2 weeks ongoing
  • Weight adjustments: Allowed per FDA labeling for patients >40kg

Quantity limits are typically set at the maximum FDA-recommended dose. If you need higher doses due to weight or rapid complement turnover, your prescriber must provide clinical justification and pharmacokinetic data if available.

Required Diagnostic Testing

Each indication requires specific lab confirmation within 3 months of PA submission:

PNH Diagnostic Requirements

  • Flow cytometry: GPI-anchored protein deficiency on ≥2 cell lineages (CD55/CD59)
  • Supporting labs: LDH ≥1.5x upper normal limit, low platelets, elevated creatinine
  • Exclusion: Must rule out Shiga toxin E. coli-related hemolysis

Myasthenia Gravis Requirements

  • Antibody testing: Positive anti-acetylcholine receptor (AChR) antibodies
  • Functional assessment: MG-ADL score ≥6 for adults ≥18 years
  • Treatment history: Documented inadequate response to pyridostigmine

NMOSD Requirements

  • Antibody confirmation: Positive anti-aquaporin-4 (AQP4) antibody in blood serum
  • Clinical documentation: History consistent with NMOSD attacks
  • Specialist evaluation: Neurologist consultation required

Site of Care and Specialty Pharmacy Requirements

Cigna requires Soliris infusions in the "least intensive, medically appropriate setting." Here's how the process works:

Specialty pharmacy coordination:

  1. Accredo or Express Scripts handles drug distribution
  2. Cold chain management with signature-required delivery
  3. 2-7 business day standard shipping timeline
  4. REMS enrollment verification before dispensing

Approved infusion sites:

  • Physician's office (preferred for stable patients)
  • Certified infusion centers
  • Hospital outpatient facilities
  • Home infusion (may require separate authorization effective 2026)
Tip: Cigna's Specialty Care Options Case Manager can help redirect you to a more cost-effective infusion site if your current location is unnecessarily intensive.

Evidence to Support Medical Necessity

When submitting your PA or appeal, include these evidence sources:

Clinical guidelines:

  • FDA prescribing information for on-label use
  • Specialty society recommendations (American Society of Hematology for PNH, etc.)
  • Peer-reviewed studies supporting your specific indication

Required clinical documentation:

  • Complete diagnosis workup with ICD-10 codes
  • Treatment history with specific dates and outcomes
  • Current symptom severity and functional impact
  • Contraindications to alternative therapies

Sample "Meets Criteria" Documentation

Here's a template paragraph structure for medical necessity letters:

Patient [Name] has a confirmed diagnosis of [condition] based on [specific diagnostic test] performed on [date]. The patient meets Cigna's coverage criteria under policy IP_0549, including [age requirement] and [specialist consultation]. Previous treatment with [prior therapy] resulted in [specific outcome/failure]. Current clinical status shows [severity indicators] requiring complement inhibition therapy. Meningococcal vaccinations were completed on [date], meeting the ≥2-week requirement before treatment initiation.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing vaccination records Submit CDC vaccination cards or provider attestation MenACWY and MenB completion dates
Incomplete diagnostic workup Provide specific lab results Flow cytometry for PNH, antibody tests for MG/NMOSD
Site of care edit Request medical necessity review Clinical justification for infusion location
Quantity limits exceeded Submit weight-based dosing rationale Patient weight, pharmacokinetic data if available
"Not medically necessary" File internal appeal with clinical evidence Specialty guidelines, peer-reviewed studies

Source: Cigna PA Forms and Requirements

Pennsylvania Appeals Process

If Cigna denies your Soliris request, Pennsylvania offers a robust appeals system with high success rates:

Step-by-Step Appeals Timeline

  1. Internal Appeal (First Level)
    • Deadline: 180 days from denial
    • Timeline: 15-30 days for standard, 72 hours for urgent
    • Submit via: Cigna member portal or written request
  2. Internal Appeal (Second Level)
    • Automatic: If first level is denied
    • Timeline: Additional 15-30 days
    • Includes: Peer-to-peer review option
  3. Pennsylvania Independent External Review
    • Deadline: 4 months after final internal denial
    • Success rate: ~50% of appeals overturned in 2024
    • Timeline: 45 days standard, 72 hours urgent
    • Submit at: pa.gov/reviewmyclaim
Pennsylvania Success Story: In 2024, the Pennsylvania Insurance Department's Independent External Review program helped overturn 259 of 517 health insurance denials, with many involving expensive specialty drugs like Soliris. The state-supervised process gives patients a meaningful second chance when insurers initially deny coverage.

Required Appeal Documents

  • Original denial letter
  • Complete medical records
  • Prescriber's clinical rationale
  • Relevant clinical guidelines
  • Lab results and diagnostic tests

Need help with appeals? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify denial reasons and drafts point-by-point rebuttals aligned to Cigna's own coverage policies, potentially saving months in the appeals process.

Frequently Asked Questions

How long does Cigna's PA process take in Pennsylvania? Standard prior authorization takes 72 hours; expedited requests are processed within 24-72 hours when marked urgent due to health risk.

What if Soliris isn't on my Cigna formulary? You can request a formulary exception through the same PA process. Include clinical justification for why covered alternatives aren't appropriate.

Can I start treatment while waiting for PA approval? No. Cigna requires PA approval, REMS enrollment, and vaccination completion before treatment initiation. Starting early could result in non-coverage.

Does step therapy apply if I failed treatments in another state? Yes, document all previous treatments regardless of where they occurred. Cigna accepts treatment history from other providers and states.

What's the difference between medical necessity and experimental denials? Medical necessity denials question whether the treatment is appropriate for your condition. Experimental denials claim the treatment isn't proven effective. Both can be appealed with clinical evidence.

How do I find my Cigna specialty pharmacy? Call the member services number on your insurance card. Most Cigna plans use either Accredo or Express Scripts for Soliris distribution.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with Pennsylvania insurance issues, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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