By Counterforce Health Team in Acthar Gel (repository corticotropin injection) —

How to Get Acthar Gel Covered by Cigna in New York: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Acthar Gel Covered by Cigna in New York

Cigna requires prior authorization for Acthar Gel (repository corticotropin injection) with documented failure or contraindication to corticosteroids for approved indications like infantile spasms and MS exacerbations. Submit your PA request through CoverMyMeds or fax Cigna's current PA form with comprehensive medical necessity documentation. If denied, you have 180 days for internal appeals, then can file an external review through New York State DFS within 4 months. First step today: Verify your specific Cigna formulary status and gather documentation of prior corticosteroid trials or contraindications.

Table of Contents

  1. Cigna's Coverage Policy for Acthar Gel
  2. FDA Indication Requirements
  3. Step Therapy and Medical Exceptions
  4. Quantity Limits and Dosing Restrictions
  5. Required Diagnostics and Documentation
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Common Denial Reasons and Solutions
  10. New York Appeals Process
  11. Costs and Patient Support
  12. FAQ

Policy Overview

Cigna covers Acthar Gel (repository corticotropin injection) under strict utilization management across all plan types—HMO, PPO, and Medicare Advantage. The drug is typically placed on specialty tier 4 formularies with high cost-sharing and mandatory prior authorization.

Plan Types and Coverage:

  • Commercial Plans: Prior authorization required; managed through Express Scripts/Accredo specialty pharmacy
  • Medicare Advantage: Enhanced PA requirements with step therapy protocols
  • Medicaid Managed Care: Follow Cigna commercial policies with additional state requirements
Note: Self-funded employer plans may have different criteria. Verify your specific plan documents through the Cigna member portal.

Indication Requirements

Cigna restricts Acthar Gel coverage to specific FDA-approved indications with the strongest evidence base:

Primary Covered Indications:

  • Infantile spasms (children under 2 years) - requires neurologist prescription
  • Multiple sclerosis exacerbations (adults) - requires MS specialist or neurologist
  • Select rheumatologic conditions (case-by-case review)
  • Nephrotic syndrome (limited circumstances)

Off-Label Use: Rarely covered without exceptional clinical circumstances and peer-reviewed evidence supporting superiority over standard therapies.

Step Therapy and Medical Exceptions

Cigna mandates documented failure or medical contraindication to preferred corticosteroids before approving Acthar Gel.

Required Prior Therapies:

  • For MS exacerbations: IV methylprednisolone or high-dose oral prednisone
  • For infantile spasms: Oral prednisolone or ACTH alternatives
  • For other conditions: Condition-specific corticosteroid protocols

Medical Exception Pathways:

  • Documented allergy or severe adverse reaction to corticosteroids
  • Contraindications due to comorbid conditions (severe diabetes, active infection)
  • Prior treatment failure with adequate duration and dosing
Tip: Document specific adverse events, dates of treatment, and clinical outcomes. Vague statements like "patient didn't tolerate steroids" typically result in denial.

Quantity Limits and Dosing Restrictions

Cigna enforces quantity limits aligned with FDA labeling and clinical guidelines:

Indication Typical Quantity Limit Renewal Requirements
Infantile Spasms 5mL vial (80 units/mL) Clinical response assessment at 2-4 weeks
MS Exacerbations Single course (varies by protocol) Per-episode authorization required
Other Conditions Case-by-case review Quarterly reauthorization with outcomes data

Dosing Frequency: Must align with FDA labeling. Off-label dosing requires extensive clinical justification and peer-reviewed support.

Required Diagnostics and Documentation

Comprehensive clinical documentation is essential for PA approval:

Essential Documentation:

  • ICD-10 diagnosis codes (specific to indication)
  • Neurologist or specialist consultation notes
  • EEG results (for infantile spasms) or MRI findings (for MS)
  • Laboratory values (baseline and monitoring)
  • Prior treatment records with dates, doses, and outcomes

Timing Requirements:

  • Diagnostic tests within 6 months of PA request
  • Recent specialist evaluation (within 90 days)
  • Current clinical status documentation

Site of Care and Specialty Pharmacy

Acthar Gel must be dispensed through Cigna's contracted specialty pharmacies:

Primary Specialty Pharmacy: Accredo (Express Scripts network)

  • Phone: 800-803-2523
  • Requires separate enrollment and benefits verification

Administration Sites:

  • Home administration (with proper training)
  • Physician office or infusion center
  • Outpatient hospital (if medically necessary)
Important: Retail pharmacy dispensing is not permitted. Attempting to fill at retail will result in automatic denial.

Evidence to Support Medical Necessity

Strong clinical evidence is crucial for PA approval. Reference these authoritative sources:

Key Evidence Sources:

  • FDA Prescribing Information for approved indications
  • American Academy of Neurology guidelines for infantile spasms
  • National MS Society treatment recommendations
  • Peer-reviewed studies from PubMed supporting specific use cases

Clinical Guidelines to Reference:

  • Infantile spasms: Document hypsarrhythmia on EEG and specialist recommendation
  • MS exacerbations: Evidence of acute neurologic deterioration requiring intervention

Sample Medical Necessity Letter

Use this template structure for your PA submission:

Medical Necessity Letter for Acthar Gel

Patient: [Name, DOB, Member ID]
Diagnosis: [Specific diagnosis with ICD-10 code]
Prescriber: [Name, specialty, NPI]

Clinical Summary:
[Patient name] is a [age]-year-old with [specific diagnosis] who requires Acthar Gel due to [specific medical necessity]. Current clinical status includes [relevant symptoms/findings].

Prior Therapy Documentation:
Patient previously trialed [specific corticosteroid] at [dose] for [duration] from [dates]. Treatment resulted in [specific outcome/adverse event]. [Additional prior therapies as applicable].

Contraindications to Standard Therapy:
[Specific contraindications or intolerance to corticosteroids with clinical details].

Rationale for Acthar Gel:
Based on FDA labeling and [cite specific guidelines], Acthar Gel is indicated for [condition] when [criteria]. Expected treatment duration is [timeframe] with monitoring via [specific parameters].

Supporting Documentation Attached:

  • Specialist consultation notes
  • Relevant imaging/lab results
  • Prior treatment records
  • Clinical literature citations

Prescriber Signature and Date

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Not medically necessary" Provide specialist letter with clinical rationale Neurologist/specialist consultation notes
"Step therapy not met" Document specific prior failures with dates/doses Pharmacy records, clinical notes showing adverse events
"Experimental/investigational" Reference FDA approval and clinical guidelines FDA labeling, peer-reviewed studies
"Quantity exceeds limits" Justify dosing based on patient-specific factors Weight-based calculations, specialist recommendations

New York Appeals Process

New York offers robust appeal rights for insurance denials:

Internal Appeals (Cigna):

  • Timeline: 180 days from denial date
  • Process: Submit written appeal with additional clinical documentation
  • Expedited: 24-72 hours for urgent medical needs

External Review (New York State):

  • Authority: New York Department of Financial Services
  • Timeline: Must file within 4 months after final internal denial
  • Cost: Maximum $25 fee (waived for financial hardship)
  • Decision: Binding on Cigna if approved
From our advocates: We've seen success with New York external appeals when families provide comprehensive specialist documentation and cite specific FDA labeling language. The key is demonstrating that Cigna's denial contradicts established medical evidence. While not guaranteed, thorough documentation significantly improves outcomes.

Required Forms:

Costs and Patient Support

Manufacturer Support:

Additional Resources:

  • Patient Access Network Foundation grants
  • HealthWell Foundation assistance programs
  • State pharmaceutical assistance programs

Cost Considerations:

  • Single 5mL vial typically costs $30,000-40,000
  • Most patients require multiple vials per treatment course
  • Specialty pharmacy copays range from $100-500+ per fill

FAQ

How long does Cigna prior authorization take for Acthar Gel? Standard review takes 3-5 business days. Expedited reviews (for urgent medical needs) are completed within 24-72 hours.

What if Acthar Gel is non-formulary on my Cigna plan? You can request a formulary exception by demonstrating medical necessity and failure of formulary alternatives. The process requires the same documentation as standard PA.

Can I request an expedited appeal in New York? Yes. New York allows expedited external appeals for urgent medical needs, with decisions within 72 hours (24 hours for urgent drug denials).

Does step therapy apply if I tried corticosteroids outside New York? Yes, if properly documented. Provide complete medical records showing prior treatment attempts, doses, duration, and outcomes from any provider.

What happens if my appeal is denied? After exhausting Cigna's internal appeals, you can file for external review through New York DFS. Their decision is binding on Cigna.

How do I find my specific Cigna formulary? Log into your Cigna member portal or call member services. Formularies change annually, so verify current status.

When navigating insurance coverage for complex specialty medications like Acthar Gel, having expert support can make the difference between approval and denial. Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies change frequently; verify current requirements through official sources.

Sources & Further Reading

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