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

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

Quick Answer: Cigna requires prior authorization for all Acthar Gel (repository corticotropin injection) indications, with mandatory step therapy proving corticosteroid failure or intolerance. Submit PA through Express Scripts/Accredo with comprehensive clinical documentation. If denied, Virginia residents can appeal internally within 180 days, then pursue external review through the State Corporation Commission Bureau of Insurance. Start by downloading Cigna's Acthar Gel Vial CCRD Prior Authorization Form and working with your prescriber to document prior treatment failures.

Table of Contents

Policy Overview: How Cigna Manages Acthar Gel

Cigna classifies Acthar Gel (repository corticotropin injection) as a specialty-tier medication requiring prior authorization across all plan types—commercial HMO/PPO, Medicare Advantage, and Medicaid managed care. Coverage is governed by policy IP0178, effective through 2025, which emphasizes evidence-based use and cost-effective alternatives.

The medication is dispensed exclusively through Cigna's specialty pharmacy partner Accredo (1-800-803-2523), not retail pharmacies. All requests undergo clinical review by Express Scripts' utilization management team, with standard review timelines of 5 business days and expedited review available within 72 hours when health is at risk.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all indications Cigna PA Form
Formulary Tier Specialty, non-preferred Member portal or EOB
Step Therapy Mandatory corticosteroid trial Policy IP0178
Quantity Limits Multidose vials only Coverage criteria
Specialty Pharmacy Accredo required 1-800-803-2523
Appeals Deadline 180 days from denial Denial notice

FDA-Approved Indications & Coverage

Acthar Gel has broad FDA approval for multiple conditions, but Cigna's coverage criteria are more restrictive. The FDA label includes infantile spasms, multiple sclerosis exacerbations, rheumatologic conditions, and several other indications.

Cigna-Covered Indications

First-Line Approval:

  • Infantile spasms in children under 2 years
  • Multiple sclerosis exacerbations (after corticosteroid failure)

Case-by-Case Review:

  • Rheumatoid arthritis (after ≥2 DMARD failures)
  • Psoriatic arthritis (specialist prescription required)
  • Systemic lupus erythematosus (refractory cases)
  • Nephrotic syndrome (resistant/relapsing disease)
  • Sarcoidosis (severe, unresponsive forms)
Note: Off-label uses require exceptional clinical justification and are rarely approved without peer-reviewed literature support.

Step Therapy Requirements

Cigna mandates documented failure or intolerance of conventional corticosteroids before approving Acthar Gel for most indications. This step therapy requirement is the most common reason for initial denials.

Required Documentation for Step Therapy

Your prescriber must provide specific evidence of:

  1. Failed corticosteroid trials with exact dates, doses, and outcomes
  2. Intolerance or contraindications to systemic steroids
  3. Clinical rationale for why Acthar Gel is necessary when alternatives failed

Exception: For infantile spasms, step therapy requirements may be waived, but clinical documentation of seizure frequency and severity is still required.

Common Step Therapy Agents

  • IV methylprednisolone (for MS exacerbations)
  • Oral prednisone (for rheumatologic conditions)
  • High-dose corticosteroids (condition-specific)

Quantity & Frequency Limits

Cigna restricts Acthar Gel to multidose vials only—single-dose SelfJect injectors are not covered for most indications. Dosing must align with FDA-approved ranges and condition-specific protocols.

Approved Dosing by Indication

Condition Typical Dosing Duration Reauthorization
Infantile spasms 150 units/m² IM daily × 2 weeks, then taper 4-6 weeks Rarely approved
MS exacerbations 40-80 units IM/SC every 24-72 hours 3 weeks per episode New episodes only
Rheumatologic 40-80 units IM/SC every 24-72 hours Variable Requires response data

Initial approvals are typically limited to one month, with reauthorization requiring documented clinical improvement and ongoing medical necessity.

Required Clinical Documentation

Comprehensive clinical documentation is essential for approval. Missing or incomplete information is the second most common denial reason after step therapy failures.

Clinician Corner: Medical Necessity Checklist

Essential Elements:

  • ICD-10 diagnosis codes with clinical severity
  • Complete treatment history with specific dates and outcomes
  • Laboratory results and imaging studies supporting disease activity
  • Patient weight/body surface area for dosing calculations
  • Planned monitoring protocols for safety
  • Specialist consultation notes (when required)

Sample Medical Necessity Statement: "Patient is a [age]-year-old with [diagnosis, ICD-10] who has failed [specific corticosteroid, dose, duration] due to [outcome/adverse effects]. Current disease activity documented by [labs/imaging/clinical findings]. Acthar Gel [dose] is requested per FDA labeling for [duration] with planned monitoring including [specific parameters]."

Specialty Pharmacy Routing

All Acthar Gel prescriptions must be filled through Accredo, Cigna's contracted specialty pharmacy. Retail pharmacies cannot dispense this medication under Cigna plans.

Accredo Process

  1. Prescriber submits PA through Cigna portal or fax to Express Scripts
  2. Upon approval, prescription automatically routes to Accredo
  3. Accredo contacts patient for delivery coordination
  4. Home delivery typically within 2-3 business days of approval

Accredo Contact: 1-800-803-2523

Evidence for Medical Necessity

When appealing denials or submitting complex cases, citing peer-reviewed evidence strengthens your request. Focus on condition-specific guidelines and comparative effectiveness data.

Key Evidence Sources

  • FDA prescribing information for approved indications
  • American Academy of Neurology guidelines for infantile spasms
  • National MS Society treatment recommendations
  • American College of Rheumatology position statements
Tip: Include 2-3 relevant citations in your medical necessity letter, focusing on evidence that directly supports your patient's specific clinical scenario.

Appeals Process in Virginia

Virginia residents have robust appeal rights through both internal Cigna processes and external state oversight. Understanding these pathways is crucial for overturning wrongful denials.

Internal Appeals with Cigna

Level 1 Internal Appeal:

  • Submit within 180 days of denial notice
  • Decision within 30 days (standard) or 72 hours (expedited)
  • Include additional clinical evidence and peer-reviewed literature

Level 2 Internal Appeal:

  • Submit within 60 days of Level 1 denial
  • Independent medical review by clinical peer
  • Same timelines as Level 1

External Review Through Virginia SCC

After exhausting internal appeals, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance. This independent process has overturned many specialty drug denials.

Virginia External Review Process:

  • File within 120 days of final internal denial
  • Contact SCC Bureau of Insurance: (877) 310-6560
  • Submit Form 216-A (verify current form)
  • Independent Review Organization decision within 45 days
  • Expedited review available (72 hours for urgent cases)
Virginia Advantage: The state's external review process is free and binding on insurers. Many patients succeed in getting coverage through this pathway when internal appeals fail.

Common Denial Reasons & Solutions

Understanding typical denial patterns helps you submit stronger initial requests and more effective appeals.

Denial Reason Solution Documentation Needed
Step therapy not met Document corticosteroid failures Specific dates, doses, outcomes
Not medically necessary Cite FDA label and guidelines Peer-reviewed evidence, severity markers
Experimental/investigational Emphasize FDA approval Official labeling, established use
Quantity/frequency exceeded Justify dosing per condition Weight-based calculations, protocols
Alternative available Prove alternatives failed/contraindicated Trial history, intolerance documentation

Cost Support Options

Even with insurance coverage, Acthar Gel can involve significant out-of-pocket costs. Several support programs may help reduce financial burden.

Financial Assistance Programs

  • Mallinckrodt Patient Support: Copay assistance and financial hardship programs
  • Chronic Disease Fund: Grants for eligible conditions
  • State pharmaceutical assistance programs: Virginia-specific options

Contact the manufacturer or your specialty pharmacy for current program details and eligibility requirements.

FAQ

How long does Cigna prior authorization take for Acthar Gel in Virginia? Standard review is 5 business days, with expedited review available within 72 hours when health is at risk.

What if Acthar Gel is non-formulary on my Cigna plan? Submit a formulary exception request with your PA, documenting why formulary alternatives are inappropriate for your condition.

Can I request an expedited appeal in Virginia? Yes, both Cigna internal appeals and Virginia external review offer expedited pathways when delays could jeopardize health.

Does step therapy apply if I failed corticosteroids outside Virginia? Yes, document prior failures regardless of where treatment occurred. Include complete medical records from previous providers.

What happens if my appeal is denied? After exhausting Cigna's internal process, Virginia residents can file for external review through the State Corporation Commission, which provides independent medical review.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals with the right clinical evidence and procedural requirements. Visit www.counterforcehealth.org to learn how we can help streamline your prior authorization and appeals process.

For complex cases requiring additional support, Counterforce Health specializes in creating comprehensive appeals that address payer-specific requirements and include the clinical evidence needed for approval.

Sources & Further Reading

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

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