By Counterforce Health Team in Prolastin-C (alpha1-proteinase inhibitor) —

How to Get Prolastin-C Covered by Cigna in Ohio: Complete 2025 Guide to Prior Authorization and Appeals

Answer Box: Getting Prolastin-C Covered by Cigna in Ohio

To get Prolastin-C covered by Cigna in Ohio, you need prior authorization proving severe alpha1-antitrypsin deficiency with documented emphysema. The fastest path: (1) Gather genotype testing (Pi*ZZ), low AAT levels (<11 μmol/L), and spirometry showing FEV1 ≤65%, (2) Submit Cigna's Alpha1-Proteinase Inhibitor PA form via your pulmonologist through CoverMyMeds or the provider portal, (3) If denied, file internal appeal within 180 days, then external review through Ohio Department of Insurance. Start today by requesting genetic testing and lung function studies if not already done.

Table of Contents

  1. Cigna's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Formulary Preferences
  4. Required Diagnostics and Documentation
  5. Site of Care Requirements
  6. Step-by-Step: Fastest Path to Approval
  7. Common Denial Reasons & Solutions
  8. Appeals Process in Ohio
  9. Costs and Patient Support
  10. FAQ

Cigna's Coverage Policy Overview

Cigna covers Prolastin-C (alpha1-proteinase inhibitor) under its medical benefit for commercially insured members and some Medicare Advantage plans in Ohio. The coverage follows Cigna's policy IP0387, which applies to all alpha1-proteinase inhibitor products including Prolastin-C, Glassia, Zemaira, and Aralast NP.

Key policy points:

  • Prior authorization required for all members
  • Coverage limited to FDA-approved indications only
  • Specialty pharmacy routing through Express Scripts/Accredo
  • Home infusion preferred over clinic administration for cost savings
Note: Self-funded employer plans (ERISA) may have different appeals processes, but most follow similar clinical criteria.

Medical Necessity Requirements

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Age 18 years or older Birth date verification Cigna Policy IP0387
AAT Level <11 μmol/L (<80 mg/dL) Lab report with specific method Cigna Policy IP0387
Genotype Pi*ZZ, Z-null, null-null, or SZ Genetic testing report Cigna Policy IP0387
Lung Disease Emphysema confirmed by imaging Chest CT or HRCT report Cigna Policy IP0387
Prescriber Pulmonologist (for emphysema) Specialist referral/consultation Cigna Policy IP0387
Smoking Status Non-smoker or ex-smoker Provider attestation Cigna Policy IP0387

Specific Clinical Criteria

For emphysema associated with AAT deficiency, ALL must be met:

  • Baseline serum AAT level <11 μmol/L (<80 mg/dL by radial immunodiffusion)
  • Confirmed severe genotype (Pi*ZZ, Z-null, null-null, SZ, or other rare variants)
  • Chest imaging showing emphysema (CT or high-resolution CT)
  • Patient is 18 years or older
  • Prescribed by pulmonologist
  • Current non-smoker or documented smoking cessation

Alternative indication: For AAT deficiency-associated panniculitis, additional requirements include biopsy confirmation and documented failure or intolerance to dapsone therapy.

Step Therapy and Formulary Preferences

Cigna prefers Glassia and Prolastin-C over other alpha1-proteinase inhibitor products. As of 2025, step therapy requirements include:

Product Hierarchy

  • Preferred: Prolastin-C, Glassia
  • Non-preferred: Zemaira, Aralast NP (require trial/failure of preferred agents)

Documentation for non-preferred products: If requesting Zemaira or Aralast NP, you must document:

  • Trial and failure OR intolerance to both Glassia AND Prolastin-C
  • Specific adverse reactions or lack of efficacy
  • Clinical rationale for the requested alternative
Tip: Start with Prolastin-C or Glassia to avoid step therapy delays. Both have similar efficacy profiles and weekly dosing schedules.

Required Diagnostics and Documentation

Essential Lab Work

  1. Alpha1-antitrypsin level (quantitative)
    • Method: Radial immunodiffusion or nephelometry
    • Required threshold: <11 μmol/L (<80 mg/dL)
    • Timing: Within 12 months of PA submission
  2. Genetic testing (genotype/phenotype)
    • Pi typing showing severe deficiency variants
    • Common severe genotypes: Pi*ZZ, Z-null, null-null, SZ
    • Must confirm hereditary AAT deficiency

Pulmonary Function Testing

  • Spirometry with FEV1 measurement
  • Chest imaging (CT or high-resolution CT) showing emphysema
  • Documentation of disease progression if available

Clinical Documentation Checklist

  • Pulmonologist consultation notes (within 3 months)
  • Complete medical history including smoking status
  • Current medication list and prior therapy trials
  • Treatment response goals and monitoring plan
  • Patient weight for dosing calculations (60 mg/kg weekly)

Site of Care Requirements

Cigna follows a least intensive setting policy, preferring home infusion over clinic administration for cost management.

Home Infusion (Preferred)

  • Advantages: Lower cost, patient convenience, covered under medical benefit
  • Requirements: Adequate venous access, ability to monitor for reactions
  • Support: PROLASTIN DIRECT program provides coverage assistance

Clinic Administration

  • When allowed: Poor venous access, need for medical supervision, patient preference with justification
  • Documentation needed: Medical necessity letter explaining why home infusion isn't appropriate
  • Facilities: IVX Health and other specialty infusion centers accepted
From our advocates: One patient initially denied clinic coverage successfully appealed by documenting anxiety-related complications with home infusion and the need for immediate medical support during treatment.

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Testing (Patient + Pulmonologist)

  • Timeline: 2-4 weeks
  • Action: Complete AAT level, genetic testing, spirometry, chest CT
  • Submit to: Pulmonologist for review and treatment planning

2. Gather Required Documentation (Clinic Staff)

  • Timeline: 1 week
  • Action: Compile lab results, imaging, clinical notes, smoking cessation records
  • Submit via: Medical records to prior authorization team

3. Complete Prior Authorization Form (Pulmonologist)

4. Include Medical Necessity Letter (Pulmonologist)

  • Timeline: Same day as PA submission
  • Action: Detailed letter addressing all coverage criteria
  • Submit via: Attach to PA form electronically

5. Follow Up on Submission (Clinic Staff)

  • Timeline: 24-48 hours after submission
  • Action: Confirm receipt and track review status
  • Submit via: Provider portal or customer service (verify current number)

6. Monitor Decision Timeline (Patient + Clinic)

  • Timeline: 5-15 business days for standard review
  • Action: Request expedited review if urgent (24-72 hours)
  • Submit via: Call Cigna utilization management for expedited requests

7. Prepare for Potential Appeal (All)

  • Timeline: Immediate if denied
  • Action: Review denial letter, gather additional evidence
  • Submit via: Internal appeal process within 180 days

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
"Diagnosis not confirmed" Submit genetic testing results Pi typing report showing severe variant
"Not medically necessary" Cite FDA labeling and ATS/ERS guidelines FDA Prolastin-C label, clinical guidelines
"Alternative therapy available" Document step therapy compliance Trial/failure records for preferred agents
"Inappropriate dosing" Recalculate based on patient weight Weight-based calculation (60 mg/kg weekly)
"Insufficient documentation" Provide complete clinical picture All required labs, imaging, specialist notes

Appeals Process in Ohio

Ohio residents have robust appeal rights under state insurance law and the Affordable Care Act. The process includes internal appeals with Cigna followed by external review through the Ohio Department of Insurance.

Internal Appeals with Cigna

  1. Timeline: File within 180 days of denial notice
  2. Process: Two levels of internal review available
  3. Documentation: Include denial letter, medical records, specialist rebuttal
  4. Expedited option: Available for urgent cases (ongoing treatment)

External Review in Ohio

  1. Eligibility: After exhausting internal appeals for medical necessity denials
  2. Timeline: Request within 180 days of final internal denial
  3. Process: Independent Review Organization (IRO) conducts binding review
  4. Contact: Ohio Department of Insurance at 1-800-686-1526
Note: External review decisions are binding on Cigna and typically completed within 30 days (72 hours for expedited cases).

When dealing with insurance coverage challenges, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and drafts point-by-point rebuttals aligned to each plan's specific requirements, potentially improving approval rates for complex therapies like alpha1-proteinase inhibitors.

Ohio-Specific Resources

  • Ohio Department of Insurance Consumer Services: 1-800-686-1526
  • UHCAN Ohio: Consumer advocacy for health insurance issues
  • OSHIIP: Ohio Senior Health Insurance Information Program (Medicare-related)

Costs and Patient Support

Manufacturer Support Programs

  • PROLASTIN DIRECT: Coverage support, prior authorization assistance, patient education
  • Copay assistance: May be available for commercially insured patients (verify eligibility)
  • Patient access programs: Financial assistance for qualified patients

Foundation Grants

  • Alpha-1 Foundation: Patient assistance programs and advocacy
  • HealthWell Foundation: Potential copay assistance for AAT deficiency treatments
  • Patient Advocate Foundation: Case management for insurance appeals

State Resources

  • Ohio Medicaid: Coverage for eligible low-income patients
  • Ohio Department of Insurance: Consumer protection and appeal assistance

FAQ

How long does Cigna prior authorization take in Ohio? Standard review takes 5-15 business days with complete documentation. Expedited review (for urgent cases) takes 24-72 hours. Submit early to avoid treatment delays.

What if Prolastin-C is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Cigna generally prefers Prolastin-C, so non-formulary status is uncommon for 2025 plans.

Can I request an expedited appeal in Ohio? Yes, for ongoing treatment or when delays would seriously endanger your health. Contact Cigna utilization management directly and document the urgency.

Does step therapy apply if I've used other AAT products outside Ohio? Previous therapy records from any state count toward step therapy requirements. Provide complete treatment history with outcomes documentation.

What's the difference between internal and external appeals? Internal appeals are reviewed by Cigna staff, while external appeals use independent medical experts through Ohio's state process. External review decisions are binding on Cigna.

How much does Prolastin-C cost without insurance? Annual costs commonly exceed $80,000, with some analyses showing average payer spending around $127,000 per year for AAT augmentation therapy.

Can family members get genetic testing covered? Testing for at-risk relatives (siblings, children of Pi*ZZ patients) may be covered with appropriate documentation of family history and clinical suspicion.

What happens if Ohio Medicaid denies coverage? Ohio Medicaid has its own appeal process through the Ohio Department of Medicaid, including state fair hearings and external medical reviews separate from commercial insurance appeals.

Sources & Further Reading

For comprehensive support with insurance appeals and prior authorization challenges, Counterforce Health provides specialized assistance in transforming coverage denials into successful approvals through evidence-based appeals strategies.

This guide is for informational purposes only and does not constitute medical advice. Coverage policies may vary by plan type and can change. Always verify current requirements with Cigna directly and consult your healthcare provider for medical decisions. For assistance with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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