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

How to Get Prolastin-C Covered by Cigna in New Jersey: Appeals, Forms & Alternative Options

Quick Answer: Getting Prolastin-C Covered by Cigna in New Jersey

Eligibility: Adults with severe alpha-1 antitrypsin deficiency (serum level <11 mcM/<80 mg/dL) and emphysema. Fastest path: Submit prior authorization with pulmonologist's medical necessity letter including genotype, lung function tests, and smoking cessation documentation. First step today: Call Cigna at the number on your insurance card to request PA forms, or have your doctor submit through the provider portal. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) offers external review within 180 days.

Table of Contents

When Formulary Alternatives Make Sense

Before pursuing a formulary exception for Prolastin-C, consider whether Cigna's preferred alpha1-proteinase inhibitor alternatives might work for your situation. All FDA-approved AAT therapies show equivalent clinical efficacy in maintaining protective serum levels and slowing lung function decline.

When alternatives are appropriate:

  • You haven't tried other AAT products before
  • No documented allergic reactions to plasma-derived proteins
  • Willing to work with your pulmonologist on product selection
  • Insurance coverage is a primary concern

When to insist on Prolastin-C specifically:

  • Previous intolerance or allergic reactions to Glassia, Aralast NP, or Zemaira
  • Documented clinical deterioration on alternative products
  • Infusion site or administration requirements favor Prolastin-C's formulation
  • Your specialist has medical reasons for preferring this specific brand

Typical Prolastin-C Alternatives on Cigna

Based on Cigna's 2024 formulary policies, these alternatives may have different coverage tiers or step therapy requirements:

Preferred Options (Often Lower Cost-Sharing)

  • Glassia: Often first-line choice; 60-minute infusion weekly
  • Prolastin-C: May be preferred on some Cigna plans despite higher cost

Step Therapy Alternatives

  • Aralast NP: Typically requires trial of both Glassia and Prolastin-C first
  • Zemaira: Coverage varies by specific Cigna plan type
Note: Step therapy means you must try and fail (or demonstrate intolerance to) preferred options before accessing non-preferred alternatives.

Coverage Requirements Comparison

Product Typical Cigna Tier Prior Auth Required Common Step Therapy Administration
Glassia Specialty (Tier 5) Yes None (often first-line) IV, 60 min weekly
Prolastin-C Specialty (Tier 5) Yes Varies by plan IV, rate adjustable
Aralast NP Specialty (Tier 5) Yes After Glassia + Prolastin-C IV, rate adjustable
Zemaira Specialty (Tier 5) Yes Plan-dependent IV, rate adjustable

Access considerations:

  • Glassia: Widest coverage, shortest infusion time
  • Prolastin-C: May have supply advantages, liquid formulation available
  • Aralast NP: Often requires most documentation for approval
  • Zemaira: Newer product, coverage policies still evolving

Monitoring requirements are identical across all products: serum AAT levels, liver function tests, and pulmonary function assessments every 6-12 months.

Exception Strategy for Prolastin-C

If Prolastin-C isn't your plan's preferred option, you can request a formulary exception through Cigna. Success requires demonstrating medical necessity for this specific product.

Medical Necessity Documentation Checklist

Your pulmonologist's letter should include:

Required Clinical Elements:

  • ✅ Confirmed severe AAT deficiency (serum level <11 mcM or <80 mg/dL)
  • ✅ Documented emphysema or COPD with FEV1 <65% predicted
  • ✅ Current non-smoking status (verified within 6 months)
  • ✅ Specialist involvement (pulmonologist prescription or consultation)

For Prolastin-C Specifically:

  • ✅ Trial and failure/intolerance of preferred alternatives (Glassia, others)
  • ✅ Clinical rationale for why Prolastin-C is medically necessary
  • ✅ Documentation of adverse reactions to other AAT products (if applicable)
  • ✅ Specific formulation needs (liquid vs. powder, infusion rate requirements)

Evidence That Strengthens Your Case

Include supporting documentation such as:

  • Genotype testing results (PiZZ, PiSZ, or equivalent severe variants)
  • Infusion reaction reports from previous AAT products
  • Hospital records showing exacerbations while on alternative therapy
  • Pharmacy records proving previous trials of preferred products
From our advocates: "Patients who included detailed infusion logs showing specific reactions (time, symptoms, interventions needed) to alternative products had notably higher approval rates for their preferred AAT brand. The key is objective documentation, not just 'didn't tolerate well.'"

Switching Logistics and Coordination

If you need to try an alternative before getting Prolastin-C approved, coordinate carefully with your healthcare team.

Before Switching Products

  1. Baseline labs: Get current AAT serum level, liver function panel
  2. Document current status: Lung function, symptom severity, quality of life measures
  3. Infusion site preparation: Ensure your infusion center can accommodate the new product
  4. Insurance verification: Confirm the alternative is covered and pre-authorized

During the Trial Period

  • Monitor closely: Watch for infusion reactions, changes in symptoms
  • Keep detailed logs: Date, time, dose, any side effects or concerns
  • Regular lab monitoring: AAT levels after 2-4 infusions, then per protocol
  • Stay in touch: Report any issues to your pulmonologist immediately

Documentation for Later Exception Request

If the alternative doesn't work well:

  • Clinical notes: Provider documentation of inadequate response or side effects
  • Lab results: AAT levels that don't meet targets, or other safety concerns
  • Patient reports: Symptom diaries, quality of life impacts
  • Objective measures: Pulmonary function changes, exacerbation frequency

Re-trying for Prolastin-C Later

After completing a documented trial of alternatives, you can request Prolastin-C with stronger evidence.

Timeline considerations:

  • Most insurers require at least 30-90 days trial of alternatives
  • Document the entire trial period thoroughly
  • Don't wait until clinical deterioration to request the switch

Strengthened request should include:

  • Complete trial documentation from alternative product
  • Comparative lab results (before/during alternative vs. historical on Prolastin-C)
  • Provider attestation that Prolastin-C is medically necessary
  • Updated clinical status and any decline during alternative therapy

Appeals Playbook for New Jersey

If Cigna denies your initial request, New Jersey offers robust appeal rights through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals with Cigna

First Level Internal Appeal:

  • Timeline: Submit within 180 days of denial
  • Method: Call Cigna member services or submit written appeal
  • Review period: Cigna has up to 30 days for standard review, 72 hours for expedited
  • Documents needed: Original denial letter, additional medical records, provider letter

Second Level Internal Appeal:

  • Timeline: If first appeal denied, submit within 60 days
  • Process: Independent medical review within Cigna
  • Expedited option: Available if delay would seriously jeopardize your health

External Review Through IHCAP

After completing Cigna's internal appeals, you can request external review:

Eligibility:

  • Completed both levels of internal appeals with Cigna
  • Denial based on medical necessity or similar clinical grounds
  • Submit within 180 days of final internal denial

Process:

  • Submit to: Maximus Federal Services (contracted by New Jersey)
  • Cost: Free to you (Cigna pays all review costs)
  • Timeline: Decision within 45 days of complete submission
  • Reviewers: Independent physicians with appropriate specialty expertise

Contact Information:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467
  • Submit appeals directly to Maximus (verify current portal link with DOBI)
Important: If the external reviewer overturns Cigna's denial, the insurer must comply and provide coverage. This decision is binding under New Jersey law (N.J.S.A. 26:2S-11).

Common Denial Reasons & Solutions

Denial Reason How to Address Required Documentation
"Not medically necessary" Provide ATS guidelines showing AAT therapy indication Serum AAT <11 mcM, FEV1 <65%, pulmonologist letter
"Step therapy not completed" Document trial/failure of preferred alternatives Pharmacy records, provider notes on intolerance/failure
"Investigational/experimental" Cite FDA approval and established guidelines FDA labeling, peer-reviewed efficacy studies
"Non-formulary drug" Request formulary exception with medical necessity Clinical rationale why alternatives insufficient
"Quantity/frequency limits" Justify standard dosing (60 mg/kg weekly) Weight-based calculation, dosing references

Costs and Financial Assistance

Manufacturer Support:

New Jersey Resources:

  • State pharmaceutical assistance programs (verify eligibility)
  • Hospital charity care programs for infusion costs
  • Alpha-1 Foundation may provide guidance on financial resources

FAQ

How long does Cigna prior authorization take in New Jersey? Standard PA requests: up to 15 business days. Expedited requests (if delay would harm your health): 72 hours. Your doctor can request expedited review when submitting.

What if Prolastin-C is completely non-formulary on my plan? You can still request a formulary exception. Provide strong medical necessity documentation and evidence that covered alternatives are inadequate for your specific situation.

Can I appeal if I'm denied during step therapy? Yes. If you experience serious side effects or clinical deterioration during step therapy, document everything and request immediate exception to the preferred product.

Does step therapy apply if I was stable on Prolastin-C before switching to Cigna? Sometimes insurers waive step therapy for established therapy, but this isn't guaranteed. Provide documentation of your previous stable treatment and any clinical risks of switching.

How do I get expedited review? Your doctor must attest that a delay in treatment would seriously jeopardize your life, health, or ability to regain maximum function. This applies to both PA requests and appeals.

What's the success rate for external appeals in New Jersey? While specific AAT therapy data isn't published, approximately 50% of external appeals nationwide are decided in favor of patients, especially when medical evidence strongly supports the request.

Counterforce Health helps patients and providers navigate complex insurance approvals for specialty medications like Prolastin-C. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that address payer requirements point-by-point. When you're facing a denial for alpha1-proteinase inhibitor therapy, having the right documentation and appeal strategy can make the difference between approval and ongoing delays in accessing this life-sustaining treatment.

For complex cases involving multiple denials or appeals, consider working with specialists who understand both the clinical requirements for AAT therapy and the specific coverage policies of major insurers like Cigna. The right approach can help ensure you get access to the most appropriate therapy for your alpha-1 antitrypsin deficiency.

Sources & Further Reading

Disclaimer: This information is for educational purposes and doesn't constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For official New Jersey insurance regulatory information, visit the Department of Banking and Insurance website.

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