By Counterforce Health Team in Pombiliti (cipaglucosidase alfa-atga) —

Getting Pombiliti (Cipaglucosidase Alfa) Covered by Cigna in Pennsylvania: Prior Authorization, Appeals, and Cost-Saving Strategies

Quick Answer: Getting Pombiliti Covered by Cigna in Pennsylvania

Cigna requires prior authorization for Pombiliti (cipaglucosidase alfa-atga) and places it on Tier 5 specialty formulary. First step: Have your prescriber submit PA through CoverMyMeds or ExpressPAth with genetic confirmation of Pompe disease and documentation that you're not improving on current enzyme replacement therapy. If denied, you have 180 days for internal appeals, then 4 months for Pennsylvania's external review program, which overturns ~50% of denials. Commercial insurance patients can access Amicus copay assistance to reduce costs to $0/month.

Table of Contents

  1. What Drives Pombiliti Costs
  2. Understanding Your Cigna Benefits
  3. Patient Assistance Programs
  4. Prior Authorization Process
  5. Appeals Roadmap for Pennsylvania
  6. Specialty Pharmacy Coordination
  7. Annual Planning and Renewals
  8. Scripts for Key Conversations

What Drives Pombiliti Costs

Pombiliti (cipaglucosidase alfa-atga) carries a list price of approximately $650,000 annually when combined with Opfolda, making it one of the most expensive specialty medications. Your out-of-pocket costs depend on several Cigna benefit design factors:

Formulary Tier Placement Cigna places Pombiliti on Tier 5 (Specialty), which typically requires 20-40% coinsurance rather than fixed copays. This means you pay a percentage of the drug's cost rather than a flat fee.

Prior Authorization Requirements Cigna requires prior authorization for all specialty medications like Pombiliti. Their coverage policy IP0591 outlines specific clinical criteria that must be met.

Step Therapy Considerations You may need to demonstrate inadequate response to other enzyme replacement therapies (Lumizyme or Nexviazyme) before Cigna approves Pombiliti, unless your doctor can justify bypassing this requirement.

Note: Pennsylvania residents benefit from stronger step therapy protections that allow medical exceptions when clinically appropriate.

Understanding Your Cigna Benefits

Before starting the approval process, gather this essential information from your Cigna plan:

Key Questions to Ask Cigna

Call the number on your insurance card and ask:

  • "Is Pombiliti on my plan's formulary, and what tier?"
  • "What's my specialty drug coinsurance percentage?"
  • "Do I have a specialty drug out-of-pocket maximum?"
  • "Is step therapy required for Pombiliti?"
  • "Which specialty pharmacy must I use?"

Information to Document

Detail Where to Find It Why It Matters
Plan year deductible Summary of Benefits Affects when copay assistance begins
Specialty coinsurance % Formulary document Determines your share of costs
Out-of-pocket maximum Benefits summary Your annual cost ceiling
Specialty pharmacy network Provider directory Required for dispensing

Patient Assistance Programs

Multiple programs can dramatically reduce your Pombiliti costs:

Amicus ASSIST Copay Program

Eligibility: Commercial insurance patients in Pennsylvania Benefit: Reduce monthly costs to as little as $0 How to Apply: Your prescriber submits a Patient Referral Form to Amicus ASSIST Contact: 1-833-AMICUS-A (1-833-264-2872)

Important: Medicare and Medicaid patients cannot use manufacturer copay programs but may qualify for other assistance.

PAN Foundation Grant

Annual Support: Up to $6,800 for medication costs plus $4,800 for insurance premiums Eligibility: Household income ≤400% of Federal Poverty Level with qualifying insurance Coverage: Includes Pombiliti, Opfolda, and other Pompe treatments Apply: PAN Foundation Patient Portal or call 1-866-316-7263

Specialty Pharmacy Case Management

Accredo, Cigna's specialty pharmacy partner, provides:

  • Prior authorization support
  • Financial assistance navigation
  • Insurance benefit verification
  • Coordination with patient assistance programs

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Prescriber Preparation (1-2 days)
    • Gather genetic testing confirming Pompe disease
    • Document current/prior enzyme replacement therapy
    • Record inadequate response to current treatment
  2. Submit Prior Authorization (Same day)
    • Use CoverMyMeds for fastest processing
    • Alternative: ExpressPAth portal or fax to 1-866-873-8279
    • Include all required clinical documentation
  3. Cigna Review (72 hours standard, 24 hours urgent)
    • Clinical team reviews against policy criteria
    • Decision communicated to prescriber and patient

Medical Necessity Requirements

Your doctor must document:

  • Diagnosis: Confirmed Pompe disease with genetic or enzymatic testing
  • Current therapy: Details of enzyme replacement therapy you're receiving
  • Inadequate response: Specific measures showing lack of improvement
  • Weight requirement: Patient weight ≥40 kg (88 pounds)
  • Concurrent therapy: Confirmation you're not receiving other GAA enzyme therapies
Clinician Corner: Include specific functional measures (6-minute walk test, FVC, muscle strength assessments) and timeline of decline or plateau on current therapy.

Appeals Roadmap for Pennsylvania

Pennsylvania's strengthened appeals system gives you multiple chances to overturn denials:

Internal Appeals (First Step)

Timeline: 180 days from denial to request internal appeal Process: Submit written appeal to Cigna with additional clinical evidence Success Rate: Industry average 40-60% for specialty drugs with strong evidence

Pennsylvania External Review (Final Step)

New Advantage: Pennsylvania launched its Independent External Review Program in January 2024 Success Rate: ~50% of appeals overturned in first year Timeline: 4 months from final internal denial to request external review Process: Submit request through Pennsylvania Insurance Department portal

Appeals Documentation Checklist

  • Copy of original denial letter
  • All medical records supporting medical necessity
  • Peer-reviewed studies supporting Pombiliti use
  • FDA prescribing information
  • Professional society guidelines (if applicable)
  • Letter from treating physician explaining clinical rationale
From our advocates: We've seen strongest appeal success when families include a timeline showing functional decline on current therapy alongside research demonstrating Pombiliti's clinical benefits for their specific situation. Always submit appeals promptly—don't wait until deadlines approach.

Specialty Pharmacy Coordination

Working with Accredo

Cigna typically requires specialty medications like Pombiliti to be dispensed through Accredo. Key coordination tips:

Initial Setup:

  • Accredo contacts you after PA approval
  • Verify shipping address and preferred delivery schedule
  • Confirm insurance benefits and copay assistance enrollment

Ongoing Management:

  • Schedule deliveries around infusion appointments
  • Monitor for insurance changes that could affect coverage
  • Coordinate with infusion center for proper storage

Alternative Specialty Pharmacies

Some Cigna plans allow other specialty pharmacies. Confirm network status before transferring prescriptions to avoid coverage issues.

Annual Planning and Renewals

What Changes Each Year

  • Formulary placement: Drugs can move tiers or be removed
  • Prior authorization criteria: Requirements may become stricter
  • Copay assistance: Manufacturer programs have annual enrollment periods
  • Out-of-pocket maximums: May increase with plan changes

Renewal Reminders

October-November: Review next year's formulary and benefits December: Renew copay assistance programs before January 1 January: Confirm PA is still active for new plan year

At Counterforce Health, we help patients and clinicians navigate these annual changes by analyzing plan documents and preparing renewal documentation before coverage gaps occur.

Scripts for Key Conversations

Calling Cigna About Coverage

"Hi, I'm calling about prior authorization for Pombiliti, spelled P-O-M-B-I-L-I-T-I. My doctor says I need this medication for Pompe disease. Can you tell me the status of PA request [reference number] and what additional information might be needed?"

Requesting Peer-to-Peer Review

"I'm calling to request a peer-to-peer review for my patient's Pombiliti denial. The patient has confirmed Pompe disease and has shown inadequate response to current enzyme replacement therapy. When can we schedule a call with your medical director?"

Pharmacy Benefit Verification

"I need to verify specialty pharmacy benefits for Pombiliti. What's the patient's coinsurance percentage, annual deductible remaining, and which specialty pharmacies are in-network?"

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all patients Cigna policy IP0591
Formulary Tier Tier 5 (Specialty) Cigna formulary
Step Therapy May be required Plan-specific policy
Specialty Pharmacy Accredo typically required Cigna specialty pharmacy guide
Appeals Deadline 180 days (internal) Plan documents
External Review 4 months after final denial PA Insurance Department

When Coverage Gets Complex

For challenging cases involving multiple denials or complex clinical situations, specialized support can make the difference. Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by analyzing denial letters, identifying specific coverage gaps, and crafting evidence-based rebuttals that align with payer policies.

Frequently Asked Questions

How long does Cigna prior authorization take for Pombiliti? Standard reviews take up to 72 hours. Urgent requests are processed within 24 hours when clinical urgency is documented.

What if Pombiliti isn't on my Cigna formulary? Request a formulary exception through your prescriber. Include clinical rationale and evidence that formulary alternatives are inappropriate.

Can I get expedited appeals in Pennsylvania? Yes, both Cigna internal appeals and Pennsylvania external reviews offer expedited processes when delays could seriously jeopardize your health.

Does step therapy apply if I've tried other treatments outside Pennsylvania? Previous treatment history from other states should count toward step therapy requirements. Provide complete medical records to document prior therapies.

What's the difference between Cigna Medicare Advantage and commercial coverage for Pombiliti? Medicare Advantage follows CMS formulary rules and has different appeal timelines. Commercial plans may offer more flexibility but vary by specific benefit design.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies and appeal procedures can change. Always verify current requirements with Cigna and consult your healthcare team for medical decisions. For assistance with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department consumer services line.

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