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

Getting Pombiliti (cipaglucosidase alfa-atga) Covered by Cigna in Ohio: Prior Authorization, Appeals, and Cost-Saving Strategies

Quick Answer: Your Path to Pombiliti Coverage

Cigna requires prior authorization for Pombiliti (cipaglucosidase alfa-atga) in Ohio. The fastest path: 1) Have your doctor complete Cigna's PA form with evidence of late-onset Pompe disease diagnosis and ERT failure, 2) Submit via fax (855-840-1678) or through Accredo specialty pharmacy, 3) If denied, file internal appeal within 180 days, then external review through Ohio Department of Insurance if needed. Commercial insurance patients may qualify for $0 copay through Amicus ASSIST. Start today by gathering your GAA enzyme test results, prior ERT history, and current clinical assessments.

Table of Contents

Understanding Pombiliti Coverage with Cigna

Pombiliti (cipaglucosidase alfa-atga) is classified as a Tier 5 specialty drug under Cigna's formulary, meaning it requires prior authorization and carries the highest out-of-pocket costs. This enzyme replacement therapy, used with Opfolda (miglustat), treats adults with late-onset Pompe disease who aren't improving on standard ERT.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must be approved before dispensing Cigna PA form Cigna Policy
Tier 5 Specialty Highest copay/coinsurance tier Your formulary document Cigna Formulary
Accredo Dispensing Must use Cigna's specialty pharmacy myCigna portal or call Cigna Specialty Pharmacy
Medical Necessity Documented ERT failure required Clinical notes, assessments Coverage Policy

The annual cost for Pombiliti plus Opfolda approaches $650,000 at list price, making manufacturer assistance and careful benefit navigation essential for most patients.

Prior Authorization Requirements

Step-by-Step: Fastest Path to PA Approval

  1. Gather Documentation (Patient/Clinic)
    • GAA enzyme activity ≤40% of normal OR pathogenic GAA gene mutations
    • Complete prior ERT history with documented failure/inadequate response
    • Current clinical assessments (motor function, respiratory function, 6-minute walk test)
    • Timeline: 1-2 days to collect
  2. Complete PA Form (Prescriber)
    • Use Cigna's specific Pombiliti form
    • Include all asterisked fields and clinical rationale
    • Specify infusion setting (home/ambulatory preferred)
    • Timeline: Same day completion
  3. Submit Request (Clinic/Pharmacy)
    • Fax to 855-840-1678 or submit via Accredo
    • For urgent cases, call 800-882-4462 after faxing
    • Timeline: Immediate submission
  4. Track Status (Patient)
    • Use myCigna app or website
    • Standard review: 1-5 business days
    • Urgent review: 24 hours
    • Timeline: Check daily

Medical Necessity Checklist for Clinicians

Your PA approval hinges on documenting these key elements:

Diagnosis ConfirmationLaboratory evidence: GAA enzyme activity ≤40% of normalOR genetic testing showing pathogenic GAA mutationsConfirmed late-onset Pompe disease diagnosis
ERT Failure DocumentationAt least 12 months of prior ERT (Lumizyme/Nexviazyme)Lack of improvement or decline in motor/respiratory functionObjective measures: FVC decline, reduced 6MWT distance, motor function scoresSevere infusion reactions (if applicable)
Current Clinical StatusBaseline assessments for motor and respiratory functionTreatment goals and monitoring planJustification for infusion setting

Cost Factors and Assistance Programs

Understanding Your Out-of-Pocket Costs

Cigna's Tier 5 specialty tier typically means:

  • Commercial plans: 25-40% coinsurance after deductible
  • Medicare Advantage: $150-400+ monthly copay during coverage gap
  • Annual out-of-pocket: Can reach $10,000+ without assistance

Manufacturer Support: Amicus ASSIST

Counterforce Health helps patients navigate these complex assistance programs, but you can also apply directly:

Commercial Insurance Patients:

  • Copay card: May reduce costs to $0/month
  • Eligibility: Private/commercial insurance required (no Medicare/Medicaid)
  • Apply: Call 833-264-2872 or visit AmicusAssist.com

Uninsured/Underinsured Patients:

  • Patient Assistance Program: Free medication for eligible patients
  • Requirements: Financial need assessment and documentation
  • Process: Submit Patient Referral Form with financial information
From Our Advocates: We've seen patients initially quoted $8,000+ monthly costs get approved for $0 copay assistance within 48 hours of applying to the manufacturer program. The key is applying before your first infusion and having your insurance information ready. Don't assume you won't qualify—income limits are often higher than expected.

Additional Cost-Saving Strategies

  • Foundation grants: Organizations like HealthWell Foundation may offer assistance
  • State programs: Ohio has limited specialty drug assistance programs
  • Employer benefits: Check if your plan offers specialty drug cost caps

When Cigna Says No: Appeals Process

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient ERT failure documentation Submit detailed treatment history Prior therapy records, objective decline measures
Missing diagnostic confirmation Provide lab/genetic results GAA enzyme test or genetic report
Infusion setting not justified Explain medical necessity Clinical rationale for hospital-based infusion
Concurrent ERT therapy Confirm single-agent use Current medication list, treatment plan

Internal Appeals Process

Level 1 Internal Appeal:

  • Timeline: File within 180 days of denial
  • Process: Written request with clinical justification
  • Decision: 72 hours (non-urgent) or 24 hours (urgent)
  • Submit: Via myCigna portal or written request

Level 2 Internal Appeal:

  • Timeline: File within 60 days of Level 1 denial
  • Process: Independent medical review by Cigna
  • Decision: Same timelines as Level 1
Tip: If Cigna doesn't respond within mandated timelines (72 hours non-urgent, 24 hours urgent), your request may be automatically approved under Ohio law.

Ohio External Review Rights

If Cigna's internal appeals fail, Ohio law provides external review through independent medical experts.

External Review Process:

  • Eligibility: Medical necessity denials involving clinical judgment
  • Timeline: File within 180 days of final Cigna denial
  • Process: Submit through Ohio External Review System
  • Decision: 30 days standard, 72 hours expedited
  • Outcome: Binding on Cigna if overturned

How to File:

  1. Create OH|ID account in Ohio External Review System
  2. Submit request with all documentation
  3. Include any additional medical evidence
  4. For urgent cases, have treating provider submit written statement

Ohio Department of Insurance Support:

  • Consumer hotline: 1-800-686-1526
  • Website: insurance.ohio.gov
  • External review guidance: Available online with step-by-step instructions

Specialty Pharmacy Coordination

Working with Accredo

Cigna requires Pombiliti dispensing through Accredo specialty pharmacy. Here's how to coordinate effectively:

Initial Setup:

  • Accredo contacts you after PA approval
  • Verify insurance, shipping address, and infusion site
  • Schedule delivery 2-3 days before infusion date
  • Confirm cold-chain handling requirements

Ongoing Coordination:

  • Refill timing: Order 7-10 days before next infusion
  • Insurance changes: Notify immediately to avoid disruption
  • Travel: Plan 2-3 weeks ahead for shipment coordination
  • Side effects: Report to both Accredo and prescriber

Counterforce Health can help streamline this process by ensuring all documentation is properly submitted and tracking approvals across multiple systems.

Annual Planning and Renewals

What Changes Each Year

  • Formulary updates: Tier placement may change January 1st
  • PA requirements: Criteria may be updated annually
  • Copay assistance: Manufacturer programs reset each calendar year
  • Deductibles: Restart in January, affecting out-of-pocket costs

Renewal Checklist (October-December):

  • Review next year's formulary for Pombiliti placement
  • Reapply for manufacturer copay assistance
  • Update PA if required by new policy year
  • Coordinate with Accredo for seamless transition
  • Plan for potential January supply gap

FAQ: Common Questions

How long does Cigna prior authorization take for Pombiliti in Ohio? Standard review takes 1-5 business days from receipt of complete documentation. Urgent reviews are completed within 24 hours.

What if Pombiliti is non-formulary on my Cigna plan? You can request a formulary exception with clinical justification. This requires demonstrating medical necessity and often comparing to covered alternatives.

Can I request an expedited appeal if denied? Yes, if the delay would seriously jeopardize your health. Your prescriber must provide written support for expedited review.

Does step therapy apply if I've failed ERT outside Ohio? Documentation of prior ERT failure from any state is typically accepted, but ensure records are complete and accessible.

What happens if I lose Cigna coverage mid-treatment? Contact Amicus ASSIST immediately. They can help coordinate with new insurance or provide bridge coverage through patient assistance programs.

Scripts for Key Conversations

Calling Cigna Member Services: "Hi, I need to check the status of a prior authorization for Pombiliti, spelled P-O-M-B-I-L-I-T-I. My member ID is [number]. This is for late-onset Pompe disease treatment. Can you tell me if the request has been received and what the expected timeline is?"

Requesting Peer-to-Peer Review: "I'm calling to request a peer-to-peer review for my patient's Pombiliti prior authorization denial. The patient has documented late-onset Pompe disease with clear ERT failure over 18 months. I have additional clinical data that supports medical necessity. When can we schedule the review?"

Contacting Ohio Department of Insurance: "I need to file an external review for a Cigna denial of Pombiliti for late-onset Pompe disease. The internal appeals have been exhausted, and this involves medical necessity determination. Can you guide me through the external review process?"

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and requirements may change.

Sources & Further Reading

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