By Counterforce Health Team in Myozyme (alglucosidase alfa) —

How to Get Myozyme (Alglucosidase Alfa) Covered by Cigna in New York: Complete PA Guide and Appeals Process

Answer Box: Getting Myozyme Covered by Cigna in New York

Myozyme (alglucosidase alfa) requires prior authorization from Cigna for Pompe disease coverage in New York. Your specialist must submit documentation confirming GAA enzyme deficiency or genetic testing, along with weight-based dosing calculations. Submit via CoverMyMeds or fax to 855-840-1678. If denied, New York residents have strong appeal rights through the state's External Appeal Program with binding decisions within 72 hours for urgent cases.

First step today: Have your metabolic, genetic, or neuromuscular specialist gather your diagnostic test results and submit the prior authorization request through Cigna's preferred portal.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Setup
  5. Common Denial Reasons & Solutions
  6. New York Appeals Process
  7. Cost Considerations
  8. Step-by-Step Approval Process
  9. FAQ

Plan Types & Coverage Implications

Cigna offers several plan types in New York, each with different implications for Myozyme coverage:

HMO Plans: Require referrals to specialists and typically have more restrictive networks. You'll need a primary care physician referral to see the metabolic or genetic specialist who can prescribe Myozyme.

PPO/EPO Plans: Allow direct access to specialists without referrals, making it easier to see the required prescribing specialist. These plans often have broader networks but may have higher out-of-pocket costs.

Medicaid Managed Care: New York's Medicaid program covers approximately 40% of residents. Medicaid managed care plans through Cigna follow state guidelines for rare disease treatments and typically have more generous coverage for medically necessary treatments like enzyme replacement therapy.

Note: Regardless of plan type, all Cigna members need prior authorization for Myozyme, and the clinical requirements remain the same.

Formulary Status & Tier Placement

Myozyme's formulary status varies by specific Cigna plan, but it's typically placed on a high-tier specialty formulary requiring prior authorization. The medication may be classified as non-formulary in some plans, requiring a formulary exception request.

Coverage Requirements Table:

Requirement Details Documentation Needed
Diagnosis Pompe disease (ICD-10: E74.02) GAA enzyme assay and/or genetic testing
Prescriber Metabolic, genetic, or neuromuscular specialist Board certification credentials
Dosing 20 mg/kg IV every 2 weeks per FDA label Weight-based calculations
Renewal Annual review required Progress notes, functional assessments

Prior Authorization Requirements

Based on Cigna's coverage policies, Myozyme requires comprehensive prior authorization documentation:

Medical Necessity Criteria

  • Confirmed diagnosis of acid alpha-glucosidase deficiency (Pompe disease)
  • Deficient GAA enzyme activity or biallelic pathogenic GAA gene variants
  • Prescription by qualified specialist (neurologist, geneticist, or metabolic specialist)
  • Appropriate dosing: ≤20 mg/kg IV every 2 weeks
  • Plan for monitoring efficacy and adverse events

Submission Process

  1. Online Portal: Submit through CoverMyMeds (preferred method)
  2. Fax: 855-840-1678 for standard requests
  3. Phone: 800-882-4462 for urgent verbal authorization
  4. Timeline: 72 hours to 14 days for standard review; 24-72 hours for expedited cases

Specialty Pharmacy Setup

Cigna partners with Accredo Specialty Pharmacy for Myozyme distribution. Here's how to enroll:

Patient Enrollment Steps

  1. Contact Accredo: Call 800-803-2523 to initiate enrollment
  2. Provider Submission: Your doctor faxes the enrollment form to 888-302-1028
  3. Benefits Verification: Accredo coordinates with Cigna to verify coverage
  4. Delivery Coordination: Schedule delivery to your home, doctor's office, or infusion center

Required Information

  • Patient demographics and insurance details
  • Prescriber information including NPI and license numbers
  • Clinical information: diagnosis codes, weight, allergies, concurrent medications
  • Prescription details: strength, directions, quantity

You can manage your account through the myCigna app or MyAccredoPatients.com.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient diagnostic evidence Submit complete enzyme/genetic testing GAA activity levels, genetic test results
Non-specialist prescriber Transfer prescription to qualified specialist Board certification, specialist credentials
Dosing outside FDA label Provide clinical justification Weight calculations, treatment plan
Lack of medical necessity Submit comprehensive clinical letter Disease progression, functional decline data

New York Appeals Process

New York offers robust patient protections for insurance denials through the Department of Financial Services (DFS).

Internal Appeals (Required First Step)

  • Timeline: File within 180 days of denial
  • Process: Submit appeal letter with supporting documentation to Cigna
  • Decision: Cigna has specific timeframes to respond based on urgency

External Appeals Through New York DFS

If your internal appeal is denied, you can request an external review:

  • Timeline: File within 4 months of final adverse determination
  • Cost: $25 maximum (waived for financial hardship or Medicaid)
  • Process: Submit application through DFS portal
  • Decision: Independent medical expert reviews case; decision is binding
  • Expedited Review: 24 hours for urgent drug denials, 72 hours for standard

Support Resources

  • DFS External Appeal Information: 800-400-8882
  • Community Health Advocates: 888-614-5400 (free counseling)
  • Email Support: [email protected]

When appeals succeed, insurers must cover the service and refund your filing fee.

Cost Considerations

Myozyme is an expensive specialty medication, with cash prices around $1,026 per 50-mg vial. Most patients require multiple vials per infusion based on weight.

Financial Assistance Options:

  • Manufacturer Support: Check Sanofi's patient assistance programs
  • Copay Cards: May be available for commercial insurance
  • Foundation Grants: National Organization for Rare Disorders (NORD) and other foundations
  • State Programs: New York may have additional rare disease support
Tip: Even with insurance coverage, specialty medications often have high cost-sharing. Explore all assistance programs before starting treatment.

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis (Patient/Provider): Ensure GAA enzyme testing or genetic testing is complete and documented
  2. Specialist Referral (Patient): Schedule with metabolic, genetic, or neuromuscular specialist if not already established
  3. Gather Documentation (Provider): Compile diagnostic tests, weight calculations, treatment plan
  4. Submit Prior Authorization (Provider): Use CoverMyMeds portal or fax to 855-840-1678
  5. Enroll with Accredo (Patient): Call 800-803-2523 while PA is pending
  6. Monitor Status (Patient): Check approval status through myCigna app
  7. If Denied, Appeal Immediately (Patient/Provider): File internal appeal within 180 days

Expected Timeline: 3-14 days for initial PA decision; additional 2-4 weeks for appeals if needed.

Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Myozyme. Our platform analyzes denial letters and payer policies to create targeted, evidence-backed appeals that address each plan's specific requirements. We help patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and craft compelling medical necessity arguments.

Clinician Corner: Medical Necessity Letter Essentials

When writing medical necessity letters for Myozyme, include these key elements:

Clinical Documentation:

  • Confirmed Pompe disease diagnosis with specific test results
  • Patient's current functional status and disease progression
  • Weight-based dosing calculations per FDA labeling
  • Monitoring plan for efficacy and safety
  • Lack of suitable alternatives for enzyme replacement therapy

Evidence Base:

  • FDA prescribing information for approved indications
  • Published clinical trial data supporting efficacy
  • Professional society guidelines for Pompe disease management
From our advocates: We've seen successful appeals that include detailed functional assessments showing disease progression alongside genetic testing confirmation. Specialists who document specific enzyme activity levels and explain why immediate treatment is necessary tend to have higher approval rates, especially when they reference the progressive nature of Pompe disease and the critical window for intervention.

FAQ

How long does Cigna prior authorization take for Myozyme in New York? Standard reviews take 72 hours to 14 days. Expedited reviews for urgent cases are completed within 24-72 hours. You can check status through the myCigna app or by calling member services.

What if Myozyme is non-formulary on my Cigna plan? You can request a formulary exception by having your specialist submit a medical necessity letter explaining why Myozyme is medically necessary and no formulary alternatives are appropriate for your condition.

Can I request an expedited appeal if Cigna denies coverage? Yes, both Cigna's internal appeal process and New York's external appeal process offer expedited reviews for urgent medical needs. Document why delayed treatment poses serious health risks.

Does step therapy apply to Myozyme for Pompe disease? Based on current Cigna policies, there's no explicit step therapy requirement for Myozyme in Pompe disease, as it's the primary FDA-approved enzyme replacement therapy for this rare condition.

What happens if I move from another state to New York? New York's external appeal rights apply to all residents, regardless of where your plan originated. You'll have access to the state's consumer-friendly appeal process through DFS.

How do I find a qualified specialist to prescribe Myozyme? Look for board-certified neurologists, geneticists, or metabolic specialists with experience treating lysosomal storage disorders. Children's hospitals often have specialized metabolic clinics.

What if my employer plan is self-funded? Self-funded plans may not be subject to state insurance laws, but they often follow similar processes. Check your Summary Plan Description for specific appeal procedures and timelines.

Can Community Health Advocates help with my Cigna appeal? Yes, Community Health Advocates provides free assistance to New York residents with insurance appeals and can help you navigate both Cigna's process and state external appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may vary by specific plan and change over time. Always verify current requirements with Cigna directly and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals, consider working with Counterforce Health or other qualified advocacy services.

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