By Counterforce Health Team in Xenpozyme (olipudase alfa-rpcp) —

How to Get Xenpozyme (Olipudase Alfa) Covered by Aetna CVS Health in New York: Complete Appeals Guide

Answer Box: Getting Xenpozyme Covered by Aetna CVS Health in New York

Quick Answer: Aetna CVS Health requires prior authorization for Xenpozyme (olipudase alfa-rpcp) with documented ASMD diagnosis via genetic testing or enzyme deficiency labs. Submit requests through your prescriber with complete clinical documentation. If denied, you have 4 months to file an external appeal with New York's Department of Financial Services for a binding decision. Start by ensuring your doctor has confirmed ASMD diagnosis and prescriber expertise documentation.

First Step Today: Contact your prescribing physician to verify they have your genetic test results or enzyme deficiency labs, and confirm they're recognized as an ASMD specialist by Aetna.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Clinical Criteria Requirements
  5. Cost and Financial Support
  6. Denials and Appeals Process
  7. Renewal and Reauthorization
  8. CVS Specialty Pharmacy Requirements
  9. New York External Appeal Rights
  10. Troubleshooting Common Issues

Coverage Basics

Is Xenpozyme Covered by Aetna CVS Health?

Yes, but with restrictions. Xenpozyme appears on Aetna's 2024 prior authorization drug list, meaning coverage is available but requires pre-approval. The drug is covered specifically for non-CNS manifestations of acid sphingomyelinase deficiency (ASMD) in adults and pediatric patients.

Which Aetna Plans Cover Xenpozyme?

Most Aetna commercial plans and Aetna Better Health (Medicaid) plans in New York include Xenpozyme on formulary with prior authorization requirements. Coverage varies by specific plan design, so verify your individual benefits through the Aetna member portal or by calling member services.

Coverage at a Glance
Requirement Details Source
Prior Authorization Required for all plans Aetna PA List 2024
Formulary Status Covered with restrictions Aetna Clinical Policy Bulletin
Step Therapy Not typically required Aetna ASMD Policy
Quantity Limits Based on weight-based dosing Clinical policy guidelines
Site of Care Infusion center preferred Aetna Infusion Policy
Age Limits None (pediatric and adult) FDA labeling

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis Documentation (Patient/Prescriber)
    • Obtain genetic testing results showing SMPD1 gene variants, OR
    • Lab confirmation of acid sphingomyelinase deficiency in blood/tissue
    • Timeline: May take 2-4 weeks if testing needed
  2. Verify Prescriber Qualifications (Prescriber)
    • Ensure prescribing physician specializes in ASMD or metabolic disorders
    • Document consultation with ASMD specialist if primary prescriber isn't specialized
    • Submit credentials with PA request
  3. Complete Clinical Documentation (Prescriber)
    • Medical necessity letter citing non-CNS symptoms
    • Baseline organ function assessments (spleen, liver, lung)
    • Treatment goals and monitoring plan
    • Timeline: 1-2 business days
  4. Submit Prior Authorization (Prescriber/Office Staff)
    • Use Aetna provider portal or designated PA forms
    • Include all required clinical documentation
    • Timeline: Same day submission possible
  5. Track Approval Status (Patient/Prescriber)
    • Standard review: 30-45 days
    • Expedited review: 72 hours for urgent cases
    • Follow up via provider portal or phone

Timeline and Urgency

How Long Does Aetna Prior Authorization Take?

  • Standard Review: 30-45 days from complete submission
  • Expedited Review: 72 hours for urgent medical situations
  • Incomplete Submissions: Additional 14-21 days for missing documentation

When to Request Expedited Review

Request expedited processing when:

  • Patient has severe, rapidly progressing ASMD symptoms
  • Delay in treatment poses serious health risks
  • Current supportive care is insufficient

Contact Aetna utilization management directly at the number on your provider portal to request expedited review with clinical justification.

Clinical Criteria Requirements

What Documentation Does Aetna Require?

Diagnostic Requirements (Choose One):

  • Genetic testing confirming pathogenic SMPD1 gene variants
  • Laboratory measurement showing acid sphingomyelinase deficiency in:
    • Peripheral leukocytes
    • Cultured fibroblasts
    • Lymphocytes

Clinical Documentation Requirements:

  • Confirmation of non-CNS ASMD manifestations
  • Baseline assessments of affected organs (spleen, liver, lungs)
  • Treatment goals and expected outcomes
  • Monitoring plan for infusion reactions and clinical response

Prescriber Qualification Requirements

According to Aetna's clinical policy, Xenpozyme must be prescribed by or in consultation with a physician experienced in managing ASMD. This typically includes:

  • Metabolic disease specialists
  • Geneticists
  • Hematologists with lysosomal storage disease experience

Cost and Financial Support

Understanding Your Out-of-Pocket Costs

Xenpozyme costs vary significantly based on your specific Aetna plan:

  • Specialty tier copays: Typically $50-$150 per fill
  • Coinsurance plans: Usually 20-40% of drug cost
  • Deductible plans: Full cost until deductible met, then copay/coinsurance applies
Tip: Call the number on your insurance card to get your specific Xenpozyme cost estimate before starting treatment.

Patient Assistance Programs

Sanofi CareConnectPSS Program:

  • Provides financial assistance and insurance support
  • Helps navigate prior authorization process
  • Contact: 1-800-745-4447, Option 3
  • Website: Xenpozyme Financial Assistance

Sanofi Patient Connection:

  • May provide medication at no cost for eligible patients
  • Income and insurance requirements apply
  • Application required through SanofiPatientConnection.com

For patients in New York, Counterforce Health can help identify additional patient assistance programs and foundation grants that may cover Xenpozyme costs not covered by insurance. Visit their website for comprehensive coverage support.

Denials and Appeals Process

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documents
Insufficient diagnostic evidence Submit genetic testing or enzyme assay results Lab reports, genetic counselor summary
Prescriber not qualified Provide specialist credentials or consultation notes CV, board certification, consultation letter
Experimental/investigational Cite FDA approval and clinical guidelines FDA label, treatment guidelines
Not medically necessary Submit detailed clinical justification Medical necessity letter, symptom documentation

Aetna Internal Appeals Process

Level 1: Standard Appeal

  • Timeline: File within 180 days of denial
  • Decision timeframe: 30 days (15 days for urgent)
  • Submit via: Aetna provider portal or written appeal

Level 2: Peer-to-Peer Review

  • Request physician-to-physician discussion
  • Available after Level 1 denial
  • Can expedite resolution for complex cases

New York External Appeal Rights

If Aetna denies your internal appeals, New York residents have powerful external appeal rights through the Department of Financial Services (DFS).

Key Benefits:

  • Binding decisions: DFS external reviewers can override Aetna's denial
  • Independent review: Medical experts evaluate your case without insurance company influence
  • Precedent database: Searchable database of past decisions helps build your case

Filing Requirements:

  • Must file within 4 months of Aetna's final denial
  • Maximum fee: $25 (waived for Medicaid or financial hardship)
  • Submit via: DFS External Appeal Portal
From Our Advocates: We've seen several New York patients successfully overturn Aetna denials for rare disease medications through DFS external appeals. The key is thorough documentation of medical necessity and citing relevant precedent decisions from the DFS database. While outcomes vary, patients who submit complete clinical records and specialist support letters have achieved favorable results.

Renewal and Reauthorization

When to Renew Your Xenpozyme Authorization

Most Aetna prior authorizations for Xenpozyme require renewal every 6-12 months. Your prescriber will receive notification 30-60 days before expiration.

Renewal Requirements:

  • Evidence of clinical benefit (improved organ function, symptom reduction)
  • Continued medical necessity
  • Updated treatment goals and monitoring results
  • Specialist confirmation of ongoing need

What Changes Trigger Re-review?

  • Dose increases beyond approved amounts
  • Changes in infusion frequency
  • New prescribing physician
  • Plan changes or insurance switches

CVS Specialty Pharmacy Requirements

Why Was My Prescription Transferred?

Aetna typically requires Xenpozyme to be dispensed through CVS Specialty Pharmacy for:

  • Specialized handling and storage
  • Patient education and support services
  • Coordination with infusion centers
  • Insurance benefit optimization

CVS Specialty Enrollment Process

Your prescriber must complete the CVS Lysosomal Storage Disorders Enrollment Form including:

  • Patient demographics and insurance information
  • Complete prescription details with dosing escalation plan
  • Medical necessity certification
  • Handwritten prescriber signature (electronic signatures not accepted)

Submission: Fax to 1-800-323-2445 or submit via e-Prescribe Patient Support: Call CVS Specialty at 1-800-237-2767 for enrollment status

Troubleshooting Common Issues

Portal Access Problems

  • Aetna Provider Portal Down: Call provider services at 1-800-624-0756
  • Missing Forms: Download current forms from Aetna Forms Page
  • Submission Errors: Verify all required fields completed and documents attached

Communication Breakdowns

  • No Response to PA: Follow up after 5 business days
  • Conflicting Information: Request supervisor review
  • Urgent Situations: Call Aetna utilization management directly

Getting Help in New York

Community Health Advocates: Free insurance counseling at 888-614-5400 New York Department of Financial Services: Consumer assistance at 1-800-342-3736 Counterforce Health: Specialized support for prescription drug appeals - visit their website for expert guidance on turning denials into successful approvals.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Xenpozyme in New York? Standard review takes 30-45 days; expedited review for urgent cases takes 72 hours. Submit complete documentation to avoid delays.

What if Xenpozyme is non-formulary on my plan? Request a formulary exception through your prescriber with medical necessity documentation. Aetna has established coverage criteria, making approval possible with proper documentation.

Can I request an expedited appeal in New York? Yes, both Aetna internal appeals and New York DFS external appeals offer expedited review for urgent medical situations with appropriate clinical justification.

Does step therapy apply to Xenpozyme? No, Xenpozyme is the only FDA-approved treatment for ASMD, so step therapy requirements typically don't apply.

What happens if I move from another state to New York? Your Aetna coverage continues, but you gain access to New York's external appeal rights. Existing prior authorizations typically transfer, but verify with member services.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan benefits and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For complex prior authorization and appeal support, consider working with specialized services like Counterforce Health, which helps patients navigate insurance denials and secure coverage for specialty medications.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical documentation to create targeted, evidence-backed responses. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for medications like Xenpozyme, ensuring that necessary treatments reach patients who need them.

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