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

Get Xenpozyme (olipudase alfa-rpcp) Covered by Cigna in North Carolina: Complete Prior Authorization Guide and Appeals Process

Answer Box: Quick Path to Approval

Xenpozyme (olipudase alfa-rpcp) requires prior authorization from Cigna in North Carolina. To get approved: (1) Confirm ASMD diagnosis with genetic testing and enzyme assay, (2) Have a metabolic specialist submit the PA request through CoverMyMeds or Cigna's portal with required documentation, (3) Submit prescription to Accredo specialty pharmacy simultaneously. Standard review takes 72 hours. If denied, file internal appeals within 180 days, then request Smart NC external review through the NC Department of Insurance within 120 days of final denial.

First step today: Contact your metabolic disease specialist to gather diagnostic confirmation and initiate the PA process.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Cost Considerations
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Xenpozyme Covered by Cigna?

Xenpozyme (olipudase alfa-rpcp) requires prior authorization across all Cigna plan types in North Carolina, including commercial, Medicare Advantage, and Medicaid plans. The medication may not appear on standard formularies, requiring a formulary exception request for non-formulary coverage.

Which Plans Are Affected?

All Cigna plans in North Carolina require PA for Xenpozyme:

  • Commercial employer plans
  • Individual marketplace plans
  • Medicare Advantage plans
  • Medicaid managed care plans

Note: Self-funded employer plans may have different requirements—check with your HR department for specific procedures.

Prior Authorization Process

Who Submits the Request?

Your metabolic disease specialist or medical geneticist must submit the prior authorization request. Cigna requires specialist involvement for all ASMD-related therapies.

Step-by-Step: Fastest Path to Approval

  1. Gather Diagnostic Documentation (Patient/Clinic)
    • Genetic testing results showing pathogenic SMPD1 mutations
    • Enzyme assay confirming deficient acid sphingomyelinase activity
    • Clinical notes documenting ASMD diagnosis
  2. Submit PA Request (Prescriber)
    • Use CoverMyMeds or Cigna provider portal
    • Include all required clinical documentation
    • Specify non-CNS ASMD indication
  3. Submit Prescription (Prescriber)
    • Send prescription to Accredo specialty pharmacy simultaneously
    • Include NDC codes and administration details
  4. Track Status (Patient/Clinic)
    • Monitor through provider portal or call Cigna
    • Follow up within 72 hours if no response

Required Documentation Checklist

  • Confirmed ASMD diagnosis (genetic + enzyme testing)
  • Baseline clinical assessments (liver/spleen size, lung function, platelet counts)
  • Specialist consultation notes
  • Treatment plan with monitoring schedule
  • Prior therapy documentation (if applicable)
  • Insurance card and patient demographics

Timing and Urgency

Standard Review Timeline

  • Electronic submission: 72 hours for standard review
  • Paper/fax submission: Up to 15 business days
  • Expedited review: 24-72 hours (requires clinical urgency documentation)

When to Request Expedited Review

Request expedited processing if:

  • Patient's health could be seriously jeopardized by waiting
  • Disease progression is rapid
  • Current supportive care is failing

How to request: Mark "URGENT" on PA form and include physician certification of medical urgency.

Medical Necessity Criteria

Core Requirements for Approval

Coverage at a Glance

Requirement What It Means Where to Find It Source
ASMD Diagnosis Genetic + enzyme confirmation Lab reports, specialist notes Cigna Policy
Specialist Prescription Metabolic disease specialist involvement Provider credentials Cigna Policy
Non-CNS Disease CNS involvement excludes coverage Clinical assessment FDA Label
Age Appropriateness FDA-approved age ranges Patient demographics FDA Label

Diagnostic Requirements

Definitive ASMD diagnosis requires both:

  1. Enzyme Testing: Deficient acid sphingomyelinase activity (<10% of normal) in leukocytes or fibroblasts
  2. Genetic Testing: Biallelic pathogenic variants in SMPD1 gene
Clinician Corner: Medical necessity letters should reference both diagnostic modalities and cite the FDA prescribing information for indication-specific requirements.

No Step Therapy Required

Unlike many specialty medications, Xenpozyme has no step therapy requirements because no FDA-approved alternatives exist for ASMD treatment. However, documentation of supportive care may strengthen your case.

Cost Considerations

Understanding Your Coverage

  • Tier placement: Typically Tier 4 or 5 (specialty tier)
  • Copay vs. coinsurance: Most plans use percentage-based coinsurance (20-40%) for specialty drugs
  • Annual out-of-pocket maximum: Applies to reduce total yearly costs

Savings Options

  • Sanofi Patient Support: Check Xenpozyme.com for copay assistance programs
  • Foundation grants: National Organization for Rare Disorders (NORD) and other rare disease foundations
  • State programs: North Carolina may have additional assistance—contact Smart NC at 855-408-1212

Denials and Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient diagnosis Provide complete genetic + enzyme testing Lab reports, specialist interpretation
CNS involvement Clarify non-CNS manifestations Neurological assessment, imaging
Lack of specialist involvement Get metabolic specialist consultation Referral, specialist notes
Missing baseline assessments Submit required clinical data Organ function tests, imaging

Appeals Process in North Carolina

Internal Appeals (Cigna)

  1. First-level appeal: File within 180 days of denial
  2. Second-level appeal: Available if first level denied
  3. Expedited appeals: 24-72 hour turnaround for urgent cases

External Review (Smart NC)

If internal appeals fail:

  1. Eligibility check: State-regulated plan required (not self-funded)
  2. Timeline: File within 120 days of final Cigna denial
  3. Process: Submit external review form to NC Department of Insurance
  4. Decision: Independent Review Organization provides binding decision within 45 days (72 hours for expedited)
Contact Smart NC: Call 855-408-1212 for free advocacy assistance with your external review request.

Appeal Script for Patients

"I'm calling to file an internal appeal for the denial of Xenpozyme for my confirmed ASMD diagnosis. I have additional clinical documentation from my metabolic specialist that wasn't included in the original request. Can you please provide the appeal form and fax number for submission?"

Renewal Requirements

When to Reauthorize

  • Initial approval: Typically 6-12 months
  • Renewal timeline: Submit 30-60 days before expiration
  • Required documentation: Evidence of clinical benefit or disease stabilization

Renewal Documentation Checklist

  • Updated specialist assessment
  • Clinical response measurements (organ size, function tests)
  • Treatment adherence documentation
  • Continued medical necessity justification

Specialty Pharmacy Requirements

Why Accredo?

Cigna requires Xenpozyme to be filled through Accredo, their specialty pharmacy partner, for:

  • Cold chain management
  • Infusion coordination
  • Prior authorization integration
  • Clinical monitoring support

Setting Up with Accredo

  1. Prescription transfer: Automatic when PA approved
  2. Patient enrollment: Accredo will contact you directly
  3. Delivery coordination: Arrange infusion center delivery
  4. Insurance verification: Accredo handles benefit verification

Troubleshooting Common Issues

Portal Problems

  • CoverMyMeds down: Use Cigna provider portal as backup
  • Missing forms: Contact Cigna provider services at number on your card
  • Status unclear: Call Cigna pharmacy services directly

Documentation Issues

  • Lab results delayed: Request expedited processing from lab
  • Specialist unavailable: Telemedicine consultation may be acceptable
  • Prior records missing: Contact previous providers immediately

Communication Breakdowns

  • Accredo coordination: Ensure prescriber and Accredo have same PA approval number
  • Insurance verification: Double-check member ID and plan details
  • Appeal deadlines: Calendar all important dates immediately

Frequently Asked Questions

How long does Cigna PA take for Xenpozyme in North Carolina? Standard electronic submissions are typically decided within 72 hours. Paper submissions can take up to 15 business days.

What if Xenpozyme is non-formulary on my plan? Submit a formulary exception request along with your PA request, providing clinical justification for why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if your health could be seriously jeopardized by waiting. Your prescriber must certify the urgency in writing.

Does step therapy apply if I've failed treatments outside North Carolina? No step therapy is required for Xenpozyme since no FDA-approved alternatives exist for ASMD. Document any prior supportive care attempts.

What if my employer plan is self-funded? Self-funded plans aren't subject to North Carolina's external review process. Contact your HR department for specific appeal procedures.

How do I know if Smart NC external review applies to my case? Your plan must be state-regulated (not self-funded) and the denial must be based on medical necessity or experimental treatment determination. Call Smart NC at 855-408-1212 to verify eligibility.

When to Get Additional Help

Consider seeking specialized assistance if you encounter:

  • Multiple PA denials despite complete documentation
  • Complex insurance plan structures
  • Tight appeal deadlines with extensive documentation needs

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to payer-specific requirements. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes for specialty medications like Xenpozyme.

From Our Advocates: In our experience working with ASMD cases, the most successful appeals include both the genetic testing results and a detailed letter from the metabolic specialist explaining why enzyme replacement therapy is medically necessary given the patient's specific clinical presentation. Having baseline organ function measurements also strengthens the case significantly.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For additional help with North Carolina insurance appeals, contact Smart NC at 855-408-1212 or visit the North Carolina Department of Insurance website.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.