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

How to Get Xenpozyme (Olipudase Alfa) Covered by Cigna in Michigan: Complete Appeal Guide with Forms and Timelines

Answer Box: Getting Xenpozyme Covered by Cigna in Michigan

Xenpozyme (olipudase alfa-rpcp) requires prior authorization from Cigna for all ASMD cases, with fulfillment through Express Scripts/Accredo specialty pharmacy. First step today: Have your specialist submit the PA form with genetic testing results (biallelic SMPD1 variants) and enzyme activity <10% of normal controls via CoverMyMeds or fax to Accredo at 888.302.1028. If denied, you have 180 days to file internal appeals, then 127 days for Michigan DIFS external review. Success rates: 80-85% for peer-to-peer reviews, 70-78% for comprehensive internal appeals.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all ASMD cases Cigna provider portal or CoverMyMeds Cigna Policy
Specialty Pharmacy Must use Accredo (Cigna's preferred) Prescription routes to Accredo automatically Accredo PA Info
Genetic Testing Biallelic SMPD1 pathogenic variants required Lab report from CLIA-certified facility FDA Label Requirements
Enzyme Activity ASM activity <10% of normal controls Blood test (leukocytes) or fibroblasts Cigna Coverage Criteria
Specialist Prescription Geneticist, metabolic specialist, or pulmonologist Provider credentials on file Cigna Policy
Non-CNS Only Not approved for central nervous system symptoms Clinical documentation FDA Label

Step-by-Step: Fastest Path to Approval

  1. Confirm ASMD Diagnosis (Specialist/Lab)
    • Order genetic testing for SMPD1 mutations if not done
    • Obtain ASM enzyme activity results (<10% normal)
    • Timeline: 2-3 weeks for results
  2. Gather Required Documentation (Clinic Staff)
    • Medical records showing non-CNS manifestations
    • Prior therapy attempts (if any)
    • Weight-based dosing calculations
    • Document needed: Complete clinical history
  3. Submit Prior Authorization (Prescriber)
  4. Request Peer-to-Peer if Denied (Prescriber)
    • Call Cigna provider services immediately
    • Success rate: 80-85% for specialty medications
    • Timeline: 24-48 hours to schedule
  5. File Internal Appeal if Needed (Patient/Prescriber)
    • Submit within 180 days of denial
    • Include comprehensive medical necessity letter
    • Timeline: 30 days for pre-service review
  6. Escalate to Michigan DIFS (Patient)
    • File external review within 127 days of final denial
    • Use DIFS online form
    • Timeline: 60 days standard, 72 hours expedited
  7. Track and Follow Up (Patient)
    • Monitor all deadlines
    • Maintain appeal log with dates and reference numbers

Read Your Denial Letter

When Cigna denies Xenpozyme, look for these specific denial codes:

Medical Necessity Denials:

  • "Not medically necessary" - Challenge with clinical evidence
  • "Experimental/investigational" - Cite FDA approval (July 2022)
  • "Insufficient documentation" - Resubmit with complete records

Administrative Denials:

  • "Missing prior authorization" - Submit PA form immediately
  • "Non-preferred specialty pharmacy" - Route to Accredo
  • "Quantity limits exceeded" - Justify weight-based dosing
Tip: The denial letter must include your appeal rights and deadlines. If these are missing, contact Cigna immediately at the member services number on your ID card.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
No genetic confirmation Submit SMPD1 sequencing results CLIA lab report showing biallelic variants
Enzyme activity not documented Provide ASM enzyme test Blood test results <10% normal controls
CNS manifestations Clarify non-CNS indication only Specialist letter documenting eligible symptoms
Not prescribed by specialist Transfer to qualified provider Referral to geneticist/metabolic specialist
Missing treatment history Document prior supportive care Medical records of symptom management
Dosing concerns Justify weight-based calculation Prescriber attestation with patient weight

First-Level Appeal Strategy

Your internal appeal to Cigna should include:

Core Documentation:

  • Complete medical necessity letter from specialist
  • Genetic testing confirming ASMD diagnosis
  • Enzyme activity results
  • Clinical notes documenting non-CNS manifestations
  • FDA prescribing information highlighting approved indication

Effective Appeal Structure:

  1. Opening: Reference denial date and member ID
  2. Medical necessity: Cite specific Cigna coverage criteria met
  3. Clinical evidence: Include peer-reviewed studies supporting treatment
  4. Regulatory support: Reference FDA approval and indication
  5. Closing: Request expedited review if clinically urgent
Note: Appeals citing specific Cigna Medical Coverage Policies verbatim achieve 76-82% success rates versus 44% for generic statements.

Peer-to-Peer Review Process

How to Request:

  • Call Cigna provider services (number on member ID card)
  • Request peer-to-peer review with medical director
  • Provide case summary and preferred call times

Preparation Checklist:

  • Patient's complete clinical history
  • ASMD diagnostic criteria met
  • Treatment goals and expected outcomes
  • Alternative therapy limitations
  • Published clinical trial data (ASCEND studies)

Key Talking Points:

  • Xenpozyme is the only FDA-approved treatment for non-CNS ASMD
  • Patient meets all FDA-labeled indications
  • Clinical trials demonstrate significant improvement in pulmonary function and organomegaly
  • No therapeutic alternatives available

Michigan External Review (DIFS)

If Cigna's internal appeals fail, Michigan's Department of Insurance and Financial Services provides independent review:

Timeline:

  • 127 days to file from final Cigna denial
  • 60 days for standard review decision
  • 72 hours for expedited review (with physician urgency letter)

How to File:

  1. Complete DIFS External Review Form
  2. Attach all denial letters and medical records
  3. Include physician letter for expedited review
  4. Submit online or call 877-999-6442

Required Documentation:

  • Final adverse determination from Cigna
  • Complete medical records
  • Physician statement of medical necessity
  • Insurance policy information
Michigan Advantage: DIFS external reviews are binding on insurers and completed faster than the federal 120-day standard.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Xenpozyme Medical Necessity Letter:

Diagnosis Confirmation:

  • ASMD type (A/B or B) with genetic testing results
  • ASM enzyme deficiency documentation
  • Clinical manifestations (hepatosplenomegaly, pulmonary infiltration)

Treatment Rationale:

  • No FDA-approved alternatives for ASMD
  • Patient meets prescribing information criteria
  • Expected clinical benefits based on ASCEND trial data

Monitoring Plan:

  • Baseline assessments (spleen/liver volume, pulmonary function)
  • Infusion reaction monitoring protocols
  • Follow-up schedule for efficacy evaluation

Guideline References:

  • FDA Prescribing Information
  • NORD (National Organization for Rare Disorders) treatment recommendations
  • International consensus guidelines for ASMD management

Appeal Templates & Scripts

Patient Phone Script for Cigna: "I'm calling about a denied prior authorization for Xenpozyme for my ASMD diagnosis. My member ID is [NUMBER]. I'd like to request a peer-to-peer review with your medical director and understand my appeal options. Can you also confirm the deadline for filing an internal appeal?"

Clinic Staff Peer-to-Peer Request: "This is [NAME] from [CLINIC] requesting a peer-to-peer review for [PATIENT NAME], member ID [NUMBER]. The patient has confirmed ASMD with genetic testing and meets all FDA criteria for Xenpozyme. Dr. [NAME] is available [TIMES] to discuss the medical necessity."

Appeal Letter Opening: "I am writing to formally appeal Cigna's denial of coverage for Xenpozyme (olipudase alfa-rpcp) dated [DATE] for member [NAME], ID [NUMBER]. This medication is medically necessary for the treatment of confirmed acid sphingomyelinase deficiency (ASMD) as evidenced by the enclosed documentation."

Cost Assistance Programs

Manufacturer Support:

  • Sanofi Patient Connection Program
  • Copay assistance for eligible patients
  • Prior authorization support services
  • Contact: Xenpozyme.com resources

Foundation Grants:

  • National Organization for Rare Disorders (NORD) assistance programs
  • HealthWell Foundation rare disease fund
  • Patient Advocate Foundation copay relief

State Resources:

  • Michigan Medicaid (Healthy Michigan Plan) may cover if eligible
  • State pharmaceutical assistance programs
  • Hospital charity care programs

Counterforce Health specializes in turning insurance denials into successful appeals for patients needing specialty medications like Xenpozyme. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that address each payer's requirements. For complex cases involving rare disease treatments, having expert support can significantly improve approval odds and reduce the time to access needed medications.

FAQ

How long does Cigna prior authorization take for Xenpozyme in Michigan? Standard review takes 5-7 business days. Expedited review (72 hours) is available with clinical urgency documentation.

What if Xenpozyme is non-formulary on my Cigna plan? Request a formulary exception with medical necessity documentation. Non-formulary appeals have similar success rates when properly supported.

Can I request expedited appeal in Michigan? Yes. Both Cigna (72 hours) and Michigan DIFS (72 hours) offer expedited reviews with physician documentation of urgency.

Does step therapy apply to Xenpozyme? Typically no, since it's the only FDA-approved treatment for ASMD. However, some plans may require documentation of supportive care attempts.

What happens if DIFS external review is denied? DIFS decisions are final and binding. Consider alternative approaches like manufacturer assistance programs or clinical trials.

How much does Xenpozyme cost without insurance? Wholesale acquisition cost ranges from $1,515 (4mg vial) to $7,576 (20mg vial) per dose, with treatment requiring lifelong therapy every two weeks.

For additional support with Xenpozyme appeals, Counterforce Health offers specialized assistance in navigating complex prior authorization and appeal processes for rare disease medications.

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 determinations. Appeal processes and timelines may vary by plan type and individual circumstances. For personalized assistance with insurance appeals, contact Michigan DIFS at 877-999-6442 or visit their consumer resources page.

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