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

How to Get Xenpozyme (olipudase alfa-rpcp) Covered by Humana in Florida: PA Forms, Appeals & Cost Support

Answer Box: Getting Xenpozyme Covered by Humana in Florida

Fastest path to approval: Submit prior authorization with genetic confirmation of ASMD (SMPD1 mutation), documented spleen volume ≥5 multiples normal, and DLco ≤70% predicted. Humana typically requires specialty pharmacy dispensing and approved infusion sites. First step today: Have your prescriber gather diagnostic documentation and submit PA request through Humana's provider portal. If denied, you have 65 days to appeal. Florida residents can request external review through the Department of Financial Services if internal appeals fail.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Genetic confirmation Pathogenic SMPD1 mutation Genetic test results Humana Policy
Enzyme deficiency Reduced ASM activity Lab results showing enzyme levels FDA Label
Spleen enlargement ≥5 multiples of normal MRI or ultrasound results Medical Policy
Lung function DLco ≤70% predicted Pulmonary function tests Medical Policy
Specialist prescriber ASMD specialist required Neurologist, hepatologist, or geneticist Coverage Criteria
Site of care Approved infusion center Specialty infusion facility Billing Guide

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis (Patient & Doctor) Gather genetic testing showing SMPD1 mutation and enzyme activity results. Expected timeline: 1-2 weeks if tests are complete.

2. Document Clinical Criteria (Doctor) Obtain current spleen volume measurements and pulmonary function tests (DLco). Submit through Humana provider portal. Expected timeline: 2-3 days.

3. Submit Prior Authorization (Doctor) Include all diagnostic documentation, specialist consultation, and treatment plan. Humana typically responds within 7-14 days for standard requests.

4. Choose Specialty Pharmacy (Patient) Select a Humana-contracted specialty pharmacy. CenterWell Specialty Pharmacy is Humana's preferred network option.

5. Coordinate Infusion Site (Patient & Pharmacy) Arrange administration at an approved specialty infusion center in Florida. Verify site is in Humana's network.

6. Monitor for Approval (Patient) Track request status through Humana member portal. Contact customer service at 1-800-HUMANA if no response within 14 days.

7. Begin Treatment (Patient) Once approved, coordinate first infusion appointment. Initial approval typically covers 6 months with annual renewals.

Understanding Your Costs

Xenpozyme costs vary significantly based on your Humana plan type and coverage tier. The wholesale acquisition cost ranges from approximately $1,515 for a 4mg vial to $7,576 for a 20mg vial (as of January 2025).

Medicare Advantage Plans

If you have Humana Medicare Advantage, Xenpozyme will likely be covered under your medical benefit (Part B) rather than prescription drug coverage (Part D) since it's an infusion therapy. Your costs may include:

  • Deductible (if applicable)
  • Coinsurance (typically 20% after deductible)
  • Infusion administration fees

Commercial Insurance Plans

For employer-sponsored or individual Humana plans, costs depend on your specific benefit design and whether Xenpozyme is on formulary.

Note: Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Xenpozyme. Their platform analyzes denial letters and creates evidence-backed appeals tailored to your specific plan's requirements.

Manufacturer Assistance Programs

CareConnect Copay Assistance (Commercial Insurance Only) Sanofi offers copay assistance for eligible patients with commercial insurance. This program can help reduce out-of-pocket costs for copays, coinsurance, and deductibles.

  • Eligibility: U.S. patients with commercial insurance
  • Not eligible: Medicare, Medicaid, VA, DOD, TRICARE, or state programs
  • Contact: 1-800-745-4447 or CareConnect website

Patient Assistance Program For uninsured or underinsured patients, Sanofi may provide Xenpozyme at no cost through their patient assistance program.

  • Eligibility: Uninsured patients or those unable to access medication through insurance
  • Application: Through CareConnect at 1-800-745-4447
Medicare patients: Since you cannot use manufacturer copay cards, focus on appeals and formulary exceptions if facing high costs.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documentation Needed
Insufficient genetic evidence Submit complete genetic panel SMPD1 mutation analysis from certified lab
Missing specialist consultation Obtain ASMD specialist evaluation Letter from neurologist, hepatologist, or geneticist
Inadequate organ measurements Provide current imaging Recent MRI/ultrasound showing spleen volume
Site of care not approved Request exception or change location Medical necessity for specific infusion site
Step therapy required Document contraindications Medical records showing why alternatives won't work

Appeals Process in Florida

Internal Appeal (First Level) You have 65 days from denial notice to file an internal appeal with Humana. Submit through:

Timeline: Humana must respond within 7 days for urgent requests, 30 days for standard appeals.

External Review (Second Level) If internal appeal fails, Florida residents can request external review through an independent organization.

Tip: For urgent situations requiring immediate treatment, you can request expedited appeals at both internal and external levels.

From Our Advocates

We've seen patients successfully overturn Xenpozyme denials by ensuring their genetic testing documentation clearly shows both the SMPD1 mutation and enzyme deficiency levels. One common issue is incomplete genetic panels that don't include enzyme activity measurements—having both pieces of evidence significantly strengthens your case.

Specialty Pharmacy Requirements

Xenpozyme must be dispensed through a specialty pharmacy due to its complex handling and administration requirements. In Florida, Humana contracts with several specialty pharmacy networks:

Preferred Options:

  • CenterWell Specialty Pharmacy (Humana's own network)
  • Accredo Specialty Pharmacy
  • CVS Specialty

Requirements:

  • Cold chain storage and shipping
  • Coordination with infusion centers
  • Prior authorization verification
  • Patient education and monitoring

Site of Care Restrictions: Most Humana policies require administration at specialty infusion centers rather than hospital outpatient departments, unless medically necessary. Verify your specific infusion site is in-network before scheduling.

When to Escalate

Contact Florida Insurance Regulators: If you've exhausted internal appeals and need additional assistance, contact:

State External Review: Florida contracts with independent medical experts to review denied claims. This process is binding on insurers if they rule in your favor.

Additional Support: Counterforce Health can help analyze denial letters and create targeted appeals based on Humana's specific policies and Florida regulations. Their platform specializes in rare disease medication appeals and understands the complex requirements for treatments like Xenpozyme.

FAQ

How long does Humana prior authorization take for Xenpozyme in Florida? Standard requests typically take 7-14 days. Urgent requests must be processed within 72 hours. Track status through the Humana member portal or by calling customer service.

What if Xenpozyme is not on Humana's formulary? You can request a formulary exception. Your doctor must provide a statement explaining why covered alternatives are inappropriate. The process follows the same timeline as prior authorization.

Can I get expedited approval if I'm already on treatment? Yes, if there's an urgent medical need. Your doctor must document why delays could cause serious harm. Expedited requests receive decisions within 72 hours.

Does step therapy apply to Xenpozyme? Since Xenpozyme is the only FDA-approved treatment for ASMD, step therapy typically doesn't apply. However, some plans may require documentation that supportive care measures have been tried.

What happens if my appeal is denied? You can proceed to external review through Florida's independent review process. This is free and the decision is binding on Humana.

Are there quantity limits on Xenpozyme? Yes, most plans limit dosing to 3 mg/kg every two weeks, consistent with FDA labeling. Higher doses require additional justification.

Can I switch infusion sites if needed? Yes, but the new site must be in Humana's network and meet specialty infusion requirements. Some plans may require prior notification.

How often do I need reauthorization? Initial approvals typically last 6 months, with annual renewals thereafter. Your doctor must document continued medical necessity and treatment response.

Sources & Further Reading

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 guidance specific to your situation. For assistance with insurance appeals and coverage determinations, consider consulting with healthcare coverage specialists who understand the complexities of rare disease medication access.

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