By Counterforce Health Team in Elelyso (taliglucerase alfa) —

How to Get Elelyso (taliglucerase alfa) Covered by Humana in Ohio: Complete Prior Authorization Guide

Answer Box: Getting Elelyso (taliglucerase alfa) Covered by Humana in Ohio

Humana requires prior authorization for Elelyso (taliglucerase alfa) across all Ohio plans in 2025. To get approval: (1) Have your Gaucher specialist submit a PA request with confirmed Type 1 Gaucher disease diagnosis, enzyme deficiency labs, and clinical severity documentation. (2) Address any step therapy requirements by documenting prior ERT trials or contraindications. (3) Use Humana's plan-specific PA form via provider portal or fax. Standard decisions take 7-30 days; expedited reviews are available for urgent cases within 72 hours.

Start today: Contact your prescriber to confirm they have your complete Gaucher diagnostic workup and ask them to check Humana's current Elelyso coverage policy for your specific plan type.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding and Billing Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Appeals Process in Ohio
  11. Frequently Asked Questions
  12. Quick Reference Checklist

Who Should Use This Checklist

This guide is designed for Ohio residents with Type 1 Gaucher disease who need Elelyso (taliglucerase alfa) covered by Humana insurance, along with their healthcare providers. You'll find this most helpful if you're facing:

  • Initial prior authorization requirements for Elelyso
  • A denial that needs to be appealed
  • Questions about step therapy or medical necessity documentation
  • Confusion about Humana's specialty pharmacy requirements

Expected outcome: Following this checklist systematically increases your chances of approval by ensuring all of Humana's documented requirements are met upfront, reducing delays and denials.

Member & Plan Basics

Verify Active Coverage

Before starting any prior authorization process, confirm:

  • Your Humana plan is active and includes prescription drug coverage
  • Elelyso falls under your plan's medical benefit (most common) or pharmacy benefit
  • Your current deductible status and specialty drug cost-sharing

Plan Type Matters

Humana offers different products in Ohio with varying requirements:

  • Medicare Advantage: Prior authorization required; check 2025 Medicare PAL
  • Ohio Medicaid (Healthy Horizons): PA required; follows Ohio Medicaid rules
  • Commercial plans: Varies by employer group; check your specific formulary
Tip: Call the member services number on your insurance card to confirm your exact plan type and whether Elelyso requires prior authorization for your specific coverage.

Clinical Criteria for Approval

Diagnosis Documentation Required

Humana's Elelyso coverage policy requires confirmed Type 1 Gaucher disease with:

Requirement Documentation Needed
Enzyme deficiency Glucocerebrosidase activity <15% of normal range in leukocytes or fibroblasts
Genetic confirmation Biallelic pathogenic variants in GBA1 gene
Clinical severity Evidence of anemia, thrombocytopenia, hepatosplenomegaly, or bone disease
Prescriber qualification Specialist (hematologist, geneticist, or metabolic specialist)

Step Therapy Considerations

Many Humana plans require trial of preferred ERTs before approving Elelyso. Document:

  • Previous trials of imiglucerase (Cerezyme) or velaglucerase alfa (VPRIV)
  • Specific adverse reactions, inadequate response, or contraindications
  • Clinical rationale for why Elelyso is medically necessary over alternatives

From our advocates: We've seen cases where patients experienced infusion reactions to other ERTs but got Elelyso approved quickly when their specialist documented the specific allergic reactions and provided a detailed medical necessity letter explaining why Elelyso was the only viable option.

Coding and Billing Requirements

HCPCS and Dosing Information

  • J-code: J3060 (Injection, taliglucerase alfa, 10 units)
  • Standard dosing: 60 units/kg every 2 weeks via IV infusion
  • Billing units: Total dose ÷ 10 (e.g., 6,000 units = 600 billable units)
  • Supply limits: Maximum 700 billable units per 14-day period

ICD-10 Diagnosis Codes

  • E75.22 - Gaucher disease (primary)
  • Support with specific manifestation codes as applicable:
    • D64.9 - Anemia, unspecified
    • D69.6 - Thrombocytopenia
    • R16.0 - Hepatomegaly

Documentation Packet Essentials

Provider Note Requirements

Your prescriber's documentation should include:

  • Complete Gaucher disease history and diagnosis timeline
  • Current clinical status with specific lab values and imaging results
  • Treatment goals and expected outcomes
  • Dosing rationale based on patient weight and clinical response

Medical Necessity Letter Components

A strong letter addresses each Humana criterion:

  1. Confirmed diagnosis with enzyme assay results and genetic testing
  2. Clinical severity with current CBC, organ size measurements, bone involvement
  3. Prior treatment history including specific ERTs tried, duration, and outcomes
  4. Treatment rationale explaining why Elelyso is medically necessary
  5. Monitoring plan for safety and efficacy assessment

Required Attachments Checklist

  • Enzyme assay results showing glucocerebrosidase deficiency
  • Genetic testing confirming GBA1 mutations
  • Recent CBC and comprehensive metabolic panel
  • Imaging showing hepatosplenomegaly (if applicable)
  • Previous ERT treatment records and outcomes
  • Current prescriber's medical license and specialty certification

Submission Process

Finding the Right Form

Humana's prior authorization requirements vary by plan type:

Submission Methods

  • Electronic: Humana provider portal (preferred method)
  • Fax: Plan-specific fax numbers listed on PA forms
  • Phone: For urgent/expedited requests only
Note: Electronic submissions typically process faster and provide automatic confirmation numbers for tracking.

Required Fields That Cause Rejections

Common incomplete submissions lack:

  • Patient's exact Humana member ID and plan type
  • Prescriber's NPI number and specialty designation
  • Specific diagnosis with ICD-10 codes
  • Detailed clinical justification addressing each coverage criterion
  • Complete contact information for follow-up questions

Specialty Pharmacy Routing

Humana's Preferred Network

For most Humana plans, CenterWell Specialty Pharmacy is the preferred vendor for Elelyso. Benefits include:

  • Lower patient cost-sharing
  • Integrated prior authorization support
  • Coordination with infusion centers
  • Contact: 1-800-486-2668

Ohio-Specific Considerations

For Humana Healthy Horizons (Medicaid) in Ohio, pharmacy benefits are managed by Gainwell as the Single Pharmacy Benefit Manager. Confirm network specialty pharmacies through Ohio Medicaid resources.

Transfer Process

If switching from another specialty pharmacy:

  1. Contact CenterWell Specialty Pharmacy to initiate transfer
  2. Provide current pharmacy information and prescription details
  3. Confirm insurance benefits and copay assistance programs
  4. Schedule delivery timing to avoid treatment gaps

After Submission: What to Expect

Timeline for Decisions

Review Type Standard Timeline Expedited Timeline
Standard PA 7-30 calendar days Not applicable
Expedited PA Not applicable 72 hours
Peer-to-peer review 2-5 business days 24-48 hours

Status Tracking

  • Record your confirmation number for electronic submissions
  • Check status through Humana provider portal
  • Call member services if no response within expected timeframes
  • Document all communications with dates and representative names

What to Record

Keep detailed records of:

  • Submission date and method
  • Confirmation numbers
  • All phone conversations with dates and outcomes
  • Any additional documentation requests
  • Decision letters and next steps

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Incomplete diagnostic documentation
  2. Missing step therapy justification
    • Fix: Document specific reasons other ERTs failed or are contraindicated
    • Evidence needed: Detailed treatment history with dates, doses, and outcomes
  3. Non-specialist prescriber
    • Fix: Ensure prescriber is a qualified specialist in Gaucher disease
    • Requirement: Hematologist, geneticist, or metabolic specialist
  4. Insufficient clinical severity documentation
    • Fix: Provide current lab values showing anemia, thrombocytopenia, or organ involvement
    • Benchmark: Reference normal ranges and degree of abnormality
  5. Wrong plan-specific form or process
    • Fix: Verify current PA requirements for your exact Humana product
    • Check: Humana PA lists by plan type

Appeals Process in Ohio

Internal Appeals with Humana

If your initial request is denied:

  • Timeline: 60-65 days from denial date to file appeal
  • Method: Submit through provider portal or member services
  • Decision timeframe: 30 days standard, 72 hours expedited

Peer-to-Peer Review

Request a clinical discussion between your prescriber and Humana's medical director:

  • Usually available within 2-5 business days
  • Allows real-time discussion of clinical details
  • Often resolves denials without formal appeal

External Review in Ohio

After exhausting Humana's internal appeals, Ohio residents can request external review:

Important: Self-funded employer plans follow federal ERISA rules, not Ohio's external review process.

Frequently Asked Questions

Q: How long does Humana prior authorization take for Elelyso in Ohio? A: Standard reviews take 7-30 days. Expedited reviews (for urgent medical situations) are completed within 72 hours.

Q: What if Elelyso is not on my Humana formulary? A: Request a formulary exception with medical necessity documentation. You may receive temporary coverage while the request is reviewed.

Q: Can I get expedited approval if I'm currently on another ERT? A: Yes, if switching due to adverse reactions or treatment failure that creates urgent medical need. Your prescriber must document the urgency.

Q: Does Humana cover Elelyso for pediatric patients in Ohio? A: Yes, for patients 4 years and older with confirmed Type 1 Gaucher disease, following the same PA requirements.

Q: What if I've been stable on Elelyso but Humana requires step therapy? A: Document your current stable status and request continuation of existing therapy. Include clinical outcomes and any risks of switching treatments.

Q: Are there copay assistance programs for Elelyso? A: Yes, Pfizer offers Gaucher Personal Support (GPS) which includes financial assistance programs.

Quick Reference Checklist

Before Starting

  • Confirm active Humana coverage and plan type
  • Verify Elelyso requires PA for your specific plan
  • Gather complete diagnostic documentation
  • Identify qualified specialist prescriber

Documentation Package

  • Medical necessity letter addressing all Humana criteria
  • Enzyme assay results (<15% normal activity)
  • Genetic testing confirming GBA1 mutations
  • Current CBC and clinical assessment
  • Prior ERT treatment history and outcomes
  • Prescriber specialty certification

Submission

  • Use correct Humana PA form for your plan type
  • Submit via preferred method (electronic portal)
  • Record confirmation number and submission date
  • Set calendar reminder to check status

After Submission

  • Track status through provider portal
  • Respond promptly to any information requests
  • Coordinate with specialty pharmacy once approved
  • Document all communications and decisions

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer requirements, saving time and improving approval rates for complex specialty medications like Elelyso.

When you're facing a denial or complex prior authorization process, having expert support can make the difference between approval and continued delays. Counterforce Health specializes in navigating these exact scenarios, helping ensure that patients get access to the treatments they need.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional help with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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