By Counterforce Health Team in Elelyso (taliglucerase alfa) —

How to Get Elelyso (taliglucerase alfa) Covered by Aetna CVS Health in Ohio: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Started

Elelyso (taliglucerase alfa) requires prior authorization from Aetna CVS Health for Type 1 Gaucher disease. In Ohio, the fastest path to approval involves: 1) Confirming your diagnosis with enzyme testing and genetic results, 2) Using Aetna's Medical Exception/Prior Authorization form with complete clinical documentation, and 3) Submitting via phone (1-855-240-0535) or electronic portal for faster processing. Standard decisions take up to 15 business days; expedited reviews complete within 72 hours when medically urgent.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. Common Denial Reasons and Solutions
  7. Appeals Process in Ohio
  8. Renewal and Re-Authorization
  9. Financial Assistance Options
  10. FAQ

What This Guide Covers

This comprehensive guide helps patients with Type 1 Gaucher disease and their healthcare teams navigate Aetna CVS Health's prior authorization process for Elelyso (taliglucerase alfa) in Ohio. Whether you're starting treatment or switching from another enzyme replacement therapy, this guide provides the forms, timelines, and appeal strategies you need.

Elelyso is an FDA-approved enzyme replacement therapy for patients 4 years and older with Type 1 Gaucher disease. At approximately $839-899 per 200-unit vial according to Pfizer's pricing disclosures, prior authorization is standard practice for this specialty medication.

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Elelyso. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements.

Before You Start: Verify Your Coverage

Step 1: Identify Your Plan Type

Check your insurance card to determine which type of Aetna coverage you have:

  • Aetna Commercial/CVS Health (employer or marketplace plans)
  • Aetna Better Health of Ohio (Medicaid managed care)
  • Aetna Medicare plans

Step 2: Confirm Elelyso Coverage

Call the member services number on your card to verify:

  • Whether Elelyso is covered under your pharmacy or medical benefit
  • Your formulary tier and any quantity limits
  • Whether step therapy requirements apply
  • Your expected copay or coinsurance
Note: Most Aetna plans require CVS Specialty Pharmacy for Elelyso dispensing, as it's on their specialty distribution drug list.

Gather Required Documentation

Coverage Requirements at a Glance

Requirement What You Need Where to Find It
Confirmed Diagnosis Beta-glucocerebrosidase enzyme assay + genetic testing Lab reports showing GBA gene mutations
ICD-10 Code E75.22 (Gaucher disease) Medical records
Prescriber Qualification Specialist in metabolic/lysosomal disorders Hematologist, geneticist, or metabolic specialist
Clinical Documentation Disease manifestations, prior therapies Medical records, imaging studies
Prior Authorization Form Aetna's prescription drug PA form Aetna provider portal

Essential Clinical Documentation

Your healthcare provider will need to submit:

  1. Diagnostic Confirmation
    • Enzyme assay showing deficient beta-glucocerebrosidase activity
    • Genetic testing confirming GBA gene mutations
    • Clinical notes documenting Gaucher disease manifestations
  2. Disease Burden Documentation
    • Splenomegaly and/or hepatomegaly (imaging reports)
    • Hematologic involvement (recent CBC showing anemia/thrombocytopenia)
    • Skeletal complications (bone pain, fractures, osteopenia)
    • Functional impact on daily activities
  3. Treatment History
    • Previous enzyme replacement therapies tried
    • Reasons for switching (if applicable)
    • Any contraindications to alternative treatments

Submit Your Prior Authorization Request

Fastest Path to Approval (7 Steps)

  1. Verify eligibility through Aetna member services
  2. Complete diagnostic workup with enzyme and genetic testing
  3. Obtain Aetna's PA form from their provider portal
  4. Compile clinical documentation including all required elements above
  5. Submit via phone (1-855-240-0535) for fastest processing
  6. Request expedited review if medically urgent
  7. Follow up within 5 business days if no response

Submission Options

Electronic Submission (Fastest)

  • Use Aetna's provider portal through Availity
  • Electronic prior authorization (ePA) provides significantly faster turnaround
  • Automated system can return decisions within hours for straightforward cases

Phone Submission

  • Call 1-855-240-0535 (Monday-Friday, 8 AM-6 PM CT)
  • Have all documentation ready before calling
  • Request confirmation number and expected decision timeline

Fax Submission

  • Use fax number provided on the PA form
  • Include cover sheet with patient information
  • Follow up by phone to confirm receipt
Tip: Aetna recommends submitting precertification requests at least two weeks in advance of your planned treatment start date.

Follow-Up and Timeline Expectations

Standard Review Timelines

  • Commercial/Marketplace Plans: Up to 15 business days for standard review
  • Expedited/Urgent: Within 72 hours when delay could jeopardize health
  • Ohio Medicaid (Aetna Better Health): Up to 10 calendar days for routine, 48 hours for urgent

When to Follow Up

Call Aetna if you haven't received a decision within:

  • 5 business days for expedited requests
  • 10 business days for standard requests
  • 15 business days (maximum timeframe)

Sample Follow-Up Script

"Hi, I'm calling to check on the status of a prior authorization request for Elelyso for [patient name], member ID [number]. The request was submitted on [date] with reference number [if available]. Can you provide an update on the review status and expected decision timeline?"

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit detailed clinical rationale Disease manifestations, functional impact, treatment goals
"Experimental/investigational" Cite FDA approval and guidelines FDA label, clinical studies
"Step therapy required" Document contraindications to preferred agents Medical records showing intolerances or failures
"Insufficient documentation" Provide complete diagnostic workup Enzyme assay, genetic testing, specialist evaluation

Medical Necessity Letter Checklist

Your prescriber should include:

  • Problem statement: Type 1 Gaucher disease with specific manifestations
  • Prior treatments: Other ERTs tried and outcomes
  • Clinical rationale: Why Elelyso is medically necessary
  • Supporting evidence: FDA approval, treatment guidelines
  • Treatment plan: Dosing regimen and monitoring schedule

Appeals Process in Ohio

Internal Appeals with Aetna

First-Level Appeal

  • Submit within 180 days of denial
  • Use Aetna's appeal form or written request
  • Include additional clinical documentation
  • Decision within 30 days (72 hours if expedited)

Peer-to-Peer Review

  • Request physician-to-physician discussion
  • Aetna medical director reviews case with prescriber
  • Can often resolve issues without formal appeal

Ohio External Review Process

If internal appeals are unsuccessful, Ohio residents can request external review through the Ohio Department of Insurance:

  1. Eligibility: Must exhaust Aetna's internal appeals first
  2. Timeline: Request within 4 months of final denial
  3. Process: Submit through ODI's External Review System online
  4. Decision: Independent review organization decides within 30 days (72 hours if expedited)
  5. Binding: Aetna must cover if denial is overturned

Ohio Consumer Hotline: 1-800-686-1526 for assistance with appeals

Renewal and Re-Authorization

When to Resubmit

  • Most Elelyso authorizations are approved for 12 months
  • Submit renewal requests 30-60 days before expiration
  • Calendar reminders help avoid treatment interruptions

Renewal Documentation

Include evidence of treatment benefit:

  • Improved hematologic parameters (hemoglobin, platelets)
  • Reduced organ volumes (liver/spleen measurements)
  • Decreased bone pain or skeletal complications
  • Enhanced quality of life measures

Financial Assistance Options

Pfizer Support Programs

  • Pfizer Patient Assistance Program: Income-based medication assistance
  • Copay support: May reduce out-of-pocket costs for eligible patients
  • Contact: 1-844-989-7284 or PfizerRxPathways.com

Foundation Grants

  • National Gaucher Foundation: Financial assistance for treatment costs
  • Patient Advocate Foundation: Copay relief programs
  • HealthWell Foundation: Disease-specific grants

CVS Specialty Pharmacy Support

CVS Specialty provides benefits verification and financial assistance screening for Elelyso patients, including coordination with manufacturer programs.

FAQ

How long does Aetna CVS Health prior authorization take in Ohio? Standard decisions take up to 15 business days, while expedited reviews are completed within 72 hours when medically urgent. Electronic submissions are typically faster than fax or mail.

What if Elelyso is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and providing clinical justification for why preferred alternatives aren't appropriate.

Can I request an expedited appeal if denied? Yes, if your prescriber certifies that delay would seriously jeopardize your health or ability to regain maximum function, you can request expedited review with 72-hour turnaround.

Does step therapy apply if I've been on Elelyso in another state? Continuation of current therapy is typically approved without step therapy requirements, but you'll need documentation of your treatment history and current clinical status.

What happens if my appeal is denied? Ohio residents can request external review through the Ohio Department of Insurance, where an independent medical expert reviews your case. This decision is binding on Aetna.

How much does Elelyso cost without insurance? The wholesale acquisition cost is approximately $839-899 per 200-unit vial, with typical dosing requiring multiple vials per infusion depending on patient weight and prescribed dose.

Counterforce Health transforms insurance denials into successful approvals by analyzing payer policies and crafting targeted appeals with the right evidence and clinical documentation. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for rare disease treatments like Elelyso.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult your healthcare provider and insurance plan for specific guidance. For additional help with Ohio health insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.

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