By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (Odevixibat) Covered by Aetna CVS Health in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Bylvay Covered by Aetna CVS Health in Georgia

Bylvay (odevixibat) requires prior authorization through Aetna CVS Health and is listed as "not formulary" on most plans, requiring a medical necessity exception. Your fastest path to approval: 1) Confirm genetic diagnosis of PFIC or Alagille syndrome, 2) Document failed trials of ursodiol and bile acid sequestrants, 3) Submit PA request through Aetna provider portal with specialist consultation. Start today: Call member services at the number on your insurance card to confirm your specific formulary tier and PA requirements. If denied: Georgia allows external review within 60 days through the Georgia Department of Insurance.

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 Tracking
  6. Typical Timeline Expectations
  7. Handling Requests for Additional Information
  8. If Your Request Is Denied
  9. Renewal and Reauthorization
  10. Coverage Requirements at a Glance
  11. Appeals Process in Georgia
  12. Common Denial Reasons and Solutions
  13. FAQ
  14. Printable Checklist

What This Guide Covers

This guide helps patients with progressive familial intrahepatic cholestasis (PFIC) or Alagille syndrome—and their healthcare teams—navigate Aetna CVS Health's prior authorization process for Bylvay (odevixibat) in Georgia. We'll walk through the specific documentation requirements, appeal procedures, and Georgia-specific consumer protections that can help you secure coverage for this specialty medication.

Bylvay is a costly specialty drug (ranging from approximately $14,000 to $45,000 per month depending on dosing) that requires careful justification for insurance approval. With the right preparation and documentation, many patients successfully obtain coverage through Aetna's medical necessity review process.

Before You Start: Verify Your Coverage

Step 1: Confirm Your Plan Type and Formulary Status

Call the member services number on your Aetna insurance card to verify:

  • Your specific plan formulary (Standard, Advanced Control, etc.)
  • Whether Bylvay requires prior authorization or is non-formulary
  • If your plan requires specialty pharmacy dispensing
  • Whether the drug falls under pharmacy or medical benefit
Note: Based on 2024-2025 Aetna formulary documents, Bylvay is listed as "NF" (Not Formulary) on most plans, meaning coverage requires a formulary exception request.

Step 2: Verify In-Network Status

Ensure your prescribing physician is in-network with Aetna. For specialty medications like Bylvay, you'll typically need:

  • A gastroenterologist or hepatologist as the prescriber
  • Consultation documentation if prescribed by another specialist

Step 3: Check Pharmacy Benefit Requirements

Aetna often requires specialty medications to be dispensed through CVS Specialty Pharmacy or other designated specialty pharmacy partners. Confirm this requirement during your member services call.

Gather Required Documentation

Essential Clinical Documentation

Diagnosis Confirmation:

  • Genetic testing results confirming PFIC or clinical diagnosis of Alagille syndrome
  • ICD-10 codes (verify with your physician)
  • Age verification (≥3 months for PFIC, ≥12 months for Alagille syndrome)

Severity Documentation:

  • Clinical notes documenting moderate to severe pruritus
  • Pruritus severity scales or patient-reported outcomes
  • Impact on quality of life documentation

Prior Treatment History:

  • Documentation of trials and failures/intolerance of:
    • Ursodeoxycholic acid (ursodiol)
    • At least one bile acid sequestrant (cholestyramine, colesevelam, or colestipol)
    • Other conventional treatments (antihistamines, rifampin, naltrexone)
  • Specific reasons for discontinuation or lack of efficacy

Laboratory Results:

  • Baseline liver function tests
  • Fat-soluble vitamin levels
  • Bile acid levels (if available)

Administrative Requirements

  • Completed Aetna prior authorization form (obtain from provider portal)
  • Prescriber attestation of medical necessity
  • Chart notes from specialist consultations
  • Current medication list and dosing rationale

Submit Your Prior Authorization Request

Submission Methods

Provider Portal (Preferred):

  • Log into Aetna's provider portal
  • Navigate to prior authorization section
  • Upload all required documentation as a complete packet

Fax Submission:

  • Use the fax number specified on the PA form (verify current number)
  • Include cover sheet with member ID and drug name
  • Confirm receipt with follow-up call

Clean Request Packet Checklist

  • Completed PA form with all fields filled
  • Genetic testing or diagnostic confirmation
  • Prior treatment failure documentation
  • Current clinical notes from specialist
  • Laboratory results (baseline and recent)
  • Prescriber attestation letter
  • Insurance card copy
  • Patient demographics verification
Tip: Incomplete submissions are a leading cause of delays. Review your packet twice before submitting.

Follow-Up and Tracking

Day 3: Call to confirm receipt and obtain reference number Day 10: Status check call Day 20: If no decision, request expedited review if clinically appropriate Day 30: If approaching deadline, prepare appeal documentation

Sample Call Script

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

Documentation During Calls

Keep a log with:

  • Date and time of call
  • Representative name and ID number
  • Reference numbers provided
  • Next steps or requested information
  • Promised callback times

Typical Timeline Expectations

Standard Review Timelines

Aetna Internal Review:

  • Standard requests: 30-45 days
  • Expedited/urgent requests: 72 hours
  • Additional information requests: Add 10-14 days

Georgia-Specific Protections:

  • Aetna must provide written notice of denials
  • Members have 180 days to file internal appeals
  • External review must be requested within 60 days of final internal denial
Note: Urgent medical situations may qualify for expedited review. Discuss with your physician if delays could impact your health.

Handling Requests for Additional Information

Common Information Requests

Medical Necessity Clarification:

  • More detailed treatment history
  • Specialist consultation notes
  • Additional laboratory data
  • Literature supporting off-label use (if applicable)

Response Strategy:

  • Respond within requested timeframe (typically 10-14 days)
  • Provide comprehensive documentation
  • Include peer-reviewed literature when relevant
  • Request expedited review if clinically indicated

Working with Your Healthcare Team

Your physician may need to provide:

  • Letter of medical necessity
  • Peer-to-peer consultation with Aetna medical director
  • Additional clinical documentation
  • Alternative treatment rationale

If Your Request Is Denied

Understanding Denial Reasons

Review your denial letter carefully for specific reasons:

  • Non-formulary status
  • Lack of medical necessity
  • Insufficient prior treatment documentation
  • Age or diagnostic criteria not met

First-Level Appeal Process

Internal Appeal (Required First Step):

  • Submit within 180 days of denial notice
  • Include additional supporting documentation
  • Request peer-to-peer review if appropriate
  • Consider expedited appeal for urgent situations

Appeal Documentation:

  • Original denial letter
  • Additional medical records
  • Updated physician letter
  • Relevant clinical guidelines or literature
  • Patient impact statement (optional)

Appeals Process in Georgia

Georgia External Review Rights

If your internal appeal is denied, Georgia law provides additional protection through external review:

External Review Process:

  • Must be requested within 60 days of final internal denial
  • Conducted by independent medical reviewers
  • Free to consumers
  • Binding on insurance companies

How to Request External Review:

  • Contact Georgia Department of Insurance Consumer Services: 1-800-656-2298
  • Submit application through Georgia DOI website
  • Include all relevant medical documentation
  • Specify urgent review if medically necessary

External Review Timeline:

  • Standard review: 30 business days
  • Expedited review: 72 hours for urgent situations
  • Decision is binding on Aetna

Additional Georgia Resources

Georgians for a Healthy Future: Provides consumer assistance with insurance appeals and can offer guidance on the external review process.

Georgia Legal Services Program: May assist with complex cases involving Medicaid or other public insurance appeals.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Diagnosis PFIC or Alagille syndrome Genetic testing or clinical diagnosis FDA Label
Age ≥3 months (PFIC), ≥12 months (ALGS) Birth certificate or medical records FDA Labeling
Prior Treatments Failed ursodiol + bile acid sequestrant Treatment history documentation Payer policies
Prescriber Gastroenterologist or hepatologist Specialist consultation notes Typical PA requirements
Formulary Status Non-formulary on most Aetna plans Medical necessity exception required Aetna Formulary Documents
Appeal Deadline (GA) 60 days for external review Denial letter, medical records Georgia DOI

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Non-formulary status Request formulary exception Medical necessity letter, prior failures
Insufficient prior treatments Document additional trial/failure history Detailed treatment timeline, reasons for discontinuation
Age below threshold Verify age requirements for diagnosis Birth records, diagnostic confirmation
Lack of specialist involvement Obtain specialist consultation Hepatologist or gastroenterologist evaluation
Experimental/investigational Emphasize FDA approval FDA labeling, clinical guidelines

Renewal and Reauthorization

Planning for Reauthorization

Timeline:

  • Initial approvals typically for 3 months
  • Renewals may extend to 12 months
  • Start reauthorization process 30 days before expiration

Required Evidence for Renewal:

  • Updated laboratory results
  • Clinical response documentation
  • Continued medical necessity
  • Specialist evaluation
  • Treatment adherence records

Demonstrating Clinical Benefit

Document improvements in:

  • Pruritus severity scores
  • Quality of life measures
  • Laboratory parameters
  • Growth and development (pediatric patients)

FAQ

Q: How long does Aetna prior authorization take in Georgia? A: Standard requests take 30-45 days. Expedited reviews for urgent situations are completed within 72 hours.

Q: What if Bylvay is non-formulary on my plan? A: You can request a formulary exception by demonstrating medical necessity and providing documentation of prior treatment failures.

Q: Can I request an expedited appeal in Georgia? A: Yes, both internal appeals and external reviews can be expedited if your medical situation is urgent and delays could cause serious harm.

Q: Does step therapy apply if I failed treatments in another state? A: Treatment history from other states should be accepted if properly documented. Provide comprehensive records from previous healthcare providers.

Q: What's the difference between internal and external review? A: Internal review is conducted by your insurance company. External review is performed by independent medical experts and is binding on the insurer.

Q: How much does Bylvay cost without insurance? A: Bylvay costs approximately $14,000-$45,000 per month depending on dosing, with annual costs potentially exceeding $100,000.

Printable Checklist

Before Starting:

  • Verify formulary status and PA requirements
  • Confirm specialist is in-network
  • Check specialty pharmacy requirements

Documentation to Gather:

  • Genetic testing results or diagnostic confirmation
  • Prior treatment failure documentation
  • Current specialist consultation notes
  • Laboratory results (LFTs, vitamin levels)
  • Completed PA form
  • Insurance card and member information

Submission Process:

  • Submit complete packet via provider portal or fax
  • Obtain confirmation and reference number
  • Schedule follow-up calls
  • Document all interactions

If Denied:

  • Review denial letter for specific reasons
  • File internal appeal within 180 days
  • Gather additional supporting documentation
  • Consider external review if internal appeal fails

When navigating complex prior authorization processes for specialty medications like Bylvay, having expert support can make a significant difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed submissions. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements, potentially saving weeks of back-and-forth communication.

For patients in Georgia facing Aetna denials, remember that you have strong consumer protections through the state's external review process. With proper documentation and persistence, many patients successfully obtain coverage for Bylvay through the appeals process. The key is thorough preparation, timely submission, and understanding your rights under Georgia insurance law.

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 company for the most current requirements and procedures. Insurance policies and state regulations may change, so verify all information with official sources before making decisions about your care.

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