How to Get Bylvay (odevixibat) Covered by Aetna (CVS Health) in New Jersey: Complete Timeline and Appeals Guide
Answer Box: Getting Bylvay Covered by Aetna in New Jersey
Aetna (CVS Health) requires prior authorization for Bylvay (odevixibat) with approval typically within 24 hours for complete commercial plan submissions. Key requirements: specialist prescription, genetic diagnosis confirmation (PFIC or Alagille syndrome), documented prior therapy failures, and baseline labs. If denied, you have 180 days to appeal internally, then can request New Jersey's IHCAP external review within 4 months of final denial.
First step today: Contact your hepatologist to gather genetic testing results, prior therapy documentation, and liver function tests, then submit PA through Aetna's Availity portal.
Table of Contents
- What Affects Bylvay Approval Timing
- Pre-Submission Preparation (0-2 Days)
- Submission to Initial Review (1-5 Days)
- Additional Information Requests (1-7 Days)
- Decision Window & Outcomes
- If Denied: New Jersey Appeals Process
- Renewal Cycles & Reauthorization
- Timeline Overview
- Coverage Requirements at a Glance
- Common Denial Reasons & Solutions
- FAQ
What Affects Bylvay Approval Timing
Several factors influence how quickly Aetna processes your Bylvay (odevixibat) prior authorization in New Jersey:
Plan Type Impact:
- Commercial plans: 95% approved within 24 hours when complete
- Medicare Advantage: Up to 14 days standard, 72 hours expedited
- Medicaid: Follows state timelines (typically up to 14 days)
Documentation Completeness: Missing genetic testing, prior therapy records, or specialist notes can delay approval by 5-10 days while additional information is requested.
Submission Method: Electronic submission through Aetna's Availity portal processes fastest, while fax submissions may take 2-3 additional days.
Pre-Submission Preparation (0-2 Days)
Essential Documentation Checklist
Before submitting your prior authorization, gather these required documents:
Patient Information:
- Insurance card and member ID
- Complete demographics and contact information
- Aetna precertification form
Clinical Documentation:
- Genetic testing results confirming PFIC (ATP8B1, ABCB11 mutations) or Alagille syndrome (JAG1, NOTCH2 mutations)
- Specialist consultation notes from hepatologist or gastroenterologist
- Baseline laboratory results: liver function tests and fat-soluble vitamin levels
- Documentation of moderate to severe pruritus
Prior Therapy Evidence:
- Trial and failure/intolerance of ursodeoxycholic acid (Ursodiol)
- At least one symptomatic pruritus therapy attempted (cholestyramine, rifampicin, or antihistamines)
- Specific dates, doses, duration, and reasons for discontinuation
Tip: Incomplete documentation is the #1 cause of delays. Verify you have all items before submission to avoid the additional information request cycle.
Submission to Initial Review (1-5 Days)
Fastest Submission Path
- Log into Availity Portal: Use Aetna's electronic system for real-time tracking
- Complete PA Form: Include all clinical attachments in initial submission
- Verify Submission: Confirm receipt and track status online
What Reviewers Check First:
- FDA-approved indication match (PFIC ≥3 months, Alagille syndrome ≥12 months)
- Specialist prescriber credentials
- Genetic diagnosis confirmation
- Prior therapy documentation completeness
New Jersey Regulatory Timeline
Under New Jersey insurance regulations, Aetna must process standard prior authorizations within reasonable timeframes. Commercial plans typically decide within 24 hours when submissions are complete.
Additional Information Requests (1-7 Days)
If Aetna requests additional information, respond immediately to avoid delays:
Common Requests:
- Updated liver function tests (if older than 3 months)
- More detailed prior therapy documentation
- Specialist letter explaining medical necessity
- Dosing rationale based on weight/age
How to Respond Quickly:
- Submit via the same portal/method as original request
- Reference original PA number in all communications
- Include cover letter summarizing what's being provided
Counterforce Health helps patients and clinicians navigate these complex documentation requirements by automatically identifying what evidence payers need and drafting targeted responses that align with Aetna's specific criteria.
Decision Window & Outcomes
Typical Approval Timeline
| Plan Type | Standard Decision | Expedited Decision |
|---|---|---|
| Commercial | 24 hours | Same day |
| Medicare Advantage | Up to 14 days | 72 hours |
| Medicaid | Up to 14 days | 72 hours |
Reading Your Approval Letter:
- Approved: Note the authorization number, quantity limits, and expiration date
- Approved with modifications: Check for dose/quantity restrictions
- Denied: Review specific denial reasons for appeal strategy
When to Request Expedited Review
Request urgent processing if:
- Severe pruritus is significantly impacting quality of life
- Risk of liver disease progression without immediate treatment
- Patient is currently stable on Bylvay from previous coverage
If Denied: New Jersey Appeals Process
New Jersey offers robust appeal rights through a two-tier system: internal Aetna appeals followed by independent external review.
Internal Appeal with Aetna
Timeline: File within 180 days of denial notice Decision: Aetna must respond within 30 days (72 hours if expedited)
Required Documentation:
- Copy of original denial letter
- Updated clinical notes supporting medical necessity
- Peer-reviewed literature supporting Bylvay use
- Specialist letter addressing specific denial reasons
New Jersey IHCAP External Review
If Aetna upholds the denial, you can request independent review through New Jersey's Independent Health Care Appeals Program (IHCAP).
Key Details:
- Deadline: 4 months (120 days) after final internal denial
- Cost: Free to patients
- Timeline: Decision within 30 business days
- Success Rate: Approximately 50% of external appeals favor consumers
- Contact: NJ DOBI Consumer Hotline: 1-800-446-7467
IHCAP Process:
- Complete internal appeals with Aetna first
- Submit external review request to Maximus Federal Services (current IHCAP administrator)
- Independent physician panel reviews case
- Decision is binding on Aetna
Note: New Jersey law requires insurers to continue coverage pending appeal outcomes in most cases, ensuring uninterrupted access to medically necessary treatments.
Renewal Cycles & Reauthorization
Bylvay Reauthorization Timeline
- Initial approval: 3-6 months
- Renewal cycle: Every 12 months
- Submission timing: 30 days before expiration
Required Renewal Documentation:
- Updated liver function tests and vitamin levels (within 3 months)
- Clinical notes demonstrating continued benefit or medical necessity
- Confirmation that FDA indication criteria remain met
- Evidence of ongoing specialist management
Processing Time: Renewals typically process within 1 week for complete submissions.
Timeline Overview
Complete Bylvay Approval Process
| Milestone | Timeline | Action Required |
|---|---|---|
| Document gathering | 0-2 days | Collect genetic testing, labs, prior therapies |
| PA submission | Day 1 | Submit via Availity portal |
| Initial review | 1-2 days | Aetna reviews for completeness |
| Additional info (if needed) | 3-7 days | Respond to any requests immediately |
| Final decision | 1-24 hours after complete | Approval/denial notification |
| Appeal (if denied) | Within 180 days | File internal appeal |
| IHCAP external review | Within 120 days of final denial | Submit to NJ independent review |
Coverage Requirements at a Glance
| Requirement | Details | Documentation Needed |
|---|---|---|
| Diagnosis | PFIC (≥3 months) or Alagille syndrome (≥12 months) | Genetic testing results |
| Prescriber | Hepatologist or gastroenterologist | NPI and specialty credentials |
| Prior Therapies | Failed/intolerant to Ursodiol + ≥1 pruritus treatment | Clinical notes with dates, doses, outcomes |
| Baseline Labs | Liver function tests, fat-soluble vitamins | Results within 3 months |
| Clinical Evidence | Moderate to severe pruritus documented | Specialist assessment notes |
| Age Requirements | PFIC ≥3 months, ALGS ≥12 months | Birth date verification |
Source: Aetna Precertification Requirements
Common Denial Reasons & Solutions
| Denial Reason | Solution Strategy |
|---|---|
| Non-formulary status | Submit formulary exception with clinical justification |
| Age below threshold | Verify patient meets FDA age requirements (≥3 months PFIC, ≥12 months ALGS) |
| Lack of specialist involvement | Obtain hepatology/GI consultation and prescription |
| Insufficient prior therapy | Document specific trials of Ursodiol and symptomatic treatments |
| Missing genetic confirmation | Submit genetic testing confirming PFIC or Alagille syndrome mutations |
| "Experimental/investigational" | Provide FDA labeling and approval information |
FAQ
How long does Aetna prior authorization take for Bylvay in New Jersey? 95% of complete commercial plan submissions are approved within 24 hours. Medicare Advantage may take up to 14 days.
What if Bylvay is non-formulary on my Aetna plan? You can request a formulary exception by demonstrating medical necessity and providing clinical documentation supporting Bylvay's use for your specific condition.
Can I get expedited approval if my child has severe symptoms? Yes, request urgent review if severe pruritus significantly impacts quality of life. Include physician documentation of urgent medical need.
Does step therapy apply to Bylvay? Aetna may require trial of ursodeoxycholic acid and symptomatic pruritus treatments before approving Bylvay. Document failures/intolerance to these therapies.
What happens if I move to New Jersey from another state while on Bylvay? Document your current stable treatment and submit continuation of therapy request with your new Aetna plan. Previous authorization and clinical stability can support approval.
How much does Bylvay cost if not covered? Cash prices range from $14,152-$44,562 per 30 capsules, with annual costs potentially exceeding $100,000. Manufacturer support programs may be available.
Can my doctor appeal on my behalf? Yes, providers can file appeals for patients. Many choose to do this to ensure proper clinical documentation and faster processing.
What if Aetna doesn't respond within their timeline? Under federal law, failure to respond within required timeframes may result in automatic approval. Contact New Jersey DOBI if timelines aren't met.
From our advocates: We've seen families successfully overturn initial Bylvay denials by working closely with their hepatologist to document the child's quality of life improvements on previous therapy and gathering comprehensive genetic testing results. The key is presenting a complete clinical picture that clearly demonstrates medical necessity.
When navigating complex prior authorization requirements, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and payer policies to identify exactly what documentation Aetna needs, then helps draft point-by-point rebuttals that align with their specific criteria.
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance.
Sources & Further Reading
- Aetna Precertification Requirements
- New Jersey Department of Banking and Insurance
- IHCAP Consumer Information
- Bylvay FDA Prescribing Information
- Aetna Member Appeals Process
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