By Counterforce Health Team in Orladeyo (berotralstat) —

How Long Does It Take to Get Orladeyo (berotralstat) Approved by Aetna CVS Health in Texas? Complete Timeline Guide

Quick Answer: Orladeyo Approval Timeline with Aetna CVS Health in Texas

Standard timeline: 2-30 days for complete submissions. Aetna CVS Health requires prior authorization for Orladeyo (berotralstat) with documented HAE diagnosis, step therapy failures, and specialist involvement. Fastest path: Submit electronically through Availity portal with complete documentation from an allergist/immunologist. Start today: Gather C1-INH lab results, prior therapy records, and request medical necessity letter from your HAE specialist. Texas law mandates expedited 72-hour decisions for urgent cases and provides external review rights if denied.

Table of Contents

  1. What Affects Approval Timeline
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window & Typical Outcomes
  6. If Denied: Appeal Timeline in Texas
  7. Renewal Cycles & Reauthorization
  8. Timeline Visual Guide
  9. Time-Saving Tips
  10. FAQ

What Affects Approval Timeline

Several factors determine how quickly Aetna CVS Health processes your Orladeyo prior authorization in Texas:

Documentation Completeness is the biggest factor. Complete submissions with all required elements typically receive decisions within 2-3 business days, while incomplete requests can take the full 30-day maximum as additional information is requested.

Specialist Involvement significantly speeds approval. Requests from allergists, immunologists, or HAE specialists are processed more efficiently than those from primary care physicians, as reviewers expect these specialists to understand HAE management protocols.

Step Therapy Requirements add time if not properly documented. Aetna typically requires documented failures of preferred HAE prophylaxis agents like Takhzyro or Haegarda before approving Orladeyo. Having this documentation ready prevents delays.

Submission Method impacts processing speed. Electronic submissions through the Availity portal are processed faster than fax submissions, typically within 2-3 business days versus 5-7 days for paper submissions.

Pre-Submission Preparation (0-2 Days)

Gathering complete documentation before submission prevents delays and expedites approval:

Essential Documentation Checklist

Laboratory Evidence (Required)

  • C1-INH functional level (must be below normal range or <50%)
  • C1-INH antigenic level (typically <19 mg/dL or below lab's lower limit)
  • C4 complement level (below reference range or <14 mg/dL)
  • Genetic testing results if available

Clinical Documentation

  • HAE specialist evaluation notes
  • Attack frequency and severity documentation
  • Prior therapy trials and outcomes (Takhzyro, Haegarda, Cinryze)
  • Reasons for discontinuation of previous treatments

Administrative Requirements

  • Current insurance card and member ID
  • Prescriber NPI and DEA numbers
  • ICD-10 code D84.1 (hereditary angioedema)
  • Requested quantity: 28 capsules per 28 days
Tip: Request a comprehensive medical necessity letter from your HAE specialist that addresses all Aetna criteria in one document. This prevents back-and-forth requests for additional information.

Submission to Initial Review (1-5 Days)

Texas State Requirements

Under Texas law, Aetna must acknowledge receipt of prior authorization requests within 1 business day and provide initial decisions within specific timeframes:

  • Standard requests: 30 calendar days maximum
  • Expedited requests: 72 hours for urgent cases
  • Post-service requests: 60 calendar days

What Reviewers Check First

Aetna's initial review focuses on:

  1. Diagnosis confirmation through lab values
  2. Age eligibility (≥12 years for Orladeyo)
  3. Step therapy compliance or documented exceptions
  4. Prescriber qualifications (specialist preferred)
  5. Formulary status and tier placement

Electronic Submission Advantage: Submissions through Availity are typically reviewed within 2-3 business days if complete, compared to 5-7 days for fax submissions to 1-866-249-6155.

Additional Information Requests (1-7 Days)

If Aetna requests additional information, you have 14 calendar days to respond in Texas. Common requests include:

Frequent Additional Information Requests

Missing Lab Values

  • Complete C1-INH testing if only partial results provided
  • Recent lab work (within 12 months)

Insufficient Step Therapy Documentation

  • Detailed records of previous HAE prophylaxis trials
  • Specific reasons for discontinuation (side effects, lack of efficacy)
  • Duration of each therapy attempted

Specialist Consultation

  • Evaluation by allergist/immunologist if prescribed by primary care
  • HAE-specific treatment history and rationale
Note: Responding within 48 hours of additional information requests keeps your case in active review status and prevents queue delays.

Decision Window & Typical Outcomes

Standard Decision Timeline

Days 1-3: Initial review of complete submissions Days 4-7: Additional information requests if needed Days 8-15: Final review and determination Days 16-30: Maximum allowable decision time under Texas law

Typical Approval Outcomes

Immediate Approval (30-40% of complete submissions)

  • All criteria met with specialist documentation
  • Clear step therapy failures documented
  • Complete lab and clinical evidence

Conditional Approval (20-30% of cases)

  • Approved with specific quantity limits
  • Requires periodic monitoring reports
  • May include trial period restrictions

Denial Requiring Appeal (30-50% of initial submissions)

  • Common reasons: insufficient step therapy, missing specialist evaluation, incomplete lab work

If Denied: Appeal Timeline in Texas

Texas law provides strong appeal rights with specific timelines:

Internal Appeal Process

Filing Deadline: 180 days from denial notice Aetna Response Time: 30 days for standard appeals, 72 hours for expedited Required Documentation: Original denial letter, additional clinical evidence, prescriber support

External Review Rights

If internal appeal is denied, Texas provides Independent Review Organization (IRO) rights:

Filing Window: 4 months from final internal denial Review Timeline: 20 days standard, 5 days for urgent cases Cost: Free to patient (insurer pays IRO fees) Decision: Binding on Aetna if approved

Texas Department of Insurance Contact: 1-800-252-3439 for IRO guidance

Expedited Appeal Process

For urgent cases where delay could jeopardize health:

  • Timeline: 72 hours maximum
  • Concurrent filing: Can file expedited external review simultaneously
  • Requirements: Prescriber statement of medical urgency

Renewal Cycles & Reauthorization

Initial Authorization Period

Orladeyo approvals typically last 6-12 months initially, with reauthorization required based on:

Attack Rate Reduction: Documentation showing decreased HAE attack frequency compared to baseline Clinical Improvement: Chart notes demonstrating functional benefits Continued Medical Necessity: Ongoing specialist oversight and monitoring

Reauthorization Timeline

Start Process: 30-60 days before expiration Required Documentation: Updated attack logs, specialist evaluation, current lab work if requested Decision Timeline: Same as initial authorization (up to 30 days)

From our advocates: "We've seen the smoothest reauthorizations when patients maintain detailed attack diaries and have their HAE specialist submit renewal requests 45 days early. This prevents treatment interruptions and allows time for any additional documentation requests."

Timeline Visual Guide

Milestone Standard Timeline Expedited Timeline Key Actions
Pre-Submission 1-2 days Same day Gather documentation, verify coverage
Initial Submission Day 0 Day 0 Submit via Availity portal or fax
Acknowledgment 1 business day 1 business day Confirm receipt, get reference number
Initial Review 2-5 days 24-48 hours Aetna reviews completeness
Additional Info Request Days 6-10 N/A Respond within 48 hours if possible
Final Decision Days 15-30 Within 72 hours Approval/denial notification
Internal Appeal 30 days to decide 72 hours File if denied
External Review 20 days to decide 5 days IRO binding decision

Time-Saving Tips

Portal Usage Best Practices

Availity Portal Advantages:

  • Real-time status tracking
  • Faster processing (2-3 days vs. 5-7 for fax)
  • Automatic confirmation receipts
  • Direct communication with reviewers

Bundled Evidence Strategy

Submit all documentation in one comprehensive package:

  • Complete lab panel results
  • Specialist consultation notes
  • Prior therapy documentation
  • Medical necessity letter addressing all criteria

Direct Specialty Routing

Request that submissions go directly to Aetna's specialty pharmacy reviewers who are more familiar with HAE management protocols and can make faster decisions.

CVS Specialty Contact: Verify current contact through member portal for fastest routing.

FAQ

How long does Aetna CVS Health PA take for Orladeyo in Texas? Standard timeline is 2-30 days, with complete electronic submissions typically decided within 2-3 business days. Texas law requires decisions within 30 days for standard requests and 72 hours for expedited cases.

What if Orladeyo is non-formulary on my Aetna plan? You can request a formulary exception with medical necessity documentation. This may add 5-10 days to the review process but doesn't change the overall 30-day maximum timeline.

Can I request an expedited appeal in Texas? Yes, if waiting for standard processing could jeopardize your health. Your prescriber must provide a statement of medical urgency, and Aetna must respond within 72 hours.

Does step therapy apply if I failed treatments outside Texas? Yes, documented treatment failures from any state count toward step therapy requirements. Ensure you have complete records from previous providers.

What happens if Aetna misses Texas deadlines? Under Texas law, missing mandated response deadlines may result in automatic approval or grounds for complaint to the Texas Department of Insurance.

How do I track my PA status? Use the Availity portal for real-time updates, or call Aetna provider services with your reference number. Electronic submissions provide better tracking than fax submissions.

Counterforce Health helps patients and clinicians navigate complex prior authorization processes like Orladeyo approvals with Aetna CVS Health. Our platform analyzes denial patterns, generates evidence-backed appeals, and tracks payer-specific requirements to improve approval rates. Learn more about our prior authorization support services.

For additional assistance with insurance appeals in Texas, contact the Texas Department of Insurance at 1-800-252-3439 or visit their website for consumer guidance. The Office of Public Insurance Counsel (1-877-611-6742) also provides free help with insurance disputes.

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 specific coverage decisions. Insurance policies and state regulations may change; verify current requirements with official sources.

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