By Counterforce Health Team in Orladeyo (berotralstat) —

How to Renew Orladeyo (Berotralstat) Coverage with Aetna CVS Health in New York: Timeline, Documentation & Appeals

Answer Box: Renewing Orladeyo Coverage with Aetna CVS Health in New York

Orladeyo (berotralstat) requires annual reauthorization with Aetna CVS Health for HAE prophylaxis. Start renewal 60-90 days before expiration by documenting attack frequency reduction, submitting via Aetna's provider portal, and preparing appeal evidence if denied. New York residents have robust external appeal rights through the Department of Financial Services within 4 months of denial.

First step today: Check your current authorization expiration date on your Aetna member portal or call member services at the number on your insurance card.

Table of Contents

  1. When to Start Your Renewal Process
  2. Evidence You'll Need to Update
  3. Building Your Renewal Packet
  4. Timeline and Submission Process
  5. If Your Coverage Lapses
  6. Annual Plan Changes to Monitor
  7. Personal Progress Tracker
  8. Appeals Process in New York
  9. FAQ

When to Start Your Renewal Process

Most Orladeyo authorizations with Aetna CVS Health require annual renewal. Here's when to begin:

Start 60-90 days early if:

  • You're approaching your first annual renewal
  • Previous renewals took longer than 30 days
  • Your attack patterns have changed significantly
  • You've had dosing adjustments or side effects

Start 30-45 days early if:

  • Previous renewals were straightforward
  • Your HAE remains well-controlled
  • No recent hospitalizations or emergency treatments
Tip: Set a calendar reminder 90 days before your current authorization expires. Most Aetna members can find their authorization end date in their online member portal.

Evidence You'll Need to Update

For successful Orladeyo renewal, document these key outcomes since your last approval:

Attack Frequency Documentation

  • Pre-Orladeyo baseline vs. current attack rate
  • Monthly attack logs showing sustained reduction (ideally ≥50%)
  • Severity changes (mild/moderate/severe ratings)
  • Duration of attacks when they occur

Real-world studies show Orladeyo reduces HAE attacks by 29-100% in most patients, including those with HAE-nC1-INH.

Clinical Response Measures

  • AECT (Angioedema Control Test) scores: Improvement from baseline (target ≥15)
  • Quality of life assessments
  • Reduction in rescue medication use (icatibant, ecallantide)
  • Hospitalizations or emergency department visits

Safety and Tolerability

  • Side effect documentation (common: abdominal pain, vomiting, diarrhea)
  • Any dose adjustments due to tolerability
  • Drug interactions or contraindications that developed
  • Adherence rates and missed doses

Building Your Renewal Packet

Core Documentation Required

Document Type What to Include Where to Get It
Attack diary Monthly frequency, severity, triggers Patient logs, HAE apps
Provider letter Clinical response, medical necessity HAE specialist
Lab results C1-INH levels if retested Laboratory
Prescription history Fill dates, adherence patterns Pharmacy records

Medical Necessity Letter Checklist

Your HAE specialist should address:

  1. Current HAE status: Attack frequency reduction with specific numbers
  2. Prior therapy failures: Document previous prophylaxis attempts
  3. Clinical rationale: Why Orladeyo remains optimal choice
  4. Monitoring plan: Ongoing safety assessments
  5. Treatment goals: Sustained attack prevention
Clinician Corner: Include peer-reviewed evidence such as the recent case series showing sustained attack reduction in HAE-nC1-INH patients, with AECT score improvements from <10 to 15.

Timeline and Submission Process

Aetna CVS Health Renewal Process

Submit via:

  • Availity provider portal (fastest)
  • Specialty Medication Request Form (fax: 1-855-330-1716)
  • Phone: 1-855-582-2025 (TTY: 711)

Expected timelines:

  • Standard review: 30-45 days from complete submission
  • Expedited review: 72 hours if medically urgent
  • Incomplete submissions: Additional 14-30 days for missing documents
Note: Submit at least 2 weeks before your current authorization expires to avoid coverage gaps.

If Your Coverage Lapses

Immediate Bridge Options

While not substitutes for long-term prophylaxis, these options can help during coverage gaps:

Bridge Therapy Administration Key Notes
C1-INH concentrates IV (Cinryze) or SC (Haegarda) May require separate PA
Lanadelumab (Takhzyro) SC injection every 2-4 weeks Alternative prophylaxis option
Rescue medications Icatibant, ecallantide For breakthrough attacks only

Important: Contact BioCryst at 1-833-633-2279 for patient assistance programs that may help during coverage gaps.

Emergency Access Options

  • Aetna urgent PA: For immediate medical necessity
  • Emergency supply: Many pharmacies provide 72-hour supplies
  • Manufacturer support: BioCryst patient assistance programs

Annual Plan Changes to Monitor

January Formulary Updates

Aetna typically makes formulary changes on January 1st, but changes can occur throughout the year. Monitor for:

  • Tier placement changes: Higher copays or coinsurance
  • New prior authorization requirements: Additional documentation needed
  • Step therapy additions: Required trial of alternatives first
  • Quantity limit modifications: Dose or supply restrictions

Plan Design Shifts

  • Specialty pharmacy networks: CVS Specialty vs. other providers
  • Site of care requirements: Home vs. clinic administration
  • Provider network changes: In-network HAE specialists
Tip: Review your Summary of Benefits and Coverage (SBC) each open enrollment period for changes affecting specialty medications.

Personal Progress Tracker

Use this template to monitor your renewal process:

Authorization Details:

  • Current expiration date: ___________
  • Renewal submission date: ___________
  • Aetna reference number: ___________

Clinical Metrics:

  • Attacks per month (pre-Orladeyo): ___________
  • Attacks per month (current): ___________
  • AECT score improvement: ___________
  • Side effects: ___________

Submission Checklist:

  • Attack diary compiled
  • Provider letter obtained
  • Lab results gathered
  • Prior auth form completed
  • Submission confirmed

Appeals Process in New York

Internal Appeals with Aetna

If your renewal is denied, you have 180 days to file an internal appeal:

  1. Submit appeal letter with additional clinical evidence
  2. Request peer-to-peer review with HAE specialist
  3. Include new documentation addressing denial reasons

New York External Appeals

New York offers robust external appeal rights through the Department of Financial Services:

Timeline: File within 4 months of Aetna's final denial Process: Submit NY External Appeal Application Decision timeframe: 30 days standard, 72 hours expedited Cost: Up to $25 fee (waived for Medicaid/hardship)

Submit to:

  • Mail: DFS, P.O. Box 7209, Albany, NY 12224
  • Fax: (800) 332-2729
  • Expedited: Call (888) 990-3991 immediately after faxing

When to Request Expedited Review

Request expedited appeals if:

  • Current attack frequency is increasing
  • You're experiencing severe breakthrough attacks
  • Delay in treatment could jeopardize your health

FAQ

How long does Aetna CVS Health prior authorization take for Orladeyo renewals? Standard renewals typically take 30-45 days from complete submission. Expedited reviews for urgent medical needs are completed within 72 hours.

What if Orladeyo becomes non-formulary on my plan? You can request a formulary exception with documentation that Orladeyo is medically necessary and that formulary alternatives are inappropriate or have failed.

Can I appeal if I move to New York from another state? Yes, New York's external appeal rights apply to all residents with coverage through plans regulated by New York, regardless of where you previously lived.

Does step therapy apply to Orladeyo renewals? Step therapy requirements vary by plan. If new step therapy is added, you may qualify for an exception based on your successful response to Orladeyo and prior therapy failures.

What happens if I miss my renewal deadline? Contact Aetna immediately to request a retroactive authorization. You may need to pay out-of-pocket temporarily while the renewal is processed.

How do I get help with appeals in New York? Community Health Advocates offers free assistance at 888-614-5400. They can help you understand your rights and file appeals.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies, then drafts point-by-point rebuttals with the right clinical evidence and regulatory citations to maximize approval chances.

For complex renewals like Orladeyo, having professional support can make the difference between approval and denial. Counterforce Health's system understands payer-specific workflows and produces letters that meet procedural requirements while tracking deadlines and required documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and appeal procedures may change; verify current requirements with official sources.

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