By Counterforce Health Team in Orladeyo (berotralstat) —

How Long Does It Take to Get Orladeyo (Berotralstat) Approved by Cigna in New York? Complete Timeline & Appeals Guide

Answer Box: Fast-Track to Orladeyo Coverage

Cigna typically approves Orladeyo (berotralstat) within 2 days if you submit complete documentation through Express Scripts. Key requirements: HAE type I/II diagnosis with low C1-INH (<50% normal), HAE specialist prescription, and lab documentation. If denied, file an internal appeal within 180 days, then New York's external review within 4 months for binding decisions. Start today: Verify your HAE specialist meets Cigna's criteria and gather C1-INH/C4 lab results with reference ranges.

Table of Contents

What Affects Orladeyo Approval Timing

Several factors determine how quickly Cigna processes your Orladeyo (berotralstat) prior authorization:

Benefit Type: Cigna manages specialty drugs like Orladeyo through Express Scripts/Accredo, which completes nearly all prior authorization reviews within 2 days of receiving complete information.

Complexity of Criteria: Orladeyo requires specific documentation for hereditary angioedema (HAE) types I or II only. Cigna's updated January 2026 policy mandates HAE specialist involvement and lab confirmation of low functional C1-INH (<50% normal).

Documentation Completeness: Missing labs, specialist attestation, or attack history can trigger additional information requests, extending approval by 5-14 days.

Pre-Submission Prep (0-2 Days)

Essential Documentation Checklist

Before submitting your prior authorization, gather these required documents:

Lab Results (with reference ranges):

  • Functional C1-INH assay showing <50% of lab normal
  • Serum C4 levels (typically low in HAE types I/II)
  • Genetic testing results if available

Clinical Documentation:

  • HAE attack history and frequency
  • Prior prophylaxis treatments and outcomes
  • Current symptoms and functional impact

Prescriber Requirements:

  • Prescription from or consultation with allergist/immunologist or HAE specialist
  • Medical necessity letter detailing diagnosis and treatment rationale
Tip: Cigna's coverage policy CNF_647 excludes HAE type III (normal C1-INH), so confirm your specific HAE type before submitting.

Submission to Initial Review (1-5 Days)

How to Submit Your Prior Authorization

Electronic Submission (Fastest): Submit through Express Scripts' electronic prior authorization (ePA) portal or CoverMyMeds. Electronic submissions reduce processing times significantly, with many decisions within 24-48 hours.

Standard Timeline:

  • Day 1: Submission received and logged
  • Day 2: Clinical review begins
  • Days 2-5: Decision rendered for complete submissions

What Reviewers Check First:

  1. HAE type I/II diagnosis confirmation
  2. Specialist prescriber credentials
  3. Lab values meeting coverage criteria
  4. Age requirement (≥12 years for Orladeyo)

Additional Information Requests (1-7 Days)

If Cigna requests additional information, you typically have 5 business days to respond. Common requests include:

Missing Lab Documentation:

  • C1-INH functional assay with lab reference ranges
  • Historical C4 levels showing consistent abnormalities

Specialist Verification:

  • Confirmation of allergist/immunologist or HAE specialist credentials
  • Consultation notes if not directly prescribed by specialist

Clinical Clarification:

  • Attack frequency documentation
  • Prior therapy failures or contraindications
Note: Respond to information requests immediately to avoid delays. The clock continues ticking during hold queues.

Decision Window & Outcomes

Typical Approval Scenarios

Standard Approval: Covers 90-day or 1-year supply depending on policy terms. Check your approval letter for specific quantity limits and refill authorization.

Conditional Approval: May require step therapy completion or specific monitoring parameters.

Partial Approval: Sometimes covers reduced quantities pending additional documentation.

Reading Your Approval Letter

Approved Orladeyo prescriptions through Cigna typically route to Accredo specialty pharmacy for home delivery, with 7-10 day fulfillment after approval.

If Denied: Appeals Timeline

Internal Appeal Process

First-Level Appeal:

Second-Level Appeal (Optional):

  • Available if first appeal denied
  • Similar timeline and documentation requirements

Expedited Appeals for Urgent Cases

For patients experiencing frequent HAE attacks, physicians can request expedited review by certifying that standard timing would jeopardize health. Cigna processes urgent specialty drug appeals within 24 hours.

Renewal Cycles & Reauthorization

Continuation Criteria

For patients already on Orladeyo, Cigna's reauthorization requires documentation of favorable clinical response, such as:

  • Reduced attack frequency compared to pre-Orladeyo baseline
  • Decreased attack severity or duration
  • Improved quality of life measures

When to Start Renewal Process

Begin reauthorization 30-45 days before your current approval expires. Document attack rates both before and after starting Orladeyo to demonstrate clinical benefit.

Timeline Visual & Milestones

Milestone Timeline Action Required
Pre-submission prep 0-2 days Gather labs, specialist letter, attack history
Initial submission Day 1 Submit via ePA or provider portal
Clinical review Days 1-2 Cigna reviews against coverage criteria
Decision or info request Days 2-5 Respond immediately to any requests
Final determination Days 2-7 Approval routes to Accredo; denials trigger appeal rights
Specialty pharmacy fulfillment 7-10 days post-approval Accredo ships medication

Time-Saving Tips

Portal Usage: Submit through Express Scripts' electronic system rather than fax to reduce processing time by 1-3 days.

Bundled Evidence: Include all required documentation in initial submission to avoid back-and-forth requests.

Direct Specialty Routing: Ensure your HAE specialist submits the PA directly rather than routing through primary care.

Proactive Communication: Call Express Scripts 2-3 days after submission to confirm receipt and check status.

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Age <12 years Orladeyo approved for ≥12 years only; consider alternative HAE prophylaxis
HAE type III diagnosis Cigna covers types I/II only; provide genetic testing if available
Missing specialist involvement Obtain prescription from allergist/immunologist or HAE specialist
Insufficient lab documentation Submit functional C1-INH assay <50% normal with lab reference ranges
Concurrent prophylaxis Justify dual therapy or discontinue other HAE prophylaxis agents

New York External Review Rights

When Internal Appeals Fail

New York residents have strong external review rights through the Department of Financial Services (DFS). After exhausting Cigna's internal appeal process, you can file for independent review.

Key Benefits:

  • Binding decisions on Cigna
  • 72-hour expedited review for urgent cases
  • 24-hour decisions for non-formulary drug denials
  • Independent medical experts review your case

How to File External Review

Deadline: 4 months from final internal denial

Preferred Method: Online DFS Portal with case tracking

Required Forms:

  • Comprehensive Physician Attestation
  • Medical Necessity - Expedited (for urgent cases)

Contact for Help: Call 800-400-8882 or email [email protected]

From our advocates: We've seen New York external reviewers overturn Cigna denials for rare disease treatments when patients provide comprehensive medical literature supporting off-label use or challenging "experimental" determinations. The key is submitting peer-reviewed evidence alongside specialist attestations about medical necessity.

FAQ

How long does Cigna PA take in New York? Express Scripts typically completes Orladeyo prior authorization within 2 days of receiving complete documentation, regardless of your New York location.

What if Orladeyo is non-formulary on my Cigna plan? File a formulary exception request with medical necessity justification. New York's external review can expedite non-formulary denials within 24 hours.

Can I request an expedited appeal? Yes, if your physician attests that delays would jeopardize your health due to frequent HAE attacks. Cigna processes urgent appeals within 24 hours.

Does step therapy apply to Orladeyo? Cigna may require trials of other HAE prophylaxis agents (like Takhzyro or C1-INH products) before approving Orladeyo, depending on your specific plan.

What counts as medical necessity for Orladeyo? HAE types I/II diagnosis with documented attacks, specialist prescription, and lab confirmation of C1-INH deficiency per Cigna's coverage criteria.

How much does Orladeyo cost with Cigna coverage? Costs vary by plan design, but the wholesale acquisition cost is approximately $44,484 per 28-day supply. Check BioCryst's patient assistance programs for copay support.

Counterforce Health: Streamlining Your Appeal Process

When facing complex prior authorization requirements or appeals, Counterforce Health helps patients and clinicians navigate insurance denials by creating targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with your specific payer's requirements, potentially reducing the time and complexity of getting treatments like Orladeyo approved.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage determinations. Insurance policies and procedures may change; verify current requirements with Cigna directly.

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