How to Get Orladeyo (berotralstat) Covered by Humana in New York: Appeals, Forms & State Protections
Answer Box: Getting Orladeyo (berotralstat) Covered by Humana in New York
Orladeyo (berotralstat) requires prior authorization from Humana in New York for hereditary angioedema (HAE) prophylaxis. The fastest path to approval: ensure your HAE specialist submits complete documentation including C1-INH lab results, attack history, and prior therapy failures through Humana's provider portal. If denied, you have 65 days to appeal and can request New York's binding external review through the Department of Financial Services. Start today: Contact your prescriber to begin the prior authorization process and gather your C1-INH test results.
Table of Contents
- Understanding Humana's Coverage Requirements
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Playbook for Humana in New York
- Medical Necessity Letter Checklist
- New York State Protections & External Appeals
- Cost-Saving Options & Patient Assistance
- FAQ: Common Questions About Orladeyo Coverage
Understanding Humana's Coverage Requirements
Orladeyo (berotralstat) is covered by Humana Medicare Advantage plans for hereditary angioedema prophylaxis, but requires prior authorization under strict criteria. Here's what Humana requires:
Coverage at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all plans | Humana PA Search Tool | Humana Policy |
| Age Requirement | Patient must be ≥12 years old | FDA labeling | FDA Approval |
| Specialist Requirement | Prescribed by/with allergist or immunologist | Humana policy | Coverage Criteria |
| Diagnosis Documentation | Confirmed HAE with C1-INH labs | Clinical notes | Humana PA Requirements |
| Appeal Deadline | 65 days from denial notice | Medicare rules | CMS Guidelines |
Key Documentation Required:
- C1-INH antigenic and functional levels (showing deficiency)
- C4 complement levels
- Detailed HAE attack history
- Prior therapy trials and outcomes
- Specialist consultation notes
Step-by-Step: Fastest Path to Approval
1. Confirm Your Diagnosis Documentation
Who: You and your HAE specialist
What: Gather C1-INH lab results showing deficiency on two separate occasions
Timeline: Before PA submission
Source: HAE diagnostic guidelines
2. Document Prior Treatment History
Who: Your specialist
What: Detailed records of previous HAE therapies tried, failed, or not tolerated
Timeline: Include in PA submission
Why: Humana requires step therapy documentation
3. Submit Prior Authorization
Who: Your prescribing physician
What: Complete PA form with all required documentation
How: Humana provider portal (preferred for fastest processing)
Timeline: Humana responds within 1 business day for 95% of complete electronic requests
4. Track Your Request
Who: You or your clinic
What: Monitor PA status and respond to any requests for additional information
Where: Humana member portal or by calling member services
5. Prepare for Potential Peer-to-Peer Review
Who: Your specialist
What: Be ready to discuss medical necessity with Humana's medical director
Key Points: Attack frequency, functional impairment, prior therapy failures
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "Not medically necessary" | Submit detailed attack history and functional impairment | ER visits, missed work/school, attack diary |
| "Step therapy not met" | Document failures/intolerances of alternatives | Pharmacy records, adverse event reports |
| "Insufficient diagnostic workup" | Provide complete HAE testing | C1-INH levels, C4, genetic testing if needed |
| "Age requirement not met" | Confirm patient is ≥12 years old | Birth certificate, medical records |
| "Prescriber not qualified" | Have HAE specialist co-sign or take over prescription | Specialist consultation note |
Tip: Keep detailed records of all HAE attacks, including date, severity, location, treatment needed, and impact on daily activities. This documentation is crucial for appeals.
Appeals Playbook for Humana in New York
Internal Appeal (First Level)
- Deadline: 65 days from denial notice
- How to Submit: Humana appeals form or written letter
- Timeline: 72 hours for standard requests, 24 hours for expedited
- Required: Member info, drug details, prescriber statement addressing denial reasons
External Review (New York State)
If your internal appeal is denied, New York offers binding external review through the Department of Financial Services:
- Deadline: 4 months from final adverse determination
- Cost: $25 (waived for Medicaid or financial hardship)
- Timeline: 72 hours for expedited, 30 days for standard
- Form: NY External Appeal Application
- Expedited Available: For urgent drug needs (24-hour decision)
Note: New York's external review decisions are binding on Humana and have a strong track record—many specialty drug denials are overturned when proper documentation is provided.
Medical Necessity Letter Checklist
Your HAE specialist should include these elements in the medical necessity letter:
Clinical Documentation
- Confirmed HAE diagnosis with lab results (C1-INH, C4)
- HAE subtype (Type I or II)
- Attack frequency and severity before treatment
- Impact on quality of life and function
- Emergency department visits or hospitalizations
Prior Treatment History
- Previous HAE prophylaxis medications tried
- Reasons for discontinuation (ineffective, intolerable, contraindicated)
- Specific adverse events or failures documented
- Duration of each treatment trial
Orladeyo-Specific Rationale
- Why Orladeyo is medically necessary for this patient
- Expected clinical benefits
- Monitoring plan for efficacy and safety
- Reference to FDA approval and clinical guidelines
Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters and creating targeted, evidence-backed appeals. Their platform streamlines the documentation process and identifies the specific criteria needed for approval, making it easier to secure coverage for medications like Orladeyo.
New York State Protections & External Appeals
New York provides robust protections for patients denied specialty medications:
Your Rights in New York
- External Review: Independent medical experts review your case
- Binding Decisions: If approved, Humana must cover the medication
- Expedited Process: 24-hour decisions for urgent drug denials
- Financial Protection: $25 fee refunded if you win
How to File External Appeal
- Complete your internal appeal with Humana first
- Receive final adverse determination
- Submit NY External Appeal form within 4 months
- Include all supporting documentation
- Pay $25 fee (or request waiver)
Getting Help
- DFS Consumer Helpline: 1-800-342-3736
- Community Health Advocates: 888-614-5400 (free counseling)
- Online Portal: DFS External Appeal Portal
Cost-Saving Options & Patient Assistance
Even with insurance coverage, Orladeyo can be expensive. Here are ways to reduce costs:
BioCryst Patient Support
- BioCryst CARE Program: Copay assistance and patient support
- Eligibility: Commercial insurance patients
- Contact: Visit BioCryst's official website or call their patient support line
Foundation Assistance
- Patient Access Network (PAN): Grants for HAE medications
- HealthWell Foundation: Copay assistance programs
- National Organization for Rare Disorders (NORD): Patient assistance programs
Specialty Pharmacy Benefits
Many patients find better coverage through specialty pharmacy benefits versus retail pharmacy. Ask your doctor about specialty pharmacy options in your area.
Counterforce Health can help identify the best coverage pathway and assist with appeals if your initial request is denied, ensuring you get access to the medications you need.
FAQ: Common Questions About Orladeyo Coverage
How long does Humana prior authorization take in New York? Humana commits to responding within 1 business day for 95% of complete electronic prior authorization requests. Incomplete requests may take longer.
What if Orladeyo is non-formulary on my plan? You can request a formulary exception through Humana's exception process. Your doctor must provide a statement explaining why formulary alternatives are inappropriate.
Can I request an expedited appeal? Yes, if a delay would seriously jeopardize your health. Your doctor must attest to the medical urgency. Expedited appeals get 24-hour decisions for urgent drug needs.
Does step therapy apply if I've failed treatments outside New York? Yes, document all prior therapies regardless of where they were tried. Include pharmacy records and medical notes showing failures or intolerances.
What happens if my external appeal is denied? External review decisions in New York are final and binding. However, you may have other options like requesting a different HAE medication or exploring patient assistance programs.
How much does Orladeyo cost without insurance? The wholesale acquisition cost is approximately $44,484 per 28-day supply as of 2025. Patient assistance programs can significantly reduce out-of-pocket costs.
Can my primary care doctor prescribe Orladeyo? While technically possible, Humana typically requires prescription by or consultation with an HAE specialist (allergist, immunologist, or hematologist) for prior authorization approval.
What if I'm traveling and need Orladeyo filled in another state? Contact Humana member services about out-of-network pharmacy coverage. Some plans offer temporary fills or mail-order options for specialty medications.
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 details. Insurance policies and state regulations may change.
Sources & Further Reading
- Humana Prior Authorization Search Tool
- New York Department of Financial Services External Appeal Process
- CMS Medicare Part D Appeals Guidelines
- Hereditary Angioedema Association Treatment Guidelines
- Community Health Advocates of NY
- FDA Orladeyo Approval Documentation
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