By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Covered by Aetna CVS Health in Florida: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Orladeyo Covered by Aetna CVS Health in Florida

Orladeyo (berotralstat) requires prior authorization from Aetna CVS Health for hereditary angioedema (HAE) prophylaxis. Your fastest path to approval: (1) Confirm HAE diagnosis with C1-INH lab results and clinical criteria, (2) Document any failed prior therapies, and (3) Have your doctor submit a complete prior authorization request through Aetna's provider portal. If denied, you have 180 days to appeal internally, followed by external review through Florida's process. Start by calling the number on your insurance card to verify current requirements.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before coverage Aetna Precertification Lists
HAE Diagnosis Lab-confirmed C1-INH deficiency or dysfunction Aetna Clinical Policy
Age Requirement 12 years and older FDA labeling via prescriber
Clinical Criteria Recurrent angioedema or abdominal pain episodes Aetna Clinical Policy
Formulary Status Specialty tier (verify with plan) Member portal or pharmacy benefits
Appeals Deadline 180 days from denial notice Federal standard

Step-by-Step: Fastest Path to Approval

1. Confirm Your HAE Diagnosis (Patient + Doctor)

Timeline: 1-2 weeks if labs needed

Your doctor needs specific lab results showing either:

  • C1-INH antigenic level below normal, OR
  • C1-INH functional level below normal, OR
  • Normal C1-INH with genetic testing showing pathogenic variants in F12, angiopoietin-1, plasminogen, KNG1, HS3ST6, or MYOF

Plus one clinical criterion:

  • Recurrent laryngeal edema
  • Non-inflammatory subcutaneous angioedema lasting >12 hours
  • Self-remitting abdominal pain lasting >6 hours
Source: Aetna's HAE Clinical Policy

2. Document Prior Treatment History (Doctor)

Timeline: 1-3 days

Gather records showing:

  • Previous HAE medications tried (if any)
  • Reasons for discontinuation (ineffective, side effects, contraindications)
  • Current attack frequency and severity
  • Impact on quality of life

3. Submit Prior Authorization Request (Doctor's Office)

Timeline: 1-2 business days to submit

Your doctor submits through:

  • Aetna provider portal (preferred)
  • Phone: Check your insurance card for provider services number
  • Fax: Obtain current fax number from Aetna

Required documentation:

  • Completed prior authorization form
  • HAE diagnosis with lab results
  • Clinical notes supporting medical necessity
  • Prior treatment history (if applicable)

4. Wait for Initial Decision

Timeline: 30-45 days standard, 72 hours expedited

Aetna will review and either:

  • Approve: You'll receive approval notice with any conditions
  • Deny: You'll get written notice with specific denial reasons

5. If Denied: File Internal Appeal

Timeline: Must file within 180 days

Submit appeal with:

  • Written appeal letter
  • Additional clinical evidence
  • Peer-reviewed studies supporting Orladeyo use
  • Updated medical necessity letter
Tip: Request a peer-to-peer review where your doctor speaks directly with Aetna's medical director.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Not medically necessary" Submit detailed attack history, quality of life impact, and HAE treatment guidelines
"Step therapy required" Document contraindications or failures with other HAE prophylaxis medications
"Non-formulary" Request formulary exception with comparative effectiveness data
"Age restriction" Confirm patient is ≥12 years; provide FDA labeling for pediatric use
"Insufficient documentation" Provide complete C1-INH lab results and clinical criteria per Aetna policy

Appeals Process for Aetna CVS Health in Florida

Internal Appeal (Level 1)

Timeline: 180 days to file, 30-60 days for decision

How to file:

  • Online: Aetna member portal
  • Phone: Member services number on your insurance card
  • Mail: Address provided in denial letter
  • Fax: Number in denial letter

Required documents:

  • Appeal form
  • Copy of denial letter
  • Medical records supporting necessity
  • Doctor's letter explaining why Orladeyo is appropriate

External Review (If Internal Appeal Fails)

Timeline: 4 months to file, 45 days for standard decision

Florida uses the federal HHS-administered external review process:

How to file:

Cost: No charge for federal external review

Expedited review: Available for urgent medical situations - decision within 72 hours

Source: Healthcare.gov External Review Process

Financial Assistance and Cost Support

BioCryst Empower Patient Services

Contact: 1-866-5-EMPOWER (866-536-7693)

  • $0 copay for commercially insured patients (up to annual maximum)
  • Financial assistance regardless of insurance status
  • Quick Start shipments (typically less than one week)
  • 24/7 pharmacist support
Source: Orladeyo Empower Patient Services

Alternative Cost Options

  • GoodRx discount: Up to 80% off retail price, as low as $1,575.31 per fill
  • Patient assistance program: Free medication for qualifying patients
  • State pharmaceutical assistance: Check Florida Department of Health programs

When navigating complex insurance approvals for specialty medications like Orladeyo, many patients find success working with coverage specialists. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements.

When to Escalate Beyond Insurance

Florida Department of Financial Services

If you're having trouble with the appeals process:

Consumer Helpline: 1-877-MY-FL-CFO (877-693-5236) Online complaints: Submit through Florida Department of Financial Services website What they can help with:

  • Ensuring you receive full appeal rights
  • Facilitating communication with insurers
  • Investigating systemic issues

State Insurance Consumer Advocate

Available through the Chief Financial Officer's office for systemic insurance issues affecting multiple consumers.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Florida? Standard reviews take 30-45 days. Expedited reviews for urgent medical needs are completed within 72 hours. You can request expedited review if delays would seriously jeopardize your health.

What if Orladeyo is not on my formulary? You can request a formulary exception by providing clinical documentation that Orladeyo is medically necessary and more appropriate than covered alternatives. Your doctor will need to explain why formulary options won't work for your specific case.

Can I get Orladeyo covered if I haven't tried other HAE medications? This depends on your plan's step therapy requirements. Some patients may need to try and fail other prophylactic treatments first, unless there are documented contraindications or medical reasons why other options aren't appropriate.

What counts as medical necessity for Orladeyo? According to Aetna's policy, medical necessity requires confirmed HAE diagnosis plus recurrent symptoms that significantly impact quality of life and warrant prophylactic treatment.

Does Florida have any special protections for HAE patients? Florida follows federal insurance regulations for specialty medications. The state requires coverage of certain clinical trial costs and has some limits on step therapy requirements for prescription drugs.

What if my doctor isn't familiar with HAE? Consider asking for a referral to an immunologist or allergist who specializes in HAE. The Hereditary Angioedema Association maintains a directory of HAE specialists who understand the condition and insurance requirements.

How much does Orladeyo cost without insurance? The wholesale acquisition cost is approximately $44,484 per 28-day supply as of 2025. However, patient assistance programs can significantly reduce or eliminate out-of-pocket costs for qualifying patients.

Can I appeal if I'm on a Medicare Advantage plan through Aetna? Yes, but Medicare Advantage plans have slightly different appeal timelines and processes. External reviews for Medicare Advantage must be completed within 72 hours for expedited cases.

From our advocates: We've seen HAE patients succeed with Aetna appeals when they provide comprehensive attack diaries showing frequency and severity, along with detailed explanations of why oral prophylaxis is preferable to injection therapies. The key is painting a complete picture of how HAE impacts daily life and why Orladeyo specifically addresses the patient's needs better than alternatives.

For complex cases involving multiple denials or unusual circumstances, specialized coverage advocacy services like Counterforce Health can help develop comprehensive appeals that address payer-specific requirements and leverage the right clinical evidence to support approval.

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 terms and medical circumstances. Always consult with your healthcare provider and insurance company for guidance on your individual situation. Coverage requirements and processes may change; verify current information with official sources.

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