Aetna · Orladeyo · US health-plan appeal rights

Orladeyo denied for failing step therapy by Aetna?

Q: How long do I have to appeal a Aetna Orladeyo denial?

Internal appeal window: Typically 180 days from the denial date. External review window: Typically 60–120 days after the final internal denial. The clock starts from the date on the denial letter.

Step-therapy denials usually flip when the appeal documents that prior alternatives were tried and failed, or were contraindicated, or aren't safe for the patient.

By Michael John Ryan, Founder & Privacy Officer, DenialHelp, LLC

Last reviewed 2026-05-10

Policy data current as of 2026-04-26

US health-plan appeal rights

Cite: Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules

Most US health plans are required by federal law to give you both an internal appeal (where the insurer reconsiders) and an external review (where an independent reviewer decides). The exact timelines and processes depend on what kind of plan you have — marketplace / employer group, self-funded, Medicare Advantage, or Medicaid MCO — but in every case there's a window after the denial during which you have the right to fight it.

Internal appeal window

Typically 180 days from the denial date

External review window

Typically 60–120 days after the final internal denial

What Aetna typically requires

Aetna's specific coverage criteria for orladeyo are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

Source policy: Aetna Clinical Policy Bulletin — HAE Agents — Orladeyo (Berotralstat) PA

The Aetna angle on Orladeyo

## Why Aetna Issued a Step-Therapy Denial for Orladeyo

Aetna's step-therapy (also called "fail-first") requirement for Orladeyo (berotralstat) means the plan requires you to try and document failure of one or more other HAE prophylactic agents before it will authorize coverage of Orladeyo. For hereditary angioedema, this most commonly involves prior trials of other approved prophylactic options. The denial does not mean Orladeyo is inappropriate for you — it means Aetna has not yet received documentation that the step-therapy sequence has been satisfied.

## Why This Denial Is Appealable

Step-therapy protocols must include an exception process. Under many state step-therapy laws (and under federal law for certain plan types), plans must grant an exception when: (a) the required prior drug is contraindicated or expected to cause adverse effects, (b) the patient has already tried and failed the required drug, (c) the patient is stable on the requested drug from another payer and switching poses a health risk, or (d) the required drug is otherwise not clinically appropriate. If any of these apply to your situation, you can request a step-therapy exception alongside or in lieu of a formal appeal.

## Federal Appeal Framework

Step-therapy exception request: File this first, with prescriber documentation. Many states have enacted step-therapy laws with mandatory exception timelines (often 72 hours for urgent cases).
Internal appeal (ERISA §503 / ACA §2719): File within 180 days of the denial. Aetna must respond within 30 days for pre-service denials.
External review: Available after exhausting internal appeals. The window is generally 4 months from the final internal adverse determination. The external reviewer's decision binds the plan.
Expedited review: If a step-therapy denial delays care for an active or high-frequency attack patient, request expedited review at every level.

## Documentation to Gather

1. Prior-treatment history — this is the centerpiece of a step-therapy appeal. Provide dated chart entries, pharmacy records, and prescriber notes for every HAE prophylactic agent previously tried, with outcomes and reasons for discontinuation or inadequacy. 2. Step-therapy exception grounds — your prescriber should document in writing which specific exception applies (contraindication, prior failure, clinical inappropriateness) and why. 3. Diagnosis and severity documentation — HAE diagnosis confirmation, attack frequency, severity, and any urgent or life-threatening episodes. 4. Prescriber medical-necessity letter — should address Aetna's step-therapy criteria directly, citing each prior step tried (or explaining why each step cannot be tried), and explaining why Orladeyo is the appropriate next step. 5. Current Aetna step-therapy policy — obtain the exact required steps from Aetna's clinical policy for Orladeyo and confirm your appeal addresses each one.

## Criteria-Mapping Structure

Obtain Aetna's published step-therapy criteria for Orladeyo. List each required step in a table. For each step: (a) document that it was tried (with dates and outcomes from the chart), or (b) document why it cannot be tried (with prescriber attestation). If you are requesting an exception rather than documenting completion of all steps, map each exception criterion from Aetna's policy to the corresponding prescriber statement and chart evidence. A complete, structured response of this kind is the most efficient path to a favorable step-therapy determination.

Next steps

Find the date on the denial letter — your appeal window starts there.
Read your plan's Summary of Benefits and Coverage (SBC) for the specific deadlines.
Request the insurer's claim file in writing — they must provide it.
Submit your appeal in writing with new clinical evidence and a physician statement.

Get the letter drafted

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Related appeal guides

Other Aetna appeals

Other denial reasons for Aetna Orladeyo

denied as not medically necessary denied as non-formulary denied for missing prior authorization denied as experimental or investigational denied as not FDA-approved for this use

This guide describes general US federal appeal rights based on Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules. Your specific plan documents (Summary of Benefits and Coverage, Evidence of Coverage) override anything here. DenialHelp is not your lawyer and not your physician — we draft appeal letters that your physician signs. Outcomes depend on your insurer's decision and factors outside our control. Reviewed by Michael John Ryan on 2026-05-10. Editorial standards: denialhelp.com/authors.