CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Orladeyo_Acas.20250709 2

Defines Medicaid coverage and prior authorization criteria for Orladeyo (berotralstat) for prevention of hereditary angioedema (HAE) attacks in patients >=12 years, including initial and continuation criteria, dosing limits, exclusions, and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Orladeyo_Acas.20250709 2

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2021

Next Review Date

Key ActionAuthorization granted for 6 months when initial criteria are met; prescriber must be or consult with an allergist/immunologist or HAE specialist and provide required laboratory/genetic documentation and clinical history.

SourceLink

POLICY UPDATE CHANGES

No material changes

>=12Minimum age for coverage

1Capsules per day allowed

6 moAuthorization duration

Not coveredAcute HAE treatment coverage

Coverage Summary

Defines Medicaid coverage and prior authorization criteria for Orladeyo (berotralstat) for prevention of hereditary angioedema (HAE) attacks in patients >=12 years, including initial and continuation criteria, dosing limits, exclusions, and quantity limits. Authorization for initial and continuation use may be granted for 6 months when specified clinical, laboratory/genetic, prescriber, and response criteria are met. Dose is limited to one Orladeyo 150 mg capsule per day and use is not allowed in combination with Andembry, Cinryze, Takhzyro or Haegarda. Other causes of angioedema must be ruled out and short-term or long-term prophylaxis requirements are specified. Quantity limit: 1 capsule per day.

Effective: 2021-05-01. Last review: 2025-07.

Coverage thresholds / key limits

Age requirement>= 12 years

Dose limit<= one 150 mg capsule per day

C1-INH functional level threshold< 50% (or below lab lower limit of normal)

High-dose antihistamine trial>= 1 month (refractory to trial)

Disability from HAE (eligibility)> 5 days per month

Authorization duration6 months

Acute HAE treatment coverageNot for acute attacks

Initial Therapy Criteria

Initial Approval

Authorization for 6 months may be granted when ALL of the following are met:

Indication for use

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Continuation criteria

Documentation that the member meets the criteria for initial approval.
Documentation that the member has had a favorable clinical response (i.e., decrease in HAE acute attack frequency, decrease in HAE attack severity, or decrease in duration of HAE attacks) since initiating Orladeyo prophylactic therapy compared with baseline.
Member has documentation of reduced use of medications to treat acute attacks since starting treatment.

Not Covered / Limitations

Situations where Orladeyo is not covered:

Not covered / limitations

Use for treatment of acute HAE attacks is not covered.
All other indications beyond FDA-approved and listed compendial uses are considered experimental/investigational and not medically necessary.

Provider Actions

Prior Authorization

Prior authorization required for Orladeyo

Authorization granted for 6 months when initial criteria are met; prescriber must be or consult with an allergist/immunologist or HAE specialist and provide required laboratory/genetic documentation and clinical history.

Documentation Required

Laboratory and genetic documentation required

Provide lab confirmation of C1-INH antigenic or functional levels or genetic testing confirming listed mutations or family history with refractory response to high-dose antihistamine.

Billing Rule

Dose and combination restrictions

Do not exceed one 150 mg capsule per day; do not combine Orladeyo with Andembry, Cinryze, Takhzyro or Haegarda.

Denial Risk

Use for acute attacks or unlisted indications will be denied

Claims for treatment of acute HAE attacks or indications considered experimental/investigational are not medically necessary and will not be authorized.

Clinical Evidence

Orladeyo [package insert], BioCryst Pharmaceuticals, Inc.; October 2024.

Randomized phase 3 trial showing efficacy for prevention of HAE attacks (Zuraw et al. J Allergy Clin Immunol. 2020).

Background

Orladeyo (berotralstat) is an oral once-daily therapy indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older. It is not indicated for treatment of acute HAE attacks.

HAE: Hereditary angioedema.

C1-INH: C1 inhibitor (antigenic and functional levels used to diagnose HAE type I/II).