ModifiedMass General Brigham Health PlanPolicy N/A

Orladeyo (berotralstat) Effective 01/01/2023

Prior authorization and quantity-limit policy for Orladeyo (berotralstat) for prevention of hereditary angioedema in adults and pediatric patients ≥12 years, covering initial approval, reauthorization, specialty dispensing requirement, quantity limits, and clinical/laboratory eligibility criteria.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOrladeyo (berotralstat) Effective 01/01/2023

Policy CodePolicy N/A

Change TypeModified (requirements added)

Effective DateJan 1, 2023

Next Review Date

Key ActionPrior authorization is required for Orladeyo; provide relevant laboratory or genetic documentation and meet clinical criteria for initial approval or reauthorization.

SourceLink

POLICY UPDATE CHANGES

Added requirement of adverse effect or contraindication to icatibant for certain members with normal C1-INH.

Policy separated out MassHealth vs Commercial/Exchange with effective date 01/01/2023.

6 monthsInitial/Reauthorization Approval Duration

30Monthly Quantity Limit

>=50%Required Attack Reduction for Reauthorization

Coverage Summary

Scope: Prior authorization and quantity-limit policy for Orladeyo (berotralstat) for prevention of hereditary angioedema in adults and pediatric patients ≥12 years. Coverage stance: covered_with_criteria. Effective date: 2023-01-01. Monthly quantity limit: 30 capsules per 30 days. Initial and reauthorization approvals are issued for 6 months.

Key Thresholds

Initial/Reauthorization Approval Duration6 months

Monthly Quantity Limit30 capsules per 30 days

Required Attack Reduction for Reauthorization>= 50% reduction in frequency of attacks

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ALL of the following criteria are met and documentation is provided:

ALL of the following

Member will be using Orladeyo for the prevention of hereditary angioedema attacks
Orladeyo will not be used in combination with medication used for the prophylaxis of HAE attacks
One of the diagnostic criteria
- C1 inhibitor deficiency/dysfunction confirmed by laboratory testing
  - One of the following C1-INH findings
    C1 inhibitor (C1-INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test
    Normal C1-INH antigenic level and a low C1-INH functional level (functional C1-INH less than 50% or C1-INH functional level below the lower limit of normal as defined by the laboratory performing the test)
- Genetic mutation: Member has an F12, angiopoietin-1, plasminogen, or kininogen-1 (KNG1) gene mutation as confirmed by genetic testing
- Normal C1 inhibitor with clinical criteria
  - One of
    Family history + refractory to antihistamine trial: Member has a documented family history of angioedema and the angioedema was refractory to a trial of high-dose antihistamine (e.g., cetirizine) for at least one month
    Adverse effect or contraindication to icatibant: Member has adverse effect or contraindication to icatibant (generic for Firazyr)

Continuation Therapy Criteria (Reauthorization)

Reauthorization operational detail: approvals are for 6 months and require documentation that the member meets initial approval criteria, has experienced a significant reduction in attack frequency (e.g., ≥50%), and has reduced use of medications to treat acute attacks.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Orladeyo; authorization may be granted for members new to the plan who are currently receiving Orladeyo or when initial clinical and laboratory criteria are met.

Documentation Required

Laboratory and genetic documentation required

Provide documentation of relevant laboratory testing (C4, C1-INH antigenic and/or functional levels) or genetic testing confirming F12, angiopoietin-1, plasminogen, or KNG1 mutation, and documentation of trial of high-dose antihistamine or contraindication/adverse effect to icatibant when applicable.

Billing Rule

Specialty pharmacy dispensing

Fill at a contracted specialty pharmacy as medication is designated specialty.

Step Therapy

Step requirement regarding icatibant

For members with normal C1-INH and family history of angioedema, require refractoriness to a trial of high-dose antihistamine for at least one month or an adverse effect/contraindication to icatibant.

Documentation Required

Reauthorization efficacy documentation

For reauthorization, document ≥50% reduction in attack frequency and reduced use of acute-attack medications.

Background & Definitions

Background: Orladeyo (berotralstat) is an oral plasma kallikrein inhibitor indicated to prevent HAE attacks in adults and pediatric patients 12 years and older. The policy requires laboratory or genetic confirmation for diagnosis (C4, C1‑INH antigenic and/or functional levels, or genetic testing for F12, angiopoietin-1, plasminogen, or KNG1 mutations) and specifies reauthorization efficacy measures including documented ≥50% reduction in attack frequency and reduced use of acute-attack medications.

Definitions: C1-INH functional level — Functional measurement of C1 inhibitor activity; low defined as less than 50% or below the laboratory's lower limit of normal.

Revision History

2022-09-21material