CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2025 P 1452-3

Agamree® (vamorolone) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization and reauthorization criteria for Agamree (vamorolone) for treatment of Duchenne muscular dystrophy in patients ≥2 years, approval durations, and notes on exclusions and automated approval processes applicable to UnitedHealthcare commercial plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyAgamree® (vamorolone) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1452-3

Change TypeNew programsubsequent non-material updates

Effective DateJan 17, 2026

Next Review Date

Key ActionPrior authorization/notification required; initial approvals issued for 12 months for Duchenne muscular dystrophy and reauthorizations for 12 months when positive clinical response is documented.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program created for Agamree (vamorolone).

Added exclusion footnote and updated reference.

Annual review with no changes.

12 monthsInitial approval duration

12 monthsReauthorization duration

≥2 yrsApproved patient age (indication)

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Coverage Summary & Scope

Background: Agamree (vamorolone) is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Scope summary: Coverage is covered with criteria (prior authorization/notification); initial and reauthorization approvals are issued for 12 months. Note that Agamree is typically excluded from coverage for some plans and plan-specific tried/failed criteria, supply limits, medical necessity rules, or step therapy may apply; state mandates and member-specific benefit plans may also impact coverage. UnitedHealthcare may use automated approval processes in some cases.

Key Program Statistics

Initial approval duration12 months

Reauthorization duration12 months

Approved patient age (indication)≥2 years

Program Number1

Initial Authorization Criteria

Initial Authorization

Agamree will be approved when ALL of the following are met:

Initial Authorization criteria

Diagnosis of Duchenne muscular dystrophy

Reauthorization (Continuation Therapy) Criteria

Reauthorization (Continuation Therapy)

Agamree will be reapproved when ALL of the following are met:

Reauthorization criteria

Clinical response: Documentation of positive clinical response to Agamree therapy

Provider Actions & Operational Requirements

Prior Authorization

Prior Authorization Required for Initial and Reauthorization

Prior authorization/notification is required. Initial approvals are issued for 12 months when a diagnosis of Duchenne muscular dystrophy is provided. Reauthorizations are issued for 12 months when documentation of positive clinical response is provided.

Documentation Required

Document Clinical Response

For reauthorization, the provider must document a positive clinical response to Agamree therapy. This documentation is required to meet the reauthorization criterion.

Prior Authorization

Automated Approvals Possible

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic using automated processes. Use of automated approval and re-approval processes varies by program and/or therapeutic class.

Applicable Codes

Relevant diagnosis coding referencedICD-10

No codes listed

Clinical Evidence & Definitions

Evidence: Agamree [package insert]. Coral Gables, FL: Catalyst Pharmaceuticals, Inc.; June 2024.

Note: The package insert supports the indication for Agamree as a corticosteroid for treatment of Duchenne muscular dystrophy in patients aged 2 years and older and is the manufacturer reference cited in this policy.

Definitions: Agamree — Brand name for vamorolone.

Policy Revision History

7/2024program_created

New prior authorization program created for Agamree (vamorolone).

10/2024change_noted

Added exclusion footnote and updated reference.

10/2025annual_reviewLatest

Annual review with no clinical policy statement changes.