CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy ProgramsPolicy N/A

Agamree® (vamorolone) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Defines UnitedHealthcare commercial plan prior authorization and medical necessity position for Agamree (vamorolone) for treatment of Duchenne muscular dystrophy (DMD), including therapeutic equivalence to prednisone and exclusion/try-fail guidance; applies to plans subject to program rules and state/federal mandates.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare

PolicyAgamree® (vamorolone) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy N/A

Change TypeProgram created; exclusion footnote added; annual review

Effective DateJan 17, 2026

Next Review Date

Key ActionProviders must check member-specific benefit plans and state mandates for exclusion or tried/failed criteria and obtain authorization if required.

SourceLink

POLICY UPDATE CHANGES

Program created (New program) in 7/2024.

10/2024: Added exclusion footnote and updated reference.

10/2025: Annual review with no changes to criteria; background and references updated.

EquivalentTherapeutic equivalence

ExcludedUsual coverage status

7/2024,10/2024,10/2025P&T review dates

Coverage Determination

Coverage Determination for Agamree (vamorolone)

Policy statements regarding medical necessity and coverage for Agamree are:

ALL of the following

Agamree is a corticosteroid indicated for treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older (per package insert).
UnitedHealthcare Pharmacy and Therapeutics Committee has determined Agamree is therapeutically equivalent to prednisone for DMD and does not offer a clear advantage in efficacy or overall safety.
Coverage outcome
- Agamree is not medically necessary for treatment of Duchenne muscular dystrophy.
- Agamree is typically excluded from coverage; tried/failed criteria may be in place depending on plan specifics.
State mandates, federal regulatory requirements, and the member-specific benefit plan coverage may impact final coverage determination; refer to plan specifics.
UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval/reauthorization processes vary by program.

Coverage stance: Not covered — Agamree is typically excluded from coverage and is not considered medically necessary compared with other corticosteroids for DMD.

Scope: Defines UnitedHealthcare commercial plan prior authorization and medical necessity position for Agamree (vamorolone) for treatment of Duchenne muscular dystrophy (DMD); applies to plans subject to program rules and state/federal mandates and may be modified by member-specific benefit plans.

Note on plan impacts: State mandates, federal regulatory requirements, and the member-specific benefit plan coverage may affect final coverage determinations; other utilization management programs or automated claim/reauthorization logic may also apply.

Definition referenced: Tried/Failed criteria means a plan-specific requirement that a member must have tried and failed other therapies (e.g., prednisone) before coverage of Agamree is considered.

Provider Requirements & Authorization

Prior Authorization

Prior authorization/medical necessity program applies

Agamree is managed under a prior authorization/medical necessity program; providers must check member-specific benefit plans and state mandates for exclusion or tried/failed criteria and obtain authorization if required.

Check member-specific benefit plans and state mandates; obtain authorization if required.

Documentation Required

Use of claims and diagnosis history for approvals

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis (ICD-10) and/or claim logic; providers should ensure accurate claims/diagnosis history is present.

Ensure accurate prior claim/medication history and ICD-10 diagnosis codes are present.

Evidence & References

Key evidence includes the Agamree package insert (Agamree [package insert], Catalyst Pharmaceuticals, June 2024).

Randomized trials and publications assessing vamorolone are cited, including Neurology 2024 and JAMA Neurol 2022.

The Pharmacy & Therapeutics Committee concluded therapeutic equivalence to prednisone, finding no clear advantage in efficacy or overall safety.

Background

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

P&T finding and coverage impact: The UnitedHealthcare Pharmacy & Therapeutics Committee determined Agamree is therapeutically equivalent to prednisone and does not offer a clear advantage in efficacy or overall safety; therefore Agamree is not medically necessary for DMD and is typically excluded from coverage.

Quick attributes

Policy governance (P&T dates)P&T approval dates: 7/2024, 10/2024, 10/2025

Therapeutic equivalenceTherapeutically equivalent to prednisone

Usual coverage statusTypically excluded (tried/failed criteria may apply per plan)

Effective date1/17/2026

Last review date10/01/2025