CurrentAvMedPolicy N/A

Prior authorization for Agamree (vamorolone) and deflazacort products

This document governs pharmacy prior authorization and step-edit requests for Agamree (vamorolone) and deflazacort products (Emflaza, Jaythari, Pyquvi) for AvMed members; it specifies documentation and clinical criteria prescribers must meet for initial and reauthorization approvals.

Policy Summary

PayerAvMed

PolicyPrior authorization for Agamree (vamorolone) and deflazacort products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and submit the pharmacy prior authorization/step-edit request form with all required fields and supporting documentation to request initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 / 12authorization durations (months) — initial and reauthorization

>=2 yrsminimum member age for initial approval

3 morequired prednisone trial

3 morequired deflazacort trial before Agamree

2 bottlesquantity limit for Agamree

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Authorization (6 months):

Initial Authorization - top level

Significant intolerable adverse effects to prednisone: Cushingoid appearance OR truncal obesity OR undesirable weight gain (>= 10% body weight over a 6-month period) OR diabetes and/or hypertension that is difficult to manage
At least one required if using intolerance pathway
Behavioral adverse event pathway: Behavioral adverse event persisted beyond the first 6 weeks of prednisone therapy AND change in time of prednisone administration was attempted and was unsuccessful
Both required if using behavioral adverse event pathway
Baseline motor assessments:

Policy Summary

PayerAvMed

PolicyPrior authorization for Agamree (vamorolone) and deflazacort products

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and submit the pharmacy prior authorization/step-edit request form with all required fields and supporting documentation to request initial authorization.

SourceLink

On This Page

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6-Minute Walk Test (6MWT) OR North Star Ambulatory Assessment (NSAA) OR Hammersmith Functional Motor Scale (HFMS) OR Motor Function Measure (MFM)

One baseline motor assessment required

Reauthorization

Covered when ALL of the following are met for Reauthorization (12 months):

Reauthorization - top level

Motor assessment improvement/stabilization: 6-Minute Walk Test (6MWT) OR North Star Ambulatory Assessment (NSAA) OR Motor Function Measure (MFM) OR Hammersmith Functional Motor Scale (HFMS)
One required
Reduction in intolerable side effects: Improvement in Cushingoid appearance OR truncal obesity OR weight gain OR diabetes and/or hypertension management OR behavior
One required

Therapy must not be used concurrently with live vaccines. Initiation is also excluded when there is an active infection documented at the time of request.

Requests that do not meet all Initial Authorization criteria are not eligible for approval. Common reasons for denial include missing required documentation (for example, confirmation of DMD, serum creatine kinase results, baseline motor assessment, or chart notes/pharmacy claims verifying prior therapy) and failure to show required prior therapy trials such as a minimum 3‑month trial of prednisone (and for Agamree requests, a minimum 3‑month trial of generic deflazacort tablets unless the member cannot swallow tablets).

Drug and Clinical Coding

Drug product identifiersNDC

NDC	Quantity and product descriptors provided; form references products rather than specific NDCs

inv-06: Serum creatine kinase activity

Serum creatine kinase activity threshold>= 10 times upper limit of normal

When measuredAt some stage of the illness prior to initiating therapy

Documentation requiredSubmit laboratory documentation showing CK activity >=10x ULN

Prescriber Submission & Documentation Requirements

Prior Authorization

Submission and initial authorization

The prescribing physician must sign and clearly print name on the pharmacy prior authorization/step-edit request form (preprinted stamps are not valid). Fax the completed form to 1-305-671-0200. All required fields (including provider phone and fax) must be complete, correct, and legible. Missing, incomplete, or illegible information may delay processing or result in denial.

Fax: 1-305-671-0200
Prescriber signature required (no preprinted stamps)
Ensure provider phone and fax numbers are included

Step Therapy

Required prior therapy trials

Initial authorization is for 6 months; reauthorization is for 12 months. All listed clinical criteria must be met for approval and appropriate supporting documentation must be submitted with the request.

Initial Authorization: 6 months
Reauthorization: 12 months
All clinical criteria must be met for approval

Documentation Required

Required supporting documentation

To support each checked clinical criterion, submit all relevant documentation such as lab results, diagnostic reports, baseline and follow-up motor assessment scores, chart notes, and prior pharmacy paid claims. Requests lacking supporting documentation may be denied.

Include lab results (e.g., serum creatine kinase activity)
Include diagnostics and mutation documentation for DMD
Submit baseline and follow-up motor assessments (6MWT, NSAA, HFMS, or MFM)
Provide chart notes or pharmacy paid claims verifying prior prednisone trial (minimum 3 months) and, for Agamree, trial of generic deflazacort tablets (3 months) unless unable to swallow tablets

Denial Risk

Incomplete or illegible request

Missing or illegible information on the prior authorization request can lead to processing delays or denial. Ensure all fields are complete and legible before submission.

Incomplete or illegible requests may be delayed or denied
Ensure all required fields and documentation are provided

Denial Risk

Failure to meet clinical criteria

Failure to meet any of the listed clinical criteria (initial or reauthorization) may result in denial. Confirm member meets diagnosis, age, laboratory thresholds, prior therapy trials, and documented intolerance or contraindication to prednisone as applicable.

All criteria must be met for approval
Failure to provide verification (chart notes, claims, labs) may result in denial

Background

Duchenne muscular dystrophy (DMD) is a genetic neuromuscular disorder confirmed by documented abnormal dystrophin or a pathogenic mutation in the dystrophin gene. Standard management includes corticosteroids (for example, prednisone or deflazacort) to slow disease progression; vamorolone (Agamree) is an alternative corticosteroid‑like agent considered when members meet the program criteria, including age, biochemical evidence (for example, serum creatine kinase ≥ 10 times the upper limit of normal), specialist involvement, prior therapy trials, baseline motor assessment, and intolerance to or adverse effects from prednisone.

Definitions and Clinical Thresholds

inv-13: DMD confirmation

DefinitionDuchenne Muscular Dystrophy (DMD) confirmed by documented presence of abnormal dystrophin or confirmed mutation of the dystrophin gene

Required documentationSubmit pathology/genetic testing report or other documentation confirming abnormal dystrophin or dystrophin gene mutation

RelevanceOne of the mandatory initial authorization criteria for Agamree/deflazacort coverage

inv-14: Elevated creatine kinase

Elevated creatine kinase criterionSerum creatine kinase activity >= 10 times the upper limit of normal prior to initiating therapy

TimingMeasured at some stage of the illness before therapy start; must be documented

Evidence to submitLaboratory results demonstrating CK >=10x ULN must be provided with the authorization request

Initial Therapy Criteria

Initial Therapy

Initial authorization (6 months) requirements:

Initial Therapy - drug-specific

Significant intolerable adverse effects to prednisone: Cushingoid appearance OR truncal obesity OR undesirable weight gain (>= 10% body weight over a 6-month period) OR diabetes and/or hypertension difficult to manage
At least one required if using intolerance pathway
Behavioral adverse event pathway: Behavioral adverse event persisted beyond the first 6 weeks of prednisone therapy AND change in time of prednisone administration was attempted and was unsuccessful
Both required if using behavioral adverse event pathway
Baseline motor assessments: 6-Minute Walk Test (6MWT) OR North Star Ambulatory Assessment (NSAA) OR Hammersmith Functional Motor Scale (HFMS) OR Motor Function Measure (MFM)
One baseline motor assessment required

Reauthorization / Continuation Criteria

Step Therapy Requirements

Step	Requirement
1	Member must have had a minimum THREE (3) month trial of prednisone (verified by chart notes or pharmacy paid claims)

Step	Requirement
2	For Agamree requests: member must have had a minimum THREE (3) month trial of generic deflazacort (Emflaza) tablets unless member is unable to swallow tablets (verified by chart notes or pharmacy paid claims)

Quantity Limits

inv-19: Agamree (vamorolone) quantity limit

Quantity limit2 bottles per 26 days

ProductAgamree (vamorolone)

Dosage form note6 mg/kg taken orally once daily (see dosing guidance); maximum daily 300 mg for patients >50 kg

Site of Care and Dispensing

Note

Use specialty pharmacy Proprium Rx for dispensing

Specialty-dispensed items are provided by Proprium Rx; ensure the prescription is processed through the specialty pharmacy as indicated on the form.