CurrentConnectiCarePolicy C27685-A

Agamree (vamorolone) Coverage for Duchenne Muscular Dystrophy

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Prior authorization coverage for oral Agamree in members with Duchenne muscular dystrophy who are at least 2 years old, including initial and continuation criteria, documentation, dosing, and administration requirements.

Policy Summary

PayerConnectiCare

PolicyAgamree (vamorolone) Coverage for Duchenne Muscular Dystrophy

Policy CodePolicy C27685-A

Change TypeNo material clinical or coverage changes

Effective DateJune 6, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation confirming DMD, baseline motor function, prednisone-related adverse effects, infection status, and contraindication review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2+Minimum member age

6 moInitial authorization

12 moContinuation authorization

6 mg/kgOral dose

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CurrentConnectiCarePolicy C27685-A

Agamree (vamorolone) Coverage for Duchenne Muscular Dystrophy

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Policy Summary

PayerConnectiCare

PolicyAgamree (vamorolone) Coverage for Duchenne Muscular Dystrophy

Policy CodePolicy C27685-A

Change TypeNo material clinical or coverage changes

Effective DateJune 6, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation confirming DMD, baseline motor function, prednisone-related adverse effects, infection status, and contraindication review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2+Minimum member age

6 moInitial authorization

12 moContinuation authorization

6 mg/kgOral dose

85%Continuation adherence

Coverage Criteria

Initial Therapy

Covered for initial therapy when ALL of the following are met.

Initial therapy requirements

DMD confirmation
- Genetic confirmation: Genetic testing documents a dystrophin deletion or duplication mutation, or other qualifying genetic confirmation.
- Muscle-biopsy confirmation: Muscle biopsy confirms absence of dystrophin protein.
Baseline motor assessment
- 6MWT: 6-minute walk test (6MWT).
- NSAA: North Star Ambulatory Assessment (NSAA).
- MFM: Motor Function Measure (MFM).
- HFMS: Hammersmith Functional Motor Scale (HFMS).
Prednisone-related adverse effects
- Cushingoid appearance.
- Central obesity: Central or truncal obesity.
- Undesirable weight gain of at least 10% of body weight over 6 months.>= 10% over 6 months
- Difficult-to-manage diabetes or hypertension: Diabetes and/or hypertension that is difficult to manage according to the prescribing physician.
- Neuropsychiatric effects: Abnormal behavior or aggression while receiving prednisone that has required or would require a prednisone dose reduction.
Infection status: The prescriber attests that the member does not have an active or latent untreated infection, including active ocular herpes simplex, tuberculosis, or hepatitis B.
Assessment is according to the FDA label.
Contraindication review: The prescriber attests, or the clinical reviewer determines, that the member does not have an unaddressed FDA-labeled contraindication to Agamree.
Contraindications include known hypersensitivity to vamorolone or any inactive ingredient and administration of live or live-attenuated vaccines.

Continuation Therapy

Covered for continuation therapy when ALL of the following are met.

Continuation therapy requirements

Adherence is at least 85% of the time, or adherence below 85% is attributable to temporary discontinuation for surgery or treatment of an infection.>= 85% unless an allowed temporary interruption applies
Verified by the prescriber or member medication fill history.
Safety: The prescriber attests, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity.
Infection monitoring: The prescriber attests to ongoing monitoring for development of infection, including tuberculosis and hepatitis B reactivation, according to the FDA label.
Positive motor response

Duchenne Muscular Dystrophy Indication

Covered for the FDA-approved indication when the patient meets the specified age and disease requirements.

FDA-approved indication: Patient has Duchenne muscular dystrophy and is 2 years of age or older.Age >= 2 years

Agamree is indicated for the treatment of DMD in patients 2 years of age and older.

Coverage is excluded when the member has an untreated active or latent infection, including active ocular herpes simplex, tuberculosis, or hepatitis B. The infection must be addressed before Agamree therapy can be covered.

Agamree treatment is not covered when an FDA-labeled contraindication remains unaddressed. Contraindications include known hypersensitivity to vamorolone or any inactive ingredient; live or live-attenuated vaccines must not be administered.

Uses of Agamree other than treatment of Duchenne muscular dystrophy are considered experimental or investigational and are subject to the applicable off-label policy.

Live or live-attenuated vaccines must not be administered during Agamree treatment.

Agamree is contraindicated in members with hypersensitivity to vamorolone or to any inactive ingredient in Agamree.

Initial Therapy Criteria

Agamree Initial Therapy

Initial therapy requires ALL of the following clinical, safety, and documentation requirements.

Agamree initial therapy requirements

DMD confirmation
- Genetic confirmation: Genetic testing documents a dystrophin deletion or duplication mutation, or other qualifying genetic confirmation.
- Muscle-biopsy confirmation: Muscle biopsy confirms absence of dystrophin protein.
Baseline motor assessment
- 6MWT:

Continuation Therapy Criteria

Agamree Continuation Therapy

Agamree continuation therapy requires ALL of the following requirements.

Agamree continuation requirements

Adherence is at least 85% of the time, or adherence below 85% is attributable to temporary discontinuation for surgery or treatment of an infection.>= 85% unless an allowed temporary interruption applies
Verified by the prescriber or member medication fill history.
Safety: The prescriber attests, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity.
Infection monitoring: The prescriber attests to ongoing monitoring for development of infection, including tuberculosis and hepatitis B reactivation, according to the FDA label.

Coding and Related Requirements

HCPCS CodeHCPCS

Prednisone-Associated Weight Gain

Qualifying adverse effectPrednisone-associated undesirable weight gain

ThresholdAt least 10% body-weight increase

Measurement periodOver 6 months

Medication Adherence

Minimum adherenceAt least 85% of the time

VerificationVerified by the prescriber or member medication fill history

ExceptionAdherence below 85% is allowed when surgery or infection treatment required temporary discontinuation

Provider Submission and Review Guidance

Prior Authorization

Initial Prior Authorization

Submit an initial prior authorization request with member-specific medical information for case-by-case review. If dosing is based on weight, body surface area, or another member-specific measurement, include that measurement; initial authorization is available for 6 months.

Coverage may be reviewed using updated FDA-label information when the requested drug received a label update within the prior 180 days.
Additional information may be requested to complete the medical-necessity review.

Prior Authorization

Reauthorization

For reauthorization, document continued clinical appropriateness and the member’s response to therapy. Continuation authorization is available for 12 months when adherence, safety monitoring, objective response, and prednisone-related outcomes are adequately documented.

Document adherence of at least 85% based on prescriber verification or medication-fill history, or explain a temporary interruption for surgery or infection treatment.
Document no intolerable adverse effects or drug toxicity and ongoing monitoring for infection.

Policy Background

Agamree (vamorolone) coverage is available for members with Duchenne muscular dystrophy who are 2 years of age or older. Initial therapy requires objective confirmation of DMD, documentation of a baseline motor-function assessment, and clinically significant prednisone-related adverse effects, along with confirmation that infection risks and FDA-labeled contraindications have been addressed. Continued therapy requires adherence, safety and infection monitoring, an objective positive motor response using the same baseline assessment, and improvement in prednisone-related symptoms or side effects.

Definitions and Assessment Measures

Undesirable Weight Gain

DefinitionUndesirable weight gain

ThresholdAt least 10% increase in body weight

TimeframeOver 6 months

MRC Muscle-Strength Scale

ScaleMedical Research Council muscle-strength scale

Range0 to 5

Interpretation0 means no movement; 5 means normal strength

Dosing and Quantity Limits

Agamree Quantity

DrugAgamree (vamorolone)

Quantity6 mg/kg

AdministrationOrally once daily

Maximum daily dosage300 mg for members weighing more than 50 kg

Agamree Standard Dosage

Standard dosage6 mg/kg once daily

RouteTaken orally, preferably with a meal

Site of Care and Administration

Billing Rule

Use pharmacy benefit and home self-administration

Agamree is an oral medication recommended for pharmacy-benefit coverage and patient self-administration at home.

Policy Summary

PayerConnectiCare

PolicyAgamree (vamorolone) Coverage for Duchenne Muscular Dystrophy

Policy CodePolicy C27685-A

Change TypeNo material clinical or coverage changes

Effective DateJune 6, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation confirming DMD, baseline motor function, prednisone-related adverse effects, infection status, and contraindication review.

SourceLink

On This Page

6MWT response: 6-minute walk test demonstrates stabilization or less-than-expected decline.

NSAA response: North Star Ambulatory Assessment demonstrates stabilization or less-than-expected decline.

MFM response: Motor Function Measure demonstrates stabilization or less-than-expected decline.

HFMS response: Hammersmith Functional Motor Scale demonstrates stabilization or less-than-expected decline.

Improvement in prednisone-related effects: Documentation shows improvement in symptoms or side effects associated with prednisone, including improvement in neuropsychiatric symptoms when applicable, or return to baseline growth-curve expectations or maintenance of the same growth curve when excessive weight gain was the qualifying adverse effect.

These examples are not exhaustive.

6-minute walk test (6MWT).

NSAA: North Star Ambulatory Assessment (NSAA).

MFM: Motor Function Measure (MFM).

HFMS: Hammersmith Functional Motor Scale (HFMS).

Prednisone-related adverse effects

Cushingoid appearance.
Central obesity: Central or truncal obesity.
Undesirable weight gain of at least 10% of body weight over 6 months.>= 10% over 6 months
Difficult-to-manage diabetes or hypertension: Diabetes and/or hypertension that is difficult to manage according to the prescribing physician.
Neuropsychiatric effects: Abnormal behavior or aggression while receiving prednisone that has required or would require a prednisone dose reduction.

Infection status: The prescriber attests that the member does not have an active or latent untreated infection, including active ocular herpes simplex, tuberculosis, or hepatitis B.

Contraindication review: The prescriber attests, or the clinical reviewer determines, that the member does not have an unaddressed FDA-labeled contraindication to Agamree.

Contraindications include known hypersensitivity to vamorolone or any inactive ingredient and administration of live or live-attenuated vaccines.

Initial Therapy — Duchenne Muscular Dystrophy

Initial treatment is covered for the FDA-approved indication when ALL of the following are met.

Initial approved indication: Patient has Duchenne muscular dystrophy and is at least 2 years old.Age >= 2 years

No compendial approved off-label uses are listed.

Positive motor response

6MWT response: 6-minute walk test demonstrates stabilization or less-than-expected decline.
NSAA response: North Star Ambulatory Assessment demonstrates stabilization or less-than-expected decline.
MFM response: Motor Function Measure demonstrates stabilization or less-than-expected decline.
HFMS response: Hammersmith Functional Motor Scale demonstrates stabilization or less-than-expected decline.

These examples are not exhaustive.

Submit objective response using the same baseline motor milestone assessment, with stabilization or less-than-expected decline, plus improvement in prednisone-related symptoms or adverse effects.

Documentation Required

General Medical-Necessity Documentation

Be prepared to provide additional documentation supporting medical necessity, benefit eligibility, and noninvestigational use. ConnectiCare may request records and may deny reimbursement or take other appropriate action when submitted information does not support coverage or reflects inappropriate or excessive billing.

Medical records and test results may be required.
Include the credentials of the provider ordering or performing the drug or service.
Additional information may be requested for coverage determination, quality improvement, and fraud, waste, and abuse prevention.

Documentation Required

Initial Clinical Documentation

For the initial request, document Duchenne muscular dystrophy and the member’s baseline motor function. The clinical record must also establish clinically significant prednisone-related adverse effects and address infection and FDA-labeled contraindication requirements.

Confirm DMD by genetic testing, such as a dystrophin deletion or duplication mutation, or by muscle biopsy showing absence of dystrophin protein.
Submit a baseline score from one assessment: 6-minute walk test (6MWT), North Star Ambulatory Assessment (NSAA), Motor Function Measure (MFM), or Hammersmith Functional Motor Scale (HFMS).
Document clinically significant prednisone adverse effects: Cushingoid appearance; central obesity; weight gain of at least 10% over 6 months; difficult-to-manage diabetes or hypertension; or neuropsychiatric effects requiring or expected to require prednisone dose reduction.
Include the required prescriber attestations regarding untreated infection and unaddressed FDA-labeled contraindications.

Documentation Required

Continuation Documentation

Each continuation request must show that therapy remains safe, effective, and clinically beneficial. Document adherence, infection monitoring, objective motor-function response, and improvement in the prednisone-related symptom or adverse effect that supported initial coverage.

Adherence must be at least 85%, unless lower adherence is explained by temporary discontinuation for surgery or infection treatment.
Document no intolerable adverse effects or drug toxicity and ongoing monitoring for infection, including tuberculosis or Hepatitis B reactivation.
Use the same baseline assessment—6MWT, NSAA, MFM, or HFMS—to show stabilization or less-than-expected decline.
Additional objective evidence may include muscle-strength testing such as the MRC scale, pulmonary testing such as FVC or maximal expiratory pressure, and timed functional tests such as standing, stair climbing, running or walking 30 feet, or wheelchair propulsion 30 feet.
Document improvement in prednisone-related effects, including neuropsychiatric symptoms or excessive weight gain, such as return to expected baseline growth-curve expectations or maintenance on the same growth curve.

Documentation Required

Consultation Documentation

The drug must be prescribed by, or in consultation with, an appropriately qualified specialist. When prescribed in consultation, submit the consultation notes with both the initial request and every reauthorization request.

Acceptable prescribers or consultants include board-certified neurologists, neuromuscular disorder specialists, orthopedic specialists, physical medicine and rehabilitation specialists, neurodevelopmental disability specialists, or physicians experienced in treating DMD.

Unsupported block type: denial_risk

6-Minute Walk Test

Test6-Minute Walk Test (6MWT)

MeasureDistance a patient can walk in 6 minutes

ConditionsOn a flat, hard surface

Time to Stand Test

TestTime to Stand Test (TTSTAND)

MeasureTime required to stand to an erect position

Starting positionFrom a supine position on the floor

Time to Run/Walk 10 Meters

TestTime to Run/Walk 10 meters (TTRW)

MeasureTime required to cover 10 meters

ActivityRunning or walking

North Star Ambulatory Assessment

AssessmentNorth Star Ambulatory Assessment (NSAA)

Format17-item rating scale

PurposeMeasures functional motor abilities in ambulatory children with Duchenne muscular dystrophy and monitors disease progression and treatment effects

Maximum daily dosage

300 mg for patients weighing more than 50 kg

Agamree 2 mg/kg Dosage

Dose2 mg/kg once daily

Dose adjustmentSome patients may respond to 2 mg/kg daily, and doses may be titrated down based on individual tolerability

Hepatic impairmentRecommended for mild to moderate hepatic impairment, with a maximum of 100 mg daily for patients weighing more than 50 kg

Agamree 4 mg/kg Dosage

Dose4 mg/kg once daily

UseWhen administered with strong CYP3A4 inhibitors

Maximum daily dosage200 mg for patients weighing more than 50 kg