CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Akansas PASSE

Policy governs medical-benefit coverage and prior authorization criteria for Exondys 51 (eteplirsen) (J1428) for treatment of Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping, including initial and reauthorization requirements, dosing, site of service and quantity-limit basis.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeRevised (non-material most recently)

Effective DateJan 1, 2022

Next Review Date

Key ActionPrior authorization is required for Exondys 51 and submit chart/lab notes confirming mutation amenable to exon 51 skipping plus documentation of independent ambulation for initial and reauthorization requests.

SourceLink

POLICY UPDATE CHANGES

Criteria on member's ambulatory status and independent walking ability added to initial (10/16/2017).

Policy converted into new format (11/29/2016).

Policy revised on 06/23/2020 (revised date recorded).

1Covered Indication (DMD amenable to exon 51 skipping)

6 monthsInitial approval duration

6 monthsReauthorization approval duration

Coverage Summary & Scope

This policy governs medical-benefit coverage and prior authorization criteria for Exondys 51 (eteplirsen) (Billing code J1428) for treatment of Duchenne Muscular Dystrophy (DMD) with mutations amenable to exon 51 skipping. Exondys 51 is a medical-benefit therapy, designated a non-preferred product that requires prior authorization and documentation of the DMD gene mutation and ambulatory status. Effective date: 2022-01-01; Last review: 2020-06-23.

Quick facts and thresholds

Covered IndicationDuchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping

Initial approval duration6 months

Reauthorization approval duration6 months

Dose30 mg/kg once weekly

Initial Therapy Criteria

Covered Indication - Initial Authorization for Duchenne Muscular Dystrophy (DMD)

Covered when ALL of the following are met:

ref": "b1_0", "title": "Covered Indication - Initial Authorization for Duchenne Muscular Dystrophy (DMD)"}

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Initial Authorization - Dosing and Approval Duration

ref": "b1_1", "title": "Initial Authorization - Dosing and Approval Duration"}

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Reauthorization / Continuation Criteria

Reauthorization Criteria for Duchenne Muscular Dystrophy (DMD)

Covered when ALL of the following are met:

ref":

title": "Reauthorization Criteria for Duchenne Muscular Dystrophy (DMD)"}

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Unproven / Not Medically Necessary

Not Medically Necessary

Not covered when the following apply:

ref": "b3_0", "title": "Not Medically Necessary"}

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Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Exondys 51 as a non-preferred product under the medical benefit.

J1428

Documentation Required

Mutation confirmation and ambulatory status documentation

Submit chart/lab notes confirming a DMD gene mutation amenable to exon 51 skipping, three chart notes confirming ambulatory independent walking for initial request, and chart notes within 30 days showing continued independent ambulation for reauthorization.

Chart/lab notes confirming DMD gene mutation amenable to exon 51 skipping
Three chart notes confirming ambulatory independent walking for initial request
Chart notes within 30 days prior to reauthorization showing continued independent ambulation

Billing Rule

Quantity limit

Quantity limits are based on weight; dose billed based on J1428 unit = 10 mg.

Dose billed based on J1428 unit = 10 mg; quantity limits based on patient weight

Clinical Evidence & Definitions

Evidence: Package Insert: Exondys 51 [Package Insert], Sarepta Therapeutics, September 2016.

Background/benefit context: Exondys 51 (eteplirsen) is provided under the medical benefit (billing code J1428, unit = 10 mg) and is a non-preferred product; prior authorization is required and quantity limits are based on weight. Site of service allowed includes office/outpatient/home.

Ambulatory and walking independently: Walking without side-by-side assist, cane, walker, wheelchair, etc.; objective documentation required in chart notes.

Revision History

2016-11-29policy_conversion

Policy converted into new format (11/29/2016).

2017-10-16material_change

Criteria on member's ambulatory status and independent walking ability added to initial (10/16/2017).

2020-06-23revisedLatest

Policy revised on 06/23/2020 (revised date recorded).

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeRevised (non-material most recently)

Effective DateJan 1, 2022

Next Review Date

SourceLink

On This Page

OpenPayer

PHARMACY POLICY STATEMENT Akansas PASSE

Coverage Summary & Scope

Initial Therapy Criteria

Reauthorization / Continuation Criteria

Unproven / Not Medically Necessary

Applicable Codes

Provider Actions & Billing Rules

Clinical Evidence & Definitions

Revision History