CurrentCignaPolicy N/A

Muscular Dystrophy - Deflazacort Preferred Specialty Management Policy

Defines Cigna's preferred specialty management program for deflazacort products for treatment of Duchenne muscular dystrophy (DMD), including preferred vs non-preferred products, prior authorization and exception criteria, and documentation requirements for plan members and providers.

Policy Summary

PayerCigna

PolicyMuscular Dystrophy - Deflazacort Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAdded products & exception criteria

Effective Date05/20/2024

Next Review Date

Key ActionObtain prior authorization and document trial of a Preferred Product (generic deflazacort tablets, Jaythari tablets, or Kymbee) before requesting a Non-Preferred product unless an exception applies.

SourceLink

POLICY UPDATE CHANGES

Added generic deflazacort oral suspension to Non-Preferred Products.

Added Pyquvi oral suspension to Non-Preferred Products and added new exception criteria; added Jaythari tablets and Kymbee to the Preferred Products.

Added Jaythari oral suspension to Non-Preferred products with the same exception as the other Non-Preferred oral suspension products.

4brand/generic products listed on policy header

1 yearauthorization length for approvals

≥2 yrsFDA indication age (general)

Policy Summary

PayerCigna

PolicyMuscular Dystrophy - Deflazacort Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAdded products & exception criteria

Effective Date05/20/2024

Next Review Date

SourceLink

On This Page

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Coverage and Exception Rules

Non-Preferred Product Exception Criteria

Non-Preferred products are covered as medically necessary only when the specified exception criteria are met.

Emflaza tablets exception

A: Patient meets the standard Muscular Dystrophy - Deflazacort Prior Authorization Policy criteria.
B: Patient has tried one of: generic deflazacort tablets, Jaythari tablets, or Kymbee (documentation required).
C: Patient cannot take the Preferred Products due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction (documentation required).

Non-preferred oral suspensions exception

A: Patient meets the standard Muscular Dystrophy - Deflazacort Prior Authorization Policy criteria.
B (one of)
- i: Patient has tried one of: generic deflazacort tablets, Jaythari tablets, or Kymbee (documentation required).
- ii: Patient cannot swallow or has difficulty swallowing tablets.

Fallback when prior auth criteria met but no trial of preferred: If the patient meets the standard prior authorization criteria but has not met the trial/documentation requirement for preferred products, approval for a Preferred Product will be authorized (patient will be approved for a Preferred Product rather than a Non-Preferred Product).

Operational direction in policy statement

Any request for coverage that does not meet the policy’s specified exception criteria is considered not medically necessary. The Preferred Specialty Management program requires that patients meet the standard Muscular Dystrophy - Deflazacort Prior Authorization Policy criteria and any non-preferred product request must satisfy the listed exception criteria to be approved; any other exception is considered not medically necessary. All approvals are issued for 1 year.

Requests for non-preferred products that do not meet the stated exception criteria will be denied as not medically necessary. The program is designed to encourage use of Preferred Products (generic deflazacort tablets, Jaythari tablets, or Kymbee); if the patient meets the standard prior authorization criteria but has not tried a Preferred Product, approval will be for a Preferred Product rather than a non-preferred product. Documentation of prior use is required when applicable.

Prior Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization Required — All deflazacort medications (preferred and non-preferred) require prior authorization under the Muscular Dystrophy - Deflazacort Prior Authorization Policy. Approvals are issued for 1 year.

All deflazacort products (tablets and oral suspensions) require PA
Approvals granted for 1 year

Step Therapy

Try Preferred Product First

Try Preferred Product First — A preferred product must be tried before a non-preferred product will be approved unless a documented exception applies.

Preferred products: generic deflazacort tablets, Jaythari tablets, Kymbee
Non-preferred products include Emflaza (tablets and oral suspension), generic deflazacort oral suspension, Jaythari oral suspension, Pyquvi oral suspension

Step Requirement for Deflazacort Products

Step	Requirement / Exception	Approval Length
1	Patient must try a Preferred Product (generic deflazacort tablets, Jaythari tablets, or Kymbee) prior to approval of a Non-Preferred Product; documentation of prior use is required (chart notes, prescription claims, receipts, or other patient-specific documentation). If the patient meets the standard Muscular Dystrophy - Deflazacort prior authorization criteria but has not met the trial/documentation requirement, approval will be authorized for a Preferred Product instead of a Non-Preferred.	1 year
Non-Preferred brand tablets (Emflaza tablets)	Approve for 1 year if ALL are met: (A) patient meets the standard Muscular Dystrophy - Deflazacort prior authorization criteria; AND (B) patient has tried one of generic deflazacort tablets, Jaythari tablets, or Kymbee (documentation required); AND (C) patient cannot take the Preferred Products due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) that per the prescriber would result in a significant allergy or serious adverse reaction (documentation required).	1 year (when criteria met)
Non-Preferred oral suspensions (Emflaza oral suspension, generic deflazacort oral suspension, Jaythari oral suspension, Pyquvi oral suspension)	Approve for 1 year if BOTH are met: (A) patient meets the standard Muscular Dystrophy - Deflazacort prior authorization criteria; AND (B) patient meets ONE of: (i) patient has tried one of generic deflazacort tablets, Jaythari tablets, or Kymbee (documentation required); OR (ii) patient cannot swallow or has difficulty swallowing tablets. If prior auth criteria are met but the trial/documentation for preferred products is not met, approve Preferred Product instead.	1 year (when criteria met)

Key Terms

Deflazacort — definition and age-specific indications

DefinitionDeflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD).

General FDA age indicationIndicated for DMD in patients ≥ 2 years of age; efficacy and safety not established in patients < 2 years.

Jaythari, Kymbee, Pyquvi age indicationJaythari, Kymbee, and Pyquvi are indicated for DMD in patients ≥ 5 years of age.

Regulatory noteEmflaza oral suspension marketing exclusivity affects approvals; other agents are not approved in patients < 5 years due to exclusivity.

Clinical Background

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD). The efficacy and safety of deflazacort are established for patients aged ≥ 2 years for deflazacort in general, while certain branded or formulation-specific products (for example, Jaythari, Kymbee, and Pyquvi) have age indications that may differ (commonly ≥ 5 years). Formulation differences (tablets versus oral suspension) and product-specific labeling inform the policy’s preferred versus non-preferred designation and the exception pathways for patients unable to use preferred formulations.