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HealthPartners

Coverage criteria policies

Eteplirsen (Exondys 51™)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is not applicable for Exondys 51 because it is considered investigational/experimental. The provider and facility will be liable for payment unless:

  • The provider notifies the member that a specific service has been determined by HealthPartners to be investigational/experimental; and
  • The member signs a waiver agreeing to pay for the specific non-covered service being rendered; and
  • The claim has been billed with a GA modifier indicating such. If the member has signed a waiver agreeing to pay for the specific service then the member will be liable for payment.

Coverage

Exondys 51 is considered1 investigational/experimental and is therefore not covered.

Indications that are not covered

Exondys 51 is not covered for any additional indication including, but not limited to, Duchenne Muscular Dystrophy. There is not sufficient reliable evidence in the form of high quality peer-reviewed medical literature to establish the safety and efficacy of this treatment or its effect on health care outcomes in these conditions.

Definitions

Exondys 51 is FDA-Approved for:

Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with Exondys 51. A clinical benefit of Exondys 51 has not been established. Continued FDA approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes are not covered when used for Exondys 51 (eteplirsen):
HCPC

Codes

Description

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J3490

Unclassified Drugs

NDC

Codes

Description

60923036302

Eteplirsen 100mg/2ml vial

60923028410

Eteplirsen 500mg/10ml vial

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Exondys 51 [Prescribing Information]. Cambridge, MA: Sarepta Therapeutics, Inc. September 2016.
  2. Mendell JR, Rodino-Klapac LR, Sahenk Z, et al. Eteplirsen for the treatment of Duchenne muscular dystrophy. Ann Neurol. 2013 Nov;74(5):637-47.

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Policy activity

  • 03/13/2017 - Date of origin
  • 05/03/2017 - Effective date

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