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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

Eteplirsen (Exondys 51) requires prior authorization from HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Exondys 51 is generally covered subject to the indications listed below when all of the following criteria are met, and per member plan documents.

Initial Authorizations:

  1. Diagnosis of Duchenne muscular dystrophy with documentation of DMD gene amenable to exon 51 skipping; and
  2. Prescribed by a neurologist with expertise in the diagnosis of DMD; and
  3. Chart note documentation that the patient has a 6- Minute Walk Test (6MWT) ≥ 300 meters while walking independently prior to beginning Exondys 51 therapy. 6MWT must be performed within 8 weeks of starting therapy; and
  4. Exondys 51 has been started in childhood, prior to the age of 14 year old; and
  5. Exondys 51 is prescribed within the FDA approved dosing regimen.
  6. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial authorizations will be provided for 6 months.

Reauthorizations:

  1. Prescribed by a neurologist with expertise in the diagnosis of DMD; and
  2. Chart note documentation that the patient continues to be ambulatory; and
  3. Chart note documentation that the patient continues to have a 6- Minute Walk Test (6MWT) ≥ 300 meters while walking independently. 6MWT must be performed within 8 weeks of reauthorization; and
  4. Exondys 51 has been started in childhood, prior to the age of 14 year old; and
  5. Exondys 51 is prescribed within the FDA approved dosing regimen.

Reauthorizations will be provided for 6 months.

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.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

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.

HCPC

Codes

Description

J1428

Injection, eteplirsen, 10 mg

NDC

Codes

Description

60923036302

Exondys 51 100 MG/2ML SOLN

60923028410

Exondys 51 500 MG/10ML SOLN

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. October 2018.
  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
  • 01/01/2019 - Effective date
Review date
  • 02/2019
Revision date
  • 11/05/2018

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