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Coverage criteria policies

Exondys 51™ – Minnesota Health Care Programs

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

Exondys 51 requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

Exondys 51 is generally covered subject to the indications listed below and per your plan documents:

  1. Patient must have a diagnosis of one of Duchene muscular dystrophy (DMD); and,
  2. Patient must have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping; and,
  3. Must be prescribed by a provider specializing in genetics or neurology; and,
  4. Provider’s specialty must be provided at time of request; and,
  5. At time of request, prescriber must confirm whether or not the patient is currently enrolled in clinical trials for Exondys 51
Quantity Limit:
  1. 30 mg/kg once weekly
  2. Patient’s most current weight (rounded to the nearest kg) must be provided at time of request
Approvals:
  1. Initial approval will be limited to 6 months in duration
  2. Renewal approval will be limited to 6 months in duration
    1. Renewals must be prescribed by a provider specializing in genetics or neurology; and,
    2. Provider’s specialty must be provided at time of request; and,
    3. Chart notes must be supplied at time of request showing patient is responsive to treatment defined as:
      1. Maintain or increase in physical function from baseline; or,
      2. Progression has been slower than otherwise would have been expected in this patient population.

Denial criteria

Patient is currently enrolled in clinical trials for Exondys 51.

Background Information

A clinical benefit of Exondys 51 has not been established. Exondys 51 is FDA-approved for the 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. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.

Exondys 51 must be administered intravenously by a qualified healthcare professional. EXONDYS 51 is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

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 (For billing prior to 1/1/18 use J3490 or C9484 for OPPS billing)

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. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/exondys-51.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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