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Antisense Oligonucleotide Benefits to Change for Texas Medicaid, Effective August 1, 2020

Last updated on 7/31/2020

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Effective for dates of service on or after August 1, 2020, antisense oligonucleotide benefits will change for Texas Medicaid.

Overview of Benefit Changes

Major changes to this medical benefit include the following:

  • Adding prior authorization for golodirsen (Vyondys 53) (procedure code J1429)
  • Additional prior authorization criteria for eteplirsen (Exondys 51) (procedure code J1428)

Prior Authorization for Golodirsen (Vyondys 53)

Effective for dates of service on or after August 1, 2020, prior authorization will be required for golodirsen (Vyondys 53) (procedure code J1429).

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Clinician-Administered Drugs Handbook, subsection 13.1, “Prior Authorization Requirements,” for general prior authorization and white bagging information that will apply to all antisense oligonucleotides.

Initial Requests

An initial request for golodirsen (Vyondys 53) must include the following documentation to support medical necessity:

  • Genetic testing must confirm that the client's Duchenne muscular dystrophy (DMD) gene is amenable to exon 53
  • Baseline renal function test (i.e., Glomerulus Filtration Rate, GFR) with therapy initiation and continuation.
  • Current client weight, including the date the weight was obtained; the weight must be dated no more than 30 days before the request date.
  • Baseline function testing documented in patient chart or electronic health record.

Testing tools that can be used to demonstrate physical function include, but are not limited to:

  • Brooke Upper Extremity Scale
  • Baseline 6MWT (6-minute walk test)
  • Pediatric Evaluation of Disability Inventory

Golodirsen (Vyondys 53) should not be used concomitantly with other exon skipping therapies for DMD.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Clinician-Administered Drugs Handbook, subsection 13.1.1, “Initial Requests (for all Antisense Oligonucleotides),” for the additional documentation requirements that apply to all antisense oligonucleotides.

Recertification/Extension Requests

A recertification/extension request for golodirsen (Vyondys 53) must include documentation of the following:

  • Continual renal function test while on golodirsen (Vyondys 53) therapy.
  • The client’s current weight and the date on which the weight was obtained. The weight must be dated no more than 30 days before the request date.

Golodirsen (Vyondys 53) should not be used concomitantly with other exon skipping therapies for DMD.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Clinician-Administered Drugs Handbook, subsection 13.1.2, “Recertification/Extension Requests (for all Antisense Oligonucleotides),” for the additional documentation requirements that apply to all antisense oligonucleotides.

Golodirsen (Vyondys 53) should not be continued on clients who experience decreasing physical function while on the medication.

Additional Prior Authorization Criteria for Eteplirsen (Exondys 51)

The current prior authorization criteria for an eteplirsen (Exondys 51) request will be expanded to indicate that eteplirsen (Exondys 51) should not be used concomitantly with other exon skipping therapies for DMD.

For more information, call the TMHP Contact Center at 800-925-9126.