Skip to main content

Prior Authorization Criteria for Viltolarsen (Viltepso) Effective March 1, 2021

Last updated on 2/12/2021

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.

Beginning March 1, 2021, prior authorization criteria will be effective for viltolarsen (Viltepso) (procedure code C9071) for Texas Medicaid.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook, subsection 7.7.1, “Prior Authorization Requirements,” for general prior authorization and white bagging information that will apply to all antisense oligonucleotides.

Initial Requests

An initial request for viltolarsen (Viltepso) 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
  • 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 renal function test (i.e., Glomerulus Filtration Rate) and urine protein-to-creatinine ratio should be measured before starting treatment.

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.

Viltolarsen (Viltepso) should not be used concomitantly with other exon skipping therapies for DMD.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook, subsection 7.7.1.1, “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 viltolarsen (Viltepso) must include documentation of the following:

  • Continual renal function monitoring while on viltolarsen (Viltepso) 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.

Viltolarsen (Viltepso) should not be used concomitantly with other exon skipping therapies for DMD.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook, subsection 7.7.1.2, “Recertification/Extension Requests (for all Antisense Oligonucleotides),” for the additional documentation requirements that apply to all antisense oligonucleotides.

Viltolarsen (Viltepso) should not be continued on clients who experience decreasing physical function while on the medication.

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