Provider Alert! Viltepso Prior Authorization Update
Date: February 19, 2021
Effective Date: March 1, 2021
Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated to the COVID-19 event. TCHP reserves the right to update and/or change this information without prior notice due to the evolving nature of the COVID-19 event.
Call to action: Viltepso (viltolarsen) is a clinician-administered drug indicated for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping. Viltepso will become available through Texas Medicaid effective March 1, 2021, under the Healthcare Common Procedure Code (HCPCS) code C9071. The clinical criteria for Viltepso can be found below.
Viltepso is the third exon-skipping FDA approved treatment for DMD, and the second treatment for exon 53 (the other being Vyondys-53 [golodirsen]). Viltepso works similar to Vyondys-53 and has been studied in children aged 4 – 10 years of age, whereas Vyondys-53 is studied for children 6 to 13 years of age.
How this impacts providers: Members will need to meet the following criteria to obtain Viltepso:
An initial request for Viltepso (viltolarsen) must include the following documentation to support medical necessity:
- Genetic testing must confirm the individual’s DMD gene is amenable to exon 53 skipping.
- Current client weight, including the date the weight was obtained; the weight must be dated no more than 30 days before the requested date.
- Baseline renal function test (i.e., Glomerulus Filtration Rate, GFR) and urine protein-to-creatinine ratio should occur before starting treatment
- Baseline function testing documented in patient chart or electronic health record. The prescribing provider can use testing tools to demonstrate physical functions, including, but not limited to, the following:
- Brooke Upper Extremity Scale
- Baseline 6MWT (6-minute walk test)
- Pediatric Evaluation of Disability Inventory
- Viltepso should not be used concomitantly with other exon-skipping therapies for DMD.
A recertification/extension request for Viltepso must include documentation of the following:
- Continual renal function test while on Viltepso therapy.
- Current client weight and the date on which the weight was obtained; the weight must be dated no more than 30 days before the requested date.
- Viltepso should not be continued as a treatment for individuals who experience decreasing physical function while on the medication.
Next steps for providers: Providers should follow the billing guidance for HCPCS Code C9071 Viltepso available on the TMHP Notice for dates of service on or after March 1, 2021.
Refer to the Outpatient Drug Services Handbook Chapter of the Texas Medicaid Provider Procedure Manual for more details on the clinical policy and prior authorization requirements.
If you have any questions, please TCHP Pharmacy Department at: firstname.lastname@example.org.