Additional Prior Authorization Criteria for Qalsody Procedure Code C9157 Effective Oct. 1, 2023


What is changing:

Effective Oct. 1, 2023, the Texas Health and Human Services Commission (HHSC) implemented prior authorization criteria for Qalsody procedure code C9157. This treatment is for amyotropic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Authorization requirements:

When all the following criteria below is met, HHSC will consider prior authorization approval of Qalsody (Toferesen) therapy:

  • Confirm the client is 18 years of age or older.
  • Diagnostic testing confirms client has amyotrophic lateral sclerosis (ALS)
  • Genetic testing must confirm that the mutation is in superoxide dismutase 1 (SOD1) gene is present.
  • Documentation of baseline measure of the plasma neurofilament light chain (NfL).
  • Documentation of baseline functional ability (such as climbing stairs, walking, and speech) prior to treatment initiation.

Renewal or Continuation Therapy:

The client must meet all of the following requirements for renewal or continuation therapy:

  • Confirmation that client met all initial authorization approval criteria at the time of initial approval.
  • Confirmation that the client has responded positively to therapy as evident by any improvement in the (NfL) measurement as compared to baseline.
  • Documentation that client has stabilization in disease state and has shown a slowed pattern in the disease progression.
  • Documentation of the absence of unacceptable toxicities (aspetic meningitis, serious myelitis and/or radiculitis, papilledema, and elevated cranial pressure) from Tofersen therapy.

Refer to the Texas Medicaid Provider Procedure Manual (TMPPM) for the Outpatient Drug Services Handbook Chapter on the clinical policy and prior authorization requirements.

Providers, for questions or additional information, please:

The above material is for informational purposes only and is not a substitute for the independent medical judgment of a physician or other health care provider. Physicians and other health care providers are encouraged to use their own medical judgment based upon all available information and the condition of the patient in determining the appropriate course of treatment. The fact that a service or treatment is described in this material is not a guarantee that the service or treatment is a covered benefit and members should refer to their certificate of coverage for more details, including benefits, limitations and exclusions. Regardless of benefits, the final decision about any service or treatment is between the member and their health care provider.