Provider Alert! Clinical Criteria for Qalsody® (procedure code C9157) effective October 1, 2023

Provider Alert! Clinical Criteria for Qalsody® (procedure code C9157) effective October 1, 2023

Date: October 19, 2023

Attention: All Providers

Effective Date: October 1, 2023

Call to action: Texas Children’s Health Plan (TCHP) would like to let providers know that effective October 1, 2023, Texas Health and Human Services Commission (HHSC) will be implementing prior authorization criteria for Qalsody® (procedure code C9157).Qalsody® (Tofersen) is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene

Prior Authorization Requirements:

Criteria for Initial Approval:

  1. Patient is 18 years of age or older AND
  2. Patient has confirmed diagnosis with testing for amyotrophic lateral sclerosis (ALS) AND
  3. Patient has confirmed genetic testing for the presence of a mutation in the superoxide dismutase 1 (SOD1) gene AND
  4. Patient has documentation of baseline measure of the plasma neurofilament light chain (NfL) AND
  5. Patient has documentation of baseline functional ability (e.g., climbing stairs, walking, and speech) prior to treatment initiation.

Criteria of Renewal or Continuation of Therapy:

  1. Patient has met all initial authorization approval criteria at the time of initial approval AND
  2. Patient has responded positively to therapy as evident by any improvement in the plasma neurofilament light chain (NfL) measurement as compared to baseline AND
  3. Patient has documentation showing stabilization in disease state and slowed pattern in disease progression AND
  4. Patient has absence of unacceptable toxicities (aseptic meningitis, serious myelitis and/or radiculitis, papilledema and elevated cranial pressure) from Tofersen therapy.

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.

Why is this important?

TCHP recognizes we may serve potentially impacted patients in our membership. We want to ensure that the member meets clinical evidence for treatment.

Next steps for providers: Prescribers should share this communication with their staff. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting member has met all approval criteria in support for Qalsody® approval.

Note: If request is for a non-U.S. Food and Drug Administration (FDA) approved dose or indication, medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.

If and when there any updates or changes related to the coverage for Qalsody®, we will promptly communicate those changes to you.

If you have any questions, please email TCHP Pharmacy at:

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