Prior Authorization Criteria for Carvykti Begins December 1, 2022

Date: November 28, 2022 Attention: Providers Subject: Effective date: December 1, 2022 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: Texas Children’s Health Plan (TCHP) will revise clinical prior authorization criteria for Carvykti (Ciltacabtagene autoleucel) effective December 1, 2022. It is a B-cell maturation antigen-directed genetically modified autologous T cell immunotherapy indicated to treat adult clients with relapsed or refractory multiple myeloma after four or more lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. How this impacts providers: Prior authorization criteria for Carvykti (Ciltacabtagene autoleucel) will be the following:

• Clientis 18 years of age or older
• Client has histologically confirmed diagnosis of relapse or refractory multiple myeloma (diagnosiscodes: C90.00, C90.02)
• Clients has relapsed or refractory disease and has received four or more lines of the following systemic therapies before treatment with ciltacabtagene autoleucel:
  • A proteasome inhibitor
  • An immunomodulatory agent
  • An Anti-CD38 monoclonal antibody
  • Clientdoes not have primary central nervous system lymphoma/disease
  • Clientdoes not have an active infection or inflammatory disorder
  • Clienthas not received prior CAR-T therapy
• Clientdoes not have primary central nervous system lymphoma/disease
• Clientdoes not have an active infection or inflammatory disorder
• Clienthas not received prior CAR-T therapy

Ciltacabtagene autoleucel (Carvykti) (procedure code Q2056) is limited to once per lifetime. Certified healthcare facilities must enroll and comply with the Risk Evaluation and Mitigation Strategies (REMS) requirements for each drug administered under this policy. Next steps for providers: 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 email Provider Relations at: providerrelations@texaschildrens.org.For access to all provider alerts,log into: www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers