Prior Authorization Criteria Update for Breyanzi and Kymriah

Date: July 27, 2022Attention: All ProvidersEffective Date: September 1, 2022Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated with 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) would like to inform providers that the Health and Human Services Commission (HHSC) will update the prior authorization criteria for Breyanzi (Q2054) and Kymriah (Q2042) effective September 1, 2022. The U.S. Food and Drug Administration (FDA) has approved additional indications for Breyanzi and Kymriah. In addition to its current indication, Breyanzi is now approved to treat adult clients 18 years of age and older who have large B-cell lymphoma with the following:

• Refractory disease to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy; or
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age; or
• Relapsed or refractory disease after two or more lines of systemic therapy.

In addition to its current indication, Kymriah is now approved to treat adult clients 18 years of age and older who have relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. How this impacts providers: Prior authorization approval for Breyanzi (lisocabtagene maraleucel) treatment in adult clients with large B-cell lymphoma will be considered once all the following criteria are met:

• Client is 18 years of age or older
• Client must have large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy
• Client has histologically confirmed diagnosis of one of the following:
  • C8240 – C8250, C8330 – C8339, C8390 – C8399, C8510 –C8519, C8520 – C8529, or C8580 – C8589
• Client does not have primary central nervous systemlymphoma/disease
• Client has not received prior CD-19 directed CAR-Ttherapy
• Client does not have an active infection or inflammatory disorder

Prior authorization approval for Kymriah (tisagenlecleucel) treatment in adult clients with relapsed or refractory follicular lymphoma (FL) will be considered once all the following criteria are met:

• Client is 18 years of age or older
• Client has relapsed or refractory disease after two or more lines of systemic therapy
• Client has histologically confirmed diagnosis of one of the following:
  • 00, C82.01, C82.02, C82.03, C82.04, C82.05, C82.06, C82.07, C82.08 or C82.09
• Client does not have primary central nervous systemlymphoma/disease
• Client has not received prior CD-19 directed CAR-Ttherapy
• Client does not have an active infection or inflammatory disorder

Next steps for providers: Providers are encouraged to 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 Network Management at: providerrelations@texaschildrens.org.For access to all provider alerts,log into: www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers