Axicabtagene ciloleucel (Yescarta™)

OFFICE ADMINISTRATION - MEDICAL BENEFIT

Indications for Prior Authorization:

  • Treatment of patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma

Patients must meet the following criteria for the indication(s) above:

  • Prescribed by an oncologist, AND
  • 18 years or older, AND
  • Chart note documentation confirms diagnosis of relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma), AND
  • Patient has tried and failed two or more lines of systemic therapy (RCHOP-rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and at least one other guideline recommended line of systemic therapy), AND
  • Approval already authorized for T cell collection, AND
  • Patients will receive a lymphocyte-depleting chemotherapy (cyclophosphamide and fludarabine) before the Yescarta infusion, AND
  • Will be administered in a certified healthcare facility (must be enrolled and comply with the REMS requirements including on-site, immediate access to Actemra (tocilizumab injection for IV use) ensuring at least two doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, and with certified healthcare providers trained on the management of CRS and neurologic toxicities), AND
  • Prophylacitc systemic corticosteroids will not be used as they may interfere with Yescarta's activity

Dosing:

  • For autologous use only
  • Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of Yescarta (administered on fifth, fourth and third day before Yescarta infusion)
  • Premedicate with acetaminophen and an H1-antihistamine
  • Confirm availability of tocilizumab prior to infusion
  • Target dose is 2 x 106 CAR-positive viable T cells per kg body weight (maximum 2 x 108 CAR-positive viable T cells)

Approval:

  • 1 infusion

Last review date: November 28, 2018