KYMRIAH (tisagenlecleucel suspension)

KYMRIAH (tisagenlecleucel suspension)

OFFICE ADMINISTRATION - MEDICAL BENEFIT

Indications for Prior Authorization:

• Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

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

• Prescribed by an oncologist, AND
• 25 year or under, AND
• Chart note documentation confirms diagnosis of B-Cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse (Ph+ ALL: refractory disease or greater than or equal to 2 relapses and failure of 2 TKIs; Ph- ALL: refractory disease or greater than or equal to 2 relpases), AND
• If Ph- ALL: tried and failed blinatumomab, inotuzumab ozogamicin, AND
• Approval already authorized for T cell collection, AND
• Patients will receive a lymphocyte-depleting chemotherapy (cyclophosphamide and fludarabine) before the Kymriah 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 Kymriah 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 Kymriah's activity, AND
• Will not be infused if a patient has unresolved serious adverse reactions (including pulmonary reactions, caridac reactions, or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden folling lymphodepleting chemotherapy

Dosing:

• For autologous use only
• One single dose of Kymriah is infused 2 to 14 days following completion of lymphodepleting chemotherapy (cychlophosphamide and fludarabine)
• Premedicate with acetaminophen and an H1-antihistamine
• Confirm availability of tocilizumab prior to infusion
• Patients 50kg or less: 0.2 to 5.0 x 10⁶ CAR-positive viable T cells per kg body weight IV
• Patients above 50kg: 0.1 to 2.5 x 10⁸ total CAR-positive viable T cells (non-weight based) IV

Approval:

• 1 infusion