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Nypozi — Medical Mutual

Management of CAR T-cell related Toxicity

Preferred products

  • Zarxio

Initial criteria

  • If the request is for Granix, Neupogen, Nivestym, Nypozi, or Releuko, patient had an inadequate response or has a contraindication or intolerance to Zarxio
  • Bone Marrow Transplant (BMT)
  • Peripheral Blood Progenitor Cell (PBPC) mobilization and transplant
  • Prophylactic use in patients with solid tumors or non-myeloid malignancy AND one of the following: Patient undergoing myelosuppressive chemotherapy with expected febrile neutropenia incidence of >20%; OR Patient undergoing chemotherapy with incidence 10–20% AND one or more patient-related risk factors; OR Patient undergoing chemotherapy with incidence <10% AND two or more patient-related risk factors
  • Treatment of chemotherapy-induced febrile neutropenia AND either: Patient has been on prophylactic therapy with filgrastim or tbo-filgrastim; OR Patient has not received prophylactic therapy AND has ≥1 risk factor (sepsis syndrome, age >65 years, ANC <100/mcL, duration of neutropenia >10 days, pneumonia or other documented infection, invasive fungal infection, hospitalization at time of fever, prior febrile neutropenia)
  • Patient who experienced neutropenic complication from a prior cycle of the same chemotherapy
  • Acute Myeloid Leukemia (AML): Used in patients receiving induction/consolidation or re-induction chemotherapy; OR Used for relapsed or refractory disease
  • Bone Marrow Transplantation failure or Engraftment Delay
  • Severe Chronic Neutropenia: ANC <500/mm3 AND diagnosis of congenital neutropenia OR cyclic neutropenia OR idiopathic neutropenia
  • Myelodysplastic Syndromes (MDS): Symptomatic anemia with no del(5q), Lower risk disease (IPSS-R Very Low, Low, Intermediate), Erythropoietin ≤500 mUnits/mL, Used with ESA, AND one of: Ring sideroblasts ≥15% (or ≥5% with SF3B1 mutation) AND no response to luspatercept; OR Ring sideroblasts <15% (or <5% with SF3B1 mutation) AND no response to ESA or luspatercept
  • Patients acutely exposed to myelosuppressive doses of radiation (H-ARS)
  • Management of CAR T-cell related Toxicity: Patient receiving CAR T-cell therapy AND experiencing neutropenia related to therapy
  • Wilms Tumor (Nephroblastoma): Favorable histology disease AND used with cyclophosphamide-based chemotherapy (Regimen M or I only)

Reauthorization criteria

  • If the request is for Granix, Neupogen, Nivestym, Nypozi, or Releuko, patient had an inadequate response or has a contraindication or intolerance to Zarxio
  • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements and performance status
  • Absence of unacceptable toxicity from the drug (examples: splenic rupture, ARDS, anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, capillary leak, tumor growth stimulation, aortitis, alveolar hemorrhage, thrombocytopenia, cutaneous vasculitis, MDS/AML in certain settings)

Approval duration

4 months