Rolvedon — Medical Mutual

Preferred products

• Neulasta
• Fulphila

Initial criteria

• Patient had an inadequate response or has a contraindication or intolerance to Neulasta or Fulphila; AND
• Prophylactic use in adult patients with solid tumors or non-myeloid malignancy; AND
• Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia >20%; OR
• Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia 10% to 20% AND one or more of the following co-morbidities:
• - Age >65 years receiving full dose intensity chemotherapy
• - Extensive prior exposure to chemotherapy
• - Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation
• - Persistent neutropenia (ANC ≤ 1000/mm3)
• - Bone marrow involvement by tumor
• - Condition that can potentially increase the risk of serious infection (i.e., HIV/AIDS with low CD4 counts)
• - Recent surgery and/or open wounds
• - Poor performance status
• - Renal dysfunction (creatinine clearance <50 mL/min)
• - Liver dysfunction (elevated bilirubin >2.0 mg/dL)
• - Chronic immunosuppression in the post-transplant setting, including organ transplant

Reauthorization criteria

• Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements, performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug (examples: splenic rupture, ARDS, serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulation of malignant cells, aortitis, myelodysplastic syndrome, acute myeloid leukemia, etc.)

Approval duration

4 months