IBCL-015 The Financial Toxicity of FDA-Drugs Approved for Malignant Hematology

Context: The high prices of cancer drugs affect the care of cancer patients and our health care system. Objective: Many Food and Drug Administration (FDA) drugs (FDADs) are available now for patients with malignant hematology (MH). Design: We reviewed one monthly supply price (OMSP) for FDADs for MH approved between 2011 and 2021. Setting: We performed a retrospective review of randomized clinical trials that led to FDAs approval for MH. Sixty-three FDADs were identified. Patients or Other Participants: FDADs were divided into disease groups: acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), myelodysplastic syndrome + myeloproliferative neoplasms (MDS+MPN), and lymphoma. Interventions: We compared prices between drug.com and UpToDate. The percentage change was low (0.18). Main Outcome Measures: We calculated the median of OMSP for FDADs for each group. We compared the median of OMSP between oral (PO), subcutaneous (SQ), and intravenous (IV) FDADs. Results: The median of OMSP for AML, CML, ALL, CLL, and MDS+MPN were $30923 [range, 5989 to 36099], $19343 [range, 20834 to 22570], $84749 [range, 75839 to 373000], $15263 [range, 3532 to 23091], and $15284 [range, 8060 to 24157], respectively. All FDADs for ALL patients were IV. The median of OMSP for MM and lymphoma were $20982 [range, 12054 to 441,743] and $23091 [range, 6834 to 475000], respectively. The median of OMSP for PO, SQ, and IV FDADs were $18291 [range, 2628 to 31,686], $18370 [range, 6934 to 22583] and $24691 [range, 2090 to 93660] (discounting CAR-T cell therapy), respectively. The median of OMSP for FDADs approved from (2011 to 2016) and (2016 to 2021) were $22233 (range, 8300 to 23091) and $24517 (range, 2352 to 475000), respectively. The median household monthly income was $6,558 in 2020 in the United States (US). There are currently no generic drug products of FDADs available in the US. Conclusions: MH patients are affected by treatment-related financial harm. The need for generic versions to lower the price is urgent. IV FDADs are more expensive than PO or SQ. The value of drugs should be considered in formulating treatment guidelines.