Presentation (CTI)

OBJECTIVES: Antibody-drug conjugates (ADCs) are a class of biopharmaceuticals that utilize monoclonal antibodies to selectively deliver potent cytotoxic agents to the tumor site. ADCs have evolved significantly in recent years for multiple disease areas, especially cancer, putting them at the forefront of modern therapeutic advancements. This review aimed to identify US-based cost-effectiveness evaluations (CEA) for the FDA approved ADCs.
METHODS: We used clinicaltrials.gov (CT.gov) to identify trials investigating ADCs in oncology, primarily in the US, and analyzed their trial status. Subsequently, we verified their status of drug development through press releases, either by FDA or the company websites. CEA for all FDA-approved drugs were also identified and reviewed.
RESULTS: CT.gov provided 242 hits, from which 66 ADCs were identified. 49 of them were phase I/II trials, while 17 were in phase III. Primary disease areas targeted by identified ADCs were lung cancer, breast cancer, and lymphoma. 11 ADCs have received FDA approval since 2011. Additionally, 8 ADCs have received Orphan Drug Designation only, 10 ADCs have received Fast Track/Breakthrough designations, and 5 ADCs received both designations. Most approved ADCs had multiple CEAs conducted but none were formally evaluated by the Institute for Clinical and Economic Review in the US. Some ADCs have received approval by FDA for multiple indications, however, it was observed that the incremental cost-effectiveness ratio (ICER) for the majority of them remained above willingness-to-pay (WTP) threshold of $150,000 per QALY.
CONCLUSIONS: This review identified that while approval of ADCs is rising in the US, their cost-effectiveness remains uncertain in the current scenario. We did not account for a commercially confidential discount for the lack of data; hence it cannot be confirmed if the ICERs will remain above WTP threshold of $150,000 per QALY when these discounts are considered.