OBJECTIVES: The breakthrough therapy designation (BTD) pathway aims to expedite approval of drugs for serious and life-threatening conditions. BTD has been awarded to numerous oncology agents in development. This study assessed the likely impact of BTD on payer and prescriber perceptions of novel therapies, and its potential to promote market access leverage. METHODS: Across the United States, 100 medical and hematological oncologists and 25 managed care organization (MCO) pharmacy and medical directors completed online quantitative surveys to capture their views on BTD. RESULTS: Surveyed payers were unanimous that BTD will influence formulary decisions for oncology drugs; some 40% said BTD would result in more favorable tier placement, while 37% expect fewer prescribing controls. However, none of our surveyed payers considered themselves yet very familiar with the BTD pathway. In contrast, one third of surveyed oncologists declared themselves to be very familiar with BTD. Furthermore, almost all oncologists said that BTD will affect their prescribing; almost 50% agreed that an agent with accelerated approval based on Phase II data and BTD will more likely be prescribed than such an agent without BTD. Notably, while BTD includes no guarantee of access to other regulatory pathways other than fast track designation, surveyed oncologists and payers often associate accelerated approval and priority review with BTD. CONCLUSIONS: BTD instills confidence in payers and prescribers, such that this accolade looks set to positively influence reimbursement conditions, drive uptake, and promote market access for a given agent. Moreover, associating BTD with accelerated approval and priority review likely further inspires positivity towards BTD agents. However, that payer respondents are at least somewhat unfamiliar with the BTD pathway must be considered. Manufacturers with BTD agents must formulate their market access strategy early and efficiently, ensuring that payers are fully aware of the benefits and advantages that secured this classification.