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November 2022 Question of the Month

In the next 5 years, what outcome is most likely for FDA management of accelerated approvals with subsequent failed confirmatory trials?

Status quo with extended review timelines and limited FDA authority: 64%

Legislative change leading to additional FDA authority and actions: 27%

Increased pharmaceutical manufacturer voluntary actions: 9%

January 2023 Question of the Month

How will payers manage reimbursement of multiple interchangeable biosimilars?

MAC reimbursement: 10%

Generic non-MAC reimbursement rate: 10%

Brand reimbursement rate: 40%

Specialty drug specific rate: 40%

Average Sales Price (ASP): 0%

Average Manufacturer Price (AMP): 0%

National Average Drug Acquisition Cost (NADAC): 0%

In which area could you or your company most benefit from additional training?

Biosimilars and interchangeability requirements: 46.1%

Dynamics that drive PBM and health plan decisions: 15.4%

Various hurdles a prescription must clear before being dispensed: 15.4%

Changing 340B landscape: 15.4%

Flow of funds and prescriptions through the pharmacy channels: 7.7%

Pharmacy chain initiatives and strategy updates: 0%

In the next 5 years, what outcome is most likely for FDA management of accelerated approvals with subsequent failed confirmatory trials?

Status quo with extended review timelines and limited FDA authority: 64%

Legislative change leading to additional FDA authority and actions: 27%

Increased pharmaceutical manufacturer voluntary actions: 9%