In the wake of the COVID-19 pandemic and the ensuing economic fallout, pharmaceutical companies could face a range of measures designed to cut government spending on medicines. From relaxing intellectual property rights to delaying reimbursement, In Vivo examines what might be in store for industry.

Value-based contracting in the US is moving toward high-cost drugs for rare disease and away from lower cost chronic treatments as payers plan for the coming pipeline of cell and gene therapies. Marketed gene therapies all have some kind of risk sharing deal in place but further progress on the most innovative payment models is hampered by regulatory and operational challenges.

Behind a popular drug discount program are pharmacy benefits managers and even drug companies themselves, raising questions about whether such businesses may yet be another player in an opaque and complicated supply chain that is facilitating higher US drug prices, even as the most prominent company in the space, GoodRx, routinely criticizes soaring list prices. 

Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.