Comprehensive Pre-Launch Planning for Competitive Novel Vaccine

The client prepared to launch a new vaccine product into a competitive market, raising challenging questions such as how the Advisory Committee on Immunization Practices (ACIP) would assess the value of its product against the competition, what factors may influence the development of the Food & Drug Administration (FDA) product label, and what opportunities may be leveraged to achieve reliable reimbursement at premium pricing. The client sought to address these questions to strengthen its evidence package, tailor its target product profile (TPP), optimize its launch timing, and hone its pricing strategy.

We conducted a benchmarking exercise to characterize pricing and launch trajectories, post-launch population coverage and growth trends, pricing and ACIP recommendation evolution, and competitive product positioning.

We then assessed why and how ACIP may modify its recommendations for vaccinations against the target indication, identified factors that influence ACIP’s likelihood of issuing a recommendation for vaccine products, characterized opportunities to strengthen the evidence package, and generated business intelligence to support an ACIP engagement strategy. We considered how different TPPs and pricing scenarios may affect ACIP reviews and recommendations, and how pricing strategy may influence utilization and market share of the client’s vaccine under different recommendation scenarios.

In addition, we analyzed how the vaccine candidate may be perceived, assessed, and recommended by the FDA’s Center for Biologics Evaluation and Research (CBER) and identified opportunities to leverage data from past and ongoing studies to obtain a differentiated and competitive product label from CBER.

The client obtained knowledge critical to planning for the launch of its novel vaccine product. We delivered strategic insights and recommendations that have enabled the client to mitigate risks as it launches into a competitive environment. Our work enabled the client to forecast ACIP review scenarios, tailor its TPP, pricing strategy, and evidence-generation plan to achieve favorable ACIP review outcomes, establish ACIP and FDA engagement strategies, and forecast payer perceptions of its product.