Reimbursement and Regulatory Due Diligence on Specialty Pharmacy

As the client considered purchasing a rare and orphan diseases specialty pharmacy, it aimed to evaluate regulatory dynamics and any associated risks that may affect volume and pricing of the target’s products.

We conducted an in-depth evaluation to assess potential risks to demand and pricing for the pharmacy’s top products by revenue and gross profits, including impacts of legislative and regulatory dynamics related to drug pricing and accelerated approval pathways for rare and orphan disease products. We analyzed all relevant policies of legislative and regulatory bodies at both the state and federal levels, including the Centers for Medicare & Medicaid Services and the Food & Drug Administration.

For each state and federal policy, we identified any trends that may impact the attractiveness of the orphan pathway for manufacturers and assessed how manufacturers seek out channel partners for distribution. We provided an overview of each policy, assessed the likelihood and timing of its implementation, analyzed its relative impact on the target’s business, and summarized the strategic risks and opportunities the client should consider.

Our detailed health policy assessment and specialized due diligence report validated the client’s broader industry thesis while also gating the risks associated with the regulatory and pricing environment. The client purchased the asset in 2022.