Expert perspectives on life sciences strategy, commercialization, and market dynamics.
Expert perspectives on life sciences strategy, commercialization, and market dynamics.
As the Inflation Reduction Act (IRA) continues to upset the pharmaceutical landscape, manufacturers are constantly monitoring policy changes and analyzing trends to try and make sense of the current market. Recent policy dynamics surrounding drug negotiations by the Centers for Medicare & Medicaid Services (CMS) reveal some key wins, losses, and strategic pivot opportunities for […]
Introduction Gene therapies have transformed treatment for devastating diseases by offering one-time, potentially curative therapies where few or no effective alternatives exist. While acknowledging this transformation in medicine, the healthcare industry has also had to grapple with how to balance the meaningful benefits of gene therapies with their substantial cost. With treatment costs often reaching […]
The life sciences industry is entering a period where policy is no longer a downstream consideration—it is actively shaping the commercial trajectory of products from the earliest stages of development. The Policy-Driven PMA Pivot Series explores how evolving healthcare policy, reimbursement dynamics, and pricing pressures are fundamentally changing how pharmaceutical and biotech companies approach market […]
Part 6 of 6 of The Policy-Driven PMA Pivot Series: While this series has examined the impact of individual policy changes, assessing them in isolation provides only a partial view. In practice, manufacturers will contend with the compounded effect of these policies, as their interdependencies and reinforcing dynamics collectively redefine the pricing and access landscape. […]
Part 5 of 6 of The Policy-Driven PMA Pivot Series: The combined forces of federal legislation (impacting all PBMs by requiring 100% rebate pass-through and flat-fee compensation structures), and the settlement outcomes of the FTC’s suit with Express Scripts, one of the largest PBMs (requiring a standard formulary offering that does not prioritize high list-price, […]
Part 4 of 6 of The Policy-Driven PMA Pivot Series: Alternative access models have begun to emerge to challenge the traditional PBM-rebate pricing structure that has historically governed how patients access medications in the US market. Whether in response to the shifting policy landscape or as an independent indicator that the GTN bubble was becoming […]
Part 3 of 6 of The Policy-Driven PMA Pivot Series: Months of anticipation following the current administration’s Most-Favored Nations (MFN) executive order and letters to 17 top pharmaceutical companies has culminated in the past quarter in three CMS reimbursement models – GLOBE (Part B FFS), GUARD (Part D), and GENEROUS (Medicaid). These current administration policies […]
Part 2 of 6 of The Policy-Driven PMA Pivot Series: Since its enactment in 2022 under the prior administration, key drug pricing provisions of the Inflation Reduction Act (IRA) have been fully implemented, including Part D Redesign in 2025 and the first 10 CMS-negotiated maximum fair prices (MFPs) for drugs in initial price applicability year […]