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 […]
Part 1 of 6 of The Policy-Driven PMA Pivot Series: Market access has become one of the most critical determinants of a successful pharmaceutical launch in the United States. However, developing an effective market access strategy has grown significantly more complex over the past decade. Rising healthcare costs, gaps in coverage from traditional health plans, […]
The Inflation Reduction Act’s (IRA) Part D redesign provisions went into effect on January 1, 2025, fundamentally restructuring cost-sharing corridors and upsetting the marketplace. By increasing plan and manufacturer liability, particularly in the catastrophic phase, this legislation intended to lower the financial burden on beneficiaries. When the IRA passed, the commonly held hypothesis in the […]
In 2026, rare disease investors are prioritizing more than promising science. From commercial readiness to clear revenue pathways, expectations are shifting — and companies must evolve to secure funding and long-term growth.
Market access uncertainty is reshaping how life sciences companies forecast revenue and plan for launch. As pricing pressure, policy changes, and payer dynamics evolve, commercial teams must adopt more agile, data-driven forecasting strategies to stay competitive.