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.
Pharmaceutical forecasting has always required navigating uncertainty, but the volatility of today’s access environment has fundamentally changed how assumptions must be built, stress-tested, and communicated. Emerging legislation, shifts in payer behavior, and new commercial models are just a few of the many factors reshaping how products are priced, reimbursed, and adopted. Historical analogs and stable […]
Forecasting the commercial potential of rare disease assets is high stakes. Small differences in assumptions have an outsized impact on forecasted revenues due to small patient populations. Unique rare disease forecasting challenges include: These challenges make it difficult to develop a credible picture of today’s diagnosed and treated populations and tomorrow’s addressable opportunity. Forecasts must […]
The oncology landscape is expanding at an unprecedented pace and major breakthroughs are creating more possibilities. But quality innovation alone is no longer enough to guarantee commercial success, and the oncology pipeline is crowded. Manufacturers must solidify their strategic positioning early in order to win market share. Driver of pipeline congestion include: Newly druggable targets: […]