The US pharmaceutical industry is grappling with changes brought on by the health policy priorities of President Trump’s administration, which has laid out a strategy to reduce drug prices, re-shore pharmaceutical manufacturing, and overhaul federal healthcare programs. The impact of these policies is amplified by the administration’s realignment of federal healthcare agencies under a unified “Make America Healthy Again” vision. In this second installment of a two-part series, we explore how through a combination of executive actions, legislative reforms, and sweeping agency leadership changes, the Trump Administration is reshaping how drugs are approved, priced, manufactured, and reimbursed. (October 2025)

Cell and gene therapies offer the potential for long-lasting and potentially curative outcomes for patients with serious and often rare diseases. With the Trump administration’s evolving healthcare policies in relation to cell and gene therapies creating ambiguity around regulatory and reimbursement frameworks, manufacturers must adopt a more proactive posture toward market access strategy to ensure optimal access and product adoption. This white paper outlines six key strategies that will not only improve the odds of reimbursement and adoption but also help ensure that patients who need these life-changing and often curative therapies receive them. (September 2025)

Currently, the US Congress is actively pursuing a range of healthcare policy initiatives and reforms, reflecting efforts to enhance transparency, reduce costs, and improve access to care. These policy changes, combined with shifts in tariffs and trade relations, have created new challenges and opportunities for pharmaceutical companies. Ultimately these policies will shape the approach manufacturers may take to pricing and market access, trade and distribution, and research and development. In this first installment of a two-part series, we explore Congress’s current focus, aiming to uncover how proposed legislation may shape the future of healthcare and the biopharmaceutical pricing and market access landscape in the United States. (June 2025)

As the healthcare landscape continues to evolve, understanding the trends in managed care is more critical than ever in ensuring market access success for biopharmaceutical products and delivering superior healthcare to patients. With pressure to control costs, improve care quality, and navigate regulatory complexities, managed care organizations are faced with significant challenges and opportunities in the years ahead. To better understand the changes that major stakeholders are anticipating and those stakeholders’ key areas of focus, SciVida conducted wide-ranging interviews with executives from leading managed care organizations. In this paper, we detail the results of those discussions across four key categories: controlling direct and indirect healthcare costs; improving healthcare quality and member experience; adapting to regulatory, compliance, and policy uncertainties; and enhancing contracting and/or partnerships with branded drug manufacturers. (May 2025)

The introduction and passage of the Inflation Reduction Act of 2022 (IRA) was a paradigm shift in the approach that the Centers for Medicare & Medicaid Services (CMS) takes to drug pricing and reimbursement within the Medicare channel. CMS was tasked with establishing a program to negotiate maximum fair prices (MFPs) for certain high-expenditure, single-source drugs covered by Medicare. To date, the agency has selected 25 products for price negotiation, with MFPs scheduled to go into effect in 2026 for 10 of those products and in 2027 for the remaining 15.

As the landscape for rare diseases evolves, orphan disease markets that once had few or no FDA-approved therapies are now becoming more competitive, with new, innovative treatments emerging to address symptoms, modify disease progression, and even offer cures. However, with this growing competition comes a critical need for strategic market access positioning to ensure commercial success.

Seven years on from the approval of the first CAR T therapy, the market dynamics surrounding the technology continue to change. This paper explores the continued CAR T market evolution in the areas of new reimbursement approaches, target expansion, and the rise of allogeneic T-cell immunotherapies. (January 2025)

Pharmacy benefit managers have come under intense scrutiny in recent months from the Federal Trade Commission (FTC), which has accused PBMs of driving up the prices of specialty drugs and monopolizing the distribution of those products. While the full fallout of the FTC’s actions is yet to be seen, this article outlines the potential implications for manufacturers of specialty products. (December 2024)

The role of health systems in the delivery of care in the US has been on the rise over the past decade. As health systems continue to evolve and consolidate, they can exert significant influence over branded drug utilization, leading to the need for biopharma executives to develop an effective strategy for engaging with health system customers. This white paper explores their evolving role, trends in consolidation and the impact on branded drug access, growth of the 340B program and financial considerations, and more, and then maps out the key business questions for life science organizations to address when developing a health system strategy. (November 2021)

Four years after the launch of the first CAR T-cell therapy, we now have five on the market and a host of others on the way. This white paper maps out key learnings and implications from the pioneers, what we can expect to see over the next several years in the category, and where we still have questions remaining to be answered. (August 2021)