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Continue LogoutPharma companies face pressure to demonstrate value and justify pricing in an environment defined by three disruptive forces: rising costs and disease burden, policy shifts that threaten revenue streams and slow innovation, and growing provider consolidation that reshapes access and prescribing dynamics. Together, these forces are creating a more volatile operating reality where balancing innovation with affordability — and tailoring value propositions to increasingly diverse stakeholders — has never been more critical.
These fundamental shifts require pharma companies to move faster by generating rigorous evidence earlier, proving value under compressed timelines, changing how they reach patients and providers, and treating Generative AI (GenAI) as both a technical tool and a cultural transformation. Let’s explore five trends that illustrate how these pressures are shaping pharma strategy today.
Rising spending on drugs and recent policy changes mean purchasers are taking on more financial risk, and they’re responding by raising the bar for evidence to guide access. Access decisions increasingly hinge on outcomes-based contracts, broader step therapy requirements, and specific evidence frameworks. For example, CMS is working to modernize coverage with evidence development (CED), making greater use of real-world evidence (RWE) to support Medicare decisions. In parallel, the FDA is updating their RWE guidance and purchasers and independent assessors are refining health technology assessment (HTA) frameworks to become more comprehensive and dynamic. Both sets of guidance continue to influence access for high-cost and complex therapies, raising the evidentiary bar for pharma manufacturers. This is reshaping how pharma approaches evidence generation.
| Old approach | New approach | |
|---|---|---|
| Focus | Focused narrowly on regulatory endpoints and FDA standards | Tailored to payer-defined outcomes and cost offsets, and care setting realities |
| Ownership | Evidence trapped in Health Economics and Outcomes Research or medical affairs silos | Driven by cross-functional teams across access, data science, and clinical strategy |
| Timing | Treated as a post-launch compliance task | Embedded early to shape and accelerate market access strategy |
| Role in access | Optional add-on for market access | Critical differentiator for value positioning and formulary wins |
The definition of value is changing. Access increasingly depends on the relevance and specificity of evidence pharma can bring forward. To remain competitive, companies must:
Shorter commercial windows, higher development costs, and expedited approvals are forcing pharma to identify and engage patients earlier, with greater precision, and to sustain that focus across the product lifecycle. Pharma companies must know in advance who will benefit from a product and sustain engagement post-launch to support label expansion and long-term return on investment (ROI).
Evidence that demonstrates benefits for specific patient subgroups is now critical for both approval and access. Even in high-prevalence categories, payers and regulators expect early data on subgroup outcomes. For example, GLP-1s show how both high-impact evidence for subgroups and RWE can accelerate approvals, expand indications, and secure long-term advantage.
Leading pharma sciences companies must:
Health systems are weighing more variables than ever when deciding where to direct resources. With operating margins projected to drop by up to 13% by 2028 — and 34% of systems already planning long-term cuts to the drug budget — cost is no longer the stand-alone metric for ROI. Systems are also evaluating how well products fit into their broader clinical and operational priorities, including impacts on margins, workflow, and outcomes. This complexity is changing how health system leaders assess value.
There’s no one-size-fits-all approach. Health systems differ in their purchasing priorities: Some prioritize patient experience and outcomes, while others focus on margin or innovation. These variations influence how committees evaluate products, meaning pharma must adapt its value narrative to align with each system’s decision-making lens. No two health systems will evaluate value in the exact same way. Still, the following six archetypes provide a useful way to understand the most common orientations committees bring to purchasing decisions.
| Archetype | Value definition for products | Key metrics |
|---|---|---|
| Basic review | Competitively priced, safe, and meet basic organizational and care standards |
|
| Traditionalist | Contribute to high-quality outcomes and cost-effective care |
|
| Clinically-driven | Set the system apart from competition by offering market-leading outcomes and cutting-edge innovation |
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| Financially-driven | Contribute to healthy short- and long-term margins in fee-for-service and/or value-based payment models |
|
| Holistic | Contribute to high-quality outcomes, cost-effective care, and potentially help achieve broader system goals |
|
| Trailblazer | Contribute to success on distinct system goals related to care quality, financials, market share, operations, and/or other key differentiators for the organization |
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To align with health system priorities, pharma must create a feedback loop that tests and refines evidence against what matters to decision-makers:
Ongoing feedback keeps value messages resonant with what matters most to health systems and ensures pharma can adapt to each system’s strategic and clinical priorities.
As care moves closer to the consumer — through home, digital, and ambulatory settings — distribution becomes more complex. Distribution decisions must now factor in a shrinking brick-and-mortar footprint, direct-to-consumer (DTC) channels, and home-based care. To ensure access, pharma must design distribution models that balance reach, control, and experience.
Patients now expect convenience and speed, so wait time and proximity drive care choices — 81% of patients use digital tools to interact with pharmacies. In response, some manufacturers are launching DTC channels to meet patients where they are.
At the same time, retail pharmacy disruptors — like Amazon and Mark Cuban Cost Plus — are bypassing the traditional payer-pharmacy benefit manager (PBM) model with transparent, direct-to-provider and -consumer channels. White and clear bagging are also increasing, creating friction over sourcing, reimbursement, and care coordination.
What life sciences should do:
GenAI’s promise depends on practical integration into everyday workflows, from content development and insight generation to supply chain forecasting and field team enablement. While early adoption in pharma was narrowly focused on drug development, AI is now driving value across commercial, regulatory, and medical affairs functions.
But while the potential is huge, successful AI adoption depends on avoiding pitfalls — such as treating adoption as a plug-and-play solution instead of a strategic transformation, underinvesting in change management, or failing to implement workflows and data foundations to support AI at scale. These can lead to underused tools, compliance risks, and a lack of trust among users.
Successful adopters encourage experimentation with AI tools and cross-functional alignment. To unlock AI’s full potential:
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