The healthcare policy landscape in the US is shifting rapidly. Last week, President Trump signed a sweeping Executive Order (EO) aimed at lowering prescription drug prices – a follow-up to his February EO on healthcare price transparency. With two major policy announcements in just two months, the administration has made one thing clear: drug pricing reform is a cornerstone of the new health agenda.

The April 15 EO targets a long-standing imbalance in pharmaceutical development: the comparative disadvantage faced by small molecule drugs. Under current policy, biologics receive longer market protection, which has unintentionally driven R&D dollars away from small molecule innovation and toward biologics – a phenomenon often referred to as the ‘pill penalty.’

By addressing this disparity, the administration is attempting to realign incentives. The EO aims to spur new investment in small molecule therapies, many of which offer broader population reach, faster development timelines, and lower production costs. However, this recalibration may still create uncertainty across the R&D ecosystem, as manufacturers weigh shifting policy dynamics with commercial potential.

The two EOs represent a coordinated effort to tackle high drug prices from both ends: by increasing transparency and by rebalancing incentives to promote affordability and competition.

Building on transparency: the foundation for market reform

The latest EO follows closely on the heels of the February announcement, which focused on making healthcare pricing more transparent. That order requires hospitals, payers, and drug manufacturers to provide clear, accessible pricing information. The aim is to empower patients with the data needed to make informed healthcare decisions and to encourage consistency in pricing across the system.

Together, the two EOs represent a coordinated effort to tackle high drug prices from both ends: by increasing transparency and by rebalancing incentives to promote affordability and competition. For pharma, this translates into a dual mandate – prepare for increased scrutiny while also demonstrating measurable value.

Implications for pharma

These policy shifts are not isolated changes – they are reshaping the framework in which market access decisions are made. At VML Health, we see a number of potential implications for pharma:

  • Impact on innovation strategy: Redirecting R&D incentives toward small molecules may alter pipeline planning. Companies will need to reexamine development timelines, target indications, and their overall portfolio mix in light of evolving ROI considerations.
  • Pressure on orphan drug development: As policy reforms ripple through the industry, the already-challenging economics of rare disease treatments may face new hurdles – particularly for therapies without dedicated incentives.
  • Adjusted ROI expectations: New pricing pressures – including those from Medicare negotiations and price caps – are prompting companies to rethink revenue forecasts and investment models.
  • Acceleration of value-based approaches: With price under greater scrutiny, there is heightened urgency to demonstrate not just clinical efficacy, but real-world outcomes. Expect value-based agreements (VBAs) to become increasingly central to US access and reimbursement strategies.

Despite these headwinds, the evolving policy landscape presents an opportunity to rethink how value is defined, captured, and communicated.

What we’re watching

As with any major policy shift, the ultimate impact will depend on how these orders are implemented. At this stage, we have more questions than answers:

  • How will the administration enforce these policies? Will CMS or other federal bodies lead execution, and what timelines will be set?
  • Will price reductions trickle down to patients? Or will intermediaries such as pharmacy benefit managers (PBMs) influence how those benefits are distributed?
  • Which stakeholders will absorb pricing pressures? Will manufacturers bear the brunt, or will we see structural adjustments across the supply chain, including changes to rebate and contracting models?

The answers to these questions will shape how companies respond – and how they build access and pricing strategies in the months and years ahead. We’ll be monitoring developments closely.

The environment for market access is shifting quickly and becoming more complex. Success will depend on engaging early, preparing strategically, and clearly articulating value to stakeholders across the healthcare ecosystem.

Navigating market access complexity

In this evolving landscape, one thing is clear: the environment for market access is shifting quickly and becoming more complex. Success will depend on engaging early, preparing strategically, and clearly articulating value to stakeholders across the healthcare ecosystem.

At VML Health, we specialize in helping pharma companies adapt to policy changes like these. We provide:

  • Early-stage market access strategy, integrated with clinical development and evidence planning.
  • Value communication frameworks that resonate with payers, providers, and patients under heightened cost and outcome scrutiny.
  • Full-service health agency support driving market access education and content, and launch readiness, ensuring teams are aligned and prepared.

Whether you are responding to the ‘pill penalty’, preparing for VBAs, or communicating value in a constantly evolving marketplace – VML Health is your go-to partner for access strategy in real time.

The healthcare environment is changing fast. Value and transparency are no longer future goals – they’re immediate requirements. Let’s get ahead of them together.

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