The global regulatory and payer policy landscape is evolving rapidly, introducing new regulations and strategic shifts that will significantly influence pricing and market access (P&MA) strategies for the pharmaceutical manufacturers. These transformations will impact market entry approaches, reimbursement frameworks, and portfolio optimisation, creating both challenges and opportunities for them.
Global early access stakeholders must prioritise proactive planning, agile adaptation, and cross-functional collaboration. Early identification of market access opportunities, close monitoring of policy changes, and the ability to quickly adjust pricing and access strategies will be critical for navigating both risks and opportunities in 2025 and beyond.
Ultimately, those who can anticipate and respond to payer policy evolution-leveraging up-to-date policy insights such as that provided by Access Infinity team and fostering strong internal and external partnerships-will be best positioned to ensure optimal patient access and commercial success in the shifting global landscape.
Access Infinity closely analysed two key payer policies from the perspective of P&MA implications for pharmaceutical manufacturers, focusing on how they can strategise to seize opportunities and address challenges.
Trend #1. UK: Early VPAG Review: Can the UK Become a Global Market Leader?
The UK government is bringing forward its review of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) to June 2025, ahead of the previously planned autumn timeline. This will align with the release of the NHS Ten-Year Plan and the Life Sciences Sector Plan, both seen as critical to revitalising the UK’s position as a global leader in health innovation.
Trend #2. ES: The Preliminary Draft Law on Medicines and Health Products
The Spanish Council of Ministers has approved a Preliminary Draft Law on Medicines and Health Products focusing on accelerating access to innovative treatments, ensuring the sustainability of the healthcare system, and strengthening strategic autonomy.
Strategic Market Access: Proactive Planning and Agile Adaptation in a Shifting Payer Landscape
The pharmaceutical industry is facing a rapidly evolving global payer policy environment, characterised by intensifying cost-containment measures, shifting evidence requirements, and complex pricing/HTA frameworks. These changes demand a fundamental shift in market access and pricing strategies—moving from reactive responses to a model of proactive planning and agile adaptation.
Proactive Planning: A Necessity for Market Success
To navigate these complexities, pharmaceutical manufacturers must anticipate policy shifts, assess their impact, and develop forward-looking strategies that align with the payer expectations. A robust proactive approach enables pharma companies to optimise pricing models, ensure reimbursement success, and strengthen their value proposition within HTA frameworks. Establishing early engagement with payers, refining value communication, and integrating real-world evidence into decision-making will be critical for long-term sustainability.
Agility: The Key to Adapting to Market Uncertainty
The dynamic payer landscape requires manufacturers to embrace flexible and adaptive strategies. As pricing and market access regulations tighten and competition intensifies, the ability to swiftly adjust reimbursement strategies, address emerging access hurdles, and refine commercial models will separate market leaders from those struggling to maintain access. Companies must embed cross-functional collaboration and responsive decision-making into their market access frameworks to ensure resilience in uncertain conditions.
Navigating 2025 and Beyond: A Strategic Imperative
With 2025 shaping up as a pivotal year, pharma global and local market access and pricing teams must closely monitor policy developments, anticipate upcoming regulatory/ HTA/ pricing shifts, and position themselves ahead of potential challenges. By embracing proactive planning and agile adaptation, pharmaceutical manufacturers can thrive in an evolving payer environment, securing competitive advantages while meeting the needs of both healthcare systems and patients.
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Authored by
Nikhil Taxak, Ph. D, APAC Head, Pricing and Market Access Data and Analytics*
Anupama Somu, Associate Manager, Data Team
Mahesh Jaju, Associate Manager, Data Team
David McConkey, Partner
Brett Gardiner, Senior Partner
All authors represent Access Infinity
*Corresponding author: nikhil@accessinfinity.com
