Global spending on pharmaceuticals is forecast to exceed pre-pandemic outlook to $1.2 trillion by 2028 (IQVIA, 2024 ). Health systems across the world face increasing calls for access to highly innovative, and often very expensive, medicines for patients with significant unmet need. Exciting new developments in science and technology give rise to ever more personalised medicines, pushing the boundaries of existing regulatory, pricing and reimbursement systems. Apart from high prices, the challenges for countries are wide ranging. From a lack of generic competition, disparities in access, inadequate health insurance coverage, supply chain disruptions, to policy and regulatory challenges. Strategies to overcome these challenges require the adoption of multi-faceted approaches. Different approaches are needed in high, middle, and low-income countries. The question of affordability could be a relatively straightforward one if there was a high degree of certainty about the benefits of expensive medicines. However, regulators are speeding up evaluation, taking the advantage of new approaches to evidence collection and analysis, including real-world evidence. Fewer medicines are coming to market with an open and shut case for value, leaving payors and commissioners with significant (financial) risks to manage. In the United Kingdom, the government uses the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth as a vehicle to promote innovation and access to cost-effective medicines, commensurate to their value to patients and the NHS, while also supporting sustainability of NHS finances (UK Government, 2024 ). Other mechanisms such as the Cancer Drugs Fund and Innovative Medicines Fund are being used to manage access and collect further evidence to support the assessment of value for the NHS (NHS England, 2024 ). Several provisions in the Inflation Reduction Act address drug pricing, including allowing the Secretary of HHS to negotiate prices in Medicare Parts B and D for selected medications and introducing Medicare rebates for drug prices that rise faster than inflation (U.S. Department of Health & Human Services, 2024 ). Stakeholders across the spectrum of research, development, regulatory approval, and market access should act, together, to ensure valuable novel medicines are getting to patients fast, and at a reasonable cost to the (tax)payer. Starting with ensuring the evidence base for assessment of value is comprehensive, at an early stage of development. Health Technology Assessment is well placed to manage this process, taking a life-cycle approach to appraising the value of innovative technologies (Trowman et al., 2023 ).
References
IQVIA . (2024). The Global Use of Medicines 2024: Outlook to 2028 .
NHS England . (2024). Innovative Medicines Fund .
Trowman, R., Migliore, A., & Ollendorf, D. A. (2023). Health technology assessment 2025 and beyond: lifecycle approaches to promote engagement and efficiency in health technology assessment. International Journal of Technology Assessment in Health Care , 39(1), e15. doi: 10.1017/S0266462323000090
UK Government . (2024). 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth .
U.S. Department of Health & Human Services . (2024). New HHS Reports Illustrate Potential Positive Impact of Inflation Reduction Act on Prescription Drug Prices .