The process of Health Technology Assessment (HTA) has been a key tool used by many European governments over the last two decades to evaluate healthcare innovations and ensure that those paying for healthcare get as much value—and benefit for patients—from their investment as possible.
HTA systems assess the level of innovation and value promised by new medical therapies before making reimbursement decisions. The process has long been a complex one, with the use of HTA varying across the continent, driven by the variation in local context and priorities. European countries have different systems for evaluating new treatments that make use of varied skill sets and use a range of criteria for determining value and deciding whether to pay for them. In many cases, more than one agency is involved in HTA, and in countries with more devolved systems of managing healthcare, regional organisations also have a role in the assessment process.
All the countries discussed in this report have well-developed HTA systems but face growing challenges in assessing the value of the newest innovative treatments, especially in the area of oncology. Many of these innovative products are personalised or targeted at smaller populations, and often have less evidence behind them because of the difficulties in finding enough patients to make up a large Phase 3 clinical trial. Some are part of combination regimes or require companion diagnostics to identify the most appropriate patient groups. These innovations are sometimes categorised under a new class of treatments— advanced therapy medicinal products— which are treatments based on genes, tissues or cells. For this reason, we refer in this paper to “innovative therapies” rather than “innovative drugs.”
All of these factors mean that existing HTA systems, and associated payer organisations, are finding it increasingly challenging to evaluate and introduce these therapies in an equitable and sustainable fashion. Our empirical analysis of 12 innovative therapies across eight countries shows a large variation in “time to HTA decision” and “time to patient access”, both between countries and between therapies within countries. We describe how reforming the HTA process is likely to involve the expansion of more flexible systems for providing access to promising, early-stage therapies, new approaches to building an evidence base for innovative care, and a revisiting of the definition of value. Much of this activity is already happening in the world of HTA, but progress is sometimes slow. Through our analysis, we identify the following key takeaways.
- HTA structures and methodology are coming under increasing pressure to adapt
- A greater range of conditional agreements are needed to improve patient access
- Improved data collection infrastructure is required
- Greater transparency in the decision-making process should become the norm
- Patient views need to play a greater role in decision-making, as well as deliberation
- Greater harmonisation can be helpful but remains challenging
Supplemental material for this report can be found here:
