Health technology assessments have increasingly become the norm in Europe and abroad as nations seek to maximize the use of high-quality prescription drugs while maintaining cost controls. HTA is a key tool for payers to determine what a drug is truly worth and therefore worth reimbursing. In HTA, drugs are measured for the clinical effectiveness, but in many cases also their cost-effectiveness. Pushed by heavyweights like NICE, HTA offers the chance for innovative drugs to show their benefits, but are oftentimes used by payers to avoid funding costly therapies or lowering prices. It’s a double-edged sword for industry, and as the trend matures, payers are increasingly sharing ideas across borders.
EUnetHTA, the European Network for Health Technology Assessment, is at the forefront of this push. Founded in 2006 to connect public HTA agencies, research institutions, and health ministries on a regional, national, and European level, EUnetHTA was seen as creating a sustainable system of HTA knowledge sharing and facilitating efficient use of resources available for HTA in member countries. With 68 organizations from 28 EU member states, as well as Norway and Switzerland, this agency stands as a significant presence in HTA, which tends to vary considerably by country (think ICERs in the UK and SMR ratings in France for instance).
At a recent EUnetHTA conference in Paris organized by the French National Health Authority (HAS), members of national agencies, universities, and biotech companies posed questions and exposed problems related to the wide variation in HTA across Europe.
In her keynote address at the conference, French Health Minister Marisol Touraine highlighted the significance of HTA in relation to increasing drug prices, emphasizing a need for cost-containment balanced with accelerated access to new medicines. HTA has long been a key element of the French government’s healthcare policy, shaping pricing and reimbursement decisions, but the wide variation in HTA systems across European governments has resulted in consequent disparities in drug pricing and reimbursement, leading to frustration for players in the pharmaceutical industry hoping to launch new drugs simultaneously across various markets. In recent years, there has been an influx of innovative but expensive drugs in markets across Europe, making discrepancies in HTA even more relevant. EUnetHTA has attempted to improve collaboration in European countries in regards to these discrepancies, most recently focusing on new hepatitis C drugs by creating a core HTA for the new generation of drugs and translating it into local reports.
At the conference, Panos Kanavos of the London School of Economics and Political Science presented data from his work on Advance-HTA—a research project that aims to advance and strengthen the methodological tools and practices relating to the application and implementation of HTA. These data suggest that the clinical evidence utilized by HTA bodies across Europe is relatively similar, but the resulting reimbursement recommendations are quite different. Kanavos proposed that more detailed analysis of HTA differences, resulting from both social and scientific value judgments, will help EUnetHTA partners improve collaboration in HTA.
“The elephant in the room that hasn’t been mentioned is the FDA and the impact they can have on the evidence generation aspect,” Keith Abrams from the University of Leicester, said in response to Kanavos. “I can cite a number of examples where companies may have wanted to do a head-to-head trial, patients wanted them to do a head-to-head trial, European HTA agencies wanted them to do a head-to-head trial, and the FDA wanted a placebo-controlled trial. You can guess what actually got done—and that has implications.”
Because head-to-head trials compare drugs directly, they allow for a more definitive answer about which drug is more effective. This could consequently result in positive outcomes for patients seeking treatment and pharmaceutical companies launching more effective drugs. However, the time and effort required to conduct studies comparing new medicines directly against a variety of older medicines could also inhibit pharmaceutical companies from quickly launching drugs into new markets by conducting one primary placebo-controlled trial, and as a result, prevent sick patients from receiving new treatments. Currently, HTAs may perform a meta-analysis to compare products against similar comparators such as placebo.
As HTA continues to evolve, it is important for organizations such as EUnetHTA to create a space where open dialogue can occur. Ultimately, both patients and pharma will benefit from greater collaboration between health technology assessment institutions and health ministries across Europe. For industry, how this trend develops could have a profound impact on uptake across countries.
Additional information on HTA use in specific countries can be found at Decision Resources Group’s Global Market Access Solution, available at https://gmas.decisionresourcesgroup.com/