drug evaluation

Health Technology Assessment (HTA) is climbing up the agenda in many European countries due to increasing healthcare costs and budgetary pressures .

Limited resource According to the European Society of Intensive Care Medicine (ESICM), assessing health technology is a critically important focus of healthcare providers and funding agencies due to the major resource limitations that affect healthcare today.

Between 5 and 10 percent of the gross domestic product is spent on healthcare in Europe. Health Technology Assessment is a multi-disciplinary approach in which medical technologies, such as drugs and devices are assessed in terms of their clinical performance and cost effectiveness. HTA is increasingly being used by governments to identify which drugs and devices offer best value for money. Their ultimate goals are to improve the healthcare decision-making process, reduce waste and deliver cost efficient healthcare.

In the second paper of the A Healthy Market? series, An Introduction to Health Technology Assessment , Dr. Meir P Pugatch, director of research, and Francesca Ficai, senior researcher from the Stockholm Network, said: “Governments find themselves dealing with growing demands for the financing of innovative health-related technologies without the necessary budgetary resources”.

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Many European countries have used HTA in various forms for many years and have established HTA bodies and programs, such as the National Institute for Health and Clinical Excellence (NICE) in the UK and the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany.

Market access and manufacturers

Medicine watchdogs such NICE and IQWiG, give payers advice on which drugs and devices are effective. They may also have the power to recommend which products will receive reimbursement. As these decisions can reduce or expand the market access of a product, manufacturers who cannot show that their products are perform well and are value for money, may find their market access limited. As a result, manufacturers are spending more time on planning their research, to ensure they can provide the data need to support their formal HTA submissions. This process is often referred to as the “4th hurdle”.

In a recent interview with Pharma IQ Chrissie Fletcher, director and head of international biostatistics at Amgen, said: “The Health Technology Assessment dossier is really the single opportunity that people have to convince payers of the value of a new product coming through. So in order to do that effectively, the more that that data is available for that dossier, and it’s reported in the right way, means that you’re going to have your best chance. And it should be as comprehensive and as transparent and as unbiased as possible.”

Fletcher also spoke of Biopharma’s increasing attention to focus on products for sub-populations she said: In addition, a lot of our work is beginning to focus around sub-populations of interest. In particular, heath authorities are looking to see do we have any sub-populations, which are more cost effective. So often we need to make sure that we come up, we have enough data in the literature to look at sub-populations not of our own drugs, but also of our comparators.” HTA will change how we do business

Many stakeholders in healthcare believe HTA is the key to better health services. Earlier this year, Dr Béresniak, chief executive of Data Mining International in Switzerland, a partner in the ECHOUTCOME project and leader of one of the Work Packages, said to European Commission CORDIS: “Most European decision-makers require health technology assessment (HTA) studies to evaluate costs and performance of health interventions.”

As a result, manufacturers of drugs and devices will continue to evolve their research practices, to ensure their products demonstrate efficacy and value for money. Fletcher said: “I believe the Health Technology Assessment is evolving, it has been evolving for a number of years; the importance is continuing to increase. In particular, a couple of areas that I’d like to discuss today are the concept of the relative effectiveness or, in the US it’s often termed the comparative effectiveness research. This is obviously really going to be a fundamental change in how we do our business.”

drug evaluation

Health Technology Assessment Climbs Up the European Agenda due to Lack of Resources

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