Health Technology Assessment is gaining importance in regulatory decisions about the registration and reimbursement of health technologies in a growing number of European states. It is essential to involve patients in this process, and not only because the law requires such involvement in many countries, but also because evidence shows that patients who are informed about and included in decisions concerning their own health also have better health outcomes.
HTA is a scientifically demanding, complex process involving pharmacoeconomics, ethics, risk-benefit assessment, the understanding of clinical research data, and many more. Understandably, a major part of the EUPATI patient expert course discusses HTA, and prepares patient representatives for this demanding job.
EUPATI fellow Paola Kruger reports about her experience with working in HTA in Italy.
HTA is an area where the benefits of patient involvement are still highly debated, so I was happy when a Pharma Company asked me to take part in a HTA review of a new drug they had developed and that was due to be available for patients soon.
Three disease-specific Patient Associations were asked to give their contribution to the review alongside me, which made the task particularly interesting because normally only disease-specific patient representatives are asked to be part of the process. We were all given full details of the Clinical Trial, together with a summary of the drug’s main characteristics and economic evaluation that had been prepared by the Health Economy Department of a leading University. This document was given to us with a double aim: to provide us with objective, additional information on the drug, but also to receive feedback on the readability and usefulness of such a report. The document was indeed well written and very patient-friendly, which made our task lighter and allowed us to concentrate on the relevant parts, rather than wasting time trying to decipher the medical jargon.
In the end we had to each write a detailed report with all our comments, and after completion of the task we were given access to each other’s reports and everything was later condensed in a publication. We also had a feedback meeting with the Pharma Company. I don’t know how much patients’ views are taken into consideration yet, but it is important to take advantage of such opportunities because it is only when the other stakeholders understand how valuable our comments are that they will start to turn patient involvement in HTA into a standard procedure.