The practical effectiveness (real data, real-world data, RWD) becomes a very important part of decision-making process in the HTA area, both for applicants and for the decision-maker. These data can provide information and have a significant impact on the reimbursement strategy, e.g. on the comparators selection, the preparation of pharmacoeconomic analyses (clinical, economic and financial) and on the proposals of risk-sharing schemes (RSS).
RWD is essential to determine long-term safety profile of the drug, the quality of life in patients, drug impact on the treatment standards in a country, as well as the legitimacy of a drug reimbursement.
MAHTA offers the opportunity to prepare a study to collect RWD and / or qualitative analysis of such data, statistical analysis of the data and its inclusion in pharmacoeconomic analyses.