Paweł Kawalec

The use of the National Health Fund databases as a source of real-world evidence

Patient medical records and administrative healthcare databases are possible sources of real-world evidence (RWE), i.e., evidence on the potential benefits and risks of a medical product. RWE can complement the evidence from randomized clinical trials. The wide range of information collected by the National Health Fund (NFZ) and the Ministry of Health in Poland ensures the versatility of the data that cover almost all patients treated in Poland. In addition to administrative data (without detailed information about patients and their disease), electronic medical records of some patient groups can be obtained from special programs (e.g., KOS-Zawał) or the System of Monitoring Drug Programs (SMPT). Low usage (only 37 studies) but high usability of NFZ databases as a source of RWE were identified. Joint analysis of data from administrative databases and SMPT can increase the credibility of the study, but limits the study to only patients treated within the Drug Programs.

Diabetes mellitus is now recognized as a societal disease that significantly burden health care systems in highly developed as well as developing countries and constitutes a serious problem of public health world-wide. The aim of this study was to estimate the value of reimbursement of diabetes-related drugs in 2012 and 2013 and to analyze indirect costs generated by diabetes in Poland in 2012.

It was revealed that reimbursement of glucose test strips, antidiabetic drugs and insulins covered by the National Health Fund was as high as 1.3 billion PLN in 2012 and 1.5 billion PLN in 2013 and the dominant cost drivers were glucose test strips (49% of costs in 2012 and 52% of costs in 2013) and insulins (40% and 38% of total reimbursement costs due to diabetes, respectively).

Total indirect costs of diabetes type 1 and type 2 in 2012 were as high as 59 million PLN and 66,5 million PLN and absenteeism due to sick leave was a main cost driver (61% in diabetes type 1 and 95% in diabetes type 2, respectively).

In summary, costs associated with diabetes constitute a serious burden for the National Health Fund as well as for the Social Insurance Institution in Poland.

The current challenge for healthcare systems is to assess the clinical and economic value of non-drug technologies. Attempts have been made to use Health Technology Assessment, a standard method used in many countries to assess and make decisions regarding the reimbursement of medicines. The use of health technology assessment for non-drug technology can be a challenge because of the lower availability of high-quality scientific evidence in comparison with drugs. In several European countries attempts were made to develop guidelines for the clinical and economic evaluation of non-drug technologies; we presented specific guidelines prepared by British and French HTA agencies: NICE and HAS, respectively. In the case of Poland, the role of the Agency for Health Technology Assessment and Tariff System (AOTMiT) is to assess and appraise all medical technologies and services claiming public money funding; most of these assessments concern drug technologies. Only 103 of 1,550 orders (6.6%) issued by the Ministry of Health, from 1^st January 2012 to 1^st July 2018, were related to non-drug technologies. The health services assessed by the AOTMiT include different non-drug medical technologies, both specialized medical devices as well as surgical interventions or diagnostic procedures or screenings. Orders for non-drug technologies issued by the Ministry of Health vary in scope and type of assessment.