OBJECTIVES

Technology appraisals (TA) by health technology assessment (HTA) bodies continue to pose a potential hurdle to broad access of innovative medicines in Europe, including Poland. Risk-sharing agreement (RSA) are a potential means of increasing chances of acceptance. The aim of this study was to compare TA outcomes of the Polish HTA body (Agencja Oceny Technologii Medycznych i Taryfikacji; AOTMiT) and UK reimbursement bodies (National Institute for Health and Care Excellence; NICE, Scottish Medicines Consortium; SMC) for medicines in neurology area (F01-G99 of the ICD-10-CM Codes) and analyze RSA trends in Poland.

METHODS

Published outcomes of TAs carried out by AOTMiT between 2015 and 2018 were reviewed and matched to the TAs carried out by NICE/SMC. Fisher's exact test for a 2x2 contingency table was carried out to obtain odds ratio (OR) for a negative HTA outcome. Recommendations on including RSA in positive HTA decisions by AOTMiT were analyzed in two periods (2018 vs. 2015-2017).

RESULTS

A total of 76 HTA submissions were identified (47 from AOTMiT and 29 from NICE/SMC). The rejection rate was 40.4 % by AOTMiT and 13.8% by NICE/SMC. The OR for a negative HTA recommendation was 4.24 (95% CI 1.27 to 14.20, p=0.018) between AOTMiT and NICE/SMC. RSA were recommended in 90% of positive TAs by AOTMiT in 2018 compared with 33% in positive TAs in 2015-2017 (OR=2.4; 95%CI 0.47 to 12.61, not significant).

CONCLUSIONS

Poland remains a challenging market for innovative neurology medicines with fourfold higher odds of HTA rejection compared to the UK. Increasing trend of positive HTA recommendations with suggestions on RSA may positively influence future acceptance rate by AOTMiT for innovative medicines in neurology area.