OBJECTIVES

To assess the impact of REA on HTA assessments in France, Germany and England.

METHODS

All publicly available REA reports and corresponding appraisal reports from the Haute Autorité de Santé (HAS), the Institute for Quality and Efficiency in Health Care (IQWIG) and the National Institute for Health and Care Excellence (NICE) were identified. Clinical, health-economic outcomes and final decisions were extracted from these documents.

RESULTS

Three of the four REAs published within the Joint Action 3 of the EUnetHTA project were evaluated by at least one of the three HTA bodies (HTAb) of interest: midostaurin, regorafenib, and alectinib.

Assessment of midostaurin with chemotherapy in the treatment of FLT3-positive acute myeloid leukaemia was performed by HAS and NICE. NICE recommended midostaurin and recognized its clinical benefit. The HAS evaluation was similar to the REA, but concluded limited added medical benefit (AMB) due to uncertainties regarding the impact of autologous stem cell transplantation. The AMB is deemed as proven and no evaluation was required by IQWIG due to its orphan drug status.

Assessment of regorafenib in the treatment of adult patients with hepatocellular carcinoma previously treated by sorafenib was performed by HAS and NICE. Both HTAb recommended regorafenib in restricted clinical situations as formalized in the REA report.

Assessment of alectinib as a first-line treatment in adult patients with ALK-positive advanced non-small cell lung cancer was performed by HAS, IQWIG and NICE. Similarly to the REA report, all three HTAb recognized the high quality evidence to support its clinical benefit with immaturity of overall survival data to quantify AMB.

CONCLUSIONS

On the basis of these first examples, the predictability of HTA assessments in France, Germany and England based on REA seems to be reliable. However, further assessments are needed to confirm these initial findings.