OBJECTIVES

This study aimed to investigate the factors affecting decisions on oncology-related health technology assessments (HTAs) in Germany, Spain and the UK.

METHODS

HTA dossiers submitted to German G-BA and UK NICE and therapeutic positioning reports issued by Spanish AEMPS until April 2019 were analyzed. Assessments with added benefit in Germany, inclusion in the national reimbursement list in Spain and reimbursement recommendation with/without restrictions in the UK were interpreted as positive decisions. Decisions were regressed on assessments’ general characteristics and type of evidence presented in dossiers in a logistic regression framework.

RESULTS

The study included 436 assessments (75.2% positive) on 122 agents [GER: 153 assessments/73.9% positive; ESP: 72/65.3%; UK: 221/79.6%]. Controlling for all general characteristics such as indication type and assessment year, the following characteristics were associated with a higher probability of a positive decision: orphan status (OR: 3.19, p<0.01), presented RCT evidence (OR: 2.24, p=0.04), assessment in the UK (OR: 2.14, p=0.02, reference group: GER), whereas first-line treatment (compared to further treatment lines; OR: 0.63, p=0.07) and inclusion of evidence from indirect treatment comparisons (ITC; OR: 0.56, p=0.06) was associated with a negative success probability.

CONCLUSIONS

Evidence from RCTs and orphan status increase the probability of a successful HTA. Obviously, presentation of ITC evidence, especially in GER and ESP, is an indicator for weaker head-to-head evidence, which might explain the negative association between ITC evidence and HTA success.