OBJECTIVES :

HTA is based on either clinical and/or economic evaluations. Evaluation criteria are usually similar, however clear differences in conclusions and recommendations sometimes exist between health agencies. This study aims to evaluate disparities between HTA decisions for NOACs in the prevention of stroke and systemic embolism in NVAF patients.

METHODS :

NOAC HTA reports were reviewed for Australia, Canada, France, the Netherlands, Spain, Sweden and the UK. Based on available data for dabigatran, rivaroxaban and apixaban, NICE, SMC, CADTH, PBAC and HAS were selected. Their evaluations were appraised using the Drummond checklist, with additional considerations from EUnetHTA and INAHTA recommendations.

RESULTS :

NICE assessed the three NOACs in 2012-13. Compared to warfarin, all were deemed cost-effective, with ICERs below £20,000 to £29,500 per QALY gained. Similarly, SMC and CADTH accepted all three molecules between 2011 and 2013. PBAC issued a positive opinion on dabigatran, leading to reimbursement in 2011. In 2012, clinical uncertainties in the cost-utility analysis were initially noted for rivaroxaban, questioning its superiority over warfarin. Apixaban was also first rejected, mostly because of uncertainty around a potentially unacceptably-high ICER. Both were eventually reimbursed in 2013 under risk-sharing agreements. Unlike other agencies, HAS recommended NOACs in second line after VKA, because no other antidotes were available and anticoagulation monitoring was problematic. Dabigatran was assessed in 2008; apixaban and rivaroxaban followed in 2012, all with an SMR as “important”. In 2014, HAS revised dabigatran’s SMR to “moderate” because the balance between efficacy and safety events was deemed “average”. The decision was eventually upheld in 2018 in its latest “efficiency notice”. Consequently, NOACs are less accessible to French patients, and with different degrees of reimbursement between them.

CONCLUSIONS :

Disparities in HTA recommendations can result in inequities in access to NOACs. These disparities occasionally impact patients indirectly in those countries which benchmark the decisions of other agencies.