Lessons Learned from NOACs and CV Drugs That Have Launched in the EU5, US, JP and BR? An HTA Review and Evidence Generation Standpoint

OBJECTIVES: We investigated how NOACs and CV drugs gained market penetration and determined their price evolution over time via secondary research. We have identified the evidence packages that were presented at the initial HTA assessment and any subsequent data packages and if the HTA assessment differed from the original assessment.

METHODS: We looked at NOACs and CV products that are available in the EU and US. We had evaluated the evidence that was initially submitted and any additional evidence (via re-evaluation or submission of real-world evidence) and their initial HTAs and any use of MEAs were documented and pricing changes (if any) from launch

RESULTS: A total of 5 products were investigated in our research and can conclude that price stabilisation is possible within both the US and EU5. HTA reports are important for pricing potential and re-evaluations are key to pricing erosion, however pricing erosion is minimal even after HTA assessments. Clinical guidelines are essential for the success of uptake and can lead to accelerated approvals in subpopulations with high unmet need.

CONCLUSIONS: The trial design is essential as the threshold of evidence is ever increasing with payers expecting trials to include active comparators and appropriate endpoints. Manufacturers need to learn how to deal with poor HTA results and address the criticisms from one HTA submission to another and if there are consistently poor reviews, there is an issue with the evidence and it will need addressing through a critical evidence review and further evidence generation.