Challenge
A pharmaceutical company sought to demonstrate the efficacy and safety of a novel therapy for adults with persistent urinary symptoms who had previously received first-line pharmacological treatment. A key challenge in the HTA evaluation was the absence of head-to-head clinical trials comparing the therapy with the primary comparator considered relevant by the HTA authority. The lack of direct comparative evidence created a critical evidence gap for the reimbursement evaluation.
Solution
Clevidence designed and delivered a comprehensive evidence package aligned with the HTA authority’s PICO framework, ensuring that the analysis addressed the comparator and outcomes prioritized for reimbursement decision-making.
The approach integrated evidence from the therapy’s pivotal clinical trials and applied indirect treatment comparisons using network meta-analysis methodology to estimate relative effectiveness in the absence of direct comparative trials.
Impact
This methodology enabled a rigorous and transparent evaluation of relative effectiveness, covering key clinical outcomes, patient-reported outcomes, and safety outcomes relevant to the HTA authority.
The resulting evidence package provided a robust and decision-relevant foundation for assessing the therapy’s clinical value, strengthening the HTA submission and supporting informed reimbursement decision-making.