Challenge
A pharmaceutical company required support throughout the Health Technology Assessment (HTA) and reimbursement process in Portugal for a medicine intended to treat a pulmonary infection.
The process required the preparation and adaptation of a body of clinical and economic evidence, aligned with the anticipated requirements of the national HTA authority. In particular, it was necessary to anticipate the PICO framework likely to underpin the assessment, update the available comparative evidence, and ensure its appropriate integration into the submission dossier.
In addition to the pharmacotherapeutic assessment phase, the company also required specialised support during the economic evaluation.
Solution
Clevidence provided integrated support across the different stages of the HTA process, from the preparation of the clinical evidence through to the economic evaluation.
As an initial step, the anticipated PICO framework for the assessment was forecast, allowing the population, intervention, comparators and outcomes most relevant to the Portuguese HTA process to be identified in advance.
Based on this framework, the evidence provided by the company was reviewed and adapted to meet the requirements of the national assessment. The work included:
· Assessing the existing clinical evidence against the anticipated PICO framework;
· Updating the systematic literature review (SLR) provided by the company to incorporate the most recent and relevant evidence;
· Developing a network meta-analysis (NMA) based on the comparators and outcomes defined in the PICO and the studies identified through the updated SLR;
· Generating new comparative evidence to position the medicine against the relevant comparators;
· Preparing the pharmacotherapeutic assessment report, integrating unmet medical needs and the clinical and comparative evidence generated in a structured manner.
Anticipating the evidence requirements at an early stage enabled the analyses to be aligned from the outset with the clinical questions considered most relevant to the assessment.
Following completion of the pharmacotherapeutic assessment phase, Clevidence continued to support the client throughout the economic evaluation, helping to address additional evidence and analytical requirements identified during the process.
Impact
Clevidence’s integrated approach provided the client with a robust, up-to-date body of clinical and comparative evidence specifically developed to meet the requirements of the Portuguese HTA process.
Anticipating the PICO framework, updating the SLR and developing an NMA strengthened the evidence base supporting the pharmacotherapeutic assessment and provided consistent support for the positioning of the medicine against the relevant therapeutic alternatives.
By supporting the process from clinical evidence preparation through to the economic evaluation, Clevidence ensured a consistent and coherent approach across the different stages of assessment and funding, supporting the medicine’s market access strategy in Portugal.