Novel modelling framework to evaluate components of a safety profile

Demonstrating a treatment’s safety benefits against another treatment with similar efficacy

The challenge

Traditional economic modelling approaches for healthcare products were limited to evaluating only the efficacy outcomes, excluding the impact that a product safety profile could have during decision making processes. Therefore, when assessing two products with similar efficacy yet different safety profiles, the benefit of the product with the preferable safety profile would not necessarily be apparent in the traditional cost-effectiveness model. Therefore, we identified a need to explore ways of strengthening the safety profile story within economic analysis.

The solution

We developed a new modelling framework to provide a stronger message about the differences in the safety profile of treatments. The model evaluates both the distribution of adverse events for treatments and the total cost for the safety profile of the different products. Additional analysis can also be conducted to explore the likelihood of discontinuation and the time to events. The model is referred to as the Safety Profile Model™.

Key results

The Safety Profile Model™ provides clear value messaging on the safety profile of products, demonstrating and quantifying the benefits of a safety profile in terms of its patient impact and disutility. The Safety Profile Model™ demonstrates the relative safety benefits of treatments with similar efficacy. It evaluates the different components of a safety profile to show the wider benefits of the product, predicting the likelihood and timing of potential adverse events and the resources required to manage them.

Value to the client

The model can utilise early trial data to produce an economic evaluation based on the safety data from clinical trials. It can be standalone or incorporated into an existing cost-effectiveness framework to increase the focus on safety profiles for products. The flexible framework allows tailoring of analyses based on the product/therapy area need. The model allows our clients to demonstrate the wider patient and payer benefits of products for reimbursement.