ADVANCEMENTS IN METHODS OF SURVIVAL BENEFIT ESTIMATION FOR NOVEL ONCOLOGY DRUGS AND THEIR APPLICATIONS IN ICER REVIEWS
Clinical trials for a number of emerging cancer therapies, such as immuno-oncology treatments, have identified patients who achieve long-term remission following therapy. In situations where a significant proportion of individuals achieve durable remission, traditional survival models may not be appropriate to represent the complex hazard functions. Furthermore, they have been found to introduce bias into survival assessments and influence results in cost-effectiveness analysis.
In this educational symposium, Dr. Wu will moderate and introduce common methodological challenges in modeling survival benefits for novel cancer therapies. Dr. Ramsey will present mixture cure modeling as an alternative approach to address the issues. He will briefly discuss the method and then provide an example to illustrate the differences in outcomes between the mixture cure approach and alternative modeling approaches. Dr. Ramsey will also provide guidance on when to consider mixture cure models, and then discuss some limitations in survival estimation that should be considered for novel therapies with limited follow-up data.
Dr. Xie will present other alternative methods to predict survival outcomes for treatments that can "cure" diseases. Using survival data with long-term follow-up, she will compare results using different extrapolation methods and discuss the validation of long-term survival projections.
Dr. Ollendorf will discuss the challenges facing health technology assessment (HTA) organizations in evaluating what is often immature and uncontrolled evidence on survival. In addition, he will present a number of approaches to address this uncertainty from both the evidence synthesis and decision analysis perspectives. Finally, Dr. Ollendorf will discuss the application of novel methods in a number of recent HTA reviews, including CAR-T treatments for a variety of cancers.