An updated version of the Value Framework has been developed and published by the American Society of Clinical Oncology (ASCO)’s Value in Cancer Care Task Force. The Framework incorporates elements of clinical benefit, toxicity, and symptom palliation, derived from comparative clinical trials which are combined into a score; the net health benefit (NHB).
The major changes to The Framework include modification of the NHB to better reflect differences between treatments, via the use of hazard ratios; including all side effects (not just high grade toxicities), providing a bonus point for QoL improvements; continuation of only evaluating treatments studies via head to head RCTs; focus will remain on cancer drugs, rather than other interventions.
The eventual aim of the framework is that it will become a software application that will allow the individual patient to weight categories (such as clinical benefit, toxicity etc) depending upon their preferences and circumstances. The NHB will reflect the priorities of the patient more accurately and with guidance from the physician, can help to facilitate treatment choice through shared decision making.
The revised version of the Framework defines value as a combination of clinical benefit, side effects, and improvement in patient symptoms or quality of life in the context of cost. However, it still lacks the inclusion of patient reported outcomes (PROs), even though the original framework was reported as being insensitive to the benefits of palliative care therapies and the impact on QoL.
The Task Force state they are aware that the absence of patient reported information is a deficiency, but that it reflected the absence of PROs in many clinical trials. The revised framework, does include a bonus point that can be awarded for trials that demonstrate improvement in duration of treatment-free interval, QoL, or symptom palliation. ASCO suggests that future versions of the framework will incorporate PROs as and when they are regularly collected and reported in clinical trials.
At DRG we know how important your trial PRO strategy can be in the journey of getting new products to market and demonstrating patient benefit. If you would like to find out more or need help with any aspect of PRO development, please visit our website at: www.decisionresourcesgroup.com/VGC or contact one of our clinical outcomes assessment team on Access@TeamDRG.com