The economic and ethical considerations and implications of the stratification of future oncology therapeutics

Abstract

This thesis investigates the economic impact of stratified medicine on industry and the subsequent ethical implications for patients. Stratified medicine involves the use of clinical biomarkers to indicate differential response among patients in efficacy or potential side effects of therapeutic agents. The advent of stratified medicine should, in theory, result in the safer, more effective use of therapeutic agents to treat cancer. However, reluctance remains within the broader life sciences community, in particular within the pharmaceutical industry, to embrace stratified medicine. I hypothesize that this is due to economic concerns. Firstly, an historical analysis of the rate of market adoption of stratified therapeutics is conducted by comparing the adoption velocity and time to peak sales of stratified therapeutics relative to traditional chemotherapeutics. The aim is to analyze whether historically, stratified medicines have been more or less successful in terms of speed of market adoption. To supplement this analysis interviews are conducted with investment analysts who cover pharmaceutical and diagnostics companies to gauge their views on stratified medicine. This is important due to the fact that publicly traded companies have an obligation to their shareholders, and shareholder views are shaped by the analyses of these individuals. In order to assess the future economic impact of stratified medicine on industry, particularly given that clinical biomarkers are now being developed much earlier in the R&D timeline, a model was constructed to predict economic outcomes based on various parameters associated with biomarker development.

(cont.) The aim of this model is to investigate how factors such as pricing, drug efficacy and biomarker accuracy, amongst other factors, impact the patient population, and therefore market size and economic performance for a drug with an associated biomarker. This body of analysis is then used to conduct a second set of interviews with representatives from patient advocacy groups to gauge their opinions on the ethical implications arising out of the economic considerations discussed in the first half of this thesis. In summary, this thesis undertakes a comprehensive review of the history of the adoption of stratified medicine within oncological therapeutics, and a forward-looking analysis of the economic and ethical implications with the aim of clarifying the circumstances in which stratification may be appropriate. In doing so, this thesis provides a resource to pharmaceutical companies and patient advocates attempting to chart a viable path forward in this rapidly changing field.