Mackenzie Mills is a PhD student at the Department of Health Policy. He has worked as a Research Associate for the Medical Technology Research Group in LSE Health for the past three years.
He has a BSc in Biochemistry from the University of British Colombia and an MSc in International Health Policy from the London School of Economics and Political Science.
Mackenzie's research focus includes intellectual property, regulation of medicines, pricing and reimbursement of medicines, health technology assessment, medicines negotiation, and healthcare programmes.
Title of PhD Project: Early Access to Medicines Schemes: Regulatory Policies vs HTA Practices and Their Impact on Access to Innovative Treatments
Background: There is a growing disconnect between regulatory agencies that are promoting accelerated access to medicines based on premature clinical data and health technology assessment (HTA) agencies that require robust clinical and economic evidence to recommend reimbursement of medicines. Evidence suggests that significant differences exist across countries on admittance to early access schemes, time to availability of medicines and reimbursement of medicines. While market size and firm characteristics have been linked to these differences, less is known about the impact of early access pathways and health technology assessment agencies.
What are the various mechanisms implemented internationally in order to accelerate availability of medicines to market in therapeutic areas of high unmet need?
To what extent do early access pathways accelerate availability of medicines, given HTA evidence requirements for reimbursement?
To what extent do differences in criteria applied, interpretation of evidence and use of social value judgments help explain the heterogeneity seen across settings in availability of medicines?
Methods: These research questions will be explored through a paper based this. Paper I consists of a comparison of early access pathways across 22 countries. Paper II involves an investigation of the evidence gap between regulatory agencies and HTA agencies. Paper III consists of a quantitative analysis of the determinant of time to availability of medicines across settings. Paper IV involves a quantitative analysis of the determinants of HTA agency recommendations. Finally, paper V validates the findings and addresses the limitations of papers I through IV through semi-structured interviews with key health authorities involved in the authorisation and HTA of medicines.
Primary supervisor: Dr Panos Kanavos
Secondary supervisor: Dr Joan Costa-Font