Speaker

Biography

Abstract

Lara J Wolfson

Lara Wolfson, PhD, is the Associate VP and Head of HTA Statistics at MSD in Zurich, Switzerland. Leading a team of 75+ statisticians, she pioneers quantitative solutions for Health Technology Assessment (HTA) challenges. Lara's career spans roles at Merck, Janssen, and the World Health Organization, focusing on biostatistics, health technology assesment, vaccines, epidemiology, and health economics. She also taught at Brigham Young University (US) and the University of Waterloo (Canada). Dr. Wolfson co-leads the HTA ESIG (European Special Interest Group) of EFSPI (European Federation of Statisticians in the Pharmaceutical Industry), and holds MS and PhD degrees in Statistics from Carnegie Mellon University, with an undergraduate background from Simon Fraser University.

Introduction to HTA and indirect comparisons for value assessment

Jenny Devenport

I solve problems. Throughout more than 20 years as a statistician in the healthcare industry (public health, device and drug development, and medical affairs and access), my goals are to ask the right questions and develop optimal solutions to get patients the best care. I champion scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, I get people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.

Currently I work in Product Development Data Sciences at Hoffmann La Roche, leading a team of programmers and statistical scientists with projects spanning the non-oncology portfolio from early stage through end of lifecycle. I also lead a community dedicated to creating and sharing best practices for collaboration and evidence generation supporting access and clinical practice. In addition, I work externally with industry professional societies and special interest groups to identify and execute opportunities to advance the field.

I received my M.S. and Ph.D. in the United States, where I split my energy between theoretical and applied statistics. In my free time I enjoy the exhilaration, natural beauty, and rich history while racing my sons up the mountains of Switzerland.

ITC is not for me: Why hallmark evidence may not influence HCPs

Delivering new medicines for patients is the goal of drug development. But the evidence needs of HTA / payer and clinical practice stakeholders often go beyond those required for regulators. And they are not always set in stone, but morph as the competitive landscape changes. There is a real need for product differentiation and demonstration of the relative value of new medicines compared to their predecessors to enable optimal use in clinical practice. HTA bodies have often employed ITC to compare approved treatments and evaluate relative value instead of or in addition to direct head-to-head comparisons within trials (which are not always available). But this tool is generally not something that resonates with healthcare providers (HCPs) and therefore, additional clinical studies are often required to address their questions. In this presentation, I will discuss some of the reasons–scientific, statistical, and pragmatic– that ITCs are not necessarily highly weighted in HCP clinical decision making in practice.

Alex Simpson

Alex Simpson, MSc, is an epidemiologist by training and has been working in the pharma real-world data space for 7 years. In his current role at Roche as an Access RWE Strategy Lead, he leads the development of RWD studies that are used to support reimbursement dossiers across the world which ultimately enable patients to access new therapies. Alex has a keen interest in how RWD can be used to support patient access with a particular focus in the rare disease space.

Can patient access be secured with single arm trials?

Single-arm trials (SATs) are increasingly being reviewed by payers and Health Technology Assessment (HTA) agencies in situations where a randomised clinical trial is unfeasible due to ethical or operational reasons. However, SATs pose a considerable challenge for HTA agencies when assessing new therapeutic interventions as there is no direct comparison to contextualise the findings seen from the SAT. This presentation will explore some of the alternative comparative methods that drug manufacturers may use to demonstrate treatment benefits during the HTA appraisal, some of the pitfalls associated with such methods and what the future may hold for these types of value assessments.