Health Economics and Market Access (HEMA)

To improve market access, we focus on activities that are uniquely relevant to ATMPs. We help shape early development by defining parameters of commercial viability that inform the Target Product Profile and clinical development; we optimise market opportunity, by using health economic analyses, key market access stakeholder engagement, and defining the interrelationship between value story, reimbursed price potential and corresponding evidence requirements; in preparation for launch we address data uncertainty, healthcare system affordability, and NHS preparedness.

Advanced Therapy Medicinal Products (ATMPs) face high adoption barriers and commercial risk because:

There is a lack of long-term clinical data at launch to support value claims of sustainability of effect
High manufacturing costs require high reimbursed prices to secure commercial viability
Preparing healthcare system infrastructure for adoption is resource intensive

Working with you

Our health economics and market access team can work with you to develop the health-economic strategy and models that are uniquely relevant to ATMPs and that will give your ATMP the best chance of success:

Shaping early development (pre-clinical stage)

Define parameters of commercial viability in terms of therapeutic positioning and thresholds of product performance and manufacturing costs; Inform clinical and manufacturing strategy accordingly.

Opportunity optimisation (pre-pivotal clinical trial stage)

Health economic analyses and key market access stakeholder engagement, define the interrelationship between value story, reimbursed price potential and corresponding evidence requirements; inform the evidence generation plan accordingly.

Pre-launch preparations

Address data uncertainty, healthcare system affordability, infrastructure and treatment pathway constraints; leverage Innovative reimbursement mechanisms and post-launch real world evidence collection.

Working on a cell or gene therapy innovation challenge?