NICE resubmission feasibility assessment for a rare haematological oncology asset - European specialty pharma
Snapshot
At a glance
Newmarket Strategy supported a European specialty pharmaceutical company in assessing the feasibility of a NICE resubmission for a targeted therapy in a rare, haematological malignancy, following a material shift in the treatment landscape since termination of the original appraisal.
Client
A European specialty pharmaceutical company
Challenge
The treatment landscape had changed significantly since the original appraisal was terminated, with new cell therapies and pathway changes eroding the original unmet need argument and complicating the comparator set
The challenge
When the original NICE appraisal was terminated, the access case rested on a strong unmet need argument in a landscape with limited effective alternatives. By the time of our engagement, several new cell and antibody therapies had entered the pathway at multiple lines of treatment, undermining the original positioning, altering the relevant comparator set, and raising new questions about cost-effectiveness modelling.
Our approach
We conducted a resubmission feasibility assessment and strategic review, facilitated a client workshop to align on findings, and produced a structured strategy deck setting out options and recommendations
Newmarket conducted a detailed review of the updated clinical evidence and competitive landscape, assessing the asset's residual clinical differentiation, the patient subpopulations where unmet need remained strongest, and the most defensible comparator set for a future submission. We identified the key ICER drivers under the revised landscape and assessed the implications for pricing and economic modelling. Findings were pressure-tested in a structured client workshop before being consolidated into a strategy deck setting out a clear resubmission framework, evidence requirements, and potential real-world evidence sources to strengthen a future HTA package.
The outcome
The client had a clear, evidence-based view on the viability of resubmission, the key evidence gaps to address, and a strategic framework to guide next steps
