Digistain have developed a revolutionary breast cancer treatment technology designed to reduce unnecessary chemotherapy treatments by better stratifying patients based on their risk of cancer recurrence. Traditional methods of breast cancer risk stratification are slow and expensive, using costly reagents and taking 2-8 weeks to deliver results. Digistain transforms the analysis of key biomarkers from a long costly manual wet-lab process to a rapid affordable AI-enabled solution, delivering actionable results at a fraction of the cost and time.
Digistain approached the Health Tech Enterprise team for support in understanding how the innovation would fit within the NHS’s existing care pathways and to bolster the product’s value proposition and evidence cost-effectiveness to help drive adoption.
The Technology
Digistain is an MHRA-cleared, UKCA-marked tumour profiling technology designed to assess the risk of recurrence in breast cancer patients following surgery. It predicts a patient’s 10-year risk of recurrence when treated with adjuvant endocrine therapy alone, guiding clinicians in making informed decisions about adjuvant chemotherapy.
The test generates a clear, easy-to-interpret risk score—the Digistain Prognostic Score. By providing clinicians with crucial insights, Digistain supports the development of personalised treatment plans, ensuring patients receive the best possible care while avoiding unnecessary chemotherapy.
Key benefits of the test include:
- GOLD STANDARD predictive equivalence to traditional genomic risk scoring analytics
- CLEAR insights on likelihood of breast cancer recurrence within the next 10 years
- FAST actionable results helping reduce treatment decision times
- LOWER COST enables many more people to access cancer recurrence prediction tests
- SEAMLESS integration with existing clinical workflows
The challenge was to understand how this innovation would fit within the NHS’s existing care pathways, quantify its impact on user budgets, and assess how it could be implemented at scale to optimize treatment outcomes while reducing costs.
Tailored Approach
To address this, we worked closely with the client to define two implementation scenarios: one where the technology would act as an adjunct to the existing care pathway and another where it would replace the current treatment model. We conducted an in-depth literature review and built a decision analytical model combining decision trees and Markov models to simulate the budgetary impact over five years. Our model incorporated probabilistic sensitivity analysis to account for uncertainties, offering the client a detailed understanding of the cost-effectiveness of the innovation for different patient subgroups.
Outcomes
Our support enabled the client to clearly demonstrate the significant cost-saving potential of their innovative tumour-grading technology. By implementing our comprehensive Budgetary Impact Analysis, we highlighted the potential for substantial savings over a 5-year period when the technology is introduced as a substitute for the existing care pathway. This not only bolstered the product’s value proposition but also provided a tangible framework for demonstrating its economic benefits to key NHS decision-makers, offering a strong case for adoption.
“The work by HTE was invaluable in understanding the budgetary impact of the Tumour Profiling Test. The model allowed us to identify the target patient subgroup of most interest, and for that subgroup, establish the value proposition of our innovation.” Hemmel Amrania, CEO of Digistain