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Navigating HTA Expectations for Digital Measure Evidence: A DEEP Collaboration Mission with NICE 

Overview: 
NICE (National Institute for Health and Care Excellence) is the health technology assessment (HTA) body for the NHS in England. Through the NICE Advice service—a fee-based program—NICE offers tailored support to pharmaceutical, MedTech and HealthTech companies. NICE Advice includes these core services: advice, insight, education OR strategic and scientific advice, health system engagement and insight, educational services 

This DEEP pilot centers on engaging with NICE through the scientific advice service with the goal of identifying where digital endpoints may fall short of current HTA expectations—and how to address those gaps proactively. Participating teams will explore how evidence supporting digital measures aligns with UK HTA frameworks and requirements, and how those insights may inform broader engagement across Europe. 

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Overall Goal: 
To explore how digital measures can be better supported by evidence that meets HTA expectations and to understand how regulators, HTA bodies, and healthcare systems (MHRA, NICE, NHS) work together to evaluate digital health technologies (DHTs). 

 

Specific Objectives: 

  • Identify and address evidence gaps for digital endpoints in the context of HTA evaluation. 

  • Gain early payer and HTA insights into the acceptability and value of digital measures. 

  • Understand the interplay between the MHRA, HTA bodies, and NHS in shaping market access. 

  • Compare DEEP’s Target Solution Profile (TSP) with the NICE Evidence Standards Framework (ESF) for DHTs. 

  • Generate foundational insights for engaging with other European HTA bodies. 

  • Explore pathways for the reuse and alignment of evidence between regulatory and reimbursement requirements. 

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Pilot Process:

Following selection of a representative use case (a digital endpoint), DEEP will work with participating teams to build a proof of concept. This will involve mapping the DEEP stack model to NICE’s expectations via the ESF, and conducting an evidence gap analysis with NICE to validate the robustness of the evidence in the context of a clear value proposition. 

The pilot will offer a collaborative environment for testing the DEEP model as a structured evaluation tool that aligns with HTA standards and supports informed evidence development strategies for digital measures. 

 

Potential Benefits: 

  • Early feedback on evidence requirements for DHTs from a leading HTA body. 

  • A clearer understanding of the data expectations for demonstrating the value of digital endpoints. 

  • Practical insights into the UK HTA landscape and how it intersects with regulatory processes. 

  • A potential blueprint for engaging with HTA bodies across Europe. 

  • Opportunity to refine internal processes for evidence generation, submission, and value communication. 

 

Call for Collaboration: 

DEEP invites members and non-members to co-develop this pilot alongside our team. Whether your organization is looking to test an existing digital measure, validate your approach to evidence development, or learn more about UK HTA processes—this is an opportunity to engage directly with NICE through DEEP’s structured, mission-based collaboration. 

Ideal participants include: 

  • Market access teams at pharmaceutical or MedTech/HealthTechcompanies 

  • HEOR professionals 

  • Regulatory and clinical development experts 

  • Developers of digital health technologies 

  • Consultants in HTA, regulatory strategy, and reimbursement 

 

How to Contribute: 

There are many ways to support a DEEP Collaboration Mission—whether through funding, time and expertise, or sharing previous work that aligns with the mission objectives. DEEP provides a simplified legal framework and mission contracting services to help make collaboration easy and transparent for all participants. 

 

Contact Us: 

If your organization is interested in participating or learning more, please get in touch with us 

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If you have any questions, or if your organisation would like to contribute, please reach out to us here:

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