Introduction

Target Product Profiles (TPPs) are essential tools in health technology development. They outline the minimal and desirable characteristics of a technology to meet specific health needs. Developed through literature reviews, expert input, and stakeholder consensus, TPPs guide research, development, and innovation. This article summarises the recent Health Technology Assessment Innovation Laboratory (HTA Lab) report from The National Institute for Health and Care Excellence (NICE)

Regulatory and Industry Applications

TPPs were initially developed by the US Food and Drug Administration (FDA) to facilitate communication with manufacturers. They provided a common vocabulary and understanding of product details and potential benefits early in the approval process. Today, TPPs are frequently used by industry and consulting partners during drug development. They help document minimal and desirable characteristics of new products, aiding in ‘go’ or ‘no-go’ decisions and developing market access strategies. Despite their utility, TPPs remain underused in formal regulatory interactions.

Regulatory agencies now publish TPPs to guide industry in developing products with desirable characteristics. For instance, during the COVID-19 pandemic, the Medicines and Healthcare products Regulatory Agency (MHRA) issued TPPs for diagnostics to outline necessary characteristics for UK government testing strategies. TPPs can signal areas of unmet need, supporting awareness across stakeholders and expediting the development of innovative technologies.

Potential Uses in Health Technology Assessment (HTA)

TPPs have limited consideration in health technology assessment (HTA), mainly focusing on cost-effectiveness. However, TPPs can be valuable for NICE and HTA, particularly for digital health technologies. They can be developed for demand signalling, informing and guiding product development in priority areas. Moreover, TPPs can support communication of guidance for technologies with easy replicability and multiple available products. This novel use of TPPs can provide commissioners with advice on the minimum and desirable characteristics of digital health technologies, based on clinical and cost-effectiveness evidence.

Case Study: Virtual Ward Platforms for Acute Respiratory Infections

NICE has been involved in evaluating virtual ward platforms for acute respiratory infections. This evaluation presented an opportunity to consider new types of products, such as TPPs, to capture expert input and committee discussions. The aim was to develop a draft outline of a TPP that includes items inferred from these discussions. The draft TPP covered aspects like target population, professional and patient interfaces, supported medical devices, monitoring, interoperability, safety, and effectiveness.

Developing a TPP for Digital Health Technologies

The HTA Lab explored constructing a TPP for digital health technologies, using virtual ward technology platforms as an example. NICE committee discussions on virtual wards were attended to assess the extent to which committees identify minimal and desirable characteristics of technologies. An outline of a TPP was constructed, including characteristics related to the target population, professional and patient interfaces, supported medical devices, type of monitoring, interoperability, safety, and effectiveness.

Several key considerations were identified while developing this case study. The aims of TPPs and the approach used in their development align with some aspects of committee deliberations. However, practical challenges exist in developing TPPs alongside guidance. Committees do not centre discussions around minimal and desirable characteristics, and evidence consideration takes substantial committee time. Furthermore, the TPP drew on issues related to managing the delivery of virtual wards by the National Health Service (NHS) services and the details of virtual ward platforms.

Conclusion

Information developed during NICE evaluations can provide valuable content within TPPs for digital and other health technologies. NICE is well-positioned to contribute to TPP development, but a whole-system approach led by partners with a broader view of the innovation pathway is necessary for maximum benefit. TPPs can support communication, guide product development, and signal unmet needs, ultimately improving health technology development and implementation.