In order to improve the diagnostic landscape in oncology and address a known gap or limitation in current diagnostic tools, a Target Product Profile (TPP) could be used as a signal to innovators. A TPP is a document that specifies the key characteristics and requirements of a new diagnostic test. While diagnostic TPPs have been used for some time in infectious diseases, their use in oncology has been limited. Our latest report for Cancer Research UK, written in collaboration with RAND Europe, outlines how to develop robust, fit-for-purpose diagnostic TPPs for cancer.

What is a TPP for?

A TPP needs to consider several aspects. As well as the technical requirements of the test (such as sensitivity and specificity), it needs to specify requirements relating to the context of use, accounting for NHS system design and capacity, as well as patients’ needs. Done right, TPPs can provide innovators with a clear demand signal about the types of tests needed, allowing innovators to respond appropriately to areas of unmet need.

What makes a good diagnostic TPP?

  • TPPs need to provide specifications for a diverse range of features that reflect key requirements for successful real-world use of a diagnostic test.
  • Diverse stakeholders should contribute to TPP development, including academics/researchers, healthcare professionals, diagnostic laboratory experts, research and innovation funders, innovators in research institutes and industry, regulators, health technology assessment expertise, policymakers and payers, and the patient voice.
  • TPP development has two key stages: inception (establishing core working group, governance, action plan) and implementation (scoping unmet need and key test requirements, TPP drafting, consensus building).
  • Methods to be employed for TPP development include different types of literature reviews and desk research, stakeholder consultation and consensus exploration, and economic modelling.
  • Developing fit for purpose TPPs should include a set of key guiding principles, including: (1) inclusiveness, (2) clarity on the value proposition (improvement offer) of a novel test, (3) balancing methodological rigour with pragmatic considerations while ensuring objectivity; and (4) considering a TPP’s local relevance alongside the global nature of incentives for innovation.

What is the role for health economics in TPP development?

OHE’s main input to the comprehensive report was to explore the role of early economic evaluation in the TPP development process. By performing a targeted literature review of the literature and convening a workshop with experts in HTA, health economics, policy and regulation, we explored the benefits and challenges of using early economic evaluation to inform TPP development.

The case for including the health economic lens is clear: by considering the perspective of the final decision-maker (NICE and the NHS), early economic evaluation can help to estimate what characteristics the diagnostic must have in order to achieve a favourable decision outcome in terms of cost-effectiveness. Early economic modelling can then be leveraged to:

  • define desirable parameters for certain test features (e.g., test price, diagnostic sensitivity & specificity, etc)
  • test scenarios and investigate their impact on cost-effectiveness
  • direct the value and focus of (further) evidence development

As part of the project, OHE produced an early economic modelling tool to support TPP development, along with a guide for use with key questions and resources to populate the model. While modelling is unlikely to provide an accurate estimate of the actual cost-effectiveness of the proposed test, it can help identify the most important features that impact cost-effectiveness, and signal whether a proposed diagnostic test is highly unlikely to be cost-effective.

We argue that early economic evaluation should form an essential part of TPP development, offering a clear signal to innovators of what would be of value in a new diagnostic test in oncology, thus bridging the gap between development and reimbursement considerations. By articulating the value proposition of a new technology early on and throughout the development lifecycle, we can ensure that development efforts lead to much-needed advances in oncology diagnostics, for the benefit of cancer patients.

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