Background
Target Product Profiles (TPPs) serve as strategic tools for planning medical innovation development, facilitating communication with regulators, and developing market access strategies. Modelling can assist TPPs development and provide guidance on defining attributes. This scoping review aims to outline the general steps in employing models in developing or refining TPPs and to identify the common themes of the attributes informed by modelling.
Methods
PRISMA-ScR checklist was used to guide this review. Literature search in PubMed, Scopus, Web of Science, Embase, and the World Health Organization Institutional Repository for Information Sharing (WHO IRIS) was conducted between August and September 2023. Subsequently, two researchers reviewed abstracts independently. Only full text articles used modelling to inform TPPs of health technologies with detailed modelling and methodology reported were included in this review. General information, technology-related information, TPP-related information, and model-related information were extracted from the articles and analysed thematically. EPIFORGE 2020 checklist was used to assess the reporting quality of modelling approach of the included articles.
Results
This review included 23 articles published from 2010 onward, reflecting a growing interest in using modelling to inform TPPs development. The studies covered diverse medical innovations, including drugs, vaccines, devices, procedures, and vector control tools. Commonly modelled attributes for devices included health impact, economic value, and efficacy. For non-device innovations, clinical efficacy, economic value, and dosage were the most frequently modelled attributes. The modelling process typically involved three steps: scoping, model development and validation, and analysis with recommendations. Limitations from the modelling process discussed across studies fell into three categories: evidence quality, modelling assumptions and structure, and the generalisability of findings. While some attributes, like clinical efficacy, are straightforward to model, certain attributes such as human factors require considering proxies such as compliance rates or capacity constraints.
Conclusions
This review identified common product attributes in TPPs that were informed by modelling, outlined the modelling process, and highlighted key limitations. It provided recommendations to improve the modelling approach in TPPs development and highlighted the need for further research to standardise the modelling process.
Public Interest Summary
Target Product Profiles (TPPs) are documents that outline targets for new medical innovations to effectively address specific public health needs. These documents are developed through multiple rounds of consultations with domain experts and stakeholders. We aimed to study how mathematical modelling can be used to support TPPs development. Through a systematic search, we identified and studied 23 papers that used modelling. We observed a structured three-step process: identifying the suitable model, testing and tuning the model, and using the model outputs to set the targets. Modelling was primarily applied to establish targets relating to efficacy and economic values of the medical innovations. Our findings offer insights into the role of modelling in TPPs development and inform potential future methodological guidance.