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Objectives: To develop a framework to compare integrated scientific advice (ISA) procedures, which are services available to companies to seek advice on a technology’s evidence generation plans from multiple stakeholders including regulators, health technology assessment (HTA) bodies, payers and patients Methods: Information on key aspects of European and North American ISA procedures were obtained in a desk review of websites, public domain sources and interviews with agency representatives Using this information, an analytical framework was developed in an internal workshop to describe and classify the procedures Available ISA procedures were compared using the framework, and current trends and developments identified including COVID-19 impact Results: The framework classified the characteristics of ISA procedures into five categories: Eligibility and Type of Procedure, Process for Procedure, Briefing Book Requirements, Meeting Advice Deliberations, and Advice Reporting & Follow-up When comparing procedures, similarities identified included a general focus of scope on clinical and economic (HTA bodies) advice, and a formal meeting between agency and company Key differences included variation in procedure eligibility and timelines General trends included increased demand for ISA and resulting agency capacity issues, plus impacts of COVID-19, leading to changes in existing procedure processes and development of new offerings, including: prioritisation of COVID-19-related or therapeutically-critical technologies, acceleration of processes (e g new fast-track options), change of meetings to virtual format and more detailed submission requirements, such as companies needing to submit patient-reported outcomes and post-launch evidence plans Conclusions: The initial framework provides an attempt to describe and classify ISA procedures to support comparisons and the value of seeking advice Current trends in ISA include a shift towards accelerated procedures, pragmatic approaches to deal with demands on agency capacity and implications of COVID-19 Further research needs to be performed to validate the framework to enable comparison and assess the differential value of ISA procedures |
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