Spring Intro 2023

23/03/2023

A European collaboration on HTA benefits pharmaceutical companies national HTA agencies and ultimately patients. By participating in EUnetHTA Assessments, companies have the opportunity to collaborate with EUnetHTA and shape the future of European HTA. Benefits for a pharmaceutical company are: Potentially faster and less intensive national assessment on clinical effectiveness. Head start on national work because of the availability of the EUnetHTA Submission Dossier. European scope of the EUnetHTA Assessment. Timely availability of the EUnetHTA Assessment around two weeks after publication of the European Public Assessment Report (EPAR). Pooling of expertise and experience in the assessment team. Predictable and consistent process to secure transferability of the results across Europe. Quality Assurance via tools, templates and Standard Operating Procedures (SOP). Stakeholder engagement. Professional guidance before and during the assessment by central project management. Joint Relative Effectiveness Assessments - Benefits

The Organisation for Professionals in Regulatory Affairs

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Joint Relative Effectiveness Assessment Evidentiary requirements, infections Disease case study

Potential to demonstrate added value restricted by trial design and comparators selected; ● Non-inferiority trials vs superiority trials ● Selection of comparator vs standard of care ● Surrogate endpoints: viral load (HIV); sustained virological response (hepatitis); clinical cure/microbiological eradication (anti-infectives) Non-clinical data traditionally not valued for comparative effectiveness; ● Although susceptibility and resistance is being increasingly incorporated in the value assessment Full EMA label considered; not possible to restrict to specific populations

The Organisation for Professionals in Regulatory Affairs

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