Meet the Work Package – WP3

Led by NICE (UK) and co-led by Medtronic, WP3 collaborates with Health Technology Assessment (HTA) bodies, payers, and industry to bridge the gap between Real-World Data (RWD) and its application in HTA, improving decision-making for medicines, medical devices, and drug-device combinations across Europe. 

HTA bodies evaluate the clinical and economic value of health technologies, ensuring patient access to safe, effective, and cost-efficient treatments. However, integrating Real-World Evidence (RWE), derived from sources like electronic health records, registries, and claims, into HTA processes remains challenging due to inconsistent data quality, methodological uncertainties, and limited guidance. 

WP3 addresses these challenges by: 

1. Establishing an HTA Expert Forum to collaborate with HTA bodies (e.g., NICE, NOMA, HAS), regulators, clinicians, and patient groups. This forum will identify current and emerging RWE needs in HTA and map the landscape to pinpoint barriers and opportunities. 
2. Creating a Living Library of successful and unsuccessful RWE Use Cases (UCs) to analyse best practices and lessons learned, with post-marketing evidence and life-cycle reassessments constituting important sources.
3. Producing practical, evidence-based recommendations and tools (including training) to support RWE generation, interpretation, and use in HTA. These will cover:  
   1. Data suitability at each step of the health product life cycle (e.g., completeness, timeliness). 
   2. Study design and analysis (e.g., quasi-experimental methods). 
   3. Sandbox testing of novel methods in a collaborative environment.
4. Validating guidance and tools through real-world applications in collaboration with other GREG work packages (e.g., WP4 and WP5) via Pilot Testing, refining them based on feedback. 

WP3 will work closely with other GREG work packages to ensure a multi-stakeholder approach: 

• WP1 (Evidence-Based Guidance): Aligning RWE guidance for HTA with broader standards. 

• WP2 (Regulatory Decision-Making): Harmonising RWE requirements for regulatory and HTA purposes. 

• WP4 (Medicines Development) and WP5 (Medical Devices): Pilot-testing RWE tools for medicines and medical devices. 

• WP7 (Patient Engagement): Incorporating patient perspectives into RWE guidance. 

WP3 bridges the gap between RWE and HTA acceptance by providing clear, HTA-tailored guidance and ready-to-use tools, helping HTA bodies confidently integrate RWE into evaluations. By the end of the GREG project, WP3 aims to deliver: 

• Practical guidance for HTA bodies on RWE use, including submission templates and methodological best practices. 

• A Living Library of HTA use cases for researchers, industry, and policymakers. 

• Training programs to build expertise in RWE generation and appraisal. 

• Stronger collaboration between HTA bodies, regulators, and industry to streamline RWE adoption. 

WP3 is led by NICE and Medtronic, with essential contributions from Erasmus University Rotterdam, Edwards Lifesciences, the University of Oxford, the Aragonese Institute of Health Sciences, the Norwegian Medical Products Agency, Pfizer, Novo Nordisk, Boehringer Ingelheim GmbH, Sanofi, Bristol Myers Squibb, GSK, and Mölnlycke Health Care. 

Pall Jonsson, WP3 Lead from NICE: 

“Real-world evidence can have an important role in establishing the value proposition of health interventions. However, Health Technology Assessment agencies need to trust that the evidence can reliably inform our assessments. GREG has an important role in developing this trust by highlighting where and how good quality real-world evidence can be used in our decision making.”

Frederique Debroucker, WP3 Lead from Medtronic: 

“What I find especially important in GREG WP3 is its focus on turning real-world data into practical, HTA-ready evidence. For medical devices, this is critical: value is demonstrated not only at launch, but across real clinical use, adoption, outcomes, and lifecycle reassessment.”