In our Integrated Evidence Generation blog series, we have embarked on a journey to revisit the basics and uncover the frameworks that enable transformational use of evidence. This 5-part series explores what IEG is, who the stakeholders are, why it is required, when it should be developed, and how it is achieved.

In the “Introduction to IEG Series”, we delved into the APAC regional and global environments that are shaping the need for a well-adapted IEG approach. This first ‘What’ article discusses the importance of having an IEG and how it supports regulatory and reimbursement in APAC.

What is Integrated Evidence Generation?

Integrated Evidence Generation (IEG) is a cross-functional, strategic approach that unifies evidence generation activities across geographies and throughout the product lifecycle. Unlike siloed or ad hoc evidence generation, IEG planning ensures that the data (or evidence) needs for payers, providers, regulators and patients are anticipated and met efficiently, maximizing both internal efficiency and external impact.

In this context, evidence is the systematic identification, organization, and prioritization of data and insights necessary to support a product or asset throughout its lifecycle.

IEG Across the Product Lifecycle

IEG serves different purposes and delivers varying impacts at each phase of the product lifecycle. It supports medical affairs and market access as follows:

Pre-launch (Phase 3 and before)

• Purpose: Overcoming barriers to evidence generation from clinical trials by increasing efficiency and/or reducing cost.
• Types of evidence (non-exhaustive examples): Disease landscaping by characterising unmet needs, treatment patterns and outcomes; Natural history of disease for rare diseases; Endpoint selection and/or validation such as patient reported outcomes (PRO); External/historical control arms.
• Impact/Value: Improving trial design and interpretation; Identifying heterogeneity in patient outcomes; Refining endpoints for clinical performance.

Peri-launch (Launch minus 36 months)

• Purpose: Preparing fit-for-purpose evidence for regulatory decision-making and improving speed to market.
• Types of evidence (non-exhaustive examples): Burden of disease, patient characteristics and treatment outcomes; Disease/patient/product registries; Quality of life and economic evaluations; KOL identification and prescribing behaviour analysis; Health system implementation science.
• Impact/Value: Readiness for regulatory submissions and HTA/reimbursement; Holistic KOL engagement; Scientific communications and medical education.

Post-launch/Authorization

• Purpose: Addressing barriers to patient access and commercial viability due to product performance, field force, healthcare professionals, and/or health system related factors.
• Types of evidence (non-exhaustive examples): Long-term safety and effectiveness; Comparative effectiveness; Treatment preferences and sequencing; Patient adherence/treatment satisfaction; Indication expansion/modification; MSL effectiveness and impact assessment; Health system quality improvement studies.
• Impact/Value: Improved patient access, product value messaging, treatment guidelines, clinical performance and adoption.

The Art of Tailored IEG Planning

Tailoring an IEG plan that cross-stiches the right choices of evidence, research questions, data variables, study designs and methodologies is an art form of its own. IQVIA’s Integrated Evidence Generation framework acknowledges this intricacy and is designed to demonstrate value across all stakeholders within the healthcare continuum.