Pre-Launch (Clinical R&D)

During the pre-clinical phase, the primary goal is to understand the readiness of the clinical trial data for regulatory approval. However, in APAC, this may not be the priority concern for the medical affairs, market access or commercial teams. The key questions they would like to understand are: ‘acceptability of clinical trial data by the APAC regulators’, ‘APAC patient population representation in the clinical trial’, ‘need for local evidence to support clinical trial for local regulatory approvals’, ‘unmet needs that the clinical trial may not address’, and so on.

An APAC-specific IEG strategy at the pre-launch stage will translate the global value proposition into an APAC relevant narrative. Global clinical trials, by their nature, may not capture the diversity of patient demographics, disease progression and co-morbidities observed across APAC countries. A tailored IEG strategy addresses these gaps by defining and identifying studies on the natural history of the disease, local treatment patterns and the patient journey. This evidence is crucial for building a value story that resonates with local regulators, payers, HCPs and patients. An IEG strategy proactively addresses these concerns and provides compelling evidence to support regulatory and reimbursement/access submissions.

At IQVIA, we focus on helping our medical affairs teams to address these questions using in-depth situation and analogue analysis at a market, indication and asset class level. Our expertise in local RWE sources allows us to prioritize key evidence gaps and identify the right evidence generation strategy before launch.

Peri-Launch (Regulatory and Market Access)

When the asset moves to the peri-launch phase, the objective shifts towards gaining regulatory approval and market access in key markets. At this stage, our medical affairs team is concerned with competitive market, place in therapy, identifying the economic burden of disease and the impact of asset on the current burden of disease, and identifying the right real-world evidence to support the reimbursement or access in APAC markets. This also means identifying the right managed entry agreements or early/expanded access programs applicable to the assets.

An APAC IEG strategy helps in providing timely evidence to overcome regulatory and market access hurdles. An IEG strategy not only helps in prioritizing evidence gaps for the specific market and region, but it also supports optimizing real-world evidence studies that will generate data for comparative effectiveness and local health economic evaluations. Such evidence is helpful in building a value proposition for the asset in multiple health technology assessments in APAC and helps in securing a favourable market position once product is launched.

At IQVIA, we prioritize evidence gaps in market and region with an astute objective of forecasting and designing feasible real-world studies and/or medical affairs tactical plans. Our in-depth knowledge of regulatory and HTA requirements for RWE studies across APAC ensures that the evidence generation roadmaps are practical, aligned with global vision and support local decisions.

Post-Launch (Lifecycle Optimization)

Once the asset launches, the objective of the medical affairs shifts to maximizing drug adoption and demonstrating the long-term value of the asset to the HCPs and patients. At this stage, our medical affairs teams generate evidence to support the continued use of the asset and identify the best channels to communicate the evidence supporting its value proposition of the asset to patients and HCPs.

An APAC IEG strategy will be essential in identifying studies that can generate a continuous stream of evidence demonstrating the asset’s value in a real-world setting. This is crucial for license expansion, indication extensions and driving product adoption. An IEG strategy addresses the challenge of evidence dissemination by moving beyond traditional communication methods and adopting an omnichannel strategy. This ensures that the right evidence reaches the right stakeholders—from specialists in major cities to general clinics in rural areas—through their preferred channels.

At IQVIA, in addition to developing a holistic IEG strategy to identify evidence gaps and design RWE study strategies, we translate outcomes and value stories into comprehensive evidence dissemination approaches for APAC. Our experience and data insights into local HCP and channel dynamics allow us to help teams adapt content for different HCP personas and implement impact assessment frameworks to measure the ROI of various channels.

End in Mind

When an APAC-specific IEG strategy is rooted in a strong purpose and value-driven process, it is not an optional add-on but a fundamental pillar for a product’s success. From early-stage planning to post-launch optimization, a tailored IEG strategy provides answers to the most critical questions faced by medical affairs and market access teams. By anticipating local needs and proactively planning and generating relevant evidence, pharma companies can accelerate patient access and demonstrate the true value of their assets in the region.

As your partner, we are uniquely positioned to help you address these "why" questions at every stage of the product lifecycle. Let us know which phase you're in, and we can start building a roadmap that ensures your asset's success in APAC.

For more information on evidence planning and medical affairs solutions, contact us.