Giulia: Patient experience data reduces uncertainty, strengthens evidence, accelerates launch timelines, and improves pricing and reimbursement outcomes.

• 21% higher likelihood of drug launch when patient-centric data is used¹
• 87% of drugs using patient insights reached launch, compared to 68% without²
• Early patient involvement in study design can accelerate launch by 2.5 years, generating a return of 500x the initial investment²
• Higher probability of achieving full coverage and favorable pricing due to better alignment with payer requirements³
• Patient experience data demonstrates both clinical and economic value, supporting payer negotiations and value-based healthcare models⁴

Giulia: Payers are increasingly open to patient-informed dossiers when the insights are rigorous, transparent, and clearly tied to payer-relevant outcomes. Market access teams that use well-documented patient evidence can strengthen their value story and fill evidence gaps.

Rare diseases and neurological, oncologic, and chronic symptomatic diseases are the areas where patient experience data most influences payer perspectives. When these insights are translated into measurable outcomes, such as adherence patterns, daily functioning, caregiver burden, or impact on resource use, they provide payers with a clearer understanding of real-world value and can meaningfully influence reimbursement decisions.

Giulia: Patient experience data must follow appropriate framework standards for both qualitative and quantitative evidence collection.

Several established frameworks provide guidance on how to generate reliable data:

• IMI PREFER Project (EU): provides evidence-based recommendations for designing patient preference studies that clarify benefit–risk trade-offs and patient-relevant endpoints
• FDA’s Patient-Focused Drug Development Guidance Series: defines how to collect, measure, and submit patient experience data in regulatory dossiers
• ISPOR/ISPE Patient Engagement Task Forces: works toward consensus on best practices for qualitative data synthesis and sampling
• EMA Reflection Paper: defines expectations for using patient experience data in regulatory and HTA evaluations
• The Health Economics Methods Advisory Group: recently held a public consultation on its first draft report, “Defining Appropriate Benefits for Economic Evaluation of Health Care Technologies”

Giulia: Patient engagement activities generate both qualitative and quantitative data that, when collected and analyzed using robust quality standards, provide reliable evidence for regulatory and HTA decision-making.

While patient insights are not yet consistently captured as a dedicated section in regulatory dossiers, they can be embedded across FDA, EMA, and value dossiers to strengthen the relevance of clinical and economic evidence. Patient experience data captures what truly matters to patients and how they experience benefits and burdens, helping refine endpoints and contextualize assumptions used in quality-adjusted life years, incremental cost-effectiveness ratios and budget impact models.

Our Patient Access and Evidence Solutions team has direct patient engagement and advocacy expertise and is experienced in gathering valuable patient-informed insights that support our clients’ evidence packages and meet payer and regulator needs. This cross-functional team can help shape your access and value strategy, present a compelling, patient-driven story about the burden of illness and unmet needs, and demonstrate the true value of treatments through improved quality of life for patients.