Real-World Evidence, Market Access Strategy and Planning

Alleviate payer uncertainty and maximize ROI through real-world evidence (RWE)

Given payers’ aversion to uncertainty, risk reduction is the key to achieving commercial success. Strategically showcase the true value of your drug in the real world with a focused approach at late and post-launch phases. Our dedicated teams provide comprehensive support to ensure the value of your years-long investment in clinical data, both in terms of time and resources, translates into optimal market access, enhanced ROI, and, most importantly, improved patient outcomes. By aligning our expertise with outcomes that truly matter, we help you address payer concerns and establish a foundation for long-term success.

RWE and late phase research

Parexel advises on RWE strategies in parallel with your clinical development program, to ensure payers your clinical results also generate data for reimbursement strategies.

Our RWE experts work with clients to explore the impact of a therapy and/or disease in a real-world setting, generating data that will support your value proposition to regulators, payers, physicians, and patients. We understand the need for interconnected, patient-specific, longitudinal data to track outcomes over time and partner with companies of all sizes to solve this challenge, including use of hybrid prospective/retrospective RWE studies.

Our solutions include:

• Real-world data services: Our cross-functional teams, established processes, and cloud-based technology platform generate fit-for-purpose, real-world data that strategically supports scientific or commercial analysis
• Observational / non-interventional studies: (e.g., long-term effectiveness and safety)
• Late-stage clinical trials: We offer multiple options for late-stage programs, including pragmatic trials or interventional trials with experience in peri/post-approval research to back it up

We bring:

• More than 20 years of experience in the design, implementation, and analysis of real-world studies across the globe
• A multidisciplinary approach to building RWE strategies that meets the needs of patient, payer, regulatory, and other key stakeholders
• Data search, storage, integration, and analytics capabilities, supported by an extensive and proprietary technology platform and approach
• Depth of experience in assessing evidence gaps and in evidence-generation planning
• Broad expertise in strategic, operational, clinical development, regulatory, and market access consulting, successfully conducting real-world studies of all types

Market access strategy and delivery

A robust market access strategy early in development is critical; but during clinical development phase, we know for many companies the primary focus is on regulatory approval. As payers are crucial in ensuring your medicines can treat patients, we recommend developing access strategy in parallel to the regulatory process. Our goal is to ensure that effective treatments reach patients by facilitating both regulatory approval and payer acceptance.

Building on scientific insights, payer acceptance relies on compelling scientific evidence showcasing unmet need or value. We generate insights to establish and address unmet needs, and with these insights we build two deliverables:

• Expertly crafted global access strategies
• Compelling evidence cases with data

Maximizing ROI through expansion: Once your treatment is approved and reimbursed in your target geography, we can explore additional markets for the asset to maximize ROI. By identifying new opportunities and leveraging our global expertise, we help you unlock the full potential of your product and expand its global reach.

Additionally, the comprehensive suite of services we provide includes:

Market access solutions

• Market access strategy and delivery: Craft comprehensive plans to identify target markets, assess market potential and overcome access barriers, enabling successful product launches
• Value proposition development: Define and communicate the unique value of your drug to key stakeholders, demonstrating its clinical and economic advantages over existing treatments
• Pricing and reimbursement strategy: Develop tailored pricing strategies and reimbursement models that align with local market dynamics and maximize profitability
• HTA support: Provide the necessary data and analysis to navigate the many HTA processes and secure favorable recommendations for reimbursement.
• Payer engagement: Build strong relationships with payers to understand their needs and expectations

Health economics and outcomes research (HEOR)

• HEOR strategy and delivery: Generate robust evidence on the value and outcomes of your drug to demonstrate its efficacy and cost-effectiveness to payers
• Evidence evaluation: Conduct comprehensive assessments of clinical data and evidence to support payer negotiations and health technology assessments
• Health economic modelling: Utilize advanced economic modeling techniques to quantify the economic impact and value proposition of your drug, enabling informed pricing and reimbursement strategies
• Patient-reported outcomes (PROs): Incorporate patient perspectives and experiences into the assessment of treatment outcomes, leveraging PRO data to demonstrate the real-world impact and patient-centered benefits of your drug

Advanced analytics

• Advanced parametric methods: Apply advanced parametric methods such as mixture cure fraction models and Bayesian multi-parameter evidence synthesis to successfully engage earlier with HTAs using relatively immature data with shorter patient follow-up
• Predictive analytics, machine learning, and artificial intelligence: Harness advances, including natural language processing (NLP), machine learning (ML), and artificial intelligence (AI) with predictive analytics to access critical patient insights from big data, whether gathered from clinical trials, literature, or real-world sources.
• Data visualization and programming support: Develop digital solutions with data visualization tools/apps and platforms to facilitate multi-stakeholder decision-making. Our team routinely develops indication-agnostic tools and provides bespoke programming support to staff your internal solutions

Think globally          

Navigating the needs of multiple global commercial stakeholders, with varying systems and processes to determine value and access is complex. In a rapidly evolving industry, key market dynamics demand attention:

• United States: The Inflation Reduction Act (IRA) has changed the drug market, emphasizing cost containment and sharpening the focus on ROI​​​​​​
  • Optimize engagement with the Institute for Clinical and Economic Review (ICER) 
• Europe: Health technology assessments (HTAs), not only shape European policy but also influence the US, setting rigorous standards for value demonstration.  Products must showcase not only clinical value but also economic worth and competitive differentiation
  • Prepare for EU’s Joint Clinical Assessment (JCA) scenarios 
• APAC: Navigating the Asian market requires adaptability. While Japan commits to HTAs, China’s regionalized approach means varying assessment requirements

Your trusted experts in drug commercialization

Many on our team have tenure with regulatory agencies, payers, sponsors, HTA decision-making bodies, and industry-leading organizations such as IFPA and EFPI – as well as advanced academic degrees in science, economics, health policy, and business. As a result, you benefit from academic rigor, as well as a real-world point of view relevant to reimbursement when developing and adapting your product’s evidentiary value story through the research lifecycle. We offer:

• Fully integrated solutions involving regulatory, access, RWE, medical communications, PROs, and advanced analytics teams with a direct line to our clinical colleagues
• More than 130 global evidence and access staff