Market Access Strategy and Delivery

Integrated development planning and risk management starts here – with early, smart investments yielding lifecycle payoffs

Pivotal evidence and access work streams are often launched with the start Phase III clinical trials. But by starting earlier, you can build the complete evidence package that payers require, from the outset.

At Parexel, we’re perfectly positioned with fully integrated regulatory, access, HEOR, RWE, and patient-reported outcomes (PRO) services to collect the right evidence, early in development. Starting early is key, and as a result, you benefit from a real-world point of view relevant to reimbursement while developing and adapting your product’s evidence-driven value story throughout the research lifecycle.

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 
  • AI solutions to meet JCA requirements
• APAC: Navigating the Asian market requires adaptability. While Japan commits to HTAs, China’s regionalized approach means varying assessment requirements

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 models: 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

Real-world evidence (RWE) and late-phase research

We advise on RWE strategies (including registry studies), alongside your clinical development program, to reassure payers that your clinical results are reflective of what will be evidenced in real-world clinical practice.

Our RWE experts work with you 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

Provide valuable insights into the causal association between a treatment (e.g., a drug, device, or procedure) and a particular event or outcome (e.g., long-term effectiveness and safety).

Late-stage clinical trials

We provide multiple options for late-stage programs, including pragmatic trials or interventional trials with experience in peri/post-approval research to back it up.

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