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 
• 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 planning

By integrating commercial insights throughout the clinical and regulatory phases, our consultants empower you to develop a robust market access strategy. Engagement with HTAs, payers, clinicians, and technical experts early on means we gain a deep understanding of their expectations, price sensitivities, and budgetary constraints. 

Collaborating with global teams, we devise comprehensive strategies and tools that ensure a holistic and consistent approach. Additionally, we tailor local access strategies to align with specific markets, regions, and countries.

Value communications

Create positive perceptions with scientific, medical, payer and other healthcare stakeholders to shape understanding of your product and the unmet need it addresses. This includes global/core value dossiers, AMCP dossiers, publications, medical writing, value platform development, and the development of global value dossiers.

Health economics and outcome research (HEOR)

HEOR is foundational to building an evidence-based case for the substantiation and differentiation of product value in alignment with HTA guidelines.

Evidence evaluation

Align evidence generation with market access strategy to address the needs of multiple stakeholders. This includes evidence evaluation, mixed treatment comparisons, literature reviews, systematic reviews, evidence strategy, competitive evidence analysis, network meta-analysis, and feasibility analysis for economic modeling.

Health economic modeling

Substantiate the value proposition and value differentiator of your product using real-world and clinical trial data. While there are many types of models, the most prevalent at this stage are cost-utility, budget impact, and cost efficiency.

Patient-reported outcomes (PROs)

Utilize strategic and scientific guidance on the design, implementation, and dissemination of patient-centric data generation throughout the product development lifecycle, with end-to-end reporting. Ensure the strategic application of PRO data as proof of outcomes and value and to fill evidence gaps.

Real-world evidence (RWE)

Assure payers that your clinical results are reflective of what will be evidenced in real-world 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.

Real-world data services

Generate fit-for-purpose real-world data that strategically supports scientific and commercial analysis, with our cross-functional teams, established processes, and cloud-based technology platform.

Advanced analytics

We focus on deploying innovative analytical methods grounded in the foundations of statistics and econometrics to generate fit-for-purpose health economic and real-world evidence.

Indirect treatment comparison/meta-analysis

Allow for the estimation of the relative safety and efficacy of interventions through indirect treatment comparisons (ITCs) and network meta-analyses of therapies Combining the results of multiple trials, a network of evidence may be empirically assessed to identify the best treatment(s). Our advanced methods, simulated treatment comparisons, and match-adjusted indirect comparisons provide tailored options to address your data challenges, including single-arm trials and incomplete networks.

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.

A team you can trust

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