For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
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.
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:
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.
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.
HEOR is foundational to building an evidence-based case for the substantiation and differentiation of product value in alignment with HTA guidelines.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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: