Health Economics & Outcomes Research (HEOR)

Building the Evidence Package

Parexel has industry-leading expertise in delivering every component of the evidence package. In short, our work in HEOR aims to answer the following questions:

  • What is the value of this product – to patients, payers, physicians, caregivers and society?
  • What are the key differentiating factors that drive the value proposition against the alternative treatment options? Compared to what? What are the alternatives?
  • Which unmet needs does the product address?

Market access strategy entails anticipating how payers will evaluate a product and developing support for that evaluation via a robust and comprehensive HEOR plan. The essential elements of HEOR encompass the following:
 

Health Economic Modeling

With notable Health Economic modeling capabilities, Parexel’s HEOR team develops data-driven evidence substantiating the value proposition and value differentiator claims of a given product. To further support market access strategy, Parexel is pioneering the trend of creating web-based data visualization solutions to drive evidence-generation decision-making with targeted product profiles and scenario testing. These innovative solutions complement our traditional economic modeling solutions.

Evaluations by Health Technology Assessment (HTA) bodies involve many interrelated factors involving enormous volumes of data, which must be scrupulously accurate and cogently presented. These factors include, for example:

  • What is the intended outcome? Quality of life? Extended life years?
  • Is the proposed product intended to replace another product?
  • What is the budget impact?
  • How will this disrupt market dynamics?
  • Will there an extra savings or an extra cost?
  • How does the treatment compare in terms of efficacy and safety outcomes?

Essentially, Health Economic Modeling focuses on generating evidence to address HTA and payer requirements. To underscore the asset’s value proposition, our work entails synthesizing data and translating it into understandable models for HTA submissions. This work involves:

  • Early-stage economic models and cross-indication platforms
  • Global cost-effectiveness models and country-specific model adaptations
  • Budget impact models
  • Social value and policy models
  • ICER mirror models and reviews

Critical to our expertise at Parexel is our extensive experience with various payers and HTA markets and our ability to adapt models as needed, with the requisite team to manage the volume of effort. For instance, this level of agility might be required for building a tool to support access in one market, then rolling it out to 10 more, each with different requirements. It might involve filling in evidence gaps with real-world evidence (RWE), which is becoming increasingly important as biomedical focus shifts to rare disease. Oncology, an area in which we excel, presents its own set of challenges.

Our specialized team offers flexibility and the breadth of expertise to adjust to the changing requirements of each jurisdiction to ensure timely and robust adaptation of HEOR tools. Each solution is tailored and fit-for-purpose to support access strategies and the value story for respective markets.
 

Evidence Review

Integral to the HEOR discipline is HTA-compliant systematic literature reviews of a vast array of data, encompassing existing clinical trial outcomes, impact of treatments on quality of life, product comparators, economic evidence and more. Critical to HTA submissions, these reviews are also used by medical affairs teams throughout the drug development lifecycle to support decision-making, from determining unmet needs to trial design, launch planning and post-launch. Further, these systematic literature reviews serve to augment clinical trial data in the assessment of the relative safety and efficacy of drugs.

Our team, fully dedicated to this specialized discipline, performs both qualitative and quantitative reviews. Tapping into multiple registries, we concentrate on identifying the data required for reimbursement and eliminating risk of bias. Our focus is on collecting and synthesizing all relevant evidence, working closely with our colleagues on the health economics modeling and advanced analytics teams. This side-by-side collaboration on a unified body of evidence supports preparation of a strong value dossier and ultimately helps speed time to market.
 

Advanced Analytics

Life sciences companies today can leverage an extraordinary array of technologies to support their work in evaluating the potential of their products and bringing them to market. Advances including natural language processing (NLP), machine learning (ML), artificial intelligence (AI), data visualizations and predictive modeling are critical to successful market access. The key is the expertise required to obtain critical patient insights from big data, whether arising from clinical trials or gathered from literature or real-world sources.

In developing a fit-for-purpose solution, our team develops a resilient data and analytics strategy imbued with data-driven critical thinking to support your goals. Taking a data-agnostic approach, Parexel combines unique data access, linking capability and advanced analytics toward that end. We work in partnership with a large network of vendors, linking to the data sources most relevant for the project and creating a common pool of data to be mined for critical patient insights.

Advanced analytics tools can, for example:

  • Identify gaps in trial data sets to address nuances
  • Support evidence of an asset’s curative properties
  • Inform cost-effectiveness modeling, budget impact and survival analysis
  • Eliminate bias risk
  • Aid in-site selection and setting optimal public health policies

Parexel has a wealth of experience in developing and applying complex and innovative approaches to support a robust assessment. With offices in key markets, we can identify the best databases at the local level, as well as the stakeholders and KOLs that can help us identify challenges and test assumptions.
 

Clinical Outcomes Assessments

The science of clinical outcomes assessments (COA) is intrinsic to drug development today, even as standards for use of this methodology are continually evolving. As an active participant in leading-edge industry organizations, Parexel has extensive expertise in COA. We offer strategic and scientific guidance on design, implementation and dissemination of patient-centric projects throughout the product development lifecycle, including end-to-end reporting.

Design of survey instruments entails interviewing patients to ensure that they understand how to participate, testing the integrity of the questions and evaluating the protocol. We are experts in patient-reported outcomes (PROs), including PRO licensing, translation and migration to electronic PRO (ePRO).

One of the most challenging areas in COA is in rare disease, especially because so many trials involve young children. This requires knowledge and skills beyond technical and clinical COA capabilities. At Parexel, our team has exceptional strength in pediatrics to apply to developing and validating effective COA instruments for caregivers and clinicians. Our multilingual team works with patients of all ages, all over the globe, helping our customers design COA programs that take into consideration country-specific sensitivities and nuances.

We are always available for a conversation.

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