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HEOR, Epidemiology & Market Access

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Overview

Analysis Group has a global footprint of integrated health care research capabilities. Across offices in Europe, North America, and Asia, we leverage our distinguished network of advanced-degree consultants, affiliated experts, and key opinion leaders to carry out an extensive range of work that includes real-world data (RWD) and real-world evidence (RWE) studies, post-marketing safety and effectiveness studies, indirect treatment comparisons, patient-reported outcomes (PROs), systematic literature reviews (SLRs) and meta-analysis, and AI-aided data solutions.


Our clients benefit from our highly qualified teams in London and Paris, which have substantial knowledge of local data, laws, and regulations but are also able to leverage our entire firm’s depth of expertise and integrate it seamlessly with local resources. We have supported the approval, launch, and market acceptance of numerous life sciences innovations in the EU and individual European countries. We have also provided expert input and testimony to regulatory and health technology assessment (HTA) bodies.

Focus Areas

HEOR

Analysis Group has deep experience in health economics and outcomes research topics and methodologies. Our collaborative work with clients has supported pharmaceutical products throughout their life cycles. Our economic work ranges from cost-of-illness and cost-of-adverse-events calculations to sophisticated budget models. 

Our HEOR work includes: 

  • Burden-of-illness studies
  • Comparative effectiveness research
  • PROs and patient preference research
  • Clinical research and study design
  • Personalized medicine
  • Rare disease and orphan drug research

Epidemiology & Biostatistics

Our teams use cutting-edge epidemiological and biostatistical methods to develop empirical evidence and RWE based on a range of data sources. We have extensive experience conducting studies to meet post-marketing safety requirements and to support product life cycles. 

Our experience in this area includes the following: 

  • Post-approval studies generated through our unique access to regulatory-grade data sources, including post-authorization safety and efficacy studies (PASS/PAES) for the European Medicines Agency (EMA) and country-level regulators
  • Post-authorization chart review studies for clinical trial diversity initiatives, including RWD partnerships for efficient identification of underrepresented groups 
  • Innovative RWE generation coupled with scientific and regulatory strategy for product registration, including supplementary indications and approvals 
  • Regular attendance at sponsor meetings with regulators supporting regulatory strategy and responses
  • Addressing public health concerns from regulators, including post-marketing risk mitigation programs and responses to product withdrawals and safety signals arising from clinical trials

Market Access & Commercial Strategy

Analysis Group routinely conducts research to support payer and HTA submissions globally, including in Europe, with work that is instrumental to regulatory considerations by relevant agencies. Our professionals understand reimbursement issues and stakeholder requirements in markets across the globe. We assist our clients in establishing strategies to demonstrate value, gain market access, and sustain success at the product, franchise, and enterprise levels in both regional and national markets. 

We draw on the full breadth of our economic expertise in supporting HTA submissions, using analytic methods such as cost-effectiveness analyses (CEAs), cost-minimization analyses (CMAs), and budget impact analyses (BIAs). Examples of our work in this area include:  

  • Proposing innovative model structures that fully reflect the benefits of client products
  • Leveraging different data sources to identify the most suitable model inputs 
  • Applying different methods to estimate utilities (e.g., utilities derived based on trial data or mapping)
  • Conducting CEAs and BIAs that can be adapted to the requirements of different countries
  • Generating economic tools based on CEAs or BIAs for payer communications

Modeling & Analytics

Analysis Group brings a full complement of skills in modeling, generative AI, and software engineering to a wide range of assignments in health care consulting. Frequently collaborating with members of the firm’s Data Science practice, we go beyond traditional analytics to extract complex patterns and insights from data. Our teams usecutting-edge machine learning techniques to generate powerful descriptive, prescriptive, and predictive models embedded directly into software and platforms.  

We have successfully developed AI algorithms to support a wide range of client needs, including: 

  • Applying machine learning to identify high-risk patient populations and predict treatment-resistant populations
  • Facilitating SLRs
  • Facilitating chart review and medical data extraction in multiple countries and languages
  • Identifying data sources and relevant PRO instruments and regulatory information

Cases & Publications

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First-Line Nivolumab Plus Relatlimab Versus Nivolumab Plus Ipilimumab in Advanced Melanoma: An Indirect Treatment Comparison Using RELATIVITY-047 and CheckMate 067 Trial Data

Journal of Clinical Oncology, 2024

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Associated People

Yiqiao Xin
Yiqiao Xin

Transfusion-related cost offsets and time burden in patients with myelofibrosis on momelotinib vs. danazol from MOMENTUM

Future Oncology, 2024

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Associated People

Mirko Fillbrunn
Mirko Fillbrunn

Functional trajectories before and after loss of ambulation in Duchenne muscular dystrophy and implications for clinical trials

PLOS One, 2024

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Associated People

Mirko Fillbrunn
Mirko Fillbrunn

Association between event-free survival and overall survival in early-stage triple-negative breast cancer

Future Oncology, 2023

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Benefits of Autoantibody Enrichment in Early Rheumatoid arthritis: Analysis of Efficacy Outcomes in Four Pooled Abatacept Trials

Rheumatology and Therapy, 2023

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Associated People

Mirko Fillbrunn
Mirko Fillbrunn

Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial

Open Forum Infectious Diseases, 2023

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Associated People

Mirko Fillbrunn
Mirko Fillbrunn

Associated People

Marianne Cunnington

Marianne Cunnington

Vice President

Dr. Cunnington has over 20 years of experience as a pharmaceutical industry epidemiologist. She specializes in the generation of real-world evidence (RWE) in support of the development and life cycle management of pharmaceutical and vaccine products, with a particular focus on regulatory risk management strategies and product benefit-risk assessments. Dr. Cunnington’s research expertise includes the design, negotiation, and execution of real-world components of risk management plans for new product submission to regulators in the US, UK, EU, Japan, and South Korea, including studies of post-approval safety in the EU; post-marketing requirements and commitments in the US; and pregnancy registries. Prior to joining Analysis Group, she served in several senior epidemiology positions at pharmaceutical companies, including as the chair of GSK’s peer review forum for all pharmaceutical RWE projects; as a member of GSK’s Global Safety Board; as head of epidemiology at Novartis Vaccines; and as a managing board member of Innovative Medicines’ public-private partnership initiative to build an integrated European real-world data (RWD) network to monitor medication safety in pregnancy.

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Weiguang Xue

Weiguang Xue

Vice President

Mr. Xue consults on cases involving health economics and outcomes research (HEOR). He specializes in using health economics analyses to inform product launch strategies, as well as decision making in early-stage clinical development. Mr. Xue has extensive experience in the economic evaluation of health technologies across multiple therapeutic areas, including oncology, infectious diseases, autoimmune diseases, central nervous system diseases, ophthalmology, and gynecology. His work includes cost-effectiveness analysis, budget impact analysis, systematic literature review, indirect treatment comparison, evaluation of health care resource use, global value dossier, and market access strategy. He has led successful health technology assessment (HTA) submissions to the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Medicines Strategy Group (AWMSG). He has also developed global economic models across multiple indications and led country rollouts supporting market access in Europe, North America, and Asia.

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Mirko Fillbrunn

Mirko Fillbrunn

Manager

Dr. Fillbrunn specializes in health economics and outcomes research (HEOR), biostatistics, and epidemiology. His expertise includes strategically developing and guiding the implementation of analytics throughout the entire product life cycle, including analyses of clinical trials and real-world health care data such as insurance claims, electronic health records, medical charts, and surveys. Dr. Fillbrunn’s contributions have informed clinical regulators and health care payers in both the US and global markets. His research has been published in several peer-reviewed journals and presented at clinical and health economic conferences. Prior to joining Analysis Group, Dr. Fillbrunn was a postdoctoral fellow at Harvard Medical School and Massachusetts General Hospital.

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Yiqiao Xin

Yiqiao Xin

Manager

Dr. Xin specializes in health economics and outcomes research (HEOR). She provides expertise in decision-analytic modeling methods for health technology appraisals (HTA) and has led the design and implementation of cost-effectiveness and budget impact models in multiple countries. Dr. Xin’s work has also involved evidence synthesis such as network meta-analyses and matching-adjusted indirect comparisons, indirect treatment comparisons with individual-level patient data, clinical trial analyses, survey development, and patient-reported outcome (PRO) studies. Her work spans a broad range of disease areas, including oncology, immunology, dermatology, cardiovascular diseases, diabetes, and neurology. Prior to joining Analysis Group, Dr. Xin was a research associate at an academic institution, where she focused on trial- and model-based economic evaluations and PROs, as well as providing expertise on complex literature reviews and developing R Shiny applications for conducting network meta-analysis. Her work has been presented at clinical and economic research conferences and published in various peer-reviewed journals.

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News & Events

  • Vice President Marianne Cunnington to Speak at Inaugural European Summit for Women Leaders in Life Sciences Law
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  • 2023 ASCO Annual Meeting to Feature New Outcomes Research from Analysis Group
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  • Analysis Group Researchers to Present at ISPE 2024
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  • Analysis Group to Present New Outcomes Research at 2024 ASCO Annual Meeting
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  • Analysis Group Health Care Consultants to Present at ICPE 2023
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  • Analysis Group Researchers Support FDA BLA Approval of a Regenerative Medicine Product Using Novel External Benchmarking Statistical Method
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