HEOR, Epidemiology & Market Access

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 lifecycles. 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
• Patient-reported outcomes (PROs) and patient preference research
• Clinical research and study design
• Personalized medicine
• Rare disease and orphan drug research

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 lifecycles. 

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

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

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 use cutting-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 systematic literature reviews (SLRs)
• Facilitating chart review and medical data extraction in multiple countries and languages
• Identifying data sources and relevant PRO instruments and regulatory information