HEORStrategies consultants work with clients to develop evidence generation strategies, build economic models, quantify healthcare costs and resource use, and support regulatory submissions in the US, UK, and EU.
- Evidence strategy: As part of our support for our clients’ commercialization needs, we provide evidence strategy consulting, working collaboratively with our clients to develop and implement evidence generation and communication strategies that demonstrate therapy value:
- Review existing clinical and economic evidence that supports clients’ commercialization needs
- Identify gaps in evidence that need to be filled to demonstrate therapy value
- Recommend evidence generation activities to ensure that our clients have the evidence needed to support payer requirements
- Test value propositions with payers and other stakeholders
- Communicate findings through scientific publications and white papers.
- Economic models: HEORStrategies develops economic models to inform HEOR needs for evidence, pricing and reimbursement, and health technology assessments. Our models use literature and “real-world” inputs to demonstrate therapy value and its underlying drivers:
- HEORStrategies quantifies the impact of our clients’ products on payer and other stakeholder budgets
- HEORStrategies develops cost-effectiveness models that quantify the value of our clients’ therapies, showing the costs per outcome
- We work with our clients to identify model structure, outcomes, and inputs, ensuring that our economic models address the needs of decision makers, including payers, policy makers, and other stakeholders.
- Healthcare costs and resource use: HEORStrategies works with clients to design and implement studies of healthcare resource use (HRU) and costs that provide evidence of the burden of illness for payers and other stakeholders. Analyses of HRU and costs include:
- Quantify the costs and HRU associated with different diseases and different disease states
- HEORStrategies’ experience includes expertise with quantifying HRU and costs in rare, ultra-rare, and neglected diseases
- Our experience also includes quantifying HRU and costs associated with different disease stages.
- Evaluate the impact of healthcare policies on patient access to care, use of care, costs, and health outcomes.
- Quantify the costs and HRU associated with different diseases and different disease states
- Regulatory support: HEORStrategies provides regulatory support for Food and Drug Administration (FDA) and Health Technology Assessment (HTA) submissions:
- HEORStrategies works collaboratively with customers to generate estimates of incidence and prevalence that are required for HTA submissions (EU) and orphan drug designation submissions to the FDA (US) and the European Medicines Agency (EMA)
- HEORStrategies conducts post-hoc analyses of clinical trial data to address regulatory agency requests and requirements
- HEORStrategies has expertise in regulatory requirements that enable us to provide efficient and robust regulatory support.