Health Economics and Outcomes Research (HEOR) Services

Transforming Healthcare Decisions with Economic and Outcomes-Based Evidence

In the evolving landscape of healthcare, Health Economics and Outcomes Research (HEOR) plays a pivotal role in supporting evidence-based decision-making, market access, pricing strategies, and reimbursement policies. At Clievi, we provide comprehensive HEOR solutions that integrate economic modeling, real-world evidence (RWE), patient-reported outcomes (PROs), and comparative effectiveness research (CER) to help stakeholders, including pharmaceutical companies, medical device manufacturers, payers, and regulatory agencies, make informed decisions.

Our HEOR Solutions

1. Economic Modeling and Cost-Effectiveness Analysis (CEA)

• Budget Impact Analysis (BIA): Assessing the financial impact of new interventions on healthcare systems using probabilistic sensitivity analysis (PSA) and Monte Carlo simulations.
• Cost-Utility Analysis (CUA): Comparing treatments based on Quality-Adjusted Life Years (QALYs) and Disability-Adjusted Life Years (DALYs) to determine value for money.
• Markov Models & Decision Tree Analysis: Simulating long-term disease progression, treatment pathways, and healthcare costs under uncertainty.
• Dynamic Transmission Modeling: Evaluating the economic impact of infectious disease interventions and vaccine programs.

2. Real-World Evidence (RWE) and Comparative Effectiveness Research (CER)

• Retrospective and Prospective Database Studies: Leveraging Electronic Health Records (EHRs), claims data, and registries to generate RWE.
• Propensity Score Matching (PSM) & Inverse Probability Weighting (IPW): Controlling for confounding in comparative effectiveness analyses.
• Natural Experiments & Instrumental Variable Analysis (IVA): Inferring causal relationships in healthcare interventions.
• Indirect Treatment Comparisons (ITC) & Network Meta-Analysis (NMA): Comparing multiple treatment options when head-to-head clinical trials are unavailable.

3. Patient-Reported Outcomes (PROs) and Quality of Life (QoL) Assessments

• Development & Validation of PRO Instruments: Designing disease-specific and generic health-related quality of life (HRQoL) questionnaires aligned with FDA and EMA regulatory guidelines.
• Real-World PRO Data Integration: Incorporating EQ-5D, SF-36, PROMIS, and disease-specific instruments into clinical studies.
• Multi-Criteria Decision Analysis (MCDA): Weighing clinical, economic, and patient-centered outcomes to optimize healthcare decisions.

4. Health Technology Assessment (HTA) and Reimbursement Strategy

• HTA Submissions: Developing evidence dossiers for NICE (UK), CADTH (Canada), ICER (US), IQWiG (Germany), and PBAC (Australia).
• Reimbursement and Market Access Strategy: Crafting compelling value propositions, payer negotiation strategies, and pricing models.
• Early HTA & Value Frameworks: Conducting early economic evaluations to guide product development and regulatory approvals.
• Threshold Pricing Analysis: Estimating willingness-to-pay (WTP) thresholds to inform optimal price positioning.

5. Value-Based Pricing and Market Access Optimization

• Pricing & Cost-Benefit Analysis: Aligning drug and medical device pricing with global payer expectations and reimbursement landscapes.
• Risk-Sharing Agreements (RSA) and Managed Entry Agreements (MEA): Designing performance-based and financial-based agreements for market access.
• Payer & Stakeholder Engagement: Conducting surveys and advisory boards to understand market dynamics and real-world payer expectations.

6. AI & Machine Learning in HEOR Analytics

• Predictive Analytics for Cost and Outcomes Forecasting: Using machine learning (ML) algorithms to model patient outcomes and healthcare expenditure.
• Natural Language Processing (NLP) for PROs & Literature Reviews: Extracting insights from unstructured text, systematic reviews, and health policy documents.
• AI-Driven Cost-Effectiveness Simulations: Enhancing decision-making through reinforcement learning and Bayesian network models.

Why Choose Clievi for HEOR Services?

• Regulatory Compliance & Global Alignment: Expertise in ISPOR, HTAi, NICE, CADTH, ICER, EMA, and FDA methodologies.
• Robust Statistical & Economic Modeling: Proficiency in Markov models, Bayesian networks, Monte Carlo simulations, and machine learning analytics.
• Multi-Disciplinary Expertise: A dedicated team of health economists, biostatisticians, epidemiologists, and market access consultants.
• Customized, Data-Driven Insights: Tailored solutions for pharmaceutical, biotech, medtech, and healthcare policy organizations.

Get Started with Clievi’s HEOR Solutions

Leverage data-driven economic and outcomes research to enhance your healthcare decision-making. Contact Clievi today to explore our HEOR services for clinical, regulatory, and market access success.