Health Technology Assessment (HTA) Services

Comprehensive HTA Solutions for Evidence-Based Healthcare Decision-Making

In an era where cost-effectiveness, clinical effectiveness, and real-world impact are crucial for healthcare innovations, Health Technology Assessment (HTA) plays a key role in informing reimbursement, pricing, and policy decisions. At Clievi, we provide end-to-end HTA services, integrating systematic reviews, economic modeling, real-world evidence (RWE), and stakeholder engagement to support pharmaceutical companies, medical device manufacturers, payers, and policymakers in making informed decisions.

Our HTA Solutions

1. HTA Submissions and Dossier Development

• Global HTA Alignment: Expertise in preparing submissions for NICE (UK), CADTH (Canada), ICER (US), PBAC (Australia), HAS (France), IQWiG (Germany), and other global HTA bodies.
• Value Dossier Preparation: Developing clinical, economic, and epidemiological evidence packages that align with payer expectations.
• Comparative Effectiveness Analysis (CEA): Evaluating interventions using head-to-head clinical trials, indirect treatment comparisons (ITCs), and network meta-analyses (NMAs).
• Real-World Evidence (RWE) Integration: Incorporating electronic health records (EHRs), claims data, registries, and observational studies to demonstrate real-world impact.

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

• Markov Models & Decision Tree Analysis: Simulating long-term disease progression, treatment pathways, and cost implications.
• Budget Impact Analysis (BIA): Assessing financial implications for healthcare systems using probabilistic sensitivity analysis (PSA) and Monte Carlo simulations.
• Cost-Utility Analysis (CUA): Quantifying Quality-Adjusted Life Years (QALYs) and Disability-Adjusted Life Years (DALYs) to measure intervention benefits.
• Threshold Pricing & Affordability Assessments: Estimating willingness-to-pay (WTP) thresholds for optimal price positioning.

3. Systematic Reviews and Evidence Synthesis

• Comprehensive Literature Reviews: Conducting systematic literature reviews (SLRs) and meta-analyses to assess clinical and economic evidence.
• PICO-Based Research Strategy: Using Population, Intervention, Comparison, and Outcomes (PICO) frameworks to guide evidence collection.
• PRISMA-Compliant Reporting: Ensuring transparency and replicability in systematic reviews for HTA submissions.
• GRADE Framework for Evidence Ranking: Applying Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to classify evidence strength.

4. Health Outcomes and Patient-Centered Assessments

• Patient-Reported Outcomes (PROs): Incorporating EQ-5D, SF-36, PROMIS, and disease-specific HRQoL instruments into HTA evaluations.
• Multi-Criteria Decision Analysis (MCDA): Weighing clinical, economic, and patient-centric outcomes for decision-making.
• Real-World Treatment Effectiveness: Conducting retrospective database studies, observational cohort analyses, and natural experiments.

5. Pricing, Reimbursement, and Market Access Strategy

• Global Pricing & Reimbursement Intelligence: Developing country-specific pricing and reimbursement strategies to maximize market access.
• Risk-Sharing and Managed Entry Agreements (MEA): Designing performance-based and financial-based agreements for reimbursement negotiations.
• Stakeholder and Payer Engagement: Conducting delphi panels, advisory boards, and payer landscape assessments to inform HTA strategies.
• Early HTA and Value Proposition Development: Supporting pre-market value frameworks and pricing evaluations for pipeline products.

6. AI & Machine Learning in HTA Analytics

• AI-Driven Literature Mining: Using Natural Language Processing (NLP) and deep learning to extract insights from HTA reports and publications.
• Predictive Analytics for Cost-Effectiveness Forecasting: Leveraging machine learning (ML) models for healthcare spending projections.
• Automated Meta-Analysis & Bayesian Network Models: Enhancing comparative effectiveness research through advanced AI techniques.

Why Choose Clievi for HTA Services?

• Regulatory Alignment: Expertise in HTAi, ISPOR, NICE, CADTH, ICER, IQWiG, EMA, and FDA methodologies.
• Advanced Economic & Statistical Modeling: Proficiency in Markov models, Bayesian networks, Monte Carlo simulations, and health economic evaluations.
• Multi-Disciplinary Expertise: A team of health economists, biostatisticians, epidemiologists, and market access consultants.
• Data-Driven, Customizable Solutions: Tailored HTA strategies for pharmaceutical, biotech, medtech, and healthcare policy organizations.

Get Started with Clievi’s HTA Solutions

Leverage robust HTA insights to drive healthcare innovation, reimbursement success, and market access. Contact Clievi today to explore our HTA services for regulatory and payer decision-making.