What factors should be considered when determining the likelihood of HTA success?
Affordability
- Annual Cost of Therapy: Assess the annual cost based on the projected number of patients expected to receive treatment.
- Early Budget Impact Models (BIMs): Develop models to predict the financial burden on healthcare systems, Identifying potential savings through more effective treatments.
Therapeutic Value
- Clinical Effectiveness: Evaluate how well the therapy works in controlled clinical trial environments and acknowledge potential variations in real-world effectiveness.
- Safety and Tolerability: Examine adverse effects that impact patient quality of life and treatment adherence and consider how well patients manage side effects, influencing overall therapy value.
- Clinical Uncertainty: Recognize challenges due to limited long-term data or variability in patient responses. And address uncertainties through: Post-market surveillance and adaptive trial designs to enhance understanding of the therapy's true value.
Qualitative Aspects
- Population: This involves considering demographic factors, disease prevalence, and genetic predispositions.
- Unmet Needs: Assessing how well the therapy addresses gaps in current treatment options. Therapies that offer solutions where none existed before, or significantly improve existing treatments, are highly valuable.
- Dosing and Administration: The convenience and feasibility of a therapy's dosing regimen can impact patient adherence and overall success.
- Competitor Landscape: Understanding the competitive landscape helps in evaluating a therapy's relative advantage. This involves comparing efficacy, safety, cost, and patient preferences against existing and emerging treatments.
- Real-World Evidence: Post-market data on how the therapy performs in broader, more diverse patient populations provides insights into its effectiveness and safety outside clinical trial settings.
Assessing beyond Cost-Effectiveness: Introducing FIECON Early Asset Valuation Model
With the objective to establish an overall likelihood of HTA success in the form of RAG status, early asset valuation model provides an early understanding of the cost-effectiveness, therapeutic value, and reimbursement potential of new treatments, informing strategic decisions and resource allocation.
Key Benefits:
- Strategic Decision-Making: These models guide resource allocation and prioritize development efforts by assessing cost-effectiveness and market viability.
- Identification of Evidence Gaps: They highlight data gaps, directing future research and evidence generation.
- Risk Mitigation: Early insights help address potential challenges, reducing late-stage failures.
- HTA Strategy: They identify factors influencing reimbursement, such as cost-effectiveness, therapeutic value, and qualitative aspects like disease burden.
Application of RAG status in Early Economic Modelling
The RAG status is determined through a scoring system that assigns numerical values (e.g., 1 for Red, 2 for Amber, 3 for Green) based on defined thresholds within each subdomain. These scores are then weighted to reflect their relative importance in the overall assessment.
Using the RAG status in early economic models allows for a comprehensive evaluation of an asset's potential beyond traditional cost-effectiveness. It identifies areas needing further evidence generation and highlights strategic priorities to enhance the likelihood of HTA success. This holistic approach ensures that all critical factors influencing reimbursement decisions are considered, providing a robust framework for pipeline asset evaluation.
If you are struggling with Early Value Assessment, we can help you navigate your way to maximising the probability of HTA success. Discuss your needs with us and see how we can boost your product launch: https://www.fiecon.com/landing/contact
