What are the best practices for aligning HTA submissions across different regions?

1 Understand the HTA landscape

The first step for aligning HTA submissions across different regions is to understand the HTA landscape and the key drivers and expectations of each market. This includes identifying the HTA agencies and bodies that are responsible for conducting or reviewing HTA, their scope and mandate, their methods and processes, their criteria and thresholds, their evidence requirements and preferences, and their timelines and outputs. It also includes understanding the context and environment of each market, such as the health system structure, the regulatory framework, the pricing and reimbursement mechanisms, the market access pathways, the stakeholder engagement opportunities, and the unmet needs and priorities of the target population. A comprehensive and comparative analysis of the HTA landscape can help to identify the similarities and differences across regions, and to tailor the HTA submissions accordingly.

2 Develop a global value proposition

The second step for aligning HTA submissions across different regions is to develop a global value proposition that articulates the clinical and economic benefits of the health technology for the target population, compared to the current standard of care or alternative options. A global value proposition should be based on a robust and relevant evidence base that supports the claims and assumptions of the value proposition, and that addresses the key questions and uncertainties of the decision-makers. A global value proposition should also be flexible and adaptable to the specific needs and preferences of each region, and to the changing dynamics and trends of the market. A global value proposition can help to communicate the value of the health technology consistently and convincingly across regions, and to highlight the areas of differentiation and innovation.

3 Align the HTA deliverables

The third step for aligning HTA submissions across different regions is to align the HTA deliverables, such as the clinical and economic models, the systematic reviews, the network meta-analyses, the budget impact analyses, and the value dossiers. These deliverables should be aligned with the global value proposition, and with the methods and standards of each region. This may require adapting or modifying the deliverables to account for the variations in the data sources, the comparators, the outcomes, the perspectives, the time horizons, the discount rates, the sensitivity analyses, and the presentation formats. It may also require validating or testing the deliverables with the relevant stakeholders, such as the HTA agencies, the payers, the providers, the patients, and the experts, to ensure their credibility and acceptability. Aligning the HTA deliverables can help to reduce duplication and inconsistency across regions, and to increase efficiency and quality.