Marketed products, regulatory approvals and HTA decisions
Understand regulatory approval processes and health technology assessment (HTA) decisioning to identify opportunities, mitigate risk and optimize drug development and commercialization strategies.
Definition
Criteria
Power your decision-making
with bespoke and intuitive intelligence boards
VISFO combines cutting-edge technology and deep subject matter expertise to de-silo data and enable confident decision-making. With all outputs housed in an agile, always-on delivery portal, you can quickly:
Visualize
Identify
- Regulatory guidelines, policies and procedures across markets
- Approval histories for marketed products, within and across indications
- Different HTA bodies and their processes
- Patterns in HTA outcomes and recommendations
Analyze
- Changes in regulatory guidelines, policies and procedures that may impact drug development and approval processes
- Emerging regulatory frameworks, such as those related to personalized medicine or real-world evidence
- Drug approval histories for marketed products within specific indications to identify potential market gaps and prioritize drug development efforts based on likelihood of successful market entry
- The approval history of a single product across multiple indications to forecast potential indication updates based on historical trends and emerging therapeutic needs
- HTA decisions for marketed products, including positive and negative outcomes, and the reasoning behind these to understand evidence requirements and other factors that contribute to favorable HTA decisions
Use cases
Align your evidence and value messages with the specific requirements and preferences of HTA agencies and payers in each target market
Anticipate and address potential market access hurdles
Use competitor benchmarking to improve product positioning and payer appeal, increasing the likelihood of favorable reimbursement decisions
Design trial endpoints that maximize the chance of meeting expected regulatory and HTA requirements
Design trials that satisfy multiple regulatory bodies on the first submission
Facilitate strategic prioritization of your development portfolio based on regulatory and HTA forecasting
Develop external communication strategies that align with HTA and payer requirements
Craft scientifically robust and strategically aligned communication materials
Design and implement studies that effectively meet post-market requirements
Delivered through Helix
Modular knowledge base
Interactive data visualizations for easy self-serve analysis and insight surfacing
Comprehensive opinion leader profiles for effective interaction planning and engagement
Multiple data export options for rapid insight sharing across your business
Customizable, modular knowledge bases with no user limits
