VISFO
Knowledge base

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.
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Marketed products, regulatory approvals and HTA decisions

Definition and criteria

A well-recognized, highly respected and trusted expert with significant influence in their field. KOLs are often thought leaders and educators, whose perceptions are likely to impact the opinions and decisions of others in their professional network. To be considered a KOL, an individual may fulfill some or even all of the following criteria:

Criteria 1

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Criteria 6

Marketed products, regulatory approvals and HTA decisions

Power your decision-making

with bespoke and intuitive intelligence boards

Visualize

VISFO combines cutting-edge technology and deep subject matter expertise to de-silo data and enable confident decision-making. With all outputs housed in our fully interactive, AI-enhanced knowledge base. Teams can drill down from high-level strategy to granular evidence, surfacing the right information in seconds.

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 

A VISFO "intelligence board" showing various components of the “Marketed products" offering in desktop view. Included are visualizations of a "Competitive landscape comparison", an "Efficacy, safety and market share" analysis and a "Market entry and development milestones". A mobile screen shows a "Competitive landscape comparison" visualization as well as the available filters.
HelixAI
Marketed products, regulatory approvals and HTA decisions

Use cases

How can this help your team...

Medical Affairs

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

Market Access

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

Clinical Development

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

See it in action with an interactive demo

See how VISFO’s precision intelligence and collaborative approach ensures you have the right insights, at the right time, to make the best possible strategic decisions.
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