Market Access

Evidence-focused integrated access solutions at the nexus of clinical and regulatory experience.

Understanding the Market Potential

VCLS have strong understanding of the HealthTech investors’ requirements, and have helped hundreds of emerging biopharmaceutical and medical technologies’ companies build their business case and strategy.

In order to take sound investment decisions, the HealthTech companies and their investors need to understand the market potential for their product. This implies understanding the environment in which a product will position itself.

We can help you:

  • Understanding the unmet medical needs
  • Estimating the size of the possible target populations
  • Understanding the competition
  • Understanding the pricing and reimbursement potential
  • Estimating the revenue potential
  • Formulating the value propositions
Neighborhood VCLS Innovation Center

Understanding the HTA Evidence Requirements

We have handled 1/4 of all consolidated or non-consolidated EMA/HTA parallel consultations and 1/2 of the Orphan Drugs Parallel Consultations in Europe.

Regulators’ and Health Technology Assessment Authorities’ requirements are not the same – it’s the critical to bridge this gap as early as possible during the health tech product development stage to avoid the common "too little too late" outcome with products receiving a marketing authorization and launching without the required evidence to support their value proposition.

We can help you:

  • Performing consolidated or non-consolidated parallel consultations between regulatory and HTA authorities
  • Performing multi-HTA EUNetTA Consultations
  • Performing gap analysis of existing versus required evidence
  • Building an evidence generation roadmap

Expert Voice

Hear insights from our experts at the World Orphan Drug Congress and Pharma Pricing Market Access Congress.

 

Planning the Health Economic and Outcomes Research (HEOR) Evidence Generation

VCLS outcomes researchers and health economists have collectively supported the integration of clinical, economic and humanistic endpoints into of hundreds of clinical trials in Europe and the US.

In order to have the required evidence needed to obtain HTA recommendations and appropriate pricing and reimbursement conditions, it is needed to plan the evidence generation alongside the clinical trial program.

We can help you:

  • Performing gap analysis of available vs required evidence
  • Planning the evidence generation strategy
  • Selecting and integrating clinical, economic and humanistic outcomes research parameters into clinical trials and studies
  • Building the economic models