Access Strategies

Our aim is to support healthcare systems to adopt the best choice in the societal perspective.

Solutions

Market Access covers a group of activities intended to provide access to the appropriate treatment opportunity for the appropriate group of patients and at the appropriate price and reimbursement conditions.
This ability is closely linked to the evidence synthesis available for the specific medicine and device.

ISHEO strives to promote access to innovative technologies helping physicians, health managers and innovative companies to look at the whole impact of a technology innovation.

ISHEO works to define evidence-based market access strategies.

Market Access

Focus

Isheo works to supporting companies to prepare and submit Value Dossier in compliance with the requirements of regulatory authorities like EMA, National Medicines Authorities, or Notified Bodies for Medical Devices.

MEDICINES

  • Support to Centralized and National Procedure Marketing Authorization for Medicines for Human Use (CHMP+National Medicine Agencies)
  • Value Dossier
  • Early Dialogue preparation
  • Submission of Elegibility Request
  • Notification of intesion to submit
  • Cost-effectiveness and Budget-impact analyses
  • Submission

MEDICAL DEVICES

  • Technical File/Dossier for CE Mark
  • CER - Clinical Evaluation Report
  • Submission to notified body
  • Declaration of conformity

Focus Italy

With a specific focus on Italy, we support companies to adapting the Value Dossier for National submission, and preparing Dossier of innovation designation.

 

Gainin national and regional access

Health system structures are varied, with different rules of engagement and procurement. The team at ISHEO helps innovative companies manage the different types of health accounts relying on evidence-based strategies.

After a proper evidence synthesis, ISHEO will build customized tools in order to allow companies to communicate the Value Proposition of their innovation at national and regional level. 

The development of content built upon ISHEO’s consulting and research activities are usually constructed with Digital support, to help inform all stakeholders about the value of new medicine or medical device.

Regional and Local support (focus Italy)

  • Regional dossier
  • Dynamic infografics
  • PPT for Value Story presentation
  • Regional Calculators
  • Dedicated webApp
  • Regional and Local Stakeholders Map
  • Customized strategies for the specific rules and requirements of each region.