Global Market Access Services

By being able to integrate our expertise in health economics, outcome research and P&R, our team is capable of systematically and creatively develop and implement a strategy that will maximize your product’s potential

Services

  • Establishing price-proposal & application at the Competent Authority
  • Reimbursement preparation & application at the Competent Authority
  • Complete market access dossiers including health economics cases
  • Analyse available and publically accessible reference prices of a product (price simulation)
  • Strategic advice on the possibilities for market access
  • Strategy determination for reimbursement
  • Global overview of market access for the product
  • Country specific market access road maps
  • Analysis of former examples and strategies implemented
  • Arrange preliminary communication about the product with Key Opinion Leader
  • Health Economic Modelling
  • Value Development Planning
  • Business development (sourcing companies to market products)

Price and reimbursement – complete package:

Global value dossier

  • A core value dossier is the essential tool to ensure a robust global product launch.
  • By identifying the disease burden and unmet need, clinical performance, patient benefits and economic value, the dossier is built on compelling value story for payers.
  • From our experience, the value dossier would essentially serve two key purposes:
    • To support reimbursement application
    • To serve as an internal core resource of the product’s value
  • By understanding the purpose of the GVD, ELC’s GVD project teams are able to prepare a submission-ready dossier to specifically address the needs of the local competent authorities.
  • With years of experiences, we are equipped with the know-how of structuring and presenting a clear yet concise information on the validated evidence-based value story of the product.

Local value dossier

  • Drafting of the dossier according to the specifications provided by the administrations (e.g. Transparency Commission, Joint Federal Committee, etc.): regulatory and administrative sheet, therapeutic interest notice.
  • Clinical / disease Situation
  • Current treatment(s)
  • Clinical evidence (benefit)
  • Added clinical benefit against the current standard of care (in case not included in the clinical study programme) – indirect comparisons may be needed for some countries.
  • Epidemiology
  • Number of targeted patients in each country
  • Development of a Budget Impact model
  • Cost effectiveness models (only for some countries)

Follow up management

Preparation of hearings and negotiations