Case Study SmartStep Consulting

Be prepared.

SmartStep Healthcare Strategy & Market Access Consulting provides personalized and specialized consulting services to the pharmaceutical and medical device industries to provide fast and effective market access to their products in Germany.

As one of the leading agencies for the preparation of price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV) in Germany and preparation of dossiers, we support you in the entire Early Benefit Assessment as required by § 35a SGB V.

  • Beginning with a detailed market analysis, from which we derive strategic insights for the specials needs of each drug.
  • We support you in the content-related and active preparation of dossiers including the request for early advice as well as the strategic preparation of the client for the G-BA advice meeting. Subsequently we support with the oral hearing procedures.
  • We also take care of study design and statistical data analysis as well as the processing of scientific data and literature.
  • Based on possible SHI perspectives and strategies we develop, in close work with the pharmaceutical company, the line of argument for the negotiation strategy. In addition, we also perform executive activities such as the completion of Annexes I-III or be a part of the negotiation team in the price negotiation or arbitration board.
  • In order to provide you with a comprehensive service, we also offer expertise in regulatory instruments, such as the reference price system, advisory assistance on laws concerning medicinal products and formalities, as well as specific knowledge of the reimbursement systems in inpatient and outpatient care.

To complement our services, we play an active role in European market access projects. We support our customers during national submission by developing core value dossiers, stakeholder interviews and defining European launch strategy and pricing and reimbursement advice.


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