Value dossiers & early benefit assessments

Since the Act on the Reform of the Market for Medicinal Products has taken effect, all medicinal products eligible for reimbursement that feature new active ingredients have been subject to a early benefit assessment pursuant to § 35a SGB V. Diapharm supports marketing authorisation holders in preparing value dossiers, otherwise known as health technology assessments (HTA).

Diapharm’s services for early benefit assessments include:

  • Consultancy and support in the planning of clinical trials
  • Support in planning and conducting G-BA consultations
  • Definition and evaluation of appropriate subgroups; identification of patient-relevant endpoints on the basis of existing data
  • Consultancy on/Preparation of value dossiers:
  • Project management for the entire value dossier process

Trials & appropriate comparative therapies

Marketing authorisation holders in Germany must provide evidence of a new medicinal product’s additional therapeutic benefit compared to appropriate comparative therapy in order to receive a fair price for the product. The Federal Joint Committee (G-BA) is responsible for determining the appropriate comparative therapy. However, it can often differ from the one used in control groups during clinical trials. The legal situation means that phase III trials may have to be designed differently. The only decisive point is an additional therapeutic benefit compared to appropriate comparative therapy. Marketing authorisation holders must provide evidence of this benefit on the basis of clinical trial data, which is to be presented according to certain methods in the value dossier.

The early benefit assessment

The G-BA uses this value dossier or early benefit assessment dossier to make a decision on the probability and degree of the additional therapeutic benefit. The G-BA often tasks the IQWiG with conducting a scientific assessment of the submitted cost-benefit dossier to serve as a basis for the G-BA’s decision. For marketing authorisation holders, providing the clearest-possible evidence of a medicinal product’s additional therapeutic benefit for the spectrum of indications covered in the application is therefore crucial.

Structure of the value dossier

A value dossier for early benefit assessment has to conform to the following structure:

  • Module 1: Summary of modules 2-4
  • Module 2: Information on the medicinal product and approved indications
  • Module 3: Data on appropriate comparative therapy, number of patients, cost of therapy, quality-assured use
  • Module 4: Description of methodology and findings; information on patient groups that may have an additional therapeutic benefit
  • Module 5: Literature, trial reports, application dossiers, etc.
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