Check Phase III Portfolio

Starting in phase II of the clinical development of a new pharmaceutical and even more with the beginning of the clinical phase III the crossroads are there for a successful development or a failure in the later benefit assessment and pricing & reimbursement process. Many companies neglect this strategic issue and are solely focused on obtaining the registration for their new products. This lack of strategic view on other important aspects and parameters of the clinical development leads to approved products which are not really successful marketable and which never will be granted attractive reimbursement prices by regulatory institutions.

In reference to the altered circumstances for a successful market access of new and innovative products in Germany, especially the changes regarding proof of benefits and added benefit, it’s important to align the product pipeline to the different circumstances of the AMNOG as early as possible.

The assessments of the products and the potential optimizations of the clinical evaluation should be done at the early stage of phase III in clinical development. The assessment should be repeated periodically until approval.

Mit einem systematischen und periodisch aktualisierten Assessment der Entwicklungsprodukte wird es möglich, die folgenden Entscheidungen zu unterstützen:

  • Ausrichtung der Komparatoren in den Phase III Studien auf die AMNOG-Bewertung (Zweckmäßige Vergleichs-Therapie - ZVT)
  • Wahl der optimalen klinischen Parameter (patientenrelevante Endpunkte)
  • Die für eine erfolgreiche AMNOG-Bewertung richtige Studiendauer für die Einzelindikation
  • Berücksichtigung, dass Studien für eine Subgruppenanalyse ausreichend gepowert sind
  • Prioritätensetzung in der Mittelallokation für die einzelnen Entwicklungsprojekte

 

Check Phase III Portfolio

Based on a survey the assessment is converted into a scoring model (regarding early benefit assessment § 35a SGB V, AMNOG). The following parameters are gathered and considered:

  • Transparency in the target indication
  • What do existing guidelines tell us
  • Extent of the unmet medical need
  • Economical pressure in the targeted indication
  • Clinical study program, outcomes, achieved benefit
  • Achievable reimbursement price


Based on that, the optimization potential for the client is defined

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