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.
With a methodical and periodically updated assessment of the product-in-development it is possible to support the following decisions:
- Alignment of comparators to AMNOG-assessment in phase III studies (appropriate comparative therapy - ZVT).
- The choice of the „right“ comparative therapy/product
- The focus on patient related outcomes - PROs
- The for the AMNOG-assessment required length of clinical studies for the single indication
- Consideration that studies are sufficiently powered for a subgroup analysis
- Prioritization of resource allocation for each development-project
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