Apex provides the following services:
- Fully integrated evaluation of the European market covering regulatory, price/reimbursement issues, concentrating on the five key markets
- Clear view of how a product can take advantage of the European environment
- Typical activities undertaken for a specific disease area include:
- Understanding management practices in key EU markets, ideally based on desk research supported by expert interviews
- Treatment maps for any given product for each of the key countries
- Overview of all of the current drugs and usage profiles in Europe
- Evaluation of appropriate audit data
- Epidemiology and growth estimates in the next five years
- Expert interviews to understand the pricing and reimbursement process/benchmark for the client’s product in Europe
- Understanding if there are any potential reimbursement issues (to provide comfort to partners) and access for formularies (if a hospital product)
- Establishing clinical trial requirements for a client’s product in Europe
- Overview of study design and endpoints for clinical trials completed in Europe for currently marketed products in the relevant therapy area
- Potential clinical trial designs for European clinical studies (from expert interviews)
- Confirmation of key European countries for clinical, development and commercial activities
- Apex has the capability to carry out local language desk research to understand the current treatment options in each country (from medical literature, reviews and clinical guidelines) and the cost of such treatment (based on 2008 drug book prices for each country)
Recent Examples include
The provision of these services for US clients looking to understand the EU market, to support either their European commercial strategy or their partnering discussions in Europe.
A detailed understanding of a neurological disease treatment in Europe on behalf of a US based company. The key aim of the research was to support the on-going development of the client’s product. AHC conducted KOL interviews across the 5EU countries. The KOLs were identified through AHC’s internal desk research expertise. During the in-depth interviews the KOLs were expected to evaluate the pricing options for the product and were therefore recruited on the basis they had pricing and reimbursement decision-making experience. To fully meet the objectives of the project, AHC also conducted an interview with a European pharmacoeconomic expert.
Conducting an overview of the usage patterns and clinical management in key EU countries for a psychiatric indication, to support the client’s ongoing development of a novel formulation for an existing agent. The project was carried out by desk research supported by a small number of in-depth telephone interviews.