Work package 14: Pharmacoeconomics & Commercialization
Description of the work package
PUMA applications are still rare within the European Union since the national regulations on reimbursement by health insurance companies and the established prices of the medicinal products are different within the various EU countries. Consequently, ensuring the availability of a licensed medicinal product, country-specific labelling and post-marketing surveillance throughout the entire EU requires infrastructure and resources that are beyond the capabilities of a SME like Ethicare, which will therefore require a commercial partner for full pharmaceutical development of the project.
The tasks included in our work package are described below:
- Identify the needs for enalapril minitablets within the EU: This task aims to estimate the quantitative need for enalapril in age-appropriate minitablets throughout the European Union. The obtained data will be used for calculation of the financial benefits of marketing the developed minitablets.
- Identify the risks for enalapril minitablets within the EU: Distribution of a niche product throughout Europe involves a significant financial risk. National reimbursement policies, especially those related to fixed/negotiated prices for generic products impact the turnover and profit of a medicinal product. High prices might lead to reduced use of innovative medicines by encouraging use of the former extemporaneous drug formulations again. Public awareness and dissemination as per work package 11 to all stake holders will be required for risk estimation. Potential competitive PUMA applications for enalapril or other cardiac drugs will need to be identified and continuously reviewed.
- Identify potential rare diseases and prepare orphan drug designation application: Obtaining an EU orphan drug designation might be one tool to overcome the issue of generic pricing of medicines. The feasibility of applying for a rational orphan drug use designation will be evaluated in this task. If the evaluation results in a consensus within the consortium that is in favour of seeking this designation, the application will finalized for submission. Ethicare is highly experienced in successfully applying for orphan drug designation.
- Identify a suitable pharmaceutical Sponsor: A continuous task for the consortium will be the identification of a suitable pharmaceutical sponsor and potential marketing license holder for the developed product. The search will start from day one forward and will be completed whenever a suitable partner is identified, but as soon as possible. Business models, variations of target product profiles and draft contracts for finalization of agreements with the identified pharmaceutical sponsor will be prepared within this work package.