Evidence-based reimbursement decisions and the role of formal cost-effectiveness assessments
Understand the advantages and the impact of your products in the context of the national health systems, from a pricing/health outcomes perspective. Some of the evidence-based reimbursement decision are based on a few key items which will need to be defined for your product such as:
- Efficient and “cost-effective” utilization of scarce (health care) resources as an important policy objective in the presence of limited budgets and opportunity costs
- Effective delivery against a multitude of implicitly or explicitly articulated objectives for which decision makers are politically accountable i.e. not simply the maximization of QALYs
- Trade-offs between patient groups and their different needs in the presence of a multitude of potentially conflicting health care policy objectives
- Formal health economic evaluation methodology can play a valuable role when selecting the most [technically/productively] efficient technology: to achieve a defined clinical goal with a minimum amount of resources or to maximize a specific clinical outcome from a defined budget as long as the very same patient population is affected.

Establish a European Legal Entity and Register with Agency Portals.
If you are preparing for a Marketing Authorisation in Europe you will need to establish a legal presence in Europe (EU, UK, Switzerland). You will then need to register your local representatives and your Product with Agency portals like EMA OMS, MHRA Gateway and SwissMedic. Pharma Design Limited can assist you in setting up your European legal representation and to register your Products correctly in relevant portals, so that you will be officially recognised as a developer of new medicines and be contactable by Regulatory Authorities for any communication.
Our Values
The value we bring to pharmaceutical companies falls into four main areas:
- Objective, impartial advice tailored to your needs
- Help cut your development costs
- Help reduce your time to market
- Keep your drug on the market

