Efficient access to rapidly emerging standard of care therapy

With up to 50% of drugs expected to be required to include a companion diagnostic, the absence of appropriate public sector reimbursement models is likely to deprive the European population of efficient access to rapidly emerging standard of care therapy (EPEMED White paper 2011 “Market access challenges in the EU for high medical value diagnostic tests”, Nature Reviews march 2009 “Biomarkers: The expanding global market”).

Healthcare systems today are facing unprecedented challenges, characterised by unsustainable costs, aging populations, and increased rationing of care through government reimbursement programs. At the same time, rising drug development and commercialisation costs are challenging drug companies to increase success rates in drug development and ensure clinically differentiated medicines reach patients faster.

However, despite transformational advances in the development of personalised medicines and the role of companion diagnostics to improve patient care through safer, more effective and more tailored  treatments, current reimbursement programs and other challenges are limiting patient access to these life-saving innovations and the economic benefits they offer. For example, only 3 to 5% of potential companion diagnostics are ultimately commercialized (Nature Reviews march 2009, “Biomarkers: The expanding global market”). Some associated reasons include:

• Europe’s complex and heterogenous healthcare reimbursement systems are preventing patients from fully benefiting from the potential offered through drug-diagnostic companion products.
• Current cost-based approaches based on technical cost-derived fee schedules do not reward the unique value provided by treatments supported through diagnostic tests.
• As drug companies move rapidly to incorporate personalised healthcare into their drug development efforts, the slow pace of change by payers to these innovations are creating unnecessary barriers to access of potentially life-saving treatments.

Moreover, the lack of understanding by key stakeholders of the vital importance and potential of co-dependency between companion diagnostics and the drugs themselves are a primary impediment to access and innovation.