Real World Data Europe

Apr 28, 2014 - Apr 29, 2014, London, England

Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes

Realizing the Potential of Stratified Medicines

A recent report from The Academy of Medical Sciences makes recommendations to address barriers to the widespread development and adoption of stratified medicine in the UK, in areas such as clinical development and pricing and reimbursement.



The work has been welcomed by theAssociation of the British Pharmaceutical Industry (ABPI), who co-sponsored and assisted with the development of the report. ABPI said the UK is uniquely placed to make the most of the potential of stratified medicine because of “its strong academic and industrial research base, clinical research infrastructure, and the unique potential of the NHS and health informatics.”

The AMS report noted that despite rapid advances in research and technology, existing systems for clinical development, regulation, pricing and reimbursement are preventing the widespread development and adoption of stratified and increasingly personalised medicine.

Professor Sir John Bell, Chair of the Academy of Medical Sciences group that produced the report, said: “Fast and efficient progress in the stratification - and ultimately personalisation - of medicine will rely on the collection, storage and analysis of significant amounts of data regarding the molecular and genetic basis of disease. This data driven approach to medicine requires the development of appropriate infrastructure and working practices to provide the high quality data needed to personalise medicines to individuals.”

Commenting on the AMS report Dr Louise Leong, Head of Research & Development at ABPI said in a media statement: “We are beginning to have the ability to stratify treatments, and we believe that the development of personalised medicine will bring benefits to patients and the healthcare system; it will also improve the efficiency and productivity of developing new treatments, and enhance UK competitiveness and attractiveness for drug and diagnostic research and development.”

One of the areas the report assessed wasthe UK’s pricing system. It determined that the current system removes any incentive to stratify existing products, as the size of the relevant patient population may decrease, lowering the financial return. However, by adjusting the system to enable prices to fluctuate and reflect the changing value of a product, an incentive would be in place to develop increasingly personalised medicines.

“Current pricing and reimbursement systems do not provide adequate incentives for the development of personalised medicines. A new system of pricing needs to be developed that enables prices to be adjusted over time to reflect the increases in value” said Bell.

The ABPI recently hosted the second pharma-diagnostics stratified medicine networking event, where it was agreed that biomarker testing to stratify medicines has an expanding role in clinical decision-making and a number of recommendations emerged. Included in these recommendations is that the innovative alternatives to traditional business models should be developed within the pharmaceutical and diagnostics industries and healthcare sector to incorporate a stratified approach.



Real World Data Europe

Apr 28, 2014 - Apr 29, 2014, London, England

Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes