Nowadays, diagnostics provide much more than simple assays conducted in test tubes and examining glass dishes under microscopes. They are used in large scale population screening, such as for cervical cancer, as well as for predicting whether a specific medicine or treatment will work on a patient.
As the number of approved medicines linked to companion diagnostic tests increases, we need to ensure that these are appropriately evaluated using Health Technology Assessment (HTA) so that patients can benefit.
We must recognise that the objectives of HTA and stratified medicine are aligned – ultimately increasing patient access to life-saving and life-enhancing treatments. With this in mind, last week ABPI and BIVDA jointly hosted the third pharma-diagnostics stratified medicine networking event, which focused on the principles of NICE assessment of stratified medicines, issues and future trends.
The event featured thought provoking perspectives from Adrian Newland (Chair, NICE Diagnostics Advisory Committee), Greg Rossi (AstraZeneca), Berwyn Clarke (Nalia Systems) and Adrian Towse (Office of Health Economics). A few common themes emerged in the panel and audience discussion:
There are many stakeholders involved in making stratified medicine a reality. As we go forward, it is of paramount importance to ensure full engagement in these issues.
Moving forward there will be more public sector support for the generation of robust evidence on IVD tests – e.g. NIHR Diagnostic Evidence Co-operatives, the Technology Strategy Board’s Stratified Medicine Innovation Platform, the UK Genetic Testing Network activity on gene dossiers and the Royal College of Pathologists work on the National Laboratory Medicine Catalogue.