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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PReDicT (Predicting Response to Depression Treatment)

Teaser

Summary

Depression is a common, serious and in some cases lifeâ€threatening condition, affecting around 350 million people in the world and 11% of EU citizens suffer from depression at some point in their life. Depression is associated with significant socio-economic costs and is predicted to become the greatest cause of disability worldwide by 2030. (World Health Organization, Global Burden of Disease, 2004 update). In 2010 it was estimated that there were approximately 30 million patients with depression in Europe with aggregated economic costs of approximately â‚¬92 billion. Improvements in managing the treatment of depression are urgently needed to contain rising healthcare costs, improve workplace productivity and help to address the overall economic and societal challenges facing the EU. At present there are no predictive tools to help physicians identify the appropriate treatment for patients with depression and to manage their treatment. To address this issue the eHealth P1vitalÂ® Oxford Emotional Test Battery (eH-ETB) has been developed for deployment in both primary and secondary care settings and it will be the first tool of its kind worldwide. It works by significantly reducing the time it takes to identify an effective treatment for depressed patients. Normally it takes several months before clinicians are able to identify effective antidepressant treatment for patients suffering from depression. During this lengthy period a patientsâ€™ ability to work and function socially is severely impaired by their illness. P1vital will solve this problem using the eH-ETB to identify, early in treatment, in a matter of weeks, whether an antidepressant is working and thereby significantly reduce the time required to initiate effective treatment and accelerate remission from depression. The objective of the Predicting Response to Depression Treatment (PReDicT) project was to assess the feasibility of development, validation and commercialisation of the eH-ETB for the European market.

Work performed

During the PReDicT Phase 1 project we assessed the product development activities required to enable the eH-ETB to be used in major European countries (multi-lingual) and determined what is required to validate the eH-ETB across Europe from a regulatory, clinical, patient recruitment and operational perspective. We also developed a preliminary commercialisation strategy by conducting a health economic assessment across major European countries to gain an understanding of the market size, route to adoption, pricing and reimbursement mechanisms needed to support the successful launch of the eH-ETB. Finally, we recruited leading psychiatrists with experience in conducting clinical trials with antidepressants in six European countries (UK, Finland, France, Germany, Netherlands and Spain). They advised on the design of a study that could be implemented, with minor country specific amendments, to determine whether the eH-ETB can be used to direct antidepressant treatment more effectively than current Standard of Care (SoC) in those countries.

The Phase 1 feasibility project has enabled us to confirm the need for better tools, such as the eH-ETB, to manage the treatment of depression in Europe and worldwide. The impact that the eH-ETB can have on reducing the burden of depression on patients, healthcare and society, and the market opportunity for the commercialisation of the eH-ETB in Europe, US and the rest of the world is significant. The Phase 1 work has confirmed that P1vital should move ahead with this project and secure Horizon 2020 Phase 2 funding to complete the development activities of the eH-ETB to enable product launch.

Final results

P1vital intend to launch in Europe in 2019 after completing the validation of the clinical performance and pre-commercial development of the eH-ETB. The eH-ETB would have significant patient, healthcare and societal benefits. Patients would benefit by retuning to good mental health sooner than with standard of care. For healthcare and the economy the cost saving would be very significant. The costs of depression amount to 1% of the total European gross domestic product. Aggregated economic costs for depression for 2010 were estimated at â‚¬92 billion. It is estimated that the eH-ETB has the potential to reduce these costs by more than 10%.
In summary, the unique selling points of the eH-ETB are that it: (i) will improve response and remission rates and shorten functional disability, impacting both patients and their families in their social and working lives. (ii) has the potential to significantly reduce both healthcare and societal costs. (iii) will significantly reduce ineffective prescribing of antidepressants and the associated side effects, by identifying non-response early in treatment.