Personalised Medicine in Clinical Practice A real life and concrete example for the added-value of PM for patients, payers, physicians and innovator in addressing overtreatment and healthcare budget spillage. T. Kievits Director Vitromics Healthcare Holding Former EuropaBio s PM Topic Group leader
Mark Rutte performs a PamChip test Innovation for Health, 5_2_2015 Amsterdam 2
Systemic Issues in Health Care Impact of personalised medicine: 1. Used as basis for new therapy development 2. Improving delivery of existing therapy Innovation for Health, 5_2_2015 Amsterdam 3
The start of the first project -February2012 Jose Baselga BOLERO-2 Everolimusin Postmenopausal Hormone-Receptor Positive Advanced Breast Cancer (ClinicalTrials.gov number NCT00863655; Funded by Novartis) -June2012 Koos van der Hoeven: Idea for biomarker study to avoid overtreatment in this patient group -2013 Emiel Voest: representing the Center for Personalised Cancer Treatment for final plan with Dutch health insurance company CZ and Vitrmics Conclusion of 3 party contract announced in January 2014 and clinical biomarker trial has started Innovation for Health, 5_2_2015 Amsterdam 4
Public-private partnership addresses overtreatment issue in oncology Dutch healthcare insurer CZ, the Centerfor Personalized Cancer Treatment (CPCT) and VitrOmics, a company specialised in personalized medicine, have started a joint project to address the overtreatment issue within a certain group of patients with breast cancer. The goal set by the collaborators is to provide therapy to this group much more selective than currently is done in practice. This public-private collaboration between CZ, CPCT and Vitromicsis outstanding in an area where innovation can be very difficult. It showcases the need for parties to act outside of their comfort zone to be able to innovate in healthcare. Innovation for Health, 5_2_2015 Amsterdam 5
Everolimus & Exemestane treatment Currently: no test - Up to 40% overtreatment -Side effects & delay for potential better treatment. -At 18 million Euro cost New: Drug response test Responder Study goal: find pathway biomarker (NGS & PamChip) to minimalise overtreatment Non-Responder Patients Afinitor/Exemestane non-responders Afinitor/Exemestane responders Innovation for Health, 5_2_2015 Amsterdam 6
Study characteristics Response and non-response are well defined, coupled to practice of stopping & changing treatment Total participating patients: 100 200 range Limited number of participating hospitals for high quality & lower cost Three phased biomarker investigation: open, blinded & prospective. Aimed at stratification patients before the start of the therapy with a chance versus a very low chance of therapy benefit Use of fit for purpose (e.g. use very minute sample amounts) analytically adequately validated technology platforms Innovation for Health, 5_2_2015 Amsterdam 7
Innovation incorporated Sci Signal. 2013 Apr 2;6(269) The scientific drunk and the lamppost: massive sequencing efforts in cancer discovery and treatment. Yaffe MB. Innovation for Health, 5_2_2015 Amsterdam 8
CZ, CPCT and Vitromicsproject wins the Value Based Healthcare Encouragement Award The project Public-private partnership addresses overtreatment issue in oncology from Dutch healthcare insurer CZ, the Centerfor Personalized Cancer Treatment (CPCT) and VitrOmics, a company specialized in personalized medicine, is awarded one of three 2014 Value Based Healthcare Most Exceptional Initiative Awards. The Value Based Healthcare Prizes are awarded to recognize those projects that have adopted a fundamentally new line of thinking in creating value for patients in terms of real outcomes, real cost, real connections and one common language, and are patient-centred doctor-led initiatives. Harvard University Professor Michael E. Porter is honorary chairman of the Prize, and STZ (StichtingTopklinischeZiekenhuizen) and Erasmus Medical Center are co-auspices to the Prize. Innovation for Health, 5_2_2015 Amsterdam 9
2 e and 3rd study on the way 1. Breast Cancer trial - Limit overtreatment by targeted therapy combination 2. Lung cancer - Limit chemo therapy spillage 3. Esophageal cancer - Reduce number of surgery procedures Learnings from study 1 for study 2 & 3 Patients/patient organisation involvement during the whole trial Role for Erasmus Institute for Medical Technology Assessments Process responsibility of participating hospitals to get the test-therapy combination available to the patients Joint patient-physiciandecisionmaking; Patient sdecison to go with the test result (or not) Innovation for Health, 5_2_2015 Amsterdam 10
Conclusions New personalised medicine approaches can contributeto addressing the overtreatment situations currently existing in healthcare Urgency is highto address overtreatment in oncology and relative small biomarker studies can help in these situations Patient central also means: Patients key in go/no go decisions between phases Last study phase: patients in the lead on the deciding on use of test for therapy choice Organisation of these three studies brought together the many stakeholders: Discuss trial performance and implementation Create common understanding of issues Preemt problems that can be encounterd during trial. Innovation for Health, 5_2_2015 Amsterdam 11
Lets prepare for more innovation in diagnostics! Therapy A Response Prediction with test. Non responder group Responder group Tested population Alternative therapy No test First in class test Best in class test Time Innovation for Health, 5_2_2015 Amsterdam 12