Transcript presentation_Kievits

Personalised Medicine in practice in
The Netherlands – a SME’s view
T. Kievits
Director Vitromics Healthcare Holding
Former EuropaBio’s PM Topic Group
leader
Entrepreneurship in PM
Dutch Prime Minister Mark Rutte
performs a PamChip test
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Systemic Issues in Health Care
With health care cost substantial and rising......
Affordable healthcare & innovation
(is the solidarity principle sustainable)?
Kaiser Family Foundations calculations using data from the
US Department of Health and Human Services, Agency for
Health care Research and Quality, Medical Expenditury P
anel Survey, Household Component 2009
Market access for higher priced
“niche buster” products?
Trusheim et al. Stratified medicine: strategic and economic
implications of combining drugs and biomarkers.
Nature Reviews|Drug discovery, volume 6 april 2007 287-293
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....and it is
the era of
imprecision
medicine!
J. Schork, Time for one-person trials, Nature
volume 520, 30 April 2015, 609-611
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SME opportunities for impact with
personalised medicine?
X
1. Used as basis for new therapy development
Complex projects; long development times; many parties involved;
regulatory & reimbursement hurdles; difficult market access; etc
2.
V Improving delivery of existing therapy
Still many parties involved, but less; limited to diagnostic play,
therapy already in the market and reimbursed
Our choice
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The start of our first clinical project
- February 2012
Jose Baselga
BOLERO-2 Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer
(ClinicalTrials.gov number NCT00863655; Funded by Novartis)
- June 2012
Koos van der Hoeven: Idea for biomarker study to avoid overtreatment in this patient group
- During 2013
Emiel Voest: representing the Center for Personalised Cancer Treatment (Oncology Collaboration
of Hospitals)
Wim van der Meeren from the Dutch health insurance company CZ
Tim Kievits specialised in Personalised Medicine from Vitromics
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Everolimus & Exemestane treatment
“Currently: no test”
“New: Drug response test”
Responder
- Up to 40% overtreatment
- Side effects & delay for potential better
treatment.
- At 18 million Euro cost, with substantial
unneccesary side effects
Study goal: find pathway biomarker
(NGS & PamChip) to minimalise
overtreatment
Non-Responder
Patients
Afinitor/Exemestane non-responders
Afinitor/Exemestane responders
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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.
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Public-private partnership
addresses overtreatment issue in oncology
Result: a three party contract could be announced in January 2014 and the
clinical biomarker trial has been started
• “Dutch healthcare insurer CZ, the Center for Personalised Cancer
Treatment (CPCT) and VitrOmics, a company specialised in personalised
medicine, have started a joint project to address the overtreatment issue
within a certain group of patients with breast cancer”
• “…. to provide therapy to this group much more selective than currently is
done in practice”
• “…. outstanding in an area where innovation can be very difficult”
• “…. showcases the need for parties to act outside of their comfort zone…”
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Study characteristics
• Response and non-response are well defined, coupled to practice of
stopping & changing treatment
• Total number of patients participating: 100 – 200 range
• Limited number of participating hospitals for high quality & lower cost
• Three phased biomarker investigation: open, blinded & prospective.
• Start is observational (as close to routine practice as possible)
• 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
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CZ, CPCT and Vitromics win the
Value Based Healthcare Award
The project “Public-private partnership addresses overtreatment issue in
oncology” from Dutch healthcare insurer CZ, the Center for Personalised
Cancer Treatment (CPCT) and VitrOmics, a company specialized in
personalised 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 (Stichting Topklinische Ziekenhuizen)
and Erasmus Medical Center are co-auspices to the Prize.
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2e and 3rd study on the way
2nd study: Lung cancer (prepared for funding) - Limit chemo
therapy
www.lung.org lung-cancer-fact-sheet.html may 2015
3rd study: Esophageal cancer (study is financed) - Reduce
surgery
provide patient with better care after successful radio-chemo
therapy (~ 30% of the patients in CROSS protocol)
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Conclusions
• New personalised medicine approaches contribute to addressing
overtreatment situations currently existing in healthcare
• SME role in bringing parties together on relevant trial topic:
– Discuss trial performance and implementation
– Create common understanding of issues
– Preemt problems that can be encounterd during trial
– Assure role of patients
• Urgency is high to address overtreatment in oncology and relative small
biomarker studies can help in these situations
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Personalised Medicine in practice in
The Netherlands – a SME’s view
[email protected]