personalised medicine: a nationwide initiative for an equal access to cancer treatment in france
DESCRIPTION
EuroBioForum 2012 | 18 April 2012 Presentation by Frédérique Nowak, Head of Pathology and Genetics, French National Cancer InstituteTRANSCRIPT
Personalized Medicine: A nationwide initiative for an equal access to cancer
treatment in France
Frédérique Nowak
Institut National du Cancer – 18/04/2012
2
Institut national du cancer (INCa)
• The French National Cancer Institute is a health and science agency dedicated to oncology.
• INCa was created through the Public Health Act of 9 August 2004
• INCa is involved in all aspects of the fight:
- Public health : Observation – Prevention - Screening
- Care: Improve the quality of care for all cancer patients
- Research: Orient the national cancer policy towards international competition
- Information: Give every individual the means to help fight cancer
3
The cancer plan 2009-2013
The Cancer Plan 2009-2013:
• follows on from the Cancer Plan 2003-2007
• 5 areas :
Research
Observation
Prevention-screening
Patient care
Life during and after cancer
• 30 measures/ 118 actions
Towards molecular subsets of cancers
Molecular genetics deciphers severe frequent cancers into specific rare cancers
Molecular alterations shared in several cancers
One drug is now efficient for the treatment of several « rare cancers »
4
Molecular subsets of non small cell lung cancer : 20,000 patients
The shift of paradigm for cancer treatment
Predictive tests for targeted therapies prescription
5
BCR-ABL translocation: 1- BCR-ABL detection
2- BCR-ABL quantification
3- ABL mutation
Chronic Myeloïd Leukemia/ Acute Lymphoblastic Leukemia
Imatinib prescription
1- Imatinib prescription
2- Monitoring of minimal residual disease
3- Resistance to Imatinib
KIT and PDGFRA mutations
GIST Imatinib prescription
HER2 amplification Breast and gastric cancers Trastuzumab prescription
KRAS mutations Colorectal cancer Panitumumab and cetuximab prescription
EGFR mutations Lung cancer Gefitinib and erlotinib prescription
ALK translocations Lung cancer Crizotinib prescription
BRAFV600 mutation Melanoma Vemurafenib prescription
Ensuring equity of access to innovation: France organisation of molecular centres for personalized medicine
The programme is operated by the INCa/Ministry of Health since 2006
6
28 regional centres
Partnerships between
several laboratories located
in University hospitals and
cancer centres
Regional organization
Cooperation between
pathologists and biologists
Objectives
Perform molecular testing
for all patients;
Whatever the healthcare
institution status (public
hospitals, private
hospitals…);
Perform high quality tests;
leukemia, solid tumours
Brest•
• Marseille
Bordeaux •
• Besançon• Nantes
Caen •
• Lyon
• Lille
• Poitiers
Rennes •
• Angers
• Nancy
• Clermont
Ferrand
• Dijon
Montpellier/
Nîmes •
• NiceToulouse •
• St Etienne
• Tours
• Rouen
• Grenoble
• Reims
• Limoges
• Strasbourg/
Mulhouse/
Colmar
Brest•
• Marseille
Bordeaux •
• Besançon• Nantes
Caen •
• Lyon
• Lille
• Poitiers
Rennes •
• Angers
• Nancy
• Clermont
Ferrand
• Dijon
Montpellier/
Nîmes •
• NiceToulouse •
• St Etienne
• Tours
• Rouen
• Grenoble
• Reims
• Limoges
Brest•
• Marseille
Bordeaux •
• Besançon• Nantes
Caen •
• Lyon
• Lille
• Poitiers
Rennes •
• Angers
• Nancy
• Clermont
Ferrand
• Dijon
Montpellier/
Nîmes •
• NiceToulouse •
• St Etienne
• Tours
• Rouen
• Grenoble
• Reims
• Limoges
• Strasbourg/
Mulhouse/
Colmar
St Cloud/
Versailles • •
Villejuif
• Paris (2) : AP-HP, Curie St Cloud/
Versailles • •
Villejuif
• Paris (2) : AP-HP, Curie
Provides nationwide molecular diagnostic tests
7
Benefit for all patients
Molecular tests are performed :
For all patients
free of charge for patients & hospitals
With compensation of local pathologists for sample shipments
Ensure that all patients effectively benefit from molecular testing
Rapid access to innovation: EGFR testing in lung cancer
Mutations : 9,6%
60 % of external prescriptions
Median time for results : 7 days
Non contributive results :
June 2009 : gefitinib approvals by EMA for patients with activating mutations of
EGFR in their tumours
3,7%
1,5%
5,2%
0,0
5,0
non amplifiable DNA
depleted sample Rate of tumor cells below detection
thresold
No
n c
on
trib
uti
ve r
esu
lts
(%)
1269 2667
16834
20761
0
10000
20000
2008 2009 2010 2011
Nom
bre
de p
ati
ents
Funding mechanisms
Offer the best treatment to patients considering the cost – effectiveness ratio
Seed fundings from INCa for the test set-up
Performance and cost evaluation
Recurrent annual fundings from the French Ministry of Health insurance
9
This programme benefits also from INCa/private partnerships
10
EGFR testing for lung cancer patients
1 724 patients + 15 000 patients -
Cost of gefitinib treatment
Example of gefitinib treatment : €69M spared cost for the health insurance
(gefinitib treatment:
38 weeks DFS; Mok 2009)
(gefinitib treatment:
8 weeks DFS; Mok 2009)
€ 35M
€ 69M
Spared cost of gefitinib treatment
€ 1.7M
Ensure the best quality for molecular tests
11
Implementation of a quality assurance programme
• Elaboration of guidelines for:
- the detection of mutations in solid tumors;
- the organization of molecular testing;
- Reports of molecular tests
• Implementation in 2011 of a national External Quality
Assessment for the 28 centres (BCR-ABL, KRAS, EGFR)
Assurance quality optimization
guide the molecular genetics centres to becoming accredited to
ISO 15189 standard as soon as possible
A new approach for rapid access to targeted therapies
Biomarkers for targeted therapies currently
evaluated in clinical trials (Phases I to III) :
Cancer Molecular target
Lung
EGFR mutations
KRAS mutations
HER2 mutations
BRAF mutation
PI3KCA mutations
ALK translocations
Colon - rectum
KRAS mutations
BRAF mutations
microsatellite instability if < 60 years
Melanoma BRAF mutations
KIT mutations
Anticipate the launch of new molecules
For the 20,000 patients with lung adenocarcinoma,
additional analysis of :
- EGFR mutations conferring resistance to TKI-EGFR;
- KRAS, HER2, PI3KCA and BRAF mutations;
- ALK translocation.
For the 17,000 patients with colorectal cancer,
additional analysis of :
- BRAF mutation;
- MSI test.
BRAF and cKIT mutations for patients with melanoma
The INCa allocated €3.5M in 2010 and €2.8M in 2011 for the prospective detection
of emerging biomarkers
Be ready to perform the test as soon as the therapy is available
Improve interface with research
Make the most of the generated data=> implementation of a lung cancer
database :
funded by INCa, coordinated by IFCT (Intergroupe Français de Cancérologie
Thoracique) and molecular genetics centres representatives
evaluate the correlation between molecular alteration identification and targeted
therapy prescription
collect both clinical data, molecular data and clinical follow up of patients
Improve interfaces with clinical research
Potential evolution of their mission : molecular genetics centres could
become testing laboratories for clinical trials
Improve interfaces with translational research
14
Towards an « all in one approach »: implementation of next generation sequencing techniques for clinical diagnostics
An expanding list of predictive tests
Conclusions and perspectives
o This initiative for targeted cancer treatment in France shows that :
innovation can be successfully integrated into the healthcare system
molecular stratification is cost effective
this organization could be easily expanded in other european settings
o These molecular genetics centres are key to help develop translationnal research and to sustain progress
o They are instrumental to facilitate access to the best care and improve patient’s survival and quality of life
o Training of medical students and professionals to personalised medicine
16