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Personalized Medicine:,[object Object],Can a non-profit public organization,[object Object],afford it – and for what purpose ?,[object Object],Nicky Liebermann  MD, Head – Community Medicine Division,[object Object],ShmuelKlang PHD, Head – Pharmacology and Pharmacy ,[object Object],Clalit Health Services,[object Object]
February 13, 2006:,[object Object],  ‘Clalit Health Services’ will fund the most advanced  test for breast cancer patients that will determine if they require chemotherapy.,[object Object],   The test, called 'Oncotype DX', allows identifying ,[object Object],    which patients will benefit from a chemotherapy,[object Object],    treatment, and which patients can be spared this,[object Object],    harsh treatment.,[object Object],A breakthrough and news for breast cancer patients:,[object Object]
Why ???,[object Object],The Israeli medical insurance system –,[object Object],National health law,[object Object],4 HMO’s as service and insurance givers,[object Object],COMPETITION !!!!,[object Object],Every quarter any ensuree can change HMO,[object Object],Fixed basal basket of services,[object Object],Fixed payments (by the state),[object Object],   So we can compete only on quality, service and innovation,[object Object]
Why,[object Object],In Israel, polls found that women lead the family and its decisions in the fields of education and health. So the woman will chose the physician, the HMO/health plan etc.,[object Object],OncotypeDX-Breast presented the opportunity to tell breast cancer patients, with a sound level of certainty that after the surgery they are probably healthy !!!,[object Object]
Last why,[object Object],A wide psychological gap exists between the definition of a cancer patient, and a “cured” one. This impacts the health status of the whole family, it’s life style, it’s spirit.,[object Object],Clalit decided to invest the needed amount in order to offer it’s customers this product and by it to try and promote the general and personal health status of these families.,[object Object]
The process,[object Object],Oncologists cooperation – Imperative !!!!,[object Object],Accepted guidelines/protocol,[object Object],Medical and economical survey and sharing of the DATA with the clinicians,[object Object],The decision was to introduce the new technology for Clalit’s ensurees – accompanied by a common research with the company and the oncologists,[object Object]
Method,[object Object],The medical division developed assigned form for OncotypeDX Breast  approval.,[object Object],The form contains the following information: ,[object Object],Tumor size and biological markers,[object Object],The treatment the patient would have received without  OnctoypeDX Breast assay,[object Object],The treatment the patient would receive for each Recurrence Score range – INTENTION TO TREAT,[object Object],Finally, based on Clalit database the patients’ actual treatment was reviewed. ,[object Object]
Analysis,[object Object],Comparing the proposed treatment the patient would have received without OncotypeDX Breast with the actual, post OncotypeDX treatment (Intention to treat vs final decision),[object Object],Comparison with the pre-written treatment according to the future RS  range with the actual treatment,[object Object]
Clalit leads the OncotypeDX breast assays performed annually in Israel,[object Object]
Clalit leads the OncotypeDX breast assays performed annually in Israel for Node + breast cancer patients,[object Object]
First change in the protocol was to approve the test for node+ cases – long before it was accepted by others.,[object Object]
Treatment Recommendation before and after OncotypeDX Breast testing(N=313),[object Object]
Chemotherapy by Risk Level,[object Object]
Average Added Cost (Saving) Per Patient,[object Object],Average added cost$1828,[object Object],Oncotype,[object Object],Recurrence costs,[object Object],Supportive care,[object Object],Chemotherapy,[object Object],Adverse events,[object Object]
Economical and Clinical Applications,[object Object],The use of OncotypeDX Breast assay changed the treatment recommendation in 40% of the cases,[object Object],84% Shifted from hormonal therapy+ chemo to hormonal therapy only.,[object Object],8% of high risk patients by RS shifted from hormonal therapy to hormonal +chemo.,[object Object],The assay cost was partially funded by saving the chemotherapy and side effects related treatment costs.,[object Object]
The quality-adjusted life year (QALY) is a measure of disease burden, including both the quality and the quantity of life lived.,[object Object],Shifting from combination Chemo+Hormonal therapy to Hormonal therapy only = side effect prevention and better health status. ,[object Object],Preventing disease recurrence for some of the patients found to be high risk by the assay.,[object Object],QALYs Gain,[object Object]
Cost-effectiveness ratio,[object Object],The QALY is based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for death.,[object Object],Cost with Oncotype DX – Cost without Oncotype DX,[object Object],QALYs with Oncotype DX – QALYs without Oncotype DX,[object Object],$1,828,[object Object],= $10,770 per QALY gained,[object Object],0.170 QALYs,[object Object]
NEJM: 2005: 353(14):1516-1521,[object Object]
Gene Profiling in Clinical Oncology - Slide 12 - N. Liebermann - But can my health system afford the cost?
Gene Profiling in Clinical Oncology - Slide 12 - N. Liebermann - But can my health system afford the cost?
Conclusion – Oncotype DX resulted in net QALY gain and increased  overall costs, with an incremental cost effectiveness ratio of  10,770 $ per QALY gained.  ,[object Object],Oncotype DX represents an effective and affordable approach to favorably affect the lives of women with ESBC.,[object Object]
OncotypeDX breast N+ poster at ASCO 2010,[object Object]
OncotypeDX was used primarily in patients with micro-metastases, and 1 positive node (84% of patient population).,[object Object],Treatment decisions in these node-positive breast cancer patients was influenced primarily by the RS results and then by the nodal status.,[object Object],Patients with Nmic and RS<31 received less chemotherapy than patients with N1-3 and RS<31. ,[object Object],All patients with RS>31 received adjuvant chemotherapy.,[object Object],OncotypeDX breast N+ poster at ASCO 2010- main points,[object Object]
Ongoing studies of Clalit with OncotypeDX breast,[object Object],Comparing treatment decision in N+ cases with RS data vs. matching control cases not analyzed for RS.,[object Object],Comparing the real recurrences vs. RS in the Clalit database of over 3,000 cases.,[object Object],ER, PR, HER2 status by IHC compared with that in RT-PCR by OncotypeDX. ,[object Object],Evaluation of the RS predictive value by clinico-pathological factors.,[object Object]
Gene Profiling in Clinical Oncology - Slide 12 - N. Liebermann - But can my health system afford the cost?
Who is in the high risk group?,[object Object],Stage II colorectal patients  ,[object Object],Low Risk patients,[object Object],High Risk patients,[object Object],30-50% ?,[object Object],50-70% ?,[object Object],1. Perforation,[object Object],94-95% 5y survival,[object Object],2. Lympho-vascular involvement,[object Object],3.Perineural invasion,[object Object],4. Preoperative CEA,[object Object],5. Obstruction,[object Object],6. < 10-12 lymph nodes examined,[object Object],7. Poor Tumor differentiation ,[object Object],8. T4,[object Object],9. Tumor budding,[object Object],DFS =4%, OS 1-2% (NS),[object Object]
Gene Profiling in Clinical Oncology - Slide 12 - N. Liebermann - But can my health system afford the cost?
Profiles & Biomarkers Used in Clalit,[object Object],OncotypeDX Breast: Early breast cancer,[object Object],OncotypeDX Colon: Stage II colon cancer,[object Object],miRview mets: Carcinoma unknown primary,[object Object],K-RAS: Metastatic colon cancer,[object Object],EGFR: Non small cell lung cancer,[object Object]
Conclusions 1,[object Object],Although “money makes the world go around”, there are other values to gain by implementing this new technology – better medical quality &  accuracy, better quality of life for the patients & families, and, may be, with the improvement in the technology of “directing therapy” – targeted medicine, that will be even cost efficient because inefficient treatments will be avoided.   ,[object Object]
Conclusions 2,[object Object],Implementation of a new technology should be supported by –,[object Object],Agreement/acceptance of the profession ,[object Object],Defined/accepted protocol of use,[object Object],Registered follow up of cases,[object Object],Sharing the results with the clinicians  ,[object Object]
Thank you,[object Object]

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Gene Profiling in Clinical Oncology - Slide 12 - N. Liebermann - But can my health system afford the cost?

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