Personalized medicine in oncology … from science to policy Philippe Couillard, August 2012
Once upon a time …
A strategy ? ! Define and simplify ! Understand the world of the decision makers ! Set clear objectives, define rewards ! Educate ! Demonstrate
Decision making in Health Care : Trade offs Access Choice Quality Costs
Quality, Cost , Access ! “The pursuit of pure, undiluted quality, however, is an impossibility, a contradiction of the fundamental admixture of forces that make healthcare feasible, which is the balance of cost, quality, and access” Personnalized Medicine In Oncology (Global Biomarkers Consortium) http://www.personalizedmedonc.com/article/personalized-medicine- oncology-landscape-next-generation-cancer-care
Different angles … Evidence informed ! Cost opportunity ! Cost benefit ! Cost effectiveness ! Cost utility ! And … political benefit
Context = Costs : going down
Context : Fact more than theory ! « A fact is a simple statement that everyone believes. It is innocent, unless found guilty. A hypothesis is a novel suggestion that no one wants to believe. It is guilty, until found effective » ! Edward Teller
Cutting edge … or bleeding edge ? More bleeding than cutting if : ! Lack of consensus ! Lack of testing ! Industry resistance to change
Where is the resistance ? The Brookside Group, 2008
Cost reduction … really ? ! Costs in health care rarely ( if ever) go down ! Better : Cost avoidance or mitigation ! More efficient use of limited resources
His/her world ! The Health Care Network and its (conflicting) stake holders ! The public service ! PMO ! Treasury and finance ! The caucus ! The opposition ! The media
Must be a « whole of government » initiative ! Supported by MOH and his/her « economic » colleagues ! Education/mobilisation effort must be broader than MOH ! Showing health AND economic benefits
The initial reactions …
“ Everything should be made as simple as possible, but not simpler. ”
Environment' • !Proximal!factors:! Biology' • !Gene%cs! smoking,!diet,!sleep! • !Muta%ons! • !Distal!factors:! • !Biomarkers! educa%on,!poverty,! geography! Prevention Disease Wellness and Diagnosis Treatment Manage- Screening ment
In essence …
Not a new story after all … less hype is good ! Gleevec and Herceptin ! As usual, not the expected « giant leap forward » but a succession of small, incremental improvements ! Parallel : The fight against AIDS
What about new inscriptions ? ! For molecules with efficacy on defined sub- groups : ! Restricted inscription ! Consensus among clinicians on ROU’s ! Commitment to follow guidelines, with independent audits ! Possible redemption for molecules initially rejected ! The path for sustainable adoption
What’s the problem ? ! Inappropriate use of limited resources ! Use of expensive treatment on non responders ! Inability to identify different natural histories (prostate ca)
Well known example: Erbitux for cancer Erbitux and Vectibix block epidermal growth factor receptors (EGFRs), inhibiting cell growth in tumors PGx helps to avoid ineffective therapy … 40% of patients with metastatic colorectal cancer have a mutation in the KRAS gene, rendering Erbitux and Vectibix ineffective. With a genetic test for KRAS mutations Poten&al)) Expensive and ineffective treatment, and potential savings)of) toxicities can be avoided for these patients $3580)per) pa&ent*) Avastin (bevacizumab) -->
A real impact on patient care
What’s the objective ? ! We will be able to increase the number of patients eligible for treatment ? ! We will be able to identify non responders before treatment is initiated ? ! We will identify patients eligible for screening?
Aim for the low hanging fruits ! Not expensive new molecules, but diagnostic tests ! Single payer systems or large organisations most likely to adopt early ! A stategy to mitigate costs, not an inflationary addition
Pitfalls/mistakes ! An initial approach increasing costs ! A simplistic discourse on health care costs ! Not investing in education ( govt, providers, media) ! Using political/media pressure, bypassing the unavoidable administrative/technical steps ! Ignoring ethical questions ! Hyperbole … wrong level of expectations
Physicians know that they don’t know …
4 goals for P.M. (U.S. Dept of Health) ! Find relationships between genetics and disease that can be put into practice ! Prevent employers and insurers from using genetic data to discriminate against individuals with pre-dispositions to disease ! Ensure genetic testing is accurate and useful ! Create standards to enable data sharing
Is there a (funded) government strategy? ! Pre-requisite for productive discussions ! If not in place, indicates lack of a united effort by stakeholders … ! BC and QC are leading
Quebec : The strategy ! 2010 : Strategy on Life Sciences and Technology ! One arm of the strategy : Comprehensive, integrated development of PM ! Combined govt-private sector funding : At least 40 M$ until 2015
Why ? ! Demography and the rise of chronic illness is a major public health issue ! Better educated and informed citizens increase the demand for services ! Increased tensions on the Health Care System in an environment of limited financial resources
The destination/vision « That Quebec be recognized as a leader in the development and deployment of PM,with major benefits in terms of health, performance of the Health system,wealth creation and excellence in research »
How ? ! Creation of the « Regroupement pour les soins de santé personnalisés », including stakeholders from the private and public sectors. ! Initial (2011-2015) phase of demonstration through « projets mobilisateurs » ! Subsequent (2015-2020) phase of acceleration ! Combined, matching public/private funding ! In relation with Genome Quebec-Genome Canada initiatives
A roadmap to success
A successful strategy ? ! Starts, but does not end with the MOH ! A « whole of government » approach ! First success : A comprehensive public-private- academic strategy ! Secure funding (public-private) ! Use « optimal use of medication » as entry point ! Develop demonstration projects with tangible benefits for patients and the HC system ! Engage the public/media on the question, put ethical issues on the table
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