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

Access

Quality Costs

Decision making in Health Care : Trade offs

Choice

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.”

Wellness Prevention

and Screening

Diagnosis Treatment Disease Manage-

ment

Biology'• !Gene%cs!

• !Muta%ons!• !Biomarkers!

Environment'• !Proximal!factors:!smoking,!diet,!sleep!

• !Distal!factors:!educa%on,!poverty,!

geography!

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

40% of patients with metastatic colorectal cancer have a mutation in the KRAS gene, rendering Erbitux and Vectibix ineffective.

Expensive and ineffective treatment, and potential toxicities can be avoided for these patients

PGx helps to avoid ineffective therapy…

Erbitux and Vectibix block epidermal growth factor receptors (EGFRs), inhibiting cell growth

in tumors

With a genetic test for KRAS mutations Poten&al))savings)of)$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