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Cancer care is increasingly tailored to individual patients, who can undergo genetic or biomarker testing soon after diagnosis, to determine which treatments have the best chance of shrinking or eliminating tumours.
In this webinar, a pathologist and clinical oncologist discuss:
● how they are using these new tests,
● how they communicate results and treatment options to patients and caregivers, and
● how patients can be better informed on the kinds of tests that are in development or in use across Canada
View the video: https://youtu.be/_Wai_uMQKEQ
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Precision Medicine in Oncology
1. Diagnostics and treatment pathways for
cancer patients
November 29, 2016
Precision medicine in oncology
2. Panelists
2
Dr. Paul Wheatley-Price
Medical Oncologist, Ottawa Hospital
President, Lung Cancer Canada
Dr. Diana Ionescu
Oncological Pathologist,
British Columbia Cancer Agency
Department of Pathology
Rachael Manion
Senior Associate, 3Sixty Public Affairs
4. 4
• Testing tumors to identify the best treatment for
the right patient at the right time
• Biomarker testing
5. Biomarkers
• A characteristic that is objectively measured and evaluated
as an indicator of normal biologic processes, pathogenic
processes, or pharmacologic responses to a therapeutic
intervention (National Institute of Health definition).
• Biomarkers can be used:
– To understand the pathobiology of the disease
– For diagnosis
– For disease monitoring
– As a specific target for drugs
5
6. Biomarkers being used across diseases – but
most frequent application in cancer
6
http://chartpack.phrma.org/personal-medicines-in-development-
chartpack/a-new-treatment-paradigm/personalized-medicines-are-
benefitting-patients-across-many-different-diseases
*FDA approvals with biomarker information in the approved labeling
Source: U.S. FDA, “Paving the Way for Personalized Medicine,” Oct 2013
7. How Can Biomarker Testing
Optimize Patient Care in Oncology?
• Correct Diagnosis
• Correct Treatment
• Correct Drug Dose
Biomarker testing identify subgroups of patients for
whom select drugs are most effective and safe
7
10. An Analogy:
Bacteria testing determines the right antibiotic
• Personalized care is not new to medicine:
– Laboratory testing to assess the sensitivity of infectious
agents to various antibiotics is an established cornerstone
in determining therapy
– This well established approach ultimately:
• Improves patient outcomes
• Avoids side effects or inappropriate treatment
• Shortens hospital stays
• Minimizes unnecessary physician visits
10
11. Testing for Appropriate Antibiotic Therapy
Long term outcomes:
• Testing process helps to limit antibiotic resistance
• Avoid health care complications (including death)
• Prevent unnecessary expenses
• This entire chain of medical events is most
efficiently and effectively directed by relatively
inexpensive but highly reliable and specialized
tests that are implemented in a timely fashion
11
12. Best Use of Health Resources
• As with antibiotics, a relatively inexpensive
laboratory test can determine the best use
of health care resources
12
13. Cancer Molecular Testing:
A revolution started with targeted therapy
• Similarly, the greater our understanding of the
molecular diversity of cancers, the greater our
awareness of their unique sensitivity and
resistance to specific drugs
• The role of oncologic pathology is increasingly
important with the introduction of precedented new
standards for companion diagnostic tests to
identify patients who will best benefit from a given
targeted anticancer drug*
13
*Butts et al. Curr Oncol. Oct 2013; 20(5): e475–e483
*Ellis et al. Journal of Thoracic Oncology • Volume 6, Number 8, August 2011
*CAP IASLC AMP Molecular Testing Guideline in Lung Cancer. J Thorac Oncol April 2013
14. As Sir William Osler noted more than a
century ago…
"As is your Pathology, so
is your Medicine"
14
Diana N. Ionescu, MD, FRCP(C), FCAP
Senior Consultant Pathologist, BC Cancer Agency
Clinical Professor, University of British Columbia
Email: dionescu@bccancer.bc.ca
16. Biomarkers are helping personalize
cancer care…
Different People’s Tumours Have
Different Biomarkers
Biomarkers commonly found in
non-small cell lung cancer
ALK EGFRKRAS PD-L1
17. Biomarkers being used across diseases – but
most frequent application in cancer
17
http://chartpack.phrma.org/personal-medicines-in-development-
chartpack/a-new-treatment-paradigm/personalized-medicines-are-
benefitting-patients-across-many-different-diseases
*FDA approvals with biomarker information in the approved labeling
Source: U.S. FDA, “Paving the Way for Personalized Medicine,” Oct 2013
21. Clinical impact of treatment
• Commenced gefitinib 250mg od Jan 2012
• Grade 1 rash and diarrhea
• Vision improved within a few weeks
21
Dec 2011 March 2012
22. Osimertinib – for emerging T790M
resistance mutation
22Janne et al. NEJM 2015; 372(18): 1689-1699
24. In Canada, biomarker tests follow a varied and complex
path to health system adoption and patient access
24
Regulatory
Authorization
Health
Technology
Assessment
Funding
Decisions
Health System
Adoption /
Patient Access
25. 25
2016 State of Play
Patients with advanced NSCLC and good PS
Wildtype NSCLC
Platinum doublet CT
Pemetrexed or
Docetaxel
Erlotinib
ALK positive
Crizotinib
EGFR positive
Gefitinib / Erlotinib
Afatinib
3rd gen TKI 2nd gen ALK
ROS1 positive
Nivolumab
Maintenance pemetrexed
Crizotinib
Line
1st
Maint
2nd
3rd
PDL1: Pembrolizumab
26. Funding for different technologies
26
Hospitals Drugs
Healthcare
providers
Laboratory
27. New assessment process for both
drugs and companion tests
27
CADTH: CDR Update – Issue 120, CADTH’s Proposed Process for the Assessment of Companion Diagnostics
28. Biomarker testing priorities
• National precision medicine strategy
• Molecular oncology strategies
– SK: 2015-2020 Strategic Plan
• Develop molecular oncology strategy
– MB:
• Manitoba Cancer Plan 2016-2021 (April 1, 2016)
– Increase access to genetic testing to support personalized treatment
• Diagnostic Services Manitoba Strategic Plan 2016-2020: Results that
Matter
– Plan, prioritize and implement molecular diagnostic tests in pathology (e.g. EGFR for lung cancer)
– Introduce next generation sequencing into the clinical laboratory (for BRCA1/2 and EGFR, etc.)
– ON: Ontario’s Cancer Plan IV, 2015-2019:
• Begin implementation of pathology accountability framework: 2019
• Develop a personalized cancer care strategy: 2019
28
29. Gaps, challenges and opportunities remain…
• No clear, consistent pathway for health system
uptake
• Rapidly evolving knowledge on the role / place of
biomarkers in treatment guidelines
• Knowledge translation to patients
• New drugs / diagnostics are perceived as challenges
to budgets / health system sustainability
• Lack of evidence development programs and data
collection
29
30. There are many ways patients can engage
Patients can ask the right questions:
• What biomarker tests are recommended and
why?
• How are the tests performed?
• How often do I need the tests?
• What do the results of the tests mean?
• How will the results affect my treatment
options?
Patients can engage in the policy discussion:
• Getting involved in personalized medicine policy
and advocacy
30
33. Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/
Notas do Editor
An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology.
With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
Many biomarkers are being studied in cancer, and what we recognize now is that no two people are exactly the same; no patients’ tumors are exactly the same.
Specifically, different people’s tumours can have different biomarkers.
For example, biomarkers tests available to lung cancer patients include:
KRAS mutation analysis: KRAS is a gene that may cause cancer when it is mutated, or changed. Tumors with a KRAS mutation do not have mutations in EGFR or ALK, and cannot be treated with drugs that target these two abnormal proteins.
ALK testing: People with a mutation in the ALK gene may respond to ALK inhibitors, which block signals that tell the tumor to grow and divide.
EGFR mutation analysis: The EGFR gene makes a protein that regulates cell survival and cell division. A test called EGFR mutation analysis can be performed to help determine whether a patient is likely to respond to treatment with an EGFR inhibitor.
PD-L1: PD-L1 is an immune-related biomarker that can be expressed on tumor cells. PD-L1 testing helps predict response to PD-L1 immunotherapies.
Testing for the presence of these biomarkers can help doctors decide whether one treatment is more likely than another to work in their patient. This can:
Improve health outcomes and provide safer treatments for patients
Reduce unnecessary treatment and adverse effects
Achieve health system efficiencies by only treating patients that are most likely to benefit from the drug
An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology.
With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology.
With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology.
With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
At the present time, there is no clear and consistent pathway to introduce a biomarker test in Canada’s health system. This can create delays and uneven coverage in accessing new personalized medicines.
Regulatory authorization:
Biomarker tests first need to be authorized by Health Canada.
There is, however, no specific process for a drug and its related biomarker test to be reviewed together by Health Canada. The drug is evaluated separately from the biomarker test, which is evaluated as a medical device. This can be a challenge in terms of coordinating and aligning the review process so that the drug and the associated test receive market authorization at the same time given that the regulatory review timelines for each of these components are different.
Health Technology Assessment:
The national health technology assessment agency CADTH has reviewed several targeted therapies, especially oncology therapies, with biomarker tests.
However, there is not currently a national standardized process for determining the clinical utility and reimbursement rates for companion diagnostic tests.
CADTH is currently working on developing a review process that will provide advice on public reimbursement of “companion diagnostics”. It plans to consult on this process and implement it in 2017.
Quebec, which has its own health technology assessment agency INESSSS, has put in place a mandatory evaluation process for biomarker tests. However, there is no pathway to evaluate the drug at the same time as its related biomarker tests.
Funding Decisions:
Funding mechanism are often not well defined and vary from one province to another
QC : has a central decision-making process for reimbursement which is based on the recommendations made by INESSS (i.e., Health Ministry decides on reimbursement of tests).
ON: Cancer Care Ontario provides funding for biomarker tests that are related to cancer therapeutics. It has a separate process for determining reimbursement. Review of tests to determine funding is also conducted by the Ontario Health Technology Advisory Committee, which is part of Health Quality Ontario and by the Genetic Testing Advisory Committee established by the Ontario Ministry of Health.
Health System Adoption:
Ultimately, even when a biomarker test has been authorized by Health Canada and is reimbursed for funding, there can still be challenges in integrating the test into clinical practice.
There can be reluctance in the medical community with regard to uptake or use of novel clinical tests. Physicians need to understand the information provided by the test and know how to integrate it into their decision making process.
Patients need to know how they can benefit from novel tests, and to understand the implications of new information the tests can provide.
SASKATCHEWAN
The SKCA’s 2015-2020 Strategic Plan identified the development of a molecular oncology strategy as an initiative it would undertake in 2015-16 and has reported that it is working with health regions to introduce molecular testing for oncology diagnosis and treatment. Each health region oversees the specific lab services in its region. http://www.saskcancer.ca/adx/aspx/adxGetMedia.aspx?DocID=726,6,1,Documents&MediaID=53c617fe-aee2-46a9-b973-893737 09ddb6&Filename=Strategic+Plan+2015-2020+FINAL.pdf
http://www.saskcancer.ca/Default.aspx?DN=53be3acb-a7fd-4e9f-926f-219b002000d6
MANITOBA
One of the goals of the DSMB’s five-year strategic plan, Diagnostic Services Manitoba Strategic Plan 2016-2020: Results that Matter, is the creation of a provincial genomics strategy for molecular diagnostics and cytogenetics, which expands over three to five years. The plan identifies four operational strategies to achieve this goal:
Develop a Provincial Genomics Testing Advisory Committee (GTAC), who will develop Manitoba’s Provincial Genomics Testing Strategy with the collaboration of key stakeholders;
Plan, prioritize and implement molecular diagnostic tests in pathology – in particular, EGFR for lung cancer;
Introduce next generation sequencing into the clinical laboratory (for BRCA1/2 and EGFR, among others); and
Build relationships and develop clinical and research partnerships to transition testing to the clinical laboratory and develop funding opportunities and proposals.
http://dsmanitoba.ca/wp-content/uploads/2015/07/DSM-Strategic-Plan-2016-2021-Final.pdf
ONTARIO:
In terms of broader cancer policy, Ontario is on its fourth multi-year cancer plan, Ontario’s Cancer Plan IV, 2015-2019, which sets out six system goals, each with their own strategic objectives (certain of which are below):
Quality of life and patient experience across the care continuum;
Safety of patients and caregivers, part of which will be to implement an accountability framework and performance management structure for pathology, among other areas, by 2019;
Equity for patients, through providing advice to government on improving access to services for specific populations, including “equitable access to specialized services”;
Integrated care across the continuum, involving standardized care plans for patients and increased availability of relevant patient clinical information to providers to support evidence-based decision-making;
Sustainability of the cancer system, part of which involves a planned evaluation of drugs funded through the Provincial Drug Reimbursement Program to determine which provides the greatest benefit to patients and its corresponding impact on the healthcare system by 2019; and
Effectiveness of cancer care, based on best evidence, in particular through the development of “a unifying strategy for personalized medicine for cancer care including personal and tumour genetics, and incorporat[ion of] recommendations into clinical practice”, with implementation beginning by 2019.
https://cancercare.on.ca/common/pages/UserFile.aspx?fileId=333871
So what do you need to know?
Well, the uptake and diffusion of biomarkers is transformative and changes the way disease is identified and managed. However, integrating biomarkers into clinical practice faces several challenges which will need to be addressed to ensure optimal patient access to new targeted and specialized therapies. Challenges include…
No clear, consistent pathway for introducing biomarkers in health system:
Lack of a systematic approach for evaluating and funding biomarkers
Inconsistent access to drugs and biomarkers based on different timelines in each province for reimbursement
Challenge of ensuring test is in place simultaneously with drug funding
Rapidly evolving knowledge on the role / place of biomarkers in treatment guidelines
Lack of knowledge translation to patients on biomarker tests and their purpose
Challenge for provinces of assessing and reimbursing multiple new entrant cancer drugs and related biomarker tests
No evidence development pathways and data collection in health systems in Canada that would help collect data on new drugs and associated tests
The illustration shows how a biomarker test is performed.
The clinician will discuss the test and the purpose of the test with his patient.
A tissue sample (biopsy) of the tumor will then be taken, and the clinician orders the biomarker test. If a patient has already had a biopsy, he or she may not have to get another one. The clinician may be able to see if the tumors are positive for certain biomarkers by testing a previous sample with a biomarker test.
The biopsy is sent to a lab and is analyzed.
The clinician will get the results and discuss treatment options with the patient based on these results.
Patients can aim to learn more and engage with their health care team and/or patient group to better understand how biomarker tests can help shape their treatment. Key questions to consider include:
What biomarker tests are recommended and why?
How are the tests performed?
How often do I need the tests?
What do the results of the tests mean?
How will the results affect my treatment options?
In this regard, I want to mention that the Canadian Cancer Survivor Network will be hosting a webinar on biomarkers on November 29th.
Patients and patients groups can also get involved in personalized medicine policy and advocacy:
work with health technology assessment agencies and payers to ensure that value assessments are patient-centered and that biomarker tests are reimbursed and included as part of patient care
work with payers to ensure that emerging paying models are aligned with personalized medicine and that they recognize the improved health outcomes from personalized medicine
In particular, patients and patient groups will get the chance to provide input on the new evaluation process for companion diagnostics that CADTH is developing in the coming months.
The illustration shows how a biomarker test is performed.
The clinician will discuss the test and the purpose of the test with his patient.
A tissue sample (biopsy) of the tumor will then be taken, and the clinician orders the biomarker test. If a patient has already had a biopsy, he or she may not have to get another one. The clinician may be able to see if the tumors are positive for certain biomarkers by testing a previous sample with a biomarker test.
The biopsy is sent to a lab and is analyzed.
The clinician will get the results and discuss treatment options with the patient based on these results.
Patients can aim to learn more and engage with their health care team and/or patient group to better understand how biomarker tests can help shape their treatment. Key questions to consider include:
What biomarker tests are recommended and why?
How are the tests performed?
How often do I need the tests?
What do the results of the tests mean?
How will the results affect my treatment options?
In this regard, I want to mention that the Canadian Cancer Survivor Network will be hosting a webinar on biomarkers on November 29th.
Patients and patients groups can also get involved in personalized medicine policy and advocacy:
work with health technology assessment agencies and payers to ensure that value assessments are patient-centered and that biomarker tests are reimbursed and included as part of patient care
work with payers to ensure that emerging paying models are aligned with personalized medicine and that they recognize the improved health outcomes from personalized medicine
In particular, patients and patient groups will get the chance to provide input on the new evaluation process for companion diagnostics that CADTH is developing in the coming months.