“Focus Areas” in Michigan

for Specific Cancers Appropriate for

Cancer Genetic Services

June 24, 2015

MICHIGAN CANCER CONSORTIUM

Debra Duquette, MS, CGC

Michigan Department of

Health and Human

Services (MDHHS)

duquetted@michigan.gov

517.335.8286

Includes both hereditary breast and ovarian cancer and Lynch

syndrome

PROMOTING SYSTEM CHANGE THROUGH EDUCATION,

SURVEILLANCE & POLICY TO ADVANCE CANCER

GENOMICS BEST PRACTICES IN MICHIGAN

Cancer Genomics Best Practices

HP 2020 marks first time for genomics objectives Drafted by multiple federal

agencies and one state health department (MDHHS) in 2009 and approved by HP2020 in 2010

Increase the proportion of women with a family history of breast and/or ovarian cancer who receive genetic counseling

Increase the proportion of

persons with newly diagnosed colorectal cancer who receive genetic testing to identify Lynch syndrome (or familial colorectal cancer syndromes)

HEALTHY PEOPLE 2020

(HP 2020) CANCER GENOMICS OBJECTIVES

http://www.healthypeople.gov/2020/topics-

objectives/topic/genomics/objectives

2013 USPSTF BRCA EVIDENCE-BASED

RECOMMENDATIONS (UPDATED FROM 2005)

http://www.uspreventiveservicestaskforce.org/Page/Topic/recommendation-summary/brca-related-cancer-risk-assessment-genetic-counseling-and-genetic-testing

Sufficient evidence to offer counseling & genetic testing for Lynch syndrome to patients newly diagnosed with colorectal cancer to reduce morbidity & mortality in relatives

Relatives of patients who test positive for Lynch could be offered counseling, testing &, if positive, increased colonoscopy

Evidence of benefit to the patient’s relatives

2009 EGAPP RECOMMENDATION ON GENETIC

TESTING FOR LYNCH SYNDROME

Gen Med 2009;11:35-41&42-65

Autosomal dominant hereditary cancer syndrome

Most common hereditary colorectal (CRC) and uterine cancer syndrome

20-80% lifetime risk for CRC cancer

Increased risk of endometrial, ovarian, urinary tract, gastric tract, small bowel, pancreas, sebaceous cancers

Due to mutations in MLH1, MSH2, MSH6, PMS2 or EPCAM genes

1-24% lifetime risks for ovarian cancer

Risk varies based on specific mutation

WHAT IS LYNCH SYNDROME (LS)?

2012 COMMISSION ON CANCER (COC)

GENETIC COUNSELING STANDARD

http://www.facs.org/cancer/coc/cocprogramstandards2012.pdf

CURRENT NCCN GUIDELINES FOR HBOC

AND LYNCH SYNDROME MANAGEMENT

http://www.nccn.org/professionals/physician_gls/pdf/genetics_s

creening.pdf

http://www.nccn.org/professionals/physician_gls/pdf/genetics_colon.pdf

Written informed consent required by Michigan law since 2000

Physician or individual acting under physician’s authority must explain and obtain writ ten consent regarding risks, benefits, l imitat ions and other specif ic details prior to presymptomatic or predict ive genetic test

MDHHS distr ibute model consent form and pamphlet at no cost Available online

Hard copies available by contacting MDHHS Cancer Genomics Program http://www.michigan.gov/documents/mdc

h/ResourcesOrderForm_344669_7.pdf

Updated consent and pamphlet coming soon!

MICHIGAN INFORMED CONSENT LAW FOR

PRESYMPTOMATIC AND PREDICTIVE

GENETIC TESTING

http://www.michigan.gov/documents/InformedConsent_6

9182_7.pdf

5 year CDC cooperat ive agreement

awarded to four pro jects

– Authorized from Affordable Care Act (EARLY Act)

and Gynecologic Cancer Education and Awareness

Act (Johanna’s Law)

– State health departments and Tribal governments

eligible

– Projects awarded to Connecticut, Michigan, Oregon

and Utah (based largely on Michigan’s past efforts)

– Funds cannot be used for research, clinical

services, lobbying efforts or fundraising

Purpose: Enhance state heal th

department ’s capaci t ies to promote and

apply evidence-based breast and ovar ian

cancer genomics guidel ines in publ ic

heal th pract ice

Develop, enhance and evaluate education,

surveillance and policy/systems change

Emphasis on partnerships

Focus on BRCA but may also include Lynch

syndrome

May identify target populations

disproportionately affected by HBOC and lack

genetic services

2 01 4 C D C F U N D I N G A N N O U N C E M E N T

ENHANCING CANCER GENOMIC BEST PRACTICES THROUGH

EDUCATION, SURVEILLANCE AND POLICY, 2014 -2019

Purpose:

Reduce breast, ovarian and colorectal cancer incidence and mortality rates by overcoming barriers and advancing health system changes to promote cancer genomics best practices

Build upon past work and add new activities

New information systems

Data collection process

Provider education

Communication (i.e., social media)

Sustain existing partnerships and build new partnerships

Utilize three core public health functions

Assessment/Surveillance

Assurance/education

Policy/system Change

PROMOTING SYSTEM CHANGE THROUGH

EDUCATION, SURVEILLANCE & POLICY TO ADVANCE CANCER

GENOMICS BEST PRACTICES IN MICHIGAN, 2014 -2019

Promoting Cancer Genomics Best Practices through Surveil lance, Education, and Policy Change in the State of Michigan, CDC-RFA-GD08-801

Purpose: move human genome applications into health practice to maximize health benefits and minimize harm through non-research activities

Awarded from CDC Office of Public Health Genomics, 2008-2012

3 year cooperative agreement (2008-2012) awarded to three grantees

Any organization eligible (except federal agency)

Translation of evidence-based recommendations for genetic tests into practice 2005 USPSTF BRCA recommendations

EGAPP recommendations on Lynch syndrome

EGAPP recommendation on breast cancer gene expression profiling

Enhancing Breast Cancer Genomics Best Practices and Policies in the State of Michigan, CDC-RFA-DP11-1114

Purpose: develop or enhance activities related to breast cancer genomics

Authorized from Affordable Care Act

Awarded from CDC Division of Cancer Prevention & Control, 2011-2014 3 year cooperative agreement (2011-2014) awarded to three grantees

State health departments and Tribal governments eligible

Promote use of BRCA1/2 clinical practices as recommended by USPSTF and NCCN Must conduct programs in policy plus surveillance and/or health education

Cannot use funds for research, clinical practice or lobbying

PAST CDC-MDHHS CANCER GENOMICS

COOPERATIVE AGREEMENT, 2008-2014

2014 video created

by CDC and Genetic

Alliance

Highlights Michigan

as model for other

states

Importance of

Partnerships!

PUBLIC HEALTH GENOMICS

IMPLEMENTATION TO SAVE LIVES: FROM

NATIONAL VISION TO STATE SUCCESS

https://www.youtube.com/watch?v=OfjkY1lLxbE&feature=youtu.be

COMPREHENSIVE CANCER CONTROL

PLAN FOR MICHIGAN, 2009-2015

Genomics Goal: Increase availability of cancer-related

genetic information to the Michigan

public and decrease barriers to risk-

appropriate services

http://michigancancer.org/

Ovarian Cancer Goal: Improve understanding of, and access

to, genetic counseling services for

women who may be at high risk for

developing ovarian cancer.

EXAMPLES OF MICHIGAN’S PAST

ACCOMPLISHMENTS FOR HP2020 BRCA

OBJECTIVE

Growth of cancer genet ic counsel ing and

BRCA test ing of ind ividuals wi th a personal

and/or fami ly h is tory of breast and/or ovar ian

cancer

BRCA Clinical Network Database

Reduced barr iers for appropr iate BRCA

test ing wi th cont inued decrease in

percentage of ind ividuals who had genet ic

counsel ing but were not ab le to pursue BRCA

test ing due to inadequate insurance

Reduced to 8.3% of those not testing in 2014

compared to 21.7% in 2008

BRCA Clinical Network Database

Increased written health plan policies for

appropriate BRCA counseling and testing

from 4 to 16 health plans

Covering over 7.5 million Michigan

members

EXAMPLES OF PAST ACCOMPLISHMENTS FOR

HP2020 LYNCH SYNDROME OBJECTIVE

Over 20,000 cancers screened for Lynch syndrome since 2008!

MDHHS CANCER GENOMICS

OUTCOMES, 2014-2019

Ultimate long term outcome Reduce incidence and mortality related to hereditary

cancers, including breast, ovarian and colorectal cancer

Short- and intermediate term outcomes (by 2019): Increase knowledge among key clinical and policy

stakeholders about cancer genetic best practices; improved access to and coverage of cancer genomics best practices [Policy/system change]

Improve ability to assess the burden of hereditary cancers and use of cancer genomics best practices; increased production and dissemination of periodic cancer surveillance reports. [Surveillance]

Increase knowledge of hereditary cancers and appropriate use of cancer genomics best practices among the public and health care providers. [Education]

Improve partnerships and coordination among key stakeholder groups regarding cancer genomics services and care. [Partnerships]

EXAMPLE OF LONG -TERM OUTCOME:

MI MORTALIT Y RATES FOR BREAST CANCER IN YOUNG WOMEN,

BLACK AND WHITE, 1990 -2012

Decrease in breast cancer in young women incidence and mortality in Michigan from 1990-2012 5.2 per 100,000 in 2010

compared to 8.7 deaths per 100,000 in 1990

In Michigan, 2012 marked the first year since 1990 that there was not a statistical difference in black/white mortality 5.2 deaths per 100,000 for young

black women vs. 4.6 per 100,000 for young white women

0

2

4

6

8

10

12

14

16

1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012

Age

-Ad

juste

d M

ort

alit

y R

ate

s (

pe

r 1

00

,00

0)

Year

Figure 4. Age-adjusted mortality rates of breast cancer in black and white females under age 50 in Michigan from 1990-2012.

White

Black

0

2

4

6

8

10

12

14

16

18

20

1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Age

-Ad

juste

d In

cid

en

ce

Rate

(pe

r 10

0,0

00

)

Age-adjusted incidence rates of ovarian cancer in females of all ages in Michigan,1990-2010.

In 2010, 753 cases diagnosed No signif icant racial

disparit ies

Annual mortality rate steady over past decade Huron, St. Joseph and

Cass highest mortality

Decline in incidence from 1990 to 2010 16.9/100,000 in 1990 to

12.7/100,000 in 2010

Alpena (22.1), Huron (19.7), Newago (18.4), Midland (18.4), Berrien (17.5), Saginaw (17.1), Bay (17.1) highest incidence in 2006-2010

EXAMPLE OF LONG-TERM OUTCOME:

AGE- ADJUSTED INCIDENCE RATES OF OVARIAN CANCER IN

MICHIGAN, 1990-2010

High incidences are in geographic regions and counties that

lack genetic services

GEOGRAPHIC FOCUS

Figure 1

Figure 2

Figure 3

Female Breast Cancer under 50 years of age Declined slightly over 20 year period from 1990-2010

Age-adjusted incidence of ~45/100,000 in 1990 to ~41/100,000 in 2010

Ten year age-adjusted incidence was 42.1/100,000 from 1998-2007 In 2010, age-adjusted incidence was 40.6/100,000 (1,332 cases)

Counties with highest age-adjusted incidence in Emmett (52.3), Manistee (52.1), Grand Traverse (51.7), Leelanau (50.4), Mason (45.2)

Ovarian Cancer Declined over 20 year period from 1990-2010

Age-adjusted incidence of 16.9/100,000 in 1990 to 12/100,000 in 2010 (753 cases)

Counties with highest age-adjusted incidence from 2006-2010 in Alpena (22.1), Huron (19.7), Newago (18.4), Midland (18.4), Berrien (17.5), Saginaw (17.1), Bay (17.1) in 2006-2010

Colorectal Cancer Declined at any age from 1990-2010

Age adjusted-incidence from 64.7/100,000 in 1990 to 41.6/100,000 in 2010 (4.691 cases)

Increased before age 50 slightly from 1990-2010

Counties with highest age-adjusted incidence from 2006-2010 in Huron, Gratiot, Oscoda, Tuscola, Lapeer

AGE-ADJUSTED INCIDENCE OF CANCERS AT

HIGHER HEREDITARY CANCER RISK IN

MICHIGAN, TRENDS AND TOP COUNTIES

BRCA CLINICAL NETWORK

Ultimate long term outcome Reduce incidence and mortality related to hereditary cancers,

including breast, ovarian and colorectal cancer

Could higher age-adjusted incidence in these geographic areas be due to hereditary cancers? Other possibilities? What are possible ways to reduce incidence related to hereditary cancer including breast, ovarian and colorectal cancer? Mortality?

INPUT FROM MCC REGARDING ULTIMATE

LONG-TERM OUTCOME

MDHHS Cancer Genomics Partners & Roles Partners Surveillance Policy Education

CDC DCPC

CDC OPHG

Jackson Laboratory/ASHG

MI Cancer Surveillance Program

MDCH Cancer Prevention & Control

Michigan Medicaid

Michigan BRFS

Michigan Cancer Consortium

Michigan Cancer Genetics Alliance

Michigan Association of Health Plans

BCBSM

Priority Health

Lynch Syndrome Screening Network

BRCA Clinical Network

Kintalk.org (UCSF)

NCCN experts

Michigan HBOC advocates (i.e. FORCE,

MiOCA, BRCAn’t Stop Me)

Michigan Lynch Syndrome advocates

(i.e. LSI, MiOCA)

MDHHS CANCER GENOMICS PARTNERS &

ROLES

CDC Expected Policy/System Change Outcomes by 2019:

Increase knowledge among key clinical and policy stakeholders

Improve access to, and coverage of, cancer genomics practices for high risk individuals

MDHHS Policy/System Change Strategy :

Develop and expand system and policy initiatives to promote increased use of recommended clinical practices and improve access to care

MDHHS Activities:

Activity P1: In years 1-3, MDCH will continue partnership with Michigan Cancer Consortium (MCC) and others to develop and promote a model for health systems regarding high breast cancer risk assessment, identification, referral and follow-up as recommended by USPSTF and NCCN

Promote Commission on Cancer (CoC) Standard 2.3: Risk Assessment and Genetic Counseling

Updated MCC/MCGA Position Statement on Genetic Counseling/Testing

Focus on health systems without cancer genetics on-site

OVERVIEW OF 2014-2019 POLICY

ACTIVITIES

What are possible ways to increase knowledge among key clinical stakeholders? Key policy stakeholders?

What are possible ways to improve access to, and coverage of, cancer genomics practices for high risk individuals? Especially in underserved cancer genomics areas?

Ideas for possible model(s) for health systems regarding high breast cancer risk assessment, identification, referral and follow-up as recommended by USPSTF and NCCN?

INPUT FROM MCC REGARDING EXPECTED

POLICY/SYSTEM CHANGE OUTCOMES

Activity P2: In years 1-

5, MDCH will develop and

implement models to

improve access to genetic

counseling and testing of

patients recently

diagnosed with ovarian

cancer as recommended

by NCCN

Unexpected 2014/2015

Policy Facilitators

December 2014

January 2015 SGO

Statement

2014-2019 POLICY ACTIVITIES

CONTINUED

Activity P3: In years 1-5,

MDCH will encourage MI health

systems to become full LSSN

members

Activity P4: In years 1-5,

MDCH will continue to partner

with MAHP and MCGA to

recognize health plans that are

aligned with Cancer Genomics

Best Practices for HBOC and

LS as recommended by

USPSTF, NCCN, EGAPP and

Michigan law

2014-2019 POLICY ACTIVITIES

CONTINUED

Activity P5: In years 1-5,

MDCH will develop and

assess multiple approaches

to implement cascade

screening best practices

util izing health system

policies, electronic reporting,

social media, health

insurance policy, laboratory

reporting and/or position

statements

2014-2019 POLICY ACTIVITIES

CONTINUED

http://kintalk.org/

CDC Expected Policy/System Change Outcomes by 2019:

Increase knowledge of hereditary cancers and genomics best practices among public and health care providers

Increase appropriate use cancer genomics best practices by the public and health care providers.

MDHHS Policy/System Change Strategy :

Develop and expand educational opportunities for the public and health care providers on hereditary cancers and cancer genomics best practices

MDHHS Education Activities:

Activity E1: In years 1-5, MDHHS Genomics will partner with CDC, MDHHS Communications, MDHHS Cancer, MCGA, MCC, FORCE, LS patient advocates, ‘local champions’ and others to increase public awareness of family history of cancer and hereditary cancer syndromes

Public awareness campaigns in geographic regions with higher age -adjusted incidence of cancers at hereditary risk

OVERVIEW OF 2014-2019 EDUCATION

ACTIVITIES

What are possible ways to increase knowledge

of hereditary cancers and genomics best

practices among public? health care providers?

What are possible ways to increase appropriate

use cancer genomics best practices by the

public? health care providers?

INPUT FROM MCC REGARDING EXPECTED

POLICY/SYSTEM CHANGE OUTCOMES

MDHHS Education Activities (continued):

Activity E2: In years 1-5, MDHHS will partner with JAX/ASHG to develop and disseminate blended learning opportunities for primary care providers (PCPs) in counties with high incidence of cancers at risk for hereditary cancer syndromes and lacking cancer genetic services

First workshop planned in Traverse City on October 17, 2015

Activity E3:In years 1-5, MDHHS will develop and disseminate existing and new patient and provider educational resources on cascade screening

Activity E4: In years 1-5, MDHHS will continue efforts to educate and provide technical assistance to MI health plans, health systems and health professional organizations about relevant cancer genetic policies and resources utilizing local cancer incidence and mortality, and BRCA and LS data whenever possible

Activity E5: In years 1-3, MDHHS will continue to maintain, evaluate and disseminate the continuing education HBOC module, and modify if needed

Activity E6: In years 1-5, MDHHS will maintain, update and disseminate existing websites relevant to this project.

OVERVIEW OF 2014-2019 EDUCATION

ACTIVITIES (CONTINUED)

First degree adult relat ives of individuals with a known deleterious BRCA or Lynch syndrome mutation Cascade screening!

Past Surveillance Data BRCA Clinical Network phone survey

Of patients with known deleterious mutations and patients who were ‘true negative’:

11.7 and 9.2 relat ives told about result

Only 2.2 and 1.1 of relat ives had subsequent test ing

BRCA Clinical Network Data Reveals health disparities

Only 3.3% of Afr ican American patients present for counseling with known mutation vs. 13.4% of white patients

Statewide data from Myriad compared to our BRCA Clinical Network ~400 single site tests ordered in MI in 2011

(increased by only 12.1% from 2008)

Compared to ~4,000 comprehensive tests (72.2% increase from 2008) and ~800 BART (370.9% increase from 2008)

54.1% of ~400 single sites ordered by genetic professionals in 2011

Patients with a personal history of ovarian cancer At risk for BRCA and LS

Past Surveillance Data

Michigan Cancer Surveillance Program

Only 3.6% of ovarian cancers diagnosed in 2006-2010 had received cancer genetic counseling

BRCA Clinical Network Data

29.4% with history of breast and ovarian cancer (n=92) had known deleterious BRCA mutation

14% (n=293) with ovarian cancer had known deleterious mutation

Of 1,218 women with cancer who did not pursue BRCA testing after counseling, 50% of women with breast and ovarian and 30.6% with ovarian cancer did not pursue BRCA testing due to inadequate insurance coverage

EXAMPLES OF MI POPULATIONS AT GREATEST RISK

FOR HEREDITARY CANCERS & IN NEED OF SERVICES

Patients with a personal history

of breast cancer diagnosed at a

young age At risk for BRCA

Past Surveillance Data

Michigan Cancer Surveillance

Program

Young Breast Cancer Survivors

surveyed and 57.3% had not received

genetic services

Top barrier was no one had

ever recommended these

services

BRCA Clinical Network

7.8% of patients with young breast

cancer found to have known

deleterious mutations

EXAMPLES OF MI POPULATIONS AT GREATEST RISK

FOR HEREDITARY CANCERS & IN NEED OF SERVICES

Patients with a personal history

of colorectal cancer At risk for Lynch Syndrome

Past Surveillance Data

Michigan BRFS, 2010

80% of individuals with colorectal

cancer and their immediate relatives

had no awareness of hereditary

cancer genetic testing

Only 3% of these individuals had

genetic testing

Michigan Cancer Surveillance

Program

Less than 2% diagnosed in 2006-

2010 had screening for LS based on

chart reviews

What are other possible ideas to increase

access to cancer genetics services for these

populations at highest risk?

INPUT FROM MCC REGARDING PAST

SURVEILLANCE/EPIDEMIOLOGY FINDINGS

Some of this presented work was supported by the Cooperative Agreement Number 5U58DP003798-03

and 1U58DP005357 from The Centers for Disease Control and Prevention (CDC). Its contents are solely

the responsibility of the presenter and do not necessarily represent the official views of the CDC.

THANK YOU!