Expanding Access to Genetic and Genomic Testing

2. Expanding Access to Genetic and Genomic Testing Chad RamseyVice President, Policy, Ovarian Cancer Research Alliance Vanessa CramerDirector, Policy, Ovarian Cancer Research Alliance Sponsored by: Genentech, Inc. #OvarianConf

3. Agenda • Setting the table: Timeline & key terms • What the guidelines say • Zooming in on our population • Insurance coverage landscape • Medicare coverage • Efforts to shore up coverage • Federal legislation on the horizon • What you can do & where to go from here

4. Setting the table: Timeline • June 2013 — Supreme Court decision ruling in Association for Molecular Pathology v. Myriad invalidates human gene patents •  Paving way for rapid expansion of clinical options for genetic testing through Next Generation Sequencing (NGS) • NGS is a high-throughput DNA sequencing technology that offers more information w/ increased efficiency at a reduced cost compared to traditional Sanger sequencing • December 2013 — USPSTF issues recommendation defining coverage eligibility for genetic testing/counseling for BRCA1/2 under Affordable Care Act’s (ACA’s) prevention benefit •  Guaranteeing coverage of genetic counseling/testing for BRCA 1/2 mutations for women with family histories indicating high risk BRCA-related cancers at no-copay • 2014 –ACA genetic testing benefit goes into effect

5. Setting the table: Key concepts & terms • Genetic testing  Multi-gene panel testing (NGS based) • Identifies germline (inherited) mutations • Detects abnormalities/predispositions individuals are born with, and how these might affect health risk for future cancers • Genomic testing  Molecular tumor profiling/testing (NGS based) • Identifies somatic mutations • Detects unique abnormalities or mutations that occur in the cancer/tumor • Underlying testing technology •  Traditional Sanger single-gene sequencing vs. Next Generation Sequencing (NGS)

6. Setting the table: In practice • Both genetic testing & molecular tumor testing guide treatment decisions & risk management strategies  OCRA’s position is that OC patients should be covered for both (*and repeat testing if necessary/applicable) & that both tests should be NGS-based • Why NGS? Because it identifies a wider range of mutations (both actionable & VUS) and is quickly displacing traditional Sanger sequencing as laboratory standard for diagnostic testing. • These mutations inform: • Options for targeted therapies like PARP inhibitors • Eligibility for clinical trials (basket/umbrella trials) • Risk-reduction interventions (oophorectomy) & fertility preservation (if applicable) • Cascade testing in family members

7. What the guidelines say • National Comprehensive Cancer Network (NCCN) & Society of Gynecologic Oncology (SGO) guidelines recommend genetic counseling and testing for all women diagnosed with ovarian cancer (regardless of family history). • On molecular tumor profiling: • NCCN guidelines state that for patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer, tumor molecular testing is recommended prior to initiation of therapy for persistent/recurrent disease. • On multi-gene panel testing: • SGO – “Comprehensive identification of hereditary ovarian cancer risk requires the assessment of at least 11 genes, so multiplex testing is likely the most efficient and cost-effective way to identify hereditary ovarian cancer risk.” • NCCN – “Multi-gene testing may be most useful when more than one gene can explain an inherited cancer syndrome. For example, though ovarian cancer is mainly associated with BRCA 1/2 mutations, it may also be associated with mutations in the following genes: BARD1, BRIP1, CHEK2, MRE11A, MSH6, PALB2, RAD50, RAD51C, and TP53.” No consensus on scope of testing (evolving)

9. Zooming in our population • OC is most common among women 55-64 years of age  In this population, 75% of insured adults have private health insurance coverage. • Rates & knowledge of genetic testing among OC survivors is consistently low According to a study from Journal of Clinical Oncology (2017): • Less than 1 in 5 individuals with a personal history of OC/BC meeting NCCN criteria have undergone genetic testing (estimates of testing rates for OC alone are as low as 10%). • Over 80% of patients w/ OC meeting NCCN criteria NEVER discussed it with their health care provider. In spite of the fact that NCCN guidelines have recommended testing for patients with a personal history of OC/BC since at least 2010.

10. Private insurance coverage landscape • Overall coverage policies for multi-gene panels & molecular tumor tests are inconsistent/have holes (some may be deemed “investigational” or only covered in extremely narrow cases) • In 2017 Nature Biotechnology published the largest systemic review of US coverage policies for multi-gene tests to date surveying coverage policies of the 5 largest US private payers that included multi-gene panel testing as of 2015.  The review found that “most multi-gene tests are not covered by payers and that there is a high degree of variability...”

11. Medicare coverage • Up until last year: • Medicare LCDs (Local Coverage Determinations) in every state covered germline genetic testing in women who had a personal history of cancer and who were under therapy for cancer while meeting additional criteria, generally synced to NCCN guidelines. • November 2018: • CMS finalized an NCD (National Coverage Determination) to provide Medicare coverage for NGS-based diagnostic testing to beneficiaries with advanced-stage cancer. •  Importantly, the NCD was sought for NGS-based somatic testing and broadly understood across stakeholders to apply only to testing for somatic mutations.

12. Medicare coverage (continued…) • January 2019: • In implementation CMS interprets the NCD to apply to all NGS-based tests – meaning that Medicare beneficiaries with early-stage cancers are no longer covered for germlinegenetic testing that use NGS as underlying technology (i.e., multi-gene panel testing) • February 2019: • OCRA, FORCE, and other cancer advocacy groups meet with CMS to discuss necessity of germline genetic testing in early-stage cancer & request agency clarify scope of the NCD accordingly • May 2019: •  CMS re-opens comment period for NCD • Now it’s a waiting game…

13. Efforts to shore up coverage • State-level legislation of all varieties providing for coverage of: • Genetic testing to individuals with a personal history of cancer (bridging gap created by ACA benefit) • Genetic/genomic testing consistent with NCCN guidelines • Be aware of jurisdictional issues & gaps • A couple of states have made play to get Medicaid coverage for NGS-based genetic/genomic testing (OR/WV)

14. Federal legislation on the horizon • In the hopper Senator Kirsten Gillibrand is introducing standalone legislation to expand & strengthen private insurance coverage of genetic/genomic testing for OC patients • Specifically, the bill creates new coverage benefits for: • Molecular tumor profiling & multi-gene panel testing for OC patients* (that use NGS as underlying testing technology) • Evidence-based risk-reduction procedures (no diagnosis of OC necessary) • *Includes scope of testing requirements to be forward looking

15. Where advocacy comes in • Spread the word  this is an emergent space that is moving at breakneck speed and research indicates survivor awareness is low • Calling for patient stories that make the case for the Gillibrand bill (!!!) • Are you a survivor who has encountered coverage issues for genetic/molecular tumor testing? • How did these tests impact your treatment? •  Note name, email (or best way to reach you) & what type of coverage you have • Be ready to reach out to Senators to ask them to cosponsor the Gillibrand bill when it drops  AND have everyone you know do the same

16. A couple of notes on advocacy in general • Sign up for OCRA’s advocacy alerts online • Get to know your Members of Congress & their platforms  Sign up for newsletters/updates & follow their social media; engage when & where you can AND BE PERSISTENT • 2020is an election year ;)  SO your voice is particularly influential

17. Questions, comments, follow up… Never hesitate to our reach out to OCRA’s Advocacy Team (small but mighty) in Washington, D.C. • Vanessa Cramer, vcramer@ocrahope.org • Chad Ramsey, cramsey@ocrahope.org, • Abby Jones, ajones@ocrahope.org