Center for Translational and Policy Research on Precision Medicine
TRANSPERS October 2021 Newsletter
Thu Oct 15, 2020
A Letter from Center Director Kathryn A. Phillips, PhD
Dear Colleagues:
In this issue, we are pleased to report on a new NIH grant to TRANSPERS that tackles the significant but vexing topic of Alzheimer’s Disease and related dementias (ADRD). The burden of these diseases is expected to double in the next 40 years, but useful treatments or a cure remain elusive. For this study we have brought together experts in dementias, precision medicine, and economic value to examine the role of genetic testing for ADRD risk.
We also highlight several high-profile contributions to the field by TRANSPERS collaborators, and provide an update to our recently published study on payer coverage for “liquid biopsy.”
As always, we welcome your thoughts, comments, and ideas for collaboration.
Best,
Kathryn A. Phillips, PhD
TRANSPERS Founding Director
TRANSPERS Awarded NIH Grant to Tackle Challenges of Using Precision Medicine to Identify Risk for Alzheimer's and Related Dementias
Alzheimer's Disease and Related Dementias (ADRD) present huge challenges for patients, health care providers, and the healthcare system. One of these challenges is how to best identify those at risk of developing dementia. Direct-to-consumer testing labs offer testing for one gene associated with late-onset Alzheimer's risk (APOEε4), although such testing is not recommended by clinical guidelines. Little is known about whether insurers cover genetic risk testing, whether risk testing could provide economic value, and how primary care providers are managing their patients who obtain APOE testing.
TRANSPERS has received a grant from the National Cancer Institute in conjunction with the National Institute on Aging to develop conceptual frameworks and methodological approaches to examine the economic, financial/coverage, and policy implications of genetic testing for ADRD risk. We are addressing key questions:
- Are insurers covering genetic risk testing for ADRD, and if so, under what scenarios? What rationales and evidence are provided for coverage or non-coverage? How does coverage vary by payer and type of dementia? Is coverage congruent with clinical guidelines and test availability?
- How are primary care physicians handling patients who present with APOE results obtained from DTC or hybrid labs? What will they need in order to manage these situations?
- What are the economic issues that will need to be examined in order to develop effective and efficient practices and policies for ADRD genetic risk testing?
The dynamic surrounding APOE testing, including consumer access to testing despite the lack of known clinical utility and with results provided to consumers outside of the clinical care context - represents an overarching challenge that we believe will increasingly become a clinical, economic, and policy conundrum. Exploration of such issues in testing for APOE and genetic risk scores for ADRD provides a paradigm for evaluating similar forthcoming tests in other conditions.
This work will be accomplished with a multi-disciplinary team that combines expertise in precision medicine and dementias: Kathryn A. Phillips, PhD; Jalayne Arias, JD; Jeroen Jansen, PhD; Maren Scheuner MD MPH; Grace Lin, MD; Jennifer Yokoyama PhD; Ana Tyler JD, MA; Michael Douglas, MS.
TRANSPERS Director Kathryn Phillips will also participate in the upcoming evidence review of a possible new treatment for Alzheimer’s Disease (aducanumab) by the Institute for Clinical and Economic Review (ICER) in spring 2021.
Thanks to TRANSPERS Collaborators and Scientific Advisors for Productive Meeting to Discuss Future Plans
TRANSPERS Collaborator, Jalyane Arias JD, Chosen as 2020 UCSF Emerging Scholar
TRANSPERS Congratulates Deborah Marshall on Recognition by Canadian Academy of Health Science and Her Recent Publication in Genetics In Medicine
The Canadian Academy of Health Sciences (CAHS) has recognized TRANSPERS collaborator Deborah Marshall, University of Calgary, for her dedication to health sciences. CAHS fellows advise the public and private sectors on complex health challenges, providing strategic and tangible solutions to help inform public policy using interdisciplinary and evidence-based assessments.
Dr. Marshall and team recently published a study in Genetics in Medicine that examined the diagnostic odyssey in children seeking diagnosis of a rare genetic disorder in terms of the time from initial consultation to most recent visit or receipt of diagnosis, the number of tests per patient, and the types of tests received. Their results confirmed and quantified the long duration of the diagnostic odyssey for these children.
TRANSPERS collaborators, Julia Trosman and Christine Weldon, Publish on Telemedicine Reimbursement in Oncology during COVID-19
Because of the uncertain behavior of COVID-19, it has become imperative for practices to limit exposure to vulnerable patients. Telemedicine has been one of the cornerstones of caring for patients with cancer during the COVID-19 pandemic. This review, published in the Journal of the National Comprehensive Cancer Network (JNCCN), provides an overview of reimbursement policy by public and private payers before and during the COVID-19 pandemic, describes implications in cancer care, and offers considerations for future reimbursement policy.
TRANSPERS Collaborator Allison Kurian's work noted in new book by Dean of the Stanford University School of Medicine Dr. Lloyd Minor on Precision Health
In a new book "Discovering Precision Health: Predict, Prevent, and Cure to Advance Health and Well-Being," TRANSPERS collaborator Allison Kurian's work is noted as a leading example of bringing new precision to risk management and screening for breast cancer. She (along with Sylvia Plevritis) created a decision-support tool to help women at high risk for breast cancer to calculate the risk they face. The tool has been used by more than 44,000 people.
TRANSPERS congratulates Dan Dohan from the UCSF Philip R. Lee Institute for Health Policy Studies
Dan Dohan was recently awarded a 5-year Academic Leadership Award (K07) from the National Institute of Aging (NIA). This mid-career development award will support Leadership to Enhance Aging Research and iNnovation in Medical Culture (LEARN-MC), which aims to increase UCSF's capacity to conduct qualitative research on aging and Alzheimer's disease and related dementias (ADRD). LEARN-MC will develop new courses, mentor trainees and investigators in qualitative methods to study culture, and establish the Medical Cultures Lab as a center of excellence for research on medical culture, aging, and ADRD.
TRANSPERS sends good luck wishes to Flavia Chen as she begins her fellowship at the Harvard Belfer Center for Science and International Affairs
TRANSPERS would like to congratulate Flavia Chen, MPH, former Deputy Program Manager for the Program in Prenatal and Pediatric Genome Sequencing (P3EGS) at University of California San Francisco, as she embarks on a fellowship at the Harvard Belfer Center for Science and International Affairs. Her research interests focus on the ethical and policy implications of translational genomics, including issues of data governance, as well as on social and policy influences on health outcomes.
The Belfer Center is pleased to announce its inaugural cohort of Technology and Public Purpose (TAPP) Fellows. The cohort comprises seven leading practitioners from government, business and civil society who are passionate about addressing public purpose considerations for emerging technology. This year's fellows will spend an academic year in-residence at Harvard University fostering an expert community to provide independent and rigorous analysis of some of today's most pressing challenges in tech. For more information.
Interest in “Liquid Biopsy” Continues to Grow: TRANSPERS Study Finds Increase in Coverage for Use of Liquid Biopsy in Cancer Patients for Private Payers and Medicare – but Broader Pan-Cancer Coverage under Medicare
Interest in using liquid biopsy tests to not only target and monitor treatment for cancer patients but also for early detection of cancer continues to grow. However, payer coverage will be a key issue to address. TRANSPERS published the first study on coverage for Liquid Biopsy (circulating tumor DNA sequencing - "ctDNA") by private payers and Medicare in JNCCN. Clinical adoption of the sequencing of ctDNA for cancer by testing bodily fluids has rapidly grown in recent years. These assays are particularly valuable in situations where testing needs to be performed rapidly and when tissue-based samples are unavailable. These so-called "liquid biopsy" tests are used to select targeted therapy and monitor non-responding or progressive tumors.
We found rapid increases in coverage for ctDNA sequencing among both private payers and Medicare – but broader pan-cancer coverage under Medicare. Private payers and Medicare began to issue coverage policies for ctDNA sequencing beginning in 2015 and 2017, respectively. Coverage has greatly increased from 2015 to 2019 in private payers with 38% covering (N=200 payers) and Medicare issuing 12 positive coverage Local Coverage Determinations (LCDs for both Non-small Cell Lung Cancer (NSCLC) and Pan-cancer (12 cancer types). Of the positive private payer policies (N=28), the majority (86%) were for NSCLC and only 4 provided coverage for pan-cancer indications. Of the seven Medicare Administrative Contractors, four have provided coverage for pan-cancer indications.
The overall trend for both private payers and Medicare is an increasing number of coverage policies, positive policies, and scope of coverage. The majority of the positive coverage policies are very specifically written with defined clinical scenarios. However, Medicare coverage policies are evolving to pan-cancer uses, which is signifying a significant shift in coverage frameworks.
Ultimately, both private and Medicare coverage policies must keep up with changing technologies such as ctDNA sequencing. Liquid biopsy tests are key areas of interest as they move into broader use not just by cancer patients but also among healthy individuals for early cancer detection.
Global Economics and Evaluation of Clinical Genomics Sequencing Working Group (GEECS) to Hold Virtual Meeting Nov. 3
GEECS will hold their annual meeting on November 3rd to finalize their latest project: global landscape of next-generation sequencing implementation. The Working Group, chaired by Kathryn Phillips, is made up of an esteemed group of health economists and policy researchers from major institutions across the globe who have been at the forefront of the incorporation of genomics into clinical care. Most recently, members of GEECS published six papers in a special theme section in Value in Health specifically focused on evaluation methods for moving precision medicine into practice and policy. This special theme section features five papers from GEECS and one paper by the ISPOR Special Interest Group on Precision Medicine and Advanced Therapies. Kathryn’s introduction lays out the context and findings of the papers. More information on GEECS.