Precision medicine tests, associated technologies, and early derived therapeutics are increasingly being adopted into clinical practice as evidence of their effectiveness grows. At the same time, many patients do not have access to precision medicine because most public and private health insurers do not yet offer coverage for genetic or genomic services unless certain clinical criteria and evidentiary standards are met. As a result, access to this next generation of promising and increasingly impactful clinical testing is often limited.

“Together, we must holistically look at the health care system and that includes social determinants of health, total lower costs, sustaining healthy populations, through focused efforts on primary and preventive care.”

Dr. Patrick Conway, President and CEO, Blue Cross and Blue Shield of North Carolina (BCBSNC) and presenter at PMWC 2018 Duke next month (full interview on PMWC blog)

Undeniably, we are still in the mode of demonstrating that routine genetic testing has value to the individual. Yet monitoring and rewarding success across larger populations as the healthcare industry moves deeper into risk-based reimbursements and pay-for-performance contracting is important and a must-have in order to generate the basis to keep advancing these genetic-based therapeutic approaches.

Strong evidence exists that accessibility to genetic testing should be a high priority for the industry based on demonstrated value of:

• Next-generation sequencing for average-risk pregnancies to help accelerate the adoption and reimbursement of non-invasive prenatal testing
• Genetic screening for all women above a certain age for gene mutations related to breast and ovarian cancer to increase life expectancy compared to traditional methods

Exciting news has taken center-stage with recent Centers for Medicare and Medicaid Services (CMS) announcements:

• CMS is considering covering the cost of the newly, FDA-approved FoundationOne CDx NGS test – a 324 gene test – that can identify key biomarkers for certain cancers
• CMS is covering diagnostic laboratory tests using NGS for patients with advanced cancer

….at present we seem to still be in the “evidence generation stage”!

However, there is definitely good reason to be hopeful that with CMS on board, albeit in a limited capacity, commercial payers may follow suit and start to explore more coverage options for precision medicine techniques.

As the precision medicine environment expands, developing financial models to account for the high initial costs of testing and treatment as well as dialing in the promise in savings through early detection and prevention of disease progression will be essential for creating a body of evidence to support the efficacy of precision therapies. With more data to guide payers, providers, and patients towards the most effective, lowest cost care plans, value-based care contracts around genetic testing and personalized therapies will likely become the path to controlling costs and ensuring better patient outcomes.

Cost clearly is one of the major hurdles of broad precision medicine adoption, an issue that must be addressed now, as drugs that are developed to target a person’s genetic or molecular characteristics are likely to be expensive and reimbursement for these targeted drugs are likely the biggest issue. At the same time, we need to continue the dialogue among all stakeholders as to how to capture the value and significant cost savings generated through early detection and treatment vs. later state interventions.

Improving Access to Precision Medicine requires…

•  Encouraging the expansion of health insurance coverage of genetic and genomic testing, including diagnostic, predictive, and pre-symptomatic testing, as well as whole genome sequencing
• Supporting the collection of evidence for the clinical utility and appropriate use of genetic and genomic tests
• Improving access to genetic counselors and other relevant professionals, including strengthening related workforce education and training efforts to ensure availability

….and we need to do this while we are still facing some of these major challenges including:

• How will the landscape of genetic testing be impacted or changed for the patient, payor, and molecular test provider?
• How do we achieve a reimbursement process that is value-based versus cost-based?
• How do we assess the value of precision medicine and molecular testing?
• What is the economic impact of precision medicine on patients, payors, pharmaceutical industry, and providers?

Join PMWC 2018 Duke this September 24-25 to be directly involved in these critical discussions at a time where we’re setting the course for the next phase of precision medicine acceleration and implementation. We have an exciting session in store for you – the “Efforts to Accelerate Precision Medicine” that focuses on these topics, with speakers:

Patrick Conway
M.D., President & CEO,
Blue Cross and Blue Shield NC

Lauren Silvis
J.D., Chief of Staff
to the Commissioner, FDA

Brian Caveney
M.D., J.D., MPH,
Enterprise-wide CMO, LabCorp