Clinical and Economic Impact of Next-Generation Sequencing Examined During Boston Healthcare’s Multi-Stakeholder Symposium

Boston, MA, December 12, 2014 --( Boston Healthcare Associates, Inc. (BHA) and Cambridge Healthtech Institute (CHI) held an engaging, multi-stakeholder symposium surrounding the unique challenges and opportunities with the use of next-generation sequencing (NGS) in oncology care. Entitled, “Capturing the Value of Next-Generation Sequencing: Clinical and Economic Impact and Emerging Business Models,” the symposium took place November 20th at the Hyatt Regency in Bethesda, Maryland. The event created a thought-provoking dialogue between providers, laboratorians, technology innovators, and payers to articulate their perspectives and experiences with NGS in clinical practice. Featuring presentations by thought leaders, lively Q&A sessions, an interactive workshop, the session concluded with a panel discussion about the potential clinical benefits of applying advances in sequencing technology to on-going clinical care.

Several key themes and insights emerged from the symposium discussions.

1. Translate the “Data Tsunami” into meaningful, clinically actionable information
As the costs of NGS sequencing decline, it is becoming easier to produce large volumes of data about gene mutations and variants. However, for NGS to successfully enter the realm of routine clinical use, better approaches are needed to translate this data into useful information. The symposium attendees discussed collaborative efforts involving labs, physicians, and software innovators to advance clinical management using NGS. This includes not only the development of technology-based solutions to facilitate physician-friendly informative test reports, but also identifying new ways of educating physicians about developments in the space and how to apply these tools.

2. Incorporation of NGS into broader clinical care requires alignment with new care management models
While academic centers are typically at the forefront of biomedical innovation, the full potential of NGS will only be realized when it is diffused into community setting practices at the “front-lines” of clinical care. These practices are facing a landscape that involves shifting financial models (independent practices moving into hospital systems, accountable care organizations (ACOs), and medical homes) as well as competitive environments. During the symposium, the CEO of Dayton Physicians Network, a multi-specialty network in Ohio comprised of comprehensive cancer care, highlighted how gene- and indication-specific information has the potential to align with the various pilot and pathway programs that his network has in place. He articulated the potential to not only improve quality outcomes and lower unnecessary costs, but also provide benefits to patients.

3. Showing the value of NGS requires innovation in data development methods
Symposium participants from both Aetna and the MolDx program of Medicare pointed out that while they see the potential value NGS, the technology itself is outpacing evidence generation to support its value. The group discussed different ways to develop and assess clinical validity, clinically utility, and evidence of value. In addition to well developed clinical trials, participants also called for open sharing of databases and registries that include information about genetic variants and associated care decision-making. Real-time collaborative data sharing among key stakeholders (payers, providers, pharma, etc.) will quickly help address these evidence gaps. This data can be used to help define and select the appropriate patient population for NGS testing (e.g., Stage III or IV lung cancer patients versus all breast cancer patients), as well as provide pharmaceutical companies rich up-to-date data around the efficacy of their products.

4. Need for leadership in defining the appropriate cost, value, and quality of NGS in clinical care
Finally, to ensure the long-term success of NGS, a reasonable system needs to be developed to examine the cost and value of the testing. New tools are needed to differentiate labs that perform NGS accurately from those that do not, and new payment methods need to be created to fairly compensate labs. New Current Procedural Terminology (CPT) codes have been created to capture these tests, but the recent announcement by the Centers for Medicare & Medicaid Services (CMS) to gap-fill the payment rates for Genomic Sequencing Procedures (GSP) means labs will need to work with payers to demonstrate the cost and value of NGS. While recent legislation such as the Protecting Access to Medicare Act of 2014 (PAMA) and the Food and Drug Administration’s (FDA) LDT guidance have added uncertainty to the space, the potential to tie NGS initiatives to the new payment methods outlined above (e.g., pathway programs, ACOs) adds hope for newer and more appropriate valuation methods.

“The Boston Healthcare symposium was an important event for collaboration among stakeholders discussing the potential clinical benefits of applying advances in sequencing technology to on-going clinical care,” said Charles Mathews, Vice President, Boston Healthcare. “At this point, the full value of the clinical and economic impact of next-generation sequencing tools is yet to be determined. But these discussions are important steps toward realizing the potential and advancing the definition and development of the necessary clinical utility evidence.”

About Boston Healthcare:
Boston Healthcare helps biopharmaceutical, medical device, and diagnostics companies unlock the value of innovation in the global health care marketplace. Boston Healthcare provides reimbursement and market access strategy services, health economics and outcomes research, market analytics and pricing strategy, and business development support to health care clients worldwide.

With offices in Boston, Washington, D.C., Berlin, and Shanghai, our unique approach, combining strategic consulting with a deep understanding of the evidence-driven value environment, gives clients a real-world edge in assessing and capturing global market and business development opportunities.

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Michal Taton