Cooling Down ICER? Five Questions to Consider

Although the value-based reimbursement train has definitely left the station and is picking up speed, those in the oncology community continue to grapple with the thorny issues around understanding and defining value in cancer care. Treatment innovations and costs are driving the value discussion in oncology. New and emerging immuno-oncology therapies, while bringing unprecedented clinical value to many patients, often carry price tags of $100,000 a year or more, and are front and center in these discussions. Patient access in an era of high-priced pharmaceuticals continues to be a major challenge, particularly as many of these innovative therapeutics entail high co-pays and/or co-insurance payments. The result is that some patients face major hurdles to accessing these innovative options.

For those in the oncology community, staying up-to-date on current and proposed value frameworks is essential—not only to advance innovation in cancer care and to ensure patient access to new therapeutic options, but also to protect cancer program economic viability in an era where payment and reimbursement may become increasingly tied to value.

In a recent Institute for Clinical Immuno-Oncology (ICLIO) webinar, a panel of leading experts provided real-world perspectives on value framework development in oncology in the U.S., with a particular focus on the Institute for Clinical and Economic Review (ICER), which has gained prominence in the past 18 months.  For those in the oncology community who may not be familiar with ICER, panelist Jennifer Hinckel, MSc, McGivney Global Advisors, provided background and offered the following five questions to consider in assessing the organization’s recent report related to non-small cell lung cancer (NSCLC):

• Does ICER have the appropriate expertise to interpret complex clinical data given that there are not disease-specific clinical experts on staff or advisory panels?
• Does ICER have processes in place to adequately prevent or limit bias or policy/political aims from slipping into its reports?
• Is ICER’s approach of evaluating products close to the time of approval (or pre-approval) appropriate, given its methodology of including only randomized controlled trial (RCT) data?
• Does ICER have sufficient staffing to review and update reports in disparate disease areas and to ensure accuracy?
• Would ICER’s various approaches meet the standards of peer view in a widely published journal?

In a recent op-ed published in the Oncology Business Review, leading lung cancer experts (including ICLIO Advisory Committee Chair, Lee Schwartzberg, MD, FACP) suggest some level-setting principles for value frameworks including the following:

• Have disease experts as evaluators and authors
• Have patient-centered endpoints, conclusions, and definitions of value
• Use rigorous methodologies reflecting evidence-based medicine
• Apply continuous review and revision
• Hold peer review and authorship to scientific standards.

Listen to the full ICLIO webinar discussion here.

As noted in a newly-released white paper from the Institute for Clinical Immuno-Oncology, all of the existing first-generation value frameworks have strengths and weaknesses. Each wrestles with defining value, and each exposes inherent tensions between payer concepts of value and the perspectives of patients and providers. As the field of immuno-oncology continues to expand, all stakeholders will need to stay informed and be prepared contribute to ongoing development of value frameworks that consider not only cost and clinical benefit, but patients’ perspectives on value in cancer care.  In the months ahead as the oncology community contributes to the discussion on value determination methodologies in the context of payer negotiations and political pressure to lower costs and enact drug pricing reform, as well as working to ensure access to new and emerging immunotherapy and combination therapies, ICLIO will continue to offer support and resources for the multidisciplinary team serving patients in communities close to home.

ICLIO is an Institute of the Association of Community Cancer Centers (ACCC). In September 2016,  ACCC submitted comments in response to ICER’s national call for proposed improvements to its Value Assessment Frameworks.