Michaela Dinan

© 2019 by American Society of Clinical Oncology. Cancer precision medicine depends on high-quality tumor biomarker tests (TBTs) for treatment selection. TBT reimbursement within the United States in the current regulatory environment is not tied to premarket evidence of clinical utility, resulting in a vicious cycle wherein low-level evidence of utility leads to poor reimbursement, thereby impeding investment in developing new, clinically valuable TBTs supported by high-level evidence. Rational, value-based TBT pricing presents many practical challenges. Precise one-to-one mapping of reimbursement to cost savings or cost effectiveness is precluded by an absence of formal cost-effectiveness analyses for many emerging TBTs, and for more established TBTs, it has become clear that such analyses may yield wildly variable, subjective estimates. To address these challenges, we propose a system of tiered reimbursement that rewards development of high-quality TBTs within specific use contexts, supported by strong evidence of analytic validity and clinical utility. We propose three use contexts of TBTs, each defined by its influence on treatment decisions relative to the current standard of care-Opt-Out, Opt-In, and the use of appropriate, alternative, effective therapies (Opt-Alt). By ensuring minimumlevels of reimbursement, this systemprovides a return on investment to encourage and support the research and development needed to generate high levels of evidence for claims of clinical utility for TBTs by using a robust, objective, and value-based system. We believe our proposed evaluation system will serve as a practical starting point to raise the bar for TBT quality and utility, which has the potential to redirect health care dollars from futile or ineffective treatment to investment in the development of high-quality TBTs needed for safe and effective precision cancer care.

BACKGROUND: Our objective was to investigate why early studies regarding adoption of the 21-gene recurrence score (RS) assay did not show an initial reduction in the number of patients with breast cancer receiving real-world chemotherapy. MATERIALS AND METHODS: We addressed 2 sources of confounding suspected in previous studies: (1) the early time frame during the initial adoption phase of the RS assay, and (2) suspected selective, increased administration to patients more likely to have been chemotherapy candidates. To address selective use during initial adoption, we used updated SEER-Medicare data from 2004 and 2011. To address individual selection bias, we examined whether RS test utilization was negatively associated with rates of local chemotherapy use assessed at the hospital referral region level using conventional ordinary least squares and instrumental variable approaches to adjust for selection bias. RESULTS: A total of 26,009 patients met inclusion criteria. Assay use was associated with a decrease in absolute percentage use of chemotherapy of 4.5% (95% confidence interval [CI], 3.2%-5.7%), which was even more pronounced in sensitivity analyses limited to later study years (2008-2011), with a decrease of 6.8% (95% CI, 5.3%-8.3%). Instrumental variable models yielded similar point estimates but were insufficiently powered to draw conclusions. CONCLUSION: Receipt of the 21-gene assay was associated with decreased utilization of chemotherapy by 2008.

PURPOSE: Efforts to curb the rising costs of cancer care while improving quality include alternative payment models (APMs), which offer incentives to reduce avoidable spending and provide high-quality and cost-efficient care. The impact of proposed APMs has not been quantified in real-world practice. In this study, we evaluated ASCO's Patient-Centered Oncology Payment (PCOP) model in existing fee-for-service (FFS) Medicare beneficiaries to understand the magnitude of potential cost savings. MATERIALS AND METHODS: SEER-Medicare data were used to identify women with advanced ovarian cancer diagnosed between 2000 and 2012 who either (1) underwent primary debulking surgery followed by chemotherapy or (2) received neoadjuvant chemotherapy followed by surgery. Medicare payments in each cohort were used to compare FFS and PCOP and to estimate the potential for cost savings across health care services received, including outpatient emergency department visits, hospitalizations, and imaging. RESULTS: Three thousand seven hundred seventy-seven primary debulking surgery and 866 neoadjuvant chemotherapy patients were included in the study, with mean total costs of $75,433 and $95,138 in 2016 US$, respectively Most costs were related to chemotherapy or hospitalization. Additional PCOP-related payments would be offset if hospitalizations could be reduced by 11.6% or imaging claims by 88%. CONCLUSION: APMs have the potential to reduce costs of current FFS reimbursement via either a large reduction in imaging or a modest reduction in hospitalizations during treatment of ovarian cancer. PCOP is a reasonable payment structure for oncologists if the additional payments can provide the necessary resources to invest in improved coordination of care.