Payers, physicians and patients are all finding themselves at the forefront of the cost versus benefit discussion as the rate of rising healthcare expenditures in the US reaches unsustainability; especially in cancer care.
It is no secret that the rate of rising healthcare costs in the US is considered unsustainable, and the cost of cancer care is one of the key indications driving expenditure for payers and patients alike.1,2,3 In response to such budgetary pressures, payers are shifting towards value-based insurance, such as integrated delivery networks (IDNs) and accountable care organizations (ACOs), while simultaneously looking to increase patient cost-share.1,4 This is especially true for expensive medications or technologies that have yet to demonstrate “value for money” where cheaper alternatives may deliver similar results.4
In this rapidly changing landscape, patients often find themselves in unfamiliar territory. They have to make difficult choices between treatments with sometimes modest clinical benefits and potentially very high costs that can have lasting, negative financial effects on them or their families.
Thus, patients often look to their physicians for advice on how to proceed with their care. But oncologists remain uncertain about exactly how cost should factor into their recommendations and prescribing; especially since it is not clear whether it is the cost to individuals, society, the payer, etc.
The American Society of Clinical Oncology (ASCO) is creating a framework that considers clinical benefit, toxicity and cost to help support the physician-patient dialogue around value in cancer care.
ASCO has put together a task force that helps define “value in cancer care” by taking into account the three main considerations of physicians and patients when choosing treatment and how these should be measured (see Figure 1).3,6,7
Figure 1: Main considerations when evaluating treatments according to ASCO
However, as some of these characteristics vary by indication, the corresponding value score for oncology therapies may also vary by indication; even within a cancer type (e.g., adjuvant vs. advanced). Furthermore, new products will likely be judged only on “initial value,” where the real value or impact of a product may not be realized for many years [e.g., Herceptin (trastuzumab) in adjuvant breast cancer]. Finally, the lack of standardized data sets across oncologic therapies may result in large variations between value ratings, potentially making it difficult to compare between products.
Even with these limitations, the goal is to have an interactive, digital interface that can help in interpreting the value of various cancer therapies (see Figure 2).3,5,6 More specifically, physicians and patients can have a more informed dialogue when selecting treatments that are best suited to their specific needs.3,6,7
Figure 2: ASCO goals for the value framework
The impact on the commercial success of oncology products, due to the evolving US healthcare landscape and increased presence of physicians and patients in the value discussion (e.g., ASCO framework), will need to be monitored
Any impact on the commercial performance of oncology products will depend on the speed at which the ASCO tool is rolled out and utilized and the level of transparency achieved throughout the process. Traditionally, assessments and pricing in the US has been very opaque, which could limit the usefulness of the framework. Regardless, it will be important for manufacturers to consider and monitor the potential impact on price, access and uptake for their current and future products.
In terms of threats, current products may see an increase in downward price pressure if their value rating is low and there are other options with higher value ratings available. Furthermore, manufacturers of new IV products will have to monitor how their value rating may be impacted if the wholesale acquisition cost (WAC) is used to calculate their value instead of the average selling price (ASP), which has a six-month lag for calculation and reporting. However, the ASCO tool could also provide opportunities by allowing manufacturers to use the ASCO tool and essentially “reverse engineer” a pricing strategy that will maximize value.
For access, it will be important to monitor the potential largest threat from IDNs, ACOs and assertive commercial payers seeking to employ value-based insurance design (VBID) techniques by focusing on rewards for increasing the quality of healthcare, while simultaneously decreasing costs.1,4 These and other VBID plans employ a series of financial incentives and disincentives to promote cost-efficient healthcare and discourage high-cost, non-efficient approaches where the same outcomes could be achieved with lower costs.4 Furthermore, the use of clinical pathways is increasing, particularly in cancer care, where inferior regimens are non-preferred or not covered and the least costly of two similar therapies is used as first line.1 As a result, negotiations related to price and access may become more intense over time.
It is unlikely that changes in Medicare coverage will occur given the “reasonable and necessary” mandate requiring Medicare & Medicaid Services (CMS) to cover the majority of Food and Drug Administration (FDA) approved products. Furthermore, publications by ASCO of this nature would not be considered “compendia” and can therefore not be utilized for coverage decisions. While CMS can reference the Patient-Centered Outcomes Research Institute (PCORI), this organization is unable to employ any measure that could be perceived as measuring the cost-effectiveness of a therapy (e.g., quality-adjusted life-years (QALY)).8 As Medicare is a key payer for cancer patients, it will be important to monitor if coverage does indeed remain stable, or if there are subtle shifts that will impact launch or negotiation considerations.
Finally, as patients begin to play a more active role in choosing their cancer care based on cost versus benefit trade-offs, increasing patient cost-share could have a-cumulative negative impact on patient uptake. Thus, therapies that are perceived to have limited clinical benefit relative to the cost may see reduced utilization, as patients decide to pursue end-of-life care rather than receiving medication or other procedures. Understanding patient willingness-to-pay and how this may change over time for both current and future therapies will be key to commercial success.
Moving forward, manufacturers will need to understand how the new ASCO tool could threaten or support their products and oncology franchises throughout the product lifecycle by factoring it into their assessments and strategies.
Figure 3: Topics for manufacturer consideration around impact of ASCO tool (not exhaustive)
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 Newcomer LN. Innovative payment models and measurement for cancer therapy. J Oncol Pract. 2014;10(3):187-189.
 Marlotto AB, Yabroff KR, Shao Y, et al: Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103:117-128.
 ASCO. ASCO in Action Brief: Value in Cancer Care. Website available at: http://www.asco.org/advocacy/asco-action-brief-value-cancer-care. Accessed March 2015.
 National conference of State Legislatures. Value Based Insurance Design. Website available at: http://www.ncsl.org/research/health/value-based-insurance-design.aspx. Accessed March 2015.
 Zafar, Y. Abernethy, AP. A Need For Health Care Reform: Cancer Care Costs and the Patient Perspective. Kaiser Health News. 2011. Website Available at: http://kaiserhealthnews.org/news/different-takes-zafar-abernethy/. Accessed March 2015.
 Cavallo J. ASCO Develops New Strategy to Increase Value in Cancer Care: A Conversation With Lowell E. Schnipper, MD. ASCO Post. 2014. Volume 5, Issue 8.
 ASCO. ASCO Value Framework Fact Sheet. Website available at: http://www.asco.org/sites/www.asco.org/files/asco_value_fact_sheet_final_10_09_14.pdf. Accessed March 2015.
 Neumann PJ; Weinstein, MC. Legislating against use of cost-effectiveness information. New England Journal of Medicine. 2010;363 (16):1495–1497.