The American Society of Clinical Oncology (ASCO) has introduced its conceptual framework to “Assess the Value of Cancer Treatment Options,” with the laudable objective to “assist physicians and patients in assessing the values of a new drug treatment.”1 As released, the ASCO framework has the potential to confound oncologists, in some instances, as follows.
As a first-line option for the treatment of metastatic non–small-cell lung cancer (NSCLC), ASCO scores cisplatin (Platinol) plus pemetrexed (Alimta) as equal with cisplatin plus gemcitabine (Gemzar) in terms of overall survival and toxicity, resulting in a net health benefit score of 0 for cisplatin plus pemetrexed. The National Comprehensive Cancer Network’s (NCCN) recommendation in its 2015 guideline for NSCLC (version 7.2015) states that “there is superior efficacy and reduced toxicity for cisplatin/pemetrexed in patients with nonsquamous histology, in comparison to cisplatin/gemcitabine,” and that “doublet chemotherapy regimens, such as cisplatin/pemetrexed, are recommended (category 1) for patients with non-squamous NSCLC who are negative for ALK rearrangements or sensitizing EGFR mutations.”
The NCCN and ASCO have come to differing conclusions in referencing the same study by Scagliotti and colleagues.2 The NCCN’s recommendation of superiority for cisplatin plus pemetrexed focuses specifically on nonsquamous histology. A thorough reading of the Scagliotti study clearly defines the differentiating results derived from the trial based on histology.
Historically, all cancers have been “orphan diseases” and small-target markets; this is ever more so now, given their molecular characteristics (never mind their histologic characteristics).
ASCO cites an estimated 26% increase in cancer care costs between 2010 and 2020, but this is actually low compared with the projected overall increase in healthcare expenditures for the same decade, from $2.6 trillion to $4.6 trillion (or a 77% increase) projected by the Centers for Medicare & Medicaid Services.3
Given the 340B pricing and Medicaid-mandated discounts, as well as manufacturer price concessions, the “monthly cost of treatment” does not represent the “real price,” and has little to no relation to the patient’s share of the expenditures.
Following that point, we have reached a reality in medical oncology where there is no real “health insurance” for most patients, given the substantial cost-sharing burden, which is perhaps a more important issue to be addressed.
Why use the quality-adjusted life-year (QALY) as a benchmark example, given the European Consortium in Healthcare Outcomes and Cost-Benefit Research’s conclusion that “QALY assessment for health decision making should be abandoned,” and that it “is not a valid health outcome”?4 Just ask the United Kingdom, which has QALY-directed poor access to new drugs and biologics and, concomitantly, has some of the lowest survival rates in Western Europe across cancer diagnoses.5
Will the value score process be an equitable facilitator for innovative, effective agents for the treatment of patients with cancer who are in need?
A major issue for economic evaluation should be the extent to which stakeholders draw dollars from the healthcare system, and the degree of value that each contributes to improving the health and life of patients and consumers.
