Constantine Mantz, MD
Assessing the value of treatment options has become much more complex over the past several years, according to Constantine Mantz, MD, chief medical officer and radiation oncologist at 21st Century Oncology in Fort Myers, Florida. Many of his patients face high out-of-pocket costs and multiple therapeutic options—some of which cost several-fold more than pre-existing therapies and yield minimal clinical benefits. “Previously, physicians would make decisions based on the diagnosis and what, in their best knowledge and judgment, represented the right selection of therapies to address that disease,” said Mantz. “Those decisions were fairly uncomplicated compared with what we have to face today.”
Many community oncologists also report that for them and their patients it is difficult to decide whether a few extra weeks of life with a new therapy is worth the now-common five-figure price tag. To help facilitate patient–provider discussions about the value of a therapy based on its clinical benefit, toxicity, and affordability, the NCCN and ASCO introduced the Evidence Blocks and Value Framework, respectively, in 2015. However, Mantz and Kenneth Adler, MD, a hematologist-oncologist at Summit Medical Group, MD Anderson Cancer Center in Morristown, New Jersey, stated that the clinical usefulness of these value frameworks is limited by the type of data used, the subjectivity of the rating process, and the lack of consensus on which of these value tools is best. Both suggested that continued improvement and development of such tools could provide a more useful platform for discussion of the cost versus clinical benefit for multiple regimens.
Although the cost of the cancer drug is an obvious source of financial burden, one advantage of the NCCN Evidence Blocks is that they are based on the recognition that multiple other associated costs must be included when assessing treatment cost, and some of these costs are incorporated into the model. The panel members who create the Evidence Blocks rate affordability of treatment on a scale of 1 to 5 and consider costs of acquisition and administration of the antineoplastic drug, point-of-care treatment, supportive drugs, tests for monitoring toxicity, and further interventions such as antibiotic therapy or hospitalization. “The affordability is a metric of cost or expense to the healthcare system,” said Robert Carlson, MD, CEO of the NCCN. “We still think [this metric] is useful to the individual patient, because if the patient learns that a regimen is unaffordable, that may precipitate a conversation with the healthcare provider, financial counselor, or insurance company to figure out what the individual cost or expense is likely to be.”
Carlson described a case in his own practice in which he considered prescribing an effective-but-expensive aromatase inhibitor for a patient with metastatic, hormone receptor-positive breast cancer. After she discovered that she would not be able to afford her insurance co-pay, she was referred to a financial counselor, who found her a co-pay assistance program to help with the remaining balance. “The reason that this whole sequence of events unfolded was because there was an indication in the decision making that this was a very expensive treatment,” said Carlson, suggesting that this conversation may not have happened without the use of a value tool to identify efficacy and cost.
However, Mantz noted that with the Evidence Blocks, expert panel members rate each of the treatments based on what they think will be most or least expensive: they don’t use objective cost data, which he stated makes the Evidence Blocks too subjective for clinical purposes.
The cost metric for the ASCO Value Framework focuses on just the estimated costs of the antineoplastic and supportive care agents because these are usually the most immediate and relevant costs to the patient and provider, according to Lowell Schnipper, MD, chair of ASCO’s Value in Cancer Care Task Force. He acknowledged that some experts have criticized the model for failing to include other variable costs, such as time away from work due to repeated infusions or hospitalizations required for certain agents. However, he said the framework is designed to promote the patient-provider dialogue. “We really wanted to focus on the medical oncology interaction and, specifically, the financial vulnerabilities that the patients are facing,” he said. “We tried to narrow it to the doctor–patient dialogue because that is what the patient comes to the doctor for,” he said.