ASCO's Value Initiative: A New Framework Seeking to Standardize Patient–Physician Interactions

Lowell E. Schnipper, MD.

Recent breakthroughs in cancer treatments have come with an enormous price, forcing patients to make difficult trade-offs between very high out-of-pocket costs and expensive treatment, with measurable but often modest health benefits.

Lowell E. Schnipper, MD, Chief of Hematology/Oncology and Clinical Director of Beth Israel Deaconess Medical Center, Boston, and Chair of the ASCO Task Force on Value in Cancer Care, introduced ASCO's new framework for assessing the value of cancer therapies at ASCO 2015. A statement detailing this conceptual framework was published online after the meeting (Schnipper LE, et al. J Clin Oncol. 22 June 2015. Epub head of print).

Commenting on this new effort, Dr Schnipper said, “Ultimately, we are optimizing a tool that a physician would have at his or her disposal in the office that would help patients understand, for a given clinical indication, what are the possible regimens, what are the ups and downs, and [how to] integrate those with the patient's personal preferences.”

Table 1.

Advanced Cancer Framework

Step 1 Determine the regimen's clinical benefit If OS is reported, assign an OS score (1–5) and multiply by 16 If OS is not reported and PFS is reported, assign a PFS score (1–5) and multiply by 11 If neither the OS nor the PFS is reported, assign a response rate score (1–5) and multiply by 8

Step 2 Determine the regimen's toxicity Calculate the sum of grades 3 to 5 toxicities for each regimen Assign a toxicity score (–20 through +20) based on the difference between the 2 regimens

Step 3 Determine bonus points Award 10 bonus points if palliation of symptoms are reported Award bonus points for treatment-free interval (5 points for 20%-35%, 10 points for 36%-49%, 15 points for 50%-74%, and 20 points for ≥75%) Calculate the total bonus points by adding the palliation bonus points and treatment-free interval bonus points

Step 4 Determine the regimen's net health benefits Add the clinical benefit score, toxicity score, and bonus points to yield the net health benefit score

Step 5 Determine the regimen's cost Insert the drug acquisition cost and the patient's copayment based on how much the treatment regimen costs monthly

Step 6 Summary assessment Evaluate each treatment regimen based on its net health benefit score (of a total of 130 points) and its cost

OS indicates overall survival; PFS, progression-free survival.

Table 2.

Curative (Adjuvant Setting) Framework

Step 1 Determine the regimen's clinical benefit If the hazard ratio for OS is available, assign a hazard ratio score (1–5) and multiply by 16 If the hazard ratio for OS is not available, assign a disease-free survival score (0–4) and multiply by 15

Step 2 Determine the regimen's toxicity Calculate the sum of grades 3 to 5 toxicities for each regimen Assign a toxicity score (–20 through +20) based on the difference between the 2 regimens If there are unresolved treatment-related toxicities at 1 year after treatment completion, subtract 5 points

Step 3 Determine the regimen's net health benefits Add the clinical benefit score and the toxicity score to yield the net health benefit score

Step 4 Determine the regimen's cost Insert the drug acquisition cost and the patient's copayment based on the total cost of treatment (cost per cycle × number of cycles)

Step 5 Summary assessment Evaluate each treatment regimen based on its net health benefit score (of a total of 100 points) and its cost

OS indicates overall survival.

Practical Metrics

ASCO Task Force on Value in Cancer Care sought feedback from the oncology community, including academia, community practices, payers, and drug manufacturers “to devise a more uniform way of thinking about how best to treat patients for given indications,” he said.

“What you see along the spectrum of care are individuals making decisions that are probably in part, if not in toto, predicated on financial issues,” said Dr Schnipper. “It's no surprise that the healthcare system has run amok from a financial perspective.”

Although the task force prioritized “clinical benefit” as the key concept driving value in healthcare, translating this into a practical, everyday value metric was a challenge.

KEY POINTS

• ▸The ASCO Task Force on Value in Cancer Care has developed an in-office tool for value-based care
• ▸This value framework aims to help patients understand all aspects of their treatment and the associated costs, and integrate their preferences into the treatment decisions
• ▸This tool will help translate clinical benefit into a practical, everyday value assessment to facilitate value discussions at the physician–patient interface

Overall survival was determined to be the best end point for clinically meaningful outcomes. Progression-free survival, although an inferior metric, should also be factored into the value equation, said Dr Schnipper, because it is often all that physicians have to work with.

The palliation of symptoms in the context of advanced disease and treatment-free interval, “because that has to be a surrogate for quality-of-life consideration,” are also important variables, along with toxicity, according to the task force.

“In comparing 2 regimens, we felt it fair to begin to think about toxicities,” said Dr Schnipper. “Is one regimen more or less toxic than the other? The clinical value to a patient of having a less-toxic regimen cannot be overstated in this setting.”

Patient Parameters Are Crucial

Although health economists often use quality-adjusted life-years saved to make policy decisions based on healthcare expenditure, Dr Schnipper underscored the difficulty in providing quality for an individual patient, especially in the setting of advanced disease.

“Patients have very, very particular needs and wishes,” he pointed out. “Some want to avoid toxicity or neuropathy, because they're violinists; some don't care about the length of life but prefer to live a high-quality, comfortable life.”

Cost is a crucial factor for many patients' decisions. “As the cost of care increases, and I'm not talking about the US economy, I'm talking about the patient sitting across from you—people exhaust their savings, so their kids may have to delay going to college. Second mortgages on the house are taken, and adherence to the medication is shown to be reduced,” Dr Schnipper said.

He noted that physicians and patients may have different understandings of the value in care.

“Patients express a great deal of value for bonding and positive relationships with their healthcare provider team…and perhaps are less preoccupied by some of the things that I just discussed as parameters,” he said. “On the other hand, how do you derive value framework without some concrete scientifically ordained variables that are reproducible from one study to another?”

The task force hopes its framework can provide a user-friendly tool that will be available at the physician–patient interface and potentially affect public policy as well.