Stakeholder Definition of Value in Cancer: Where Are We 1 Year on?

Most alternate payment models being proposed today—whether created by professional organizations like the American Society of Clinical Oncology (ASCO) or by payers like CMS or commercial plans—have a value aspect associated with them. While the clinical data presented at the annual meeting of ASCO created waves, a session on value had an equally significant impact as throngs of oncologists gathered to hear stakeholder voices define this, as yet abstract, concept of “value” in cancer care. The session brought together a patient representative, an oncologist, an ASCO representative, and a payer.

An insight into ASCO’s Value Initiative was presented by Lowell E. Schnipper, MD, chief of hematology/oncology at the Beth Israel Deaconess Medical Center.

"Defining clinically meaningful outcomes was the foundation of the Value Initiative," said Dr Schnipper. "We invited comments from multiple stakeholders on our initiative."

The objective was to seek a meaningful balance between clinical benefit, side effects, and financial toxicity, which he said is a fairly difficult act. He said it requires metrics to support these outcomes. “The question is ‘What are the clinically meaningful outcomes and who defines them?’” said Dr Schnipper.

He then went on to define some of the clinical trial endpoints most commonly used to ascertain clinical benefit: overall survival (OS), progression free survival, palliation, and toxicity. Surrogates such as complete response and partial response, he told the audience, are primarily used for breakthrough therapy designation by the FDA.

Palliation, he said, is important in the advanced disease setting, while in the adjuvant setting, OS and disease free survival are important to assess. Toxicity is also a clinically important variable in advanced disease and in the adjuvant setting, he added.

Another important factor, of course, is cost. Quality-adjusted life years is the measure that is used to include cost in the equation to base healthcare policy decisions on.

ASCO, Dr Schnipper said, is developing a framework for value that can be implemented at the doctor-patient interface. He said that ASCO will open up the value framework proposal for public commentary, with the objective of improving the tool.

Presenting the clinicians' definition of value in cancer care was Neal J. Meropol, MD, professor and chief of the division of hematology/oncology at Case Western Reserve University School of Medicine. “I’ll provide more of a physician perspective he said, based on what I hear from my patients regarding their perspective of the cost or value of their treatment,” said Dr Meropol.

He listed a few of his patient’s concerns about value:

• The cost of traveling to the site of treatment
• Insurance coverage and copayments
• Need for a specialty agent
• Denial of payment for recommended care.

“Oncologists cannot be the gatekeepers based on cost, rather we have the opportunity to be gatekeepers based on value,” said Dr Meropol.

He showed data from studies documenting that the out-of-pocket (OOP) costs with cancer are greater than with other chronic diseases. Also, the rate of bankruptcies have been documented as being significantly higher among cancer patients than in individuals without a cancer diagnosis. OOP expenses, he said, have been associated with disparities in care. He cited an example of how Medicare patients with private supplemental insurance have been shown to receive their required chemotherapy, while those without the private supplemental insurance have a lower probability of receiving it.

“Patients are open to communicating with their docs about their cost burdens,” said Dr Meropol, and cost concerns may result in patients borrowing money from family, friends or from their retirement accounts; families making sacrifices to ensure continuity of treatment, etc. There’s racial disparity as well, he said, and “economic hardship” was reported to be higher in minority populations in the first year of their cancer treatment.

However, Dr Meropol noted, “A majority of patients, we need to keep in mind, have been shown to equate quality of life with length of life.” They are also ready to pay for higher value care if they are assured of better outcomes.

But what do oncologists think?

Citing results of a study published in the Journal of Clinical Oncology nearly a decade ago, he showed that 13% of oncologists did not have a good sense of their patient’s monetary concerns as they undergo treatment. While 33% of the surveyed medical oncologists said they were not comfortable discussing cost, 25% did not discuss the financial aspects at all. Economists hypothesize that physicians are incentivized by financial reimbursements, said Dr Meropol. “To avoid these perverse incentives, we do need alternate payment models such as bundled payments, value-based insurance, and pay-for-performance, he said.

Finally, Dr Meropol highlighted some of the much-needed tools at the point of care to better manage this growing discussion on value of care.

• What’s the relative value of different treatment options?
• What are the anticipated OOP costs for my patients?
• What are my patient’s goals and preferences?
• What is the best way to communicate these issues to my patients?

Jennifer Malin, MD, staff vice president of clinical strategy at Anthem Inc, discussed “Value from the Payer Perspective.” According to Dr Malin, the ultimate payer is the employer and/or the patient. “Our discussions today should not look at the influence on the immediate concerns, rather it should help patients make informed decisions about their future—about their insurance coverage and deductibles and copays—which would impact healthcare overall,” she said.

Dr Malin introduced the clinical pathways program that identifies high-value regimens to help curb treatment costs. To formulate the program, her organization reviews evidence from trials and publications, the information is then extracted, reviewed, and analyzed. External experts from cancer centers and community practices assess clinical benefits, toxicities, and cost, and they select those regimens that can be appropriate for 80%-90% of cases. But this pathway can provide a global frame of reference, she said.

Dr Malin talked about their Quality Initiative called the “Cancer Care Quality Program” which, she said, includes their prior authorization requirement under the same umbrella. It’s a web-based platform, she said, to improve efficiency.

“It is important to think about value for all stakeholders. Reimbursement needs to be aligned to achieve desired outcomes and to achieve quality care,” emphasized Dr Malin.

Unlike at last year’s annual meeting, ASCO invited a patient advocate to contribute to the value discussion.

“Patient Priorities on Value in Treatment Choices,” was the title of the talk by Beverly E. Canin, Breast Cancer Options, Inc.

She pointed to the need to achieve common ground between physicians and patients, which she emphasized should be based on “do no harm.” She acknowledged, however, that with a hard-to-treat disease such as cancer, it’s a difficult goal.

Ms Canin said that when doctors are asked about value in cancer treatment, they do not think about the cost. With patients, on the other hand, many of them talk about their ability to communicate with their doctors as being their “value” concerns.

She showed results from one such study that showed that >38% of patients defined value in terms of “personal value,” meaning their own personal goals and objective, while 7% of patients defined it in terms of “exchange” value, referring to the communication they have with their providers.

She emphasized the fact that the term “value” needs to be clearly defined to patients; a clear communication is needed, said Ms Canin. Referring to a quote from Linda House, president, Cancer Support Community, she said that there might be a disconnect between what the physician sees as value and how the patient understands it.

Ms Canin aptly ended her talk with George Bernard Shaw’s quote, “The problem with communication is the illusion that it has occurred.”