Pathways versus Personalized Medicine

Participants at the 2015 Association for Value-Based Cancer Care annual meeting were challenged to consider the concept of value in oncology, and whether providers are truly delivering oncology care that serves society and patients with cancer. After hinting that pathways and next-generation sequencing are good steps but not the ultimate solutions, Michael Kolodziej, MD, FACP, National Medical Director, Oncology Solutions, Aetna, explained his reasoning.

“We’re in this big discussion now,” he said. “What constitutes value in oncology? You can turn this around any which way you like, but ultimately what we really want to have is the best possible outcome for our patients at a fair price. I didn’t say cheap, I said fair.”

Dr Kolodziej recognized the commonly acknowledged costs of cancer care, noting that almost every discussion begins with conversations about the rapid growth of cancer care costs compared with the cost of healthcare premiums, general medical care costs, or the growth of the US economy. The scenario is frequently described as unsustainable, and the challenge, Dr Kolodziej added, is not just the cost of care, but the perception that patients are not experiencing good outcomes despite all the money being spent on treatment.

He acknowledged that cancer drugs are expensive, and that the cost escalation of cancer care is so much faster than other elements of the US economy that it is dragging down productivity and profitability in the private sector. These concerns, however, present only half the story, he said, citing a recent study published in JAMA Oncology that determined a low correlation between the prices of oncology drugs at the time of their commercialization and disease responses to therapy. His concern, and that of the study authors, was that this indicated that drug prices were determined more by what the market will bear, rather than the benefit the drug brings to patients and society.

Turning to pathways, Dr Kolodziej shared a former advertisement for Marlboro cigarettes, pointing to the man in the advertisement to illustrate the difficulty in assessing appropriate treatment options for patients as well as the role of pathways in patient care. The image illustrates both the fallacy behind the idea of N-of-1, he said, as well as the idea of a master clinician, who can determine appropriate treatments by simply looking at a patient.

“There is no oncologist in the universe who can look at that patient and decide which of the drugs…are best for [him],” Dr Kolodziej said. “The truth of the matter is we need a construct to identify the right way to treat the Marlboro man.”

Pathways have become a key element of population management that define the best treatment for the average patient, he said. Pathways do come with challenges, he noted; national payers seem to be embracing them, local payers are not embracing them as quickly, and providers are embracing pathways that have been developed internally. This is a point of concern, Dr Kolodziej said, since many practices do not have a formal process to weigh evidence, or a way to track evidence and utilize it at the point of care. There must also be a mechanism for documenting medical decisions, as well as medical and financial consequences of those decisions. He stressed the value of a formal pathway program that provides the ability to measure performance, look for opportunities for improvement, and improve processes of care.

Costs of care may vary between patients with the same diagnosis depending on their age, health status, and therapy needs, he stated, and it is important to sort patients by their clinical features and cost profiles as reimbursement models inevitably shift to episode-based payments. Pathways are necessary, he said, to lay the groundwork for this evolving reimbursement model.

“Without a pathways-type construct,” he said, “we will never get to the point where anybody will be able to project what an episode-based reimbursement might look like. That’s why we need pathways now.”

Dr Kolodziej suggested that treatment choices solely related to epidermal growth factor receptor (EGFR) mutations do not necessarily provide the best clinical outcome for a patient, noting that deletions and point mutations must also be taken into consideration when determining therapeutic options. He referred to a recent phase 2 study that was reported in the Journal of Clinical Oncology examining 647 patients who were slotted into 5 biomarker-­matched treatment groups. Ultimately, what seemed to be standard indications for specific treatments based upon markers determined by genomic sequencing led to treatments that did not produce the expected outcomes.

The solution, he said, may be to identify appropriate subpopulations that will allow a determination of the likelihood of response based on patient characteristics and clinical elements. The use of different population models and pathways may allow the organization and alignment of complex data. Pathways have the potential to promote personalized therapy that is not just based upon genomic sequencing, but on many patient characteristics. The challenge will be to develop technology, tracking, and reporting that takes solutions that may be hidden within data to help physicians make decisions at the point of care.

“We need the ability to sort a population into the just-right size that has traditional clinical markers, where we understand the cost of care, where we put in molecular markers, and we make an intervention and can measure what happens,” Dr Kolodziej said. “Pathways are just a way of structuring complex data from multiple inputs at the point of care. That’s all it is…it’s all about thinking about all those variables and giving them common structure.”

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