Not long ago, a cancer diagnosis triggered an immediate response from patient and physician: do anything to treat the disease.
It's a noble but exhausting and costly approach. Today, the crippling cost of chemotherapy drugs, together with the rise of personalized cancer treatments, demands a re-examination of this "all in" approach.
According to the Agency for Healthcare Quality, the United States' direct medical costs for cancer were $88.7 billion in 2011. Eleven percent of that total was for prescription drugs, largely chemotherapy. As far back as 2007, 70 percent of all bankruptcies were attributable to healthcare costs; cancer patients are 2.5 times more likely to file bankruptcy – even if they have insurance.
Oncologists have been relatively silent on the issue. But at the 2015 meeting of the American Society of Clinical Oncology, Drs. Peter Bach and Deborah Schrag strongly recommended the US healthcare system "...explicitly consider cost-effectiveness in the drug approval and insurance coverage processes." Dr. Bach's Memorial Sloan Kettering colleague, Dr. Leonard Saltz, echoed this urgency in a "60 Minutes" story focused on the onerous cost of cancer drugs: "We're starting to see the term 'financial toxicity' being used in the literature. Individual patients are going into bankruptcy trying to deal with these prices."
So what's behind this financial toxicity? The explanation is long and thorny, but comes down to the cost of developing new drugs and the slippery nature of cancer itself. The cost of researching, testing and bringing new drugs to market –the bench to bedside pipeline- is phenomenally high. Once the drug gets to market, that doesn't mean it replaces others already being used to treat a certain cancer. "The choice of one drug does not preclude the concurrent or subsequent need for the other drugs. In fact, each drug is expected to be used in all patients during the course of their disease," according to Mayo Clinic Proceedings in a recent journal entry from the National Center for Biotechnology Information.
Against this backdrop, two trends are creating a supportive environment for the acceptance of precision cancer treatment---the healthcare industry's shift to value-based care and the rise of personalized cancer treatment.
Value-Based Care and Cancer Treatment
Healthcare is moving swiftly from a fee-for-service to a risk-sharing reimbursement model where payers, providers and physicians share in the reward of positive outcomes. The focus on outcomes rather than activity creates a financial incentive to identify what truly works. In turn, this increased focus generates an interest in measuring the efficiency and effectiveness of cancer treatments.
Oncology Pathways
While the shift to value-based care has accelerated in primary care, subspecialties like oncology are slower to adapt. Major payers, such as Aetna and Anthem, are setting out to change that with the introduction of "oncology pathways".
"One in three patients do not receive a treatment plan consistent with current medical evidence," says eviCORE Healthcare's Debbie Stern, quoting data from the Journal of Clinical Oncology (2011, 30: 142-50). According to Stern and other health insurance executives, there's confusion in cancer treatment. Multiple tests/panels are ordered without clarity or specificity as to why they're being ordered. Genetic tests, while promising, are increasing in number and have yet to demonstrate their clinical value.
The aforementioned "all-in" approach was not only driving up the cost of care but weren't doing anything to improve care and boost outcomes.
Oncology pathways attempt to unify fragmentation in cancer care management. These pathways, or care models, are more patient-centered and evidence-based. "We need to focus on value as the oncology solution," says Aetna's medical director Michael Kolodziej, MD.
Oncology Care Model from CMS
The Centers for Medicare and Medicaid Services couldn't agree more with the payer community. CMS joined the value-based care effort with its own initiative aimed at oncology costs when they announced a bundled payment initiative for oncologists, the Oncology Care Model. It's now only targeted at Medicare fee for service, non-hospital oncology practices. However, because of its CMS origins the OCM is likely to emerge as a model for all oncology practices to follow.
While designed to improve the entire episode of cancer care, the OCM leaves little doubt as to the real target: chemotherapy costs. Drug manufacturers better figure out how to articulate their drug's value as it relates to the new payment model and help guide oncologists to a "best practices" model for the entire scope of cancer care.
Big Pharma has begun to acknowledge the increased focus on chemo costs. A recent shift to value-based care, together with consolidation of payers and providers, will pressure them to rein in drug costs. "Across the board in the U.S., the pricing environment is more difficult," said Novartis CEO Joe Jimenez in FiercePharma . "With a consolidated payer base as well as consolidated providers, you have to assume going forward that price increases in the U.S. are going to be quite limited."
The Role of Personalized Cancer Care
Precision medicine in cancer therapeutics involves utilizing unique data from a specific patient's tumor cells to develop a treatment plan tailored to a specific patient's cancer. Such data has included genomics, proteomics, and transcriptomics. The most widely publicized use of this data for cancer treatment is genomic testing.
But there are limits to genomic testing. The data can provide dramatic new insights into cancer biology, but they only point to how cancer might respond to an agent targeted to the identified abnormality. Genomic testing is not a panacea, and applies to a very few specific mutations in cancer types – according to a 2014 study in The Lancet Oncology, genomic sequencing of tumors generated results that were helpful for between 8-13 percent of patients.
The next step, as heralded by the American Society of Hematology, is to develop functional (vs. predictive) tests, or assays, to truly harness the power of precision medicine. This companion diagnostic testing would allow both providers and payers to determine the real return on investment for the individual patient.
Functional Assays
The CorrectChemo® assay brings precision/personalized medicine to chemotherapeutics. In contrast to the predictive technologies listed above, the CorrectChemo assay is a functional assay, directly testing the patient's live cancer cells to determine the relative effectiveness of each drug tested in inducing cell death. Within 72 hours, the drugs tested against a patient's specific cancer cells are ranked in order of their ability to kill the tumor cells.
This assay provides the oncologist with valuable foresight and information on how a specific patient's cancer cells have reacted to the drugs being considered for the patient's planned therapy, prior to the patient actually beginning their chemotherapy regimen. The test can reveal the relative efficacy of generic versus proprietary drugs, single versus combinations of drugs, as well as varying dosages of the same drug. Each of these can have a direct impact on cost and outcome.
The "one size fits all" approach to cancer treatment is behind us. Pressure to control costs, together with new tests to help customize care and improve the effectiveness of cancer treatments, lies ahead. The era of precision cancer treatment is a cause for hope, and ultimately, healing, for the wallet as well as the body.
Dr. Cary Presant, a hematologist and medical oncologist, is the chief medical officer at DiaTech, maker of the CorrectChemo assay. He is currently Professor of Clinical Medicine at the University of Southern California School of Medicine and is Chairman of the California Medical Center.
The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.