Earlier this year the US Senate voted (98-2) to permanently repeal the highly criticized Medicare Part B Sustainable Growth Rate (SGR) reimbursement formula and passed the “Medical Access and CHIP Reauthorization Act of 2015” creating a new, pay-for-performance oriented Medicare reimbursements program. The program, called the Merit-Based Incentive Payment System (MIPS), will have a significant effect on reimbursement.
Not long ago, a cancer diagnosis triggered an immediate response from patient and physician: try everything to bring about a cure—a noble, if exhausting and costly, approach. But 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 was $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 principally it 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 away from a fee-for-service to a risk-sharing reimbursement model. Payer, provider and physicians share in the reward of positive outcomes. The focus on outcomes rather than activity creates financial incentive to identify what works and what does not and has generated an interest in measuring the efficiency and effectiveness of cancer treatments.
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.
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 platinum 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.