Experts at the nation's largest gathering of oncologists this week urged tough new approaches for reining in the skyrocketing cost of cancer drugs.
Pharmaceutical companies at the American Society of Clinical Oncology's annual conference in Chicago touted new cancer therapies and potential breakthroughs. But some speakers argued that the U.S. healthcare system should explicitly consider cost-effectiveness in the drug approval and insurance coverage processes.
The system is struggling due to payment policies that incentivize use of high-priced treatments whether or not those therapies are actually more effective than lower-priced alternatives. Researchers said that price tags for some cancer therapies are so high that they preclude studies comparing their effectiveness with lower-cost products.
Dr. Deborah Schrag, chief of the division of population sciences and medical oncology at the Dana-Farber Cancer Institute, presented study findings illustrating the need to compare products and make choices at ASCO. Her team compared two monoclonal antibodies—bevacizumab and cetuximab—approved by the FDA in 2004 for treatment of metastatic colorectal cancer.
Both drugs are used along with chemotherapy as a first line of treatment for the disease. After adjusting for factors such as progression-free survival, potential adverse events, quality of life and dosing, the researchers concluded that Genentech's bevacizumab, priced at $9,324 for a course of treatment, was more cost-effective than Bristol-Myers Squibb Co.'s cetuximab, priced at $20,856, and should be considered the preferred drug. “From a value perspective, this isn't hard,” Schrag said.
Fears are escalating among clinicians, policymakers and drugmakers that if strong steps are not taken, the rising cost of cancer drugs may further widen socio-economic and racial disparities in access to state-of-the art cancer care. “Why treat these prices as immutable?” asked Dr. Peter Bach, director of Memorial Sloan Kettering Cancer Center's Center for Health Policy and Outcomes, during a packed session Saturday.
The onus should not just be on the manufacturers, Bach said. Comparative-effectiveness researchers should help “close the loop” by creating cost-effectiveness formulas to help set future costs, he argued.
A number of advocates have called on the Food and Drug Administration to consider the cost-effectiveness of new drugs as a part of the approval process and for Medicare to begin negotiating with pharmaceutical companies to obtain lower prices. But unlike in other advanced countries, the FDA, Medicare and Medicaid don't take cost into account in evaluating new drugs, treatments or services, and Congress prohibits Medicare from negotiating drug prices.
“There is no clearly defined value in the United States for what society is willing to pay for cancer treatment,” said Dr. Daniel Goldstein, a fellow in the hematology and medical oncology department at the Winship Cancer Institute in Atlanta. “As soon as FDA approval occurs, the cost of the drug is essentially set. There's no time to wait for published data.”
But Dr. Larry Jameson, dean of the Perelman School of Medicine at the University of Pennsylvania, raised cautions about empowering the FDA to evaluate the cost-effectiveness of products. A better approach, he said, would be to incorporate use of new diagnostic tools that could shape clinical trials in a way that produces faster findings with fewer subjects, resulting in lower research and development costs.
“Where the FDA can have a role is in the drug discovery cycle,” Jameson said. “The ability to use these more precise diagnostics can allow you to design clinical trials that are much more targeted to patients that are likely to respond or not.”
Bach said oncologists also have the power to “just say no” to higher-priced agents. “Would we really pay an infinite amount for a microscopic benefit?”
So far, the answer has been yes.
One expert cautioned against putting doctors in the position of rationing care based on cost. “At the point of care, I don't think oncologists are going to be gatekeepers of treatments based on cost,” said Dr. Neal Meropol, chief of hematology and oncology at University Hospitals Case Medical Center, during a presentation Sunday. “However we really do have the opportunity to be gatekeepers based on value and helping our patients choose the therapies that may have the same cost but different value.”
On Monday, the CMS released data on how much more than 950,000 physicians were paid in 2013 for medical services under Medicare Part B fee-for-service. A large portion of the payments to several specialties, including oncology, were directly related to the cost of drugs administered.
For example, the average amount paid to medical oncologists for drugs was $473,926 per doctor for 24 unique drugs. For hematology/oncology, it was $583,237 for 29 drugs. For radiation oncologists, it was only $4,687. But radiation oncologists had the highest average payments for medical services, at $403,512.