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June 02, 2015 01:00 AM

Oncologists urge frank evaluation of cancer drugs' costs and value

Sabriya Rice
Steven Ross Johnson
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    ASCO/Max Gersh
    Cancer experts gathered in Chicago this week for the 2015 conference of the American Society of Clinical Oncology.

    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.

    ASCO's annual report on the state of cancer care found seven of the 10 most expensive drugs covered by Medicare in 2013 were cancer medications.

    Meanwhile, questions are mounting over whether the high prices of new therapies coming to market truly reflect their clinical effectiveness. Many examples of questionable pricing are being discussed.

    A 2013 article published in the Journal of Clinical Oncology found the average monthly price of cancer drugs had doubled from $4,500 a decade ago to more than $10,000. Researchers found only three out of the 12 cancer medications approved by the FDA in 2012 prolonged the survival of the patient, with two prolonging survival by less than two months. Nine of the 12 drugs were priced at more than $10,000 a month.

    Dana-Farber's Schrag said professional groups and federal health officials should work together to develop preferred drug regimens. Higher-priced products that are no better than cheaper alternatives should remain available for patients who cannot tolerate the preferred drug or are willing to pay more out of pocket for them, she added.

    Over the past week, ASCO launched several data-sharing and payment reform initiatives. On Monday the group announced the first-ever ASCO-led clinical trial. The Targeted Agent and Profiling Utilization Registry, or TAPUR, study will collect data on the outcomes of patients with advanced cancers who receive one of 13 molecularly targeted drugs for uses not approved by the FDA.

    ASCO leaders also announced the official rollout of CancerLinQ, a big-data initiative, which will initially include 15 U.S. oncology groups. The groups will share data from millions of electronic health records to provide clinicians with real-time feedback on trends and patient outcomes.

    In addition, ASCO leaders proposed a new payment model for cancer care using consolidated billing codes, bundled payments and care-management fees, which they hope will improve quality of care and reduce costs.

    Beyond that, however, some researchers hope to develop a national framework for establishing value-based prices for new cancer drugs before they enter the marketplace. Simply doing cost-effectiveness studies has not been effective in changing clinicians' behavior, Winship Cancer Institute's Goldstein said.

    Other initiatives are focusing on ways to incentivize oncologists to make more cost-effective choices when prescribing medications. For example, last summer health insurer Anthem started paying oncologists $350 a month for each of their patients who receive medications Anthem recommends as more cost-effective than pricier alternative products.

    Dr. Jennifer Malin, Anthem's vice president for clinical strategy, said during a presentation Sunday that the results of the company's Cancer Care Quality Program were encouraging, noting an increase in the number of patients who were prescribed drugs within the approved regimen.

    “We need to encourage clinically meaningful therapeutic innovations,” she said. “We think that by highlighting those therapies that are most effective and bring the greatest value to patients, we help to achieve that goal.”

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