Panel Discusses Costly New Oncology Drugs; Study Address Cancer Drug Shortages
By Mia Burns
Although researchers have made powerful new targeted treatment options available to oncologists who treat breast cancer patients, options such as pertuzumab are associated with high costs which raises questions about access as payers assess the value of treatment. Pertuzumab, also known as Genentech’s Perjeta, is a recombinant humanized monoclonal antibody that is approved for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer.
According to the American Journal of Managed Care, in one clinical trial, women treated with combination therapy with pertuzumab experienced significant improvements in progression-free survival, or six months greater on average, compared to women who received combination treatment with a placebo. These and other key issues surrounding proper utilization and reimbursement were the focus of an expert panel discussion that the American Journal of Managed Care convened.
The discussion, moderated by Michael E. Chernew, PhD, a professor in the Department of Health Care Policy at Harvard Medical School and co-editor-in-chief of the American Journal of Managed Care, also featured Lee N. Newcomer, MD, MHA, SVP of oncology for UnitedHealthcare, and Sandra M. Swain, MD, medical director of the Washington Cancer Institute at Medstar Washington Hospital Center in Washington, D.C.
In 2012, Dr. Newcomer wrote an article, Changing Physician Incentives For Cancer Care To Reward Better Patient Outcomes Instead Of Use Of More Costly Drugs in which he discussed the payment systems for cancer therapy. In November 2010, UnitedHealthcare began a pilot program to test the episode payment approach with five large medical oncology groups. Each group selected the treatment regimen that it believed was clinically superior for nineteen discrete clinical episodes in breast, colon, and lung cancer. The oncologists committed to at least 85 percent compliance with their chosen therapies for UnitedHealthcare patients. Exceptions are allowed for a medical contraindication or enrollment in a clinical trial. The groups can change the selected regimens at any time, but they must achieve the same level of compliance.
“I am concerned that we could create incentive programs that would in fact discourage the use of a new drug,” Dr. Newcomer said during the panel discussion. “Our episode program was designed to avoid that. In the episode program, what happens is, when pertuzumab came out, this actually occurred while we were in the middle of that pilot; we always paid the drug at cost so the physician did not lose money by switching their patients to pertuzumab. They didn’t make more money, either. In the current fee-for-service group, when pertuzumab comes out, they get a percentage as a profit margin. It is an expensive drug. They would have made more money if they were using it. In our episode program, they were able to switch to the program without any penalty whatsoever because they are not at risk for the cost of the drug, but they did not make more money, either. We changed our episode payment for caring for the patients based on outcomes. If we see that these patients are in fact living longer, or having fewer hospitalizations because their disease is controlled, then that will raise the episode payment, but it won’t be raised just because they switched to an expensive medicine. On the other hand, there is no penalty or no barrier for them making that switch if they believe that it is a better medicine. That was set up deliberately. We have to be a little careful about capitation programs where there is a fixed pot of money because that may be too much of a barrier to using newer medications that are effective.”
In addition, the panelists examined the demographics of the patient population eligible for treatment with pertuzumab and another promising new treatment, Kadcyla, also known as TDM-1. They also reviewed results from several clinical trials that examined treatment using these medications alone and in combination, with Dr. Newcomer noting that the survival benefits seen from TDM-1 in the Emilia trial are “probably one of the best responses we have seen in breast cancer in almost a decade.” These promising trial results have raised the profile of these drugs among clinicians and patients. Dr. Swain said that there was “an immediate request for those drugs as soon as they became available on the market…breast cancer patients were following this news just as closely as the physicians.”
Another issue in the oncology world is the shortage of drugs. Cancer drug shortages continue to confound the best efforts of the FDA to head them off, in part because the agency has little authority to address police what causes them to occur, according to a co-author of a study about shortages.
Dr. Keerthi Gogenini, a medical oncologist with the Abramson Cancer Center at the University of Pennsylvania, helped present one of several studies that grabbed headlines at the June meeting of the American Society of Clinical Oncologists. Evidence-Based Oncology, which is an indexed news publication that is a supplement to The American Journal of Managed Care, checked back with Dr. Gogenini and the FDA on the current state of shortages for its August issue.
Despite an FDA spokeswoman, Lisa Kubaska, PharmD, crediting the 2012 Food and Drug Safety Innovation Act with allowing the agency to identify shortages and find temporary solutions, such as importations of drugs, Dr. Gogenini said on the front lines, the picture is not that rosy, although she believes that FDA is doing what it can.“There are factors that contribute to drug shortages that the agency has limited control over,” Dr. Gogenini said.
The June surveys presented at ASCO, including the study conducted at the University of Pennsylvania, showed widespread effects of shortages. In the Penn study, 94 percent of oncologist and hematologists said patients’ treatment had been affected by shortages, and 13 percent reported that patient participation in clinical trials had been compromised.
Dr. Gogenini attributes shortages to the lack of redundancy across the manufacturing system, while others have blamed the low cost of generics, which give companies little incentive to invest in capacity for these drugs. “There are few penalties for failing to supply critical drugs, and no incentive for companies to invest in ‘excess’ capacity,” she said. “This is not something the FDA would have control over.”
Posted: August 2013