When laboratory tests are inaccurate or misinterpreted, patients may receive costly targeted drugs that provide no benefit. If the medical community doesn’t resolve the problem, payers will take action on their own.
ABSTRACT: When laboratory tests are inaccurate or misinterpreted, patients may receive costly targeted drugs that provide no benefit. If the medical community doesn’t resolve the problem, payers will take action on their own.
CHICAGO-The integration of targeted therapies into cancer care protocols has led to a marked rise in expenditures for chemotherapeutic agents. While payers support the use of agents that provide clear benefits, they are also concerned that some patients receive costly care when there is no evidence of improved outcomes.
Representatives from the payer and provider communities gathered at the 2008 Oncobiotechnology Research, Clinical and Business Summit, sponsored by Northwestern University, to discuss their most pressing concern: Eliminating waste from the chemotherapy delivery system.
Lee N. Newcomer, MD, executive vice president of UnitedHealthcare Oncology Services, Minneapolis, started off the discussion by noting that UnitedHealthcare no longer sets policy for coverage of expensive drugs. “Earlier this year, we decided that our coverage decisions would be made according to National Comprehensive Cancer Network (NCCN) guidelines,” he said.
Al B. Benson, III, MD, professor of medicine in the division of hematology/oncology, Northwestern University, Feinberg School of Medicine, pointed out that NCCN guidelines are integrated to form a cancer drug compendium.
“NCCN is now the newest drug compendium that has been approved by the Centers for Medicare & Medicaid Services for reimbursement of drugs for the treatment of Medicare patients. Unlike most other guidelines, these are updated in real time,” Dr. Benson said.
But just having a reimbursement policy in place isn’t enough. “What keeps me awake at night is how well those policies are being executed,” Dr. Newcomer said.
As an example, he cited a UnitedHealthcare study performed 2 years ago of HER2 testing in patients receiving trastuzumab (Herceptin). “We found that 4% of the patients had no HER2 pathology reports. The tests had never been done. And 8% of the reports showed underexpression of HER2, yet the tumor was called HER2 positive in the clinical records,” he said.
The plan now requires that the first claim for trastuzumab must include a pathology report that uses NCCN guidelines to determine HER2 status. But even this did not solve the problem. “As of last month, we still have a persistent 12% denial rate on trastuzumab claims, due to misinterpretation of pathology reports,” he said.
Other studies suggest a 30% error rate in HER2 testing. “So when deciding whether to treat a breast cancer patient with trastuzumab, you have a 30% chance of a lab error and a 12% chance that the results will be misinterpreted,” he said. “The issue for payers is how to make sure we are not wasting resources, and we’re getting the right drug to the right patient.”
Dr. Benson noted that a similar challenge will be coming up soon. “A series of retrospective colon cancer studies have shown that patients with a mutated KRAS gene will not receive benefit from drugs like cetuximab [Erbitux],” he said. “The problem is we find a mutated KRAS gene in about 40% to 45% of patients. What do we now offer these patients as alternative treatment? We will need to further understand the biology of their tumors to develop new biologic therapies.”
Even for patients with wild-type KRAS gene, who do receive a treatment benefit from drugs like cetuximab, he noted, “the benefit is not 100%. I would predict that payers will demand that we document KRAS status before prescribing cetuximab. This will completely transform practice.”
Steve Russek, RPh, chief clinical officer for Accredo Health Group, a specialty pharmacy unit of Medco Health Solutions in Memphis, said that employers continue to be concerned about the growing cost of providing healthcare for their employees. “For employers to hear that some of the treatments they are paying for are not effective because available laboratory tests are not being used will play very poorly and will push them into putting some coverage rules in place,” he said.
Dr. Newcomer agreed: “If the medical profession doesn’t take this on, the payers will. They’ll say, ‘If you want coverage, you will have to use the following labs that we know provide valid test results.’”
Dr. Benson commented that the research community is taking a closer look at the issue of assay validation. “The goal at the end of a clinical trial is to provide the details for such validation,” he said.
With regard to public payers, the “concepts and the vocabulary” to contend with these important issues are still in their infancies, commented Bruce Quinn, MD, PhD, a senior health policy specialist for the law firm Foley Hoag of Boston.
“Cost-effectiveness research can mean a treatment is cheaper in the long run by avoiding hospitalization,” he said. “Or it could mean there is a least costly alternative, such as when three drugs are equivalent but one is less costly. Or it could mean, throw people out of the life boat because they are too expensive for the rest of us to deal with. These are the kinds of entirely distinct situations that are usually lost in the public debate about cost effectiveness.”
Will it reach a point that payers will refuse to pay for high-cost drugs when the benefits are modest? “I don’t think that we’re close to a crisis in the U.S.,” Dr. Newcomer said, “but eventually we will have to have those discussions, maybe 4 to 5 years out when Medicare is predicted to go under.”
In the meantime, he said, “there is a ray of hope if we live by the rules. We have to stick with NCCN rules and follow our own guidelines. The key is not wasting the precious resources we have.”