New Medicare rules for a small but promising class of cancer drugs may cause thousands of lymphoma patients to lose access to the treatment - in some cases the only therapy available to them.
The companies that make the drugs, and patient advocates, say the changes will sharply cut reimbursement for the medicines next year, and they predict many hospitals will stop offering the treatments. The Medicare changes come amid new evidence that the medicines, called Bexxar and Zevalin, are effective.
The drugs are given to treat non-Hodgkins lymphoma, the fifth-most common cancer, and are usually prescribed for patients who have not responded to other therapies. Clinical trial data show that they put the disease into remission for years in many of those patients.
After Jan. 1, Medicare will reimburse hospitals about $16,000 for each treatment with the drugs, which a patient needs to receive only once. GlaxoSmithKline, which markets Bexxar, say it is priced at almost $30,000 per treatment, and Cambridge-based Biogen Idec, which sells Zevalin, says it costs nearly as much. Such prices are not unusual for new cancer therapies, which can cost $50,000 or more for a year of treatment.
Senior Medicare officials say they are not trying to prevent hospitals from giving Bexxar and Zevalin. They say that $16,000 is a fair price and is based on the actual prices hospitals have paid for the medicines this year.
Zevalin was introduced in 2002, and Bexxar in 2003. Until now, Medicare has reimbursed each hospital claim individually, without setting a single nationwide price for the drug. The practice has resulted in wildly varying reimbursement, Medicare says.
But the companies say Medicare's data must be inaccurate and that no hospital will offer the drugs to Medicare patients if it is losing $10,000 or more per treatment.
Hospitals typically do not disclose their reimbursement rates, or whether they make money on any given treatment. The American Hospital Association declined to comment on the matter.
Under federal rules, hospitals that do not offer a drug to Medicare patients are barred from offering it to other patients.
Doctors, lymphoma patients, and advocacy groups say they do not understand Medicare's decision. About 60,000 people are diagnosed with non-Hodgkins lymphoma every year, and 20,000 people die of the disease.
"The explanation that they're giving is really flawed," said Dr. Mark Kaminski, the co-director of leukemia and lymphoma transplant program at the University of Michigan. Kaminski helped discover Bexxar two decades ago and receives a royalty for it.
Bexxar and Zevalin are part of a new class of drugs called radioimmunotherapies. They combine a radioactive particle with a biologically engineered molecule that attaches to cancerous white blood cells.
In a trial of 414 patients scheduled to be discussed next Monday at a hematology conference, the combination of Zevalin and chemotherapy put lymphoma into remission for three years on average, compared with one year for chemotherapy alone.
Marion Swan, a spokeswoman for the Lymphoma Research Foundation, says the drugs are the only option for some patients. "Our number one concern is that patients have access to all viable treatment options," she said, "and it looks like this might be denying access."
