Bexxar, a unique cancer therapy recently developed by two University doctors, is ready to hit the Medicare market.

After getting the green light from the Center for Medicare and Medicaid Services, hospitals and other health care providers under the Medicare program can now seek federal rebates on Bexxar prescriptions to treat patients with non-Hodgkin’s lymphoma – the nation’s sixth deadliest cancer.

“The key thing here is that with getting Medicare approval, it puts the final stamp on the product so insurance carriers are more likely to reimburse it,” said Mark Kaminski, co-director of the Leukemia, Lymphoma and Bone Marrow Transplant Program at the University Comprehensive Cancer Center. “The important thing is it’s developed at the University of Michigan and was aided all the way up until the (U.S. Food and Drug Administration’s) approval,” which came in June, he added.

Kaminski, who crafted Bexxar along with former University medical researcher Richard Wahl, said recipients of the treatment benefit from a regimen of antibodies and radiation therapy.

“We make these antibodies even more potent by hooking onto these antibodies a radioactive isotope (of iodine),” Kaminski said. “It’s radiotherapy and chemotherapy combined.”

But unlike chemotherapy, which loses its efficacy over time and carries several side effects such as nausea and hair loss, Bexxar requires only two applications over two weeks and has few side effects.

“The only clear-cut repetitive side effect is that blood cell counts decrease for a period of time to recover to their normal levels,” Kaminski said. “But during the time when the blood cell count is low, the patients actually do very well.”

Once injected into the body, antibodies blast single tumor cells with radiation. By contrast, chemotherapy affects a much broader area of the body.

“(Bexxar is) targeted radiation. It’s like a smart bomb,” said spokesman Jim DeNike of Corixa Corp., the Seattle company who now shares marketing rights of Bexxar with GlaxoSmithKline, a research-based pharmaceutical firm in the United Kingdom. “The point that makes Bexxar unique is its ability to take an antibody whose job is to target a specific tumor type.”

Although DeNike declined to say if patients have received the first prescription doses of Bexxar, he said Corixa has seen “(test) patients who, after receiving one administration of Bexxar, have been surviving disease-free for more than eight years.”

In addition, Kaminski said 60 percent of test patients having NHL responded to Bexxar even after chemotherapy had lost its potency, and about 30 percent of test patients showed full remission of the cancer.

“The hope is further effort with this type of approach can eventually cure this type of disease,” Kaminski said.

While the government cannot obligate Medicare contractors to provide Bexxar, CMS policy allows health care practitioners to avail themselves of a rebate system that will make prescribing the drug more amenable to their budgets.

“(The Medicare rebates) cover the entire regimen,” said University of Michigan Health System spokeswoman Kara Gavin, adding that costs associated with Bexxar application include training staff to handle the radioactive drug.

In the future, Medicare’s approval of Bexxar may persuade other health insurance carriers to cover the treatment, health personnel said.

“Private payers typically at least look at or take a lead from CMS and Medicare,” DeNike said. “That doesn’t mean they need to follow it, but it is not uncommon for private payers to at least take a lead.”

Although Corixa and GlaxoSmithKline receive all revenues from sales of Bexxar, Kaminski said the University gets royalties on those exchanges.

Currently, nearly 300,000 Americans live with NHL, according to the National Cancer Institute. Kaminski said about 30,000 people will die of the disease this year.





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