Monday, February 19, 2007

Insurer Ordered to Pay $40,000 for 'Off-Label' Use of Biologic Drug Rituxan

State insurance officials in New York have ordered a major health insurance provider to pay $40,000 to reimburse a young woman for “off-label’’ use of the world’s best-selling cancer treatment, biologic drug Rituxan.

It’s unclear what impact the ruling against United Healthcare will have, but it illuminates an increasingly-embattled corner of healthcare: When doctors decide to use costly biologics to treat conditions for which they have not been approved, are managed care providers required to pay?

Drugs like Rituxan, which the FDA has approved to treat non-Hodgkin's lymphoma and rheumatoid arthritis, are among the priciest on the market. But physicians and researchers have discovered that these biologics may be the most effective treatment for other intractable illnesses.

So, doctors try such “off-label” uses. Evidence suggests that Rituxan, for example, works on lupus, multiple sclerosis and the strain of Hodgkin’s disease that Jennifer McDonald had.

McDonald was first diagnosed with Hodgkin’s disease in 2004, when she was 17. After a standard chemotherapy treatment, the disease went into remission. When it recurred in 2005, her physician, Dr. Jennifer Pearce, turned to Rituxan, along with a new chemotherapy regimen.

Rituxan, a recombinant chimeric monoclonal antibody which binds to a key class of white blood cells, was developed jointly by Biogen-Idec Inc. of Cambridge, Mass. and Genentech Inc. of San Francisco. It had sales of $1.8 billion in the United States in 2005, more than any other cancer drug.

The new treatment worked for McDonald. But the young woman’s insurer refused to pay the $40,000 bill for the biologic, arguing that it wasn’t approved for use in treating Hodgkin’s disease, according to state records. McDonald, backed by Dr. Pearce and attorneys from the Albany Law School near her home in upstate New York, fought the denial.

The state insurance department turned to an expert panel to hear the appeal. Three doctors who specialize in treating cancer reviewed the medical literature and concluded that Rituxan was an appropriate treatment, “likely to be more beneficial than any other existing standard health service” to treat McDonald.

New York state officials told the Biologic Drug Report the ruling sets no immediate precedent beyond McDonald’s case, and it is unclear as to whether the decision will prompt the insurer to change any of its policies.

A United Healthcare representative sidestepped detailed questions, indicating only that “there are sometimes differing opinions" about whether a drug should be covered.

The law professor who helped represent McDonald, Prof. Joe Connors, said he wonders how many times life-saving therapies -- particularly costly biologics -- aren’t even tried following an initial rejection. “Many patients around the country might not had as zealous an advocate as Dr. Pearce and might choose to not prescribe it in the first place,’’ he said.

But with a number of biologics in clinical trials for possible future approval for additional indications, there are sure to be more battles ahead over whether managed care should pay for “off-label” uses of new therapies.

It’s an issue that’s of concern to many insurers, said Mohit M. Ghose, a spokesman for America's Health Insurance Plans, a trade group. “There’s a lot of conversation as to how these high-end cancer drugs and biotechnology drugs are handled."

-- by Matt Pacenza