In Druker’s study published in the New England Journal of Medicine last month, 53 of 54 patients who took Gleevec, then called STI-571, had stabilized blood counts within four weeks. Few side effects were reported.
C.M.L is caused by an acquired genetic defect in which pieces of chromosomes 9 and 22 break off and switch places producing an abnormal gene that signals the white blood cells to continue to divide rapidly. Of the 54 patients in Druker’s study, seven got what’s called a complete cytogenic remission — their genes no longer had the defective chromosome.
A New England Journal editorial accompanying the study said the drug show great promise, but cautions, “There is no evidence that STI-571 prolongs life. Important clinical problems could still emerge.”
Although Novartis predicts that private insurers will not balk at paying for the drug, Gangloff reminds her readers that they may initially be rejected and have to go through an appeals process to get coverage.
David Epstein, president of Novartis oncology, says that the company has an “ethical obligation” to provide the drug for anyone who has C.M.L.
“We are in the process of educating doctors about the drug,” Epstein says. ” We will make sure that every C.M.L. patient will be able to get the drug. Our biggest challenge will be Medicare patients because right now Medicare doesn’t pay for most oral cancer medications.”
The program works this way: Call the Novartis hotline at 1-877-GLEEVEC, and an employee will take your information over the phone. If you earn from zero to $43,000 per year and have no insurance coverage, you can receive the drug for free. If you earn up to $100,000, you can get Gleevec for a significantly reduced rate.
Epstein went on to say that the Novartis patient assistance program is the largest in scope in the drug industry. Other companies have offered assistance but not to as many people.
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