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Now that it has filed for federal approval of Glivec (STI571), Novartis Oncology is beginning to lobby insurance companies to actually cover the new drug treatment for chronic myelogenous leukemia.
Within the next month, Novartis officials will begin meeting with advisory boards and medical and pharmacy directors of insurance companies, said Gloria Stone, a Novartis spokeswoman.
"Obviously we hope there's no resistance," she said. "I think when you have an oncology drug, they look at it a little differently, so we hope they understand the importance of it. They recognize, for example, that cancer is something where you don't necessarily have a lot of options."
There are no federal laws requiring insurance companies to cover certain drugs. Some states do have their own laws regulating insurance company prescription drug coverage, but the industry is largely on its own when it comes to deciding specifically which medications it will pay for.
Most insurance companies, particularly managed care organizations such as HMOs, have either a tiered or formulary system for paying for drugs. Under the tier system, patient copayments depend on whether the drug is a generic, a preferred drug, or a nonpreferred drug, with the latter costing the most out of pocket. Under the formulary system, insurance companies have a list of drugs they will cover; drugs not on the formulary are not covered.
Novartis has not yet determined how much Glivec will cost, Stone said. "We're still working on that," she said.
It's too early for patients to begin trying to convince their health plan to cover the costs of Glivec, Stone said. "I don't think at this point there's anything they can do," she said.
Novartis filed for approval of Glivec on Feb. 27 for use in patients in chronic, accelerated or blast phase who have tried Interferon treatment unsuccessfully, Stone said.
"Filing the registration package in just 32 months after the first human dosing demonstrates the dedication of Novartis employees and investigators who have devoted themselves to making Glivec available to patients in need," said David Epstein, president of Novartis Oncology.
There have been some erroneous media reports about the FDA review status granted to Glivec, confusing the terms fast-track status and priority review.
The drug has received fast-track status - and only for patients in the blast crisis phase of CML, Stone said. "That's because of the truly unmet medical needs of patients in blast crisis," she said.
"If the Food and Drug Administration approves it, it would be for that category," Stone said.
However, once the FDA approves a drug, doctors can prescribe it for reasons other than the FDA-granted approval. That means doctors could prescribe Glivec to patients who are not in blast phase or who have not tried Interferon at all.
"It's a matter of physicians making the best judgments about its use," Stone said. "In the U.S., it's at the sole discretion of the physician."
In addition, fast-track status does not guarantee approval of the drug within six months of filing the application. "In effect it means the FDA has committed to meeting with us on a fairly scheduled basis and looking at our material quickly and working with us more quickly," Stone said. "The fast-track status is only for blast crisis. It might not mean anything for priority review."
The FDA would not comment specifically on the Glivec application, citing confidentiality until drugs are actually approved. However, FDA spokeswoman Susan Cruzan said that in general, when a drug is given fast-track status, the FDA has 45 days from the manufacturer's filing to review the application. "Once that happens, we will make a decision about whether it will be given a priority review and then notify the company," Cruzan said.
When a drug is granted priority review, the FDA has six months to decide whether to approve or reject the drug application.
Novartis is optimistic Glivec will receive priority review. "A lot of cancer drugs get a P-1 approval," Stone said.
Cruzan agreed. "A lot of times if these are new treatments for diseases that have no other good treatments, they most likely would be considered priority," she said.
Glivec could be rejected, approved, or deemed "approvable," Stone said. If deemed "approvable," certain FDA requirements must be met, such as a review of the data submitted in the drug application and filing more material with the FDA, Stone said.
Novartis plans to attend a meeting of the FDA Oncologic Drugs Advisory Committee in June, Stone said. "If they choose to have us participate in that meeting, it's because this is an important drug to take a look at."
If Glivec is approved as hoped in the United States, it would be available on the market "very definitely within a month of the approval," Stone said. The delay in getting it to market is only a matter of completing paperwork and importing the drug and getting it off the docks, she said.
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