Generic treatment for chronic myeloid leukemia could save millions

U.S. insurance companies and patients can realize thousands in cost savings with the patent expiration of Novartis' Gleevec in January, Johns Hopkins researchers have announced. 

See also: The ups and downs of generic drugs

If all chronic myeloid leukemia (CML) patients upon diagnosis were started on imatinib mesylate,the generic form of Gleevec, the cost of treatment per patient over five years would be nearly $100,000 less than it is now, a recent study published in the Journal of the National Cancer Institute has asserted.

As a result, a health insurer with 100 patients with CML could save $9.1 million over five years, the researchers at Johns Hopkins Bloomberg School of Public Health and the University of Chicago found.

CML is a relatively rare cancer that starts inside the bone marrow. Approximately 6,000 Americans are diagnosed with CML every year, and up to 90% survive five years on drugs such as Gleevec.

“If we start all patients on the generic form of Gleevec and it works, then they are on a generic for the rest of their lives,” said William V. Padula, PhD, an assistant professor in the Department of Health Policy and Management at the Bloomberg School. “This amounts to a huge cost savings for them and their insurers.”

Newer medicines formulated to treat CML, such as dasatinib (Sprycel) and nilotinib (Tasigna), have come on the market since Gleevec was launched in 2002 and are “priced competitively in the $80,000-90,000/year price range,” Padula told Drug Topics.

See also: Generic drugs: How to keep those cost savings coming

Equivalent response rates with CML treatments

In nearly 90% of cases, patients are now started on one of these newer drugs, depending upon physician preference, but research has shown that for the three drugs, overall five-year survival rates are equivalent.

Now that Gleevec has lost patent exclusivity in the United States, its price is expected to drop 60% to 90% as competitive generic forms of imatinib enter the U.S. market.

“Under this situation, imatinib will become the most affordable, cost-effective, first-line therapy of CML, compared to its branded competitors,” Padula said.

CML patients tend to switch drugs during the course of treatment if they experience side effects or if one drug doesn’t appear to be effective. This results in nearly 50% of patients taking Gleevec for some or all of the time over a five-year period.

Minimal risk

“There is minimal risk to starting all patients on imatinib first,” Padula said. “If the patient can’t tolerate the medication or it seems to be ineffective in that patient, then we can switch the patient to a more expensive drug. Insurance companies have the ability to dictate which drugs physicians prescribe first, and they regularly do. Doing so here would mean very little risk to health and a lot of cost savings.”

If insurers decided to pay only for imatinib as the first-line medication — instead of permitting physician preference — and if the patient stayed on imatinib for five years, the savings would be even greater than $100,000.

“This five-year time point is significant, since it is the amount of time hematologists and oncologists typically use to measure progression-free survival or overall survival from remission in CML patients."

Next, Padula said, he and his colleagues “are interested in observing the real-time price of imatinib, to see whether the price actually drops as predicted. Based on the outcome, if the price drops differently than expected, then we may re-evaluate the cost-effectiveness of these options.”