Significant Reduction in Treatment Costs Are Anticipated With the Emergence of Generic TKI

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Significant Reduction in Treatment Costs Are Anticipated With the Emergence of Generic TKI
Significant Reduction in Treatment Costs Are Anticipated With the Emergence of Generic TKI

With the January 2016 expiration of the patent on Gleevac, significant cost savings can be realized by insurance companies and patients. Just 15 years ago, Gleevac (imatinib) changed chronic myeloid leukemia (CML) from a fatal disease to a treatable illness.1

If all patients with CML were treated with the generic form of imatinib from diagnosis, the cost of treatment per patient over 5 years would be nearly $100,000 less than it is now, according to this study. Most patients with CML need daily medication for the rest of their lives; that translates to $9.1 million over 5 years for a health insurer covering 100 patients with CML. CML is diagnosed in an estimated 6000 American each year, and approximately 90% survive on imatinib, which is manufactured and sold by Novartis Pharmaceuticals Corporation.

"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 of Public Health at Johns Hopkins University in Baltimore, Maryland, and leader of this study. "This amounts to a huge cost savings for them and their insurers."

Though Gleevac was the first drug to successfully treat CML, 2 other drugs that act as tyrosine kinase inhibitors, dasatinib (Sprycel) and nilotinib (Tasinga), have entered the market in recent years. Generic versions of these drugs will not be available for many years; the branded versions each cost approximately $75,000 for a 1-year supply. In nearly 90% of cases, patients are started on one of these newer drugs based on physician preference, but research has shown that overall 5-year survival rates of all 3 drugs are equivalent.

Drugs are switched for patients with CML if adverse effects occur or if the drug does not appear to be effective. Therefore, over 5 years, approximately half of patients with CML will take imatinib for some or all of their treatment.

If insurers covered only generic imatinib as the first-line drug, rather than allowing doctors to choose, the savings would be more than $100 000 over 5 years if the patient stayed on the generic drug the whole time. The researchers estimate the cost of imatinib will decrease from nearly $60 000 a year to less than $6000 a year as generic manufacturers make and sell imatinib.

"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."

The car industry, Padula explained, bases the price of its models on how much it costs to make each one, with a small percentage of profit factored in. Drug prices have little to do with the actual cost of what goes into manufacturing and distributing the product. Drug companies argue that prices take into account the cost of research and development, as well as the value provided to the patient.

"When patent protection is lost, the prices are set closer to the true cost of the drug," Padula said. "They're making 'General Motors' profits as opposed to pharma profits and that savings can be shared with the consumer, but only if doctors and insurers work together to make sure patients are being prescribed the more cost-effective medication."


1. Padula WV, Larson RA, Dusetzina SB, et al. Cost-effectiveness of tyrosine kinase inhibitor treatment strategies for chronic myeloid leukemia in chronic phase after generic entry of imatinib in the United States [published online ahead of print March 4, 2016]. J Natl Cancer Inst. doi:10.1093/jnci/djw003.

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