Gleevec was approved just as the Human Genome Project was wrapping up, and it served as Exhibit A for those who were looking for evidence that the era of gene-guided health care had arrived. Francis Collins, director of the Human Genome Project, spotlighted Gleevec at the project’s celebratory conclusion. Gleevec was remarkable, but it was not exceptional; rather, Collins predicted a future where any disease you could name had its own Gleevec.
Two decades later, Gleevec retains its vaunted status. “Before Gleevec” and “after Gleevec” has come to mark the moment when personalized medicine shifted from aspiration to reality. Patients from Druker’s early trials who are still alive serve as powerful reminders of how Gleevec “changed everything.” The president and CEO of the Leukemia & Lymphoma Society marked the 20-year anniversary of Gleevec’s FDA approval, noting, “It was the birth of precision medicine: the right drug to the right patient at the right time.”
That’s the short version anyway. A closer look at what followed after the FDA approval, on the other hand, paints a different picture.
There were warning signs right away. The article in Time, after conveying the enthusiasm, concluded by pointing out that the drug sold for well over $2,000 a month. That translated into an annual cost of between $25,000 and $30,000. The Novartis CEO admitted the price was steep, but there was good reason, he countered. The existing therapies for chronic myelogenous leukemia were priced similarly. Moreover, the market for Gleevec was small, and Novartis invested $600 to 800 million in the research and development of a new drug. The higher-than-usual price tag was necessary to offset the company’s financial commitment to the lifesaving treatment; Novartis might not even make much of a profit on its new drug. The price, the CEO said, could even come down if the population of patients who took the drug expanded.
The price of Gleevec stayed in the $25,000-to-$30,000-a-year range for some time. Then something strange happened. Around 2006, the price began climbing. The market for Gleevec had indeed expanded after its release because it changed a deadly blood cancer into something that could be managed like a chronic disease, which by the Novartis CEO’s own reasoning should have brought the price down. Around the same time several other drugs that worked similarly, called “tyrosine kinase inhibitors” based on the proteins that they shut down, also came out alongside Gleevec. One, in fact, was Novartis’ own Tasigna. Economics 101 would suggest the arrival of competitors drives down prices, but the exact opposite happened. The newcomers were priced even higher than Gleevec, in the $5,000-to-7,000-a-month range. And the listed price of Gleevec gravitated up toward that of the new arrivals. Starting late in the first decade of the 21st century, the price of Gleevec steadily rose, 5 percent one year, 8 percent another, then nearly 20 percent. Patients who paid $2,200 a month in 2001 were paying triple that amount a decade later. By 2011, Novartis was making more than $4 billion annually.
The chronic myelogenous leukemia community, appalled by what was unfolding, eventually cried foul. In 2012, patients and loved ones of those with the disease posted a petition to Change.org asking members of Congress to intervene on Novartis’ price hikes. One patient who was in Druker’s original trial of STI-571 complained, “It is borderline criminal to force people to make the choice between life (being able to afford the Gleevec) and death (being financially unable to buy the drug that will save their lives).” Another supporter of the petition simply pleaded, “My grandma needs this medicine.”
