As price tags for recently FDA-approved drugs to treat chronic myelogenous leukemia (CML) have soared past the $100,000 level, a group of more than 100 oncologists have characterized the price tags as “too high and unsustainable,” and argued that prices may impede needy patients’ access to treatment and threaten the sustainability of healthcare systems in an article published online April 25 in Blood.
Hagop Kantarjian, MD, of MD Anderson Cancer Center in Houston, and co-authors suggested that physicians should advocate for lower prices as part of the Hippocratic Oath to do no harm. They also estimated that lower prices could increase pharma profits by increasing the number of patients on therapies that nudge CML into the chronic disease realm.
“Of the 12 drugs approved by the FDA for various cancer indications in 2012, 11 were priced above $100,000 per year. Cancer drug prices have almost doubled from a decade ago, from an average of $5,000 per month to more than $10,000 per month.”
Why? Pharmaceutical companies have lobbied that the costs of bringing new agents to market is $1 billion, but others place the figure on the $60 million to $90 million range. Typically, new drugs are priced within 10 to 20 percent of the most recent similar drug on the market.
CML therapies have followed a distorted process. In 2001, when the FDA approved imatinib, its potential benefits were unknown and the price tag of $2,200 per month hovered near the standard treatment at the time—interferon.
This price point, coupled with a prevalence of 30,000 patients in the U.S. and full market penetration, would deliver annual revenue of $900 million, allowing Novartis to recoup development costs in two years.
However, imatinib and new tyrosine kinase inhibitors (TKIs) exceeded expectations and helped drop CML mortality from 10 to 20 percent to 2 percent. Patients’ life spans are close to normal and CML mimics a chronic condition, provided patients remain on therapy.
The annual price tag for imatinib skyrocketed to $92,000 in 2012, which may fuel the coonection between drug prices and bankruptcies. Meanwhile, Novartis pocketed annual revenues of $4.7 billion in 2012. The price increase occurred “despite the fact that all research costs were accounted for in the original proposed price,” new indications were approved and the population of CML patients on imatinib increased.
TKIs approved for CML in the U.S. cost between $92,000 and $138,000, double the European selling point. And CML survival in the U.S. hovers in the 60 percent range, compared with 80 percent in Sweden.
“Unaffordable drug prices may be preventing many patients from accessing these life-saving drugs,” wrote Kantarjian et al.
“We believe the unsustainable drug prices in CML and cancer may be causing harm to patients,” they continued, while urging physicians to advocate for lower drug prices.
“We propose to begin the dialogue by organizing regular meetings, involving all parties concerned, to address the reasons behind high cancer drug prices and offer solutions to reduce them,” Kantarjian and colleagues concluded.