Those who have been following the saga of the leukemia wonder drug imatinib mesylate or Glivec (spelled Gleevec in North America to standardize pronunciation) may recall that it was said to be the first medicine for which a global price was set. At the time of its 2001 FDA approval, the worldwide price was US$2400/month, for a base dosage of a 30 day supply of 400mg caps. Indeed, Novartis CEO Daniel Vasella went to great lengths to discuss and justify both the high price and the pricing decision in his subsequent infomercial-type book Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical History. The Gleevec story is notable too in that the typical pharma claim that the price is justified by R & D costs, was refuted by researcher Brian Druker MD, who detailed how most of the initial work on imatinib was publicly funded and he had to convince Novartis to produce enough of it to begin clinical trials with CML patients. Dr. Druker has also gone on record to criticize the price being charged for Glivec.
Since then patients in wealthy countries mostly have been clamoring for their public or private insurance to cover the drug (and its second-line successors) not that something be done about the price that is exorbitant even in their economies. Novartis invested heavily in worldwide patient relationship marketing for Glivec , which has contributed to this phenomenon, a topic explored previously in this blog. In recent years, it has become much more common to hear complaints from US patients and even some of the big-box disease associations, about the escalating price of drugs like Glivec and especially for new biologics. But it has been rare to to hear demands that something be done about drug prices.
So the recent posting of a patient petition on change.org calling for action to reduce the price of Gleevec is notable: Novartis and US Representatives in Congress: Reduce to patients the cost of the drug, Gleevec.
The introduction of the petition reads:
Novartis developed this drug in the 1990s. In the years since then the price of the drug has increased astronomically. Novartis must have paid their research costs long ago, but the price just keeps rising. Patients with CML leukemia are dependent on the drug to keep them alive. Our US representatives should work with FDA to pressure Novartis to reduce the cost
Setting aside the issue of misunderstanding that there are no price controls on prescription drugs in the US open market and that the FDA does not regulate drug prices, the petition is significant as a reflection of the increasing desperation of middle-class privately insured patients. They are among the majority here whose insurance status and/or income levels typically disqualify them for the patient assistance programs much touted by Novartis, whose global Gleevec sales generated $4.7B in 2011. Many US patients are now finding that the Gleevec price has skyrocketed at the same time that insurers are requiring them to pay a much larger share of its hefty price tag. The situation is quite simply unsustainable.
One person who signed the online petition shared:
I started taking Gleevec June 1, 2001, when it was first approved by the FDA. It cost $2400 for 30 pills. Now, these same pills cost $7367 per month. I pay $1035 per month for insurance to cover this cost. My insurance Co. gets billed for the drug. Why has Novartis raised the price so much? …
A look at Costco’s online pharmacy, which has a reputation, anecdotal at least, for offering “good value” retail prices on Rx meds in the US, found the following cash price for a month’s supply of an average dose (dosage is individualized) of 30 tabs : GLEEVEC 400 MG TABLET $6,264.59
While Novartis is continuing its drag on its patent fight to combat the imatinib generics already on the market in India, these cannot yet be exported to the US. The original US patent for Glivec expires in 2015. In 2009, Sun Pharma filed for and received tentative FDA approval for a generic imatinib for when that day comes.
Given the power of the pharma lobby the future remains very uncertain for any relief on the price of Gleevec , but the clamor of voices from the grassroots is a healthy development.