Pharmalot: WSJBy Ed SilvermanOctober 20, 2013Responding to the ongoing controversy over the prices for new hepatitis C treatments, U.S. Sen. Bernard Sanders [I-Vt.] will probably hold a hearing – possibly before the year ends – to examine how the cost is affecting the U.S. Department of Veterans Affairs, according to his spokesman. Sanders is chairman of the Senate Committee on Veterans’ Affairs.
His interest in a hearing comes as the expense of these medicines helps fuel a national debate over the rising cost of prescription drugs. New hepatitis C treatments, in particular, have caused a ruckus, because they promise cure rates exceeding 90%, which is prompting a sudden surge in prescribing – and subsequent concerns over the effect on insurance budgets. For the past several months, pharmacy benefit managers and state Medicaid programs have complained that the cost of Sovaldi, a treatment sold by Gilead Sciences, may become unsustainable. Sovaldi costs $1,000 a pill, or $84,000, for a 12- week regimen. Gilead maintains the treatment is a cheaper alternative to older forms of care that may be less successful and involve costly hospitalization.
Federal programs may feel the pinch, as well. A recent forecast from the Veterans Department indicated that Sovaldi will cost the department about $1.3 billion over the next two years. And that’s after a discount the VA receives that brings the cost per pill down to about $543, according to department documents provided earlier this year to the U.S. Senate Committee on Veterans’ Affairs. A Veterans Affairs spokeswoman writes us that the department added Sovaldi to its national formulary, or list of drugs for which coverage is provided, last March. As of October 1, more than 5,300 veterans have received treatment with Sovaldi, she writes, adding that about 225 patients are started on the treatment each week.
And so, Sanders “is interested [in holding a hearing,] among other reasons, because of the impact on the VA,” his spokesman tells us. The timing for a hearing, however, remains uncertain. The spokesman says a hearing may occur following the upcoming midterm elections on Nov. 4, “but it’s really up in the air.” This is not the first time Congress has responded to concerns over the cost of hepatitis C medicines. Last July, two members of the U.S. Senate Finance Committee asked Gilead to provide financial information about the $11 billion deal in which it acquired the treatment, R&D costs and subsequent pricing forecasts. A committee spokesman tells us the probe remains under way, but could not offer an update.
We asked Gilead, which has more recently received FDA approval to sell a newer, fixed-dose combination treatment called Harvoni that includes Sovaldi and another compound, for comment and will update you accordingly. [UPDATE: A A Gilead spokeswoman later sent us this note: "We are not aware of a hearing but we are cooperating with the Committee and responding to their questions."] This is the second time in recent weeks that Sanders has indicated concerns about prescription drug costs. Earlier this month, he was one of two members of Congress who launched an investigation into generic drugs and asked 14 drug makers to provide data on what was called the “escalating prices they have been charging” for some medicines.
I favor reform of the US patent system, and look to what is happening in India as a template. I also favor revoking corporate charters in some instances. The ability to incorporate is, like patents, a privilege granted by US citizens because they expect to receive benefits of corporate business activity.
This is a replay of the statin marketing strategy, population testing followed by medication for every indication.
The information I have seen is that very few with Hep C will develop liver issues, but with the mandate all will be treated. Certainly this is a condition that warrants close follow up, but not every patient needs this “cure.”
Steve Lucas
I have read that which patients will develop cirrhotic livers cannot yet be predicted. Is that true?
This is what happens when the “bean counters” get to make “business” decisions with people’s lives. Anyone who thinks the “invisible hand of the market” has any moral sense it fooling themselves.
The entire trademark/copyright/patent system in the US is a victim of regulatory capture and needs to be massively reformed, check that, scrapped and rewritten. Not only are pharma patents ridiculous but so are software patents. Patent trolls who make nothing and have no real business make millions off threatened lawsuits. Trademarks are also absurdly protected thanks to Sonny Bono and his favors to Disney.
I’m afraid Genentech set the pattern for this kind of overcharging.