[Ip-health] question regarding government use for HCV drugs in U.S. at event on U.S. drug pricing

Steven Knievel sknievel at citizen.org
Wed May 11 07:57:06 PDT 2016

I had the opportunity to ask a question of Matt Salo, executive director of the National Association of Medicaid Directors as well as Tim Gronniger, deputy chief of staff of the Centers for Medicare & Medicaid Services (CMS), regarding the possibility of the U.S. government making use of 28 USC 1498 (government use) to procure generic HCV drugs.

See the video at the bottom of the page linked in this URL: bipartisanpolicy.org/events/educational-series-on-affordable-medicines-federal-policy/  

My question begins at 23:00 in the video at the very bottom of the page.

Here is a rough transcript of Matt Salo's response -- any errors in transcription are my own:

"Sure, um so, again, and I think the issues around hepatitis C are unique enough for a lot of different reasons, including, you know, the number of people that have it, the cost of the drug, and the fact is, as Jerry pointed out, that the CDC and lots of other people are saying, with good reason, this is the number one public health threat in this country. That makes this a very unique issue. Unlike all of the Shkreli stuff, unlike all of the specialty, and the biologic.this is unique. We have advocated in a lengthy letter to the hill, a range of things that could be done that might include that. Personally, I don't care how much profit the manufacturers get for doing this. This is..they've created a wonderful, wonderful product; we should encourage them to do so; what we are saying is that the Medicaid program, which is based on state general revenues, simply cannot absorb the hit of covering a hep C for a million, I think more like a million people over 700,000, but whatever. We can't do that, so something needs to be done, and we recommended a whole lot of things Congress could do, ranging from increase the federal match for this drug, or buy the supply chain, and make, and guarantee Gilead and AbbVie and Merck and whoever get as much profit as they want to give them, just we can't do it, so something's gotta be done. That could be one of them; will it happen? I mean, I liken it to smallpox and, you know, polio, you know, those were legitimate national public health threats. We didn't in those instances just say, 'welp, we've got a cure, good luck figuring out how to pay for it for people!' We had a national strategy, and we just don't have that here and we need it."

The CMS representative misunderstood the question, but he replied with a few comments presumably speaking to the Xtandi march-in request. Here is a rough transcript of those:

"So the, yeah, on that question, it's an NIH authority, something they said they'll  look at on a case-by-case basis, and I would refer you to a letter to Congressman, I believe it was Doggett, that they sent recently, to lay out the specifics of our response."

[I interjected off-mic that he was confusing what I was asking about with march-in, which is a distinct measure]

"Okay, happy to follow up."

Steven Knievel
Campaign Coordinator | Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7769
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