Ahead of PDUFA Date, US Congress Places Pressure on Gilead's Pricing for Quad
A group of 13 members of the US Congress have written a letter to United States drug firm Gilead Sciences expressing concern over reports on the potential pricing of its new HIV/AIDS combination treatment Quad.
IHS Global Insight Perspective
The announcement that members of Congress have expressed concern over the potential pricing of Gilead's Quad highlights the increasing political activism in the United States over pharmaceutical pricing, and follows a similar move in 2011 over the pricing of URL Pharma's Colcrys. In the absence of formal pricing mechanisms, this manner of "naming and shaming" perceived offenders of high prices of pharmaceuticals in the US remains the key political mechanism by which pricing is monitored in the market.
Gilead has yet to respond to the letter publicly, but clearly it puts pressure on the company by placing the limelight on the drug's reported annual USD34,000 price tag.
The prescription drug user fee act date for Quad is 27 August, and expectations are for a full approval, although there have been some question marks over its effect on renal function. IHS Global Insight does not expect a formal announcement on pricing until then.
A group of 13 members of the United States Congress have written a letter to John Martin, the chief executive of US drug firm Gilead Sciences, expressing their concern over reports on the potential pricing of its new HIV/AIDS combination treatment Quad (elvitegravir + cobicistat + emtricitabine + tenofovir). Expectations are for a price of between USD26,000 and USD34,000, and the Congressmen claim that this alone could result in a funding crisis for the governmental AIDS Drug Assistance Programs (ADAPs). The letter is available here.
The letter acknowledges that Gilead has issued a price freeze in effect until 2013 for drugs provided to the ADAP, but there have been significant above-inflation price increases to the commercial market that are having a knock-on effect on the ADAP, according to the Congressmen. Specifically, it highlights the 7.9% price increase on Truvada (emtricitabine + tenofovir), 7.3% on Complera (rilpivirine), and 6.6% on Atripla (emtricitabine + tenofovir + efavirenz). These price increases are pressing affordability for privately insured patients, who are subsequently turning to the Ryan White Part B programme for help on co-payments and deductibles, according to the letter. The Congressmen note that, given the link between the Ryan White programmes and funding of the ADAP, Gilead's dominance of the HIV/AIDS market is already creating pressure on the ADAP that will tip over the edge with the reported Quad pricing.
Outlook and Implications
The PDUFA date for Quad is 27 August, and expectations are for a full approval, although there have been some question marks over its effect on renal function. IHS Global Insight does not expect a formal announcement on pricing until then. Naturally, there is a degree of guesswork involved in the reported range of USD26–34,000 per year, but this is based on a potential 20% premium over Complera (emtricitabine + rilpivirine + tenofovir disoproxil fumarate), which in turn had a 4% premium on Atripla (efavirenz + tenofovir + emtricitabine).
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