T-20 approved in US and Europe, but at a cost

Roche’s HIV fusion inhibitor T-20 (enfuvirtide, Fuzeon) received scientific approval in the US and Europe late last month, paving the way for the manufacturer to commence marketing the drug.

But there is widespread alarm at the high price announced by the company for the drug. In Europe, Roche announced pricing of €18,980 (A$33,898) for a year’s supply of the drug — more than double the price of the most expensive existing HIV drugs and 50 percent higher than the price most analysts had predicted. Several weeks later, US pricing was announced at a similar level.

Although Australian pricing will not be determined until the drug passes through the approval process, the news has heightened concerns among treatment activists that local availability of the drug is likely to be tightly restricted once it is approved.

In the US, AIDS activists said that the high price of the drug would lead to chaos in the already strained public health system.

Mark Milano, of ACT UP/New York, said that the price would force AIDS Drug Assistance Programs, which provide treatment to uninsured Americans, to cut access to other drugs, restrict entry to their programs, or increase already lengthy waiting lists. “This will hasten the death of thousands of people with HIV in the US,” he said.

Roche has defended the high price, arguing that T-20 is one of the most complex pharmaceutical products ever marketed and pointing to the drug’s US$600 million (A$1bn) development cost.
“It is critical that we can recoup the investment that we make in bringing drugs like Fuzeon forward,” David Reddy, head of Roche’s AIDS business, told the Financial Times.

There is also concern over Roche’s ability to meet demand for the new drug. With output from the firm’s specially built Colorado plant well below initial expectations, global shortages of the drug are predicted, despite the high price.
The barrage of criticism that Roche and the drug’s developer, Trimeris Pharmaceuticals, have faced over T-20’s pricing point to an emerging concern: with fewer companies involved in HIV/AIDS treatment research, and with strong demands that drugs be made available at affordable prices, especially in the developing world, some argue that the incentive for developing new drugs may be reduced.