Roche has announced that T-20, its fusion inhibitor, will be made available prior to licensing at 18,980 euros (£12,700) a year ($20,380). This price is almost 50% above the level predicted last summer by financial analysts (see aidsmap news story), and the highest price yet charged for any antiretroviral.
Roche says that the price is justified because the manufacturing process for T-20 is much more complicated than for any other antiretroviral; its synthesis involves over 100 steps, and the company says that it has cost more than $800 million to develop the drug, including substantial investment in specialised manufacturing facilities.
Subject to local agreements, pre-licensing access to the drug will begin shortly. The drug is already being supplied free to a small number of patients with the greatest clinical need, although Roche says that not all 40 places allocated to the UK have been filled. These places are available to patients at any clinic in the UK, not only those which participated in the phase III study of the drug.
T-20 is currently under review by Europe’s drug regulatory body, the EMEA, and is expected to be given scientific approval in May or June. Roche will be able to begin marketing the drug around three months later.
The US price will not been announced until the Food and Drug Administration completes its review of T-20, promised by March 16.