T-20 to sell at 18,980 euros: most expensive HIV drug yet

Keith Alcorn
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This article is more than 22 years old.

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.

Glossary

fusion inhibitor

Anti-HIV drug targeting the point where HIV locks on to an immune cell.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

phase III

The third and most definitive stage in the clinical evaluation of a new drug or intervention, typically a randomised control trial with the new intervention compared to an existing therapy or a placebo, in large numbers of participants (typically hundreds or thousands). Trial results are used to evaluate the overall risks and benefits of the drug and provide the information needed for regulatory approval.

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.

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