HIV and ID Observations

The recently approved once-daily integrase inhibitor dolutegravir is now in pharmacies and, like every new HIV drug, the price — around $14k/year — has generated some controversy.

For the record, here are the per-year wholesale acquisition costs of the three FDA-approved integrase inhibitors.

• Raltegravir:  $12,976
• Elvitegravir:  $13,428 (once disentangled from the price of TDF/FTC)
• Dolutegravir:  $14,105

If you add the $12 or 15K for the ABC/3TC or TDF/FTC respectively, you get the total cost of initial therapy. So these integrase-based regimens cost more than TDF/FTC/EFV (22.5K) or TDF/FTC/RPV (23.2K), and less than boosted atazanavir- or darunavir-based regimens, which are around 30k.

Now obviously these are all big numbers — HIV treatment is expensive — but the flip side is that it’s so staggeringly effective that it generally meets acceptable criteria for cost-effectiveness given the huge added years of life.

But incremental cost-effectiveness is another matter — meaning, is the additional cost of one drug over another justified, and/or good value?

Here, then, are two opposite perspectives on the dolutegravir pricing:

1. The price is fair, according to the U.S.-based Fair Price Coalition. Dolutegravir is an improvement over currently available options, and the slight premium pricing over raltegravir and elvitegravir/cobicistat is justified. Furthermore, the company met with and heeded community advice on price before the release of the drug — a laudable practice.
2. The price is unfair, according to the advocacy group HIV i-Base, which is based in London. The makers of dolutegravir went “for gold” in pricing the drug in the United States, and will therefore severely limit the use of dolutegravir in Europe and likely also in resource-limited settings (though prices in these locations are not yet set).

Your thoughts?