Launch of once-daily, two-drug regimen at an annual list price of $27,540 resists out-of-control pricing trend for HIV single-tablet regimen approvals

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WASHINGTON, DC, APRIL 9, 2019 – The Fair Pricing Coalition (FPC) today welcomed U.S. Food and Drug Administration approval of Dovato (dolutegravir/lamivudine), the first two-drug, single-tablet antiretroviral regimen for use by people living with HIV initiating treatment for the first time, and expressed its appreciation for a wholesale acquisition cost (WAC) that bucks the trend of runaway HIV drug pricing.

 

“After the blistering annual launch prices set for the two of the most recent single-tablet regimens, Biktarvy ($35,000) and Symtuza ($42,000),” said Tim Horn, Chair of the FPC, “the WAC price of $27,540 set for Dovato ushers in some much-needed sanity in drug pricing for highly effective, well-tolerated, and easy-to-take HIV treatment. The FPC asked and ViiV listened.”

Dovato contains the integrase strand transfer inhibitor dolutegravir (Tivicay), with a current annual WAC price of $20,880, and the nucleoside reverse transcriptase inhibitor lamivudine, with a current brand-name (Epivir) annual WAC price of $4,980. Dovato’s price therefore represents a $1,680/year premium over the combined priced of the brand-name component parts. Although FPC would have preferred pricing that was more closely aligned with the WAC price for Tivicay plus the National Average Drug Acquisition Cost (NADAC) for generic lamivudine (~$500 per year), FPC still believes Dovato represents good value for payers.

 

“ViiV should be charging less for Dovato given that lamivudine is available generically, but it did the right thing by setting a price well below the realm of typical prices for single-tablet regimens,” said Paul Arons, MD, a member of the FPC. “Two-drug regimens using the current era’s more powerful antiretrovirals show promise ‎of being as safe and effective as standard three- or four-drug regimens. They should, however, be significantly cheaper, and Dovato achieves this.”

 

The net price of Dovato for various public and private payers, following various discounts and rebates to payers, is expected to be substantially lower than most other single- and multi-tablet regimens in wide use today. “This is good news for patients and providers looking to avoid side effects with the use of a third drug – usually tenofovir, abacavir, or a boosting agent – and should be viewed favorably by insurers,” said FPC member and former Co-Chair Lynda Dee. “FPC is also glad to know that Dovato will be included in the existing copay assistance card and patient assistance programs with the same criteria set for all of ViiV’s products.”

 

The safety and efficacy of Dovato is supported by data from two randomized, double-blind, controlled trials (GEMINI-1 and GEMINI-2) in adults living with HIV with no antiretroviral treatment history. In these clinical trials, which included more than 1,400 volunteers initiating HIV therapy for the first time, 91% of those receiving Dovato versus 93% of those receiving Tivicay plus Truvada (tenofovir disoproxil fumarate [TDF]/emtrictabine) had viral loads below 50 copies/mL at Week 48. Both regimens were well tolerated. Differences in renal and bone biomarkers significantly favored the Dovato group, similar to that observed in other clinical trials comparing TDF with non-TDF regimens.

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