Fair Pricing Coalition welcomes Gilead Sciences’ pricing of its new single-tablet regimen Genvoya in parity with Stribild, urges controlled costs across U.S. payer landscape

The Fair Pricing Coalition (FPC) today welcomed Gilead Sciences’ pricing of its new single-tablet regimen Genvoya in parity with its predecessor Stribild. Though the wholesale acquisition cost (WAC) of $31,362 per year hardly reverses a trend of exorbitant drug pricing in the United States, it underscores a growing recognition that HIV treatment expenditures are beyond what the market can reasonably bear.

“Genvoya, the first coformulation to be approved containing tenofovir alafenamide (TAF), is an important improvement over Stribild containing tenofovir disoproxil (TDF), particularly for an aging population of people living with HIV at increased risk of kidney problems and bone density loss,” says Lynda Dee, co-chair of the Fair Pricing Coalition. “Our request to Gilead that Genvoya be priced neutrally with Stribild was heard. We now need to ensure that this welcome addition is priced affordably for all cash-strapped public insurance programs and that future TAF-inclusive coformulations are priced to ensure access for all people living with HIV.”

Genvoya’s WAC is the price point where many negotiations with payers begin and strident advocacy to further control costs continues. “The next step is for negotiations to proceed with public insurance programs that receive discounts and rebates that serve to lower the cost below the WAC price,” says FPC member David Evans. “Most of these programs are in fragile financial shape and, when considering TAF-inclusive regimens, will require parity with the deeply discounted prices of the older coformulations containing TDF. We appreciate Gilead’s stated commitment to negotiate in good faith with these programs and will be watching to make sure that takes place.”

FPC also implores Gilead to approach its WAC determinations for future TAF-inclusive coformulations, including FTC/TAF (F/TAF) and rilpivirine/FTC/TAF (R/F/TAF)—the company’s follow-up products to Truvada and Complera that are likely to be approved by the FDA in April and July, respectively—with caution. Whereas Genvoya contains 10 mg of TAF, R/F/TAF will contain 25 mg TAF and F/TAF will be available as two coformulations: one containing 10 mg TAF for use in regimens containing boosting agents and another containing 25 mg TAF for use in combination with antiretrovirals that don’t require boosting, such as dolutegravir.

“Our request to Gilead was that the highest dose of TAF to be used in combination with other antiretrovirals be priced in parity with TDF,” says Murray Penner, FPC co-chair. “A WAC price for either dosing formulation of F/TAF or rilpivirine/F/TAF that is above that for Truvada or Complera, two combination tablets that debuted at high prices and have undergone numerous cost hikes, would be a serious misstep.”

TAF-inclusive coformulations are entering the U.S. marketplace on the brink of a watershed moment in HIV drug pricing history. “An initial report of TAF’s potential advantages over TDF was published in 2001; it is a shame people living with HIV had to wait until 2015, just two years before TDF’s patent expiration, to take advantage of its more favorable kidney and bone toxicity profile,” said Tim Horn, an FPC member. “TAF’s net benefit over TDF, notably whether it will significantly reduce the risk of serious renal disease and bone fractures, is not totally clear. Additionally, the pending arrival of lower-cost generic TDF and generic-inclusive coformulations—along with the potential for regimens employing fewer drugs to achieve and maintain viral suppression—are important factors with which Gilead must contend.”

“Like Triumeq, ViiV’s single-tablet regimen approved in 2014 that is priced below the sum of its parts, the neutral pricing between Gilead’s Genvoya and Stribild hopefully signals an end to drug pricing that has spiraled out of control,” says FPC member Paul Arons, MD. “It’s now time for a downward trend, not only because of shifting dynamics in the marketplace, but because personal and public health benefits to people living with HIV require ready access to safe and effective treatment options, despite limited resources.”

Leading Advocates and Organizations Call on Gilead to Price TAF Responsibly

John C. Martin, PhD Chief Executive Officer
Gilead Sciences
333 Lakeside Drive Foster City, CA 94404

Dear Dr. Martin:

In advance of the Fair Pricing Coalition’s October 12, 2015, meeting with Gilead Sciences’ senior staff to discuss wholesale acquisition costs (WACs) and access plans for tenofovir alafenamide fumarate (TAF)-inclusive coformulations, the signers of this letter urge your company to carefully consider product pricing that effectively addresses the need for cost-contained HIV care delivery in the United States.

As we are certain you are aware, payers have become increasingly conscious of price when making decisions about prescription drug coverage, even for life-threatening conditions such as HIV infection. This is evident in continued reliance on specialty drug tiering and the growing use of prior authorization by employer-based and Affordable Care Act health insurance plans. We are also seeing restricted access by state Medicaid programs and Medicaid managed care organizations, notably the downgrading of coformulated antiretrovirals to non-preferred status, subject to prior authorization and quantity limits.

People living with HIV and their healthcare providers welcome the anticipated benefits of substituting TAF for tenofovir disoproxil fumarate (TDF) as a component of elvitegravir/cobicistat/emtricitabine (E/C/F/TAF), rilpivirine/emtricitabine/TAF, and in 10 and 25 mg dosages coformulated with emtricitabine (F/TAF). We would like to ensure that all people living with HIV have access to these new formulations that may lower the risk of bone and kidney toxicity in accordance with phase III clinical trials (1). Access to TAF, however, may well hinge on the actual price paid by private health insurers, Medicaid programs, and AIDS Drug Assistance Programs (ADAPs).

We urge Gilead to price these new TAF-inclusive coformulations in parity with regimens containing TDF. This is particularly vital for Medicaid programs and ADAPs, where CPI penalties and discounts that Gilead has offered for TDF-inclusive coformulations have dramatically increased access through lower prices. Unless equivalent discounts are offered for TAF-inclusive coformulations, these drugs will be inaccessible to people living with HIV who need it most.

We are recommending that, with discounts and rebates, Gilead ensure that all payers do not pay more for TAF-inclusive regimens than TDF-inclusive regimens. Specifically, we urge that there be price parity based upon the 25 mg dose of TAF. The 10 mg dose in E/C/F/TAF and the second F/TAF coformulation should be priced proportionately lower.

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