John C. Martin, PhD Chief Executive Officer
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.