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.

There are revitalized federal and state efforts under way to substantially increase the proportion of people living with HIV with maximally suppressed viral loads. This is further compounded by the pending availability of lower-cost generic versions of TDF, which is currently classified as a recommended regimen component in the DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. To remain viable in this cost-containment environment, TAF-inclusive coformulations cannot follow the historical trend of being priced higher than that of predecessors, particularly when TAF may be seen as offering only incremental benefit at a premium price.

We support the Fair Pricing Coalition’s request for pricing parity and the arguments in favor of that scheme presented in this letter. It is our hope that the launch of TAF-inclusive regimens exemplifies the history of the pharmaceutical industry working in partnership with people living with HIV, health care providers, and payers to ensure access to safest, most effective antiretroviral therapy options at a fair price.

Very truly yours,

Aastha Gram Seva, Jamui, Bihar, India
ACRIA, New York, NY
Action Communautaire pour le Bien Ítre de l’Enfant et de la Femme au Burkina (ABEFAB), Ouagadougou, Burkina Faso
ActionAIDS, Philadelphia, PA
African American Health Alliance, Dunkirk, MD
AIDS Action Baltimore, Baltimore, MD
AIDS Alabama, Birmingham, AL
AIDS Foundation of Chicago, Chicago, I
AIDS Legal Council of Chicago, Chicago, IL
AIDS Resource, Williamsport, PA
AIDS Task Force of the Upper Ohio Valley, Wheeling, WV
AIDS Treatment Activists Coalition, Denver, CO
AIDS United, Washington, DC
AIDSNET, Bethlehem, PA
Albany Damien Center, Albany, NY
ALPHA Pittsburgh, Inc., Pittsburgh, PA
American Academy of HIV Medicine (AAHIVM), Washington, DC
Amida Care, New York, NY
Apicha Community Health Center, New York, NY
Asian & Pacific Islander Wellness Center, San Francisco, CA
AVAC:Global Advocacy for HIV Prevention, New York, NY
Bolivian Network of People Living with HIV/AIDS, La Paz, Bolivia
Cameroun TB Group, Melen, Cameroun
Cascade AIDS Project, Portland, OR
Charleston Area Medical Center Ryan White Part C Program, Charleston, WV
Children’s Hospital of Pittsburgh HIV Center, Pittsburgh, PA
CHOW Project, Honolulu, HI
Christie’s Place, San Diego, CA
Clarion University/Northwest Alliance, Clarion, PA
Community Networks, Inc., Martinsburg, WV
Covenant House of WV, Charleston, WV
Dab the AIDS Bear Project, Jacksonville, FL
Doctors of the World USA, New York, NY
Dream Weaver Organisation, Tema, Ghana
Drive for Universal Healthcare, Springfield, IL
Engender Rights Centre for Jutsice (ERCJ), Lusaka, Zambia
Entre Hermanos, Seattle, WA
Fenway Health, Boston, MA
Florida Keys HIV Community Planning Partnership, Key West, FL
Foundation for Integrative AIDS Research, Brooklyn, NY
Freedom care, Chennai, Tamil Nadu, India
Fundation Femme Plus, Kinshasa, Democratic Republic of the Congo
G III Associates, Washington, DC
Gender Justice League, Seattle, WA
Global Justice Institute, New York, NY
Harm Reduction Coalition, New York, NY
He Intends Victory, Irvine, CA
Health Education Network, Corvallis, OR
HealthHIV, Washington, DC
HIV Dental Alliance, Atlanta, GA
HIV Medicine Association, Arlington, VA
HIV Prevention Justice Alliance, Chicago, IL
Housing Works, Inc., New York, NY
Hyacinth AIDS Foundation, statewide, NJ
JAPETI, Jakarta, Indonesia
Latino Commission on AIDS, New York City, NY
Lehigh Valley Health Network, Allentown, PA
LILA Italian League for Fighting AIDS, Bologna, Italy
Living Hope Organization (Livhorg) Support Group for PLWHA Nigeria, Umuahia, Nigeria
Louisiana Latino Health Coalition for HIV/AIDS Awareness (LLHC), New Orleans, LA
Long Island Association for AIDS Care, Inc., Hauppauge, NY
Lowcountry AIDS Services, North Charleston, SC
Lowcountry AIDS Services Consumer Advisory Board, North Charleston, SC
Maui AIDS Foundation, Wailuku, HI
Medical University of S.C., Charleston, SC
Mendocino County AIDS/Viral Hepatitis Network, Ukiah, CA
Metropolitan Community Churches, New York, NY
Miami Valley Positives for Positives, Dayton, OH
Migrant Clinicians Network, Austin, TX
National Alliance of State & Territorial AIDS Directors, Washington, DC
National Coalition for LGBT Health, Washington, DC
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National Minority AIDS Council, Washington, DC
Naya Goreto, Kathmandu, Bagmati, Nepa
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New Jersey Association on Correction, Trenton, NJ
Nightsweats & T-cells Co., Cleveland, OH
NoFLACweb.org, Pensacola, FL
North Central Texas Planning Council, Fort Worth, TX
One in Four Chronic Health, Portland, OR
PeterCares House, Greenbelt, MD
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Pittsburgh AIDS Task Force, Pittsburgh, PA
Positive Life Series Palm Springs, Palm Springs, CA
Positive-Generation, Yaounde, Cameroun
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PPF limpopo, Polokwane, Limpopo, South Africa
PROFOH, Houston, TX
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Project Inform, San Francisco, CA
PSPS, San Juan, PR
Racial and Ethnic Health Disparities Coalition, Dunkirk, MD
Rural Christian Network, Nsawam, Ghana
Ryan/Chelsea-Clinton Community Health Center, New York, NY
San Francisco AIDS Foundation, San Francisco, CA
Shubert Botein Policy Associates, Brooklyn, NY
TAW-Cameroun, Ngoa ekelle, Cameroun
Test Positive Aware Network (TPAN), Chicago, IL
Thai AIDS Treatment Action Group, Bangkok, Thailand
The Ihangane Project, Aptos, CA
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Thrive Alabama (formally the AIDS Action Coalition of Huntsville), Huntsville, AL
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Triad Health Project, Greensboro, NC
Uganda Network of AIDS Service Organisations (UNASO), Kampala, Uganda
Unity Fellowship Church, New York, NY
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Victory Post Test Group, Kisumu, Kenya
VillageCare, New York, NY
VNSNY CHOICE, New York, NY
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William F. Ryan Community Health Network, New York, NY
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cc: Gregg H. Alton, Executive Vice President of Corporate and Medical Affairs
Cara Miller, Senior Director, Public Affairs
(1) Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, conformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomized, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Apr 15. doi: 10.1016/S0140-6736(15)60616-X.