Open Letter to Manufacturers of HIV and Hepatitis Medications Opposing 2017 Price Increases

FINAL LETTER – November 29, 2016

Submitted to AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen Therapeutics, Merck, and ViiV Healthcare

The undersigned organizations and individuals submit this letter in response to price increases you took in 2016 on antiretroviral (ARV) drugs to treat HIV, and in advance of what has become a standard New Year’s practice of boosting Wholesale Acquisition Costs (WACs) for ARVs without regard to how that will affect patient access to these life-saving treatments. We also write to express concerns about future price increases for direct acting antivirals (DAAs) for the treatment of Hepatitis C (HCV), which are already priced beyond what insurers and people living with HCV can reasonably bear.

Included below, please find the U.S. Fair Pricing Coalition’s table documenting two years of increases, along with its pricing and access principles and requests. These issues are especially relevant in light of resulting cost-containment restrictions instituted by both public and private payers.

Since 2010, some ARV prices have even been raised twice in the same year, the most blatant example being Gilead’s dual hits in 2016 on Complera and Stribild, totaling 14.3% and 12.1% respectively. In all cases, the price increases exceed the rise in the Consumer Price Index (CPI), a measure of inflation, sometimes two to three times or more. They even exceed the medical CPI, which is always more than the overall CPI, arguably due in part to excessive drug prices.  In fact, average annual ARV increases have ranged from 5% to 8% ­— even higher in some instances — while the overall CPI has averaged 2.5% per year over the past 10 years.

We also have overwhelming evidence that exorbitant drug pricing has resulted in hepatitis C (HCV) patients being unable to access DAA combinations, which achieve up to 99% cure rates with minimal side effects. As examples of resulting obstacles, payers have initiated specialty tiering, coinsurance, and prior authorization restrictions for HIV and HCV drugs, with additional cost-containment measures in place for DAAs, such as fibrosis scoring qualifications, prescriber limitations, sobriety requirements, and detrimental rationing among incarcerated individuals.

Generally ignoring urgent community pleas to refrain from any price increases, and certainly no increases over medical CPI, the companies listed here have raised prices as follows (the columns show percent increases in 2015 and 2016, and overall since FDA approval):

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The FPC and signers of this letter firmly believe that upwardly spiraling drug prices are already beyond the limit of any conceivable justification, are unsustainable, and will further prevent HIV and HCV patients from accessing life-saving ARVs and DAAs. Thus, we urgently request that you agree to a two-year price freeze on ARVs and DAAs to offset, in part, the price increases of your ARV drugs since FDA approval, and the initial WAC prices of your Hepatitis C DAAs. We are aware of industry claims that no one actually pays the WAC price. However, we also know that all discounts start from that point, resulting in inflated, inconsistent, and unsustainable consumer prices.

If companies insist on instituting price increases, at the very most they should occur only once annually, no sooner than two years after FDA approval, and they should not exceed the overall increase in the medical CPI for the preceding year.

If any manufacturer of ARVs takes more than one annual price increase above medical CPI, or in the case of DAAs, any price increase whatsoever, we pledge to mobilize to notify and inform the public at every possible opportunity about any and all unreasonable and unfair pricing policies. President-elect Trump and Congressional leaders have provided bipartisan support for reining in excessive drug pricing, another pragmatic reason to curb your annual overreach. We urge you to heed these warnings, and reject any contemplated price increases.

Organizational signatories:

Access Support Network of San Luis Obispo and Monterey Counties
ACT UP LONDON
ACT UP New York
ACRIA
ADAP Advocacy Association
ADAP Educational Initiative
Advocates for Youth
AIDS Action Baltimore
AIDS Alabama‎
AIDS Foundation of Chicago
AIDS Treatment Activists Coalition
Any Positive Change Inc.
American Academy of HIV Medicine
American Sexual Health Association
AmidaCare
AVAC
Berkeley Free Clinic – Hep TEV Section
Big Bend Cares Inc.
Black AIDS Institute
Boulder Community Health-Beacon Center
Boulder County AIDS Project
CAEAR Coalition
Cares Community Health
The Center for Housing & Health
Center on Halsted
Chicago Women’s AIDS Project
Chicago House and Social Service Agency
CHOW Project
Coachella Valley Community Research Initiative, Inc.
Colorado Health Network
Colorado Organizations Responding to AIDS (CORA)
Community Access National Network
C.O.R.E. Medical Clinic, Inc.
CrescentCare
DC Fights Back!!
G III Associates
Gay Liberation Front NYC
GMHC
GNP+ (Global Network of People Living with HIV)
Good Samaritan Project
Harm Reduction Coalition
Harlem United
Health GAP
Health People
Healthy Rhythm Community Art Gallery
Hep C Alliance
Hep Free Hawaii
Hispanic Health Network
HIV Medicine Association
Illinois Alliance for Sound AIDS Policy (IL ASAP)
Illinois Public Health Association
Latino Commission on AIDS
Liver Health Connection
Los Angeles Community Health Project
LLHC (Louisiana Latino Health Coalition for HIV/AIDS Awareness)
Marin AIDS Project
National Alliance of State & Territorial AIDS Directors
Needle Exchange Emergency Distribution (NEED)
NMAC
Oasis Clinic
Okaloosa AIDS Support & Informational Services, Inc
Orange County Needle Exchange Program (OCNEP)
Pharma Greed Kills
Point Defiance AIDS Projects
Positive Iowans Taking Charge
Positive Life Palm Springs
Positive Women’s Network – USA (PWN-USA)
Project Inform
Projekt Information e.V.
Promise of Justice Initative
Sacramento Area S.T.O.P. Hepatitis Task-Force
San Francisco Hepatitis C Task Force
Santa Rosa Community Health Centers
San Francisco Department of Public Health
Southern AIDS Coalition
Southern HIV/AIDS Strategy Initiative (SASI)
Tennessee Association of People With AIDS
Test Positive Aware Network
Treatment Action Group
Treatment Access Expansion Project
Treatment Educat10n Network
Trystereo/New Orleans Harm Reduction Network
VOCAL New York
United States People Living with HIV Caucus
Universities Allied for Essential Medicines
University of Sussex
The Wall Las Memorias Project
Western North Carolina Community Health Services (WNCCHS)
Westside HIV/AIDS Regional Planning Council (WHARP), Chicago
Zephyr LTNP Foundation, Inc.

Individual signatories

Bernice Armould
Jim Banta
Ann Bardue
Gilbert Barrett
Michael Bauer
Jeffrey Beal
Sara Brewer
Christopher Cannon
Orlando Chavez
Lara Coffin
Kris Coontz
Jan Diamond
Michael Dorosh
Erin Dupuis
Ryan Eagle
Andria Efthimiou-Mordaunt
Isabelle Erbacher
Juan Fernandez Ochoa
Ann Finkelstein
Steven Flinn
Saoirse Folsom
Jim Fouratt
Alexandra Greenberg
Tami Haught
Mark Hubbard
Rosie James
Outi Kallunki
George Kerr III
Paul Kowal
Louise Kyle
Xuan Li
William Longbotham
Jennifer Lorvick
Colleen Lynch
Sara Lyttle
Najwa Maqbool
Paul Maurizio
Eric McNatt
Madeline Meisburger
Mark Milano
Bethany Miller
Jay Mills
Enrique Moresco
Priyanka  Narahari
Gerry Nealon
Katrina Nguyen
Stephanie Prohaska
Temple Robinson
Robin Roth
Merila Runlel
Juuso  Sallinen
Luis Santiago
Matt Sharp
Craig Shehea
Cynthia Springer
Peter Staley
Anna Steiner
Annunziata van Voorene
Wim Vandevelde
Reginald Vicks
Will Wilson

Fair Pricing Coalition Core Pricing and Access Principles and Requests

Pricing

• Institute a price freeze for all currently approved HIV and HCV drugs for the next two years, and for a two-year period henceforth from the date of FDA approval on all new HIV and Viral Hepatitis drugs.

• Thereafter, if you must, take no more than one price increase annually, and at no more than the rise of the medical CPI. In addition, provide the FPC with prior notice within the bounds of relevant laws, of the rationale for all price increases, and if possible, a call in advance to discuss any “potential” increase.

Access Programs

Robust access programs are a necessity to assist uninsured and underinsured individuals in obtaining necessary medications, and have become increasingly important for adequately insured individuals facing substantial out-of-pocket costs resulting from payer cost-containment measures. Even with a company’s commitment to such programs, further changes are necessary in order to adapt to the changing healthcare environment and the mounting burden of increasing drug prices. Nor can these access programs be used as an excuse for a company’s continued excessive pricing tactics.

• Where allowable by law, provide all privately insured individuals living with HIV and/or HCV with 100% coverage of all out-of-pocket (OOP) costs, including co-pays, deductibles, co-insurance or any other related charges for all HIV and Viral Hepatitis prescriptions, including mail order prescriptions. We make this request in light of reports from individuals throughout the U.S. who are not taking their medications because they cannot afford the rapidly increasing OOP costs.

• Donate to a highly functioning and qualified foundation pursuant to all relevant laws, particularly to assist Medicare Part D recipients who cannot use manufacturers’ programs to defray co-pays, co-insurance and deductibles, but who may seek assistance from such foundations to help with these costs.

• Continue use of HHS’s Common PAP Application Form, requesting no additional information from applicants than is already requested on the current form, and participate in HarborPath to foster ease of access to medications through your PAPs. Both help to streamline the multiple forms and programs that provide HIV and Viral Hepatitiis medications to low-income individuals without health insurance.

• Disclose to the FPC the number of patients on your HIV and HCV access programs (i.e., co-pay assistance and PAPs), and your eligibility formulas for underinsured patients in your PAPs. Provide transparency on your PAP website(s) about the eligibility criteria for underinsured individuals.

ADAPs

• Continue providing significant, additional discounts/rebates to ADAPs beyond those required by the 340B program for all existing and new ARVs and DAAs.

• Provide full rebates on partial payments made by ADAPs, as is the current industry standard and guidance from HRSA, pending any changes in HRSA’s final rule on the topic.

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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