Fair Pricing Coalition Troubled by Unjustified 2017 Drug Price Increases by HIV Pharmaceutical Manufacturers

NEW YORK, NY, February 27, 2017–The Fair Pricing Coalition (FPC) today expressed its dismay and frustration at manufacturers of some of the most frequently prescribed antiretrovirals for treatment of HIV, citing exorbitant Wholesale Acquisition Cost (WAC) price increases ushered in with the new year. The WAC price increases implemented by these industry leaders show complete disregard for an annual FPC year-end appeal, which included an additional 90 organizational and 61 individual signatories.

“Pharmaceutical corporations continue to make annual, sometimes twice-yearly, incremental increases on HIV drugs, and their arguments that the increases are necessary to ensure new drug discovery and don’t contribute to nationwide limitations in care for all are less and less compelling every year,” said FPC Co-chair Emalie Huriaux. “These increases are like a death by a thousand paper cuts, slowly bleeding money from consumers and threatening the ability of people with HIV to access lifesaving treatment. The FPC continues to make this point year after year, and here we are again, addressing unsustainable WAC increases.”

The 2017 WAC price increases for leading antiretrovirals are two to three times the ten-year consumer price index (CPI) average of 2.5 percent; they are also higher than all medical CPI categories, which average 2 to 3 percent and are driven in part by unrestrained drug pricing. “While other companies, such as Apple or Samsung, are also quite profitable, people don’t die from the lack of an iPhone or television,” said Huriaux. “The same cannot be said about medications for people with life-threatening diseases like HIV.”

“What’s really frustrating is the growing trend among manufacturers to shift responsibility for these price increases onto other parties—pharmacy benefit managers retained by insurers to secure lower drug costs, discounts and rebates to public payers, even copay assistance programs,” said FPC Co-chair Tim Horn. “The fact remains, however, that these concessions are necessary primarily because WAC prices are beyond what the market can reasonably bear. Breaking the cycle depends, in large part, on manufacturers lowering their prices.”

Notable WAC price increases reported in January 2017 include ViiV’s 7.9% increase on Triumeq, Tivicay, and Selzentry (no price increase was reported for Epzicom, which now faces generic competition); Gilead’s 6.9% increase on its three TAF-inclusive products, Descovy, Genvoya, and Odefsey, plus two price increases on Atripla totaling 6.6%; Bristol-Myers Squibb’s 6% increase on Reyataz, Sustiva, and Evotaz; AbbVie’s 4.9% increase on Kaletra; Janssen’s 7.9% increase on Intelence, Prezcobix, and Prezista; and Merck’s 7.9% increase on Isentress. The WAC prices for several antiretrovirals, including Atripla, Reyataz, Truvada, Sustiva, and Viread, are now double or triple their launch prices.

“These price increases have real-life consequences,” said FPC member John Peller, President & CEO of AIDS Foundation Chicago. “They drive health insurance premiums higher every year, making it harder for all of us to afford insurance. They force insurance companies to make people pay more for lifesaving medications or add administrative barriers, like prior authorization, that cause endless access delays.”

No increases have been announced so far on the recently developed Direct Acting Antivirals (DAA) for treating the hepatitis C virus (HCV). Those drugs were launched at prices so high that the resulting public outcry led to Congressional hearings.

The FPC notes that all DAA manufacturers, with the exception of Gilead, have negotiated discounts with the ADAP (AIDS Drug Assistance Program) Crisis Task Force. “We applaud the work of the Task Force and the manufacturers that have agreed to provide discounts to ADAPs, thereby making curative DAA treatment much more accessible to people coinfected with HIV and HCV,” said Horn. ADAPs can access these medications at the 340B price, which represents at least a 23.1% discount off of the Average Manufacturers Price. However, even at the 340B price, the Task Force noted in a June 30, 2016, update, prices for Gilead’s HCV treatments are excessive compared with the negotiated prices of other companies.

The FPC submitted its letter with 151 signatories to all of the major HIV and HCV drug manufacturers in November 2016, demanding a price freeze or, if absolutely necessary, no more than one price increase annually, not to exceed the overall increase in the medical CPI for the preceding year. Letters also reiterated the need for more robust company patient savings programs to offset skyrocketing out-of-pocket costs associated with these expensive medications being placed in specialty drug tiers, and cited increasing U.S. government opposition to excessive drug pricing. While such programs are under fire from the health insurance industry and large payer groups, who argue that the programs steer people away from cheaper drugs that are equally effective, it has been well documented that expensive co-payments and co-insurance lead to gaps in treatment for people with HIV or HCV, who don’t have cheaper alternatives and who would experience significant medical harm.

In response, most manufacturers arranged conference calls with the FPC for further discussion of their pricing principles. Claiming legal proscriptions, however, companies stated while they can receive input before pricing increases, they can only notify the FPC and general public after the price increases have been implemented. While the companies reiterated their support for patient access, primarily through patient assistance and co-pay assistance programs, they nevertheless uniformly proceeded to raise WAC prices unreasonably anyway.

FPC Releases New Report Urging Modernization of Existing Laws to Rein in Drug Pricing

The Fair Pricing Coalition announces the release of “Tackling Drug Costs: A 100-Day Roadmap,” an analysis of existing federal statutes and regulations that should be strengthened to dramatically lower the prices of drugs and biologics in the U.S. The report, distributed to the President-elect’s transition team and Congressional leaders, provides a roadmap that can be implemented quickly on the heels of growing bipartisan support for feasible measures to control the skyrocketing costs of prescription medications.

tackling-drug-costs-cover

Executive Summary (293 KB)
Full Report (906 KB)
Model Legislation (304 KB)
Infographics (736 KB)

“The American drug pricing system is in disrepair,” said FPC member Sean Dickson, lead author of the report and Senior Manager, Health Systems Integration, at NASTAD (National Alliance of State and Territorial AIDS Directors) in Washington, DC. “Political inertia and existing statutory penalties are failing to stop exorbitant drug prices. Significant restructuring of payer systems is certainly one approach. However, our analysis clearly indicates that the incoming Administration and Congress can readily strengthen and modernize the existing framework to reduce federal drug spending and discourage egregious price increases in the private market.”

Cost control regulations and statutes already exist. Federal legislation, however, has not maintained pace with drug manufacturers’ tactics to circumvent these measures. The report highlights four pathways to promptly modernize and strengthen existing regulations and statutes to control drug costs, drawing on existing authority and concrete legislative actions:

  • Fix the Formulas: Modernize and strengthen current ceiling price formulas to ensure that government payers are not paying more than commercial payers;
  • Enhance Existing Penalties: Remove inflation penalty caps, increase penalties on drugs with the most egregious price hikes, and apply penalties to new drugs with launch prices far in excess of top sellers in the same class;
  • Pool Purchasing Power: Increase inter- and intra-agency collaboration to consolidate Federal and State negotiating power; and
  • Pull Back the Curtain: Buttress existing transparency tools while studying the effects of additional manufacturer price and payer cost disclosures.

“FPC has spent many years pleading with the pharmaceutical industry, particularly those responsible for manufacturing lifesaving human immunodeficiency virus (HIV) and hepatitis C virus (HCV) drugs and biologics to keep their prices in check as to not create hugely problematic access barriers,” explained FPC Co-Chair Tim Horn, co-author of the report and the Deputy Executive Director, HIV & HCV Programs, at Treatment Action Group (TAG) in New York. “Pharma clearly isn’t listening and it appears to be doubling down on messaging and lobbying efforts to justify its egregious pricing.

“It is high time for the government to clamp down on drug pricing tactics that drive up health care costs and invariably hurt health care consumers,” Horn said. “Bipartisan Congressional support for cost restraints has grown and President-elect Trump, who has voiced support for a more proactive role of government in drug pricing, must forcefully confront one of the most significant barriers to lifesaving treatment in the U.S.”

“Manufacturers continue to price prescription drugs and biologics beyond what the U.S. market and healthcare consumers can reasonably bear,” said FPC Co-Chair Emalie Huriaux, who is also Director of State and Federal Affairs at Project Inform in San Francisco. “For people living with HCV, in particular, significant challenges accessing curative treatment have become commonplace, particularly among those accessing care through federal or state programs. Enough is enough. With this roadmap to quickly control drug costs without jeopardizing market-driven ingenuity, along with other emerging proposals for sweeping reforms to rein in domestic and global drug spending, we hope that the Administration and 115th Congress will prioritize swift and meaningful action against runaway drug pricing.”

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):

screen-shot-2016-11-16-at-9-58-22-am

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 Criticizes Gilead Sciences for Unconscionable Second Round of 2016 HIV Drug Price Hikes

The Fair Pricing Coalition (FPC) again censures Gilead Sciences for its drug pricing practices, this time for 7 percent price increases for Complera and Stribild—just six months after taking 7 percent and 5 percent price increases on the same antiretroviral (ARV) products in January.

“Gilead’s relentless pursuit of ARV market dominance, at the expense of public and private insurers and the American public, knows no bounds,” said FPC co-chair Lynda Dee. “This isn’t simply a cunning effort to squeeze profits out of both Complera and Stribild before one of their main components, tenofovir disoproxil (TDF), goes off patent; it’s also a scheme to maximize the number of people living with HIV using Gilead’s newer tenofovir alafenamide (TAF)-inclusive coformulations in advance of generic TDF-based regimens becoming available.”

Odefsey and Genvoya, newer versions of Complera and Stribild that contain TAF instead of TDF, were launched in the U.S. in November 2015 and March 2016, respectively, at wholesale acquisition cost (WAC) prices of $28,150 and $30,930 per year—both in parity with Complera and Stribild. With the July price increases, the WACs for Complera and Stribild are now $30,092 and $34,686 respectively, whereas the WAC prices for Odefsey and Genvoya remain the same.

TDF, Gilead’s 2001 breakthrough ARV for HIV and a component of Complera and Stribild (as well as Atripla and Truvada), is expected to come off patent in December 2017, with generic TDF-inclusive combination tablets becoming available in early 2018. Though TAF is equally efficacious and less likely to negatively affect markers of kidney and bone health compared with TDF, TDF remains a safe and effective component of ARV therapy for many people living with HIV. Coformulated with other generic medications, such as lamivudine, generic TDF may be a durable HIV treatment option associated with lower costs.

According to FPC member Tim Horn: “The July price increases are primarily indicative of an abhorrent tactic in an economic climate demanding a break from crushing healthcare costs: inflating the prices of older drugs to cast newer expensive drugs in an artificial light of being cheaper options. In turn, private insurers will either drop Complera or Stribild entirely or place even greater restrictions on their use, thereby hastening the uptake of Odefsey and Genvoya among people living with HIV. Once patients are started on or switched to TAF-inclusive regimens, it will be that much harder for patients and providers to seriously consider the merits of products containing generic TDF when they become available—and Gilead is banking on this.”

“FPC applauded Gilead for pricing its new TAF products, Odefsey and Genvoya, in parity with its older TDF products,” said Dee. “It suggested to us that Gilead was becoming cognizant of the systemic pitfalls of pricing medications beyond what the market can reasonably bear. Unfortunately, it didn’t take long for the company to manipulate HIV drug prices to fend off the threat of safe, effective, and potentially cheaper generic alternatives. It’s shameless.”
***

The Fair Pricing Coalition, founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues, and to help control drug costs for patients who are privately insured, underinsured and uninsured. The FPC also works to ensure access for individuals covered by state AIDS Drug Assistance Programs (ADAPs), Medicare, and Medicaid. For more information about the Fair Pricing Coalition and its history, visit: fairpricingcoalititon.org.

Fair Pricing Coalition Applauds AbbVie/Express Scripts Deal for Viekira Pak, Urges Similar Price Negotiations Across Payer Landscape to Maximize Access to Curative Hepatitis C Treatment

For Immediate Release
Contact: Lynda Dee (410) 332-1170 or lyndamdee@aol.com

In addition to welcoming U.S. Food and Drug Administration (FDA) approval of Viekira Pak™ (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) for hepatitis C virus (HCV) genotype 1 infection on December 19, 2014, the Fair Pricing Coalition (FPC) applauds manufacturer AbbVie’s deal with pharmacy benefit management (PBM) organization Express Scripts to ensure access to the co-packaged curative regimen for all people living with hepatitis C virus (HCV) for whom treatment is indicated.

“Viekira Pak is an important addition to the expanding curative treatment armamentarium for hepatitis C, with its documented 91 to 100 percent cure rates in Phase III clinical trials involving people with HCV genotype 1, the most common form of the infection in the United States,” said FPC Co-Chair Lynda Dee. “No less exciting is the recently announced pricing deal between AbbVie and Express Scripts, which will make highly curative therapy available to many people with HCV genotype 1 unable to access other combination regimens, such as Gilead Science’s Harvoni® (ledipasvir and sofosbuvir), due to cost-containment restrictions.”

Under the terms of the deal announced Sunday, December 21, AbbVie will offer a substantial discount on the co-packaged regimen’s Wholesale Acquisition Cost (WAC) price of $83,300. In exchange, Express Scripts will make Viekira Pak the preferred option to its clients living with HCV genotype 1, regardless of disease severity or the prescriber’s specialty. In the absence of this deal, curative therapy may have been limited to those with advanced fibrosis (stage F3 or F4) and those receiving care from a liver disease specialist—both of which are among some of the prior authorization requirements in place for Gilead’s Sovaldi® and Harvoni.

Harvoni and emerging options will likely be covered by Express Scripts for patients for whom Viekira Pak is not recommended, such as patients with advanced (decompensated) cirrhosis or for those who cannot tolerate ribavirin (a requirement for individuals with HCV genotype 1a or for patients who have undergone a liver transplant).

The AbbVie/Express Scripts deal is expected to be a game changer in the arena of treatment access, in which manufacturers will no longer be able to charge what they believe the U.S. market will bear, but rather what PBMs and cost-cutting insurance carriers will actually pay for. “Though Express Scripts is the largest PBM in the U.S., it is by no means the only payer covering people living with hepatitis C” said FPC Co-Chair Murray Penner. “We need to see AbbVie continue its good-faith negotiations with other payers, including state Medicaid programs.  It will behoove other drug manufacturers to do so as well.”

“Maintaining provider and patient choice is critical to advocacy work focusing on treatment affordability and access,” explained David Evans, an FPC member. “In a landscape where HCV drugs have adopted ever-escalating prices and payers are limiting choice to contain costs, any deal that dramatically expands the number of people who can receive curative therapy must be applauded.”

For qualified individuals living with hepatitis C who have financial difficulties accessing Viekira Pak, the AbbVie Patient Assistance Program provides medication at no cost. A co-pay assistance program will also be available for commercially insured patients being treated with Viekira Pak. Out-of-pocket costs for eligible patients will be as little as $5.00 per month for most patients. Additionally, AbbVie has launched a patient support program, called proCeed™, which is intended to provide a broad range of patient support options. The proCeed program can be accessed at www.viekira.com or by calling 1-844-2-PROCEED.

Download the full press release here: FPCPRViekiraPakv_FINAL

***

The Fair Pricing Coalition, founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues and to help control drug costs for patients who are privately insured, underinsured and uninsured. The FPC also works to ensure access for recipients of state ADAPs, Medicare, and Medicaid as well as for other underinsured and uninsured individuals. For more information about the Fair Pricing Coalition and its history, visit: fairpricingcoalition.org

Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

Fair Pricing Coalition Welcomes Approval of Gilead Sciences’ Combination Tablet for Hepatitis C, Urges a Uniform Price for Curative Treatment

Download the press release: Harvoni_FPC_101314_FINAL

The $63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni (sofosbuvir and ledipasvir) should be extended to 12- and 24-week curative treatment durations.

The Fair Pricing Coalition (FPC) today applauded the October 10, 2014, U.S. Food and Drug Administration (FDA) approval of Harvoni, a combination tablet containing the direct acting antivirals (DAAs) sofosbuvir and ledipasvir for the curative treatment of genotype 1 hepatitis C, and called upon Gilead Sciences to establish a uniform price per cure, regardless of the length of therapy.

The FPC, a coalition of HIV and viral hepatitis treatment activists, recognizes the significant advance in treatment success and convenience of Harvoni, but is disappointed at the Wholesale Acquisition Cost (WAC) of $1,125 per once-daily tablet, or $63,000, $94,500, and $189,000 for an 8-, 12-, and 24-week course of treatment, respectively.

The FPC maintains that these costs, particularly for the 12- and 24- week courses of treatment, are exorbitant. Since they are now published, however, FPC concludes that the WAC of $63,000 for eight weeks of Harvoni, which is projected to be the most common duration of treatment as more people living with genotype 1 hepatitis C learn of their infection and seek care, should be made the uniform cost per cure, regardless of the length of therapy.

Harvoni’s FDA approval follows that of Sovaldi® (sofosbuvir) on December 3, 2013, the price of which was denounced by FPC. The $84,000 WAC ($1,000 per pill) of Sovaldi has since brought rebukes from insurers, activists, government officials, health care providers, and people living with hepatitis C.

While Gilead has contended that the total price for a course of treatment with a Sovaldi-containing regimen was a modest increase compared with previous standards of care, this is an invalid argument based on the incorrect premise that these regimens were appropriately priced to begin with. So, although an eight-week course of Harvoni will result in a lower cost-per-cure than previous regimens, the $1,125 WAC per pill means that coverage for the 50 percent or more of people living with genotype 1 hepatitis C who require 12 or 24 weeks of therapy will be unreasonably costly and therefore potentially unattainable.

“Harvoni is a remarkable breakthrough in hepatitis C treatment,” explained FPC Co-Chair Lynda Dee. “It is easy to take, is associated with cure rates between 94 and 99 percent, is safe and effective in advanced liver disease, is much less toxic than older regimens, and has a manageable drug interaction profile. Yet its price sours our appreciation of these long-awaited agents, particularly now that we have examples that curative treatment is inaccessible to many because of out-of-control escalator drug pricing.”

Gilead’s pricing of Sovaldi, and now Harvoni, puts these medications on a par with the pricing of pharmaceuticals that are much more costly to manufacture and often for rare diseases, despite the fact that Sovaldi and Harvoni are relatively inexpensive to produce, and that at least 3.5 million people are estimated to be living with hepatitis C in the United States. These costs are putting unprecedented pressure on public and private insurers, and stripping patients and providers of the required autonomy to make treatment decisions based on need.

The FPC recognizes that Gilead Sciences is maintaining their free medications program for low-income, uninsured patients, and expanding subsidies that greatly minimize out-of-pocket expenditures, such as co-payments and co-insurance costs, associated with the placement of Harvoni and Sovaldi in specialty drug tiers. Yet these programs are unable to address all disparities of access to treatment due to excessive pricing, resulting in a two-tiered system of care based on insurance coverage and ability to pay.

“Many resource-constrained programs, such as Medicaid, have only been covering Sovaldi-containing regimens for patients with advanced liver disease, despite the fact that people with early stages of disease can transmit the virus to others and may suffer health consequences if treatment is delayed,” said Murray Penner, FPC Co-Chair. “People living with hepatitis C who seek access to these medications are also being required to undergo degrading evaluations related to drug and alcohol use, factors which have not been scientifically substantiated as determinants of the success or failure of treatment. It remains unclear if the reduced cost associated with eight weeks of Harvoni treatment will mollify these programs and we fear these restrictions will be extended, particularly for those requiring 12 or 24 weeks of treatment.”

“A remarkably safe, effective, and easy-to-take tablet means that if it is financially accessible to the many millions of people who desperately need it, we can actually imagine eliminating this insidious disease nationally and globally,” said Dee. “Gilead has failed to comprehend that pricing its curative treatments beyond what the market can bear is a shortsighted business tactic and a failed public health opportunity, both to the detriment of people living with hepatitis C.”

Fair Pricing Coalition Highlights Major Barriers to Life-Saving Treatment in Affordable Care Act Health Insurance Marketplace Plans

New report offers short- and long-term solutions to minimize out-of-pocket expenses and maximize access to treatment for all Qualified Health Plan beneficiaries living with HIV and/or hepatitis C

For Immediate Release
February 6, 2014
Contact: Lynda Dee 410-332-1170 or lyndamdee@aol.com

Discriminatory practices by Qualified Health Plans (QHPs) in the health insurance marketplaces, exorbitant drug pricing by the pharmaceutical industry, and a lack of clear guidance from the federal government regarding the legality of co-payment assistance programs for QHP beneficiaries are proving to be major barriers to affordable treatment for HIV and hepatitis C, according to a new policy guide produced by the Fair Pricing Coalition (FPC).

“The QHPs mandated by the Affordable Care Act are good news for many people living with HIV and/or hepatitis C, as it means they can’t be denied health insurance, because of pre-existing conditions,” explained FPC Co-Chair Lynda Dee. “This ensures the provision of essential health benefits, including important primary care services, access to specialists, and prescription drug benefits.”

“However, many plans are proving financially disastrous for people living HIV, hepatitis C, and other chronic diseases,” Dee added. “This situation is made worse by high drug prices being set and increased annually by manufacturers, along with an inexcusable lack of direction from the U.S. Department of Health and Human Services regarding co-pay assistance programs for people receiving care under ACA-mandated plans.”

According to FPC’s policy guide, Health Insurance Marketplace Plans and People Living with HIV and/or Viral Hepatitis: The Success of the Affordable Care Act Requires Fair Drug Pricing and Access, numerous drug pricing and access issues are becoming increasingly apparent:

  • Some health insurance companies are not including certain standard-of-care HIV medications in their formularies, essentially circumventing the non-discrimination backbone of ACA.
  • Many QHPs are placing prescription medications for HIV and hepatitis C in “specialty drug” tiers (Tier 4 or 5), which impose extremely high out-of-pocket costs.
  • High prices of drugs used to treat HIV and hepatitis C are a key driver of QHPs placing standard-of-care medications in the highest tiers, resulting in prohibitive out-of-pocket costs.
  • QHPs are failing to be transparent regarding their drug formularies and the associated cost sharing, thereby prohibiting people living with HIV and/or hepatitis C from making educated plan choices.
  • Some manufacturers and not-for-profit payers have indicated that they are unwilling to extend their co-payment assistance programs to QHP beneficiaries because of conflicting government guidance.

“These are major barriers to life-saving treatment, when in fact we need to be making access to affordable treatment as easy as possible,” said Tim Horn, an FPC member. “Nationally, only 25 percent of people living with HIV are receiving HIV treatment and keeping the virus in their blood in check. This is essential in terms of protecting their own health and preventing ongoing transmission of the virus. We need to get more people on treatment, not fewer, which won’t be possible if they cannot afford their costly medications.”

Among the possible short- and long-term solutions offered by the FPC:

  1. Require access to all U.S. Department of Health and Human Services (HHS)- preferred and HHS-alternative antiretrovirals for HIV and all FDA-approved treatments for hepatitis C.
  2. Monitor tiering of HIV and hepatitis C drugs for discriminatory practices, such as placing all recommended treatment options on the highest cost-sharing or specialty tiers.
  3. Mandate QHP benefits and drug formulary transparency.
  4. Confirm Secretary of Health Kathleen Sebelius’ indication that manufacturers and non-profit payers may help defray out-of-pocket costs for medications under ACA through co-payment assistance programs.
  5. Lower the out-of-pocket spending caps for individuals and families with incomes up to 250 percent of the federal poverty level.
  6. Insist that insurance companies include HIV and hepatitis C expertise on their pharmacy and therapeutics committees or that they consult disease experts regarding formulary and tiering decisions.

“The problems outlined in the policy report are not insurmountable,” said Dee. “The FPC believes that the Affordable Care Act, while not perfect, has tremendous potential to redress disparities for U.S. residents whose access to healthcare has previously been at the whim of conflicting political and economic forces. This applies not only to HIV/AIDS and viral hepatitis, but also to many other chronic, debilitating, and costly health challenges beyond the capacity of individuals to manage on their own.”

The FPC supports urgent attention to these matters for all U.S. residents at this moment of new hope for achieving universal, affordable, quality health care.

The FPC policy guide can be accessed here:

https://fairpricingcoalition.org/wp-content/uploads/2014/02/FPC-QHP-Policy-Guide-Feb-2014-1.pdf

_______________

The Fair Pricing Coalition (FPC), founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues and to help control drug costs for patients who are privately insured, underinsured and uninsured.  The FPC also works to ensure access for recipients of state ADAPs, Medicare, and Medicaid as well as for other underinsured and uninsured individuals.

 

 

FPC DENOUNCES PRICING OF GILEAD’S NEW QUAD ANTIRETROVIRAL STRIBILD™

BALTIMORE, August 28, 2012 — While the Fair Pricing Coalition (FPC) applauds the Food and Drug Administration’s (FDA) approval of Gilead’s new 4-in-1 anti-HIV/AIDS single tablet regimen, Stribild™, we strongly protest the $28,500 annual Wholesale Acquisition Price (WAC) price announced by Gilead Sciences, Inc.

“This is a long-anticipated addition to the options available to people living with HIV/AIDS and their healthcare providers”, said Lynda Dee, FPC spokesperson. “However, in pricing the new drug more than 35% above the $21,000 per year WAC price of its own best-selling single-tablet regimen, Atripla™, Gilead has created an environment of restricted access and financial hardship for patients impacted by current dire economic conditions and US healthcare costs and whose very lives depend on access to more convenient treatments,” Dee added.

Gilead appears to be pricing cobicistat, its own booster component of Stribild™, comparably with Abbott Laboratories’ Norvir™ which includes Abbott’s unconscionable 400% price increase while its closest competitor Merck & Co.’s integrase inhibitor Isentress™, plus Truvada™ needs no booster and has an annual WAC price of $26,200. Thus, Stribild’s™ booster component cobicistat is more like excess baggage than an achievement worth $2,000 above the only other approved integrase inhibitor combination. There may also be a greater risk of kidney side effects with Stribild™ than with the Merck integrase inhibitor combination.

“Gilead asked for community input in setting the price of its new product, and invited the FPC to the negotiating table in June for discussions,” said Dee. “We thought we had reached a reasonable understanding with Gilead, but evidently the company is more interested in filling its coffers than in reasonable and fair pricing. I’m shocked at the price they have set, and would call this a betrayal of the spirit of our negotiations“, she added. “We will now consult with our community partners, government allies as well as public and private payers to determine the best course of action to take,” she concluded.