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.

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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):

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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 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 Praises Congressional Committee Hearing on Drug Pricing; Blasts HIV Pharmaceutical Manufacturers for Heedless New Year Price Increases

The Fair Pricing Coalition (FPC) commends the House Committee on Oversight and Government Reform for its hearing today on drug price increases for older, off-patent medications. The hearing was spurred by a 5,000% rise in the price of pyrimethamine (Daraprim) for toxoplasmosis. At the end of December 2015, the FPC urged Turing Pharmaceuticals to restore its lower price (already a hefty $13.50 a pill), and has been disappointed that no action has yet been taken. We hope the hearing leads to policy actions that prevent companies from having free rein to price-gouge older drugs with little or no competition.

On the heels of today’s hearing and other federal investigations into unjustified drug pricing, the FPC is outraged that manufacturers of some of the most frequently prescribed antiretrovirals for treatment of HIV ushered in exorbitant Wholesale Acquisition Cost (WAC) price increases with the new year. The WAC increases show complete disregard for a year-end plea by FPC to industry leaders urging them to refrain from any price increases or, barring that, certainly no increases over the medical Consumer Price Index (CPI).

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“With committees in both houses of Congress investigating out-of-control drug pricing in response to intensifying public frustration, it defies logic that we’re starting 2016 with arbitrary increases in drug prices already at the upper limit of any conceivable justification,” said FPC Co-Chair Lynda Dee. “This trend is unsustainable and will continue to hinder patient access to life-saving HIV treatment and prevention, as well as curative hepatitis C regimens.”

“We made this point very clearly to executives at the major pharmaceutical companies in our annual plea for price freezes,” said FPC Co-Chair Murray Penner. “Yet our December 2015 letters went unheeded. We are once again looking at WAC increases mostly in the 7 to 8 percent range, all over last year’s exorbitant prices.”

Though the January 2016 CPIs—measures of inflation—have not yet been announced, the 2016 WAC increases for leading antiretrovirals are approximately three times higher than the ten-year 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 (see preceding table).

Current drug prices are unsustainable and are preventing people living with HIV from accessing life-saving antiretrovirals. “HIV care providers are reporting an uptick in Medicaid and private plans requiring prior authorization for antiretroviral drugs, particularly for preferred standard-of-care single tablet regimens,” said FPC member Andrea Weddle. “Most concerning are provider reports that some insurance coverage requests are being denied outright. While denials are presently rare, it is nonetheless disturbing that people living with HIV are now facing these sorts of challenges.”

Egregious drug pricing has also resulted in a clear inability of people living with hepatitis C virus (HCV) to access many of the direct-acting antivirals (DAAs) that achieve as much as a 99% cure rate with minimal side effects. “Numerous health plans, both public and private, have instituted treatment utilization polices and prior authorization processes that are based on cost-containment concerns, rather than on the best and most current clinical science,” explained FPC member Emalie Huriaux. “Nowhere is this more apparent than in state Medicaid programs, many of which cover DAAs only for patients with advanced fibrosis or cirrhosis, contrary to published guidelines. Many of these programs also have policies that deny curative therapy to people who use drugs or alcohol, despite guidelines and clinical evidence that this population should be prioritized for treatment, both for their personal health and to prevent ongoing transmission of the virus.”

As exemplified by today’s House Committee on Oversight & Government Reform hearing, runaway drug pricing continues to be of tremendous interest to Congressmen, Senators, and presidential candidates of both parties. “The political pressure is now on, meaning there is yet another pragmatic reason for HIV and hepatitis C drug manufacturers to curb their overreach,” said FPC member Tim Horn. “In this election year, our hope is that industry will show restraint, and respect public awareness of the burgeoning crisis of health care financing. Unfortunately, it appears we’re not off to a very good start.”

Fair Pricing Coalition Recognizes Merck’s Lower Price for Curative Hepatitis C Treatment, Calls for Manufacturers to Reduce Excessive Prices and Increase Patient Assistance

The Fair Pricing Coalition (FPC) today expressed appreciation for Merck’s & Co. Inc.’s decision to launch its new curative hepatitis C (HCV) treatment, Zepatier, at a price below existing HCV treatments in a tacit acknowledgement that existing high prices have hurt patients and are untenable for the market. Zepatier’s $54,600 list price is lower than the egregious prices for Gilead Sciences’ Harvoni ($94,500) and AbbVie’s Viekira Pak ($83,319), and represents a step in the right direction. Even at this price, however, the FPC is still concerned that patients may not be able to afford to cure their HCV – preventing the U.S. from ending the HCV epidemic and increasing system-wide healthcare costs.

Merck’s lower price follows substantial public and Congressional scrutiny of HCV treatments. After an exhaustive investigation, the Wyden-Grassley Senate Finance Committee report concluded that Gilead Sciences’ HCV pricing was focused on “maximizing revenue,” not “fostering broad, affordable access.” While Merck’s lower price may increase patient access to HCV treatments, we hope that Merck will work to ensure that prior approval restrictions instituted by public and private payers will be eliminated once and for all.

“High costs of treatment have led insurers to severely restrict patient access to curative HCV treatment,” said FPC Co-Chair Lynda Dee. “While companies insist that patients will not bear the full cost of treatment, many patients are not receiving any treatment at all because insurers refuse to pay these exorbitant prices. Merck’s willingness to set Zepatier’s initial price lower than the competition must be followed with negotiated insurer discounts that allow patients easy access with minimal cost-sharing.”

As the population with HCV ages, public programs like Medicare are facing unprecedented costs from curative treatments. “Because Medicare is not allowed to negotiate for lower drug prices, Medicare spending exists at the whim of drug manufacturers,” explained FPC member Emalie Huriaux. “These costs are passed on, in part, to patients, who must pay a percentage of the drug’s cost as co-insurance. Merck’s lower price may reduce some Medicare costs, but patients will still face massive cost-sharing, hurting their ability to access necessary treatment.” We hope Merck will offer Medicare and Medicaid programs additional rebates so that very needy patients will be able to access this exciting new HCV regimen.

Excessive HCV prices have led insurers to routinely deny patient access to lifesaving HCV treatment, including refusing treatment to patients without advanced fibrosis or those who have recent histories of substance use. These practices have no medical basis. The FPC commends Merck for studying the efficacy of Zepatier in patients who use drugs. For any denials by insurers, HCV drug manufacturers must ensure broad patient assistance programs are available to fill in the gaps, guaranteeing that patients receive necessary treatment.

“Recently, Gilead Sciences changed its patient assistance program to refuse free treatment to individuals denied access by their insurer,” said FPC member Tim Horn. “We hope that Merck’s lower pricing means they will reject this deplorable practice and provide free access to patients denied by public and private payers.”

“We will be watching closely to ensure that Merck has robust patient assistance and co-pay assistance programs,” added FPC co-chair Murray Penner. “Merck must ensure that all patients, including Medicaid patients, often the most financially needy of all, have access to Zepatier.”

Contact: Lynda Dee
(410) 332-1170
lyndamdee@aol.com

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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Fair Pricing Coalition Blasts HIV Pharmaceutical Manufacturers for Unjustified 2015 Drug Price Increases

Community requests for price freezes to strengthen affordable access to life-saving treatments go ignored

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 calling for a two-year price freeze, with several companies setting 2015 prices that far exceed the typical rise in the Consumer Price Index (CPI).

“The FPC firmly believes that upwardly spiraling drug prices are already at the upper limit of any conceivable justification, are unsustainable, and will continue to hinder patient access to life-saving HIV treatment and prevention options, as well as recently approved curative hepatitis C virus (HCV) regimens,” said FPC Co-Chair Lynda Dee. “We made this point, plainly and clearly, to executives at the major pharmaceutical companies again in 2014, yet we are once more looking at WAC increases that are generally between 7 and 10 percent over last year’s already indefensible prices.”

Though the January 2015 CPIs—measures of inflation—have not yet been announced, the 2015 WAC price increases for leading antiretrovirals are two to three times higher than the ten-year 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.

“Several companies are, once again, guilty of unsubstantiated price gouging, with Bristol-Myers Squibb (BMS) being the most egregious example,” said FPC Co-Chair Murray Penner. “Despite that BMS was recently granted a reprieve on the anticipated 2014 loss of patent exclusivity for Sustiva, allowing it to reap an additional two years of exclusivity on U.S. sales of the drug, the company decided that this windfall occasioned by endless patent evergreening was not enough, and increased the 2015 WAC for Sustiva by nearly 10 percent—the largest price increase reported thus far this year. And this followed two 2014 increases, totaling 16.7 percent, contributing to a total price increase of approximately 150% since the drug was approved in 1998.”

 

Starting January 1, the annual WAC price for Sustiva (efavirenz) increased from $9,352 to $10,260. Importantly, this price increase directly impacts the WAC of the efavirenz-containing single-tablet regimen Atripla, which is now $25,874 per year, compared with $24,965 at the end of 2014. The 2015 Atripla annual WAC is also more than 85% higher than its 2006 launch price of approximately $13,800 per year.

Other notable WAC price increases reported on January 1 include Janssen Therapeutics’ Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine) (7.9% each); a 6.9% increase in the WAC price for Merck’s Isentress (raltegravir), and a 7.9% increase in the WAC price for BMS’s Reyataz (atazanavir). WAC price increases for ViiV Healthcare’s HIV drug products are anticipated during the first quarter of 2015. AbbVie is not expected to increase the price on its drug products, at least not this quarter.
Shielded by claims of legal proscriptions, the companies notify FPC and the general public of price increases only after they have already been decided. As there is rarely an opportunity for comment or other public input into these price determinations, the FPC submitted letters to all of the major HIV drug manufacturers in December 2014, demanding a price freeze or, if absolutely necessary, no more than one price increase annually (some antiretroviral prices have been raised twice in one year), 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 (OOP) costs associated with these expensive medications being placed in specialty drug tiers.

“We commend many companies for complying with our requests for more generous assistance programs to help cushion the blow associated with exorbitant OOP costs, but we have been unambiguous in noting that ever-increasing drug prices only encourage payers to place all HIV and HCV medications in specialty tiers, and raise cost sharing requirements, and establish even more draconian prior authorization restrictions,” explained Dee. “Our demands that major HIV companies refrain from compounding the average consumer’s economic hardship and inflating prices beyond the brink of what health care delivery under the Affordable Care Act can reasonably bear have been ignored. The time has come to inform and mobilize the public regarding the pharmaceutical industry’s reluctance to heed reasonable requests regarding its unjustified pricing policies.”

Contact:
Lynda Dee
(410) 332-1170
lyndamdee@aol.com

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

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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

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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.