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.”

The Fair Pricing Coalition (FPC) applauds the Wyden-Grassley US Senate bipartisan Sovaldi investigation spotlighting a greed-driven pricing strategy behind Gilead’s $1,000 per pill hepatitis C drug launch

FOR IMMEDIATE RELEASE

Date: December 3, 2015 – The US Senate Finance Committee ranking member Ron Wyden (D-OR) and senior committee member Chuck Grassley (R-IA) issued a scathing bipartisan investigative report on December 1, 2015, revealing a Gilead Sciences, Inc. pricing strategy showing little concern for patient access to its lifesaving drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir).

“The report, which took 18 months to complete, is amazingly thorough and comprehensive, worthy of the US Senate and a Pulitzer Prize for investigative reporting,” said FPC co-chair Lynda Dee.

Sovaldi was approved by the FDA on December 6, 2013—a first-in-class hepatitis C drug that helped usher in a new era of short-course, all-oral, well-tolerated, and highly curative treatment.

Unfortunately, Gilead turned this long-awaited treatment option into a perfect storm of near-impossible drug access, marked by public and private insurance roadblocks in the form of prior approval, fibrosis, and strict sobriety requirements. These were instituted because government and industry payers could not afford the unconscionable cost of Sovaldi (a wholesale acquisition cost of $1,000 per pill for a total of $84,000 for a typical course of hepatitis C treatment) and later Harvoni ($94,500 for a typical treatment course).

Dee, cured of hepatitis C using a Sovaldi-inclusive regimen, explained: “With tears in my eyes, I literally begged Gilead at their FDA approval hearing to price Sovaldi reasonably so that it could be accessed by the hundreds of thousands of people who had been waiting so long for effective, less toxic hepatitis C treatments. The FPC met with Gilead before the launches of both Sovaldi and Harvoni, urging them to set their prices reasonably to avoid the cost-containment firestorm that is now the new normal for hepatitis C drugs. What was a dream scenario is currently a nightmare of bureaucratic insurance barriers.”

The Senate investigation found that Gilead provided supplemental rebates to only five Medicaid programs in 2014. “The poorest people in most of the country face the greatest access barriers to all the new hepatitis C regimens,” said FPC Co-Chair Murray Penner. “These barriers have worsened as Gilead recently narrowed eligibility for its Support Path program to exclude patients who have any form of insurance, even if that insurance denies access to Sovaldi and Harvoni. These barriers all result from unsustainable drug prices initiated by Gilead.”

The Senate report also provides clear evidence of Gilead’s greed and blatant disregard of stakeholder insight, stating: “Based on all of the information reviewed, it appears that in pricing its line of [hepatitis C] drugs Gilead may have underestimated the warnings of patient groups, insurers, health care providers, and other organizations about the potential impact that price would have on access…While publicly saying it prioritized patient access, Gilead set Sovaldi’s price at a level where ultimately many patients would not receive treatment. Sovaldi was on the market for almost a year without serious competitors, allowing Gilead to maintain a high effective price despite efforts by many payers to negotiate volume or treatment discounts or rebates.”

Additionally, according to the Wyden-Grassley report:

  • More than $1.3 billion was spent by Medicaid programs for Sovaldi in 2014, but only 2.4% of Medicaid patients with hepatitis C were actually treated because of the excessive price of Sovaldi.
  • In the 18 months that Gilead’s drugs have been on the market, Medicare’s monthly spending on hepatitis C treatments increased more than six-fold from $116.4 million in January 2014 to $793.2 million in June 2015.
  • Medicare’s average pre-rebate monthly spending on hepatitis C drugs grew to $765 million during the first six months of 2015, more than double the average monthly expenditure of $349.5 million.
  • Prisoners in the US Bureau of Prisons (BOP) system were also adversely affected. In fiscal year 2014, the year Sovaldi became available to treat prisoners with hepatitis C, the BOP’s spending on hepatitis C drugs increased 14%, even though the number of patients treated decreased 52%.

“This remarkable investigative report is an indictment against Gilead and the US drug pricing system which allows lifesaving drugs to be priced beyond what the market can reasonably bear,” said Dee.

At his press conference, Senator Wyden observed that drugs for other diseases like Alzheimer’s, diabetes, and cancer are in the pipeline. He noted that prices similar to those for the newest hepatitis C drugs are clearly not sustainable by private insurance companies and government payers.

The FPC wishes to thank Senators Wyden and Grassley, the Minority Staff of the Senate Finance Committee, and Senator Grassley’s staff for their Herculean efforts in compiling this investigative bipartisan report on hepatitis C drug pricing based on over 20,000 documents. The FPC was delighted to assist in this investigation

The full Senate Finance Committee report is available at: http://www.finance.senate.gov/newsroom/ranking/release/?id=3f693c73-0fc2-4a4c-ba92-562723ba5255. A press conference given by Senators Wyden and Grassley can be viewed at: https://www.youtube.com/watch?v=rxd_PTFoouo.

Contact:
Lynda Dee
(410) 332-1170 or (443) 756-2581
lyndamdee@aol.com

***

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 Gilead Sciences’ pricing of its new single-tablet regimen Genvoya in parity with Stribild, urges controlled costs across U.S. payer landscape

The Fair Pricing Coalition (FPC) today welcomed Gilead Sciences’ pricing of its new single-tablet regimen Genvoya in parity with its predecessor Stribild. Though the wholesale acquisition cost (WAC) of $31,362 per year hardly reverses a trend of exorbitant drug pricing in the United States, it underscores a growing recognition that HIV treatment expenditures are beyond what the market can reasonably bear.

“Genvoya, the first coformulation to be approved containing tenofovir alafenamide (TAF), is an important improvement over Stribild containing tenofovir disoproxil (TDF), particularly for an aging population of people living with HIV at increased risk of kidney problems and bone density loss,” says Lynda Dee, co-chair of the Fair Pricing Coalition. “Our request to Gilead that Genvoya be priced neutrally with Stribild was heard. We now need to ensure that this welcome addition is priced affordably for all cash-strapped public insurance programs and that future TAF-inclusive coformulations are priced to ensure access for all people living with HIV.”

Genvoya’s WAC is the price point where many negotiations with payers begin and strident advocacy to further control costs continues. “The next step is for negotiations to proceed with public insurance programs that receive discounts and rebates that serve to lower the cost below the WAC price,” says FPC member David Evans. “Most of these programs are in fragile financial shape and, when considering TAF-inclusive regimens, will require parity with the deeply discounted prices of the older coformulations containing TDF. We appreciate Gilead’s stated commitment to negotiate in good faith with these programs and will be watching to make sure that takes place.”

FPC also implores Gilead to approach its WAC determinations for future TAF-inclusive coformulations, including FTC/TAF (F/TAF) and rilpivirine/FTC/TAF (R/F/TAF)—the company’s follow-up products to Truvada and Complera that are likely to be approved by the FDA in April and July, respectively—with caution. Whereas Genvoya contains 10 mg of TAF, R/F/TAF will contain 25 mg TAF and F/TAF will be available as two coformulations: one containing 10 mg TAF for use in regimens containing boosting agents and another containing 25 mg TAF for use in combination with antiretrovirals that don’t require boosting, such as dolutegravir.

“Our request to Gilead was that the highest dose of TAF to be used in combination with other antiretrovirals be priced in parity with TDF,” says Murray Penner, FPC co-chair. “A WAC price for either dosing formulation of F/TAF or rilpivirine/F/TAF that is above that for Truvada or Complera, two combination tablets that debuted at high prices and have undergone numerous cost hikes, would be a serious misstep.”

TAF-inclusive coformulations are entering the U.S. marketplace on the brink of a watershed moment in HIV drug pricing history. “An initial report of TAF’s potential advantages over TDF was published in 2001; it is a shame people living with HIV had to wait until 2015, just two years before TDF’s patent expiration, to take advantage of its more favorable kidney and bone toxicity profile,” said Tim Horn, an FPC member. “TAF’s net benefit over TDF, notably whether it will significantly reduce the risk of serious renal disease and bone fractures, is not totally clear. Additionally, the pending arrival of lower-cost generic TDF and generic-inclusive coformulations—along with the potential for regimens employing fewer drugs to achieve and maintain viral suppression—are important factors with which Gilead must contend.”

“Like Triumeq, ViiV’s single-tablet regimen approved in 2014 that is priced below the sum of its parts, the neutral pricing between Gilead’s Genvoya and Stribild hopefully signals an end to drug pricing that has spiraled out of control,” says FPC member Paul Arons, MD. “It’s now time for a downward trend, not only because of shifting dynamics in the marketplace, but because personal and public health benefits to people living with HIV require ready access to safe and effective treatment options, despite limited resources.”

Leading Advocates and Organizations Call on Gilead to Price TAF Responsibly

John C. Martin, PhD Chief Executive Officer
Gilead Sciences
333 Lakeside Drive Foster City, CA 94404

Dear Dr. Martin:

In advance of the Fair Pricing Coalition’s October 12, 2015, meeting with Gilead Sciences’ senior staff to discuss wholesale acquisition costs (WACs) and access plans for tenofovir alafenamide fumarate (TAF)-inclusive coformulations, the signers of this letter urge your company to carefully consider product pricing that effectively addresses the need for cost-contained HIV care delivery in the United States.

As we are certain you are aware, payers have become increasingly conscious of price when making decisions about prescription drug coverage, even for life-threatening conditions such as HIV infection. This is evident in continued reliance on specialty drug tiering and the growing use of prior authorization by employer-based and Affordable Care Act health insurance plans. We are also seeing restricted access by state Medicaid programs and Medicaid managed care organizations, notably the downgrading of coformulated antiretrovirals to non-preferred status, subject to prior authorization and quantity limits.

People living with HIV and their healthcare providers welcome the anticipated benefits of substituting TAF for tenofovir disoproxil fumarate (TDF) as a component of elvitegravir/cobicistat/emtricitabine (E/C/F/TAF), rilpivirine/emtricitabine/TAF, and in 10 and 25 mg dosages coformulated with emtricitabine (F/TAF). We would like to ensure that all people living with HIV have access to these new formulations that may lower the risk of bone and kidney toxicity in accordance with phase III clinical trials (1). Access to TAF, however, may well hinge on the actual price paid by private health insurers, Medicaid programs, and AIDS Drug Assistance Programs (ADAPs).

We urge Gilead to price these new TAF-inclusive coformulations in parity with regimens containing TDF. This is particularly vital for Medicaid programs and ADAPs, where CPI penalties and discounts that Gilead has offered for TDF-inclusive coformulations have dramatically increased access through lower prices. Unless equivalent discounts are offered for TAF-inclusive coformulations, these drugs will be inaccessible to people living with HIV who need it most.

We are recommending that, with discounts and rebates, Gilead ensure that all payers do not pay more for TAF-inclusive regimens than TDF-inclusive regimens. Specifically, we urge that there be price parity based upon the 25 mg dose of TAF. The 10 mg dose in E/C/F/TAF and the second F/TAF coformulation should be priced proportionately lower.

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