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