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 Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir)

The Fair Pricing Coalition (FPC) today expressed disappointment at the price Janssen Therapeutics set for Olysio (simeprevir), a second generation protease inhibitor (PI) approved by the U.S. Food and Drug Administration on November 22, 2013 for the treatment of chronic hepatitis C (HCV) in genotype 1 patients.  Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360.  Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

“While we are very excited to have more effective and more tolerable treatment options for people living with hepatitis C, we are concerned about the overall cost of treatment,” said FPC HCV Co-Chair Lorren Sandt. “Janssen did price Olysio comparatively with other HCV PIs, but the bar previously had been set too high.  We strongly urged Janssen to price Olysio lower than current regimens to help address the overall cost of therapy, which continues to spiral out of control.”

The FPC is gravely concerned about the continued precedent this pricing has on the future of HCV therapy.  Industry experts have stated their expectations that Gilead Sciences’ new direct acting antiviral, sofosbuvir, will be approved by the FDA in the next few weeks.  While the cost of sofosbuvir is not yet known, patients and doctors may look to combine these therapies (off label), resulting in an expected doubling of the current price of therapy.

“We know that this is just the initial price,” said Sandt.  “Other HCV protease inhibitor manufacturers quickly increased prices after their initial 2011 launch. For example, a 12-week course of Vertex’s PI Incivek (telaprevir) had a WAC price of $49,000 at launch, but is now priced at $66,155.  We caution Janssen not to continue this unacceptable trend. Treatment is just too costly for the majority of people living with chronic HCV,” concluded Sandt, “and we fear that barriers to patient access will be inevitable as a result.”

Anticipating the price of Olysio, the FPC urged Janssen to expand their access programs to ease the fiscal challenges that patients will face when trying to purchase Olysio. The FPC acknowledges that the Johnson & Johnson Patient Assistance Foundation agreed to expand the eligibility criteria for Olysio from 200% to 500% of the Federal Poverty Level (FPL). While this is a step in the right direction, it is not as generous as the program Vertex established for their PI, which is a maximum household income of $100,000 per year. The FPC also applauds Janssen’s intent to initiate a $25,000 per course of treatment co-pay program for Olysio.  Unfortunately, the legal status of such programs for the Qualified Health Plans in the new Affordable Care Act Exchanges remains in question, possibly making Olysio access out of reach for many ACA patients.

“We thank Janssen for responding to our requests to increase the eligibility level of their PAP for Olysio and for developing a generous co-pay assistance program,” said Murray Penner, a member of the FPC.  “We know that co-insurance costs will be very high for patients.  Despite the access programs Janssen has in place, we are very concerned that the high price of Olysio, coupled with high co-insurance costs for patients, will result in limited access to Olysio.”