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