Tag Archives: Open Forum Infectious Diseases

Absolute Denial of HCV DAA Treatment Not Only Common, But Rising

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The high cost of curing Hepatitis C (HCV) with newer Direct-Acting Antiviral (DAA) drugs has been the fodder of many an article since their introduction into the commercial market in 2013 with Sovaldi (Gilead) and Olysio (Janssen). When Harvoni (Gilead) entered the market in 2014, its Wholesale Acquisition Cost (WAC) of $94,500 for 12 weeks of treatment, it was dubbed “The $1,000-a-Day Pill” by the media and a Congressional investigation was launched in the U.S. State Medicaid programs insisted that treating everyone with HCV on their rolls would not only obliterate their pharmacy budgets, but do so exponentially.

Gilead Sciences tried to do their part by offering a manufacturer Patient Assistance Program (PAP) that offered drastically reduced or free fills on these prescriptions if patients were denied coverage by Medicaid, Medicare, or their private insurer. That program was quickly inundated by patients whose payors instructed them to “…go and get it for free from Gilead.” By 2015, Gilead was forced to restrict the PAP to only the uninsured and those whose insurance denied coverage.

Now, new research published in Open Forum Infectious Diseases has found that, between 2014-2017, 52.4% patients with private insurance who were prescribed DAAs to treat their HCV infection were absolutely denied treatment (defined as “a lack of fill approval by the insurer”). In addition 34.5% of patients on Medicaid were denied, and a paltry 14.7% of patients with Medicare insurance were denied (Gowda, et al, 2018). These findings are compounded by similar research conducted regarding HCV treatment in correctional settings that found less than 1% of inmates infected with HCV in state correctional facilities were receiving treatment (Paukstis, 2018).

denied square red grunge stamp

Photo Source: emdlaw.com

This appalling record of absolute denials of treatment are a large part of why the U.S. has fallen behind comparable nations in achieving the elimination goals set forth by the World Health Organization in 2016, calling for the elimination of HCV as a public health crisis by the year 2030. Worse, these denials have come as the cost of treatment has dropped dramatically, from its high point with Harvoni, to its lowest point with AbbVie’s Mavyret, which has a WAC of $26,400 for 8 weeks of treatment ($39,600 for 12 weeks). Moreover, Mavyret sports comparable Sustained Virologic Response (SVR – “cure”) rates to Sovaldi, Harvoni, and Epclusa (Gilead). Worse still is that the WAC is largely a useless price point, as the vast majority of payors enter into pricing negotiations with the drug manufacturers and receive discounts and rebates that reduce that cost to a mere percentage of the WAC.

And, yet…

America’s healthcare problems are all solvable…in we are willing to go on the offensive against the corporate interests that we’ve allowed to run roughshod over our nation’s healthcare system since the late 1970s. We have allowed private insurers, drug manufacturers, and other private entities to turn healthcare away from being a profession designed to cure people – a system that we, as a nation, helped to flourish and turned into the best in the world in the mid-1900s – and into a for-profit industry whose main priorities revolve around further enriching the already rich.

We can combat diseases like HCV; hell, we managed to eradicate polio in the U.S. by 1979 with a vaccine that was created in 1953 and came into commercial use in 1955, with an oral vaccine following in 1961.

Jonas Salk, the creator of the first polio vaccine, once told Edward R. Murrow, when asked who owned the patent for the vaccine, “Well, the people, I would say. There is no patent. Could you patent the sun?”

Since that time, countless business writers and corporate shills have derided Salk’s statement, going so far as to call it “Communist propaganda.” And, yet, it is because of Salk’s vaccine that we managed to eradicate polio in much of the modernized world.

We need to get back to this way of thinking, as it relates to healthcare. It’s time to pull the profits out of healthcare, altogether, and if that means dismantling the private insurance market, then so be it.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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