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Hepatitis C is Killing Americans in Record Numbers while
Patients Cannot Access Life Saving Medicine
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Hepatitis C deaths have set new records in every year since at least 2003, but the continued rise is alarming.
Posted5.10.2016byDavid Rein
http://www.norc.org/Blog/pages/sparks-post.aspx?BlogId=79
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Hi This is Jules Levin of NATAP www.natap.org
I cannot find the words to say how strongly I agree with the author David Rein. I have been working on HIV & HCV policy since 1998 when I saw the coming HCV problem. In 1996 I started & led the effort to force accelerated & early access to HIV protease inhibitors forcing the FDA & manufacturers to comply and more recently getting the NIH to support HIV & Aging research funding. I was the first to meet with the NYC DOH & the Ryan White Council in 1998 where the outcome was opening the first 9 HCV/HIV Coinfection clinics in NYC & a $1 mill budget allocation to HCV/HIV coinfection for NYC for several years. As well in 2001 I started policy project to get HCV language in the Ryan White Care Act which was accomplished in the 2006 reauthorized Care Act, language I helped to write with the Kennedy office. With the price rebates/discounts these HCV drugs are so inexpensive when put into context: 12 weeks treatment is a "cure" and once cured the benefits to patients are immeasurable to patients and to the healthcare saves a ton of money over the long-term. $35,000 or $25,000 is a one-time cost to cure a patient, its a bargain. HIV therapy (ART) costs $14,000 a year but its forever so in 1 year the Federal government spends $10 Billion on Medicaid & Medicare on HIV domestically. We could cure all & eliminate HCV for $12 Billion for treatment costs which would save over the long-term at least $80 Billion but its also estimated as much as $800 Billion when one considers broad health & economic savings like patients going back to work as well as direct HCV health care costs and the affect of HCV on comorbidities & its related healthcare costs: HCV contributes to several cancers and metabolic diseases including kidney disease. Unless a patient is treated in very early disease the risk for cancer and death is vastly increased. The deaths of patients is at the doorstep of the Federal & State governments particularly The White House & Congress who knowingly allow the restrictions to access to treatment to persist sentencing thousands to death & for not providing the adequate funding needed for a National Testing & Linkage To Care Program, we need $250 million to begin this project, which I have submitted in a detailed proposal how to do this but it has been denied at every turn in my multi-year effort to get this funded & in place. HIV activists in the mid 1990s were great as they effectively embarassed The White House & Congress & forced the Federal government to face HIV & now we spend Billions every year on HIV, rightfully so, but there is no such activist movement in the USA, there are no activists yelling in the streets as there was back in those days, those activists today would be at the door of The White House, Congress & HHS/FDA, as they literally stormed the FDA doors back in the 1990s. So Federal & State, and Medicaid officials retain the confidence they can do whatever they want, as they refuse to budge at all. Federal officials like the HHS only respond to being embarassed. In NYS where I work & live, State Medicaid officials refuse to budge one inch to remove the horrible & deadly restrictions that they allow Medicaid Managed Care insurers to impose. These restrictions allow only patients with advanced HCV disease to be treated & prevent IDUs & substance abusers from being treated; is it no wonder why thousands are dying of HCV. The most highly impacted patient populations are IDUs, communities of color: African-Americans & Latinos, inner city patients where HCV lives & impacts America, a forgotten & tosssed away group of people. If we had a "cure" for heart disease or diabetes with 12 weeks therapy do you think America would allow The White House & Congress to do this, we would have full & unfettered Federally funded programs to eliminate the disease. We need fully funded "HCV Test & Treat" programs to eliminate HCV in America, I estimate $500 Million to get going with a good effort. The Federal & State officials & Congress are disgraceful for not doing this, history will judge them.
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The views expressed here are those of the blogger alone and do not reflect those of NORC, the CDC, or any other individual or institution. The post has not been reviewed, edited, or approved by any of Dr. Rein’s current or former co-authors or funders.
According to the CDC and reported recently by Lena Sun in the Washington Post, Hepatitis C now kills more people annually than the next 60 reportable infectious diseases combined, and, yes, the list of the next 60 infectious diseases includes HIV. In fact, hepatitis C has been killing more Americans than HIV since 2007, a fact the CDC first reported in 2012. That hepatitis C deaths set a new record in 2014 is not surprising. Hepatitis C deaths have set new records in every year since at least 2003, but the continued rise is alarming given that the vast majority of these deaths are preventable with the wide range of treatments now available.
In 2010, my NORC colleague John Wittenborn and I, along with CDC coauthors (none of whom have reviewed this blog post, nor do I claim to speak for them or the agency. This post reflects my thoughts alone), shopped a paper forecasting the mortality we are seeing today to three major American medical journals. Each of the journals rejected the paper on the grounds that we had forecasted too many deaths and that the annual rate of increase was too fast. At the time, we argued to the editors that we had done everything we could to err on the side of underestimation and that we privately thought our forecasts were too low.
Finally, our article was published in Digestive and Liver Diseases, the official journal of several Italian, French, and Israeli Hepatology and Gastroenterology Societies. The article first appeared online in late 2010, and in it, we predicted that without action, deaths from hepatitis C would increase to 18,200 (CI: 6,500 to 43,600) annually by the year 2020, peak at 36,000 in 2033, and kill over a million Americans by the year 2060. Our abstract concluded, “Because current rates of screening and treatment are low, future morbidity and mortality from hepatitis C are likely to increase substantially without public health interventions to increase treatment.”
Unfortunately, the actual number of deaths CDC now reports for 2014 (19,659) is higher than our 2020, forecast suggesting that a true crises is upon us. I would have preferred for the reviewers to have been right. Tragically, tens of thousands of Americans are dying of hepatitis C for myriad inter-related reasons: lack of awareness of infection, under-investment in a national effort, and impeded access to affordable treatment. In 2016, Congress spent $1 on viral hepatitis prevention for every $23 it spent on HIV prevention, and that includes only CDC funding. This is not to say that federal funding for HIV prevention should be reallocated to hepatitis C (Americans save $230,000 for every case of HIV prevented), but merely to point out that a similar response and investment is desperately needed to prevent the coming waves of deaths caused by hepatitis C.
While drug prices could always be lower, the fact of the matter is that prices have already fallen quite significantly since a new generation of highly effective drugs was first introduced in December 2013. While further reductions in pharmaceutical prices would certainly increase access, the debate over drug pricing has crowded out much of the conversation about insurance barriers that prevent diagnosed patients who seek treatment from accessing care. Beginning in December of 2014, when competing treatments were first introduced by AbbVie and later Merck, prices paid for hepatitis C treatments have fallen for all organized insurance payers. Considerer the following;
According to the Wall Street Journal, between December 2014 when the FDA approved the second new generation hepatitis C treatment from AbbVie and February 2015, Gilead and AbbVie had negotiated steeply discounted pricing agreements covering 80% of patients with hepatitis C in the United States.
⋅ By early 2016, Gilead routinely offered payers a discount of at least 45% with other major manufacturers forced to match or better Gilead’s price.
⋅ The not-for-profit cost-effectiveness research group ICER determined that Gilead’s average price discount of 46% combined with clinically observed shorter treatment durations made possible by new generation combination therapies resulted in an average treatment cost of $40,000 per patient treated.
⋅ The same ICER report stated that a cost of $40,000 per patient treated “is viewed by many payers as manageable without resorting to severe treatment delays or cuts in other services.”
⋅ According to Politico New York, New York State Medicaid pays and average of $28,000 per patient for hepatitis C therapy.
⋅ The often cited cost of $1,000 per pill for hepatitis C treatment refers to the initial December 2013 average wholesale price of Gilead’s Sovaldi. Not only is this price now routinely discounted by 46% or more, but Sovaldi has been supplanted as the first line of treatment by combination therapies (in chronological order of FDA approval, Gilead’s Harvoni, AbbVie’s Vikiera Pak, and Merck’s Zepatier.
The real news on pricing is the recent decision by the U.S. Veterans Administration to drop all restrictions of hepatitis C treatment in exchange for steep price discounts. Manufacturers are offering even larger discounts (rumored to be in access of 80% or less than $20,000 per patient treated) in order to maintain their place on the VA’s formulary.
For a recent publication, I had the opportunity to review 13 studies of the cost-effectiveness of new generation treatments for hepatitis C published between 2012 and 2015. All 13 studies found treatment to be cost-effective, and though the evidence is yet to be published, it is highly likely that treatment may be cost-saving at cost below $20,000 per patient treated especially given new evidence published in the same article that the cost of untreated hepatitis C is higher than previously estimated. In addition, in November of 2015 the US Centers for Medicaid and Medicare Services issued a letter advising State Medicaid offices that hepatitis C treatment is a required benefit for all State programs that cover prescription drugs provided that manufacturers participate in Federal cost rebate programs (which all do).
Given the recent news on the accelerating numbers of deaths from hepatitis, the time has come for serious consideration of the following solutions:
⋅ All payers drop coverage restrictions and offer hepatitis C treatment to all diagnosed patients who wish to be treated.
⋅ An increase in funding by the federal government to help identify more currently asymptomatic cases, improve education of health care providers and citizens about the dangers and risk factors of hepatitis C, and provide access to treatment for those who are uninsured.
⋅ As part of its oversight role, the government should monitor developments that might facilitate or impede access to treatment for individuals with hepatitis C.
⋅ Drug companies should be encouraged to continue existing price discounts.
With greater attention to hepatitis C diagnosis and treatment we hopefully can turn the tide of preventable hepatitis C deaths. What do you think are our most promising solutions?
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