Tag Archives: World Health Organization

Veterans Affairs Department Provides Reliable Proving Ground for HCV Treatment

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 Veterans Health Administration (V.A.) is one of the most frequently and vocally derided health systems in America. Since its inception in 1930, the V.A. has been plagued by scandal, fraud, malpractice, and quality of care issues. There has been no single decade since 1930 when the V.A. hasn’t faced some sort of scandal, whether it be massive oversights in patient care, exorbitant wait times just to be seen, squalid facilities, or infection outbreaks. One Veteran said to me, during an exchange, “The V.A. can’t get good doctors in there, because nobody wants to be associated with the V.A.” Realistically, the V.A. has earned its poor reputation through decades of mismanagement, underfunding, understaffing, and inconvenient locations. Furthermore, every President since Franklin D. Roosevelt has promised to fix, once and for all, the V.A. health system. None have managed to do so, in whole.

Logo: U.S. Department of Veterans Affairs

Source: U.S. Department of Veterans Affairs

But, it’s not all bad. Improvements, though incremental and rarely immediate, have been made, and there are areas where the V.A. performs brilliantly. Perhaps the best example of this is how the V.A. has dealt with Hepatitis C (HCV) within Veteran populations.

In March of 2016, the V.A. announced that it would be expanding coverage for HCV treatment using Direct-Acting Antivirals (DAAs) to all Veterans in its health system who have the virus regardless of their disease stage (Kime, 2016). Since that time, the V.A. has proven to be the most successful public or private health system in the U.S. for screening, testing, treating, and curing HCV. More importantly, they achieve this not by limiting care to the sickest, but by opening access to the cure for HCV to all members.

As of June 2018, 83.5% of the V.A. Birth Cohort (those born between 1945-1965) have been screened and received HCV testing (U.S. Department of Veterans Affairs, 2018). Since 2014, the V.A. has treated 110,220 (through June 2018), and an average of 323 Veterans are starting treatment every week. The cure rates with all oral DAA therapies is 95%. These statistics are phenomenal, and if they were to be replicated in every healthcare setting, we could likely beat the World Health Organization’s 2030 target for HCV elimination a year or so early. We likely won’treplicate the V.A.’s success in other programs, but that’s a whole other kettle of fish.

So, what does all of this success mean for everyone else? Well, because of the nature of the V.A., all of the data collected are an excellent source of…well, data for other researchers to use for the purposes of making retrospective analyses to assess the risks and benefits of modern HCV therapies (May, 2018). Essentially, because the V.A. has provided treatment using every HCV DAA available, we have a broad base of knowledge to do comparative analyses of efficacy between the various DAAs and across various age, race, and health demographics.

While the V.A. does have serious problems to correct, they are doing a lot of things “right.” HCV – the most fatal disease in the U.S. – just happens to be one of those.

References:

  • Unites States Department of Veterans Affairs. (2018, August). Hepatitis C Virus (HCV) VA IS A NATIONAL LEADER IN HEPATITIS C TESTING, CARE, AND TREATMENT. Washington, DC: United States Department of Veterans Affairs: Office of Public Affairs: Media Relations. Retrieved from: https://www.hepatitis.va.gov/pdf/VA-HCV-Fact-Sheet.pdf

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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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Washington State Unveils New Effort to Eliminate HCV by 2030

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

Washington state Governor Jay Inslee signed a directive on September 28th, 2018 that directs state agencies, tribal governments, and other local public health officials to coordinate on a strategy to eliminate the Hepatitis C Virus (HCV) from the state by 2030 (Pacheco-Flores, 2018). This is the first state-led effort in the U.S. to attempt to achieve the 2030 elimination goal set forth by the World Health Organization (WHO) in May 2016.

Gov. Jay Inslee

Photo Source: Spokesman.com (AP Photo/The Olympian, Tony Overman)

Inslee announced this directive at a news conference at Harborview Medical Center in Seattle explaining that the approach uses a combination of increased and expanded prevention screening and increased access to HCV Direct-Acting Antivirals (DAAs) that serve as a functional cure for the disease. Officials estimate that there are 65,000 people living with HCV in Washington state.

There is also a money-saving aspect to this plan that would involve pooling together multiple state departments with purchasing power for drugs (e.g. – Department of Corrections and Department of Social and Health Services). This method, which will also soon be employed in Massachusetts, would allow the state to pull funds into a general purchasing fund to purchase the drugs in bulk at a lower cost-per-capita. This is particularly useful given the relatively recent introduction of lower-priced DAAs such as AbbVie’s Mavyret that have lowered the cost of treatment-per-patient significantly since the initial introduction of DAAs in 2013.

One of the biggest barriers to elimination is going to be the screening/testing apparatus and implementation component. The majority of Washingtonians (and, in fact, all Americans) are unaware that they are infected with HCV, in no small part because there have been few properly funded efforts to adequately screen and test for the disease. While the rapid testing kits are relatively cheap, confirmatory blood testing and genotyping are considerably more expensive. As the directive was only just signed, there are few details about how these procurement and payment processes are going to work. Realistically, given the emerging demographics of new HCV infections nationwide – younger, poorer, and potentially drug-addicted, it is safe to assume that a large swath of those living with HCV may not possess the financial resources to afford to pay for these services. Is the state going to pay for those who cannot afford it? (Likely, not.)

Beyond just cost-related issues, it has been difficult, given the structure of the American healthcare model and funding, to ensure that high-risk demographic groups such as the homeless, rural populations, and People Who Inject Drugs (PWIDs) receive the proper amount of focus they deserve. These populations are notoriously difficult to engage in even basic healthcare services, much less preventative testing and follow-up care.

At the 2017 International AIDS Society conference in Paris, an Australian researcher and provider, when speaking of reaching rural populations stated, “It’s just not that hard.” In nations with universal healthcare, it ISN’T that hard to do proper outreach into these communities, because there’s no question of who will pay for it. In the backward, hackneyed U.S. healthcare system, however, “Who’s going to pay for this,” is a legitimate barrier to doing outreach. Without a specified payor lined up, there is no guarantee that there will be funds to pay for services either from the patients, from the state, or from private insurers. And the sad reality of the U.S. healthcare system is that the best of the suboptimal care is reserved for those who can afford it.

So, while Governor Inslee has taken a great first step, he must work to ensure that the initiative is adequately funded with the presumption that 80%+ of those who need services will be unable to personally pay for them.

References:

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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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French Study Finds Universal HCV Screening Cost Effective

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

In May 2016, the World Health Organization (WHO) adopted a goal of eliminating Hepatitis B (HBV) and C (HCV) by 2030.  Some major nations are on the way to achieving that goal (Australia, for instance); others, like the U.S., are not. One reason why the U.S. is falling so far behind others is that we frequently fail to identify patients who are infected with HCV because the screening guidelines are woefully outdated, focusing primarily on “one-time testing” for patients in the Birth Cohort (those born between 1945-1965) and patients whose doctors knowthey use or have used injection drugs.

Journal of Hepatology

Photo Source: EASL

A new study out of France, however, has found that a combination of universal screening for and immediate treatment of HCV was the most cost-effective way to combat the virus. The study, published in the Journal of Hepatology, found that, using their model which did away with “highest risk” screening models like the one used in the U.S., reduced the incidence of hepatic events (i.e. – cirrhosis, decompensated cirrhosis, and liver-related mortality) in undiagnosed adults over the age of 18. The model also considered treatment initiation for all patients with fibrosis scores of 2 or higher, which resulted in reduced Chronic HCV prevalence in one year’s time; treatment initiation regardless of fibrosis score decreased prevalence significantly. A Healio article on this study has a much better explanation of the findings than the Journal of Hepatologysummary, and it can be found at this link:

https://www.healio.com/hepatology/hepatitis-c/news/online/%7B7c00ba17-af2b-4ddb-b0b2-26c8d6fed926%7D/universal-hcv-screening-in-adults-cost-effective-decreases-prevalence

While universal screening and treatment likely would be cost-effective in France (as well as other countries that offer Universal Healthcare), I predict that it would be incredibly difficult to replicate that finding here, in the U.S., primarily because of the way our for-profit healthcare system is structured. Between being constantly (and increasingly) bilked by private insurers and pharmaceutical companies, and the resultant exorbitant costs of testing and treatment, the U.S. is not currently positioned to adopt this strategy. In order for this strategy to be successful, the U.S. would have to fundamentally overthrow the existing healthcare payor model and adopt an intelligent policy of universal provision – an unlikely occurrence given the current legislative and executive political makeup.

That said, there is little stopping better prepared and positioned nations from adopting this strategy, and ensuring that their nations are able to eliminate HCV by 2030.

References:

  • Deuffic-Burban, S., Huneau, A., Verleene, A., Brouard, C., Pillonel, J., Le Strat, Y., Cossais, S., et. al. (2018, July 01). Assessing the cost-effectiveness of hepatitis C screening strategies in France. Journal of Hepatology. https://doi.org/10.1016/j.jhep.2018.05.027

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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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United Kingdom to Attempt Ambitious HCV Plan

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

In 2016, the World Health Organization (WHO) set for the globe an ambitious plan for the elimination of both Hepatitis B (HBV) and Hepatitis C (HCV) by 2030 (WHO, 2016). In fact, most of the developed First World nations are on track to achieving this goal – the U.S., of course, being the sole lagging nation – while other developing nations – China, Russia, India, and some 5 dozen other countries – have virtually no chance of achieving that goal given existing policies (Connor Roche, 2017). The United Kingdom’s (UK’s) National Health Service (NHS) has developed a far more ambitious goal – the elimination of HCV in the UK by 2025.

NHS sign in foreground, with Big Ben in the background

In order to accomplish this goal, the NHS will be launching the single largest medicines procurement it has ever undertaken in an effort to further drive down the cost of HCV Direct-Acting Antivirals (DAAs). Reporting from Pharmaphorum Connect suggests that NHS is currently paying around £10,000 (≈$14249.30) for a single patient, far lower than the list price that averages £35,000 (≈$49872.55), which is about on par with what certain American programs for lower-income individuals are paying (Staines, 2018).

NHS England currently enjoys a “No Cure, No Fee” payment model with pharmaceutical companies, meaning that if Sustained Virologic Response (SVR) is not achieved using a DAA drug, the manufacturer will refund the cost of the regimen (Alcorn, 2018). This payment model has allowed NHS to save tens-of-thousands of pounds (GBP) per patient, particularly with those who were unable to achieve SVR with a first round of DAAs. The ability to re-treat patients without additional costs is an invaluable tool in limited the high cost of treatment – one that should be replicated, here in the U.S.

To meet the WHO goal of elimination by 2030, the NHS would have to treat and cure 10,000 patients per year; to meet the new NHS elimination goal of 2025, that number would have to increase to 16,000-17,000 per year (Alcorn). That increase may, however, prove unachievable unless rates of diagnosis increase, and the Polaris Observatory warns that without such diagnosis increases, the number of patients being treated could drop to just 5,000 per year (Alcorn).

While the goal is laudable, without cooperation between the NHS and pharmaceutical companies (or an exponential increase in NHS funding specifically for HCV, which is unlikely given the current political climate), it is more likely that NHS will have to fall back on attempting to meet the WHO goal of 2030.

References:

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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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U.S. Falling Behind in HCV Elimination Goals

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

Nine nations are on track to eliminate Hepatitis C (HCV) by 2030 – Australia, Egypt, France, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar. Notably absent from this list is the United States. The World Health Organization (WHO) set a target goal of 2030 for the elimination of HCV as a public health crisis in 2016. Despite this goal, only nine nations are on target to meeting that deadline.

World Health Organization logo

Part of what makes the elimination of HCV so difficult, particularly in the U.S., is the steps required to actively combat the disease: treating 7% of the HCV-infected population without restrictions; actively working on harm reduction issues (e.g. – Syringe Services Programs); actively screening patients. These three steps require making HCV a political priority at a time when other issues – foreign intervention, taxation, economic concerns, and the provision of healthcare as a right – dominate the political landscape.

In the U.S., each of these key steps that make elimination a possibility are hampered by a fundamental disagreement between warring political factions about the role of government in healthcare. The current administration occupying the Executive Branch has taken numerous steps – cutting funding, leaving funding levels flat, and cutting/underfunding staffing – that further complicate already difficult issues related to adequately combatting HCV in the U.S.

At the heart of each of these steps is the issue of funding. The high cost of HCV Direct Acting Agents (DAAs) – the current standard of care for curing HCV – has led almost every state-run healthcare program to restrict access by introducing Prior Authorization (PA) pre-requisites in order to even be considered for treatment. These PA requirements can include liver fibrosis scores (F-scores) above a certain level, that prescribing physicians either be or work in conjunction with hepatologists, gastroenterologists, or infectious disease specialists, abstinence from alcohol and/or recreational drugs for a predetermined period, and other restriction not placed upon patients needing treatment for other deadly diseases. The purpose behind these PA requirements are ostensibly to ensure that only patients who are likely to complete the relatively short regimens receive treatment, but in effect serve as cost saving measures to ensure that programs don’t have to pay for the drugs.

Harm reduction programs are equally contentious within the U.S., though Syringe Services Programs (SSPs) are gaining in popularity as a result of the prescription opioid and heroin crises sweeping our nation’s suburban and rural areas. Despite the increase in approvals for the establishment of SSPs in otherwise politically and socially conservative areas of the country, many states and Federal regulations place restrictions on how funds can be spent, meaning that syringes and other injection supplies may not be allowed to be purchased using taxpayer-funded monies.

Image promoting needle exchange for IDUs

Beyond that, local communities are beginning to experience a pushback against SSPs from residents who fear that the very presence of the programs in their neighborhoods, alone, leads to or has created a public health concern. Several counties in Indiana, where both HIV and HCV infection rates have seen increases due to Injection Drug Use (IDU), have voted to remove approval for SSPs and other Harm Reduction Clinic efforts in 2017 in no small part because of erroneous claims that the programs create hazardous waste and attract unwanted People Who Inject Drugs (PWIDs) into otherwise “drug free” communities. These fears have been stoked by elected officials (sheriffs, prosecutors, and/or legislators) who stalwartly refuse either to believe the research and evidence presented to them, or the real world results of the programs.

Screening for HCV in the U.S. is another costly endeavor, as Federal funds for state-level screening efforts fall far short of what is needed to adequately combat the spread of HCV. Moreover, there is currently no Federal requirement that certain populations be routinely screened. This leaves screening, tracking, and reporting guidelines up to the individual states, most of whom simply do not have the funds to engage in such a costly effort. Without adequate screening protocols in place on a national level, the U.S. cannot hope to meet elimination targets.

The U.S., for much of the 20th Century, led the world in the eradication of public health threats. This status has been erased, largely because of political efforts to reduce the role that government plays in healthcare compounded with the ever-increasing costs of healthcare. It is time for the U.S. to take a stand, reclaim its standing, and put behind us the burden of for-profit healthcare.

References:

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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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Hepatitis C Therapies Added to WHO Essential Medicines List

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

Since 1977, the World Health Organization (WHO) has published its Essential Medicines List containing the medications considered to be the most effective and safe to meet the important needs in a health system. This year, the organization has included the following Hepatitis C (HCV) Direct Acting Agents (DAAs) Sovaldi (Gilead), Olysio (Janssen), Harvoni (Gilead), Viekira/Viekira XR (AbbVie), Daklinza (Bristol-Myers Squibb), Technivie (AbbVie), and Epclusa (Gilead) (WHO, 2017). Notably absent from this list is Zepatier (Merck) – to date, the lowest priced HCV DAA with a Wholesale Acquisition Cost (WAC) of $54,600.

World Health Organization logo

Since the 2013 launch of Sovaldi and Olysio, new drugs to treat HCV have entered the market at a relatively rapid pace, from just two drugs in 2013, to nine drugs by 2016. That said, two or more new drugs hit the market in 2017:

AbbVie’s new next generation protease inhibitor & NS5A inhibitor known as G/P or GLECAPREVIR/PIBRENTASVIR; Gilead’s new triple [combination] of Sofosbuvir + Velpatasvir + Voxilaprevir which contains their new protease inhibitor (Vox.); [Merck’s new triple combination] (Uprifosbuvir) + Grazoprevir + Rusasvir; [Janssen’s] new triple AL-335 + Odalasvir + Simeprevir (Levin, 2017).

With so many treatment expensive options available to treat HCV, as well as the availability of reasonably priced generics in lower-income countries, there is little doubt that these medicinal cures for HCV should be included in every nation’s list of essential drugs. Furthermore, research shows that the generic versions of Sovaldi, Daklinza, and Rebetol (Ribavirin) are as effective as their brand name counterparts (Preidt, 2016).

Some concerns exist, however, that the high cost of treating HCV in nations who are forced to pay the high price for brand name drugs will prevent these cures from reaching the patients most in need. The Centers for Disease Control and Prevention (CDC) recently released a report detailing how restrictive state Medicaid policies – as well as state restrictions regard Syringe Exchange Services/Programs (SESs/SEPs) – are contributing to the vast increase in new HCV infections (CDC, 2017). Most states’ Medicaid programs require Prior Authorization (PA) standards for HCV drugs that are stricter than for most cancer-related treatments, in no small part because those prerequisites serve as cost containment tools – the more complicated and cumbersome the requirements, the less likely the program is to have to cover the cost of treatment.

While the inclusion of HCV DAAs to the WHO Essential Medicines List is an important step forward toward nations including them on their own lists, the high cost of the medications may prove prohibitive to some nations doing so. As the battle over “what the market will bear” soldiers on, HEAL Blog will continue to monitor the situation.

References:

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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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