Tag Archives: World Health Organization

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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