Monthly Archives: May 2016

More Sad News on the Home Front

By: Marcus J. Hopkins, Blogger

LOGO: Center for Improving Value in Health Care (CIVHC)

Photo Source: CIVHC

A May 19th report from Colorado Public Radio cited a study from the non-profit Center for Improving Value in Health Care (CIVHC) that found that, “…in spite of the availability of new revolutionary drugs, 89 percent of Coloradans [in] (sic) with Hepatitis C did not receive any treatment for their condition.” This number was reached by analyzing claims data from the Colorado All Payer Claims Database (CO APCD) for the commercial insured (excluding those on self-insured plans), Medicaid, and Medicare Advantage members in 2013 and 2014.

What makes this study so frustrating, for me, is that I’ve been following the progress of Colorado’s healthcare system as it relates to HCV and HIV since the beginning of 2015, and have to say that, while there will always be some people who are denied coverage, Colorado’s healthcare provisions are some of the best in the nation, particularly for co-infected patients living in the state. In comparison to several other states, Colorado’s Medicaid coverage for HCV Direct Acting Agents (DAAs) is one of the most comprehensive coverage models in the nation, and the amazing work being done by the state’s AIDS Drug Assistance Program (ADAP) is beyond reproach.

On the ADAP side of the equation, the program was one of the first in the nation to offer coverage for their co-infected patients through one of their five payer formularies – Standard ADAP Formulary (for the uninsured), HIV Medication Assistance Program (HMAP), Bridging the Gap Colorado (BTGC), HIV Insurance Assistance Program (HIAP), and Supplemental Wrap-Around Program (SWAP). For their uninsured clients, they consistently offer coverage up to the point where funds are no longer available for treatment, and have made significant strides toward including additional funds in their annual budget for treatment of HCV.

So, when I read that 90% of Coloradans diagnosed with HCV are not receiving treatment, I had to look a little bit further into the study. What troubles me is that the data is representative of the years 2013 and 2014, two of the most, if not the most we’re likely to see, volatile years for the HCV treatment landscape. Gilead Sciences and Janssen Pharmaceutical released Sovaldi and Olysio, two drugs that were meant to serve as companions in a new twelve-week regimen to treat HCV. Gilead’s product, alone, came out with an introductory Wholesale Acquisition Cost (WAC) of $87,000 for twelve weeks of treatment; when Olysio was factored in at around $45,000, treatment ostensibly could cost roughly $130,000 for just twelve weeks.

The sticker shock of Sovaldi, and later Harvoni (Gilead), was so great that there were Congressional hearing on the matter, wherein Medicaid, Medicare, Veterans Administration, and private insurers all balked at the high costs associated with these drugs and sounded the klaxon that paying for these drugs to treat all their clients infected with HCV would bankrupt them all. And, honestly, they weren’t wrong. A lot of time and energy went into fighting against these high prices, finding ways to pay for treatment, and pushing for greater oversight and funding for the problem.

In just two years’ time, the standard of care for HCV was essentially rewritten to the point where the old treatments were essentially dismissed by the medical community for being too difficult to tolerate and too costly to keep repeating literally ad nauseam. Then, in 2015, the treatment landscape started to turn around, with more private insurers and public payers’ coverage practices coming under scrutiny. At the end of 2015, the Centers for Medicare and Medicaid Services (CMS) released very specific guidance instructing state Medicaid agencies to stop rationing care, as the were in violation of very clearly stated statutes that required them to cover the drugs for patients. Some states – Arizona for example – specifically stated that they would not be in compliance.

But, I wonder if, had CIVHC had access to and reported numbers for 2015, we might have seen a different report. That is not to discredit the hard work put into the project by the CIVHC or its researchers, but the circumstances are changing, and more rapidly than those numbers imply. By looking at two of the most tumultuous years in HCV treatment history, of course the data they found showed 90% of Coloradans not receiving treatment – everyone was still trying to figure out how to pay for it and pricing agreements had not yet been reached. Hopefully, their next report on the subject will be less doom and gloom, and a bit more reflective of the current treatment landscape in Colorado.
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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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Co-Existing Co-Infection Research Results

By: Marcus J. Hopkins, Blogger

One of the primary focal points of the HEAL Blog’s reporting is based around issues of affording Direct Acting Agents (DAAs) for treating Hepatitis C (HCV). Much of what is written concerns the struggles faced my people mono- or co-infected with HCV who cannot afford the high cost of treatment – and, if we’re being honest, out-of-pocket, few people realistically can afford the treatments unless they have ridiculously good insurance. One issue we infrequently cover, however, is the effectiveness of these DAA drugs on co-infection populations with HIV and HCV.

Chart showing Hepatitis C Direct Acting Antiviral Agents

Photo Source: 2014: HIV, HCV, and HBV Update David Spach, MD Professor of Medicine, Division of Infectious Diseases University of Washington Last Updated: June 12, 2013.

There are a few terms to go over, before we start:

  • SVR – Sustained Virologic Response is the most widely used efficacy endpoint in clinical studies of hepatitis C, and represents the eradication of HCV from the body
  • 2D RegimenOmbitasvir-Paritaprevir-Ritonavir (Technivie).
  • 3D Regimen – Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak)

The general assumption in the U.S. has been that co-infected patients attain similar SVR results with DAA drugs as do their mono-infected peers. While outliers always exist, inevitably, someone will come forth with anecdotal evidence demonstrating that their HCV was more virulent than another’s. Two recent studies on the efficacy of DAA HCV drugs in co-infected patients, however, released results that, while not outright contradictory of one another, may lead healthcare providers to pay closer attention to the ratio of co-infected patients who achieve an SVR.

The first study, conducted by the Veterans Health Administration (VHA) determined that the co-infected saw lower SVR rates, but that that rate was lower than their mono-infected peers; the second study showed that the co-infected of achieving that SVR is much lower than their peers. While the first study did not test any of the pegylated-Interferon-based treatments – (1) Sovaldi / Olysio combo; (2) 2D; (3) 3D – while the second study showed the co-infected patients who used the Pegylated Interferon-based regimens were significantly unlikely to achieve an SVRs when compared to those patients who received 2D and 3D therapies.

In the VHA study, patients saw an overall rate of SVR exceeding 88% across the three regimens. While this overall rate still lags behind mono-infected patients, the results in the second study (out of Hospital Universitario de Valme in Seville) demonstrate why the new DAA drugs are so much better. Patients in the second study who received Interferon-based treatments augmented by sofosbuvir (Sovaldi), simeprevir (Olysio), boceprevir, or telapravir saw an SVR rate of only 55% in co-infected patients; mono-infected patients saw an SVR of only 66%.

The second study also found slightly less great news about new DAA drugs: mono-infected patients saw an SVR rate of 95%, while co-infected patients saw a rate of 89%, which may seem insignificant, in terms of interval, but the high cost of HCV therapies makes accessing the therapies for a second round if an SVR is not reached (or for a re-infection) a very pricy endeavor.

While new DAA HCV drugs are undoubtedly more effective than the only medications, there is still a long way to go in order to ensure that all patients, mono- or co-infection, are able to achieve a sufficient SVR rate similar to their peers.

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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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New Harm Reduction Focus Helps Bring Light

By: Marcus J. Hopkins, Blogger

The HIV/HCV Co-Infection Watch — published by the Community Access National Network (CANN) — recently added two new sections to its monthly report: the first focuses on the coverage offered by the Veterans Administration (VA); the second, and perhaps more involved research, focuses on Harm Reduction efforts.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

The VA section is extremely cut and dry; they recently announced that they will effectively cover all veterans who are currently eligible for benefits for HCV treatment using Direct Acting Agent (DAA) HCV therapies. The Harm Reduction section, however, requires a more nuanced approach, as each state has its own interpretation of how they implement each aspect of Harm Reduction.

For those unfamiliar with the term, “Harm Reduction” is a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use, as well as for expanding, protecting, and respecting the rights of drug users. The specifics, again, vary from state to state in their implementation, but there are overarching ideals that are used to shape these programs. In our research, we’re focusing on several very important Harm Reduction strategies:

  • Syringe Exchanges;
  • Expanded Naloxone Access;
  • Good Samaritan Laws;
  • Mandatory Prescription Drug Monitoring Programs;
  • Doctor Shopping Laws;
  • Physical Examination Requirements;
  • ID Requirements for Purchase;
  • Required/Recommended Prescriber Education; and
  • Lock-In Programs.

If this list seems exhaustive, it’s really only the tip of the iceberg. Harm Reduction strategies have a consistent track record of bringing about positive health outcomes, but little attention gets paid to them, unless there is a well-publicized health crisis – a sudden explosion of new HIV infections resulting from injection drug use, for example – that essentially forces the hand of state legislators to act. The most recent example of legislative Harm Reduction publicity came from Maine, which we covered two weeks ago, when Republican Governor Paul LePage vetoed a bill that provided expanded access to Naloxone by allowing it to be purchased from pharmacies without a prescription; his veto was quickly overturned by both Maine’s House and Senate on April 29th.

While Harm Reduction strategies have a proven record of net positive outcomes, there are always unintended consequences to any well-intentioned law. The U.S. has been in the throes of a prescription opioid addiction problem since the late 1990s, and state and federal governmental intervention is desperately needed and vitally important to help quell the ever-increasing addiction and overdose rates, HIV and HCV infection rates, and the unfortunate increase in criminal activities (such as varies classifications of theft) that tend to accompany an increase in opioid drug use. One such unintended consequence is the reduced access to prescription opioid drugs for patients whose healthcare needs truly necessitate their occasional use of a validly prescribed opioid.

I was recently asked by a very good friend if I knew of any doctors who would prescribe opioid pain relievers. This person knows the type of research I conduct, and his question stemmed from the fact that his doctor has repeatedly tried the same methods of pain relief that provide only short-term results to a chronic issue despite repeated requests to move past the less effective approach to a longer-lasting solution. My friend’s predicament is that any doctors outside of West Virginia University’s healthcare system are outside of his insurance plan’s network, which leaves him with few good options on a fixed income.

While I understand my friend’s predicament, I was unable to provide him with the answer he was seeking. What makes this problem difficult to address is that WV has one of the most vigorous legislative approaches to Harm Reduction strategies, largely because the state has been coping with a massive opioid addiction problem for at least two decades that has all but ravaged the state. It is my belief that this doctor properly using the context of WV’s opioid addiction problem to inform his overall approach to pain relief, and rightly so. For my friend, I suggested the use of a healthcare mediator or advocate during their next appointment; someone to speak on his behalf, and to try to come to a pain management approach that will allow him to better address his needs and to help the doctor understand his patient’s position – that the regimen he’s prescribing may not be the best solution for his patient.

My position, however, remains unchanged – Harm Reduction strategies are the most effective way to achieve net positive healthcare outcomes related to prescription opioid use, abuse, and addiction. While there will always be unintended consequences for some, the good of the many outweighs the complications that can arise from more stringent prescribing requirements. There is little doubt that we are facing a crisis of unprecedented scale; how we choose to deal with that, as a nation, will be of the utmost importance.

CLICK HERE to receive the monthly HIV/HCV Co-Infection Watch.
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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 Kills More Americans than Any Other Infectious Disease

By: Marcus J. Hopkins, Blogger

“Hepatitis C Kills More Americans than Any Other Infectious Disease.”

It’s hard to understate a headline like that. Sadly, it’s a headline that will likely be overlooked by the vast majority of Americans, inundated as we are by news concerning celebrities, primary politics, and whichever athlete’s scandal has made the front pages of America. It is, however, a headline that should be heeded, because it confirms what we, at the HEAL Coalition, have been trumpeting all along: we are in the midst of a burgeoning epidemic of deadly consequence.

Last Wednesday’s press release from the Centers for Disease Control and Prevention (CDC) was covered in several respected publications, but it was difficult to spot, given the post-Indiana Primary hullabaloo. That Hepatitis C (HCV) deaths in 2013 surpassed the total combined number of deaths from 60 other infectious diseases reported to the CDC – including HIV, pneumococcal disease, and tuberculosis – has not been brought to the forefront of any of these political debates as it relates to funding boggles the mind in a world where we’ve had over thirty-five years to come to grips with, fund, address, and largely stem the tide of HIV in the U.S. This should be front page news; there should be cameras and benefit concerts; where is HCV’s big name celebrity face-of-the-disease!

Model of Human Hepatitis C Virus

Photo Source: hepcprimer.com

The truth, however, is that HCV is the new HIV, in terms of national import and sheer mortality of the disease. While current figures for 2014 exist, the most current comparable information for both diseases is from 2013:

This disparity in deaths is staggering, especially when you take into account the fact that, unlike HIV, Hepatitis C is effectively curable (defined as achieving a Sustained Virologic Response [SVR]). Beyond sheer mortality rates, HCV has exponentially higher rates of transmission than HIV, the latter of which has plateaued at roughly 50,000 new cases annually in the U.S. for nearly a decade. And yet, despite the clearly more pressing need to address the widespread HCV crisis, HIV funding for FY 2016 stands at around $42.827 billion.

To break that last figure down into comparable numbers:

Not only do HCV infection and mortality rates vastly outstrip those of HIV, but the amount of funding for prevention and research is less than a tenth of the funds allocated for HIV, despite being both more virulent and curable. It is clear that additional funding for HCV-related prevention, research, and treatment is desperately needed.

To download the CDC report, CLICK HERE.
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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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Taking a LePage from an Outdated Book

By: Marcus J. Hopkins, Blogger

Naloxone does not truly save lives; it merely extends them until the next overdose,” Gov. Paul LePage (Miller, 2016).

Maine’s very own Republican Governor Paul LePage, is renown for his ability to say just the wrong thing in the absolutely worst way possible, and his above quote is an example. LePage’s comment is a part of his veto the Maine legislature’s attempt to expand the ability of pharmacies to provide naloxone – a non-habit forming drug used to counteract the effects of opioid and heroin overdoses – without the need for a prescription.

Photo of Maine Governor Paul LePage

Photo Source: Business Insider

This type of legislation is nothing unusual – roughly 30 states have similar Harm Reduction laws on the books. Maine, in fact, has already increased access to naloxone by making it readily available to emergency personnel, nurses, and other healthcare professionals, and bill LD 1547 would’ve brought Maine in line with a majority of states. The bill came about after national pharmacy, CVS, requested the bill in response to a letter from U.S. Senator Angus King (I-ME) asking the chain to expand the availability of the antidote (Mistler, 2016a). For the most part, LD 1547 enjoyed broad bi-partisan support from legislators, community members, healthcare professionals, medical associations, and public employees and servants. So well-received was the bill, that it was passed “under the hammer” – unanimously without a roll call. LePage was not one of its fans.

Maine, like most other rural areas in the U.S., is in the throes of a growing opioid and heroin abuse epidemic, and this isn’t the first time that LePage has taken a stab (pun intended) at the problem. Earlier, this year, LePage made similarly troubling comments:

“These are guys by the name D-Money, Smoothie, Shifty. These type of guys that come from Connecticut and New York. They come up here, they sell their heroin, then they go back home. Incidentally, half the time they impregnate a young, white girl before they leave. Which is the real sad thing, because then we have another issue that we have to deal with down the road” (Fuller, 2016).

The unfortunate result of this type of verbiage is that it tends to lead to further stigmatization, rather than creating any substantive solutions or net positive results. What’s sadder is that the stigma associated with opioid and heroin abuse is so pervasive in our society that those who are also unwilling or unable to read, research, or understand existing research about opioid addiction and abuse have these stereotypes of substance abusers further reinforced in their minds.

Of further concern for LePage is that his veto is likely to be overridden by Maine’s legislature. It is this author’s hope that, along with an overridden veto, the citizens of Maine are treated with a more accurate portrayal of the fight against opioid and heroin abuse and addiction; one that doesn’t portray them as “…addict[s] [with] a heroin needle in one hand and a shot of naloxone in the other.”

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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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