Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

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 Community Access National Network (CANN) will be hosting a roundtable at the headquarters of the Pharmaceutical Research and Manufacturers of America (PhRMA) on Thursday, May 11th, 2017, on the topic of Hepatitis C (HCV) in Incarcerated Populations. The roundtable will focus on various aspects of treated HCV in prison and jail settings, including the Constitutional requirement that all inmates receive treatment, as well as various barriers that prevent inmates from receiving screening and treatment.

Invite for the Community Roundtable on Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

Current estimates indicate that between 10-35% of inmates are infected with HCV, and that roughly half of those inmates don’t know that they’re infected. These estimates are, however, limited by inconsistent or non-existent screening protocols, reporting requirements, and various bureaucratic hurdles that prevent inmates from being screened. Furthermore, there are no penalties in place that hold prison and jail systems accountable for failing to screen inmates, which often results in costly lawsuits.

The Federal Bureau of Prisons released a new set of screening guidelines for HCV in October 2016, which included the recommendation that all prisons and jails adopt an “Opt-Out” screening process (Federal Bureau of Prisons, 2016). This strategy requires that HCV screening becomes part of a routine practice, and that inmates must provide “informed refusal” in order not to be screened. This strategy would be instrumental in combating the HCV epidemic running rampant among inmate populations, as well as for data gathering purposes.

Implementing this strategy across all prisons and jails in the U.S. in a difficult proposal, in no small part because it will be expensive. What makes it so expensive is that screening, itself, isn’t cheap – at least not the confirmatory tests; additionally, if prisons and jails discover that an inmate has HCV, or any other life-threatening illness, they are required under the 8th Amendment of the U.S. Constitution to treat that inmate’s illness (Estelle v. Gamble). That last part can cost prison systems tens of thousands of dollars fear each infected inmate – costs that will explode pharmacy and healthcare budgets in the short-term, but will save money in the long-term.

Furthermore, prisons appear to be extremely inconsistent about what prices they pay for drugs. The Wall Street Journal (WSJ) published a report in September 2016 per-patient cost paid by state prisons to treat HCV using Gilead’s Harvoni: the prices ranged from $46,021 in North Dakota to $91,014 in Georgia (Loftus & Fields, 2016). These numbers indicate the need for more price stabilization in the U.S. prison systems, or at the very least, consolidated price negotiation.

While the roundtable is open to the public, seating is limited. Interested parties can sign up for the event at the following address: http://tiicann.org/events.html

References:

__________

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.

Leave a comment

Filed under Uncategorized

Emory University and CDC Reveal HepVu

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 latest tool in Viral Hepatitis advocacy has arrived: HepVu (www.hepvu.org). A project of Emory University’s Coalition for Applied Modeling for Prevention (CAMP) – supported by the Centers for Disease Control and Prevention (CDC) – HepVu is an interactive website that provides various data related to Viral Hepatitis (VH), with the greatest emphasis being placed upon Hepatitis C (HCV), the least accurately reported variant in the U.S.

The website features interactive maps detailing estimated prevalence data, rates of infection, mortality data, and regional impacts and comparisons on both the national and state levels. While HCV data released by the annual National Health and Nutrition Examination Survey (NHANES) conducted by the CDC produces national estimates, HepVu is the first analysis that uses a more nuanced formula that includes NHANES data, but also examines state-level reporting and statistics that includes electronic medical records (EMRs), insurance claims, and HCV-related mortality.

Other site features include infographics, explanations about the various types of VH, and the ability to print and download maps and data for use in advocacy efforts and reports. Dr. Patrick Sullivan, one of the researchers associated with creating the project, stated that making the site a resource for HCV-related advocacy and reporting efforts was an essential step in creating HepVu. This is the first HCV-related website (of which I am aware) that makes these data easily available for reprinting and citation purposes.

The contributing researchers to the website admit that this reporting is likely well below the actual prevalence and rates of infection, because screening, reporting, and tracking vary in quality and amount of data from state to state, in no small part because of a lack of Federal and state funding for HCV reporting, as well as adequate and standardized reporting requirements set by the CDC. Part of what makes this data so important is that it serves as a great starting point for advocating for increased funding for reporting and tracking – something that Congress has been slow to address, despite large increases in funding to address America’s opioid and heroin abuse crisis, the leading contributor to the rise in new HCV infections.

The primary limitation of the data presented on HepVu (and in general) is age: the vast majority of the data centers on 2010 and 2014 – seven and three years old, respectively. This complaint has been a sticking point for advocates and HCV-related organizations for several years, particularly because of the release of easily tolerated and highly effective Direct Acting Agents (DAAs) that serve as a curative treatment for HCV. Now that we have these tools to eradicate HCV, it is imperative that we begin operating on current information, rather than relying upon data that predates two presidential elections. This means that both Federal and state governments are going to have to step up to the plate and begin adequately funding screening, reporting, and tracking efforts, regardless of the high cost of these drugs.

HepVu is an excellent starting point, despite the data limitations, and so long as the statistics and information are regularly updated with more current information, it has the potential to become an invaluable tool in combating HCV and hopefully eradicating the virus from the U.S., entirely.

__________

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.

Leave a comment

Filed under Uncategorized

Treating HCV in Pediatric Patients

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 April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.

Stamp marked, "Approved" next to the initial, "FDA"

Photo Source: 3Dprint.com

Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”

The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.

One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.

Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.

References:

__________

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.

Leave a comment

Filed under Uncategorized

HCV Prescribing Lags While Prices Soar

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

An article in Newsweek in March 2017 talked about a “…crowded and confusing” landscape for treating Hepatitis C (HCV) that prevents many Primary Care Physicians (PCPs) from prescribing the new Direct Acting Agents (DAAs) to treat the disease (Wapner 2017). The argument posed is that, physicians are “…still too unfamiliar with the regimens to speak with confidence about them,” according to Ira Jacobson, a hepatologist who leads the department of medicine at Mount Sinai Beth Israel Hospital in New York. He posits that this discomfort leads them to send patients to liver specialists, or to delay treatment until more severe symptoms arise, the latter of which is a regular pre-requisite on virtually every Prior Authorization (PA) request form.

This argument caught my eye, as someone who writes about and researches coverage for these DAA drugs, as has done so since 2013. One of the most frequent conversations I heard when Sovaldi (Gilead) and Olysio (Janssen) were first released on the market was that there was confusion over which doctors could prescribe them. Unlike HIV, treatments for HCV largely lagged in the ‘completely intolerable’ realm, with patients dropping out of treatment like flies and a success rate of only around 50%. Things, however, have radically changed; the question, then, becomes, “Have doctors?”

Prescription Pad

Realistically, we have a considerable problem, in the United States, with aspiring doctors choosing to specialize, rather than going into general practice, in no small part because it guarantees them higher incomes. Higher incomes for them, however, means higher costs to consumers, in the same way that higher-priced drugs to treat chronic conditions get shunted into the highest pricing tiers. This gets passed along to consumers in the form of higher co-pays for visits ($25 for PCPs; $75 for Specialists), and higher co-pays for medications ($3 for blood pressure medication; $250 for HIV).

This problem extends, also, to prisons and jails – the high cost of treatment serves as a significant barrier to providing inmates with treatment, which presents a larger issue, because inmates have an exponentially higher incidence and prevalence of HCV than the general population (Gloucester Times, 2017). Testing prisoners is expensive, as well, as inmate populations swell, while prison healthcare budgets remain relatively stagnant. Once those prisoners are released back into the general population, if they’re unaware of being infected with HCV or whose infections have gone untreated, they can go on to infect those who are not part of the prison system, are also unlikely to be tested and treated.

Beyond just the cost of co-pays are the long-term costs of PCPs being reticent to screen or prescribe for HCV: failing to address HCV will lead to liver decompensation, liver cancer, kidney diseases and failure, higher HCV viral loads that make spreading the disease easier, jaundice, digestive illnesses, and thyroid issues, none of which are particularly cheap to treat. The host of accompanying side effects of leaving the disease untreated far outweigh the admittedly outlandish prices set by HCV drug manufacturers.

The reality is that any medical doctor who has prescribing privileges can prescribe these new treatment regimens. The vast majority of these doctors also have access to smartphones, all of which have any number of apps designed to compare new drug regimens with existing prescriptions to ferret out counter-indications; there is, in fact, an entire website specifically aimed at finding counter-indications (http://www.hep-druginteractions.org/) that also offers mobile apps. The argument that doctors are unsure of the counter-indications is really rendered moot by the existence of these easy-to-use tools.

With that, the biggest hurdle to overcome, for virtually every party involved, is the cost of treatment, and with the current administration’s funding priorities being…questionable, at best…it’s unapparent if even the existing treatment coverage landscape will exist. We’re hoping for more stable conditions, and less erratic proposals. Until then, we’ll just keep plugging to try and find a solution.

References:

__________

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.

Leave a comment

Filed under Uncategorized

New River Valley Region Reports Sharp Rise in Hepatitis C

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 New River is 360 miles long that spans three states – North Carolina, Virginia, and West Virginia – flowing from south to north (one of only a handful of rivers in the world to do so) and serves as one of the most scenic rivers in the eastern United States. It’s known for hosting some of the best white water rafting and kayaking in the U.S., and for having the third-longest single-arch bridge in the world. Nestled along some of the most rural parts of the three states in spans, the New River Valley (NRV) region is also home to a growing Hepatitis C (HCV) epidemic.

HEAL Blog has covered the exploding rates of HCV in West Virginia many times since our inception in 2013, as well as having covered those rates in the rest of the Appalachian Mountain Region (AMR). What frustrates many advocates and healthcare workers who live and work in the NRV is that the sharp increase in new HCV infections is largely a product of pharmaceutical companies’ – and healthcare providers’ – making.

Map showing the New River Valley area

Photo Source: Snipview

During the early-1990s, Perdue Pharma using rural towns and counties in the NRV as testing grounds for OxyContin, one of the most widely prescribed opioid drugs of the late-90s and early-00s. HEAL Blog has previously reported on this issue (Cassandra in the Coal Mines), and I stand by the assessment that this region and its population have been systematically targeted by the manufacturers and wholesalers of prescription opioid drugs; wholesalers have, in fact, spent several tens-of-millions of dollars settling cases in West Virginia related to oversupplying the drugs and creating “pill mills” in the state.

There is a direct link between the opioid and heroin epidemics in this region and the vast increase in new HCV infections. In December 2016, Dr. Marissa Levine warned during a meeting of the Virginia Board of Health that the state should expect a “tidal wave” of HCV and HIV primarily related to Injection Drug Use (IDU). The state saw a 21.212% increase in new HCV infections in 2015, from 6,600 in 2014 to 8,000 in 2015 (Demeria, 2016). Dr. Levine also argued that the lack of a dedicated funding stream greatly hinders the ability of the Health Department to accurately capture and track the data accurately, an argument shared by virtually every state in the U.S.

Beyond just opioid drug injection, New River Health District Health Director, Noelle Bissell, M.D., has seen a spike in acute HCV infections (as opposed to chronic conditions) linked to tattoo parlors, the use of homemade tattoo guns at parties, and in people who report more than 10 sexual partners, as well as a trend in cases associated with IDU involving methamphetamine, and in pregnant women and women of childbearing age (SWVA Today, 2017). It should be noted, however, that the Centers for Disease Control and Prevention (CDC) specifically states that the transmission of HCV via sexual activity is “not common” (CDC, 2015). The virus is inefficiently transmitted in this manner, and while it is possible in the manner Dr. Bissell describes, much of the data provided during screening is self-reported by patients – self-reporting may lead patients to purposely omit or skew their answers in an effort to avoid embarrassment or mask other behavioral risk factors.

The rural areas along the NRV are very likely to be hit with a greater explosion of HCV and HIV, and HEAL Blog will be monitoring the situation in the coming months.

References:

__________

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.

Leave a comment

Filed under Uncategorized

Generational Stigmata and HCV

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

When it comes to Hepatitis C (HCV), people in America have long assumed that it was (and is) a Baby Boomer problem. Recent statistics, however, indicate that a rapidly increasing number of new HCV diagnoses are linked to Injection Drug Use (IDU), and that IDUs will likely lead to an exponential explosion of new infections compared to previous years. With that reporting, however, a stigma has arisen amongst the Baby Boomer population (the Birth Cohort), leading some in the cohort to avoid screening for the disease. Research published in March 2016 (Joy, 2016), however, indicates that HCV infections within the Birth Cohort is much more likely to have arisen from unsafe medical practices on behalf of doctors and hospitals, rather than any lifestyle choices made on the part of patients.

The research, published in The Lancet Infectious Diseases journal, was conducted by scouring over 45,000 documents and records, examining 45,316 sequences of HCV Genotype 1a – the most common strain – and then used a technique called “phylogentic analysis” to focus on five HCV genes and trace the dynamics of the HCV epidemic. The results suggest that the initial peak of the HCV epidemic – the time when initial infection and introduction of the disease in the Birth Cohort – occurred between 1948 and 1963, far earlier than many had suggested.

These infections are most likely related to the techniques and equipment that medical professionals used in the post-World War II (WWII) era, prior to the establishment of safer technologies, equipment, blood screening, and techniques that came about in the wake of the initial HIV crisis of the 1980s and 1990s. Strict blood screening techniques were not, in fact, common place until the U.S. government mandated the practice in 1992. As such, anyone who received a blood transfusion or underwent invasive medical procedures prior to that year may have been exposed to HCV, and should be screened for the virus.

Stigmata are nothing new, however, for the Birth Cohort. This is a group who helped to push the sexual revolution and drug use of the 1960s and 70s, and began having children in the 1980s. During this time, reports of sexually transmitted diseases and viruses, as well as transmission via IDU, began gaining more media exposure, both of which gained a level of ignominy in the 1980s in relation to HIV. We must remember that many media reports indicated that HIV only impacted those in the “4 ‘H’ Club” – Heroin users, Hookers, Haitians, and Homosexuals. When this type of branding in the media and in government conversations occurs, stigmata arise that leads to people avoiding testing and treatment.

Since that time, however, infectious diseases have undergone something of facelift, with multi-million-dollar ad campaigns and outreach programs on the part of pharmaceutical companies and governments trying to spread the word about getting tested. These efforts are part of a concerted effort to reduce the stigma associated with chronic illnesses and infectious diseases that are both costly to treat and incredibly harmful to those living with them if they go untreated.

For the Birth Cohort, however, to feel as if they should be lumped in with what many view as an unsavory crowd simply goes counter to the reality of the epidemic. Screening for HCV isn’t just something that applies to those who practice risky behavioral patterns; rather, it should be something that is routine within the Birth Cohort, so that they can cure HCV and live their waning years without the concern of HCV-related illnesses and co-morbidities.

References:

  • Joy, J., McCloskey, R., Nguyen, T., Liang, R., Khudyakov, Y., & Olmstead, A., et al. (2016, March 30). The spread of hepatitis C virus genotype 1a in North America: a retrospective phylogenetic study. The Lancet Infectious Diseases16(6), 698-702. doi:10.1016/s1473-3099(16)00124-9. Retrieved from: http://dx.doi.org/10.1016/S1473-3099(16)00124-9

__________

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.

Leave a comment

Filed under Uncategorized

What is WAC and is it Outdated?

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

Every time we mention Hepatitis C (HCV) drugs, we talk about price; specifically, we speak about “Wholesale Acquisition Costs” (WACs), and how that company-designated measure sets the baseline for pricing throughout the healthcare landscape. But, the reality of pharmaceutical pricing is far messier than just the WAC cost. In response to last week’s HEAL Blog entry regarding HCV drugs and Medicare, one quite savvy worker within the public healthcare arena rightly noted that “nobody really pays that price,” which brings up a couple of equally (if not more important) questions: (1.) If nobody pays that price, why is it even used; and (2.) Why does no one actually pay those prices?

A WAC “…is, with respect to a pharmaceutical or biological, the manufacturer’s list price for the pharmaceutical or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of pharmaceutical or biological pricing data (PharmaLink, n.d.).” That definition is pretty loaded, because it really spells out the ingredients (and the problems) in the drug pricing sausage that is so frustrating to advocates and patients, alike. What one program, insurer, or individual pays for drugs may or may not be the same price paid by another, and that makes determining the actual cost of drugs problematic.

Flow chart demonstrating the confusing nature of the Wholesale Acquisition Costs

Photo Source: National Academy of Sciences

Pharmaceutical companies like to bandy about the phrase, “What the market will bear,” in relation to how they price their products, which isn’t really a fair statement, because they essentially have a captive market. They know that the products they manufacture are going to be purchased by government healthcare programs like Medicare, Medicaid, Ryan White Part B, and the Veterans Affairs (V.A.), and that those programs are essentially (and sometimes literally) required to provide their products to their clients. Outside of the U.S., in more civilized First World healthcare climes, private insurers are essentially nonexistent, as Universal Healthcare Coverage is the norm, and they can set the price they’re willing to pay, manufacturer be damned. So, “what the market will bear” really ends up meaning, “How much we can get U.S. government programs to pay without kicking up too much of a fuss.”

When the aforementioned reader says that we know it to be the case that “nobody really pays that price,” he’s 100% correct. Medicare programs are Federally-funded, state-administered programs, meaning that all fifty states, the District of Columbia, and the territories all have the ability to individually negotiate directly with manufacturers to get drug rebates and discounted prices, meaning that each individual program may pay entirely different prices, and those prices are not public information, due to existing Trade Secrets laws that prevent that data from being released from official sources. The V.A. automatically gets the “best price,” meaning that they’ll ostensibly pay the lowest price, so they’re not really in the equation. Medicare Part D, however, is a different kettle of fish, because it is essentially a market of private insurers who are reimbursed through the national Medicare program for their expenditures, and price negotiations are, for better or worse, left up to those private insurers’ employees. According to research, while having more insurers on the Part D marketplace lowers costs to consumers, the Medicaid approach of state employees doing the negotiating actually works out to be cheaper than those “Free Market” solutions.

Because the WAC is a baseline measure against which all discounts and rebate agreements are measured, it makes determining the actual end price of drugs very difficult to determine publicly, and frankly, it’s a terrible model for the U.S. to continue participating in if programs are expected to exist in perpetuity. At some point, “what the market will bear” will become “What tuned-in Americans are willing to tolerate.”

References:

__________

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.

Leave a comment

Filed under Uncategorized