Tag Archives: Hepatitis C

“Cruel and Unusual” Neglect in Prisons

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

HEAL Blog has long been banging the drum of patient healthcare access in incarcerated populations. Under Estelle v. Gamble (1976), the U.S. Supreme Court found that denying medical treatment is unconstitutional under the 8th Amendment’s “cruel and unusual punishment” clause, and established the criteria under which prisoners must file suit – “deliberate indifferent.” This essentially means that, if a patient needs medical attention, this cannot be denied, and that, if medical staff deems treatment necessary and orders it, that order must be honored, and that treatment order cannot be countermanded. Additionally, neither security staff, nor internal bureaucracies can hinder said treatment order in any way, and treatment decisions must be made based on medical need, rather than on convenience or the needs for security (Schoenly, n.d.). Estelle v. Gamble basically made inmates the only Americans for whom healthcare is a Constitutional right.

Gavel next to stethoscope

Photo Source: CorrectionalNurse.net

This argument has been successfully made as it relates to HIV, and more recently Hepatitis C (HCV), as numerous courts have ruled in favor of plaintiffs for whom HCV treatment has been denied. Courts have repeatedly rule that, regardless of the costs associated with treatment, prisons are required by the Constitution to provide Direct-Acting Antiviral (DAA) HCV drugs to inmates. Unfortunately for the states, this has the potential to explode correctional pharmacy budgets – a valid concern that, nonetheless, runs counter to case law. In order to avoid having to pay for treatment, many prisons actively avoid the Federally mandated HIV/HCV screenings required in Federal prisons by making state-level inmate screening “on request.”

When conducting research on state screening requirements, an official from the Kentucky Department of Corrections (KDOC) informed me that the state does NOT require inmates to be screened for either HIV or HCV during the intake process or on a regular basis. This is troubling, as Kentucky has the 3rd highest rate of HCV in the U.S. – 2.7 per 100,000 (Centers for Disease Control and Prevention, 2017). Kentucky also has the 10th highest rate of Opioid Overdose Deaths, having seen a 12% increase to a rate of 23.6 per 100,000 in 2016 (Kaiser Family Foundation, 2017).

Many, if not most, of those opioid drug-related death are a result of Injection Drug Use (IDU), the leading cause of new HCV infections in the U.S. With the high rate of arrest for illicit prescription opioid and heroin IDU comes a marked increase in the number of inmates living with HIV and HCV acquired via IDU. Incarceration settings are, perhaps, the best location for the U.S. to begin actively eradicating the HCV epidemic, but cost concerns make that an unlikely occurrence. Further complicating the issue is that prisons, jails, and youth correctional facilities do not have the same price bargaining powers enjoyed by Medicaid, Ryan White (AIDS Drug Assistance Programs – ADAP), and private insurers, meaning that prisons often pay the highest prices for HCV DAAs and other prescription drugs. This must change, if the U.S. hopes to adequately approach eradicating HCV.

Next week, HEAL Blog will take a look at some recent HCV-related issues in the U.S. correctional system.

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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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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Are Hepatitis C “intentional exposure” Criminalization Laws on the Horizon?

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

One of my favorite things about growing up in the 1980s/90s was hearing all about how “…this guy spit on someone, and it turned out…he had HIV.”

Inevitably, the “guy” they were talking about was supposedly arrested and charged with a felony for trying to infect someone with AIDS, and everyone would gasp in horror – how DARE someone try to spread AIDS by spitting on an innocent bystander?! If I happened to be in or around the group talking about this, I would always (not so calmly) explain to them that it is a scientific improbability that one could transmit the HIV virus by way of spit, because the concentration of the virus in spit is so low that there is almost a 0% chance that it can be transmitted outside of incredibly extreme circumstances and a concerted effort. Mind you, this was back in the late-80s/early-90s, when the AIDS panic was still in full swing. Even THEN, I wasn’t stupid enough to believe this kind of nonsense.

States that criminalize biting, spitting, or throwing of bodily fluids by people who have HIV

Little did I know, at the time, that these kinds of arrests were an actual thing. In 2017, there were 16 states that criminalize spitting, biting, and blood exposure for HIV-infected citizens (The Center for HIV Law & Policy, 2017).

I mean…

It’s 2018. These laws aren’t even based on good science!

So, because everything is awful, and America is totally known for basing their laws on good data and research, of course these fatuous laws would be extended to Hepatitis C (HCV) – one of the least effectively externally transmitted viruses.

Photo of a 27-year old man with Hepatitis C charged with spitting at Cleveland police officers.In Cleveland, OH, for example, a 27-year-old man who was drunk has been charged with First Degree Felonious Assault…for spitting on a police officer. He’s being held on $75,000 bond in the Cuyahoga County Jail, because he was drunk and spat in a police officer’s face while being put into an ambulance (Jankowski, 2018). Matthew Wenzler, the accused, has been called a “carrier” of HCV, and Cleveland Police reports state that they were “told” he is a “heroin addict.”

This isn’t even the first time Ohio has prosecuted someone for Spitting While HCV – in both State v. Price (2005) and State v. Bailey (1992), Ohio courts have upheld convictions for assault for spitting in an officer’s mouth. The neighboring state, Indiana, classifies Spitting While HCV as Class 5 or 6 felony battery…but only:

…if the accused in a rude, angry, or insolent manner places bodily fluid/waste on another person AND knew or recklessly failed to know that his or her bodily waste or fluid was infected with hepatitis [for Class 6].

…if the accused in a rude, angry, or insolent manner places bodily fluid/waste on another person AND knew or recklessly failed to know that his or her bodily waste or fluid was infected with hepatitis AND places the bodily fluid/waste on a public safety official [for Class 5] (Paukstis, 2017).

In South Dakota, a (Republican) state lawmaker has introduced legislation to make the transmission of HCV a Class 3 Felony punishable by up to 15 years in a state penitentiary and a $30,000 fine (Mercer, 2018). What makes this trouble is that this legislation is for “intentional exposure” which applies to “…transferring, donating or providing blood, tissue, organs or other infectious body parts or fluids” (Mercer). For anyone who’s paid attention over the past two years, the transplantation of HCV-infected organs has been repeatedly done, because there is now a functional cure for the disease. These organs are desperately needed at a time when the disease can be cured, and this legislation would making numerous people criminally liable for completing these procedures – the donor and anyone who approved or performed the transplant.

It should go without saying that criminalization of Viral Hepatitis (of any variety) and HIV is based not on good data or science, but upon efforts to shame and stigmatize those with the disease. It’s time for this nonsense to stop.

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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Appalachia’s Opioid Addiction Continues Wreaking Health Havoc

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 Northern Kentucky Health Department (NKHD) has reported a 48% increase in new HIV infections in the region in 2017, with 37 new cases compared to 25 in 2016. In 18 of those 37 cases (48.6%), Injection Drug Use (IDU) was listed as a primary risk factor, compared to just 5 of the 25 cases in 2016 (20%). Further analysis of these data show that the IDU-related new infections were concentrated in just two of the region’s four counties – Campbell and Kenton (Northern Kentucky Health Department, 2018).

Whenever a jump in new HIV infections occurs in Appalachia, I say to myself, “THIS! THIS will be our teachable moment! THIS will be the one that forces [state] to take action!” And, a lot of the time, I’m partially correct. The most common refrain I hear when asking state and local healthcare officials about potential HIV outbreaks is, “We don’t want this to be another Scott County, Indiana.”

Sihe HIV outbreak in Scott County, IN in 2015 (Hopkins, 2017) that saw the county’s number of new HIV infections jump from 5 per year to 216 in two years, states all across American and even the Federal government began taking actions to prevent a similar outbreak. In 2016, Congress partially lifted the ban on Federal funding for Syringe Services Programs (SSPs) – a move once thought virtually impossible given the political climate (All Things Considered, 2016). The Scott County outbreak served as a cautionary tale in state run by Conservatives – “It’s time to get with the times.”

Two hands, with one hold a needle

Photo Source: TheBody.com

Of the 18 IDU-related HIV infections, 78% were co-infected with Hepatitis C (Monks, 2018). Increases in new cases of Hepatitis C (HCV) are often the “canary in the coal mine) that leads healthcare professionals to begin more rigorous screening for HIV, particularly in areas of the country where the incidences of prescription opioid and/or heroin abuse are particularly rampant. Unlike the heroin epidemic of the 1970s, the new opioid epidemic of the modern millennium is set in rural and suburban areas of the country. Of the 220 counties identified by the Centers for Disease Control and Prevention (CDC) as being vulnerable to HIV or HCV outbreaks, 56% are in Kentucky, Tennessee, and West Virginia – the states that rank in the top four rates of Hepatitis B and HCV infections in the U.S. (Whalen & Campo-Flores, 2018).

Across the Ohio River from the Northern Kentucky Independent District, in Cincinnati, the city saw a 40% increase in new HIV infections over 2016, with a total of 129 new infections, 28 of which (22%) were IDU-related (Whalen & Campo-Flores).

HEAL Blog will continue to monitor the situation in Northern Kentucky. After all, nobody wants to be the next Scott County, Indiana

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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Advances and Risks for Hepatitis C 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

As our understanding of the Hepatitis C Virus (HCV) increases, we learn more about how the virus affects our bodies and well as develop better diagnostic and treatment tools to screen for and mitigate the comorbidities that arise from untreated HCV. New technologies can be used to test liver fibrosis without invasive biopsy tools – which remain the most effective way to measure liver damage and scarring (fibrosis) – with a high degree of accuracy…under certain conditions. Additionally, further research has indicated that, in addition to the deleterious effects of HCV on the liver, when left untreated, HCV can result in Chronic Kidney Disease (CKD).

Virtual Touch image of the kidney

Photo Source: Siemens

Virtual Touch™ Quantification (VTQ – Siemens) is a noninvasive diagnostic procedure that allows patients to undergo various types of tissue analyses without the need for surgery or biopsies using Acoustic Radiation Force Impulse (ARFI) – a sonographic technique that determines the local mechanical properties of tissue (a fancy way of saying “stiffness”). Essentially, much like an ultrasound during pregnancy, ARFI and VTQ uses a conventional ultrasound probe during abdominal ultrasonography to measure the stiffness of the liver. This is especially effective in patients with ascites – an accumulation of protein-containing (ascitic) fluid within the abdomen – an advancement over the Fibroscan (Transient Elastography – Echosens) which cannot (Bennett, 2018).

The research (Tsukano, et al., 2017) also indicates that skin liver capsule distance (SCD) – the distance between the skin and the liver capsule – corresponded highly with any discrepancies between VTQ and liver biopsy analyses. Patients with a long SCD may receive less accurate results using VTQ. Steatosis, hepatic inflammation, and hepatocyte ballooning have little effect on ARFI measurement failures (Bennett).

Chronic Kidney Disease stages

Photo Source: Sunlight Pharmacy

Another study (Park, et al., 2017) discovered that patients with HCV are at higher risk of developing CKD. The research found that Chronic HCV is associated with extrahepatic manifestations – problems that occur outside the liver, some of which are associated with the immune system, and others seem to be driven by chronic inflammation – with CKD being the most commonly reported extrahepatic condition. Untreated Chronic HCV leads to a 27% increase for developing CKD, while treating the disease using Interferon-based dual, triple, and all-oral Direct Acting Antivirals (DAAs) had a 30% reduction in risk for developing CKD. The researchers indicated that they were “disturbed” to find that 79% of patients with Chronic HCV did not receive treatment (van Paridon, 2018). The increased risk of CKD was more significant in patients age 18-49, compared to adults aged 60≥.

While more research is needed, this should serve as a caution to payors and legislators who have been reluctant to approve treatment methods for HCV patients due to associated short-term expenditures.

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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2017 Year in Review

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

As it tradition for HEAL Blog, the final post for 2017 will be a look back at the topics we’ve covered over the year and a look forward to the future.

2017 Year End, Turning into 2018

Photo Source: AGH University

HEAL Blog releases 50 posts a year (including this post), and those posts fell within one of five categories: Hepatitis Increases, Incarceration, HCV Drug Discussions, Opioids, and Other. Posts related to Hepatitis Increases focused primarily on reports of increased infection/morbidity rates in various states and population, including Hepatitis A, B, and C. Those related to Incarceration focused primarily on increased infection rates and treatment within incarceration settings (prisons, jail, and juvenile detention centers). Posts related to HCV Drug Discussions focused on pricing, availability, and treatment outcomes. Opioid-related posts focused on the toll of the opioid epidemic in the U.S. and the role they play in increasing rates of infection for HIV and Viral Hepatitis (VH). Posts that fell outside of those specific topics are categorized as “Other.” The distribution of those posts are as follows.

  • Hepatitis Increases – 17
  • Incarceration – 4
  • HCV Drug Discussions – 15
  • Opioids – 9
  • Other – 4

As the incidence of Viral Hepatitis infections continues to rise, there are specific patterns – most of the highest rates exists in states that are primarily rural or suburban (with few densely populated metropolitan areas); new Acute Hepatitis C (HCV) diagnoses tend to be in younger populations (ages 18-45) and are increasingly linked to Injection Drug Use (IDU) as the primary risk factor for infection within this age demographic. Prescription opioid abuse and heroin are playing an increasing role in the spread of HCV, not only in America, but across the globe. In the U.S., many of the rural states where HCV rates are exploding are racially and ethnically homogenous (read: primarily Caucasian/White). Despite this, even in states with low numbers of racial and ethnic minorities, African-Americans are disproportionately impacted by HCV infections as a percentage of the population – despite being fewer in number, the percentage of African-Americans infected is higher than other racial and ethnic groups.

In addition to HCV-related infection increases, homeless and indigent populations are facing vast increases in Hepatitis A (HAV) infections, particularly in metropolitan areas where homeless encampments are more densely packed and infections are more easily spread. Arizona, California, and Minnesota have all experienced high rates of HAV within their respective homeless populations, with California facing the highest rates of both morbidity and mortality. California’s HAV crisis is also quickly spreading along the coastline, heading northward. HEAL Blog will continue to monitor the situation.

As for the forecast into 2018…it’s not looking good for the U.S. With the installation of the Trump Administration’s various secretaries and their approach to management and governance, both healthcare advocates and institutional healthcare presences are considerably concerned with the path being laid before us. In addition to concerns about the appointments being made by the Trump Administration (of which there are many concerns, and far fewer appointments), the Legislative Branch’s stewardship under Republican majority in both houses has proven both hostile to the healthcare concerns of Americans, and incredibly clumsy in their attempts to address virtually any issue put before them. Both the Executive and Legislative Branches have inspired little confidence that anyone – healthy or otherwise – are going to come away from their agendas unscathed.

Both branches have, in 2017, created an environment of legislative and administrational chaos and uncertainty, both of which are reflected in the higher increases in health insurance premiums offers on the Affordable Care Act’s (ACA) insurance marketplaces. Between shortened enrollment periods and all-but-eliminated advertising and outreach budgets, enrollment is expected to fall short of its goals for insuring Americans in 2018. Moreover, this type of chaos, unreliability, and unpredictability tend to breed contempt, which may result in Republicans losing their majority in one or both houses during the 2018 midterm elections.

Of significant concern is the Republican Senate’s approach to bill crafting, which has largely been conducted in secret, without input from Democratic lawmakers, and is heavily influenced by the very special interest groups against which many of these politicians campaigned. After failing twice to repeal the ACA in 2017 despite having a majority in both houses, Senate Republicans have repeatedly attempted to cripple the law through various means, the most recent of which involved slipping into their “Tax Reform” bill an effort to repeal the individual mandate provision that requires virtually every American to purchase some sort of qualifying health insurance plan in an effort to stabilize costs once sicker clients entered the market.

In the Administrative Branch, the heads of the various Departments nominated by President Trump have done little to inspire confidence, as well. Tom Price, who was Trump’s initial pick for the Department of Health and Human Services, was forced to resign after reports indicated that he racked up $400,000 in privately chartered flights for personal and professional reasons. This was a significant departure, as previous heads took commercial flights, save for rare exceptions. Now that Price is out of the way, Trump has nominated Alex Azar, a former pharmaceutical company executive whose tenure at Eli Lilly saw a three-fold increase in the cost of the insulin over a ten-year period. Needless to say, it is less than certain that a person who oversaw such price increases will be the “…star for better healthcare and lower drug prices,” as President Trump stated in his tweet announcing his pick for the position.

Given the chaotic and unsteady stewardship of the country, it is hard to express any optimism going forward unless circumstances change dramatically.

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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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Colorado Takes Big Step Towards Eradicating 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

The state of Colorado took the enormous first step towards eradicating Hepatitis C (HCV) in the U.S. by lifting HCV treatment requirements for citizens who receive health benefits from the state’s Medicaid program. The move comes after the American Civil Liberties Union (ACLU) of Colorado filed a class-action lawsuit against the state for continuing to ration HCV care for Medicaid patients, and after health officials in the state asked for those restrictions to be removed (Brown, 2017).

ACLU logo

Photo Source: ACLU

The ACLU has been instrumental in winning treatment for patients living with HCV in the country’s incarcerated populations, filing suits against several states’ Departments of Corrections for failing to adequately supply HCV treatment to inmates whose HCV status is known. Inmates are the only Americans who are guaranteed healthcare coverage under the Constitution after a 1976 Supreme Court ruling found that “deliberate indifference” to an inmate’s medical needs constitution “cruel and unusual punishment” under the 8th Amendment (Estelle v. Gamble, 1976).

In both incarceration settings and state Medicaid programs, various hurdles have been put in place that require patients to do extra legwork to gain access to treatment that the programs must offer in order to save money on what were extremely expensive revolutionary HCV Direct Acting Antivirals (DAAs) that effectively cure patients of HCV. The most expensive of these medications, Harvoni (Gilead), has a Wholesale Acquisition Cost (WAC) of $94,500 ($1,125 per pill) for 12 weeks of treatment – the standard regimen length used to achieve Sustained Virologic Response (SVR – “cure”). Since Harvoni’s 2014 release, several new DAAs have come on the market, and after much outcry from patients, advocates, and the U.S. Congress, prices have been driven down. The most recent DAA therapies – Vosevi (Gilead) and Mavyret (AbbVie) – entered the market at $74,760 ($890 per pill for 12 weeks) and $26,400 ($471.42 per pill for 8 weeks) respectively.

Mavyret, AbbVie’s most recent HCV therapy, has the potential to be a financial game changer for state-run healthcare programs that have struggled to ensure that patients receive the treatment they need while not simultaneously destroying their pharmacy budgets to pay for it. That said, WAC costs serve only as a baseline price for any drug that enters the market, after which the various programs and insurers (payors) begin a negotiation process with the drug manufacturers to determine the final cost paid after rebates, pricing agreements, and deductions. The conventional wisdom is, “Well, nobody pays the WAC price.” Unfortunately, these final prices are not readily available to the public, as they fall under existing Trade Secrets laws that prevent the programs from publicly stating the final cost they pay for the drugs.

AbbVie's Mavyret medication

Photo Source: AbbVie

State Medicaid programs have been under considerable fire from HCV advocates, as well as the Department of Health and Human Services (DHHS), who have long stated that Medicaid programs should remove barriers to treatment that have included fibrosis score requirements (“Is the patient’s liver damaged badly enough?”) and abstinence from drugs or alcohol. Colorado’s removal of these barrier to care is a phenomenal first step that should be followed by other state Medicaid programs.

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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