Monthly Archives: February 2018

Presidential Council Offers Uniquely American Take on Lowering Drug Prices

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

Within the office of the President exists the Council of Economic Advisors (CEA) – a group of three advisors who, due to their unique training and expertise, are deemed qualified to analyze and interpret economic developments and advise the President of matters within that scope. The council consists of a chairman and two additional members, only the first of which must be confirmed by the Senate. The CEA, this month, released a White Paper (a government or authoritative report giving information or proposals on an issue) related to the topic of reducing prescription drug prices, and I have to say, as a patient advocate and someone who is pretty knowledgeable about prescription drugs and pricing, their response is entirely American in its analysis.

When it comes to pharmaceutical and biopharmaceutical drugs, Americans pay the highest prices in the world. The CEA report says that’s because the U.S. is paying the “market price” for drugs. Other developed countries who have the dreaded “single-payer” healthcare disease of which Republicans and Libertarians are so derisive institute government controls on pricing, forcing the poor, defenseless pharmaceutical giants (whose profits are measured in the billions) to comply with those controls in order to gain access to the market. The solution, the paper concludes, is to reduce “free-riding” abroad.

Did you get that? The key to reducing drug prices for Americans is to force other countries’ citizens to pay more for their drugs. Yes – rather than look at the American model of healthcare delivery and pricing (which virtually any person who’s ever looked at an itemized bill can attest is completely jacked), the CEA instead all but openly states, “Well, those other countries are just doing it wrong! Those silly Socialists and their insistence that healthcare be affordable just don’t know what they’re missing!”

The paper, which can be found here, contains lots of uniquely American concepts: the “Free Market” should dictate drug prices; because the rest of the world doesn’t have a Free Market, drug prices are artificially high; Medicaid and Medicare should stop requiring “best prices” and rebate minimums; we need more Pharmacy Benefit Mangers (PBMs) to enhance competition; make innovation more attractive through incentives.

Report Cover for the "Reforming Biopharmaceutical Pricing at Home and Abroad"

Photo Source: The Council of Economic Advisors

These “solutions,” while certainly things that could reduce the cost of pharmaceutical products, rely almost entirely upon the cooperation of private companies whose main incentives are profits – profits that are already obscene. Moreover, Americans pay for 70% of patented biopharmaceutical profits, despite being only 34% of the Organization for Economic Co-Operations and Development (OECD) market. So, rather than look at our own system and say, “Jesus – we’ve got to follow the leads of these other, healthier countries,” the solutions provided by the CEA instead insist that we not only double-down on our Free Market Madness, but that we attempt to force smarter countries to comply with our lunacy.

Obviously, this is my take on the issue, which is informed by my experience as a healthcare consumer for life (thanks, AIDS) and as someone who has closely tracked pharmaceutical development and pricing for the past five years. While virtually every other developed nation in the world, and even developing nations, pay reasonable prices for pharmaceutical products, Americans get screwed, all in the name of the “Free Market.”

How is it that America went from the government developing some of the most effective vaccines and medicines in the entire world from the 1950s through the 1970s, and then, we just handed over the reins to private companies, while funding at least half of their R&D costs, only to have the drugs sold back to us at exponentially higher prices?

The answer isn’t that other countries are doing it wrong; it’s that we are idiots, when it comes to healthcare, and before long, we’re either going to be completely priced out of the market, or intelligent people will ditch our hackneyed healthcare system, and join the rest of the Modern World and go with Universal 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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Class Action Correctional Malpractice

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

Inmates in Oklahoma prisons must have advanced liver disease before they become eligible for treatment for Hepatitis C (HCV). This means that their livers must manifest significant scarring before they’re even allowed to receive the curative treatment that will prevent further damage (Botkin, 2018).

A class action lawsuit has been filed in the state of California alleging that doctors within the prison system have denied them treatment because their liver disease isn’t advanced enough, that their disease is too advanced, and/or the drugs are too expensive (Locke, 2018).

A class action lawsuit in Missouri alleges that only five out of thousands of Missouri inmates have received treatment for HCV, desite between 10-15% of the incarcerated population being infected with HCV (Margolies & Smith, 2017).

Idaho says that nearly 1/3 of its prisoners have HCV, and it needs $3M to treat them (Boone, 2018). An inmate diagnosed with HCV while in a Mississippi prison has filed a suit alleging they’ve refused him treatment on at least nine separate occasions (Wolfe, 2018).

Inmate looking out window with bars on it

Photo Source: thedenverchannel.com

Each of these instances is indicative of a few major points: (1.) We have a growing number of prisoners within our justice system who are infected with HCV; (2.) Prison systems and/or state Departments of Corrections (DOCs) are refusing or delaying treatment; (3.) This is unconstitutional.

In last week’s HEAL Blog (“Cruel and Unusual” Neglect in Prisons), we introduced the concept of “deliberate indifference,” a measure introduced by Estelle v. Gamble (1976). This week, there’s another take – does being literally unable to afford the cost of treating inmates qualify as deliberate indifference?

The answer to that question really depends on the judge who hears the case. In 2017, U.S. District Court Judge Mark Walker in Tallahassee, Florida ruled in favor of three inmates who filed a class action lawsuit against the state of Florida, requiring the state to treat a significant portion of its 98,000 inmates (total population; not HCV-infected population) for HCV (Klas, 2017). Similarly, in Pennsylvania, a U.S. District Court Judge Robert D. Mariani ruled in favor of Mumia Abu-Jamal, an inmate who gained notoriety for his shooting of an officer who had stopped his younger brother in a traffic stop (Mayberry, 2017). Both Federal judges found that prisons are required to provide treatment for HCV, regardless of the cost.

Make no mistake, however – these rulings are few and far between; the primary issue is that it’s difficult to prove “deliberate indifference” without detailed and voluminous documentation. Even then, the measure is specifically designed to be difficult to prove (as are all burdens of proof). And the primary reason why prisons refuse or delay treatment has little to do with indifference, so much as the cost. HCV Direct-Acting Antivirals are prohibitively expensive for regular consumers; prisons, however, have even less wiggle room, as they are largely unable to negotiate on drug prices.

Where we are, at the moment, seems to be a holding point: until the drugs to treat HCV get exponentially cheaper to purchase (right now, the least expensive 8-week treatment regimen – Mavyret (AbbVie) – goes for $26,400, roughly 1/3 the cost of the cheapest drug in 2013), prison systems are unlikely to make any substantive efforts to treat HCV-infected inmate. Moreover, until the Federal government requires states to both screen and treat inmates for infectious diseases, it’s likely that HCV will continue to spread among inmates and the general population.

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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“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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