Monthly Archives: October 2016

Regimen Adherence and Abandonment

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 the biggest concerns for healthcare providers when treating a patient for any disease is regimen adherence – whether or not a patient will properly adhere to a prescribed treatment or therapy. For example, one of the most common problems with the prescription of antibiotics to treat infections is patients who abandon the regimen once they begin to “feel” better, regardless of whether or not the entire prescribed amount has been taken. Early abandonment of drugs meant to treat conditions can lead to the bacterium or virus mutating to form a resistance to the drug, making resurgences more difficult to treat. When it comes to treating chronic diseases, such as HIV and Hepatitis C (HCV), these concerns are especially important, as treating resistant strains of these viruses can be incredibly frustrating, and may leave patients with few good options, drugs with more negative side effects, and costlier therapies than those used with patients whose strains have fewer drug resistances.

Pill Box with hand putting pills in Thursday's box

Photo Source: The Good Doctor, by Medica

The reality, however, is that there are some patients who simply are not likely to adhere to medication regimens; people for whom, for whatever reason, being compliant and doing things on a consistent basis is simply not in their skillset. My maternal grandparents exhibited this kind of reluctance to scheduled medication times. Regardless of how many day/night, week/month, or even time-released pill dispensers I gave them, they were simply unable to perform the appropriate task at the appropriate time, and often ended up taking double or triple doses of certain medications, until they were receiving truly dangerous levels of prescription medications. It took my mother and I essentially taking over my grandfather’s medications and wresting control from my grandmother to ensure that he was getting the right pills at the right time, when he was in his final months.

But, is there a better way to ensure regimen adherence without essentially doing it for a patient? Clinical specialty pharmacists and nurses at Johns Hopkins Medicine have demonstrated that there may be. They use a triage method to boost adherence rates, as well as the odds of successful outcomes, particularly for HCV, called the “stoplight protocol.” Before any costly specialty drug is ordered, patients presenting to the specialty clinic with newly diagnosed HCV infection are evaluated using a standardized screening tool and tagged with a stoplight color – green, yellow, or red – that indicates how well they understand the medication’s benefits and side effects, as well as how likely they are to stick to the regimen throughout the entirely of the treatment.

The patients’ designation also dictates the programmatic monitoring of HCV patients and how frequently the receiving nursing or pharmacist follow-up. Patients in the red zone for whom treatment is deemed appropriate may be monitored weekly, via either clinic visits or by telephone, while patients in the green zone are monitored far less frequently. This tight monitoring of patients’ regimen adherence has led to a therapy abandonment rate of just 4.2% for their HCV patient population, a rate comparable to the 1% – 4.5% discontinuation rate reported for patients in closely monitored HCV drug trials. In contrast, a 2014 “real-world analysis” conducted by the CVS Health Research Institute showed an overall abandonment rate of 8.1% for patients who were taking Sovaldi.

This type of approach looks to be a winning formula in a healthcare arena where specialty drugs to treat HCV run from $54k to $94k, before pricing agreements and rebates, and may be a key component in the treatment cascade that convinces state, federal, and private payers to lessen the often stringent pre-requisites for receiving treatment, especially if the favorable rates of abandonment reported by Johns Hopkins can be replicated at the state level. Perhaps the greatest struggle payers face is determining whether or not spending so much money on a potentially unreliable patient will be worth their investment, and as harsh as that sounds, when each prescription fill costs tens-of-thousands of dollars, it’s a determination that must be looked at for the continued solvency of pharmacy budgets.
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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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Do Black Boxes Mean Red Ink for Drug Companies?

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 U.S. Food & Drug Administration (FDA) has recently concluded that new Direct Acting Agents (DAAs) to treat Hepatitis C (HCV) require a boxed warning for the drugs advising clinicians and physicians to screen patients for evidence of a past or current Hepatitis B (HBV) infection before undergoing treatment for HCV. This warning, indicated by black box on the labels of all nine current DAAs, has many investors worried that, along with consistent questions about the Wholesale Acquisition Costs (WACs) of newer HCV drugs, stock prices may face volatility in the coming years.

The new DAAs for HCV have been on the market for roughly three years, beginning with the release of Sovaldi (Gilead) and the companion drug, Olysio (Janssen), in 2013. Since that time, there has been a tremendous outcry from virtually every stakeholder involved in the issue of pricing, save for the pharmaceutical companies, themselves. Additional concerns have been raised that the modules used by companies to determine initial WAC prices is neither transparent, nor representative of the will of consumers. Arguments that pricing structures take into account “what the market will bear” have served as little comfort to advocacy groups, state agencies, and Congressional panels, all of whom are becoming less tolerant of high drug prices.

Drug prices for specialty products – those that are designed to treat very specific conditions – continue to rise at meteoric rates, and regardless of what drug companies believe the markets can bear, state and Federal budgets are largely unequipped to handle the short-term costs to treat HCV without quadrupling their annual budgets, so vast is the pool of infected patients. Beyond just the traditional patient pool, the growing HCV infection crisis in prison populations, which is largely ignored in state reporting and which faces vast issues in screening, prison budgets may soon face extreme funding issues if Federal lawsuits go against them, and require them to provide treatment to all inmates infected with the disease.

These new concerns raised by the FDA represent just the latest hurdle for pharmaceutical companies whose HCV fortunes may turn in the coming years. HBV, an as-yet incurable form of the illness, is much more easily transmittable through sexual intercourse, which may pose an additional risk for HIV/HCV co-infected patients whose HBV infection flares up as a result of using DAAs for HCV. Whether or not the reactivation of HBV in HCV treated patients is widespread is unknown, as the FDA has only identified 24 cases at the time of their ruling.
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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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Many State Prisoners Can’t Access Hepatitis C Therapies

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

Here, at HEAL Blog, we frequently speak about issues related to the cost of newer Direct Acting Agents (DAAs) to treat Hepatitis C (HCV). We’ve also covered issues related to HCV treatment in America’s prison system. Our verdict, then, as now, stands – the only U.S. citizens who are Constitutionally guaranteed healthcare are the least likely to receive treatment for HCV.

Image of the red cross behind bars

Photo Source: Solidarity Watch

A recent study published in Health Affairs confirms our observations from earlier this year: inmates who are infected with HCV are not receiving proper treatment, largely because the cost of medications puts the drugs far out of reach. For co-infected patients, the HCV is likelier to kill them, before the HIV ever will.

The finding that is most troubling is that, of the 106,266 inmates known to have HCV (reported by 41 states), only 949 inmates were receiving any form of HCV treatment by January 01, 2015 – 0.89% of reported inmates. This means that fewer than 1% of reported inmates are receiving their Constitutionally guaranteed treatment.

Another finding that’s equally appalling is that numerous state departments of corrections were receiving much smaller discounts than other state agencies. The US Senate Committee of Finance’s 2015 report on the pricing of Sovaldi and Harvoni noted that the Federal Bureau of Prisons, Department of Defense, and Department of Veterans Affairs receive at least a 24% discount on those drugs, Medicaid receives at least a 23% discount, and that the V.A. and Medicaid programs that accepted the conditions of offered rebates may receive more than a 50% discount. In contrast, ten of eighteen state departments of corrections received less than a 10% discount on Sovaldi as of September 30, 2015, with Michigan paying the full $84,000; five of nineteen states received less than a 10% discount on Harvoni.

While this study does not claim to claim to represent an estimate of HCV prevalence in US prison populations, it does admit that this limitation means that there is likely a far greater prevalence of HCV than the 106,266 inmates listed in the report. This has been suspected for some time, and was specifically alleged in a Tennessee inmate’s case against the state for withholding treatment from prisoner. A May 2016 report by the Tennessean also found that many prisons in the state simply do not test incoming prisoners, because doing so might result in a positive HCV result; admitting that the inmates have HCV would require them to treat the inmates.

While Gilead Sciences (makers of Sovaldi, Harvoni, and Epclusa) justifies the price of their medications by comparing the cost of one course of treatment to the cost of multi-year treatment costs for other diseases, state budgets are not made in such a way that accommodates that pricing philosophy, particularly if patients/inmates become re-infected. With prison budgets already strained beyond the breaking point to provide for the basic needs of their inmates, having them pay price much higher than those paid by either Medicaid or the V.A. is simply a recipe for disaster.
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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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Ohio’s Opioid Nightmare Continues

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

Yet again, Ohio’s drug users and first responders are being overwhelmed by heroin laced with a stronger opioid drugs. Seven fatal overdoses occurred in one day in Cleveland on Saturday, September 24 (Kaufman, 2016). The following Tuesday saw 27 heroin overdoses in a 24-hour period in Columbus, including two fatalities. One patient had been released from the hospital after being treated for an earlier overdose just thirty minutes prior to being picked up for a second overdose; there were two such overdose victims that first responders treated twice in the same day for being overdosed (Sullivan, 2016).

With the introduction of the powerful opioids, fentanyl and carfentanil, not only those who are addicted to prescription opioid drugs and heroin face increased risks; first responders, emergency personnel, and law enforcement officers also face increased risks of being sickened by exposure to these drugs during raids and rescue situations. So great are the risks to first responders and SWAT teams that the Drug Enforcement Agency (DEA) released a warning about the dangers of handling these powerful opioids without extreme caution (Jones, 2016).

All over the state of Ohio, first responders and crime labs are taxed to the breaking point responding to opioid and heroin overdoses. Jamie Landrum, a Cincinnati police officer, is quoted: “We were literally going from one heroin overdose, and then being on that one, and hearing someone come over [the radio] and say, ‘I have no more officers left,’” Landrum said. Three more people overdosed soon after that (Harper, 2016). At one overdose scene, a patient required at least four doses of Naloxone to be revived; after the fourth dose, he was still not responding.

Beyond the primary concerns of overdose is the reality that these drugs were never meant for use in humans, and therefore, has no human testing data from which to extrapolate even the most basic information: the lethal dose per kilogram of body weight, or how long carfentanil stays in someone’s system. This makes responding to overdoses more difficult.

Naloxone rescue kit

Photo Source: Yourblogondrugs.com

What this means for local, state, and Federal governments is more: more overdoses, more Naloxone, more time spent on each call, and ultimately more money in areas already strapped for resources. And while there’s great outcry for more resources, there seems to be little appetite for holding the pharmaceutical companies that produce these opioids financially liable for the havoc their products have wreaked upon the populace.

At this point, penalties and criminal charges have been largely reserved for prescribing physicians and individual pharmacists; holding anyone higher up the food chain responsible for the opioid epidemic has proven difficult, as the industry is very active in combating any efforts to either curb prescribing habits or to hold anyone in the industry accountable. What we really need are a few brave politicians who are willing to forego the promises of the industry that supports their reelection campaigns, and who will do what’s best for their constituents.
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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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