Monthly Archives: February 2016

Litigation and Legislation May Force Lower Prices

By: Marcus J. Hopkins, Blogger

The past three years have brought many great tidings for those living with Hepatitis C (HCV): a total of seven new HCV-specific Direct Acting Agent (DAA) regimens have been released onto the market, all of which are far more easily tolerated than the ribavirin and Pegylated interferon-based treatments, and all of which sport Sustained Virologic Response (SVR) rates of above 90% in most HCV patients. We’re now looking at the release of at least one more drug from Gilead, this year, that will be pan-genotypic – it can be used in the treatment of any genotype of HCV – as well as the possibility of injectable treatments that can be used on a regular basis, and reduce reliance upon pills.

Image of a stethoscope wrapped around a $20 bill , laying next to an open medication bottle

Affordable Healthcare

But, the reality is that these medical and technological breakthroughs cost money. Lots of money, really; and there seems to be no one willing to accept responsibility for their part in creating a market where a Wholesale Acquisition Cost (WAC) – the “baseline” for a drug’s price, before discounts and rebates – of $54,000 for twelve weeks of treatment is seen as a welcome reprieve.

Since Sovaldi (Gilead) and Olysio (Janssen) hit the market in 2013, virtually every payer and patient in the medical field has had a beef with the cost of the medications. Public and private payers, both, have essentially gone out of their way to restrict access to these medications to only the sickest of the sick, creating moral and legal arguments that may force those payers to pony up, regardless of whether or not they can “afford” the price.

On the legislative front, both California and Ohio are considering similar pieces of legislation that would require all state-run health agencies to purchase drugs at the lowest price paid by the Veteran’s Affairs (VA), which would mean that the “private” contract between manufacturers and the VA would have to become transparent. This could be either a boon or a bust, as VA prices may not be the cheapest of all the prices being paid, or in some cases, could be significantly less than one agency is paying for treating a large swath of people. Essentially, all public payers would have to pay the same price, whether or not the pharmaceutical company likes it, which could mean both a decrease in profits for them, as well as either an increase or decrease in spending for the payers.

These legislative efforts, both of which are sponsored by the AIDS Healthcare Foundation (AHF), are essentially an effort to force pharmaceutical companies to show their hand on pricing. If they’re giving a significantly lower price to one agency over another, they risk their ability to haggle for higher payments from other agencies. It’s an attempt to essentially level the playing field, and to do away with the “trade secret” nonsense that prevents publicly-funded agencies from openly discussing and publishing the exact details of these agreements.

On the litigation front, two new class action lawsuits have been filed in Washington state, aimed at forcing both private and public payers to provide HCV drugs to patients, regardless of the prices set by the manufacturers. Since Sovaldi and Olysio hit the market in 2013, payers have consistently been accused of establishing and maintaining overly and intrusively strict pre-requisites before providing HCV drugs to patients. The restrictions became so rampant that Gilead effectively severed access to its once very generous Support Path Patient Assistance Program (PAP) in response to private and public insurers refusing to pay for the drugs (despite having reached a pricing agreement with Gilead), and instructing patients to “…just go get it for free from Gilead.”

Private insurers have never been the bastion of ethical business practices; it has long been conventional wisdom that insurance companies will do their best to refuse coverage, just to save a buck, all while jacking up premiums, deductibles, and out-of-pocket costs in the process. It, therefore, comes as no surprise that they would refuse to pay for drugs.

State Medicaid programs face a particularly tough road in this legal battle, as the Centers for Medicare and Medicaid Services (CMS) issued guidance in November 2015 specifically stating that Federal law requires them to provide these drugs regardless of the price. This came after several complaints were filed stating the state Medicaid programs were violating the law by refusing to provide access to these medications on the basis of cost, alone. Arizona’s Medicaid program has reportedly stated that they will not be complying with the CMS guidance. While Washington state’s Medicaid program, Apple Care, has not released any similar responses, it’s not unlikely that they are simply refusing (or unable) to act on it.

The reality is that the high cost of these medications honestly restricts payers from providing access to these medications. In the case of Washington state, were the program to cover treatment for every Medicaid patient with HCV, the cost is estimated to be triple the total pharmacy budget for Fiscal Year 2016 ($1 billion). So, while covering the cost of treatment for everyone is the goal, that goal may simply be unfeasible if current pricing structures remain the same.
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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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Managing Drug Interactions

By: Marcus J. Hopkins, Blogger

For a while, now, HEAL Blog entries have focused on either the HIV-related, or the HCV-related treatment experience. While both perspectives play vital roles in the discussion of treatment options, focusing solely on one to the exclusion of the other leaves out a complicated truth: not every HCV treatment option is going to interact well with existing HIV regimens.

In writing this, I’m going to do my best to make certain that the data is presented in a way that is, if not “easy” to understand, at least doesn’t make any non-medical professionals want to beat me up, should they encounter me in a dark alley. Any time there’s a discussion involving medications, it’s very difficult to walk the line between detailed analysis and “palatability” – can anyone, regardless of their level of education, understand what is being said.

This becomes more difficult because recommendations are made using the chemical compound names, rather than the brand names (i.e. – “paritaprevir, ritonavir, ombitasvir, plus dasabuvir” vs. Viekira Pak). Using the chemical compounds reduces confusions when these discussions are had in other parts of the world, where drugs may have different brand names or have licensed generic options (unlike the U.S.). While that’s fantastic for medical professionals, it often leaves laypeople looking at a report as if it’s written in Latin…and, sometimes, parts of it may be.

Additionally, any discussions of medication will naturally involve oftentimes complicated processes for how those medications are (or are not) metabolized and/or absorbed into the body. These processes can also lead to great confusion amongst laypeople, largely because the average person isn’t familiar with the various enzymes, proteins, inhibitors, or types of drugs and how they involve the body. Further to that point, explaining these complex processes in ways that are easy to understand can leave out some nuance in the discussion, which may leave patients feeling like they’re not “getting the whole truth.” I have found this to be the case, particularly within populations and regions where mistrust of the government and medical professionals runs high (e.g. – Appalachia).

Essentially, the biggest concern for patients co-infected with HIV and HCV is one of drug interactions. In 2016, there are myriad treatment options for HIV, but only seven new HCV regimens that easily tolerated on their own; this means that each of those seven new options has to be paired in trials with various types of HIV regimens to so how they react with the general population to determine whether or not the drugs will be more or less effective.

Photo of a pill box with the words, "Caution"

Photo Source: Doctor Tipster

What that breaks down to is that, when treating HCV in HIV-infection populations, in order for the HCV treatment to be effective, the HIV regimen may need to be changed. Rather than go through the numerous pros and cons, it’s easier for use to give a list of combinations not suggested:

  • Antiretroviral treatment (ART) interruption to allow HCV therapy is NOT recommended (i.e. – don’t stop treating HIV in lieu of treating HCV)
  • Harvoni (Gilead) should NOT be used with cobicistat when given with Viread (Gilead)
  • Sovaldi (Gilead) and Harvoni should NOT be used with Aptivus (Boehringer-Ingelheim)
  • Viekira Pak (AbbVie) should NOT be used with Prezista (Janssen), Sustiva (Bristol-Myers Squibb), Kaletra (AbbVie), or Edurant (Janssen)
  • Viekira Pak should NOT be used in HIV/HCV co-infection patients who are not currently taking ART
  • Ribaviren (to treat HCV) should NOT be used with Videx (BMS), Zerit (BMS), or Retrovir (GlaxoSmithKlein)
  • Olysio should NOT be used with cobicistat, Sustiva, Intelence (Janssen), Viramune (Boehringer-Ingelheim), or any HIV protease inhibitor (e.g. – Kaletra, Norvir, or Reyataz)

Aside from that list of “DO NOTs,” most of the newer, single-pill HIV regimens are relatively safe to use with the newer HCV regiments, provided that there are various dosing options for the latter. Ultimately, one should never substitute the word of a blog writer (or any other writer) over the recommendations of a trained physician. This list, however, should allow patients to get a better idea of what’s out there, and how to start seeking treatment.
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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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Can’t You Feel a Brand New Day?

By Marcus J. Hopkins, Blogger

Everybody rejoice!

On January 28th, 2016, the Food and Drug Administration (FDA) announced the approval of Merck’s new HCV drug, Zepatier (elbasvir and grazoprevir) at the introductory price of only $54,000 for a twelve-week treatment. That’s roughly a 42% discount to market leader Gilead’s $13 billion-a-year blockbuster, Harvoni, and a slightly smaller discount to AbbVie’s Viekira Pak (Nisen, 2016).

That’s right! For only just above the annual median income for an American in the U.S., you, too, can treat Hepatitis C!

Although it’s fantastic news that a pharmaceutical company has finally had the gumption to release a cheaper HCV drug to serve in direct competition with Gilead, AbbVie, and Bristol-Myers Squibb (BMS), it’s equally sad that twelve weeks of treatment can ostensibly cost more money than most Americans make in a single year. Essentially, while Gilead’s sticker shock is like being punched in the stomach, Merck’s price point is like being punched in the stomach while wearing a large pillow over your front.

Zepatier is seventh HCV-specific drug to come onto the market since 2013, which is virtually unheard of, in terms of treatment options. Outside of HIV, very few diseases receive this much attention in the way of research and development. It seems like a new drug or two is approved and released in the market every other quarter, or so, which creates the guise of competition in the pharmaceutical market. Still, a $54,000 price point serves as a dinner bell to other competitors that Merck is truly trying to undercut Gilead, AbbVie, and BMS, hoping that their significantly lower price (and virtually identical Sustained Virologic Response (SVR) with 95% success rate) will convince physicians and payers to push patients into their treatment regimen in lieu of the more established brands.

Photo of Zepatier medication pack.

So, will the other drug manufacturers tacitly agree to play ball with Merck in relation to their drug pricing? My gut instinct says, “Sadly, no.” On Gilead’s part, they have the home court advantage; Harvoni’s success rate is already well established in the medical field, and its low incidence of side effects and intolerability speaks highly in its favor. In their view, it’s unlikely the doctors will opt for Zepatier over their product, because it’s a known entity.

Even though Zepatier has an arguably as good and potentially better safety factor, patients need to undergo some testing to check for polymorphisms (genetic differences) with which Zepatier doesn’t work as a well. That’s a potential hurdle in an otherwise equal product.

Another pin in Gilead’s cap is that Zepatier has been approved only for treatment of HCV Genotypes 1 and 4; Gilead is gearing for yet another drug approval in the second or third quarter of 2016, and this new drug will be pan-genotypic – it can be used to treat all genotypes of HCV. What does that mean for consumers? An eighth treatment option, for certain, but there’s no guarantee that this new product will be any cheaper than Sovaldi and Harvoni. One really can’t blame Gilead for their high prices – the first horse out of the gate gets to set the pace, and for the most part, other competitors have followed their lead.

Issues of pricing are complicated. Honestly, the Wholesale Acquisition Cost (WAC), is essentially a useless metric, because manufacturers aren’t transparent in how they arrive at that price and they also regularly enter pricing agreements with payers. So, who, exactly, is paying the WAC? Some payers receive rebates and discounts up to 50% of the WAC, so what’s the point of even having a WAC, in the first place, if you’re going to make the price of the drug a sliding scale?

Good on Merck for deciding to enter the race at a much reduced price point. It remains to be seen, however, if they can break into an already crowded field.
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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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President Obama Proposes $1.1 Billion in New Funding for Prescription Opioid & Heroin Epidemic

By: Marcus J. Hopkins, Blogger

Last week, the Obama Administration announced that the President is proposing $1.1 billion in new funding to address the prescription opioid abuse and heroin use epidemic that is currently sweeping our nation’s rural and suburban areas. The funds are earmarked to spend $920 million to expand access to medication-assisted treatment efforts, $50 million in National Health Service Corps funding to expand access to substance use treatment providers, and $30 million to evaluate the effectiveness of medication-assisted treatment programs under real-world conditions.

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President Barack Obama and others listen to Charleston Police Chief Brent Webster, foreground, during an event at Charleston, W.Va., where Obama hosted a community discussion on prescription drug and heroin abuse, Oct. 21, 2015. Photo Source: VOA News

If I sound dismissive of this effort, it’s because there are some strings attached to this proposal that makes it yet another example of how little people understand the severity of the issue and the difficulties associated with trying to address it in a rural setting. The $920 million will be allocated to states based on the “…severity of the epidemic and on the strength of their strategy to respond to it.”

The last part of that is the kicker – really, How Do You Solve a Problem Like Maria? One of the most difficult barriers to overcome in the hard-hit Appalachian Mountain Region is one of access; there simply are too few places for people with any health condition to turn.

For the past few years, the state of West Virginia has been besieged by budgetary, economic, and employment woes. In a state where the per capita income is $22,966, it’s hardly surprising that financial issues abound. Those issues are further compounded by a dearth of private and public services available across the state. We have food deserts (areas where there are no grocers or markets providing fresh foods), healthcare deserts, utility deserts – if a map of all the available services were created of West Virginia, it would resemble an actual desert, replete with a handful of oases where these services are available.

Despite the state’s efforts to combat a nearly two-decade-long opioid abuse and heroin use epidemic in the state, the fact of the matter is that there just aren’t enough physical resources – literally, buildings in place – with the capacity to serve as treatment hubs. More troubling is a proposal by the current Republican legislature to combine county health departments into nine multi-county districts, essentially forcing residents from dozens of already underserved counties to have to travel even further to get to a single health department facility. The report suggests potential savings of $12.5 million or more to the state…but doesn’t bother to take into account issues of accessibility, affordability, or the impact that this would have on one of the least healthy states in the nation.

While additional funds are always appreciated, if past precedent is indicative of anything in West Virginia, it’s that Federally-allocated, but state-administered funds for state improvements rarely go very far in a state beset by geographic and economic hardships that have been allowed to go unaddressed for decades, intransigence and failure to adapt being the name of the game in the state. How is West Virginia – the state with the highest rate of opioid overdoses in the nation – supposed to compete for these funds when the state’s legislators are actively attempting to cut healthcare costs at the expense of healthcare access? If we are to receive funds based on the strength of our plans to confront this healthcare crisis, how will it look when, rather than expanding access, we are going about shrinking it?

This additional funding proposal has the potential to be a game changer…in states with legislatures who actively seek to expand access. To be honest, I am somewhat concerned by the caveat that these funds are designed to support medication-assisted treatment efforts. Even if they are effective in reducing dependency on opioid drugs, it seems ironic that addiction to one type of drug should be addressed by the use of another type of drug. Perhaps this proposal needs a bit more work, and a lot more focus on proven harm reduction efforts, such a accessible and legal syringe exchange programs, accessible treatment and rehabilitation centers, and more attention paid on the prescribing side of the issue.

Overall, I thank the President for his consideration, and welcome him to expand his thinking to include other types of treatment.
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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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Opioid Prescription Abuse – Data vs. Addiction

By: Marcus J. Hopkins, Blogger

Every so often, I get the opportunity to speak with the hospice nurses who provide care services for my grandfather, and when they discover the focus of my research, I consistently hear the same thing – we have a huge problem with opioid addiction, abuse, and heroin usage in the state of West Virginia. Because their jobs specifically focus on providing hospice care, they’re not too engaged with the HCV aspect of the issue, but they have horror stories about relatives, friends, and neighbors looting their patients’ supply of opioid prescription drugs (from OxyContin to morphine) and either using it themselves or selling it on the street. But, the consensus is the same – this opioid epidemic is way out of control, and there doesn’t seem to be anyone doing anything about it.

This aspect – the “doing something about…” – is, perhaps, the most contentious issue within the opioid abuse conversation: what’s going to work, what is working, and who’s going to pay for it. These questions plague not only the people on the ground dealing with the fallout from opioid abuse, but the legislators tasked with combating a burgeoning problem. Additional concerns are raised about how to best cope with the growing addiction to opioid drugs, and frankly, there are simply no easy or cheap solutions to the problem.

Photo of opioid prescription drugs and an IU needle spread across money.

Photo Source: ReinventingAging.org

Tensions are further increased when “no nonsense”-style elected officials in the vein of Maine’s Paul LePage go off the rails talking about drug pushers coming to impregnate their white girls and bringing back the guillotine to deal with them. While this type of fast and loose language plays well with a certain segment of [mostly conservative] constituents, it plays a harmful role in demonizing not the repercussions of drug abuse and addiction, but the people who are involved. This creates (and reinforces) a social stigma, which research suggests serves as an internal barrier to seeking addiction treatment.

Two of the most successful legislative harm reduction strategies are Prescription Drug Monitoring Programs (PDMPs) that collect, analyze, and monitor electronically transmitted prescribing and dispensing data and Doctor Shopping Laws that attempt to prevent patients from seeking multiple prescriptions from multiple physicians for controlled substances.

PDMPs are highly effective tools for monitoring the rate of prescriptions being issues by physicians, as well as for tracking which patients receive those medications. Unfortunately, many states with those laws do not make reporting to PDMPs mandatory, which leaves it up to the physicians and pharmacists in those states whether or not they will participate. If there is less than an optimal participation rate, the purpose of monitoring the issue is not being served.

Doctor Shopping Laws are designed to penalize patients who visit multiple doctors in order to increase their on-hand supply of controlled substances (most frequently, opioid drugs). They make it illegal for patients to procure or attempt to procure controlled substances by fraud, deceit, misrepresentation, or subterfuge, and the penalties for getting caught vary by state. But, again – these laws only work if physicians and pharmacists are participating.

Another interesting aspect in relation to those harm reduction methods is how those laws affect law abiding citizens. There are concerns that these laws create a hostile environment, in which physicians are less likely to prescribe medically necessary medications for fear of violating state law. This could potentially leave patients in the lurch when trying to obtain a prescription to for valid use as prescribed. Should those patients be unable to receive a prescription from one physician, they may run the risk of running afoul of doctor shopping laws if they go to another physician in seek of help. While these scenarios are, at this point, purely anecdotal, it raises a serious concern about access to necessary treatment methods.

Sadly, this is one of the prices we must potentially pay if we wish to legitimately attempt to conquer our nation’s issues with opioid addiction. The consequence of making these drugs more difficult to obtain is that people who legitimately need them face the same hurdles as those attempting to procure them illegally. Good policy is, however, made when there is data and research to back up the initiative, whereas bad policy is often made when we cave to arguments of Pathos – stories, inspirational quotes, and vivid, emotional appeals.
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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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