Monthly Archives: March 2016

Syringe Exchange Strategies Produce Real World Results

By: Marcus J. Hopkins, Blogger

We face a growing epidemic of prescription opiate and heroin addiction, in this nation, in large part fueled by overprescribing of powerful pain relievers to patients who become addicted to their effects, but find that heroin can be both cheaper and, depending upon the batch, more potent. Sadly, this explosion in opioid addiction isn’t something that just came out of nowhere – it has been clearly and vocally predicted by medical and social researchers since 1996, when OxyContin received FDA approval and began being prescribed not to those patients whose pain levels were the most severe, but to virtually any patient who could pay for the drugs.

HEAL Blog has covered the history of OxyContin and other prescription opioids in previous 2015 editions, as well as their effects on rural Appalachia and other suburban areas, and beginning in April of 2016, the HIV/HCV Co-Infection Watch Report will be expanding its coverage of Harm Reduction efforts in the United States. The decision to expand our reporting into the world of Harm Reduction arose from the reality that, with rare exception, reports of new Chronic Hepatitis C (HCV) infections are overwhelming coming from injection drug users (IDUs), as well as a recent uptick in the number of new HIV infections as a result of injection drug use for the first time since the 1980s (Smith, 2016).

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

Photo Source: ReinventingAging.org

This increase in new HIV and HCV infections amongst IDUs was brought most sharply into focus with last year’s largely preventable (Smith) outbreak in Scott County, Indiana. As of February 01, 2016, 188 people in the area were diagnosed with HIV in only fifteen months, which overlapped 312 cases of acute HCV infection, 25% of which were co-infected (Smith). In response to this outbreak, Indiana’s largely Conservative legislature, along with Republican governor Mike Pence, overcame its decades-long rejection of syringe exchange programs (SEPs) in order to deal with the burgeoning HIV crisis (Harper, 2015). Similar actions were taken in surrounding states, as Federal, state, and local governments took notice of HCV and HIV infection reports reflective of the Indiana tragedy.

What has yet to take hold in America, however, is the reality that SEPs work. To date, many Americans (as well as citizens around the world) continue to cling to the decades-old illusion of a drug-free world (McLean, 2016), as well as to the punitive approach taken in the long-since-lost “War on Drugs.” This opposition to SEPs comes despite literally volumes of research showing that epidemics can be, and have been, averted or reduced, as evidenced in settings as diverse as Australia, China, Malaysia, Mauritius, Portugal, Switzerland, Vietnam, and Ukraine (Smith).

But, as with all things “foreign,” the concept of following in the footsteps of other nations in dealing with any crisis strikes Americans as being un-American; the mere mention that another nation is doing something right, much less “better” than America smacks of Communism and prompts accusations of trying to “inflict” Socialism upon the American public. We largely are, and have been increasingly becoming, a nation whose drug laws are based not upon research and facts, but upon fear, emotion, and a “Not In My Backyard” mentality.

There are, however, efforts to change this mentality. As evidenced by the sudden change of heart (albeit temporary) by the Indiana legislature, occasionally actual wisdom (and research) will prevail, and real Harm Reduction strategies can be put into place. Hopefully, the expansion into coverage of this topic will help to lead that charge within the HIV and HCV communities, regardless of whether people are mono- or co-infected. The whole purpose of the HIV/HCV Co-Infection Watch – nay, the very reason it exists – is to empower patients to better advocate for themselves in the healthcare debates. By tracking Federal-, state-, and local-level Harm Reduction measures, we hope to provide an invaluable tool that will allow both patients and advocates to confront and demand action from their representatives in the Legislative Branches to enact the evidence-based measures that will actually make a difference in the fight against HIV and HCV.

References:

Harper, J. (2015, June 02). Indiana’s HIV Outbreak Leads To Reversal On Needle Exchanges. Indianapolis, IN: National Public Radio (NPR): 90.1 WFYI Public Radio: Public Health: Shots. Retrieved from: http://www.npr.org/sections/health-shots/2015/06/02/411231157/indianas-hiv-outbreak-leads-to-reversal-on-needle-exchanges

McLean, S. (2016, March 21). To end HIV in drug users, stop chasing the dream of a drug-free world – Why does ‘harm reduction’ continue to be such a problem for global drug policy when it’s a proven way of reducing cases of HIV?. New York, NY: The Guardian: Global Development. Retrieved from: http://www.theguardian.com/global-development/2016/mar/21/end-hiv-drug-users-drug-free-world-harm-reduction

Smith, M. (2016, February 26). Drug-Fueled Indiana HIV Outbreak Was ‘Preventable’ – But other poor rural communities face similar risks. New York, NY: MedPage Today, LLC. Retrieved from: http://www.medpagetoday.com/MeetingCoverage/CROI/56416
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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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Co-Paying the Piper

By: Marcus J. Hopkins, Blogger

One of the biggest changes for many lower income patients under the Affordable Care Act (ACA) has been the transition to paying co-pays for their medical care. For patients living with HIV, this has been exceptionally difficult in states whose Ryan White Part B programs – the AIDS Drugs Assistance Programs (ADAPs) – have opted to pay for their clients’ insurance premiums, rather than simply directly paying for services as they’re administered. What this means for patients is that, where they once never had to worry about doctors’ visits or paying for medications, depending on their state of residence, they may not be responsible for paying co-pays for services.

To the average American with a stable, if thinly stretched, income, this may not seem like a big deal; but, to those of us living with HIV/AIDS on fixed or fluctuating incomes, this distinction may create an additional barrier to care that may not have existed, prior to now. It can be difficult to explain to people how, when one’s income is already low, paying $20-$30 for a visit to the doctor requires foregoing other basic necessities such as food or a utility bill put off until later; paying $100 for your HIV medications every month can mean that you no longer have enough to afford rent.

People who live without a chronic disease often fail to see the hardships presented with treating that disease. Outside of simply the cost of treatment, there are additional social and emotional issues at play. Having to rely on government assistance for any reason is frequently derided in our nation as a weakness; a moral failing that renders the recipient incapable of taking care of themselves. As such, there is often a guttural sense of shame and humiliation that accompanies having to rely on these assistance programs. It is this component that is so often left out of the conversation.

More than just the psychosocial aspect of seeking assistance, the reality is that, when a patient discovered their HIV-positive status, they are often unaware of the options that exist, in the way of coverage. Now that people with pre-existing conditions can no longer be barred from insurance coverage, many simply assume that private insurance is the only option available to them. In states where Medicaid services have not been expanded to include coverage for people living with HIV, many patients are unaware of the existence of the Ryan White or ADAP programs that are in place to provide assistance for lower income patients who cannot afford the cost of treatment.

Even with these programs in place, their assistance does not meet the Federal requirement for insurance coverage, and clients whose incomes are higher than the maximum allowed for exemption from the penalty for not having private insurance are often left to foot that bill, as well. This is one of several reasons why many ADAP programs are switching their coverage over to paying for private insurance, rather than a direct payment model.

For lower-income patients still having trouble paying for treatment, even with insurance, Patient Assistance Programs (PAPs) exist that can help to partially or totally defray the costs. These programs are, however, largely unknown to people outside of the “know,” as it were – if you don’t “know” about them, you don’t know about them, and oftentimes, you only find out about them through random word of mouth. Sadly, many ADAP programs’ employees are unaware of these programs, and aren’t able to provide adequate information about either their existence or the requirements for applying.

One such program – the Patient Access Network (PAN) Foundation – has long served this purpose for people who are underinsured living with HIV. The maximum award level is $7,500 per year. Patients may apply for a second grant during their eligibility period subject to availability of funding.

Unfortunately, funds available through this program have been depleted. As of March 14th, 2016, patients seeking assistance for HIV are being encouraged to go to the Patient Advocate Foundation (PAF) for assistance. Individuals who have been recently approved for grants through the PAN Foundation will not be affected. When needing additional assistance or to re-enroll, individuals are encouraged to check back with PAN to determine if the fund has been re-opened and/or to seek additional support through PAF.

LOGO: Patient Advocate Foundation

While the funds at PAN for HIV assistance have been exhausted for 2016, there are still funds available for patients who are mono- or co-infected with HCV at both PAN and PAF; one only needs to apply separately for assistance with that specific condition, as funds for HIV drugs do not carry over to HCV without an additional application.

Additionally, it should be made clear that these programs are not designed for the uninsured; rather, they are designed for the underinsured – those who carry some form of insurance, but for whom co-pays are unaffordable. It is also crucial to understand that these programs cover only the costs associated with drug co-pays; office visits and other non-pharmaceutical costs are not covered, and are left up to the individual and/or the Ryan White funds allocated to their clients.

For more information about PAF, and how it differs from the National Patient Advocate Foundation, please visit www.patientadvocate.org.

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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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Bayh-Dole Threat Sits Idle

By: Marcus J. Hopkins, Blogger

In January 2016, Rep. Lloyd Doggett (D-Texas) led a group of over 50 House Democrats in asking the Department of Health and Human Services (HHS) to open the door to using “march-in rights” to break patents whenever drug manufacturers set prices for their drugs prohibitively high. HHS Secretary Sylvia Matthews Burwell has, once again, maintained the HHS position that this simply isn’t going to happen.

If the concept of “march-in rights” seems confusing, that’s because it is. Essentially, the “march-in rights” provision of the Bayh-Dole Act allows the government to essentially ignore patent rights if government funding has been used in the creation of the patented product, and then, only if one of four criteria are met: (1) the right-holder “has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in the field of use;” (2) the right-holder has not reasonably satisfied “health or safety needs;” (3) the right-holder has not met public use requirements specified by federal regulations; or (4) the right-holder has not satisfied the Bayh-Dole requirements to give certain preferences to U.S. industry.

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

Affordable Healthcare

The Bayh-Dole Act came about in response to the economic malaise of the 1970s and to the overly complicated and incredibly bureaucratic process of being granted a patent after using Federal resources to conduct research and development. After World War II, President Roosevelt was dogged in his pursuits of scientific breakthroughs and achievements, and funding was heavily stacked in favor of leading the world in those breakthroughs. However, prior to the Bayh-Dole Act, the government had acquired around 28,000 patents, but only 5% of them were used in commercial applications (General Accounting Office, 1998). The Act was supposed to solve those problems.

The unfortunate consequence of this Act has been that private entities can use endless government funds to create products that are intended to benefit the general public, turn around to file a private patent on said product, and essentially charge whatever they please for public use of said product. As a card-carrying Socialist, myself, I find this most perverse – that taxpayer-funded products should then be sold back to the taxpayers whose money already paid for it at a potentially exorbitant price is, to my way of thinking, capitalism at its absolute worst.

Particularly in the field of medicine, this practice has led to an explosion in two things: fast development in pursuit of higher profits and exponential increases in the price of usage. We went from a system in which children were given vaccines for childhood illnesses for free at public schools, to one in which parents are required to have their children vaccinated on their own dime, even though their dimes – along with everyone else’s – have already paid for those vaccinations.

As of January 2015, no Federal agency has exercised its march-in rights. To date, I believe that is still the case. This marks the sixth petition to the HHS to exercise its march-in rights to address the ever-increase pricing issues related to “specialty” drugs – drugs marketed to specifically address only a single disease or a single aspect of a disease – two of which regarded the use of Norvir (ritonavir). The first came in 2004 after the maker of Norvir, Abbott Laboratories (now AbbVie), raised the price of their drug by roughly 400% in the U.S…but, nowhere else in the world.

That’s right: nowhere else in the world does Norvir cost as much as it does in the U.S. Globally, the wholesale cost of Norvir is between $0.07 and $2.20 a day (Drugs[dot]com, n.d.); in the U.S., that cost is about $9.20 up to $55.00 per day, depending on the dose (International Drug Price Indicator Guide, 2014).

The HHS position on price-related march-in rights has been to essentially say, “It’s Congress’ job to deal with drug prices; not ours.” Sadly, I’m not certain that Congress may ever been in a position where that can be effectively done. Although there is certainly disagreement over the degree to which the Pharmaceutical Research and Manufacturers of America (PhRMA) influences Congressional action related to drug prices, there is little disagreement that the influence is there.

PhRMA is dogged in protecting its right to charge whatever it wants for product that they insist were made using their ingenuity alone, regardless of whose money was used in the making. They’re more than willing to receive billions of dollars in federal funds to create products that are meant to heal the public, but they’re less willing to charge reasonable prices for those taxpayer-funded products. Any suggestion that this practice is either unsavory or unethical receives the “This isn’t Communist Russia!” treatment, so favored by vulture capitalists. Furthermore, any movement to address the issue of drug pricing is met with threats of leaving the country to do business in “more hospitable” climes – basically, extortion – and no member of Congress wants to be seen as a “job killer.”

In the case of drug prices, however, something clearly must be done, whether or not the drug manufacturers like it, and if legislative efforts aren’t going to happen, maybe it’s time to march-in on these territories and start putting the taxpayers’ dollars to work FOR them, rather than against them.

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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Subpoenas Served

By: Marcus J. Hopkins, Blogger

For over two years, HEAL Blog has covered issues related to access and the cost of Direct Acting Agent (DAA) Hepatitis C drugs for not only lower income patients, but patients across virtually every tax bracket. In addition to our work at the blog, we also work hard to bring information about access and coverage in the monthly HIV/HCV Co-Infection Watch, which has largely been focused on serving as an informational portal for Ryan White and Medicaid clients who rely upon those programs to provide them with comprehensive medical treatment.

During this time, we have seen access to these drugs on the part of payers nominally increase – Ryan White and Medicaid programs, as well as private insurers, supposedly expanding coverage to include the new DAA drugs – but, there have always been whispers, and sometimes shouts, alleging that, despite the promises to cover these new drugs, few patients actually receive drugs from these programs. When questioned on why patients aren’t receiving the coverage they’ve been offered, payers consistently repeat the same refrain: “If we treated everyone, we’d be broke.”

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New York State Attorney General, Eric Schneiderman (Source: Fox News)

This response, however, has not settled well with New York State Attorney General, Eric Schneiderman. After concerns that there are some insurance companies that are restricting coverage of these medications, Schneiderman has issues subpoenas to 16 health insurance companies to provide information on their coverage of HCV drugs. Specifically, he has asked for documents explaining how they decide who should and should not be covered for specific treatments.

Essentially, Schneiderman is asking these companies to justify why some patients are deemed worthy of treatment, while others are denied, a tactic which may force both public and private payers to take more aggressive action in dealing with the high cost of newer medications, not only for HCV, but for a whole host of other conditions in the specialty drugs market.

Under the current model of pharmaceutical pricing, payers have to negotiate discounts with the manufacturers, and those discounts and rebates are currently protected by trade secret laws that essentially prevent payers from making those negotiated prices available to the public. Some payers have limited access to drugs, which they then restrict to the sickest patients, and sometimes, even with the discounts, they cannot afford the drug.

The secretive nature of these negotiations is an issue of great concern to HIV and HCV advocates, because without specific pricing information, there is little room to effectively advocate for expanding funds to a specific amount to cover the costs of these drugs. Assuming that each client with HCV requires only a single 12-week regimen, how many 12-week courses can actually be afforded given each program’s respective budget, and how many patients will actually receive treatment?

In response to Schneiderman’s subpoenas, Leslie Moran of the New York Health Plan Association has stated that they “…do not take into consideration the impact of excessive and unsupported pricing of these drugs.” She’s not wrong. While the subpoenas specifically request documentation explaining why some patients merit treatment, there’s little real effort to address the root of the problem – a total lack of transparency in how manufacturers determine the price of their products.

Even on the Federal level, there’s been little effort on the part of elected officials to address this virtually opaque process. There have been a handful of Congressional hearings related to the matter, but few politicians have specifically spoken about legislative actions they plan to take that would force transparency in these decisions. In fact, there’s little political will to do so, which leaves matters in the hands of patients and AIDS Service Organizations (ASOs) to file ballot initiatives and class action suits designed to force payers – not the manufacturers – to provide coverage, regardless of the costs associated with treatment.

While Schneiderman’s attempt to address the issue of access to these drugs is certainly to be applauded as an excellent step to expanding availability, they do not go to the heart of the matter: the drugs simply cost too much. Payers are right to argue in their own defense that paying for coverage for these drugs, even with discounts, is simply unfeasible and unsustainable, given the base Wholesale Acquisition Costs (WACs) established by the manufacturers, themselves.

And so, we are yet again at an impasse; Schneiderman should be seen as attempting to fix a problem and payers are a part of the problem, but they are not the cause of the problem. Until we have sufficient and binding legislative action that forces manufacturers to justify their pricing decisions, we have little chance of combating the continual increase in healthcare costs.
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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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