Research Indicates Nearly 30% of Opioid Prescriptions Lack Medical Justification

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 posts frequently discuss the impact the opioid epidemic has upon the spread of HIV, Hepatitis B (HBV), and Hepatitis C (HCV). One aspect that we’ve discussed – prescribing habits – has recently received further study. According to new research published in Annals of Internal Medicine, 28.5% of opioid prescriptions have no record of either pain symptoms or pain-related conditions justifying their prescription (Scutti, 2018).

The study authors go out of their way to suggest that various causes may contribute to this lack of justification – failure to submit documentation, time constraints, clinic workflows, or complicated documentation systems (Scutti). In recent decades, doctors and nurses, alike, have complained about the complicated and seemingly never-ending amount of paperwork involved in providing even the most basic of care. Much of this is related to the Electronic Medical Record (E.M.R.) – software programs that are designed to account for virtually everything that can, does, or should occur with a patient. Recent studies indicate that doctors spend a little more than half of their work hours doing administrative work, rather than in face-to-face time with patients (Ofri, 2017).

Rx bottle with medicine on top of an Rx order

Photo Source: MedScape

Essentially, any time an insurer, new law, regulation, or threat of legal action appears, new field (or more) pops up in E.M.R. software that requires input on behalf of the doctor. So, realistically, it is possible that the justifications for at least some of the 28.5% of unjustified opioid prescriptions could just have been lost in the shuffle. Doctors are, after all, only human. Very well-trained, highly educated humans, but humans, nonetheless.

The other side of this argument, however, is that “doctors are human.” Doctors, like every human, are susceptible to poor influences – deals made with pharmaceutical companies to prescribe certain medications that highly addictive in lieu of other medications, for example. Or addiction; manipulation by patients; under the table dealing. At least once a week, I read an article about a doctor whose license is being suspended or revoked because they’ve been illicitly prescribing opioids or other narcotics in exchange for [x], or they’ve been selling them on the side. But, even those instances can’t account for all of 28.5%.

Yet another angle is that these drugs have become increasingly regulated since 2006 (the scope of the Annals study is 2006-2015). Since 2015, even more restrictions have been placed upon opioid prescribing, and in most states, this has resulted in dramatic decreases in the number of prescription per capita. In 2017, the opioid prescribing rate had fallen to the lowest it had been in 10 years (Centers for Disease Control and Prevent, 2017). But, even that comes with additional problems: patients turning to “street” sources for prescription opioids; patients moving off of opioids to heroin (often cut with fentanyl or carfentanil), because heroin is easier and cheaper to obtain; the resultant overdoses and increased risk of infection with HIV, HBV, and HCV.

There is no single solution to curbing the opioid epidemic. Doing so is going to require multiple approaches working in conjunction to defeat the problems. Outside of just prescriber education about opioid addiction and increase prescribing restrictions, we must also include and incorporate patient-focused harm reduction measures, such as increasing access to legal Syringe Services Programs (needle exchanges that also provide screening and testing for diseases and linkage to treatment programs for disease and addiction) and increasing access to addiction treatment programs by expanding the number of available beds.

For far too long, we have attempted to deal with these problems with siloed responses – just syringe exchanges; just prescribing restrictions; just prescriber education. This strategy is not working, and moreover, it is more expensive, in the long-run, to continue funding multiple single-focus initiatives that don’t work in tandem with one another, than it would be bring all of these resources and initiatives into one large effort. But, that will require cooperation and a lot of money up front; it’s far more palatable to fund smaller, less effective initiatives because the “ask” is lower on up-front costs. Realistically, though, it needs to be done.

References:

__________

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.

Advertisements

Leave a comment

Filed under Uncategorized

3rd Annual National Monitoring Report on HIV/HCV Co-Infection

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 Community Access National Network (CANN) will be hosting its 3rdAnnual National Monitoring Report on HIV/HCV Co-Infection on Wednesday, September 19th, beginning at 2:00 p.m. EST. This annual report provides valuable information on the state of Hepatitis C (HCV) treatment coverage, harm reduction measures to prevent transmission of HIV and HCV, and, new to this year, a brief focus on HIV and HCV testing and treatment for individuals currently incarcerated and post-incarceration.

Returning this year are yours truly (as the Project Director for the HIV/HCV Co-Infection Watch and Medicaid Watch), and Amanda Bowes, Manager on the National Alliance for State and Territorial AIDS Directors’ (NASTAD) Health Care Access Team. New presenters for 2018 include Ayesha Azam, Senior Director of Medical Affairs at the Patient Access Network (PAN) Foundation, and Jack Rollins, Senior Policy Analyst at the National Association of Medicaid Directors.

At last year’s National Monitoring Report, I focused on the increase in coverage options for both the Ryan White and Medicaid programs, showing how treatment options have expanded across the country since 2015 (when the HIV/HCV Co-Infection Watch began). Mrs. Bowes provided more detailed information available about coverage, as well as NASTAD’s efforts to expand coverage for Hepatitis C (HCV) Direct-Acting Antivirals (DAAs) within the nation’s AIDS Drug Assistance Programs (ADAPs).

This year’s event is sponsored by the ADAP Advocacy Association, Gilead Sciences, Merck, Quest Diagnostics, Walgreens, and the Pharmaceutical Research and Manufacturers of America (PhRMA).

The 3rdAnnual National Monitoring Report on HIV/HCV Co-Infection can be attended either in person at PhRMA Headquarters in Washington, DC, or remotely for non-DC residents. Registration is free and can be done online. While registration is free, there is limited seating for those attending in person and advanced registration is required to attend.

Learn more at http://www.tiicann.org/events.html#091918cr.

3rd Annual National Monitoring Report on HIV/HCV Co-Infection

Leave a comment

Filed under Uncategorized

Lower-Priced HCV Drugs Haven’t Improved Treatment Approvals

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 Free Market will work! Competition in the Hepatitis C drug market will force prices down, and everything will be okay!”

This has been the mantra of pharmaceutical companies and market watchers since the 2013 introduction of the highly-effective, but extremely expensive Direct-Acting Agents (DAAs) to treat and cure Hepatitis C (HCV). And, in point of fact, prices for treatment have decreased significantly since Sovaldi hit the market with a Wholesale Acquisition Cost (WAC) of $84,000 for twelve weeks of treatment. The latest (and cheapest) drug to hit the market – AbbVie’s Mavyret – sells for “just” $39,600 for twelve weeks of treatment. But, that twelve-week treatment period is for the most aggressive HCV cases; the recommended treatment for most patients is eight weeks, for which Mavyret goes for $26,400.

Curiously enough, however, healthcare payors have done their damnedest to not cover these drugs for patients. A study published in June of this year (2018), insurance companies deny coverage in 35.5% of cases (over 1/3 of the time); for patients with commercial insurance, the denial rates are even higher (Kaltwasser, 2018).

$100 bill with prescription medicine on it

Photo Source: Consumer Reports

As Kaltwasser points out in his MD Magazine article, previous studies published in 2016 indicated that the approval rate was much higher, and that Medicaid denial rates were higher. While Medicaid approval rates have improved (after a 2015 letter from the Centers for Medicare and Medicaid Services to state Medicaid directors informing that denials based on the cost of treatment violated Federal law), that does little to help the 56% of Americans with commercial insurance.

When patients are denied coverage, there are options – Patient Assistance Programs (PAPs) are designed to aid patients who are either underinsured or whose insurance plans deny coverage of certain drugs. Manufacturer-provided PAPs, like those offered by Gilead Sciences and AbbVie, pay for most (if not all) of the out-of-pocket expenses for purchasing the drug, whereas private PAPs, such as the PAN Foundation, provide assistance for patients whose insurance company agrees to pay for treatment and patients need assistance with the out-of-pocket costs.

Another, more common route is the appeals process, which can take weeks, if not months, and requires a lot of extra groundwork from all parties. Some patients have gone through numerous rounds of appeals and denials, just to get an approval. This process is exhausting, and frankly, it’s not good for the health of patients who go through unnecessary stress just to get the treatment they need (and pay).

Worse, still, is that, while the cost to payors has decreased along with WAC prices, the price to consumers has not.  In fact, for many patients, those costs have increased as insurers place HCV DAA drugs in “Specialty Tiers” or the highest payment tiers in their policy, meaning that patients will pay $100+ out-of-pocket for co-pays.

HIV medications – the newer ones, at least – often fall into this “Specialty Tier” as well. My monthly co-pay for my HIV medications, for example, sets me back $250/month on top of the $285+ monthly premium, for a total of over $500/month. Were these costs not covered by West Virginia’s Ryan White program, nearly ¼ of my monthly income would be dedicated solely to treating my HIV, and that leaves out the up to $500 that each of my biannual doctor visits cost me, including the $75 co-pay, plus the cost of the bloodwork, any X-Rays, or procedures I need done.

HCV patients get to go through all that, and worse, without the benefit of a Ryan White-style program that helps to cover the cost of treatment. And the cost of treatment is higher for HCV on an annual basis.

I know I’ve beaten this drum, before, but the fact is this: until such time as the U.S. joins the rest of the modern world and begins offering Universal Healthcare, patients are going to be the ones getting screwed at every turn, in addition to being nickeled and dimed for every cost a provider can cobble together every time they visit a doctor. Insurance company, pharmaceutical company, and for-profit hospital profits will soar, while patients will continue to struggle to afford even poor-quality healthcare that would be unacceptable in every other First World nation, never mind quality, comprehensive healthcare.

In the meantime, patients living with chronic illnesses are just going to have to suffer through denials, appeals, and ever-mounting medical debt that will leave us scraping by from month to month, just to make ends meet. But, hey! At least we won’t have to suffer the indignities of “Socialized Medicine,” where Conservatives insist that, as David Sedaris once put it, “…patients [will] lie dirty cots waiting for aspirin to be invented.”

Lucky. Us.

References:

__________

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.

Leave a comment

Filed under Uncategorized

NVHR, HRC, and Center for HIV Law & Policy Come Out Against Hepatitis Criminalization

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 National Viral Hepatitis Roundtable (NVHR), Harm Reduction Coalition (HRC),  Center for HIV Law & Policy (CHLP) have released a comprehensive new fact sheet regarding the criminalization of Hepatitis (NVHR, 2018). This issue is one that HEAL Blog has covered a number of times in the nearly five years since we’ve been in publication, and one that is vitally important to those who are living with Viral Hepatitis (VH).

According to the fact sheet, 13 states have laws that specifically target people living with VH by criminalizing the transmission of Hepatitis A, B, and C (HAV, HBV, and HCV, respectively), even in cases where the risk of transmission is so infinitesimal that almost no risk exists. These laws generally adhere to the equally unscientific panic associated with HIV criminalization and are intended to reduce the number of transmissions by way of penalizing people, rather than getting to the root of the issues.

Inmate looking out window with bars on it

Photo Source: thedenverchannel.com

For example – the primary manner in which HCV has been transmitted in the U.S. for much of the past decade is via Injection Drug Use (IDU). According to the Centers for Disease Control and Prevention (CDC), the prevalence of HCV among People Who Inject Drugs (PWID) is estimated to be 53.1%. Rather than focus on preventing the spread of disease among PWID by funding options that are much cheaper than incarceration – Syringe Services Programs (SSPs), increasing drug treatment facilities and funding, and placing limits on opioid prescription amounts and dosages (to reduce initial addiction) – these states instead decide to focus their efforts on criminalizing behaviors, resulting in higher rates of incarceration – the most expensive option the ensures that the state will have to be exponentially more to house, feed, and inadequately treat PWID.

Some of the scientifically unfounded “infection risks” include spitting, “allowing” someone to come into contact with blood, semen, urine, feces, or other bodily substances (NVHR). The state of Ohio, for example, makes exposure via these methods a Class 3 felony. In January of this year (2018), a man living with HCV was charged with four felonies for spitting at first responders during the course of an arrest (Jankowski, 2018). HEAL Blog covered this specific arrest in the final post of January (Hopkins, 2018). As we noted in January, neighboring Indiana classifies “Spitting While HCV” as Class 5 and/or Class 6 felony battery, depending on the circumstances and, if you can believe it, the disposition of the “offender” (e.g. – if they are rude, angry, or insolent while exposing someone to a bodily fluid).

These criminalization efforts extend beyond the general population, reaching into state and Federal prisons, resulting in far harsher punishment for inmates living with VH. For current inmates charged under HCV criminalization laws, the punishments can extend sentences for any number of years for violations that can stem from simply spitting at a guard – an action that has virtually no chance of spreading HCV.

It is time for more national organizations to stand up to states’ unscientific criminalization of both HIV, and VH. If that means going to court, then, so be it.

References:

__________

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.

Leave a comment

Filed under Uncategorized

Three HCV Drugs Quietly Pulled From Market

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

Johnson & Johnson’s hepatitis C virus (HCV) drug Olysio (simeprevir) reached blockbuster status during the second quarter, clocking about $1.2 billion in sales for the first six months of the year (Sheridan, 2014). 

This article from 2014, ominously entitled, “In evolving HCV market, Johnson & Johnson’s Olysio is a blockbuster, for the moment,” a staff writer for BioWorld – a site that provides “actionable intelligence on the most innovative drug development science…” – essentially foretold Olysio’s doom.

The groundbreaking drug first approved by the U.S. Food and Drug Administration (FDA) in 2013 was meant to serve as a companion drug to Gilead’s Sovaldi (sofosbuvir) for the treatment of HCV, Olysio was quickly became the odd man out, in terms of treatment regimens. With a Wholesale Acquisition Cost (WAC) of $66,360 for twelve weeks of treatment, Olysio’s use in combination with Sovaldi (WAC – $84,000) had patients and payors looking at a combined cost of $150,360 to cure HCV in 12 twelve weeks. Unsurprisingly, payors balked at this price point, and instead recommended Sovaldi in combination with the much cheaper ribavirin, with a WAC of between $550-$850 for twelve weeks of treatment. It may not have been as easily tolerated as Olysio, but damn it – it was exponentially cheaper.

Olysio

Photo Source: stoprod.se

By the end of 2014, Gilead had gone the extra step to push Olysio into obsolescence by releasing their breakthrough combination therapy, Harvoni (ledipasvir-sofosbuvir) at a WAC of $94,500. This single-pill regimen could be used in most patients without a ribavirin booster, and proved much easier to swallow, despite the high price point.

And then, came Viekira Pak…

And then, came Daklinza…

And then, came Technivie, Zepatier, Epclusa, Viekira XR, Vosevi, and Mavyret…

In just a few years, Janssen might as well have not even entered into the HCV market. In 2017, the company announced that it was exiting the market. And then, in May of this year (2018), Janssen pulled the plug on Olysio, altogether. Effective May 25th, 2018, Olysio became unavailable in all markets. Janssen reasoned that the availability of [cheaper] pangenotpyic drugs to treat and cure HCV had made Olysio’s presence on the market untenable.

Then, in June 2018, AbbVie – makers of Viekira Pak, Technivie, Viekira XR, and Mavyret – quietly pulled the plugs on both Technivie and Viekira XR. Neither of these drugs really got off the ground and were essentially rendered obsolete within a year or two by Mavyret, which is far cheaper and a better product. Both of these drugs will become unavailable on January 01, 2019.

These won’t be the last casualties of the HCV, either. Some Medicaid programs are playing an interesting game, at the moment, when it comes to contracted drugs for treatment. Hawaii’s Medicaid program, Med-QUEST, operates using five different Managed Care Organizations (MCOs) – AlohaCare, HMSA, Kaiser Permanente, ‘Ohana Health Plan, and United Healthcare Community Plan. AlohoCare, from June to August pared their Preferred Drug coverage for HCV treatment to only Harvoni, Zepatier, and Epclusa – a strange move considering all three drugs are more expensive than AbbVie’s Mavyret.

I say “strange,” because nearly every other Medicaid program in the U.S. has shifted to Mavyret as their preferred drug, with Epclusa and Zepatier straggling along behind. In fact, the other four MCOs that service Med-QUEST have all reduced their coverage to include only Mavyret. AlohaCare is unique amongst the other MCOs in that it is a non-profit organization wholly local to Hawaii, whereas the other MCOs are backed by large national insurers – BlueCross/BlueShield, Kaiser Permanente, WellCare, and United Healthcare. That a local non-profit would reduce its coverage of HCV to exclude the cheapest drug on the market is, again, strange.

While I cannot definitively say that there’s anything nefarious afoot, my guess is that Gilead has cut a deal with AlohaCare to offer Harvoni and Epclusa at much lower prices than Mavyret. How low? Well, we aren’t legally allowed to see those prices, because of existing trade secrets laws.

I anticipate that Daklinza will be the next drug on the chopping block, but that’s just speculation.

References:

__________

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.

Leave a comment

Filed under Uncategorized

Hepatitis C Patients Who Abuse Alcohol Suffer Worse Health Outcomes

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

Patients living with Hepatitis C (HCV) have been shown to suffer worse health outcomes if they also abuse alcohol, according to a new study published in Clinical Epidemiology (Specialty Pharmacy Times, 2018)

In addition to the common deleterious effects of excessive alcohol consumption, patients living with HCV who drink excessively also face worse rates of liver-related mortality.  Additionally, between 10-20% of those who abuse alcohol regularly develop liver disease, and 20% of patients with alcoholic hepatitis – an inflammation of the liver that occurs as a result of alcohol consumption – have HCV.

Man holding alcoholic beverage

Photo Source: everydayhealth.com

There are some basic limitations to the study – a lack of data on changes in alcohol consumption over time, as well as a lack of data on the severity of some patients’ alcohol consumption in comparison with others. These limitations make generalizing the results slightly more difficult. That said, researched pointed to previous research findings that indicate up to 30% of people living with HCV may abuse alcohol.

While these limitations exist, it is definitely worth concern, particularly in patients who have not been, or are unlikely to be tested for the virus. This concern is exacerbated in areas of the U.S. with limited access to comprehensive medical treatment, but less limited access to alcoholic beverages. When combined with other factors – endemic poverty, unemployment, and other socioeconomic woes that are shown to lead to an increase in high-risk consumption behaviors – the risk to patients living with HCV who are undiagnosed grows exponentially.

References:

__________

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.

Leave a comment

Filed under Uncategorized

AbbVie, American Legion Team Up For Veterans

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

Drug maker AbbVie (Viekira Pak and Mavyret) has teamed up with the American Legion in an effort to extend their Hepatitis C (HCV) outreach efforts to Veterans across the U.S. Their new nationwide campaign, “Take on Hep C,” launched on August 4th, 2018, and will work to provide free HCV antibody testing to Veterans and their communities, beginning with the Sturgis Motorcycle Rally in South Dakota (Bennett, 2018).

AbbVie

Photo Source: dddmag.com

The U.S. Veterans Administration (V.A.) first opened treatment access to all eligible Veterans in 2016 (Kine, 2016), quickly proving to be one of the most successful HCV treatment efforts in the U.S. Because the V.A. receives what is called “Best-Pricing” on pharmaceuticals, they have been able to keep costs contained where other government healthcare payors have been less successful (particularly Departments of Corrections). In fact, the V.A. is on track to eliminate HCV in all Veterans by the end of 2018, curing 59,200 Veterans at a cost of roughly $25,300/soldier (LaMattina, 2018).

Curing U.S. Veterans will no doubt serve as a great first step toward stemming the spread of disease, but there are concerns that still exist. When U.S. healthcare authorities speak of “elimination,” there are always communities who will be left behind – the homeless, the very poor, sexual, racial, and ethnic minorities. These populations are often left out of these treatment opportunities because they may feel ostracized by policies previously held by the military. Of particular concern are those Veterans who received dishonorable or other-than-honorable discharges from the military for being lesbian, gay, bisexual, or transgender either under the Don’t Ask, Don’t Tell (DADT) or prior policies that prohibited open service. These discharges may impact their ability to obtain services through the V.A. With the repeal of DADT, it is possible for LGBT Veterans to receive upgrades to their discharge paperwork (OutServe-SLDN, n.d.).

Ensuring that all U.S. Veterans are cured of HCV is vitally important, and this new effort by AbbVie and the American Legion will go a long way toward achieve that goal.

References:

__________

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.

Leave a comment

Filed under Uncategorized