Tag Archives: FDA

Mavyret and Vosevi Fire Salvos in HCV Price Wars

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

Over the past month, the U.S. Food and Drug Administration has approved two new Direct Acting Antivirals (DAAs) for use in treating Chronic Hepatitis C (HCV) – Vosevi (Gilead) and Mavyret (AbbVie). Both of these drugs are pan-genotypic, meaning that they can be used to treat HCV Genotypes 1-6, making them the second and third pan-genotypic regimens to be approved by the FDA. What makes Vosevi unique is that it’s the first drug approved by the FDA for patients who have previously been treated with other DAA drugs (Brooks, 2017). That, alone, gives Gilead some leeway when it comes to setting their Wholesale Acquisition Cost (WAC), which they set at $74,760 for twelve weeks of treatment.

That was in July 2017. Then, came Mavyret, from AbbVie. Rather than even bother to hide their intention, AbbVie seriously threw a spanner in the works by pricing their new drug just under 50% lower than Vosevi for a similar regimen length. For twelve weeks of Mavyret, the WAC is $39,600 – roughly 48% the cost of Vosevi. But, that’s not the kicker: Mavyret’s recommend dosage for treatment-naïve patients is an eight-week regimen, coming in at $26,400. Vosevi also has an eight-week regimen option, but at a significantly higher price point. Shots. Fired.

This isn’t the first time that AbbVie has played this pricing game, before, in an attempt to undercut Gilead. In 2014, they released Viekira Pak – a four-tablet regimen for use in treating HCV Genotype 1a & 1b – at a WAC of $83,319. While this is significantly more expensive, at the time, it was something of a blow to Gilead and Janssen (makers of Olysio). Individually, Gilead’s Sovaldi had a WAC $84,000 for twelve weeks; however, the drug was intended to be used in combination with Olysio (Janssen), which boasted a WAC of $66,360, making the total cost of the regimen $150,360. Gilead’s newer product, Harvoni – a single-pill regimen designed to be used without Olysio – came in at $94,500.

Despite the lower price, Viekira Pak never really caught on as the go-to treatment regimen for HCV, for a number of reasons: (1.) Gilead had already established relatively deep market penetration and brand recognition; (2.) the four-pill regimen was/is thought to be too cumbersome to ensure compliance with the regimen; (3.) the price wasn’t low enough to get payers to bite. Of these three issues, AbbVie managed to solve the multi-pill regimen part in 2016 with their single-pill Viekira XR, which is now the preferred regimen over the original formulation.

Chart showing HCV therapies available and their Wholesale Acquisition Costs

But, pricing wars are tricky, particularly in the world of HCV therapies. The first truly significantly lower price point came in 2016 with Zepatier – Merck’s single-pill answer to HCV treatment – with a WAC of $54,600. But, even that price wasn’t enough to overcome the drug’s significant barriers to treatment – it was notoriously difficult to prescribe, as it had several counterindications (negative drug interactions) with drugs used to treat other illnesses. This was particularly true in the case of HIV. In addition to individual pricing concerns, treatment indications often require that the drugs be used in combination with other medications, the most common of which is Ribavirin, which can cost between $550 – $850 for twelve weeks, depending on brand vs. generic pricing.

What Mavyret does that Viekira Pak/XR did/does not is put on the market a single-tablet regimen to treat six genotypes of HCV, making it incredibly versatile. Whether or not they will be able to overcome Gilead’s market dominance, however, is another question.

References:

  • Brooks, M. (2017, July 18). FDA Clears Pan-Genotypic Vosevi for Chronic Hepatitis C. New York, NY: Medscape, LLC: Medscape: News & Perspective: Medscape Medical News: FDA Approvals. Retrieved from: http://www.medscape.com/viewarticle/883095

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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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National Academies Panel Recommends Rethink on Opioids

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

A new report released by the National Academies of Science, Engineering, and Medicine (NASEM) makes several pointed recommendations about the way the United States Food and Drug Administration (FDA) approaches prescription opioid drugs, a class of pain relievers that are highly addictive and serve as a potential gateway to heroin, once supplies and sources of prescription drugs run dry (NASEM, 2017a). The panel, ordered under the Obama Administration’s FDA head in 2016, spent a year looking at the burgeoning opioid and heroin epidemics in the U.S. in an effort to better address these issues at every level of government (Diep, 2017). Among these recommendations are suggested guidelines for how the FDA considers the approval, regulation, and class scheduling of prescription opioid drugs.

National Academies of Science and Engineering Medicine

Photo Source: NASEM

Throughout the 1990s and early-2000s, pain advocates and pharmaceutical companies successfully lobbied the FDA to expand the indications (approved usage) for various high-powered opioid pain relievers that had previously been reserved for major surgeries, injuries, and palliative care. Purdue Pharma, in particular, scored a big win with its groundbreaking product, OxyContin, one of the first high-powered opioids to become commercially successful. What Purdue failed to mention while they were handing out free 30-day trial coupons for doctors to give to patients was that the drug was highly addictive. By the late-1990s, however, it became abundantly clear that these drugs had a high rate of addiction.

The recommendations put forth by NASEM as the FDA to adopt a position they term “opioid exceptionalism,” where “…the FDA thinks about opioid drugs differently from other products, …taking a public health approach to drug approvals and to other decisions about postmarket (sic) surveillance” (Servick, 2017). This would require the FDA to take into account the following:

  • benefits and risks to individual patients, including pain relief, functional improvement, the impact of off-label use, incident opioid use disorder (OUD), respiratory depression, and death;
  • benefits and risks to members of a patient’s household, as well as community health and welfare, such as effects on family well-being, crime, and unemployment;
  • effects on the overall market for legal opioids and, to the extent possible, impacts on illicit opioid markets;
  • risks associated with existing and potential levels of diversion of all prescription opioids;
  • risks associated with the transition to illicit opioids (e.g., heroin), including unsafe routes of administration, injection-related harms (e.g., HIV and hepatitis C virus), and Opioid Use Disorder (OUD); and
  • specific subpopulations or geographic areas that may present distinct benefit-risk profiles (NASEM, 2017b)

These recommendations come on the heels of a June recommendation by the FDA that pharmaceutical company, Endo, voluntarily remove its product, Opana ER, from the market in response to the public health crisis it says is in part because of illicit use of the drug by Injection Drug Users (IDUs) (Mandal, 2017). Endo recently complied with that request, despite insisting that it believes the drug to be safe when used properly (Ramsey, 2017).

Opana ER (Extended Release) is a reformulation of the drug in an effort to stem abuse by patients who were crushing the drug in order to snort it. This reformulation involved coating it with a plastic coating that Endo promised would make it “abuse deterrent/resistant.” Opana abusers, however, were quick to find a way around this by melting down the drug and its the plastic coating, filtering out the plastic through mesh, and injecting the drug directly into their bloodstream, resulting in a more intense effect (McEvers, 2016). Rather than alleviate abuse, Opana ER ended up creating a deadlier epidemic, as users were sharing needles to inject the drug, fostering the spread of both HIV and Hepatitis C (HCV). Once supplies of Opana ER dried up, those users often moved directly to heroin, as it is both cheaper and more readily available.

The NASEM recommendations will no doubt result in outcry from both pain advocates and pharmaceutical companies desperate to retain profits. Should they be adopted, the U.S. may finally be able to break its near-thirty-year abusive relationship with opioid pain killers.

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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Food and Drug Administration Pulls Opana ER from Shelves

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 April 2016, HEAL Blog wrote an entry about the fascinating and heartbreaking first episode of National Public Radio’s (NPR) series, Embedded. Host Kelly McEvers found a group of prescription opioid Injection Drug Users (IDUs) who allowed her to record an audio interview about their lives and how they use their drugs. The drug in question was Endo Pharmaceuticals’ powerful prescription opioid, Opana ER (McEvers, 2016). A little over a year after this broadcast, the Food and Drug Administration (FDA) reached the conclusion that the “…benefits of the drug may no longer outweigh the risks,” and have asked Endo to remove Opana ER from the market (Mandal, 2017).

What’s at stake here isn’t just a 4% increase in prescription opioid overdose deaths in 2016 (n=17,536), nor the 23% increase in heroin-related deaths (n=12,989); it’s not even the 73% increase in synthetic opioid-related deaths (n=9,580) (Stobbe, 2016). What’s at stake, at least for Endo Pharmaceuticals, is the $158 million in sales Opana ER brought in for Endo in 2016 – a 10% decrease from 2015 (Mandal). For Endo, pulling one of their most successful products from the market means a huge hit to their bottom line.

Opana ER pill bottle

Photo Source: Medcitynews.com

Opana ER, first introduced by Endo in 2006, was reformulated in 2012, when the manufacturers began adding a plastic coating to the outside of the pill to make it “abuse deterrent.” This move, while initially praised by the FDA and lawmakers as a great step forward to combating prescription drug abuse and addiction, simply shifted how drug users abused the drug. While the initial formulation could be crushed and easily snorted nasally, the plastic coating prevented this practice. Necessity (read: addiction) being the mother of invention, drug users found a way to abuse the drug by melting the plastic coating off, filtering the coating out through mesh, load the liquefied drug into a syringe, and injecting it straight into their bloodstreams. The McEvers Embedded piece literally goes over a step-by-step “How To” guide that is already known by IDUs.

The bottom line for states, counties, and municipalities who are having to cope with the 40,105 opioid drug-related deaths in 2016 comes down to more than just money – the issue is negatively impacting virtually every arena of daily life. Families are rent asunder, children are left orphaned, and emergency personnel are facing their own increased risk of overdose from inhaling or coming into direct contact with the powerful synthetic opioids, fentanyl and carfentanil, during overdose calls and drug busts. The risk of overdose due to exposure is so great that the Drug Enforcement Agency just this month issued a safety guide for first responders who might come into contact (Chanen, 2017).

Pain advocates who have long pushed for easy access to prescription painkillers argue that increasing restrictions places an undue burden upon patients who properly adhere to treatment regimens, using powerful prescription opioids as prescribed. To their way of thinking, regulations and prescribing limits unfairly limits the ability of those who live with chronic pain to function and/or go about their daily lives. Pain advocacy groups (many of which are conveniently funded by the very pharmaceutical companies whose drugs are at risk) have repeatedly, and in many cases successfully, lobbied state and Federal legislators to prevent the passage of any legislation that might hinder their access to these drugs.

I don’t buy it, and apparently, neither does the FDA. Endo Pharmaceuticals have said they’re “…evaluating the options and reviewing the situation to opt for an appropriate path forward.” Should the company refuse to remove the product voluntarily (as the FDA has asked), the agency intends to take steps to formally require its removal by withdrawing approval (Kean, 2017).

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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Treating HCV in Pediatric Patients

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 April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.

Stamp marked, "Approved" next to the initial, "FDA"

Photo Source: 3Dprint.com

Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”

The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.

One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.

Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.

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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The Negative Impact of Opioid Drugs Upon Children and Young Adults

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 early November 2016, a conference held at Xavier University in Ohio drawing hundreds of doctors, nurses, social workers, and addiction specialists began releasing shocking (though unsurprising) data related to the prescription opioid and heroin epidemic’s negative impact on children and teenagers. The findings indicate what many in healthcare already knew: we are at risk of creating a generation of children whose lives are fundamentally altered for the worse by addiction.

In the past few months, HEAL Blog has doggedly followed the unrelenting opioid-fueled devastation in the state of Ohio, and we have frequently brought to the fore the plight of children whose lives are have been put at risk due to their caretakers’ substance addiction and abuse. What we haven’t yet really covered has been the growing risk posed to children and teens whose access to opioids is made possible by their caretakers.

A study released in the Journal of the American Medical Association (JAMA) Pediatrics showed a 165% increase in opioid poisonings in children from 1997 to 2012 (Luthra, 2016). The rate of toddlers hospitalized more than doubled, and teens were found to be increasingly at risk of overdose (both intentional and unintentional) because they gained access to their parents’ prescription opioids without their knowledge. Both of these issues point to the need to better address overprescribing of opioid drugs, as well as to better stress the need for safer storage of prescription drugs.

Roughly 1 in 10 high school students admit to taking prescription opioid drugs for nonmedical reasons (McCabe, West, Boyd, 2013; Luthra, 2016), and roughly 40% say they got those drugs from their own prior prescriptions (Fortuna, Robbins, Caiola, Joynt, Halterman, 2016). This suggests that (1.) parents are not properly securing their own prescriptions and (2.) parents are not properly monitoring their children’s use and disposal of prescriptions. These suppositions raise questions about whether or not parents whose children or teens overdose should (or do) face negligence charges.

Prescribing guidelines continue to be tightened, as the U.S. Centers for Disease Control & Prevention (CDC) and the U.S. Food & Drug Administration (FDA) have both attempted to get physicians to limit prescriptions to shorter periods, and there is little evidence that imposing penalties upon people who fail to properly store or dispose of medications will have any appreciable impact on the adult behaviors. The concern, however, is whether or not those penalties will result in lower levels of abuse and poisoning on the part of children and teens.

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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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An Argument Against “Pain”

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

Last week, I posted a link from The Week, about John Oliver’s take on the prescription opioid epidemic. In his NSFW video, he does a largely comprehensive retrospective of how America became quickly addicted to opioid painkillers as the “go to” pain remedy beginning in the late-1990s, of course with his trademark British fire, ire, and expletive-laden delivery. Generally, this type of post generates a few laughs from my friends and agreeing comments from healthcare professionals who understand the scope of the epidemic. This time, however, I was surprised by a treatise on the perils of this type of video.

When it comes to issues where someone clearly feels “wronged” by legal prescribing guidelines, I often take a logical approach. Prescribing guidelines for opioids aren’t written to punish “responsible” patients who adhere to the dosage instructions listed on the label for medically necessary prescriptions. But, the argument that was made, in this case, was that, “…like anabolic steroids,” the risks associated with these drugs has been blown way out of proportion, and videos like these instill in physicians a sense of fear that prevents them from prescribing medically necessary drugs.

For whatever reason, friends of mine who know I work in research related to HIV, HCV, and Harm Reduction frequently come to me with their gripes about opioid prescribing guidelines. In this example, my friend had undergone oral surgery, and his physician refused to prescribe a three-day prescription for an opioid pain reliever in the state of California. My friend said that he was “forced” to get his medications on the “black market,” because his physician was “afraid to prescribe” him the drugs. Mind you, this person is not, in fact, a physician; he is, however, a bodybuilder who openly admits to taking anabolic steroids to get bigger (as per his earlier reference).

What frustrates me about this type of argument is that it presupposes that whatever type or level of “pain” someone is in requires the use of prescribed opioid painkillers; that, regardless of the prescribing guidelines, or even best practices or medical advice, their pain makes an opioid prescription “medically necessary.” It is an unfortunate consequence of living in a society with a U.S. Food and Drug Administration and prescribing guidelines that what one person, who is not a physician, believes to be medically necessary may not, in fact, be.

In a similar vein, another friend of mine, knowing that a segment of my research has to do with opioid prescribing guidelines, asked me if I knew a physician who would prescribe them to her, against her current physician’s recommendations. She believes that the pain management alternative he suggests is not long enough lasting, and that, because she doesn’t have an “addictive personality,” she should be prescribed opioids on a continuing basis to deal with her chronic pain.

For the record: I am not a physician, nor am I in touch with physicians who would violate their respective states’ Doctor Shopping laws or Lock-In regulations. I do not know where to get opioids on the “black market,” nor do I have any connections who can “hook you up” with some illegal prescription drugs. For whatever reason, my well-meaning friends, who may or may not have “addictive personalities,” have it in their heads that they know better about what drugs they should be taking than the licensed professionals who spent several years and hundreds-of-thousands of dollars to obtain their advanced medical degrees.

These prescribing guidelines aren’t just made to make individuals’ lives more complicated; they are designed to address very serious addiction issues that are leading people to their literal graves. I get it: you think your pain is great enough that you deserve special treatment. Well, you don’t. At some point, it became an issue of grave importance that no one, ever, feel any sort of pain, and that all pain needed to be treated with drugs meant to be reserved for people who were in severely unbearable pain. That is simply not the case, regardless of what your black market drug dealer tells you. Suck it up, a bit, and you will live, just as humans have managed to survive with a modicum of pain for tens of thousands of years.
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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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