Tag Archives: Food & Drug Administration

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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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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AbbVie Receives FDA Approval for Viekira XR

By: Marcus J. Hopkins, Blogger

AbbVie, the makers of the Hepatitis C (HCV) Direct Acting Agent (DAA) drug regimen, Viekira Pak, have received final approval from the Food and Drug Administration (FDA) for their new combination regimen, Viekira XR. The move by AbbVie provides patients with a simpler regimen to follow, in the hopes of increasing regimen compliance.

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

Photo Source: 3Dprint.com

The chief complaints about the AbbVie regimens from physicians and patients, alike, have been the use of multiple individual component pills – four with the original Viekira Pak, three with Technivie, and now, three with Viekira XR – as well as the dosing guidelines, which require pills to be taken at different times of the day in order to maintain consistent levels of the drug in the body. These complaints hearken back to similar complaints made about multi-pill regimens used to treat HIV, that required multiple doses per day. Regimen compliance with multi-pill regimens is thought to be lower, because patients report feeling more burdened by having to stop what they’re doing, multiple times per day, in order to take their meds. This argument seems to hold sway, as many of the newest regimens for both HIV and HCV are single-pill regimens (occasionally boosted by a second pill), which require far less effort on the part of busy patients. Viekira XR responds to this by simplifying the regimen down to a once-daily dose of one pill containing ombitasvir, paritaprevir, and ritonavir, and a second pill containing dasabuvir.

Like Viekira Pak, Viekira XR is designed for use in patients living with HCV Genotypes 1a and 1b. Technivie, which has all of the same components as Viekira Pak minus the dasabuvir, is for use in patients with HCV Genotype 4, and was the first DAA drug that was specifically used for that genotype. AbbVie may, however, face considerable competition for their new drug, unless they choose to entre the drug into the market at a lower Wholesale Acquisition Cost (WAC) that Gilead Science’s latest pan-genotypic drug, Epclusa, which hit the market in late June at a price of $75,000 before discounts, rebates, or pricing negotiations. Viekira XR has not yet received a WAC announcement at the time of writing.
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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 Almost Cleverly Named HCV Drug to Beat Them All

By: Marcus J. Hopkins, Blogger

The U.S. Food & Drug Administration (FDA) and Gilead Sciences – maker of the most commonly prescribed Hepatitis C (HCV drugs), Sovaldi and Harvoni – came out with yet another fantastic cure for Hepatitis C: Epclusa. What makes this drug a real miracle? Let’s take a look:

Epclusa is the first pan-genotypic HCV therapy, meaning that it works across HCV Genotypes 1-6. This is a potential coup for Gilead, who has faced occasional threats from other manufacturers whose drugs targeted those genotypes that neither Sovaldi, nor Harvoni (alone) addressed. The new ingredient – velpatisvir – is used in combination with the sofosbuvir (Sovaldi) from both of their earlier regimens, which one must assume is what allows it to be used across all genotypes with an average SVR (“cure”) rate of 94%. This advancement, alone, is amazing, given how difficult to treat HCV was a scant four years ago.

The second-best bit of information about Epclusa is its introductory Wholesale Acquisition Cost (WAC) of “only” $74,760 for twelve weeks of treatment.

Pill bottle of Epclusa medication for Hepatitis C

Photo Source: InfoHep.org

Gilead has become the face of congressional-, physician-, advocate-, and payer-led accusations of price gouging, with Sovaldi coming in at $84,000 and Harvoni at $94,500, and they have clearly taken the calculated risk of introducing Epclusa at almost $10k cheaper than one of its component drugs by itself. After three years of price-related bad press, there was great concern within the HCV world that their much lauded pan-genotypic drug was going to easily cost over $100k, and given the range of genotypes it’s used to treat, it stood to reason that this would be the case. Gilead, however, seems to have either learned from their miscalculation of what consumers, states, and insurers were willing to pay, or they’ve decided that the record profits they’ve enjoyed from their previous successes allowed them to offer this new drug as a significantly lower price. Either way, even before discounts and rebates, Epclusa’s price point is a net win for all parties.

My only beef with Epclusa has literally nothing to do with its efficacy or its price; rather, I’m a bit miffed at Gilead for not taking the name one step further to make it truly clever. “Epclusa” is fine, and all – the “-clusa” part clearly referencing its all-in”clus”ive pan-genotypic nature – but they really missed a golden opportunity by not placing an ‘H’ at the beginning, making it “Hepclusa,” allow for both “Hep-“ for “Hepatitis” and the ‘c’ in “-clusa” to serve a dual purpose for “Hep C.” Maybe, it’s the writer in me, but come on guys: if you’re going to be amazing, be amazing all the way.
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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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