Tag Archives: AbbVie

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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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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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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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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Footing the Bill

By Marcus J. Hopkins, Blogger

As a society we need a way of determining what is a reasonable price at the time of introduction of a new drug,” said Stephen Schondelmeyer, a University of Minnesota professor who specializes in pharmaceutical economics. “We have expanded coverage, but we haven’t done anything to control costs on the pricing side.” (Alonso-Zaldivar, 2015)

Truer words are rarely spoken in the world of healthcare coverage. In a time of unprecedented increases in “covered” Americans, the promised “savings” haven’t really materialized, either for payers or for consumers. Rather, the spending on specialty medications has increased so exponentially that both private and public payers are finding themselves faced with difficult choices, when it comes to what coverage can be offered for the amount that consumers pay.

For private insurers, the answers are simple: increase premiums, expand and strengthen prior authorization criteria to restrict access, and place the drugs in the highest available tiers with the highest drug co-pays. For public insurance programs, such as Medicaid, Medicare, and the AIDS Drug Assistance Program (ADAP), the solution is not so clear cut.

For Medicare, specifically, Federal law currently prohibits the program from negotiating with drug manufacturers for lower prices. As recently as February 2015, the Obama Administration requested authority to negotiate prices for Medicare, in large part because of the price of high-cost specialty drugs, such as Sovaldi (Gilead), Olysio (Janssen), Harvoni (Gilead), and Viekira Pak (AbbVie) (Morgan, 2015).

LOGO: Centers for Medicare & Medicaid Services

Photo Credit: Medicare Learning Network

Both Medicaid and Ryan White programs can negotiate for drug prices, but even still, those negotiations are largely kept secret, and the true cost is rarely shared with the public. For that reason, we rely on two measures to express the cost of drugs on the American market: the Wholesale Acquisition Cost (WAC) and the Average Wholesale Price (AWP). Even with those standards in place, nobody actually pays those costs, due to various rebates, negotiations, and other pricing schemes, all of which is available only if you all but threaten them with the comfort of a nice set of thumbscrews.

In fact, getting actual pricing information based on what payers actually pay, often involves Freedom of Information Act (FOIA) requests from government agencies, and threats of lawsuits to get the same information from private insurers. Much of the problem is that no one really wants to show their hand, especially when it comes to the prices that they pay for specialty drugs, because doing so might disrupt some balance of the space-time continuum, creating a paradox, and the entire healthcare system would collapse.

…or maybe, something not quite so dramatic.

It’s likely because openly stating how much everyone is paying for drugs would result in one of two outcomes:

  • Each payer would be able to compare and contrast what they were paying for various drugs, and would thereby be able start a “race to the bottom,” creating a low-bidding war. In addition, the public would be able to see how well payers were bargaining in their own best interests, rather than consumers. In this case, both insurers and drug companies would be on the losing end of the battle, and it behooves them to keep information about payment schemes private.
  • It would be revealed to both the public and the payers exactly how much of the cost drug companies are willing to eat (through rebates and other scenes) just to get their drugs on the market, thus revealing that the whole pricing model companies use to determine drug prices is a farce. In this case, drug companies would be on the losing end, primarily, because they would finally have to publicly justify in quantifiable terms the costs of their medications.

In truth, either scenario could be nothing but a net “win” for consumers. So long as the American healthcare system continues to subsist in an insurance-based market, the only real weapon consumers have against being price gouged is open, honest, and accurate pricing information – a clear explanation of how drug prices are decided, a clear explanation of what each payer is actually paying, and how much drug companies are willing to forego in order to sell more of their drugs.

Without this information being made public, how can there really be a “free market?” How can consumers make a truly informed choice if this information is kept secret? That really is the crux to dismantling the insurance scam – making everyone reveal what they’re actually paying for drugs and services.

What Dr. Schondelmeyer asserted in the opening quote of this piece is absolutely correct: the Affordable Care Act has done a great job of forcing getting people into the health insurance market, but has done very little to deliver the “savings” it promised. We’re still paying more than virtually every other economic superpower for our healthcare, and still achieving subpar results.

Now, private insurers are arguing that the cost of covering these people has become so burdensome [to their profits and bottom lines] that they need to increase premiums by up to 40%. We have effectively handed over clients to private entities without ensuring that people will be able to pay their prices, leaving the “Affordable” part of the law’s title hanging in the wind.

For how much longer can our insurance-based healthcare system continue to operate without imploding upon itself? For how much longer will consumers continue to allow drug and service pricing scams to continue, before determining that there is a better way? Sadly, I don’t think there’s enough interest on the part of Americans to do anything about it…until they’re forced to foot the bill, themselves.

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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