Tag Archives: Mavyret

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:

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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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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:

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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, 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:

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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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Absolute Denial of HCV DAA Treatment Not Only Common, But Rising

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 high cost of curing Hepatitis C (HCV) with newer Direct-Acting Antiviral (DAA) drugs has been the fodder of many an article since their introduction into the commercial market in 2013 with Sovaldi (Gilead) and Olysio (Janssen). When Harvoni (Gilead) entered the market in 2014, its Wholesale Acquisition Cost (WAC) of $94,500 for 12 weeks of treatment, it was dubbed “The $1,000-a-Day Pill” by the media and a Congressional investigation was launched in the U.S. State Medicaid programs insisted that treating everyone with HCV on their rolls would not only obliterate their pharmacy budgets, but do so exponentially.

Gilead Sciences tried to do their part by offering a manufacturer Patient Assistance Program (PAP) that offered drastically reduced or free fills on these prescriptions if patients were denied coverage by Medicaid, Medicare, or their private insurer. That program was quickly inundated by patients whose payors instructed them to “…go and get it for free from Gilead.” By 2015, Gilead was forced to restrict the PAP to only the uninsured and those whose insurance denied coverage.

Now, new research published in Open Forum Infectious Diseases has found that, between 2014-2017, 52.4% patients with private insurance who were prescribed DAAs to treat their HCV infection were absolutely denied treatment (defined as “a lack of fill approval by the insurer”). In addition 34.5% of patients on Medicaid were denied, and a paltry 14.7% of patients with Medicare insurance were denied (Gowda, et al, 2018). These findings are compounded by similar research conducted regarding HCV treatment in correctional settings that found less than 1% of inmates infected with HCV in state correctional facilities were receiving treatment (Paukstis, 2018).

denied square red grunge stamp

Photo Source: emdlaw.com

This appalling record of absolute denials of treatment are a large part of why the U.S. has fallen behind comparable nations in achieving the elimination goals set forth by the World Health Organization in 2016, calling for the elimination of HCV as a public health crisis by the year 2030. Worse, these denials have come as the cost of treatment has dropped dramatically, from its high point with Harvoni, to its lowest point with AbbVie’s Mavyret, which has a WAC of $26,400 for 8 weeks of treatment ($39,600 for 12 weeks). Moreover, Mavyret sports comparable Sustained Virologic Response (SVR – “cure”) rates to Sovaldi, Harvoni, and Epclusa (Gilead). Worse still is that the WAC is largely a useless price point, as the vast majority of payors enter into pricing negotiations with the drug manufacturers and receive discounts and rebates that reduce that cost to a mere percentage of the WAC.

And, yet…

America’s healthcare problems are all solvable…in we are willing to go on the offensive against the corporate interests that we’ve allowed to run roughshod over our nation’s healthcare system since the late 1970s. We have allowed private insurers, drug manufacturers, and other private entities to turn healthcare away from being a profession designed to cure people – a system that we, as a nation, helped to flourish and turned into the best in the world in the mid-1900s – and into a for-profit industry whose main priorities revolve around further enriching the already rich.

We can combat diseases like HCV; hell, we managed to eradicate polio in the U.S. by 1979 with a vaccine that was created in 1953 and came into commercial use in 1955, with an oral vaccine following in 1961.

Jonas Salk, the creator of the first polio vaccine, once told Edward R. Murrow, when asked who owned the patent for the vaccine, “Well, the people, I would say. There is no patent. Could you patent the sun?”

Since that time, countless business writers and corporate shills have derided Salk’s statement, going so far as to call it “Communist propaganda.” And, yet, it is because of Salk’s vaccine that we managed to eradicate polio in much of the modernized world.

We need to get back to this way of thinking, as it relates to healthcare. It’s time to pull the profits out of healthcare, altogether, and if that means dismantling the private insurance market, then so be it.

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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Is it Time for a Rethink on Hepatitis C Care?

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 the state of West Virginia, any Medicaid beneficiary who is diagnosed with Hepatitis C must personally or through their prescribing doctor consult with either an Infectious Disease specialist or a doctor whose specialty includes Hepatitis C (e.g. – a Hepatologist) in order to have their prescription for Hepatitis C (HCV) Direct-Acting Antivirals (DAAs) approved. In addition, the patient must have a Metavir fibrosis score of F2 or higher as a prerequisite, as well as abstain from illicit drug and alcohol use for a period of 3 months.

These additional barriers to treatment are not only time consuming, but potentially costly. The consultation requirement, alone, exponentially increases the amount of money Medicaid must reimburse just in order to fill a prescription that can now be obtained for potentially $10k per patient (this, according to hearsay, since actual prices paid are forbidden from being made public by existing Trade Secrets laws). Beyond that, even current screening practices tend to require patients to see a specialist, just to get screened for the disease. This is both problematic, and relatively easily remedied.

Barriers to seeing out health care. About 1 in 2 Americans admit they have put off needed health care and have avoided going to a doctor when necessary.

Photo Source: VeraQuest

With the introduction of HCV DAAs in 2013, HCV patients gained access to what was once thought improbable – a relatively easily tolerated “cure” with a high level of efficacy and considerably fewer and less serious side effects. Since that time, an additional nine HCV DAAs have been brought to the market, with newer drugs coming down the pike. The most recent release, AbbVie’s Mavyret, is a potential game changer, offering curative treatment in 8-to-12 weeks for roughly 1/3 to 1/2 the price of the most popular drugs on the market, while sharing essentially identical cure rates. In fact, Mavyret has become the Preferred Drug for several Medicaid Fee-for-Service and Managed Care Organization (MCO) plans since its approval in August of last year.

But, still, issues remain. In West Virginia, the rate of HCV more than doubled from 3.4 (per 100,000 persons) in 2015 (CDC, 2017) to a staggering 7.2 in 2016 (West Virginia Department of Health and Human Resources, 2018). While increased screening may account for this considerable increase, 68% of new Acute HCV infections listed Injection Drug Use (IDU) as the primary risk factor (WV DHHR, 2018), which indicates that increased screening of this community needs to be a priority.

Some of the ways that this can be accomplished is at the regulatory level – requiring screening of all adults in virtually every healthcare setting (e.g. – emergency rooms, primary care, community health centers, urgent care clinics, and correctional settings). In fact, in a simulation model, researchers from Boston Medical Center, Mass. General Hospital, and Stanford University found that this expanded screening protocol would increase life expectancy and quality of life, while also remaining cost effective (Legasse, 2018).

The strategy would also identify an estimated 250,000 more HCV cases than the current U.S. Centers for Disease Control & Prevention (CDC)-recommended strategy of focusing screening efforts on the Birth Cohort – individuals born between 1945-1965 (Green, 2018). This would have a projected benefit of increasing cure rates from 41% to 61%, while also reducing the risk of death from HCV-linked conditions by more than 20% compared to the current CDC guidelines (Toich, 2018).

It is clear that expanding screening to include all adults, rather than focusing efforts on the Birth Cohort and those whose doctors are aware of any other risk factors (because, let’s be honest – few people who inject drugs are open about that with most doctors, unless they’re there for an IDU-related condition or because of an overdose, at which point, it’s pretty obvious). Once we achieve THAT measure, we can move on to allowing Primary Care Physicians and Registered Nurses begin to administer and monitor HCV DAA therapy, because, it’s just not that difficult to do.

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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Colorado Takes Big Step Towards Eradicating HCV

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 state of Colorado took the enormous first step towards eradicating Hepatitis C (HCV) in the U.S. by lifting HCV treatment requirements for citizens who receive health benefits from the state’s Medicaid program. The move comes after the American Civil Liberties Union (ACLU) of Colorado filed a class-action lawsuit against the state for continuing to ration HCV care for Medicaid patients, and after health officials in the state asked for those restrictions to be removed (Brown, 2017).

ACLU logo

Photo Source: ACLU

The ACLU has been instrumental in winning treatment for patients living with HCV in the country’s incarcerated populations, filing suits against several states’ Departments of Corrections for failing to adequately supply HCV treatment to inmates whose HCV status is known. Inmates are the only Americans who are guaranteed healthcare coverage under the Constitution after a 1976 Supreme Court ruling found that “deliberate indifference” to an inmate’s medical needs constitution “cruel and unusual punishment” under the 8th Amendment (Estelle v. Gamble, 1976).

In both incarceration settings and state Medicaid programs, various hurdles have been put in place that require patients to do extra legwork to gain access to treatment that the programs must offer in order to save money on what were extremely expensive revolutionary HCV Direct Acting Antivirals (DAAs) that effectively cure patients of HCV. The most expensive of these medications, Harvoni (Gilead), has a Wholesale Acquisition Cost (WAC) of $94,500 ($1,125 per pill) for 12 weeks of treatment – the standard regimen length used to achieve Sustained Virologic Response (SVR – “cure”). Since Harvoni’s 2014 release, several new DAAs have come on the market, and after much outcry from patients, advocates, and the U.S. Congress, prices have been driven down. The most recent DAA therapies – Vosevi (Gilead) and Mavyret (AbbVie) – entered the market at $74,760 ($890 per pill for 12 weeks) and $26,400 ($471.42 per pill for 8 weeks) respectively.

Mavyret, AbbVie’s most recent HCV therapy, has the potential to be a financial game changer for state-run healthcare programs that have struggled to ensure that patients receive the treatment they need while not simultaneously destroying their pharmacy budgets to pay for it. That said, WAC costs serve only as a baseline price for any drug that enters the market, after which the various programs and insurers (payors) begin a negotiation process with the drug manufacturers to determine the final cost paid after rebates, pricing agreements, and deductions. The conventional wisdom is, “Well, nobody pays the WAC price.” Unfortunately, these final prices are not readily available to the public, as they fall under existing Trade Secrets laws that prevent the programs from publicly stating the final cost they pay for the drugs.

AbbVie's Mavyret medication

Photo Source: AbbVie

State Medicaid programs have been under considerable fire from HCV advocates, as well as the Department of Health and Human Services (DHHS), who have long stated that Medicaid programs should remove barriers to treatment that have included fibrosis score requirements (“Is the patient’s liver damaged badly enough?”) and abstinence from drugs or alcohol. Colorado’s removal of these barrier to care is a phenomenal first step that should be followed by other state Medicaid programs.

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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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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