Tag Archives: Mavyret

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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