Tag Archives: Direct Acting Agents

HCV Prescribing Lags While Prices Soar

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

An article in Newsweek in March 2017 talked about a “…crowded and confusing” landscape for treating Hepatitis C (HCV) that prevents many Primary Care Physicians (PCPs) from prescribing the new Direct Acting Agents (DAAs) to treat the disease (Wapner 2017). The argument posed is that, physicians are “…still too unfamiliar with the regimens to speak with confidence about them,” according to Ira Jacobson, a hepatologist who leads the department of medicine at Mount Sinai Beth Israel Hospital in New York. He posits that this discomfort leads them to send patients to liver specialists, or to delay treatment until more severe symptoms arise, the latter of which is a regular pre-requisite on virtually every Prior Authorization (PA) request form.

This argument caught my eye, as someone who writes about and researches coverage for these DAA drugs, as has done so since 2013. One of the most frequent conversations I heard when Sovaldi (Gilead) and Olysio (Janssen) were first released on the market was that there was confusion over which doctors could prescribe them. Unlike HIV, treatments for HCV largely lagged in the ‘completely intolerable’ realm, with patients dropping out of treatment like flies and a success rate of only around 50%. Things, however, have radically changed; the question, then, becomes, “Have doctors?”

Prescription Pad

Realistically, we have a considerable problem, in the United States, with aspiring doctors choosing to specialize, rather than going into general practice, in no small part because it guarantees them higher incomes. Higher incomes for them, however, means higher costs to consumers, in the same way that higher-priced drugs to treat chronic conditions get shunted into the highest pricing tiers. This gets passed along to consumers in the form of higher co-pays for visits ($25 for PCPs; $75 for Specialists), and higher co-pays for medications ($3 for blood pressure medication; $250 for HIV).

This problem extends, also, to prisons and jails – the high cost of treatment serves as a significant barrier to providing inmates with treatment, which presents a larger issue, because inmates have an exponentially higher incidence and prevalence of HCV than the general population (Gloucester Times, 2017). Testing prisoners is expensive, as well, as inmate populations swell, while prison healthcare budgets remain relatively stagnant. Once those prisoners are released back into the general population, if they’re unaware of being infected with HCV or whose infections have gone untreated, they can go on to infect those who are not part of the prison system, are also unlikely to be tested and treated.

Beyond just the cost of co-pays are the long-term costs of PCPs being reticent to screen or prescribe for HCV: failing to address HCV will lead to liver decompensation, liver cancer, kidney diseases and failure, higher HCV viral loads that make spreading the disease easier, jaundice, digestive illnesses, and thyroid issues, none of which are particularly cheap to treat. The host of accompanying side effects of leaving the disease untreated far outweigh the admittedly outlandish prices set by HCV drug manufacturers.

The reality is that any medical doctor who has prescribing privileges can prescribe these new treatment regimens. The vast majority of these doctors also have access to smartphones, all of which have any number of apps designed to compare new drug regimens with existing prescriptions to ferret out counter-indications; there is, in fact, an entire website specifically aimed at finding counter-indications (http://www.hep-druginteractions.org/) that also offers mobile apps. The argument that doctors are unsure of the counter-indications is really rendered moot by the existence of these easy-to-use tools.

With that, the biggest hurdle to overcome, for virtually every party involved, is the cost of treatment, and with the current administration’s funding priorities being…questionable, at best…it’s unapparent if even the existing treatment coverage landscape will exist. We’re hoping for more stable conditions, and less erratic proposals. Until then, we’ll just keep plugging to try and find a solution.

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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Hepatitis C and Medicare Part D

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

HEAL Blog has consistently covered the cost of new Direct Acting Agents (DAA) used to treat Hepatitis C (HCV), as well as the impact those prices have had on state Medicaid and AIDS Drug Assistance Programs (ADAPs). What we haven’t really covered is how those costs have impacted Medicare and the Medicare Part D program.

In addition to writing for HEAL Blog, I also serve as the Project Director for the HIV/HCV Co-Infection Watch. Last year, we looked into expanding our reporting of HCV drug coverage to include Medicare Part D markets, and what we found was that it was simply too much data to fit into an already then-76-page report. In June, I went ahead and looked at coverage for the Part D Standalone drug plans, and wound up scouring 923 different plans across the country and in five territories. What I discovered was that 922 plans covered the two most expensive HCV drugs on the market at that time – Sovaldi and Harvoni (Gilead).

That translates into staggering figures for Medicare Part D expenditures, as outline in reports from the Centers for Medicare and Medicaid Services (CMS). In 2014, spending on the three most-prescribed HCV drugs – Sovaldi, Harvoni, and Olysio (Janssen) – totaled $4.665 billion (CMS, 2016). Preliminary data obtained by the Associated Press (AP) from CMS estimate that the cost of HCV drugs to Medicare in 2015 nearly doubled, coming in at roughly $9.2 billion (Alonso-Zaldivar, 2015). This figure comes despite the introduction in 2015 of HCV therapies with lower Wholesale Acquisition Costs (WACs) than the $87,000 Sovaldi or $94,500 Harvoni.

Since the introduction of Sovaldi and Olysio in 2013, HCV drugs have consistently ranked in the top ten drug expenditures for Medicare Part D, as they have for Medicaid and the Veterans Administration (VA). The primary difference is that both Medicaid and the VA pay lower prices for the drugs as a result of state Medicaid negotiating power and the VA’s “Best-Price” rule that requires pharmaceutical companies to provide drugs at the lowest possible price. Medicare, however, is prohibited from negotiating drug prices as a result of the Medicaid Modernization Act (2003) that established Medicare Part D. One of the main provisions of the Act states that, “…in order to promote competition,” the Health and Human Services (HHS) Secretary “…may not interfere with the negotiations between drug manufacturers and pharmacies and prescription drug plans.”

President Donald J. Trump

Photo Source: UPI

Democrats have long attempted to pass legislation that would amend this provision, and may have found a new, not-so-secret weapon – President Donald Trump (Tribble, 2017). He has repeatedly stated that he believes Medicare should have this power, much to the consternation of Tom Price, Trump’s own Secretary of Health and Human Services, and Republicans, who have long held that Medicare negotiating drug prices amounts to Federal tyranny, Big Government, and anti-“Free Market” practices. But, even those Republicans are balking at the high cost of HCV drugs.

HEAL Blog will continue to watch in the coming months how this situation plays out, but we can be certain that, like every Trump initiative, the path will be fraught with confusion, disarray, and uncertainty.

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 Imperfect Prison Health System

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

One of the primary issues for people in America’s vast prison system is the issue of healthcare rights and treatment. In fact, prisoners are the only Americans who are Constitutionally guaranteed the right to treatment for health conditions under the 8th Amendment, specifically the “cruel and unusual punishments” clause (Estelle v. Gamble, 1976). This ruling has been used since 1976 to ensure that inmates who are infected with HIV, and now, Hepatitis C (HCV), receive the appropriate medical treatment to which they are guaranteed under that decision. Additional arguments can be made that using a “Treatment as Prevention” (TAP) model in incarceration settings will help to stem the spread of various Sexually Transmitted Diseases (STDs) and Infection (STIs), including both HIV and HCV.

Over the past two years, HEAL Blog has covered various aspects of the HCV treatment provision for inmates in various states. Several states, including Tennessee, Nevada, Missouri, Washington state, and Pennsylvania, are currently facing lawsuits brought my inmates and advocates in state and Federal courts to force their respective Departments of Corrections to provide treatment to HCV-infected patients. Unfortunately for the states – and more specifically, their budgets – courts have seemed inclined to agree with both advocates and inmates: providing treatment and a cure for HCV is mandatory, regardless of the expense.

Nurse administer care to an inmate.

Photo Source: Prison Protest

The primary argument used by states and their respective Departments of Corrections is that the high cost-per-patient/per-cure is simply an unreasonable expenditure, given the long-term nature of the disease (meaning the length of time from gestation to serious illness to death). The cheapest Wholesale Acquisition Cost (WAC) of the newer Direct Acting Agents (DAAs) to treat HCV – Zepatier (Merck) – is $54,600 for twelve weeks of treatment, before any discounts, rebates, or pricing agreements struck between states and the drug manufacturers. Viekira XR (AbbVie) and Epclusa (Gilead) cost $83,319 and $74,760, respectively, which makes treating inmates with HCV incredibly expensive in one go.

Gilead and other manufacturers have argued – with only moderate success – that the short-term high cost of a cure actually ends up costing less in the long-term, when compared to both the co-infections and –morbidities (co-existing conditions) that can accompany untreated HCV infections, and the long-term cost of treating other serious chronic illnesses, which over a course of several years, account for far more money being spent to treat them. While this argument may look great on paper for the manufacturers, for government employees and elected representatives who are tasked with prepared, appropriating, and allocating funds in a budgeting process, it’s simply not a feasible one. By their way of thinking, long-term illnesses represent costs that can be spread out over time, while HCV manufacturers expect a cure, right up front, set at a budget-breaking price.

States have found a unique way of getting around the 8th Amendment statute that courts have ruled guarantees treatment: they simply fail or refuse to screen incoming and existing inmates. Many states require that inmates only be screened for HIV during the intake process, allowing prison officials to essentially feign ignorance about their prisoners’ health – if they don’t know, they don’t have to treat. Unfortunately for the state, prisoners are getting wise to this tactic, and are taking them to court to force treatment. Nevada, for example, reported 593 inmates with HCV, including just two who were receiving treatment (0.34%) in 2015 (Botkin, 2017). By March 2016, a total of only nine inmates were receiving treatment.

Given the vast budget constraints placed upon states, we at HEAL Blog understand that the cost of treating every HCV-infected inmate is a potentially financially disastrous proposal, and a non-starter in virtually every state. Attempting to get around those costs by ignoring the problem is simply an unacceptable way for state and Federal prisons to operate. Yes – treatments are expensive; but, when lives are at stake, trying to get around a Constitutional obligation to treat is simply unacceptable.

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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HIV and Hepatitis C Counterindication Conundrum

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 two separate posts in 2016, HEAL Blog covered the complex world of treating Hepatitis C (HCV) infections in people co-infected with HIV. While both HIV and HCV treatment regimens have reached groundbreaking levels over the past decade, negative drug interactions between regimens to treat the two conditions still leaves something to be desired.

A recent study published in the Journal of Hepatology found that one of the most popular drugs to treat HCV, Sovaldi (sofosbuvir, Gilead), can have serious drug interactions when used in combination with Viread (tenofovir disoproxil, Gilead), as well as other drugs used to treat HIV (Semedo, 2016 & Shen, 2016). The primary issue discovered by this study (as well as other studies) is that Sovaldi and other Direct-Acting Agents (DAAs) containing sofosbuvir, such as Harvoni (Gilead) and Epclusa (Gilead), can cause liver or kidney toxicity when co-administered with Viread and other HIV drugs. This is of particular concern, as one of the main health issues caused by HCV is liver fibrosis.

The study’s co-author, Bingfang Yan (Ph.D.) suggests that a potential method of getting around this counterindication would be to administer the regimens at different times, or by using different delivery methods (e.g. – administering the HIV regimen first, or through the skin, and the HCV regimen taken orally at a different time).

One issue facing both physicians and patients is that only a handful of long-term or longitudinal studies have been conducting, meaning that both physicians and patients have only counterindication warnings to go upon, that only suggest potential side effects may occur without definitive scientific proof. This can create considerable consternation for all parties involved, as one recommendation is clear: HIV treatment should not be suspended in order to treat HCV infections. The nature of HIV is such that ceasing regimens can lead the virus to develop immunities to the components of the therapy, meaning that a new treatment option will need to be selected. While the negative side effects of HIV drugs has eased over the past thirty years, each patient’s individual body chemistry is unique, and it can take time to find the right regimen for each patient.

A fantastic resource for checking counter-indications between HIV and HCV drugs is HEP Drug Interactions, a project of the University of Liverpool in the United Kingdom. This free website allows users to use the HEP Drug Interaction Checker to see which HCV regimens have counter-indications with drugs to treat virtually any medical condition. The site is sponsored by Janssen, Gilead, Merck, Bristol-Myers Squibb, and AbbVie, each of which make drugs to treat HCV. The site also offers mobile apps for both Apple and Android devices, where users can access the same HEP Drug Interaction Checker information that is available on the full site.

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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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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