Tag Archives: Direct Acting Agents

2nd Annual HIV/HCV Monitoring Report Released

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

On September 21st, 2017, the Community Access National Network (CANN) hosted the 2nd Annual National Monitoring Report on HIV/HCV Co-Infection at the Pharmaceutical Research and Manufacturers of America (PhRMA) headquarters in Washington, D.C. Presentations were delivered by yours truly, and Amanda Bowes, Manager on the Health Care Access team for the National Alliance of State and Territorial AIDS Directors (NASTAD), both of whom focused on issues of coverage for Hepatitis C (HCV) Direct Acting Antivirals (DAAs) for the 59 AIDS Drug Assistance Programs (ADAPs) and Medicaid programs, as well as information about the U.S. Department of Veteran Affairs (V.A.) and Harm Reduction measures.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

Key findings of my presentation indicate that, as of August 2017, 33 state ADAP programs offer coverage for DAAs on their ADAP formularies, an increase of six states from August 2016. Additionally, all 50 states and the District of Columbia have offered expanded coverage for DAA drugs since August 2016. In March 2016, the V.A. began offering treatment with DAAs to every eligible veteran. In terms of Harm Reduction, several states have authorized Syringe Services Programs (SSPs) in an effort to prevent the spread of HIV, Hepatitis B (HBV), and HCV since Congress ended the ban on Federal funding for Syringe Exchange Programs in January 2016.

One other key finding was that, in seven of the states with the ten highest rates of HCV infection, ADAP programs offer either no coverage for HCV drugs or offer coverage only for older, less easily tolerated treatments requiring the use of Pegylated-Interferon (PEG-INF). These states include (in order of highest HCV infection rates): WV, KY, IN, NM, AL, NC, and OH.

Key findings of Mrs. Bowes’ detailed presentation indicate that NASTAD has actively been attempting to increase HCV DAA coverage by ADAP programs in cooperation with the Health Resources and Services Administration (HRSA) while still maintaining fiscal solvency. This consultation, in June 2016, included ADAP and Viral Hepatitis (VH) program staff, Federal partners including the Centers for Medicare and Medicaid Services (CMS), U.S. Department of Health and Human Services (HHS), HRSA, and the U.S. Department of Veteran Affairs (V.A.), providers specializing in treatment for HIV/HCV co-infection, community partners, and NASTAD staff. The meeting was comprised of a panel of Federal representatives, a presentation on the best practices for ADAP HCV treatment utilization, and a discussion of the various barriers preventing ADAP programs from expanding coverage, clinical management of HIV/HCV co-infection, and policies and procedures for HCV treatment among People Living With HIV (PLWH).

Additionally, NASTAD gathering detailed information related to how ADAP programs covered the cost of HCV DAAs, finding that programs that offered Insurance Continuation (purchasing private insurance coverage for ADAP clients) and paid for the co-pays, rather than paying the full prescription cost, were able to save considerably over paying directly for the medications.

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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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Hepatitis C Therapies Added to WHO Essential Medicines List

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

Since 1977, the World Health Organization (WHO) has published its Essential Medicines List containing the medications considered to be the most effective and safe to meet the important needs in a health system. This year, the organization has included the following Hepatitis C (HCV) Direct Acting Agents (DAAs) Sovaldi (Gilead), Olysio (Janssen), Harvoni (Gilead), Viekira/Viekira XR (AbbVie), Daklinza (Bristol-Myers Squibb), Technivie (AbbVie), and Epclusa (Gilead) (WHO, 2017). Notably absent from this list is Zepatier (Merck) – to date, the lowest priced HCV DAA with a Wholesale Acquisition Cost (WAC) of $54,600.

World Health Organization logo

Since the 2013 launch of Sovaldi and Olysio, new drugs to treat HCV have entered the market at a relatively rapid pace, from just two drugs in 2013, to nine drugs by 2016. That said, two or more new drugs hit the market in 2017:

AbbVie’s new next generation protease inhibitor & NS5A inhibitor known as G/P or GLECAPREVIR/PIBRENTASVIR; Gilead’s new triple [combination] of Sofosbuvir + Velpatasvir + Voxilaprevir which contains their new protease inhibitor (Vox.); [Merck’s new triple combination] (Uprifosbuvir) + Grazoprevir + Rusasvir; [Janssen’s] new triple AL-335 + Odalasvir + Simeprevir (Levin, 2017).

With so many treatment expensive options available to treat HCV, as well as the availability of reasonably priced generics in lower-income countries, there is little doubt that these medicinal cures for HCV should be included in every nation’s list of essential drugs. Furthermore, research shows that the generic versions of Sovaldi, Daklinza, and Rebetol (Ribavirin) are as effective as their brand name counterparts (Preidt, 2016).

Some concerns exist, however, that the high cost of treating HCV in nations who are forced to pay the high price for brand name drugs will prevent these cures from reaching the patients most in need. The Centers for Disease Control and Prevention (CDC) recently released a report detailing how restrictive state Medicaid policies – as well as state restrictions regard Syringe Exchange Services/Programs (SESs/SEPs) – are contributing to the vast increase in new HCV infections (CDC, 2017). Most states’ Medicaid programs require Prior Authorization (PA) standards for HCV drugs that are stricter than for most cancer-related treatments, in no small part because those prerequisites serve as cost containment tools – the more complicated and cumbersome the requirements, the less likely the program is to have to cover the cost of treatment.

While the inclusion of HCV DAAs to the WHO Essential Medicines List is an important step forward toward nations including them on their own lists, the high cost of the medications may prove prohibitive to some nations doing so. As the battle over “what the market will bear” soldiers on, HEAL Blog will continue to monitor the situation.

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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U.S. Department of Veterans Affairs Requests Increase in HCV Funding

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

Cover of the FY 2018 Budget Submission

Source: U.S. Department of Veterans Affairs

The United States Department of Veterans Affairs (VA) has laid out plans to continue their open treatment policy for eligible veterans living with Hepatitis C (HCV) into 2019 and beyond. The budget request sent to Congress – Fiscal Year (FY) 2018 and FY 2019 Advance Appropriations – highlights some of the successes the program has achieved in delivering comprehensive HCV treatment using Direct Acting Agents (DAAs) to cure HCV, as well as puts forth a request for an additional $751 million in funding specifically for HCV treatment. This is a $151.2 million increase from the 2018 Advance Appropriations requested in the previous year’s document.

The VA began offering treatment to all veterans in its health system regardless of their disease stage in March 2016 (Kime, 2016), a major step forward for the program, as the high cost of newer DAA drugs have proven prohibitive to decisively moving to eradicate HCV within other government healthcare programs enrollees. This also allowed veterans who were “…waiting on an appointment for community care through the Choice program [to] turn to their local VA facility for this treatment or elect to continue to receive treatment through Choice.” The Veterans Choice Program – introduced in 2015 – is a temporary benefit that allows veterans who were enrolled in VA health care prior to August 01, 2014, or who are eligible to enroll as a recently discharged combat veteran, to receive care in their communities, rather than waiting for a VA appointment or traveling to a VA facility (Peterson, 2015).

In the document recently sent to Congress, the VA also touted some of the successes of the program:

  • As of December 2016, 78.8% of Veterans in care in the 1945-1965 Birth Cohort – those most likely to have HCV in the U.S. – were screened for HCV, and the VA estimates that an additional 15,500 veterans in VA care remain undiagnosed.
  • From January 2014 through March 2017, the VA has treated over 84,000 veterans with cure rates over 90%.
  • As of February 2017, 61,000 veterans diagnosed with HCV were potentially eligible for treatment.
  • The VA estimates that approximately 80% of all veterans with HCV enrolled in VA care will be treated by 2020. Veterans remaining in the untreated pool at that time are estimated to be more difficult to engage in care due to issues like homelessness, mental health, and substance use comorbidities, or may be uninterested or unwilling to receive HCV treatment.
  • The number of total national HCV treatments increased from approximately 2,800/year in 2011-2013, to over 30,000 in 2016. This growth reflects the additional demand for HCV treatment with DAAs, beginning the second quarter of 2014 through the present.

The VA’s approach to treating veterans is a success story that CAN be repeated by other government-run healthcare programs, but doing so will require state and Federal governments to exponentially increase funding in order to eradicate HCV within the populations most likely to become infected. The Centers for Disease Control and Prevention (CDC) estimates that the vast majority of new HCV infections is a result of Injection Drug Use (IDU) among rural and suburban white men and women aged 18-35 (Dwyer, 2017). The populations are likely to also have lower incomes that may make them eligible for coverage under state Medicaid programs (in Medicaid Expansion states).

The full VA Budget Request can be viewed at the following link:

Department of Veterans Affairs – FY 2018 and FY 2019 Advance Appropriations

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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Pennsylvania Medicaid Opens HCV Treatment to Virtually All HCV 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

On May 16th, 2017, Pennsylvania’s Department of Human Services (DHS) announced changes to the state’s Medicaid policy that will expand coverage to treat virtually all enrolled clients living with Hepatitis C (HCV). Beginning July 1st, 2017, HCV-infected beneficiaries with liver scoring of F1 will become eligible for treatment coverage for the newer Direct Acting Agents (DAAs) that are highly effective, easily tolerate, and also very expensive. Beginning January 1st, 2018, clients with liver scoring of F0 will become eligible for treatment coverage. Prior to the July 1st policy change, treatment coverage will be available only to clients whose liver scoring ranges F2 to F4, unless other mitigating complications exist that warrant immediate treatment.

These changes come in response to a number of factors, most notably the 290% increase in new HCV infections between 2014 and 2015 reported by the CDC earlier this month. The deciding factor in this case, as in many other state Medicaid decisions, was the threat of a class action lawsuit. Attorneys from the Center for Health Law & Policy Innovation at Harvard Law School, the Pennsylvania Health Law Project, Community Legal Services, and Kairys, Rudovsky, Messing, & Feinberg, LLC sent a formal demand letter in late 2016 on behalf of their clients, Pennsylvania Medicaid recipients. This letter notified DHS that unless it agreed to remove “categorical coverage exclusions” of HCV medical cures from its Medicaid policy, the state could face a Federal class action law suit (Harvard Law School, 2017).

For the uninitiated, a little explanation is likely in order on the topic of “F scoring.” The “F” stands for fibrosis – the thickening and scarring of connective tissue, usually the result of injury. In relation to the liver, F scoring describes the length in expansion of fibrotic areas between portal tracts (also known as “portal triads”), and these changes are staged at F0 (No fibrosis) to F4 (Cirrhosis) (Hepatitis C Online, 2015). Patients with F4 Cirrhosis is characterized by a loss of liver cells and irreversible scarring of the liver. A healthy liver regulates the composition of blood, including the amounts of sugar (glucose), protein, and fat that enter the bloodstream. It also removes bilirubin, ammonia, and other toxins from the blood (WebMD, n.d.). A cirrhotic liver cannot properly perform these functions, leaving the patient susceptible to numerous painful and life threatening illnesses and side effects of failing or failed liver function.

The changes to Pennsylvania’s Medicaid program make it one of the first in the nation to adequately address the burgeoning HCV epidemic by treating patients early in the disease cycle. While the newer DAA drugs are all very expensive, the cost of curing patients outright, rather than continuing to pay for their long-term health degradation while waiting for their liver to become scarred enough to treat their HCV. Aside from being costly, it is also inhumane. While HIV patients underwent similar treatment in relation to the recommendation of when they begin Antiretroviral Therapies (ARTs), eventually we came to the realization that treating the disease early would result in fewer long-term complications for HIV patients. This way of thinking in terms of HCV patients is likelier to come more quickly, now that we have medically curative treatments.

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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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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