Tag Archives: HCV

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:

__________

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.

Leave a comment

Filed under Uncategorized

Navigating Patient Assistance Programs

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 HEAL Blog began publishing, we have striven to provide information about Hepatitis C (HCV) treatments, news, and issues surrounding the disease. We have also, on occasion, provided information related to Patient Assistance Programs (PAPs) that can help patients living with Hepatitis (HCV), HIV, or virtually any other illness afford the cost of their medications and treatments if they are unable to do so. Continuing along this line of thinking, today’s blog will be dedicated to three such organizations: NeedyMeds, the Patient Access Network (PAN) Foundation, and the Patient Advocate Foundation (PAF and NPAF).

Money flowing out of an open pill capsule

Photo Source: Chemistry World

NeedyMeds is a 501(c)(3) national non-profit information resource dedicated to helping people locate assistance programs to help them afford their medications and other healthcare costs (NeedyMeds, 2017a). They provide a NeedyMeds Drug Discount Card designed to lower the cost of prescription medications by up to 80% (NeedyMeds, 2017b). The discount card can be used cannot be combined with insurance or Medicaid/Medicaid drug coverage plans, but can be used in lieu of those plans to reduce the out-of-pocket costs of the medication. In some cases, using the NeedyMeds card instead of insurance may result in a lower cost to the patient than their insurance co-pay.

In addition, NeedyMeds’ website offers a variety of resources to help connect patients to other programs and organizations. These links include information pertaining to various drug-specific PAPs, a “Help with Paperwork” assistance service, a searchable database of both independent and manufacturer PAPs, and local resources to help patients apply for these programs (NeedyMeds, 2017c).

The PAN Foundation is an independent, national 501(c)(3) organization dedicated to helping federally and commercially insured people living with life-threatening, chronic and rare diseases with the out-of-pocket costs for their prescribed medications. Partnering with generous donors, healthcare providers and pharmacies, PAN provides the underinsured population access to the healthcare treatments they need to best manage their conditions and focus on improving their quality of life. Since its founding in 2004, PAN has provided more than 700,000 underinsured patients with over $2.5 billion dollars in financial assistance, through over 50 disease-specific programs. PAN has an administrative fee of only 5%. This means that $0.95 of every dollar PAN receives goes directly toward helping patients. For the last eight years, PAN spent less than one penny of each dollar it received on fundraising (PAN Foundation, 2016a).

The PAN Foundation has nearly sixty disease-specific assistance programs that help patients pay for out-of-pocket healthcare costs, including deductibles, co-pays, and co-insurance, travel expenses, and health insurance premiums, all of which are listed in a convenient, searchable database listed by condition (PAN Foundation, 2016b). This list also indicates the enrollment status of each program as Open (accepting applications for new and renewal patients), Renewal Only (accepting applications for renewal patients, only), and Fully Allocated (no longer accepting or processing applications for new or renewal patients). As of May 31, 2017, the programs for both HIV and HCV are open to new enrollees and renewals.

The Patient Advocate Foundation (PAF) is a national 501(c)(3) non-profit organization which provides professional case management services to Americans with chronic, life threatening and debilitating illnesses. PAF case managers serve as active liaisons between the patient and their insurer, employer and/or creditors to resolve insurance, job retention and/or debt crisis matters as they relate to their diagnosis also assisted by doctors and healthcare attorneys (PAF, 2012a). These services are vital to patients who may not be familiar with the complex workings of the American healthcare system (and let’s face it – most of us aren’t).

One of the primary goals of PAF (and their advocacy arm, National PAF – NPAF) is to reduce the financial burden by assisting patients in finding potential assistance that provide financial support for co-pays, discount and indigent drug programs, transportation, housing, food, utility shut offs, and by helping negotiate payment plans for treatment providers. They also assist patients by assessing eligibility and helping with enrolling patients in the various programs, as well as providing a baseline of employment-related support as needed.

As with all PAPs and independent and government programs, there are financial and other prerequisites that clients must meet in order to qualify. One of the biggest barriers to enrollment in co-pay assistance programs (both organizational- and manufacturer-funded) is enrollment in a government-funded healthcare program, such as Medicaid. Being enrolled in Medicaid generally disqualifies applicants from receiving assistance, even if the out-of-pocket expenses with Medicaid coverage are more than what patients can afford. There seems to be little “wiggle room” in PAPs that allow these patients to receive assistance, and this is a significant barrier that has yet to be addressed in any meaningful way.

Patient Assistance Programs are vital tools that can help patients afford the medications and treatments they need in order to survive. Moreover, they are resources that most patients, and even healthcare workers, rarely know about or reference, which makes them a potentially untapped source of aid in today’s volatile healthcare market. HEAL Blog will continue to monitor PAPs and to provide more information over time.

References:

__________

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.

Leave a comment

Filed under Uncategorized

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:

__________

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.

Leave a comment

Filed under Uncategorized

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:

__________

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.

Leave a comment

Filed under Uncategorized

A Conversation About HCV in Incarcerated and Post-Incarceration Settings

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 Thursday, May 11th, the Community Access National Network (CANN) hosted a Community Roundtable on Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C (HCV). Three speakers, including myself, gave presentations detailing the various barriers, opportunities, and complications that surround ensuring that incarcerated citizens receive the car to which they are legally entitled under the 8th Amendment’s “…cruel and unusual punishment” provision.

State/Federal HCV-Related Lawsuits Involving Prisons (2007-2017). At least 18 Class-Action and Civil Rights Action lawsuits were filed in 11 states between 2007-2017.

My presentation covered the legal aspect of treating HCV in prisons and jails, much of which I detailed in last week’s HEAL Blog; as such, I will spend this blog discussing the information presented by my peers:

Wayne Turner, Senior Attorney with the National Health Law Program, delivered an excellent and thorough explanation of how Medicaid-eligible incarcerated persons can have their treatment paid for through the Medicaid program if they are taken to an outside facility for care. What this means is that, using a provision written into the Medicaid law, so long as the prisoner is treated at a hospital outside of their incarceration facility, their treatment and care can be covered and paid for through the Medicaid program, rather than relying upon the prison healthcare and pharmacy budgets.

This has the potential to be a hugely beneficial resource for prisons, as treating HCV is very costly. It also raises an interesting question – would this mean that prisoners can be taken to hospitals, be prescribed one of the new Direct Acting Agents (DAAs) to treat their HCV at the hospital, and fill that prescription at the hospital pharmacy and have the drug covered by Medicaid, rather than the prison pharmacy budget? It’s an interesting question, and could be the solution needed to ensure that inmates receive the care they need.

A. Toni Young, President and CEO of the Community Education Group, also delivered a rousing call to action, discussing her work in trying to figure out how to improve access to Medicaid and HCV education both inside the prison system and for the general population. What this really requires, she posits, is that medical professionals as well as Federal, state, and local governments dramatically increase education campaigns to teach people about HCV, and most importantly, how to avoid contracting the disease, both inside and outside of prison settings.

What makes this approach vitally important is that HCV education is something that is sorely lacking in the areas that are hardest hit; not just HCV education, really – healthcare literacy in general is an issue. As such, we must, as Toni suggested, work on ways to get people to actually care about what we’re trying to teach; get them to understand that learning about and preventing the spread of HCV will save their lives.

Another fantastic point brought to the fore by Elizabeth Paukstis, Public Policy Director at the National Viral Hepatitis Roundtable, was that, despite advocates calls for prisons to treat everyone, the reality is stark – the budgets are what they are, and no matter how often or loudly we insist that they treat inmates with HCV, many states simply do not have the resources to do. At that point, litigation is really the only route that many inmates can take to ensure that they receive treatment.

This Community Roundtable was a fantastic event, and I look forward to participating in future roundtables to figure out the best ways in which we can help combat the HCV epidemic.

__________

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.

Leave a comment

Filed under Uncategorized

Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

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 Community Access National Network (CANN) will be hosting a roundtable at the headquarters of the Pharmaceutical Research and Manufacturers of America (PhRMA) on Thursday, May 11th, 2017, on the topic of Hepatitis C (HCV) in Incarcerated Populations. The roundtable will focus on various aspects of treated HCV in prison and jail settings, including the Constitutional requirement that all inmates receive treatment, as well as various barriers that prevent inmates from receiving screening and treatment.

Invite for the Community Roundtable on Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

Current estimates indicate that between 10-35% of inmates are infected with HCV, and that roughly half of those inmates don’t know that they’re infected. These estimates are, however, limited by inconsistent or non-existent screening protocols, reporting requirements, and various bureaucratic hurdles that prevent inmates from being screened. Furthermore, there are no penalties in place that hold prison and jail systems accountable for failing to screen inmates, which often results in costly lawsuits.

The Federal Bureau of Prisons released a new set of screening guidelines for HCV in October 2016, which included the recommendation that all prisons and jails adopt an “Opt-Out” screening process (Federal Bureau of Prisons, 2016). This strategy requires that HCV screening becomes part of a routine practice, and that inmates must provide “informed refusal” in order not to be screened. This strategy would be instrumental in combating the HCV epidemic running rampant among inmate populations, as well as for data gathering purposes.

Implementing this strategy across all prisons and jails in the U.S. in a difficult proposal, in no small part because it will be expensive. What makes it so expensive is that screening, itself, isn’t cheap – at least not the confirmatory tests; additionally, if prisons and jails discover that an inmate has HCV, or any other life-threatening illness, they are required under the 8th Amendment of the U.S. Constitution to treat that inmate’s illness (Estelle v. Gamble). That last part can cost prison systems tens of thousands of dollars fear each infected inmate – costs that will explode pharmacy and healthcare budgets in the short-term, but will save money in the long-term.

Furthermore, prisons appear to be extremely inconsistent about what prices they pay for drugs. The Wall Street Journal (WSJ) published a report in September 2016 per-patient cost paid by state prisons to treat HCV using Gilead’s Harvoni: the prices ranged from $46,021 in North Dakota to $91,014 in Georgia (Loftus & Fields, 2016). These numbers indicate the need for more price stabilization in the U.S. prison systems, or at the very least, consolidated price negotiation.

While the roundtable is open to the public, seating is limited. Interested parties can sign up for the event at the following address: http://tiicann.org/events.html

References:

__________

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.

Leave a comment

Filed under Uncategorized

Emory University and CDC Reveal HepVu

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 latest tool in Viral Hepatitis advocacy has arrived: HepVu (www.hepvu.org). A project of Emory University’s Coalition for Applied Modeling for Prevention (CAMP) – supported by the Centers for Disease Control and Prevention (CDC) – HepVu is an interactive website that provides various data related to Viral Hepatitis (VH), with the greatest emphasis being placed upon Hepatitis C (HCV), the least accurately reported variant in the U.S.

The website features interactive maps detailing estimated prevalence data, rates of infection, mortality data, and regional impacts and comparisons on both the national and state levels. While HCV data released by the annual National Health and Nutrition Examination Survey (NHANES) conducted by the CDC produces national estimates, HepVu is the first analysis that uses a more nuanced formula that includes NHANES data, but also examines state-level reporting and statistics that includes electronic medical records (EMRs), insurance claims, and HCV-related mortality.

Other site features include infographics, explanations about the various types of VH, and the ability to print and download maps and data for use in advocacy efforts and reports. Dr. Patrick Sullivan, one of the researchers associated with creating the project, stated that making the site a resource for HCV-related advocacy and reporting efforts was an essential step in creating HepVu. This is the first HCV-related website (of which I am aware) that makes these data easily available for reprinting and citation purposes.

The contributing researchers to the website admit that this reporting is likely well below the actual prevalence and rates of infection, because screening, reporting, and tracking vary in quality and amount of data from state to state, in no small part because of a lack of Federal and state funding for HCV reporting, as well as adequate and standardized reporting requirements set by the CDC. Part of what makes this data so important is that it serves as a great starting point for advocating for increased funding for reporting and tracking – something that Congress has been slow to address, despite large increases in funding to address America’s opioid and heroin abuse crisis, the leading contributor to the rise in new HCV infections.

The primary limitation of the data presented on HepVu (and in general) is age: the vast majority of the data centers on 2010 and 2014 – seven and three years old, respectively. This complaint has been a sticking point for advocates and HCV-related organizations for several years, particularly because of the release of easily tolerated and highly effective Direct Acting Agents (DAAs) that serve as a curative treatment for HCV. Now that we have these tools to eradicate HCV, it is imperative that we begin operating on current information, rather than relying upon data that predates two presidential elections. This means that both Federal and state governments are going to have to step up to the plate and begin adequately funding screening, reporting, and tracking efforts, regardless of the high cost of these drugs.

HepVu is an excellent starting point, despite the data limitations, and so long as the statistics and information are regularly updated with more current information, it has the potential to become an invaluable tool in combating HCV and hopefully eradicating the virus from the U.S., entirely.

__________

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.

Leave a comment

Filed under Uncategorized