Monthly Archives: June 2017

Hepatitis Policy Project Releases Report on HCV Monitoring in the U.S.

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

Report Cover: "Monitoring the Hepatitis C Epidemic in the United States"

Source: Hepatitis Policy Project

The Hepatitis Policy Project (HPP), a project of the O’Neill Institute for National & Global Health Law at Georgetown Law in Washington, D.C., released in June 2017 their latest report, “Monitoring the Hepatitis C Epidemic in the United States: What Tools Are Needed to Achieve Elimination?” The report highlights five key recommendations that the institute believes need to be implemented in order to ensure the elimination of Hepatitis C (HCV) in the United States.

It is important to note that these recommendations fall in line with what HCV advocates and organizations have been stating for years: state and Federal governments are failing to adequately address the lack of concrete reporting data for the disease that kills more Americans each year than the total combined number of deaths from 60 other infectious diseases, including HIV, tuberculosis (TB), and pneumococcal disease (CDC, 2016). The primary reason for this failure on the part of all parties: financial resources – neither the Federal, nor state governments are allocating adequate funds in order to make mandatory the reporting of HCV infections in every state, and as a result, the Centers for Disease Control and Prevention (CDC) and other research and reporting bodies must rely on inaccurate, passive, and/or outdated data reporting that is simply inefficient and unacceptable.

HEAL Blog, in May 2017, wrote about this data issue when the CDC and Emory University revealed its Hepatitis monitoring tool, HepVu, that contains data that is seven years out of date (Hopkins, 2017). Our argument contends that seven-year-old data is an ineffective tool for helping lawmakers and government agencies to craft data-driven policies and regulations. If the data is not current within one or two years, policymakers have little use for it. The HPP report makes five key recommendations designed to eliminate these data collection issues:

  • Expand and standardize reporting to the CDC: The CDC’s Department of Viral Hepatitis (DVH) is only now expanding funding efforts from 7 jurisdictions to 14 – an unacceptably (but expanded) low number. The DVH should work with Congressional appropriators to create a five-year plan to expand and build the capacity to conduct active surveillance to the great majority of states. This should include the development of a standardized reporting rubric that details the specific patient information that must be provided by clinicians and subsequently passed on to the states – a strategy that has been in place for HIV since the 1990s, and has helped to create more accurate data reporting and craft data-drive policies to address the epidemic. This will require more money.
  • Utilize electronic medical records to collect data on HCV cases and the cure cascade: Modern medicine makes great use of technology, including the collection and retention of medical records; what is lacking is a system to centralize and analyze these data. Better use of electronic medical records information could improve the consistency, quality, and accuracy of case reports made by states by lessening the burden on providers and laboratories to report new cases to state health authorities that is required under the current scheme. The current requirement for providers and labs to le reports strains their already limited time and personnel resources, and often leads to incomplete reporting. This data could instead be pulled together by state epidemiologists using an integrated electronic medical records database, which would also provide matching metrics with cases, such as race, age, gender, sex, and progress of treatment.
  • Fund epidemiological research using clinical data sets: Clinical care data are a largely untapped resource that relies on data that already exist. As such, greater efforts are needed to fund analyses of such data. This recommendation also suggests that several agencies across the Federal Health and Human Services department be directed to fund epidemiological research on HCV.
  • Integrate improved monitoring of HCV with responses to the opioid epidemic: With most new cases of HCV being related to Injection Drug Use (IDU), largely driven by the nation’s out-of-control opioid addiction epidemic, it is imperative that we tie HCV prevention and treatment efforts to substance abuse prevention and treatment measures, elevating HCV as a signature component of the national response to opioid abuse.
  • Establish and monitor HCV elimination plans across major U.S. health systems: The U.S. has several large established health systems – Medicaid, Medicare, the V.A., and various correctional systems. It is, therefore, imperative that we focus HCV elimination efforts on these major systems in order to adequately approach the elimination of HCV across all health systems. Starting with government-funded health systems allows for better monitoring of patients and patient outcomes.

The HPP report is an excellent document that outlines several real-world solutions that could (and should) be implemented across local, state, and Federal governments in order to achieve the elimination of HCV in the United States. Download the full report.

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

Food and Drug Administration Pulls Opana ER from Shelves

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 April 2016, HEAL Blog wrote an entry about the fascinating and heartbreaking first episode of National Public Radio’s (NPR) series, Embedded. Host Kelly McEvers found a group of prescription opioid Injection Drug Users (IDUs) who allowed her to record an audio interview about their lives and how they use their drugs. The drug in question was Endo Pharmaceuticals’ powerful prescription opioid, Opana ER (McEvers, 2016). A little over a year after this broadcast, the Food and Drug Administration (FDA) reached the conclusion that the “…benefits of the drug may no longer outweigh the risks,” and have asked Endo to remove Opana ER from the market (Mandal, 2017).

What’s at stake here isn’t just a 4% increase in prescription opioid overdose deaths in 2016 (n=17,536), nor the 23% increase in heroin-related deaths (n=12,989); it’s not even the 73% increase in synthetic opioid-related deaths (n=9,580) (Stobbe, 2016). What’s at stake, at least for Endo Pharmaceuticals, is the $158 million in sales Opana ER brought in for Endo in 2016 – a 10% decrease from 2015 (Mandal). For Endo, pulling one of their most successful products from the market means a huge hit to their bottom line.

Opana ER pill bottle

Photo Source: Medcitynews.com

Opana ER, first introduced by Endo in 2006, was reformulated in 2012, when the manufacturers began adding a plastic coating to the outside of the pill to make it “abuse deterrent.” This move, while initially praised by the FDA and lawmakers as a great step forward to combating prescription drug abuse and addiction, simply shifted how drug users abused the drug. While the initial formulation could be crushed and easily snorted nasally, the plastic coating prevented this practice. Necessity (read: addiction) being the mother of invention, drug users found a way to abuse the drug by melting the plastic coating off, filtering the coating out through mesh, load the liquefied drug into a syringe, and injecting it straight into their bloodstreams. The McEvers Embedded piece literally goes over a step-by-step “How To” guide that is already known by IDUs.

The bottom line for states, counties, and municipalities who are having to cope with the 40,105 opioid drug-related deaths in 2016 comes down to more than just money – the issue is negatively impacting virtually every arena of daily life. Families are rent asunder, children are left orphaned, and emergency personnel are facing their own increased risk of overdose from inhaling or coming into direct contact with the powerful synthetic opioids, fentanyl and carfentanil, during overdose calls and drug busts. The risk of overdose due to exposure is so great that the Drug Enforcement Agency just this month issued a safety guide for first responders who might come into contact (Chanen, 2017).

Pain advocates who have long pushed for easy access to prescription painkillers argue that increasing restrictions places an undue burden upon patients who properly adhere to treatment regimens, using powerful prescription opioids as prescribed. To their way of thinking, regulations and prescribing limits unfairly limits the ability of those who live with chronic pain to function and/or go about their daily lives. Pain advocacy groups (many of which are conveniently funded by the very pharmaceutical companies whose drugs are at risk) have repeatedly, and in many cases successfully, lobbied state and Federal legislators to prevent the passage of any legislation that might hinder their access to these drugs.

I don’t buy it, and apparently, neither does the FDA. Endo Pharmaceuticals have said they’re “…evaluating the options and reviewing the situation to opt for an appropriate path forward.” Should the company refuse to remove the product voluntarily (as the FDA has asked), the agency intends to take steps to formally require its removal by withdrawing approval (Kean, 2017).

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

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