Are States Obligated To Provide Expensive Hepatitis C Drugs?

Are States Obligated To Provide Expensive Hepatitis C Drugs?
By Michael Ollove, Stateline
February 10, 2016

A handful of federal lawsuits against states that have denied highly effective but costly hepatitis C drugs to Medicaid patients and prisoners could cost states hundreds of millions of dollars.

The drugs boast cure rates of 95 percent or better, compared to 40 percent for previous treatments. But they cost between $83,000 and $95,000 for a single course of treatment.

The class actions, all filed in the last eight months in federal courts in Indiana, Massachusetts, Minnesota and Pennsylvania, present a series of extremes: a deadly epidemic, a treatment that can stop the disease in its tracks and an enormous price tag.

At least 3.5 million Americans have hepatitis C, a virus spread through blood-to-blood contact that is usually contracted through the sharing of needles or other equipment to inject drugs. Left untreated, hepatitis C slowly destroys the liver. Medicaid beneficiaries, a low-income population, have a slightly higher rate of hepatitis C infection than the privately insured, and the rate among prisoners is 30 times higher than in the general population.

Federal court cases have established a lower standard for prison health care. Prisons must provide health care to inmates, but can deliver it as they see fit, as long as they don’t demonstrate “a deliberate indifference to serious medical need.”

“A medically necessary treatment is a medically necessary treatment, no matter what the cost,” said Gavin Rose, an attorney for the American Civil Liberties Union, which brought the class action in Indiana in December on behalf of Medicaid beneficiaries in that state who have hepatitis C.

Some infectious disease doctors and legal analysts agree.

“The restrictions states are using are not based on medical evidence,” said Lynn Taylor, an infectious disease doctor in Rhode Island who co-authored a study finding that a large majority of state Medicaid agencies are restricting access to the new drugs. “They make these rules up out of thin air, and they are discriminatory.”

But Matt Salo, executive director of the National Association of State Medicaid Directors, said making the drugs available to all those infected with hepatitis C “would blow up state budgets.”

“We would be spending more on this one drug than all other drugs combined,” Salo said. “There isn’t the capacity to do that.”

Corrections officials agree. Dr. Steven Shelton, medical director of Oregon’s state prison system, estimated it would cost more than $200 million to treat Oregon prisoners with the disease, an amount four times greater than the system’s entire annual health care budget.

“There would be no care for any other disease, there would be no day-to-day care, there would be no hospital care, there would be no emergency care, there would be no staff,” Shelton said.
A Leading Killer

At a recent meeting on infectious diseases, Scott Holmberg, chief of the Epidemiology and Surveillance Branch at CDC’s Division of Viral Hepatitis, reported that in 2013, more Americans died of hepatitis C than from 59 other infectious diseases combined, including HIV and tuberculosis.

But in December, the U.S. Senate Finance Committee, which investigated the impact of the high price of Sovaldi, found that in 2014, only about 2.4 percent of Medicaid beneficiaries with hepatitis C had received the drug.

Vincent Lo Re, an epidemiologist and infectious disease doctor at the University of Pennsylvania, reported in November that in Medicaid agencies in four states — Delaware, Maryland, New Jersey and Pennsylvania — nearly half of all claims for the new hepatitis C drugs had been rejected. Lo Re found a 5 percent denial rate for Medicare beneficiaries and 10 percent for policyholders with private insurance in those same states.

Lo Re said he undertook the study because so many of his patients were being turned down for the new drugs despite his insistence that they needed it. Many of those patients, he said, are advancing to more serious stages of liver disease.
Discriminatory Restrictions?

Taylor’s study, published last summer, examined how state Medicaid agencies decide who will get Sovaldi, which is manufactured by the pharmaceutical company Gilead.

At least 34 states restricted treatment to patients who had reached an advanced stage of liver disease, as determined by the level of scarring on the liver. Thirty-seven states permitted their Medicaid agencies to determine whether the potential recipient was abusing alcohol or drugs, and some required some period of abstinence. And 29 states would only consider approval if the prescriber was a specialist in gastroenterology, hepatology, infectious diseases or liver transplantation.

Some state Medicaid agencies, such as Pennsylvania’s, have recently lifted the restrictions. A spokesperson for the state Medicaid office acknowledged that the policy change would result in a “significant fiscal challenge” and the state was pressing hard for any discounts that might be available.

Separate from the lawsuits, Massachusetts Attorney General Maura Healey, a Democrat, late last month threatened Gilead with an investigation of its possible “unfair trade practice in violation of Massachusetts law” if it doesn’t lower its prices for Sovaldi and Harvoni, which it also manufactures.

The drugmaker, which has consistently said that its hepatitis C drugs are worth the price because of their effectiveness, has asked to meet with Healey.

“Gilead responsibly and thoughtfully priced Sovaldi and Harvoni,” the company said.

Taylor said states’ restrictive practices are discriminatory because they aren’t applying the same standards to treatments for any other diseases. “We don’t withhold cancer treatment to only those with the most advanced stages of the disease,” she said. “We don’t deny smokers treatment for lung cancer.”

Many doctors point out that while the new hepatitis C drugs can arrest the disease, they cannot undo liver damage.
Stopping the Spread

Advocates for universal treatment also argue that treating patients sooner rather than later spares the health system the greater costs of treating liver cancer or undertaking transplants. It also prevents the spread of the infection to others.

Several medical societies, including the Infectious Diseases Society of America and the American Association for the Study of Liver Disease, recommend early treatment for hepatitis C. The American College of Correctional Physicians says that prison doctors should decide which inmates to treat based on medical evidence, not cost. Itacknowledges, however, that to eradicate the virus in prisons, “We must be allocated adequate resources to implement the goal in a medically responsible way, including funding for disease surveillance, screening, medically appropriate evaluation and complete disease treatment.”

But paying for treatment for everyone now is unimaginable for states, which are required to balance their budgets every year, said Salo of the Medicaid directors group.

He said the penny wise and pound foolish argument isn’t relevant to the real world of state budget-making.

“It’s true if you take a time horizon of 30 years, but that’s not reasonable or rational or realistic in Medicaid,” he said. “We budget on a one-year or a two-year cycle.”

Several legal analysts said the plaintiffs in the Indiana lawsuit, which concerns Medicaid beneficiaries, might have a better chance than the prison plaintiffs in suits inMassachusetts, Minnesota and Pennsylvania.

“At first glance, I’d say the plaintiffs [in Indiana] have a strong case,” said Nicholas Bagley, a health law professor at the University of Michigan Law School. “I’ll be very curious to see what justification Indiana presents for their denials.”

The state said it could not comment on pending litigation.

John V. Jacobi, a professor at Seton Hall Law School who specializes in health policy, said the medical necessity standard does not apply to prisoners. The question in the prison cases, Jacobi said, will be whether the denial of the drugs qualifies as “deliberate indifference.”

Joel Thompson, an attorney with Prisoners’ Legal Services, who is representing prisoners in the Massachusetts case, said he thinks it does.

“People knew for years these new drugs were coming,” he said. “Prisoners were counseled for years away from the treatments that were then available because better stuff was coming with no side effects and a guaranteed cure. A fair amount of money got saved because of that, and it got saved at the expense of our clients, who only got sicker.”

CATEGORIES: Cost and Quality, Medicaid, Public Health, States

TAGS: Drug Costs

Kaiser Health News.

MHRA Recalls Six Batches Of St John’s Wort Tablets May Lead To Potential Liver Damage

From:Medicines and Healthcare products Regulatory Agency
First published:8 February 2016

Six batches of St John’s Wort Tablets containing 91,800 packs are being recalled today as a precaution because of product contamination


St John's Wort

These tablets have levels of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herbal Medicinal Products (HMPC), a European expert body.

"PAs are known to cause liver problems in humans. Symptoms of liver disorders include yellowing of the whites of the eyes and/or skin, nausea, vomiting, dark urine, abdominal pain and unusual tiredness. If you are experiencing any of these symptoms you should tell your doctor straight away."

People who have bought these particular St John’s Wort Tablets since September 2013 should check the batch numbers on the label to see if they have the affected product, says the Medicines and Healthcare products Regulatory Agency (MHRA).

Gerald Heddell, Director of Inspection, Enforcement and Standards Division at MHRA, said:

If you have one of these packs don’t take the tablets anymore and return them to the Herbal Research Company Ltd. You can contact the company on 01934 838 820 or e-mail recall@QP-Services.com to receive a pre-paid stamped addressed envelope.

PAs are known to cause liver problems in humans. Symptoms of liver disorders include yellowing of the whites of the eyes and/or skin, nausea, vomiting, dark urine, abdominal pain and unusual tiredness. If you are experiencing any of these symptoms you should tell your doctor straight away.

If you have any questions, speak to your GP, pharmacist, or other healthcare professional. Any suspected side effects can be reported toMHRA through our safety monitoring system, the Yellow Card Scheme.

The affected batches are:
Product nameBatch numberExpiry DatePack SizeFirst distributed
Asda St John’s Wort1427905/201630 tablets25/10/2013
HRI Good Mood1425505/201630 tablets29/09/2013
HRI Good Mood1466205/201630 tablets09/04/2014
HRI Good Mood1449808/201630 tablets16/01/2014
HRI Good Mood1466008/201630 tablets11/05/2014
Superdrug St John’s Wort1452308/201630 tablets08/01/2014
Produced in 2013, the affected six batches are due to expire between May and August 2016.

PAs are not found in St. John’s Wort itself. The contamination is likely to be from accidental collection of local weeds during harvesting.

Studies in animals have shown that some cancers are more common in animals exposed to PAs. This does not mean exposure to PAs will result in cancer; however some animals exposed to PA have developed some types of cancers.

MHRA is therefore taking the precautionary step of recalling these batches, although no safety issues have been reported to MHRA to date through our safety monitoring system, the Yellow Card Scheme.

Pharmacists or retailers that have affected batches on their shelves should remove them and return any remaining stock to their original supplier.
Background

1.Any suspected side effects from these tablets can be reported to MHRAthrough our safety monitoring system, the Yellow Card Scheme or by using the Yellow Card App.

2.People should return any packs to The Herbal Research Company Ltd c/o QP-Services UK Ltd, 46 High Street, Yatton, BS49 4HJ, UK. Call 01934 838820 or e-mail recall@QP-Services.com to receive a pre-paid stamped addressed envelope.

3.For medical information enquiries please contact The Herbal Research Company Ltd on telephone 01934 838820 or 07919585040 c/o QP-Services UK Ltd, 46 High Street, Yatton, BS49 4HJ, UK, or via e-mail: recall@QP-Services.com.

4.The Committee on Herbal Medicinal Products (HMPC) is the committee at the European Medicines Agency that is responsible for preparing the Agency’s opinions on herbal medicines.

5.St John’s Wort (Hypericum perforatum L.) is a flowering plant widely used as a medicinal herb. Tablets containing St John’s Wort are available in the UK as registered traditional herbal medicinal products to relieve the symptoms of slightly low mood and mild anxiety.

6.Each pack from the affected batches contains 30 tablets. The recommended dose is 1 to 2 tablets per day.

Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD).MHRA is an executive agency of the Department of Health.

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Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at https://www.twitter.com/mhrapress

Lawsuits Will Test Whether State Medicaid Plans Must Provide Expensive Hepatitis C Drugs

KHN Morning Briefing
Summaries of health policy coverage from major news organizations


Lawsuits Will Test Whether State Medicaid Plans Must Provide Expensive Hepatitis C Drugs
A handful of lawsuits are seeking to turn around state policies that limit coverage of the drugs for Medicaid enrollees and prisoners. Also, media outlets look at Medicaid news in Alabama, Iowa and Montana.

Stateline: Are States Obligated To Provide Expensive Hepatitis C Drugs?
A handful of federal lawsuits against states that have denied highly effective but costly hepatitis C drugs to Medicaid patients and prisoners could cost states hundreds of millions of dollars. The drugs boast cure rates of 95 percent or better, compared to 40 percent for previous treatments. But they cost between $83,000 and $95,000 for a single course of treatment. (Ollove, 2/9)

AL. com: Governor To Make Major Announcement Tomorrow About Medicaid
Gov. Robert Bentley will make an announcement tomorrow about a transformation of the Medicaid payment system that is expected to control the costs of the program. Federal and state sources would not release any details about the announcement, except that it relates to regional care organizations. For more than a year and a half, officials from the Alabama Medicaid Agency have been negotiating with federal officials about the transition to regional care organizations. Federal authorities must approve the state's plan before officials change the Medicaid system. (Yurkanin, 2/8)

Des Moines Register: Senators Try To Halt Medicaid Privatization Plan
State senators pushed ahead Monday with their plan to reverse privatization of the state’s massive Medicaid program, even though Iowa House Republicans have vowed to block them. A key Senate committee voted to terminate contracts awarded by Gov. Terry Branstad’s administration last year to three national managed-care companies, which are slated to start running the Medicaid program March 1. The Senate Human Resources Committee voted 9-3 on Monday afternoon in favor of Senate Study Bill 3081. Sen. David Johnson was the only Republican to join Democrats in voting for the bill. (Leys and Petroski, 2/8)

Des Moines Register: Branstad: Culver 'Torpedo'-Ing Medicaid Privatization
Gov. Terry Branstad says he views a push by Iowa Senate Democrats to repeal his Medicaid privatization program as a “partisan, political” effort and he’s disappointed that former Democratic Gov. Chet Culver also has become involved in the health care debate. Culver has scheduled town hall meetings Tuesday in Coralville and Cedar Rapids to hear from some of the people affected by Branstad’s shift to private management of the Medicaid health insurance program, which helps about 560,000 low-income and disabled Iowans. (Petroski, 2/8)

Great Falls (Mont.) Tribune: State Launches Job Training For Medicaid Recipients
The launching of a key workforce training component to Montana’s 2015 Medicaid expansion program was announced in Great Falls on Monday. Democratic Gov. Steve Bullock, Republican state Sen. Ed Buttrey and state Labor and Industry Commissioner Pam Bucy said the HELP-Link program will use the state’s 24 Job Service centers to help 70,000 moderate income Montanans qualifying for expanded Medicaid health insurance to assess their job skills, get workforce training and obtain better jobs in their communities. (Johnson, 2/8)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Related - Feb 2016 Updates
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak..


Hepatitis C virus: A time for decisions. Who should be treated and when?

Review
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Feb 6, 2016; 7(1): 33-40
Published online Feb 6, 2016. doi: 10.4292/wjgpt.v7.i1.33

Hepatitis C virus: A time for decisions. Who should be treated and when?
Bashar M Attar, David H Van Thiel Bashar M Attar, Cook County Health and Hospitals System, Rush University Medical Center, Chicago, IL 60612, United States David H Van Thiel, Advanced Liver and Gastrointestinal Disease Center, Berwyn, IL 60402, United StatesAuthor contributions: Both the authors contribute to collect of data, synthesis, and write of the manuscript.

Abstract Full Article (PDF) Full Article (WORD) Full Article (HTML)

Core tip: This study presents the burden of hepatitis C virus (HCV) infection. Current guidelines limit treatment to those with advanced liver disease (Metavir F-3 or F-4 fibrosis). This represents a small fraction of those infected having the worse prognosis. They are unlikely to infect others. In contrast, the much larger group F-0 to F-2 is the vectors for additional infections. The plague of HCV can only be eliminated if the larger groups that infect others are treated. The cost of treating this larger population is expensive but much less expensive than treating only those with advanced fibrosis in the long run.

Excerpt:

Finally, treating all HCV infected patients to include those with and without hepatic disease with DAA regimens will reduce the number of individuals developing advanced liver disease, reduce the cost of treating these cases and more importantly, reduce the cost of treatment of those with any form of HCV related disease to include not only those with F0-F2 fibrosis of the liver but also those with extra hepatic disease related to HCV infection with or without evidence for coexistent liver disease. 

Abstract
Cirrhosis is the most important risk factor for hepatocellular carcinoma (HCC) regardless of the etiology of cirrhosis. Compared to individuals who are anti-hepatitis C virus (HCV) seronegative, anti-HCV seropositive individuals have a greater mortality from both hepatic as well as nonhepatic disease processes. The aim of this paper is do describe the burden of HCV infection and consider treatment strategies to reduce HCV-related morbidity and mortality. The newly developed direct acting antiviral (DAA) therapies are associated with greater rates of drug compliance, fewer adverse effects, and appear not to be limited by the presence of a variety of factors that adversely affect the outcome of interferon-based therapies. Because of the cost of the current DAA, their use has been severely rationed by insurers as well as state and federal agencies to those with advanced fibrotic liver disease (Metavir fibrosis stage F3-F4). The rationale for such rationing is that many of those recognized as having the disease progress slowly over many years and will not develop advanced liver disease manifested as chronic hepatitis C, cirrhosis, and experience any of the multiple complications of liver disease to include HCC. This mitigation has a short sided view of the cost of treatment of hepatitis C related disease processes and ignores the long-term expenses of hepatitis C treatment consisting of the cost of treatment of hepatitis C, the management of cirrhosis with or without decompensation as well as the cost of treatment of HCC and liver transplantation.

We believe that treatment should include all HCV infected patients including those with stage F0-F2 fibrosis with or without evidence of coexisting liver disease. Specifically, interferon (IFN)-free regimens with the current effective DAAs without liver staging requirements and including those without evidence of hepatic diseases but having recognized extrahepatic manifestations of HCV infection is projected to be the most cost-effective approach for treating HCV in all of its varied presentations.

Early rather than later therapy of HCV infected individuals would be even more efficacious than waiting particularly if it includes all cases from F0-F4 hepatic disease. Timely therapy will reduce the number of individuals developing advanced liver disease, reduce the cost of treating these cases and more importantly, reduce the lifetime cost of treatment of those with any form of HCV related disease as well as HCV associated all - cause mortality. Importantly, HCV treatment regimens without any restrictions would result in a substantial reduction in health care expenditure and simultaneously reduce the number of infected individuals who are infecting others.
Keywords: Hepatitis C virus, Direct acting antivirals, Cirrhosis of the liver, Timing of treatment

INTRODUCTION

Chronic hepatitis C virus (HCV) infection is an important cause of advanced liver disease and liver-related deaths. The aim of this document is to describe the burden of HCV infection and consider treatment strategies to reduce HCV-related morbidity and mortality[1-5].

It is estimated that the incidence of hepatocellular carcinoma (HCC) in Europe and United States will peak at 2020 at which there will be 78000 new HCC cases in Europe and 27000 in the United States[6]. Cirrhosis is the most important risk factor for HCC regardless of the etiology and cirrhosis occurs in the background of 90% of cases of HCC[6].

These figures probably under estimate the actual prevalence of the disease HCV as they are based upon data that excludes groups at recognized highest risks for the infection. Despite these limitations relative to the current estimates of the disease prevalence, it is well recognized that 50%-85% of the patients infected with HCV and manifest a hepatic disease process develop a chronic hepatitis and 20%-25% of these cases progress to cirrhosis with 20% of this latter group progressing further to HCC[7-9].

RISK OF HCV INFECTION AND NEED FOR SCREENING

HCV infection has an increasing HCV-related mortality from 1.09 to 2.40 per 100000 person years in the United States from 1995 to 2004[10]. The predicted mortality of HCV related disease over a 20-year period is expected to continue to rise as more and more individuals, who are currently infected, will have their disease for many more years. As a result, the healthcare burden in direct and indirect costs related to HCV infection will continue to rise in the foreseeable future[10]. The detection of HCV RNA in serum identifies active cases manifested by replication of the virus. Lee et al[10] reported that 52%-80% of serum samples seropositive for anti-HCV have been reported to have detectable serum levels of HCV RNA. Importantly, anti-HCV seropositive individuals with detectable serum HCV RNA have an increased risk of dying from all causes, whereas the risk for anti-HCV seropositives with negative HCV RNA is similar to that of HCV seronegative individuals[9,10]. Indeed, 2394 deaths occurred in HCV positive individuals during an average follow-up period of 16.2 years. Compared to individuals, who are anti-HCV seronegative, anti-HCV seropositive individuals have a greater mortality from both hepatic as well as nonhepatic disease processes. The multivariate-adjusted hazard ratio [95% confidence interval (CI)] of 1.89 (1.66-2.15) for all causes of death in HCV seropositive individuals and 12.48 (9.34-16.66) for hepatic diseases, 1.35 (1.15-1.57) for extrahepatic diseases, 1.50 (1.10-2.03) for circulatory diseases, 2.77 (1.49-5.15) for nephritis, nephrotic syndrome, and nephrosis, 4.08 (1.38-12.08) for esophageal cancer, 8.22 (1.36-49.66) for thyroid cancer, and 4.19 (1.18-14.94) for prostate cancer. Thus, the presence of HCV seropositivity increases the risk of death from a wide array of extrahepatic disease processes. Moreover, anti-HCV seropositives with detectable HCV RNA levels have a significantly greater mortality risk for death due to both hepatic and extrahepatic diseases processes than do individuals who are anti-HCV seropositives but who are HCV RNA negative. These data imply that individuals with chronic hepatitis C having an active infection manifested by HCV-RNA positivity should benefit from antiviral treatment to reduce both their overall mortality as well as hepatic disease mortality risk[10].

Recently, the Center for Disease Control (CDC) has identified individuals born between 1945 and 1965 as well as veterans, males, people in low income groups, prisoners, those in various institutions, and African American as well as the Latino populations as being at higher risk for a HCV infection[11]. As the majority of infected individuals have little or no symptoms, they may never know that they are infected despite the fact that 75%-80% of them may develop a lifelong chronic infection that adversely affects their life quality as well as their longevity. Individuals in this latter group also include those who received plasma or blood transfusions prior to 1992, hemophiliacs, individuals on hemodialysis, organ transplant recipients, those who experience needle sticks as a result of illicit drug use or an occupational exposures and possibly those infected as a result of tattoos or the use of unsterile equipment for body piercing, children born of a hepatitis C positive mothers and those who practice unprotected or high risk sex with multiple partners (Table 1). Most importantly, these asymptomatic individuals can unknowingly transmit the disease to others, thereby perpetuating the disease process in society at large[11,12].

THERAPY AND ERADICATION OF HCV

Historically, the available therapeutic agents utilized for the treatment of chronic hepatitis C (interferon-based therapies) have had only limited success at the elimination of the disease with efficacy rates ranging between 20% and 40% manifested as a sustained viral response (SVR) 6 mo after a presumed end of treatment (EOT) course of therapy[12]. In addition, these historical treatment regimens were expensive in terms of their direct and indirect costs, albeit less so than the new direct acting antiviral agents and had numerous adverse effect that limited their acceptability by individuals, who would have been considered as appropriate candidates for therapy. Moreover, the use of IFN-based therapies are contraindicated in individuals with a variety of autoimmune disease processes, those with a clinically significant depressive disorders, and those with advanced coronary artery or cerebrovascular disease. In addition, IFN-therapies have limited efficacy in individuals with different viral genotypes as well as specific genetic as well as phenotypic characteristics that include variant IL28B polymorphisms, obesity, diabetes mellitus, ethnicity and coinfection with either HBV or HIV[13,14].

In contrast, the newly developed direct acting (DAA) antiviral therapies are administered orally and require less complex regimes. As a result, they are more readily acceptable. As a consequence of their enhanced acceptability and increased rate of drug compliance, they achieve a significantly greater efficacy rate, have fewer adverse effects and appear not to be limited by the presence of a variety of concurrent medical disease processes to include the aforementioned genetic and phenotypic characteristics that adversely affect the outcome of interferon-based therapies. It is expected that the newer 3rd generation DAAs soon to be approved by the Food and Drug Administration (FDA) are even more efficacious and are effective across all genotypes as compared to the current 2nd generation DAA agents (Table 2)[15,16].

By increasing the sustained virological response (SVR) to 90% or more from 2016 onward the number of treated cases in Belgium has been estimated to increase from 710 to 2050 in 2030 resulting in a reduction of the number of cases with cirrhosis, decompensated cirrhosis and HCC disease process which have high direct and indirect costs of care[17]. The new DAAs are reported to be most efficacious as compared to historical regimens with interferon when applied to F2-F4 cases. To obtain comparable outcomes with all cases ranging from those with F0-F4 fibrosis, 50% more cases would have to be treated, a number which would appear to be achievable with the greater acceptability and reduced frequency of adverse events associated with the newer agents. Additionally, a two-year delay in access to the DAAs has been estimated to increase HCV related morbidity and mortality by 15%. These data suggest that early rather than later therapy of HCV infected individuals would be even more efficacious than waiting particularly if it includes all cases from F0-F4 hepatic disease[17].

van der Meer et al[18] have shown in an inter­national, multicenter, long-term follow-up study from 5 large tertiary care hospitals in Canada and Europe consisting of 530 patients with chronic HCV infection, who started an interferon-based treatment regimen between 1990 and 2003, that the 10-year cumulative incidence rate of liver-related mortality or transplantation was 1.9% (95%CI: 0.0%-4.1%) with a prior SVR following treatment and 27.4% (95%CI: 22.0%-32.8%) without a SVR (P < 001). Thus, in patients with chronic HCV infection and advanced hepatic fibrosis, a sustained virological response to interferon-based treatment is associated with a lower all-cause mortality rate and obviously a substantial reduction in overall direct and indirect costs of healthcare.

Molnar et al[19] reported an association between HCV infection and the progression of chronic kidney disease. HCV infection was associated with a 2.2 fold increase in mortality, a 98% higher hazard of development of end-stage kidney, and a 15% worsening of renal function in a large cohort of United States veterans. In addition to death related to hepatocellular cancer, all-cause mortality increased with HCV infection was attributed in part to association with extrahepatic manifestations of HCV such as cryoglobulinemia, lymphoma, glomerlulonephritides, as well as rheumatologic, hematologic, and dermatologic disorders.

Simmons et al[20] reported in a meta-analysis and systematic review of 31 studies that achieving SVR in individuals with chronic HCV. After adjustment for potential confounding factors, the results of the pooled HR analysis revealed a decreased risk of all-cause mortality by approximately 50%, 74%, and 79% in the general populations, cirrhotic patients, and coinfected (HCV/HIV) individuals respectively.

Sievert et al[21] described three different treatment scenarios based upon the anticipated introduction of DAA regimens have been estimated to reduce the overall HCV disease burden. Scenario 1 evaluated the impact of increased treatment efficacy alone estimated to be 80%-90% by 2016. Scenario 2 evaluated the increased expected efficacy as well as the increase in numbers of individuals expected to be treated from a value of 2550 to 13500 by 2018 without any treatment restrictions. Scenario 3 considered the same increases in efficiency and number expected to be treated limited to those with fibrotic disease ≥ F3 during the period of 2015-2017. The authors estimated that 233490 people with chronic HCV infection. This group has included 13850 individuals with cirrhosis, 590 with HCC and 530 with liver-related deaths. Scenario 1 would result in a modest reduction in disease burden (4% decreases in HCC, decompensated cirrhosis, and liver deaths) and the overall costs related to these diseases. Scenario 3 had the greatest impact on disease burden projected at a 50% decrease in HCC, decompensated cirrhosis, and liver deaths and overall healthcare costs. Scenario 2 had only a slightly lower impact than did Scenario 3.

These data suggest that treatment regimens without any restrictions would result in a substantial reduction in health care costs and simultaneously reduce the number of infected individuals infected who can infect others (Table 3)[22,23].

The development of the second-generation protease inhibitors (PIs) had a higher antiviral efficiency as a result of their plurigenotypic range but also as they were more convenient to administer and were associated with fewer side effects[24]. The NS5B inhibitors include nucleoside/nucleotide inhibitors (NIs) and non-nucleotide inhibitors (NNIs). NIs have even higher efficacy rates and even more useful as they can be used across all genotypes.

Sofosbuvir has highly potent antiviral activity across all genotypes when used in association with pegylated interferon and ribavirin (PR). NS5A inhibitors (NS5A) also have potent antiviral activity and when used in combination with protease inhibitors are reported to achieve a SVR in GT-1b prior null responders to a prior interferon-based regimen. Several additional studies have demonstrated that interferon (IFN)-free regimens with DAA agent combinations achieve even higher rates of SVR in naïve as well as treatment-experienced GT-1 patients, who have failed prior interferon based treatment regimes. Moreover, quadruple regimens with peginterferon plus ribavirin (PR) achieve a SVR in almost all GT-1 null responders. The development of pan-genotypic direct-acting antiviral agents (NIs or NS5A.I) will allow additional new combinations with or without PR that are expected to increase the rate of SVRs for all patient populations regardless of genotype and those with cirrhosis[24].

COST OF HCV TREATMENT AND THE NEED FOR TIMELY THERAPY

In contrast to the recommendation for screening for HCV and the subsequent recognition of cases, the use of DAA therapy has been severely rationed by insurers as well as state and federal agencies. The cost of these drugs can be effectively reduced by an increase of the use of these agents to include all those patients infected with HCV rather than just those with advanced hepatic fibrosis[25,26]. The rationale for such rationing is that many of those recognized as having the disease will progress slowly over many years, many identified cases will not develop advanced liver disease manifested as advanced chronic hepatitis and cirrhosis (F3-4 cases) and experience any of the multiple complications of their liver disease requiring specific treatment[27-31].

This reasoning fails to recognize the non-hepatic consequences of hepatitis C infection and the adverse effects of these non-hepatic diseases on patient’s quality of life. This represents a short sided view of the cost of treatment of hepatitis C related disease (infections) and ignores the long-term costs of hepatitis C treatment consisting of the cost of treatment of cirrhosis, the cost of treatment of decompensated cirrhosis as well as the cost of treatment of HCC as well as the cost of liver transplantation and its long-term follow up. These costs far exceed the costs related to the treatment of hepatitis C before any of these complications occurs. In addition, this reasoning ignores the fact that hepatitis C infection is not limited to the liver per se and also includes a wide range of extra hepatic disease processes that occur in the absence of clinical liver disease and have extensive direct and indirect costs of their own (Table 4)[30-35]. These diseases affect adversely the individual’s life quality and potentially longevity[36-41]. Most importantly, the exclusion of cases with recognized hepatic disease ranging from those with F0 to F2 and those with extra hepatic disease processes fails to recognize that these individuals are the principal vectors for new cases of HCV infection[42-47]. Their treatment would be expected to greatly reduce the numbers of newly infected cases to include those with and without recognized hepatic disease and potentially eliminate the disease in the population at large[48-50].

The rationing of therapy to those with advanced liver disease, also calls into question the ethical consequences of the recommendations of the CDC and other health related organizations and societies to screen individuals for the disease if no treatment is to be made available to those identified as having the disease. To do so under these circumstances only produces anguish and inappropriate fear in those identified as having the infection[51].

The alternative approach of recognizing those that have the infection and treating them before they develop clinically evident disease associated with the tremendous costs to society in terms of direct and indirect costs of health care as a result of hepatic as well as the many extra hepatic disease processes known to occur as a result of hepatitis C infection should result in major long term reductions in health care costs[52]. Moreover, by treating these larger populations, the number of individuals, who unknowingly infect others and perpetuate the infection in the population, would be reduced with even greater overall health care cost reductions. The institution of this alternative approach incorporating a much larger population of infected individuals would make it possible for a marked reduction in cost per unit pill or course of therapy while maintaining the overall profit for pharmaceutical companies, who have expen­ded large amounts of money to bring the drugs to market[52,53].

Finally, at the day to day clinical level, treatment of patients with stages F0-F3 would be expected to be even more efficacious, be better tolerated with fewer cases dropping out of therapy than what would occur by delaying, treatment until more advanced stages of liver disease (cirrhosis, hepatic cancer, liver transplant) or not providing treatment at all[54].

Younossi et al[55] administered a questionnaire to 1923 individuals with chronic hepatitis C, genotype-1, who were enrolled in the ION trials and received HCV treatment of combination of ledipasvir and sofosbuvir (LDV/Sof) with a SVR-12 rate of 93.21%.Reduced work productivity secondary to absententeeism and presenteesim impairments dropped after achieving SVR-12 which would result in a productivity loss saving of 2.7 billion over one-year.

Tandon et al[56] using a health insurance claims database from January 2001 to March 2012, com­pared a total of 1017 patients, who completed interferon therapy and 953 patients, who discontinued therapy. Both resource utilization and healthcare cost statistically significant lower cost allocation of 3687 and 1644 dollars for all-causes and CHC-related healthcare costs, respectively, relative to those who discontinued therapy.

CONCLUSION

Many patients achieve a SVR with PEG-IFN containing therapies. The continued improvements in the ability to obtain a SVR (expected cure) of HCV have been made within the past several years. The principal reason to utilize DAAs is to avoid the side effects of IFN which enhances acceptability, compliance and efficacy of treatment. The enhanced efficacy of these agents and the shorter duration of therapy are additional benefits.

Secondly, considerable increases in the burden of HCV-related advanced liver disease and its com­plications are expected to be seen in the United States utilizing current treatment regimens. The introduction of improved DAA regimens with enhanced efficacy and a non-restricted requirement for treatment should result in an even greater impact on the total health care costs and reduce the life-long costs of HCV dis­ease management costs. A combination of increased treatment efficacy and greater utilization by treating all presentations of all the disease to include not only those with evident hepatic disease but also those without evidence of liver disease should result in major reductions in the lifetime costs of HCV related disease costs.

Finally, treating all HCV infected patients to include those with and without hepatic disease with DAA regimens will reduce the number of individuals developing advanced liver disease, reduce the cost of treating these cases and more importantly, reduce the cost of treatment of those with any form of HCV related disease to include not only those with F0-F2 fibrosis of the liver but also those with extra hepatic disease related to HCV infection with or without evidence for coexistent liver disease. Specifically, IFN-free regimens without liver staging requirements and including those without evidence of hepatic diseases but having recognized extrahepatic manifestations of HCV infection is projected to be the most cost-effective approach for treating HCV in all of its varied presentations. Therefore, treatment regimens without any restrictions would result in a substantial reduction in health care expenditure and simultaneously reduce the number of infected Individuals who are infected can infect others.

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Footnotes
Conflict-of-interest statement: The authors declare no conflicts of interest regarding this manuscript.

Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Correspondence to: Bashar M Attar, MD, PhD, MPH, Cook County Health and Hospitals System, Rush University Medical Center, 1901 West Harrison Street, Chicago, IL 60612, United States.battar@rush.edu
Received: June 24, 2015
Peer-review started: June 24, 2015
First decision: August 3, 2015
Revised: September 16, 2015
Accepted: November 13, 2015
Article in press: November 17, 2015
Published online: February 6, 2016

Estimated 146,000 New Yorkers over the age of 20 — 2.4 percent of that population have hepatitis C

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New cases of hepatitis C in NYC are on the rise

By DAN GOLDBERG 4:00 a.m. | Feb. 9, 2016

The number of New York City residents newly diagnosed with chronic hepatitis C increased to 7,691 in 2014, a 13 percent jump from 2013 and the most new cases the city has seen since 2011.

An estimated 146,000 New Yorkers over the age of 20 — 2.4 percent of that population — have hepatitis C, a bloodborne virus that damages the liver and is often spread among intravenous drug users, according to a new report from the city's health department which provides fresh evidence that state spending on wonder drugs such as Sovaldi and Harvoni is likely to continue to swell in the coming years.


Pamela Anderson On Hepatitis C - Genotype - HCV treatment regimen?

  • Monday, February 8, 2016
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Pamela Anderson On Hepatitis C 

In January ABC ran an interview with Pamela Anderson discussing her hepatitis C cure, It's unfortunate the HCV treatment regimen she used was not completely clear, Sovaldi was mentioned. (the video transcript is included below)

Today in a new article over at Time Miss Anderson stated; because I have type 3 so it’s not the most curable. One can only assume she is referring to her HCV Genotype, here is the excerpt;

Pamela Anderson on Activism, the Baywatch Movie and the End of an Era at Playboy
Kirsten Salyer 11:09 AM ET
You recently announced that you had been cured of Hepatitis C. What did that mean to you and what would you tell people diagnosed with it today?

When I was diagnosed with Hep C, I was told I only had 10 years to live, and that was 17 years ago....

Then my doctor called and said: “There’s a cure.” And I said: “Really?” And then a friend of mind did it and he was really cured. And I ended up getting the treatment for – because I have type 3 so it’s not the most curable, it’s a little rarer, it’s not the one that most people have and so they said this would work for me. I had to take two pills a day for 12 weeks and then go get tested. And I went and got tested and it’s gone. It worked. I don’t have Hep C anymore.....

ABC Breaking News | Latest News Videos
Source - Pamela Anderson Opens Up About Hepatitis C Cure

Transcript for Pamela Anderson Opens Up About Hepatitis C Cure
We have new details about the drug that may have saved Pamela Anderson's life. She made headlines by revealing she's free of hepatitis C after more than a decade learning more about the treatment that cured her. Jim Avila has the story. Reporter: For Pamela Anderson who saved lives on TVs it seemed like a real death sentence. They told me that I would die in ten years. Reporter: Diagnosed with hepatitis C. I just think looking back that I maybe was a little more reckless than I would have been. I think it's kind of a hanging over your head. Reporter: But then three months ago the incurable suddenly cured in a 12-week medical miracle. 12 weeks and gone. Yes. Reporter: Anderson had taken the new drug sovaldi and is back promoting vegan shoes and a new cooking shoes and had good health insurance covering the near six-figure price tag. Not everyone is so lucky which is why I'm staking out this man. Fred Upton, congressman from Michigan who over the last five years has blocked every bill proposed in congress to change the law that prevents medicare from negotiating the price of prescription drugs. The government isn't getting the best prices for their drugs because the government can't negotiate. Reporter: Why are you against that? We'll talk later. Reporter: We've tried to talk for two months. He says $300,000 in donations he received from drug companies in 2014 has nothing to do with it and he's working on a bill of his own to fix the problem. Look to the right. Reporter: But for now only the wealthy and well insured often have access to expensive miracle cures. I was really fortunate. Reporter: For "Good morning America," Jim Avila, ABC news, detroi

This transcript has been automatically generated and may not be 100% accurate.

Of Interest
New Hepatitis C Fact Sheets: (Sovaldi, Olysio, Viekira Pak and Technivie, Harvoni, Daklinza, and ribavirin)
Treatment Action Group has recently published hepatitis C fact sheets in both English and Spanish.

I-Team: Viewer Helps Woman Denied Gilead's Lifesaving Hepatitis C Drug

I-Team: Viewer Helps Woman Denied Lifesaving Hepatitis C Drug
February 7, 2016 11:15 PM By Lauren Leamanczyk
 

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