Companies, states interested in Louisiana Netflix-style hepatitis C plan

Companies, states interested in Louisiana hepatitis C plan

By MELINDA DESLATTE Associated Press

BATON ROUGE, La.

Three drug companies are interested in Louisiana's plan to use a Netflix-style subscription model to buy access to hepatitis C drugs for Medicaid patients and prisoners, a treatment concept being watched by other states, the state health department announced Friday.

Health Secretary Rebekah Gee wants Louisiana to pay a fee to a drug manufacturer for unlimited access to its hepatitis C medication. The state will treat as many people as it can during the access period, rather than pay a per-patient treatment price

Continue reading:
https://www.ledger-enquirer.com/news/article226991064.html 

https://www.ledger-enquirer.com/news/article226991064.html
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Hepatitis C and HIV/AIDS Medications Costliest Group of Outpatient Prescription Drugs for Medicaid

Kaiser Family Foundation
Analysis Finds that Medications for Hepatitis C and HIV/AIDS Are the Costliest Group of Outpatient Prescription Drugs for Medicaid, While Diabetes Drugs Have Posted the Sharpest Rise in Costs 
Chris Lee
Published: Feb 15, 2019
Antiviral medications, including those that treat hepatitis C and HIV/AIDS, cost the Medicaid program more money (before rebates) than any other group of outpatient prescription drugs for each year from 2014 to 2017, according to a new KFF analysis.

The analysis of utilization and spending trends finds that antivirals accounted for more than 13 percent of the $63.6 billion in Medicaid outpatient drug spending pre-rebates in 2017 — a level disproportionate to their utilization and a reflection of the high cost of these drugs. Drugs for diabetes were the second most costly group that year, accounting for 10 percent of Medicaid outpatient drug spending before rebates. Spending for diabetes drugs rose faster than for any other group, nearly doubling from 2014 to 2017 — largely due to the rising price of insulin.

Read the complete article: https://www.kff.org/medicaid/press-release/analysis-finds-that-medications-for-hepatitis-c-and-hiv-aids-are-the-costliest-group-of-outpatient-prescription-drugs-for-medicaid-while-diabetes-drugs-have-posted-the-sharpest-rise-in-costs

Recommended Reading
Medicare Part D no match for runaway specialty drug costs

Netflix Model -Countries Use Novel Strategies to Tackle Price of HCV Drugs

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas 

Hepatitis C: Out-of-Pocket Cost Burden for Specialty Drugs in Medicare Part D in 2019 

On This Blog 

Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions implemented by private insurers/Medicaid/Medicare and the effectiveness, safety and availability of generic versions of hepatitis C medications. 

Impact of Hepatitis C Virus and Insurance Coverage on Mortality

The American Journal of Managed Care February 2019

Impact of Hepatitis C Virus and Insurance Coverage on Mortality

Haley Bush, MSPH; James Paik, PhD; Pegah Golabi, MD; Leyla de Avila, BA; Carey Escheik, BS; and Zobair M. Younossi, MD, MPH

View Full-text Article Online

https://www.ajmc.com/journals/issue/2019/2019-vol25-n2/impact-of-hepatitis-c-virus-and-insurance-coverage-on-mortality

Takeaway Points

Hepatitis C virus (HCV) prevalence is significantly higher among patients with Medicaid compared with patients with private insurance and Medicare. 

Medicaid patients who are infected with HCV have a higher risk of all-cause mortality than HCV-positive patients with private insurance coverage. 

Policy makers should consider providing additional resources to Medicaid to cover all HCV-infected individuals.

The Medicaid population has significantly higher hepatitis C virus (HCV) prevalence and mortality rates than patients with private insurance. These data must be considered when policy makers assess providing additional support to Medicaid programs for HCV elimination.

ABSTRACT
Objectives: To assess the association of payer status and mortality in hepatitis C virus (HCV)–infected patients.

Study Design: For this retrospective observational study, we used the National Health and Nutrition Examination Survey from 2000 to 2010. Adults with complete data on medical questionnaires, HCV RNA, insurance types, and mortality follow-ups were included.

Methods: We used Cox proportional hazards models to evaluate independent associations of insurance type with mortality in HCV-infected individuals. These models were rerun in the subset of HCV-positive subjects to determine the association of insurance type with mortality. The data used in this study predated the implementation of the Affordable Care Act.

Results: Among 19,452 eligible participants, 311 (1.4%) were HCV positive. HCV-positive patients were older, were more likely to be non-Hispanic black and male, and had higher prevalence of hypertension (all P <.001). HCV-positive patients were also less likely to have private insurance and more likely to be covered by Medicaid or be uninsured relative to HCV-negative patients (P <.001). Among HCV-positive patients, after adjustment for confounders, those with Medicaid coverage had an increased risk of mortality compared with those with private insurance (hazard ratio [HR], 6.31; 95% CI, 1.22-29.94) and uninsured individuals (HR, 8.83; 95% CI, 1.56-49.99).

Conclusions: Patients who have HCV are more likely to be uninsured or covered by Medicaid. HCV-positive patients with Medicaid have an increased mortality risk compared with those with private insurance. Given the high burden of HCV infection and adverse prognosis among individuals covered by Medicaid, policy makers must prioritize funding and supporting Medicaid programs.

Source Full-text article:

Am J Manag Care. 2019;25(2): In Press

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas

In case you missed it

EDITORIALS 
DOI: 10.1200/JOP.18.00525
Journal of Oncology Practice
Published online before print January 22, 2019
PMID: 30668219

The Cost of Cure: Barriers to Access for Hepatitis C Virus Treatment in South Texas 
Laura Tenner, MD, MPH12; Trisha V. Melhado, MPH2; Raudel Bobadilla2; Barbara J. Turner, MD, MSED2; and Robert Morgan, PhD3

Source - Journal of Oncology Practice 

Mortality rates for hepatocellular carcinoma (HCC) are increasing faster than those of any other cancer, nearly doubling since the 1980s.1 Only one in five individuals diagnosed with HCC will survive 5 years after diagnosis despite the improvements in treatment.1 One of the top three contributing factors to HCC deaths is the high prevalence of hepatitis C virus (HCV) infection.1,2 The number of US residents currently infected with HCV is estimated at approximately 3.5 million.3 Baby boomers account for 81% of all new HCV diagnoses, and this cohort has the highest rates of HCV-related liver transplantation secondary to the development of HCC.4 Connecting patients infected with HCV to care has been problematic because approximately half of individuals with HCV are asymptomatic and are not seeking treatment.5,6

The need for HCV screening has increased significantly as a result of the development of highly effective direct-acting antiviral (DAA) treatments, which can cure more than 90% of patients.7 Curing HCV offers long-lasting, substantial health benefits including reduction in the incidence of liver cancer.7 A consensus committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) has proposed a strategy to decrease the prevalence of HCV by 2030.5 Their models predict that, if 260,000 patients can be treated annually, the incidence of HCV would be reduced by 90% relative to 2015 levels. This model presumes that all patients with chronic HCV infection would be treated, regardless of their level of fibrosis. In an effort to increase capacity to meet these treatment goals, the NASEM committee recommended using primary care as a result of the limited number of specialists to meet the high demand for HCV treatment.5 Moreno et al8 reported that expanding coverage to patients regardless of their fibrosis level was highly cost effective and saved a net social benefit of $500 billion at a $150,000 per quality-adjusted life-year valuation. The study found that the benefits of treatment extended beyond immediate improved patient health by decreasing the pool of individuals who can transmit the infection and by decreasing future health care expenditures related to end-stage liver disease.8

However, treating this population has significant challenges. For example, Texas has one of the highest liver cancer death rates in the nation.1 South Texas, specifically Region 11, encompasses a 19-county area in the Rio Grande Valley and has the highest prevalence of liver cancer in the state.9 Over the course of implementing screening and treatment guidelines, significant challenges to addressing the HCC epidemic have been identified in this region. Up to a third of individuals live in poverty, well above the state average of 17.5%, and up to a third of individuals are without health insurance (state average of 24.8%).10 This population tends to be less educated with less health care literacy.11 Furthermore, this region is more than 50,000 square miles, and access to health services is limited by lack of transportation and poor proximity to care.10 These factors all present major challenges to screening and treatment of HCV. There is a significant need for health policy to increase funding or reimbursement for social services in this region and regions like these around the United States.

Yet even privately insured individuals can experience significant cost barriers to care if they are found to be chronically infected with HCV. Because screening is a US Preventative Services Task Force recommendation,12 HCV tests and supporting laboratories are covered by insurance, but treatment can be difficult to afford. It is not unusual for HCV antiviral therapies that have previously ranged from $60,000 to $80,000 for a 12-week course of treatment to require a 20% to 30% cost-sharing responsibility by the patient.13 AbbVie recently released glecaprevir/pibrentasvir (Mavyret; AbbVie, North Chicago, IL), which has a significantly lower cost than other DAAs on the market at a cost of $13,200 per month or $39,600 for the 12-week treatment.13 This may help decrease the out-of-pocket cost, although the expense of treatment is still sizeable, especially in a region where a significant number of individuals live in poverty. A study of patients seeking treatment for HCV showed significant disparities in accessing these drugs.14 Many insurance companies as well as government-sponsored insurance are striving to decrease spending by limiting access to these medications. Up to 46% of Medicaid, 10% of private insurance, and 5% of Medicare beneficiaries have been denied treatment of HCV.14 This high cost sharing can cause significant financial toxicity to privately insured individuals, and many are faced with the decision to pursue treatment with a significant financial risk or refrain from treatment until they have irreparable damage to their liver. Sadly, it is easier for uninsured individuals to obtain DAAs due to medication assistance programs that provide the drugs for free.15 Health policy change is needed to decrease the out-of-pocket expenditures for insured patients for DAAs.

Texas Health and Human Services reports that more than 4 million individuals in the state rely on Texas Medicaid for their health insurance.16,17 There are particular concerns, however, that Texas Medicaid poses significant challenges for access to HCV care. The National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation of Harvard Law School developed the “Hepatitis C: The State of Medicaid Access” report card for each state.17 Texas was rated poorly, receiving a D+.17 The report identified severely restricted access to HCV medications as a cost-containment measure, citing requirements such as severe liver damage, a prescription written by or in consultation with a specialist, and 90 days of sobriety as the main barriers to medication access. Overall, the report cites restrictions that limit treatment to persons with severe fibrosis as one of the primary barriers to receipt of HCV medication, not just in Texas but across all state Medicaid programs.17

To the first restriction, as emphasized by the NASEM, the benefit of prevention of end-stage disease is greatly diminished or lost with restricting treatment to individuals who already have severe fibrosis. Although immediately cost effective for the organization, the pool of individuals who can transmit the infection will be not substantively decreased, so this measure does not create long-term cost savings. Legislation across all state Medicaid programs is needed to open treatment to all infected individuals.

To the second restriction, Texas Medicaid requires that a board-certified specialist must prescribe the DAA.18 Patients often face transportation challenges for specialist care as a result of the limited number of specialists in rural areas of Texas. Although telehealth programs such as Project ECHO (Extension for Community Healthcare Outcomes),19 which helps to connect primary care providers with specialists using telecommunication, are in existence in South Texas, most clinics serving vulnerable populations lack access to this consultation. More funding is needed for telehealth programs because remote specialist to primary care consultation could play a larger role for Texas Medicaid HCV treatment in South Texas.

Finally, there are restrictive requirements by Texas Medicaid concerning drug and alcohol addiction for treatment of HCV.16 If a patient has a history of illicit drug use, the patient must have initiated a substance use disorder program for 6 months before becoming eligible for treatment.16 In addition, the patient can be denied treatment if he or she consumes alcohol.16 Access to substance use disorder programs in South Texas is a significant barrier for HCV treatment because of the limited availability of treatment programs and transportation concerns.20 Data show no difference between the high rates of sustained viral response for individuals consuming alcohol while on DAAs and those who are abstinent.21 Physicians should lobby Texas Medicaid to remove this restriction. In addition, further funding to support substance abuse treatment is needed across the state.

Medical oncologists have an ethical obligation to advocate for health interventions that aid in the prevention of cancer, especially in settings where there are limited effective cancer treatment options. Although cancer death rates are decreasing in almost every other cancer, they continue to increase in liver cancer. Treating HCV infection could slow the rate of increase of HCC, yet the high price tag on curative treatments for HCV creates significant barriers to patient access, especially in areas with low socioeconomic status. Payers trying to control spending by only treating the sickest patients may undermine the benefit that might be achieved in HCV control and liver cancer prevention. Until these challenges are addressed through effective health policy reform in a collaborative effort between specialists and primary care physicians, not only on a local but also a national level, the serious impact of HCV and HCC on morbidity and mortality will not be mitigated.

Copyright © 2019 by American Society of Clinical Oncology
http://ascopubs.org/doi/full/10.1200/JOP.18.00525

Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain

Iowa Medicaid Expands Care To Hepatitis C Patients, But Restrictions Remain

By Kate Payne 

Starting this month more hepatitis C patients can qualify for care under Iowa Medicaid. But some doctors and advocates argue the remaining restrictions are immoral and illegal.

Previously, only Iowans with more advanced liver disease, a fibrosis score of F3 or above, would qualify for treatment. As of January 1, 2019, those with a score of F2 and above can request the treatment from their doctor through a process known as prior authorization, which requires they meet certain criteria beyond their need for the treatment.

Continue reading:
http://www.iowapublicradio.org/post/iowa-medicaid-expands-care-hepatitis-c-patients-restrictions-remain 

On This Blog
Controversy over the cost of hepatitis C drugs
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions of hepatitis C medications.

Medicaid patients in Puerto Rico don’t get coverage for drugs to cure hepatitis C

Medicaid patients in Puerto Rico don’t get coverage for drugs to cure hepatitis C
By Carmen Heredia Rodriguez
January 4, 2019
Drugs that can cure hepatitis C revolutionized care for millions of Americans living with the deadly liver infection. The drugs came with a steep price tag — one that prompted state Medicaid programs to initially limit access to the medications to only the sickest patients. That eased, however, in many states as new drugs were introduced and the prices declined.

But not in Puerto Rico. Medicaid patients in the American territory get no coverage for these drugs.

The joint federal-territory health care program for the poor — which covers about half the island’s population — does not pay for hepatitis C medications. They also do not cover liver transplants, a procedure patients need if the virus causes the organ to fail.

The Puerto Rico Department of Health created a separate pilot project in 2015 to provide hepatitis C medications to those sickened by the liver infection who also have HIV but expanded the program later to those with only hepatitis C. However, according to the Office of Patient Legal Services, an official territorial agency that advocates for consumers, the program ran out of funding and is no longer accepting patients only with hepatitis C.

The Puerto Rico Health Insurance Administration (ASES), which oversees Medicaid, said it is working with a pharmaceutical company to create a cost-effective system to provide these medications.

“Definitely, they need to be given coverage,” said ASES director Angela Ávila Marrero. “They need to be given care.”

Hepatitis C, a bloodborne infection, increases the risk of cirrhosis, liver cancer and death. Poor screening led many to contract the disease through tainted blood and organ transplants into the early 1990s. Today, intravenous drug use drives most of the new cases in the United States.

William Ramirez, executive director of the American Civil Liberties Union of Puerto Rico, said he is considering filing suit against Puerto Rico for failing to cover the cost of these medications for people enrolled in Medicaid.

“You’re holding back medication and thereby allowing certain people to die,” Ramirez said.

That reality is clear for Hector Marcano, 62, who stopped working roughly six years ago because of the illness. After recovering from a drug addiction, he was a case manager who worked to connect drug users to health resources.

His liver disease is leading to overall deterioration. He struggles with walking. A bout of pneumonia that left him hospitalized lingers in his racking coughs. He spends his days reading, listening to the radio and praying for the strength to keep searching for the cure.

He doesn’t understand why the government does not provide hepatitis C medications, he said, especially as there are so many people in need of them.

“So what are we waiting for?” asked Marcano. “For a pandemic to happen?”

Medicaid Costs Drive Island’s Debt Crisis

Hepatitis C afflicts approximately 3.5 million people in the United States. The virus can silently corrode the liver for years without causing symptoms.

Because of the condition’s stealthy nature and the absence of recent data, the number of people in Puerto Rico living with the virus is uncertain. Researchers on the island in 2010 estimated 2.3 percent of 21- to 64-year-old residents had the virus.

Documents provided by the Center for Health Law and Policy Innovation of Harvard Law School show medical providers reported more than 11,000 hepatitis C cases to the Puerto Rico Department of Health from 2010 to September 2016.

Cynthia Pérez Cardona, an epidemiology professor at the University of Puerto Rico and an author of multiple studies involving hepatitis C in Puerto Rico, said she is uncertain of how widespread the virus is on the island. But other statistics present a worrisome sign: A report from the island’s cancer registry found the number of new liver cancer cases increased an average of 2.1 percent annually among men and 0.7 percent among women from 1987 to 2014. Hepatitis C can cause such cancers.

Despite these warnings, Puerto Rico has fewer resources than most of the nation to care for its impoverished.

Unlike states, Puerto Rico’s federal funding for Medicaid is capped. Historically, these federal dollars have fallen far short of covering the program’s costs on the island. The territory’s crushing Medicaid expenses helped drive the island into its $70 billion debt crisis.

Under these financial constraints, said Matt Salo, executive director of the National Association of Medicaid Directors, Puerto Rico’s officials are left with a difficult choice when considering covering hepatitis C drugs.

“Rather than blowing through their cap in six months,” Salo said, “they’d blow through their cap in one month.”

Pilot Project Falls Short
In the health department’s pilot project, patients with certain conditions like uncontrolled diabetes or an active mental health condition or those who could not prove they had been sober for six months were barred.

Such restrictions rankle patients and their advocates. “You know, we do not deny lung cancer treatment for a person who smokes or diabetes treatment to a person that doesn’t eat well,” said Robert Greenwald, a professor at Harvard Law School and faculty director of the Center for Health Law and Policy Innovation.

Dr. José Vargas Vidot, a member of Puerto Rico’s Senate and a physician, submitted a petition in 2017 to various territorial agencies questioning Medicaid’s coverage of hepatitis C medications.

The Office of Patient Legal Services responded to Vargas Vidot in a letter this year confirming that the island’s Medicaid program did not cover these drugs. It also noted the health department pilot project closed its wait list after reaching 100 patients because of a lack of funding. In November, Vargas Vidot submitted legislation to require that hepatitis C medication and treatment be part of basic coverage for insurance plans and Medicaid.

Ávila Marrero said ASES is in talks with a drugmaker to create a network separate from the Medicaid program to provide medications to the patients. She said she hopes the arrangement will allow the government to get lower prices for the drugs. But no agreements have yet been reached for such a program.

Despite its success in states, suing to get coverage may not be the best option for Puerto Rico because the debt rescue package passed by Congress in 2016 includes a provision that bars creditors from taking legal action to collect from the territory.

That could apply to a lawsuit filed against the territory for not covering hepatitis C treatment in its Medicaid program, said Phillip Escoriaza, a health and federal grants law attorney in Washington, D.C., who practiced in Puerto Rico. And even if the case can go forward, it would enter the docket for a special bankruptcy court with more than 165,000 other claims, as of Dec. 14. It may be in the Puerto Rican government’s interest for things to take a long time, said Escoriaza. Once there, it could stall for years — time hepatitis C patients such as Marcano might not have.

Source:

https://khn.org/news/medicaid-patients-in-puerto-rico-dont-get-coverage-for-drugs-to-cure-hepatitis-c/

On This Blog

The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing insurance restrictions; private insurers/Medicaid - and -availability of generic versions.

In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)

Editorial

In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)

Jorge Mera, MD, Brigg Reilley, MPH, Jessica Leston, David Stephens, RN

DOI: https://doi.org/10.1016/j.amjmed.2018.10.031

The American Journal of Medicine

Publication History

Published online: November 24, 2018

Abstract 

Recent advances in Hepatitis C Virus HCV treatment could be described as revolutionary: for uncomplicated patients, treatment is nearly 100% effective, oral-only, has a low pill burden, minimal side effects, and results in a cure.1 Comparisons we have heard from clinicians are that HCV is now easier to treat than either diabetes or hypertension. Unfortunately for many patients, their state of residence is the decisive factor for whether they will receive lifesaving treatment. As part of a tribal telehealth network for HCV, we support several rural clinics successfully treating HCV and see this dilemma all too frequently.

Consider a patient with chronic HCV infection who presents with a recent history of marijuana use and has been late picking up hypertension medication. The patient has cirrhosis and is at high risk of HCV related mortality. He is enrolled in state Medicaid and highly motivated for treatment. What is the treatment plan? It depends on the state. A resident of New Mexico can start treatment without delay. If instead the patient lives in Montana, a state that determines treatment eligibility based on advanced liver fibrosis, documented sobriety, and compliance with existing medications, the consultation is effectively moot; treatment will be denied. Montana is far from alone in its HCV treatment restrictions. Patients in South Dakota, Oregon, and several other states we serve face similar hurdles …

View Full-Text Article Online:
https://www.amjmed.com/action/showFullTextImages?pii=S0002-9343%2818%2931072-6

Download PDF:
https://www.amjmed.com/article/S0002-9343(18)31072-6/pdf

Current Issue
November 2018
Volume 131, Issue 11 

Kansas Agrees To Cover Potentially Life-Saving Drugs For Patients With Chronic Hepatitis C

Kansas Agrees To Cover Potentially Life-Saving Drugs For Patients With Chronic Hepatitis C 

By Dan Margolies
Kansas has agreed to cover the cost of drugs to treat Medicaid patients with chronic hepatitis C without subjecting them to a lengthy list of requirements.

A legal settlement, which awaits final court approval, resolves a class action lawsuit alleging the state made it too difficult for hepatitis C patients to receive the potentially life-saving treatments.

The parties first notified the court in July that they had resolved the case after mediation. On Tuesday, the court set deadlines for approval of a final settlement.

“Essentially, the agreement is that all hep C patients who use Medicaid to get their drugs will be entitled to Mavyret or Harvoni, the two curative drugs, regardless of their fibrosis score,” said Lauren Bonds, legal director of the ACLU of Kansas, which along with the Shook Hardy & Bacon law firm, sued Kansas officials over the state's hep C treatment guidelines in February.

Fibrosis scores measure the health of the liver. Scores range from F0, referring to mild or no scarring of the liver, to F4, referring to significant liver damage or cirrhosis. Kansas’ privatized Medicaid program, known as KanCare, had limited coverage to patients with a fibrosis score of F3 or F4. 

Read More: http://www.kmuw.org/post/kansas-agrees-cover-potentially-life-saving-drugs-patients-chronic-hepatitis-c

On Twitter 

Hep C Calculator: an online tool for cost-effectiveness analysis of DAAs 

Shared by @HenryEChang

On This Blog

The controversy over expensive new drugs for hepatitis C
Link to a collection of current articles regarding the effectiveness and safety of generic hepatitis C medicines, addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Ohio Medicaid lifts restrictions on costly hepatitis C drugs

Ohio Medicaid lifts restrictions on costly hepatitis C drugs
By Kaitlin Schroeder, Cox Newspapers

DAYTON, Ohio -- As the opioid crisis led to a spike in new hepatitis C cases, a breakthrough prescription hit the market five years ago that could cure the viral liver disease -- but at an eyepopping price tag of $1,000 per pill.

Now, as costs are coming down and demands for compassion mount, Ohio Medicaid will let all patients get the potentially life-saving medication once diagnosed instead of providing them to only the sickest patients.

The expensive medications caused Medicaid and private insurers that manage Medicaid plans to consider whether to limit the treatment based on the patient's stage of liver damage, and many did.

But Ohio Medicaid announced this week that in an effort to mitigate the harm caused by the opioid epidemic, the department is changing policy starting Jan. 1 to begin treatment at the time of chronic hep C diagnosis.

Read More: 

https://www.wral.com/ohio-medicaid-lifts-restrictions-on-costly-hepatitis-c-drugs/17965440/?comment_order=forward

On This Blog

The controversy over expensive new drugs for hepatitis C
Link to a collection of current research articles regarding the effectiveness and safety of generic hepatitis C medicines. Read news articles addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment
September 18, 2018
The Louisiana Department of Health is currently developing a “subscription style” payment plan with pharmaceutical manufacturers to provide state residents with access to hepatitis C treatment.

HCV Next spoke with the department’s chief of staff, Pete Croughan, MD, about the landscape of HCV in the state and the novel payment model designed to expand treatment despite the expensive cost of direct-acting antivirals.

The department estimates that this plan could increase treatment from approximately 3% of people on Medicaid and in correctional facilities up to nearly 60%.

“We’ve actually had conversations with all three hepatitis C manufacturers — AbbVie, Gilead and Merck — and all three have expressed interest in potentially partnering with us,” he said. “The plan is to ultimately select a partner through a request for proposal process, but we’re willing to work with any company that gives us the best deal.”

Continue reading: 

https://www.healio.com/hepatology/hepatitis-c/news/online/%7B40062557-2921-4d74-a2a0-09617fcd446c%7D/louisiana-developing-netflix-style-subscription-plan-for-hcv-treatment

Read the September/October issue of HCV available online here:

https://www.healio.com/hepatology/news/print/hcv-next

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs".

HCV Next: Physicians Diagnosing,Treating HCV Define New Role in Opioid Crisis

Check out the July/August issue of HCV Next, just released online at Healio. 

Table of Contents

Cover Story 
Physicians Diagnosing,Treating HCV Define New Role in Opioid Crisis

The opioid epidemic in the United States has affected millions, exposing them to health risks that include a range of infectious diseases.

Feature

Point-of-Care HCV Assays: A Turning Point for Decentralized Diagnosis

Compared with traditional hepatitis virological tests, the benefit of point-of-care diagnostics is their use in patient care sites such as outpatient clinics, intensive care units, emergency departments and medical laboratories. Additionally, certain low- and middle-income countries have made use of point-of-care tests in blood banks.

In the Journals Plus

Most iatrogenic HCV cases unidentified until symptom onset
Insurance denials for HCV therapy increase in US

Meeting News
HCV outcomes worse for patients with public insurance, Medicaid
Homeless veterans with HCV diagnosed, treated via PCP outreach

Trend Watch

AASLD online HCV guide update includes key at-risk populations

Begin here.....

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions.

Elsewhere
Efficacy of Generic Oral DAAs in Patients With HCV Infection
Journal of Viral Hepatitis, July 20, 2018

N.J. Expands hepatitis C treatments for all Medicaid enrollees

N.J. Expands Vital Hepatitis C Treatments for Medicaid Enrollees 

TRENTON – The New Jersey Department of Human Services announced expanded hepatitis C treatments for all Medicaid enrollees in the state, a policy facilitated by increased funding in the fiscal year 2019 budget.

The improvement comes amid ongoing concern about increased infections due to the opioid epidemic and a growing focus on identifying and treating hepatitis C infection among Baby Boomers.

New Jersey Human Services Commissioner Carole Johnson said that under the new policy, New Jersey Medicaid will cover hepatitis C curative drug treatment once someone is diagnosed with the virus. Previously, individuals in New Jersey were required to wait until their liver had already been damaged before accessing this treatment.

Continue reading: https://www.tapinto.net/towns/passaic-valley/categories/press-releases/articles/n-dot-j-expands-vital-hepatitis-c-treatments-for-med-146

Increasing success and evolving barriers in the hepatitis C cascade of care

PLoS ONE 13(6): e0199174

Increasing success and evolving barriers in the hepatitis C cascade of care during the direct acting antiviral era 

Autumn Zuckerman, Andrew Douglas, Sam Nwosu, Leena Choi, Cody Chastain
Published: June 18, 2018
https://doi.org/10.1371/journal.pone.0199174 

With DAA therapy as the new standard of care, the HCV cascade of care (CoC) has transformed, still plagued by challenges in linkage to care yet substantially improved with regards to treatment outcomes. Interventions to emphasize screening, linkage to care, and access to treatment may address some of these challenges. Though DAA agents remain expensive for all groups, efforts to enhance and improve access across payer groups should be pursued. Integration of pharmacy services demonstrated high rates of medication access compared to previous studies, even in those with Medicaid. With new medications and modern tools, HCV treatment can be well-tolerated, effective, and result in high rates of completion.

Full Article

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Abstract

Barriers remain in the hepatitis C virus (HCV) cascade of care (CoC), limiting the overall impact of direct acting antivirals. This study examines movement between the stages of the HCV CoC and identifies reasons why patients and specific patient populations fail to advance through care in a real world population. We performed a single-center, ambispective cohort study of patients receiving care in an outpatient infectious diseases clinic between October 2015 and September 2016. Patients were followed from treatment referral through sustained virologic response. Univariate and multivariate analyses were performed to identify factors related to completion of each step of the CoC. Of 187 patients meeting inclusion criteria, 120 (64%) completed an evaluation for HCV treatment, 119 (64%) were prescribed treatment, 114 (61%) were approved for treatment, 113 (60%) initiated treatment, 107 (57%) completed treatment, and 100 (53%) achieved a sustained virologic response. In univariate and multivariate analyses, patients with Medicaid insurance were less likely to complete an evaluation and were less likely to be approved for treatment. Treatment completion and SVR rates are much improved from historical CoC reports. However, linkage to care following referral continues to be a formidable challenge for the HCV CoC in the DAA era. Ongoing efforts should focus on linkage to care to capitalize on DAA treatment advances and improving access for patients with Medicaid insurance.

Read More

Half of hepatitis C patients with private insurance denied life-saving drugs

Open Forum Infectious Diseases
Infectious Diseases Society of America

Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study
Charitha Gowda Stephen Lott Matthew Grigorian Dena M Carbonari M Elle Saine Stacey Trooskin Jason A Roy Jay R Kostman Paul Urick Vincent Lo Re, III
Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy076, https://doi.org/10.1093/ofid/ofy076
Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.
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Half of hepatitis C patients with private insurance denied life-saving drugs

University of Pennsylvania School of Medicine
PHILADELPHIA - The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) - once-a-day pills that first became available in the United States in 2014 - are highly effective, with a 95 percent cure rate and few side effects for patients with chronic hepatitis C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

"Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector," said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. "It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states."

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It's likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study's 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

"From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer," Lo Re said. "In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the liver, such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others."

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and private insurers remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all chronic hepatitis C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

"Eliminating hepatitis C in the U.S. is a feasible goal," Lo Re said, "but that's going to be hard to achieve if payers are not reimbursing for the treatment."

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Video:https://www.healio.com/hepatology/hepatitis-c/news/online/%7B3714098b-f39c-4e99-86d1-e3a7e9bebb5d%7D/hcv-outcomes-worse-for-patients-with-public-insurance-Medicaid

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Digestive Disease Week® (DDW) 2018

Coverage @ Healio
Healio staff will report live on breaking news presented at the meeting and capture video interviews with experts to gain their perspectives on important presentations.

Begin here: https://www.healio.com/gastroenterology/meeting-news/ddw-meeting

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Digestive Disease Week® (DDW) 2018
June 2-5, 2018
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Novel Medicaid Strategy Proposed to Increase Access to HCV Treatment

Infectious Disease Advisor

Novel Medicaid Strategy Proposed to Increase Access to HCV Treatment

Zahra Masoud
Implementing a novel drug purchasing strategy may dramatically increase access to drugs for hepatitis C virus (HCV) infection for patients enrolled in Medicaid without increasing state and federal costs, according to a study recently published in the Annals of Internal Medicine.

Although the annual HCV-related death toll in the United States exceeds that of a combination of HIV and 59 other infectious diseases, curative treatments introduced in 2013 resulted in sustained virologic response that has been associated with lower mortality in individuals with chronic HCV infection.

Read More: https://www.infectiousdiseaseadvisor.com/hepatitis/hepatitis-c-virus-treatment-access-may-improve-with-proposed-medicaid-strategy/article/768917/

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With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs

PBS News Hour
May 23, 2018

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With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs
New drugs can cure up to 95 percent of patients with hepatitis C, a virus that can be debilitating or deadly. And there’s been a 20 percent rise in new infections from 2015 to 2016 due to the opioid epidemic. In Oregon, a state hard-hit by the disease, new medicines combined with the big surge in those looking for treatment has led to a unique care model. Special correspondent Cat Wise reports.

Full Transcript 
https://www.pbs.org/newshour/show/with-highest-hepatitis-c-mortality-rate-in-u-s-oregon-expands-access-to-life-saving-drugs

Judy Woodruff: Now the latest on a medical breakthrough that’s starting to have an impact on a hidden, deadly epidemic in this country. New drugs can cure up to 95 percent of patients with hepatitis C, a virus that often leads to debilitating or deadly results. The drugs can save lives, prevent expensive hospitalizations and liver transplants. But some states are feeling the squeeze of the cost of this medicine. Special correspondent Cat Wise has our report for our weekly series on the Leading Edge of science.

Cat Wise: Three-point-five million Americans are living with a potentially deadly virus, and half don’t even know it. It’s hepatitis C, a blood-borne pathogen which attacks the liver and can eventually cause serious liver problems, including cirrhosis and liver cancer. Three-quarters of those with the virus are baby boomers, exposed from unscreened blood transfusions, I.V. drug use, and other blood-to-blood contact prior to the early ’90s. But now the opioid epidemic has led to a 20 percent rise in new infections from 2015 to 2016. One state where the young and the old have been hit hard by the disease is Oregon. Oregon has the highest hepatitis C mortality rate, per capita, in the country. It’s estimated about 100,000 Oregonians have been infected with the virus and more than 500 die every year. It’s been a very difficult disease to treat, but over the last four years, there’s been a revolution in hep C drugs. Many are being cured around the country now, and here in Oregon, many are coming here to the Oregon Clinic for those treatments.

Dr. Kent Benner: We never talked about cure of hep C until the last few years, and now we’re all talking about cure of hep C.

Cat Wise: Dr. Kent Benner is a gastroenterologist and hepatologist at the clinic in Portland. He says people are still dying from the disease, often because they haven’t been tested and aren’t aware they have virus until they are quite sick. But Benner says much has changed since he first started treating patients several decades ago.

Dr. Kent Benner: Treatment at that time was interferon. This required injections, shots several times a week. Quite a few side effects. We felt we were doing well if we could cure 15 or 20 percent of patients. Since late 2013, there’s been a remarkable development from a number of different companies. They have developed drug combinations that provide 95 percent cure rates in patients we treat.

Cat Wise: Costly liver transplants are often the only option when the liver becomes too badly damaged. But at earlier disease stages, the liver often starts to heal once the medicines have cleared virus from the body.

Dr. Kent Benner: Not only are we seeing liver function improve, but patients with more advanced liver disease occasionally can come off the transplant list.

Cat Wise: Sixty-four-year-old Rob Shinney, who recently had knee surgery, is one of those cured by the new hep C drugs known as direct-acting antivirals, or DAAs. Like many others of his generation, he doesn’t really know how he contracted the virus. Under the care of Dr. Benner, Shinney began a three-month treatment in late 2016 after his liver showed signs of moderate scarring known as fibrosis. Tests later confirmed he was virus-free.

Rob Shinney: I had a serious chronic illness hanging over my head that I knew could kill me. And that’s gone now.

Cat Wise: We spoke at a local pub he visits now and again with his choir friends, something he never did when he had the virus.

Rob Shinney: I swear I felt like I was 20 years younger. I had energy. I could do things. It’s great just to be able to sit around and have a beer with everybody and, you know, just enjoy life. Cat Wise: The cost of the drugs used to cure Shinney, who has private insurance, aren’t cheap. Since Gilead Sciences’ Sovaldi first hit the market in late 2013 at a whopping $84,000 for a course of therapy, competitors have steadily lowered the costs. Last year, a new medication called Mavyret was released for around $26,000. Many payers often, though, negotiate even lower prices with the drug company. Still, the drugs are expensive, and they aren’t a vaccine. If someone is cured, they can become reinfected. Access to the drugs varies widely around the country. A report last year by two national advocacy organizations found that many public and private payers choose to limit access to DAAs due to their cost, as well as other concerns. Oregon is among a number of states which have had restrictive Medicaid requirements, including denying coverage to patients in the early stages of disease and those who are abusing drugs and alcohol. But some of those restrictions are beginning to ease.

Dr. Dana Hargunani: In January, we just started covering individuals with lower stages or lower levels of fibrosis.

Cat Wise: Dr. Dana Hargunani is the chief medical officer for the Oregon Health Authority, which oversees the state’s Medicaid program. She says, while the state is starting to expand access, costs are still a significant issue. Oregon has spent more than $94 million on the drugs since 2014, covering about 1,500 people.

Dr. Dana Hargunani: The newer treatments for hepatitis C have a significant budget impact for our state. We had to get additional funding through the legislative process. We’re trying to manage our limited resources to ensure coverage for those who need it immediately for the hepatitis C treatment, as well as all the other individuals in our Medicaid program.

Cat Wise: Hargunani says another reason the state delays coverage until patients have mild liver scarring, not everyone needs the medicines.

Dr. Dana Hargunani: One in five individuals who get infected with hepatitis C will spontaneously clear their infection. Right now, the data doesn’t help us understand how to know which individuals will need to have a high-cost drug to treat and cure their infection.

Dr. Brianna Sustersic: Luckily, he doesn’t have any evidence of cirrhosis.

Cat Wise: Dr. Brianna Sustersic is a medical director at Central City Concern, a federally funded health center in downtown Portland which serves a large number of homeless individuals, many of whom have substance abuse disorders; 25 percent to 50 percent of the patients have hep C.

Dr. Brianna Sustersic: The Medicaid requirements have limited access to treatment for many of our patients. From a public health standpoint, if we are able to treat the population who is contracting this, and spreading it, then we can move toward eradicating the disease.

Cat Wise: To prove that point, and to meet a big need, the clinic and a local syringe exchange program began a small drug company-sponsored study last year to treat patients who otherwise wouldn’t have qualified for the medications; 56-year-old Kim Trano is now virus-free thanks to that trial. She says she’s felt a lot of stigma being a recovering drug user and it was hard to learn she had initially been denied drug coverage. To those who would question giving expensive medicines to someone who might become reinfected, she says:

Kim Trano: Everyone is worthy of a chance. If I were to relapse, I would all precautions not to be reinfected. And that’s pretty easy to do. Most people know how to do that.

Cat Wise: The new medicines combined with the big surge in those looking for treatment has led to a unique care model. Chris Hulstein is not a doctor. He’s a clinical pharmacist and part of a new program at Portland’s Providence Hospital. Over the past year, about 50 patients have been successfully treated by Hulstein and his colleagues. Another 30 are currently in treatment.

Chris Hulstein: A lot of the specialists are very busy managing very complex patients, and that is their role. Having a pharmacist being able to manage the patient gets patients treated faster and more successfully than we ever have been able to do before.

Cat Wise: Hepatitis C advocates are now working with the state and private insurers to open up more access to the drugs. For the “PBS NewsHour,” I’m Cat Wise in Portland, Oregon.

https://www.pbs.org/newshour/show/with-highest-hepatitis-c-mortality-rate-in-u-s-oregon-expands-access-to-life-saving-drugs

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
May 23, 2018
Sydney Lupkin, Kaiser Health News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

There’s A Cure For Hepatitis C, But Oregon Limits Access

There’s A Cure For Hepatitis C, But Oregon Limits Access
By Amelia Templeton / OPB
Oregon’s decision to continue to limit treatment based on a patient’s fibrosis score conflicts with guidelines set by health professional groups.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend that all patients with chronic hepatitis C should be treated.

The groups note that treating patients early, before significant fibrosis has developed in the liver, appears to be a particularly effective way of reducing deaths associated with hepatitis C.

Read the full article: http://ijpr.org/post/there-s-cure-hepatitis-c-oregon-limits-access#stream/0

Listen here: https://cpa.ds.npr.org/ksor/audio/2018/04/HepCCure.mp3

Opinion - It's criminal what Illinois is doing to Medicaid patients with hepatitis C

It's criminal what Illinois is doing to Medicaid patients with hepatitis C

By: OLUWATOYIN ADEYEMI, ANDREW ARONSOHN, BASMATTEE BOODRAM, DANIEL JOHNSON and MAI TUYET PHO 

Every day, Illinois Medicaid patients with hepatitis C are denied access to a simple cure to a disease that jeopardizes their life because of outdated and unconscionable restrictions on who can get this proven treatment.

Hepatitis C is a viral infection that causes inflammation and scarring of the liver. People who are infected with hepatitis C usually have no or few symptoms for decades until it reaches the end stages of disease, where patients are at risk of liver failure, liver cancer and death. Hepatitis C is a leading cause of liver-related death and need for liver transplantation in the United States. An estimated 150,000 people are affected by hepatitis C in this state alone, according to the Illinois Department of Public Health.

Continue reading: http://www.chicagobusiness.com/article/20180220/OPINION/180229999