Showing posts with label Sofosbuvir/Cost. Show all posts
Showing posts with label Sofosbuvir/Cost. Show all posts

Wednesday, August 8, 2018

Hep C and B August Newsletters - Liver Wellness Tips & Generic Direct Acting Antivirals

News updated Aug 8, 2018

August Newsletters
Welcome folks! Read the latest hep B or C news in this months collection of newsletters, published monthly by a small group of kind people devoted to educating us all about liver disease. In addition, access new blog posts with information about major issues surrounding viral hepatitis, as well as tips for maintaining a healthy liver, again, provided by a handful of inspirational writers who blog just for you. Finally read today's news updated as the day progresses, check back for updates. 

Liver Wellness Tips
In honor of World Hepatitis Day, start with:10 TERRIFIC WAYS TO LOVE YOUR LIVER THIS SUMMER, a must read series covering everything from foods containing anti-inflammatory agents to liver-friendly yoga poses! Recently launched by Al D. Rodriguez Liver Foundation.

Today's News
GIS – 08 August 2018: The Ministry of Health and Quality of Life will organise a Conference on Hepatitis C in October 2018. 
The Conference will involve the participation of experts from the United Kingdom, Australia, Egypt and South Africa so as to guide the health care professionals on treatment and elimination of hepatitis C in Mauritius.

Its main objectives will be to educate the local doctors in the new treatments of hepatitis C and to develop a large scale treatment strategy for those who have been diagnosed. The Conference also aims at sourcing affordable tests for hepatitis C and developing a strategy for eliminating hepatitis C in Mauritius by 2025.

New PHE data shows a decrease in deaths from hepatitis C but diagnoses of advanced liver disease and related cancers remain stable.

Researchers have found that a group of viruses that cause severe stomach illness — including the one famous for widespread outbreaks on cruise ships — get transmitted to humans through membrane-cloaked “virus clusters” that exacerbate the spread and severity of disease.

The World and Everything in It: hospice for the homeless.
Death with dignity - WORLD Radio Blog
At age 50, Linda is dying of Hepatitis C that she contracted from needles while she was a heroin addict. Now the disease is causing her liver to fail. She's in a lot …

August 7
Express Scripts Holding Co. said it will drop 48 drugs next year from its closely watched lineup of covered therapies, including Gilead Sciences Inc.’s HIV treatment Atripla and AbbVie Inc.’s hot-selling Mavyret medicine for hepatitis C. Express Scripts said that next year it will cover Symfi, a new HIV combo pill from Mylan NV that the benefit manager said has a 40 percent lower list price than Atripla. Express Scripts will also cover Merck & Co.’s lower-cost hepatitis C medicine Zepatier. In July, Merck said that it was cutting its list price for the drug by 60 percent.

Seeking your help to end the HIV and hepatitis C epidemics and significantly reduce the incidence of STDs in California!
Aug 7, 2018
It is time for California to develop its own Ending the Epidemic plan! The California HIV/AIDS Policy Research Centers, together with viral hepatitis and STD organizations (including Project Inform), have launched a community-driven effort to inform development of a statewide plan to end the HIV and hepatitis C epidemics and significantly reduce the incidence of STDs.

"This is a lifesaver": Patients who accepted infected kidney transplants cured of hepatitis C
Some patients in desperate need of a kidney transplant participated in a bold experiment where they received organs infected with hepatitis C. The gamble paid off.

7, 2018 (HealthDay News) -- Dialysis patients waiting for kidney transplants might safely accept an organ from a donor infected with hepatitis C virus (HCV), …

Publish date: August 7, 2018
By Mark S. Lesney ID Practitioner
Marked differences were seen in the composition of hepatitis C virus hypervariable region 1 (HVR1) when comparing HIV-coinfected (CIP) with HCV-monoinfected (MIP) individuals, according to the results of a genetic analysis of nearly 300 patients.

Study: Alcohol Abuse Increases Risks in Patients with Hepatitis C
Aug 7, 2018
The interaction between alcohol abuse and hepatitis C virus (HCV) can ... The study noted that approximately 20% of patients with alcoholic hepatitis have HCV.

August 6
Healio - Aug 6, 2018
Patients with chronic hepatitis B virus infection died an average of 14 years ... evidence of diabetes (27.2%), a history of alcohol abuse (17.7%), hepatitis C or …

FDA gives drugmakers new ways to prove opioid disorder treatments work
By Steven Ross Johnson | August 6, 2018
Under the new draft guidance, drug developers can look beyond whether medication-assisted treatments reduce patients' opioid use. They can prove efficacy through drops in mortality, emergency department visits, or transmission of hepatitis C. Other measurable outcomes could include improvements in patients' ability to resume work or school, or by the share of patients with moderate to severe forms of opioid use disorder who go into remission while using the experimental MAT therapies.

Entecavir Associated With Later Virological Relapse Than Tenofovir
Aug 6, 2018
A comparison of the nucleos(t)ide analogues tenofovir and entecavir revealed that virological relapse occurred much later for people with a chronic hepatitis B virus (HBV) infection who were e antigen negative after stopping entecavir, according to findings published in The Journal of Infectious Diseases.

Ascletis Pharma Inc. (1672.HK) announced today Ravidasvir is recommended by the World Health Organization (WHO) Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection (July 2018) as a future pan-genotypic direct-acting antivirals agent (DAA). Ascletis received the acceptance letter for Ravidasvir new drug application (NDA) from the China Food and Drug Administration (CFDA) on August 1.

Related: April 12, 2018
sofosbuvir/ravidasvir
The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best hepatitis C therapies available today, but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes,” said Dr Bernard Pécoul, Executive Director, DNDi.

Integrating Treatments for Opioid Use Disorder and Infectious Diseases
Aug 6, 2018
All healthcare providers have a role in combating the opioid use disorder (OUD) epidemic and its infectious disease (ID) consequences, according to an article published in Annals of Internal Medicine

Britain plans for opt-out organ donation scheme to save lives
LONDON Britain plans to increase the number of organ donors by changing the rules of consent and presuming that people have agreed to transplants unless they have specifically opted out.

Read The Latest News
For a quick review of news, stroll over to the good people at HepCBC to read the latest issue of the Weekly Bull.

Journal Updates
Managing Neurologic Complications of Chronic HCV Infection
Chronic hepatitis C virus (HCV) infection can cause a multitude of extrahepatic complications, including neurologic manifestations. These complications can lead to substantial neuropsychiatric deficits, such as fatigue, cognitive impairment, restless legs syndrome, Parkinson's disease, and peripheral neuropathy. In addition to detecting and managing these neurologic complications, pharmacists in community settings can promote HCV screening, improve medication access and adherence, and recommend preventive strategies patients can use to avoid transmission of this widespread infection.

International Journal of Infectious Diseases
2 August 2018
Download: High Efficacy of Generic and Brand Direct Acting Antivirals in Treatment of Chronic Hepatitis C.

August Updates On This Blog
New Articles Under: Other Conditions Related To HCV 
- Hepatitis C-Diabetes associated w-advanced fibrosis and progression in HCV non-genotype 3 patients
- Symptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings 

New Articles Under: HCC during and after direct-acting antiviral therapy in patients with hepatitis C
- Direct Antiviral Therapy of Hep C May Not Boost Hepatocellular Carcinoma Risk

New Articles Under: HCV-Statins 
- Statins: old drugs as new therapy for liver diseases?

New Articles Under: HCV-Education
- Long–term effect of liver fibrosis after SVR in patients with HCV 

July News
Spotlight on mortality trends in liver disease
One study looked at 10-year U.S. mortality trends related to chronic liver diseases, while another assessed mortality from cirrhosis and liver cancer in the U.S. from 1999 to 2016.
“It is clear that the introduction of oral, highly efficacious and well-tolerated antiviral agents has improved outcomes in patients with viral hepatitis,” they wrote. “However, future challenges with [alcoholic liver disease] and NAFLD will pose a different set of problems and will necessitate a multidisciplinary approach with a dedicated focus on minorities.”

Disparities in Access to Direct Acting Antiviral Regimens for Hepatitis C Virus (HCV): The Impact of Race and Insurance Status 
Despite highly effective and well-tolerated regimens for treating hepatitis C virus (HCV), patients face barriers in accessing treatment. In addition to suboptimal HCV screening programs and lack of effective linkage-to-care, other barriers include strict requirements from some payers to cover treatment. This study reports insurance status and Hispanic ethnicity as predictors of not receiving treatment. 

“Coordinated care has the potential to improve access to treatment for individuals with hepatitis C who are naive to direct-acting antivirals; however, having Medicaid could hamper access, according to a recent study published in PLoSONE.”

People born between 1945 and 1975 are the group of people who are most likely to suffer from chronic hepatitis C in Canada, and Greg Powell is a Canadian who is part of those people. Greg contacted the hepatitis C in the 1980s, but the diagnosis came ten years later. Greg was already suffering from hemophilia B which is a hereditary bleeding disorder, so he needed to benefit from a series of blood transfusions.

Wayne Kuznar, for MDLinx
Nearly three fourths of patients who present with acetaminophen-induced acute liver injury (ALI) or failure (ALF) are women, according to findings from a North American registry. Women with acetaminophen overdose leading to ALI/ALF were more likely than men to present with high-grade hepatic encephalopathy and have critical care needs, and more likely to have psychiatric disease and to co-ingest sedating agents with acetaminophen.

Newsletters
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
Newsletter Highlights
August Issue
HealthWise – Hepatitis C and Sugar by Lucinda Porter, RN – Lucinda discusses effects of sugar on the body, hepatitis C, and fatty liver. 
(1) State Prisons Fail to Offer Cure to 144,000 Inmates with Deadly Hepatitis C
(2) What’s Being Done to Stop the Spread of Hepatitis A in the Midwest? 
SnapShots by Alan Franciscus: 
-Efficacy of sofosbuvir and velpatasvir, with and without ribavirin, in patients with HCV genotype 3 infection and cirrhosis
-Incidence and spontaneous clearance of hepatitis C (HCV) in PWID at the Stockholm needle exchange – importance for HCV elimination
-Microenvironment eradication of hepatitis C: A novel treatment paradigm
-All‐oral direct‐acting antiviral therapy against hepatitis C virus (HCV) in human immunodeficiency virus/HCV–coinfected subjects in real‐world practice: Madrid coinfection registry findings
Abstract:  Use of ribavirin in viruses other than hepatitis C. A review of the evidence,
Genotype from Punjab, India: Expanding classification of hepatitis C virus into 8 genotypes

The National Viral Hepatitis Roundtable
The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
Save the date: Webinar August 8th on Engaging Drug Users to Fight Stigma and Access HCV
On Wednesday, August 8, 2018
National Viral Hepatitis Roundtable, the Urban Survivor's Union, the People’s Harm Reduction Alliance, and the Atlanta Harm Reduction Coalition will be hosting a webinar; Engaging Drug Users to Fight Stigma and Access HCV. These groups are working collaboratively on the "More than Tested, Empowered" project which addresses barriers to hepatitis C care faced by individuals who use drugs. The webinar will include findings from surveys delivered to healthcare providers and suggested educational messaging to improve access to hepatitis C care. In addition, each partner will discuss their methods for integrating participants into their work. After the presentation, there will be time for questions and discussion. 

Need To Talk To Someone?
If you need information and resources about finding financial help to pay for low cost testing, or finding a free or low cost clinic, or financial help with payment for treatments, please call us. We know how to find doctors and support groups. We know how to help you find resources where you live. We have experienced hepatitis C ourselves or have supported patients living with hep C. We are peer counselors. Help-4-Hep is a trusted source of information, support and referrals—all free of charge to you.
Learn more about Help-4-Hep
View all NVHR newsletters

The New York City Hepatitis C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.
July 27, 2018 - NY Governor Announces First-In-Nation Task Force To Eliminate Hepatitis C 
View: Hep Free NYC Newsletters
Review all news updates.

HCV Action
HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
Aug 3, 2018
HCV Action e-update: July 2018

World Hepatitis Alliance
We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
View Recent Newsletters 
World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis.

GI & Hepatology News
Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. 
Hot topics
Lin Chang, MD
Publish date: August 1, 2018
Hepatitis B virus reactivation, endoscopic bariatric therapy, and more.
View all updates here....

Hep-Your Guide to Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
View - all issues
Check out the talented people who blog at Hep.

Hepatitis Victoria
Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
Check out this new Liver Health app: 'Top app for liver health is LiverWELL' says influential U.S. health blogger.
View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen!

British Liver Trust
The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services. 
News: Almost half of people with Hepatitis C in the UK are unaware
On Saturday 28th July, World Hepatitis Day, the British Liver Trust unites with organisations, health professionals and supporters across the world to push for urgent …
View Recent Newsletters, here.

National Institutes of Health
A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
August Newsletter
Topics
Loneliness Affects All Ages
Health Capsule - Preventing Shingles

Harvard Health
Ask the doctors

Inspirational Bloggers
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
Latest blog entry: Tired with Liver Disease: There’s a Nap for That

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
Latest blog entry: Wading Through Medicare

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog entry: A World Without Hepatitis Advocates
Healing Your Fatty Liver

Hepatitis NSW 
We provide information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.
Latest blog entry: Govt intervenes to keep hep C elimination on track

Life Beyond Hepatitis C
Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Latest blog entry: Newly Diagnosed with Hepatitis C, What Do I Do Next?

CATIE Blog
A comprehensive website for HIV and hepatitis C information
Latest blog entry: Eliminating hepatitis C among Canadian immigrants and newcomers: how
CanHepC’s blueprint will impact my work.

Canadian Liver Foundation 
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
Latest blog entry: Life After Hepatitis C: A New Chapter

Pacific Hepatitis C Network
The Pacific Hepatitis C Network works with people living with hepatitis C, with community based organizations and with government to address concerns about hepatitis C prevention, care, treatment access and support.
Latest blog entry: A few words from PHCN’s President on World Hepatitis Day 2018

The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: - Newly Diagnosed with Hepatitis B? How Did I Get this? Learning the HBV Transmission Basics.

HepatitisC.net
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.
Latest blog entry: Should I Be Screened for Liver Cancer?

HIV and ID Observations  
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.
Latest blog entry: Really Rapid Review — International AIDS Conference 2018, Amsterdam

From The Archives 
SVR leads to significant improvement of liver fibrosis.
Research has shown people who are cured of their HCV infection experience a reduction in the rate of liver fibrosis progression, as well as improved liver function. For instance published in Antiviral Therapy/Aug 2017, evidence suggest HCV eradication or response to treatment (cure) is associated with regression of fibrosis and recovery of liver function which can be detected as early as end of treatment, check out the article: SVR in HCV leads to an early and significant improvement of liver fibrosis. In this more recent study presented at the 2018 Liver Congress researchers reported; Sustained & continued improvement in hepatic fibrosis beyond the first-year (& in the subsequent 3 years) following HCV treatment. Finally, published in Alimentary Pharmacology & Therapeutics/May 29, 2018 researchers reported: anti-viral therapy reduced liver fibrosis and steatosis in patients with chronic hepatitis C virus.

Healthy You
Simple swaps to eat less salt
The top 10 sources of sodium in the American diet include processed foods that contain several high-sodium ingredients, such as cheese and cured meats

Diet Heavy in Meat Boosts NAFLD Risk
Large study shows 40% increased risk in overweight, elderly patients

Probiotic use is a link between brain fogginess, severe bloating
Medical College of Georgia at Augusta University
While probiotics can be beneficial in some scenarios, like helping a patient restore his gut bacteria after taking antibiotics, the investigators advised caution against its excessive and indiscriminate use.

"Probiotics should be treated as a drug, not as a food supplement," Rao says, noting that many individuals self-prescribe the live bacteria, which are considered good for digestion and overall health.... 

August 6, 20184:58 AM ET
Heard on Morning Edition 
New research suggests the mix of microbes in our guts can either help — or hinder — weight-loss efforts.



Watch: Liver Function Tests
The ACG now suggests that "liver function tests" be referred to as "liver chemistries" or "liver tests.
The reasoning behind the name change is "Liver Function Tests" are not true measures of hepatic function. Listen to this 2017 short podcast hosted by Arefa Cassoobhoy, MD, MPH to learn more about test guidelines.

Recently, Lab Tests Online AU uploaded the following video explaining commonly used tests to check liver function such as; alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin, and bilirubin tests. The ALT and AST tests measure enzymes that your liver releases in response to damage or disease.



Thanks for stopping by!
Tina

Friday, July 20, 2018

Merck To Steeply Cut Price of Hepatitis C Drug Zepatier

Merck To Steeply Cut Price of Hepatitis C Drug Zepatier
July 20, 2018
The company announced that it plans to reduce other drugs in its portfolio as well. Merck will drop the price of its Hepatitis C drug Zepatier by 60%, the company announced yesterday. In addition, it plans to cut the price of “several other” drugs by 10%. In doing so, Merck went further than two competitors—Pfizer and Novartis—who said that they would not increase drug prices for the rest of 2018.
Read more: https://www.managedcaremag.com/dailynews/20180720/merck-steeply-cut-price-hepatitis-c-drug-zepatier

Merck Is Lowering Drug Prices. There’s a Catch
July 19, 2018
The drugmaker Merck said Thursday that it would lower prices on several drugs by 10 percent or more, but its rollback affects minor products and would not lower the cost of its top-selling, expensive cancer and diabetes products.
Read more: https://www.nytimes.com/2018/07/19/health/merck-trump-drug-prices.html

Of Interest
Roche Hiked Cancer-Drug Prices Before Pledge to Keep Them Flat
Bloomberg
‎July‎ ‎20‎, ‎2018
For example, Fazeli said, Merck's hepatitis C treatment Zepatier was already facing competition from a cheaper, shorter-course treatment from AbbVie Inc. Merck said on Thursday it would cut Zepatier’s price by 60 percent as part of a commitment to responsible pricing. But the company probably would already have had to apply a hefty discount to the list price, Fazeli said.
Louisiana's New Approach To Treating Hepatitis C
Louisiana is working with Gilead Sciences and other companies on a deal that would change how the state pays for expensive hepatitis C drugs, with the goal of eliminating the disease in that state.
Despite highly effective and well-tolerated regimens for treating hepatitis C virus (HCV), patients face barriers in accessing treatment. In addition to suboptimal HCV screening programs and lack of effective linkage-to-care, other barriers include strict requirements from some payers to cover treatment. This study reports insurance status and Hispanic ethnicity as predictors of not receiving treatment. These barriers occur despite the fact that HCV is the most common indication for liver transplantation and cause of hepatocellular carcinoma in the U.S. Therefore, it is critical that policymakers bring all the stakeholders together and develop a national policy to eradicate HCV infection from the U.S.

July 9, 2018
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.

Tuesday, July 17, 2018

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

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

Tuesday, July 10, 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.

Sunday, July 1, 2018

Cost-effective universal screening for hepatitis C in France

Cost-effective universal screening for hepatitis C in France
It is currently recommended in Europe that screening for hepatitis C virus (HCV) should target people at high risk of infection. In France, public health data suggest that in 2014 approximately 75 000 people aged 18 to 80 were infected by HCV, but were unaware of their status. In at least one in ten cases, these people are at an advanced stage of the disease when diagnosed. Today's treatments of HCV infection are both highly effective and well tolerated, and cure the infection in a few weeks in over 95% of cases. In Professor Yazdan Yazdanpanah's Inserm research team, Sylvie Deuffic-Burban has developed a mathematical model that assesses the efficacy and cost-effectiveness of different screening strategies, including universal screening.

This study applied data from a 2004 InVS seroprevalence survey to 18- to 80-year-olds in France, excluding people with diagnosed chronic HCV infection. The researchers developed their analytical model using a combination of these seroprevalence data and findings from studies of the characteristics of people infected (age, sex, stage of the disease at diagnosis, alcohol intake, etc.), the natural progression of the disease, the efficacy of treatments, the quality of life of the patients treated, and the cost of treatment of infection. The screening strategies assessed targeted the following groups: the at-risk population only, all men aged between 18 and 59, all people aged between 40 and 59, all people aged between 40 and 80, and everyone aged between 18 and 80, ie, universal screening.

The modeling results show that universal screening is associated with better life expectancy adjusted for quality of life than other strategies. Universal screening is cost-effective if the patients tested for HCV infection are treated rapidly after diagnosis. Sylvie Deuffic-Burban points out that "Screening, on an individual basis, enables rapid treatment, which avoids the development of serious complications. In time, collective screening helps eliminate hepatitis C from a population that has been screened without restrictions." The results of this ANRS-funded study therefore argue in favor of universal screening for HCV in France, followed by immediate treatment of those diagnosed with HCV infection. Sylvie Deuffic-Burban concludes that "Although our model is unable to test the idea, the epidemiological similarities of HCV, HIV, and HBV suggest that universal and combined screening for these three viruses could be of particular interest."

Sources: Research Article
Assessing the cost-effectiveness of hepatitis C screening strategies in France
Sylvie Deuffic-Burban, Alexandre Huneau, Adeline Verleene, Cécile Brouard, Josiane Pillonel, Yann Le Strat, Sabrina Cossais, Françoise Roudot-Thoraval, Valérie Canva, Philippe Mathurin, Daniel Dhumeaux, Yazdan Yazdanpanah
DOI: https://doi.org/10.1016/j.jhep.2018.05.027
Publication stage: In Press Corrected Proof
Published online: July 1, 2018

Article Source

Tuesday, June 19, 2018

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

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.

Thursday, June 7, 2018

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.
Link - Full Text Online
Download PDF

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

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."

Today's News
Judge gives early OK to deal to expand Medicaid hep C relief
DETROIT (AP) - A judge has given preliminary approval to a deal that would expand access to hepatitis C treatments for Michigan residents on Medicaid.

On This Blog
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Tuesday, June 5, 2018

Cost‐effectiveness of generic sofosbuvir/velpatasvir versus genotype‐dependent direct‐acting antivirals for hepatitis C treatment

In Case You Missed It
*Article downloaded and shared by @HenryEChang via Twitter. 

Cost‐effectiveness of generic pan‐genotypic sofosbuvir/velpatasvir versus genotype‐dependent direct‐acting antivirals for hepatitis C treatment
Amit Goel Qiushi Chen Jagpreet Chhatwal Rakesh Aggarwal
First published: 04 June 2018 https://doi.org/10.1111/jgh.14301

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Abstract
Background
Treatment of HCV infection with low‐cost generic direct‐acting antivirals (DAAs) available in India and other developing countries needs determination of HCV genotype (‘genotype‐dependent' regimens). Generic velpatasvir, a DAA that obviates the need for genotype determination (‘pan‐genotypic' regimen) recently became available but is costlier.

Aim
To evaluate the cost‐effectiveness of genotype‐dependent versus pan‐genotypic DAA treatments in India.

Methods
A previously‐validated microsimulation model, adapted to Indian population, was used to compare the costs and long‐term outcomes of three scenarios: no treatment, and treatment with genotype‐dependent and pan‐genotypic regimens. Input parameters were derived from literature. Using a payer's perspective and life‐time time horizon, quality‐adjusted life years (QALYs), total costs, and incremental cost‐effectiveness ratio (ICER) were calculated. Both deterministic and probabilistic sensitivity analyses were also conducted.

Results
At the current price (US$ 223 for 4 weeks), pan‐genotypic regimen was cost‐saving compared to no treatment. Compared with genotype‐dependent regimens, it increased QALYs by 0.92 and increased costs by US$ 107, but was deemed cost‐effective with an ICER of US$ 242 per QALY gained. Probabilistic sensitivity analysis also supported the cost‐effectiveness of pan‐genotypic regimen. At the reduced price of US$ 188 for 4 weeks, the pan‐genotypic regimen will become cost‐neutral to genotype‐dependent regimens (current price: US$100 for 4 weeks).

Conclusions
At current prices, velpatasvir‐based pan‐genotypic regimen is cost‐effective for HCV treatment in India where generic drugs are available. A reduction in the prices of pan‐genotypic regimen has the potential to make its use cost‐saving, while simplifying treatment in community‐level programs aimed at HCV elimination.
Continue reading:
https://jumpshare.com/v/AGnldst6EL08X8iGM13N

Available 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/India, Egypt and other lower-income countries or through online "buyers clubs"

Monday, June 4, 2018

DDW 2018 - Is an HCV cure rate of 100 percent realistic?

DDW News | Jun 4, 2018 | 2018, AASLD, DDW Daily News, Monday Issue 2018, Watch Videos

David E. Bernstein, MD, FAASLD, discusses the possibility of an HCV cure rate of 100%

Is an HCV cure rate of 100 percent realistic?
David E. Bernstein, MD, FAASLD, wants to break down the barriers preventing access to curative therapies for hepatitis C virus (HCV). Although antiviral therapy has led to a cure rate of more than 90 percent of HCV cases, Dr. Bernstein thinks more can be done to increase the cure rate.

In this DDW Daily News video exclusive, he discusses several obstacles preventing patients’ access to curative therapies, including cost concerns, public policy issues and insurance variations that have led to different state rules and regulations. Dr. Bernstein also addresses the benefits of HCV therapy and whether it’s possible to eradicate HCV and achieve 100 percent cure rate.

“It’s the only viral disease that we can actually cure, but from a public policy standpoint a significant portion of our population does not have access to these life-changing and curative therapies for unclear reasons,” says Dr. Bernstein, director of the Sandra Atlas Bass Center for Liver Diseases at the Zucker School of Medicine at Hofstra/Northwell, East Garden City, NY.
Video:
http://blog.ddw.org/is-an-hcv-cure-rate-of-100-percent-realistic/

Links
Digestive Disease Week® (DDW) 2018 June 2-5, 2018
Website - Digestive Disease Week® (DDW)
DDW Blog
DDW Daily News
On Twitter - #DDW18

DDW 2018 - Insurance coverage and mortality in patients with hepatitis C

HCV outcomes worse for patients with public insurance, Medicaid
WASHINGTON — In this exclusive video perspective from Digestive Disease Week 2018, Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, discusses insurance coverage and mortality in patients with hepatitis C in the U.S.
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

MedPage Today
WASHINGTON -- Adults with hepatitis C virus (HCV) were more likely to die if they were on Medicaid than other insurance plans, while uninsured HCV-infected …

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.

Links
Digestive Disease Week® (DDW) 2018
June 2-5, 2018
Website - Digestive Disease Week® (DDW)
DDW Blog
DDW Daily News
On Twitter - #DDW18

Tuesday, May 29, 2018

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/

New At Infectious Disease Advisor
Does Substance Use Disorder Affect Sustained Virologic Response to DAAs?
Infectious Disease Advisor
Although hepatitis C virus (HCV) treatment adherence is worse in patients with comorbid substance use disorders, sustained virologic response (SVR) to …

Thursday, May 24, 2018

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

Wednesday, May 23, 2018

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.

Tuesday, May 15, 2018

How states could be saving more hepatitis C patients

How states could be saving more hepatitis C patients
BY Stephanie Hedt May 14, 2018

USC’s Neeraj Sood and colleagues propose an approach that leverages competition among drug manufacturers, saving states money and ensuring that more people get treatment

There is a cure or the nation's deadliest infectious disease, hepatitis C, but at tens of thousands of dollars per patient in upfront costs, most insurance companies can't afford to provide the treatment to all of the estimated 2.7 million to 3.9 million of Americans who are infected. This is especially true for patients on Medicaid or in the prison system, where funding has historically been restricted.

Leading experts on hepatitis C treatment policy are recommending a new novel pricing strategy, implemented at the state level, that could help many more patients access the treatment. The recommendations were published on May 14 in the Annals of Internal Medicine, and as an extended USC-Brookings Schaeffer Initiative for Health Policy report.

"These innovative therapies can cure hepatitis C, but the high costs put them out of reach for the most vulnerable populations," said Neeraj Sood, lead author on the report and an economist at the USC Schaeffer Center for Health Policy and Economics. "We wanted to come up with a better solution where we dramatically improve access to cures, control drug spending but still maintain incentives for the development of new cures."

Recognizing the important role state programs could play in this, Sood and his colleagues have developed a novel pricing strategy targeted at state policymakers. They outline an approach that leverages competition among drug manufacturers. The end result would save the state money and would ensure treatment for a larger share of the population -- all while providing incentives for future innovation in treatments.

Leveraging State Programs to Increase Access
Given current financing systems, most states can only afford to provide treatment to a small percentage of patients with hepatitis C each year. Furthermore, drug manufacturers know the only way they can increase profits is by increasing the price per pill.

"Increasing prices raises incentives for pharmaceutical innovation but limits patient access. This is the crux of the problem," said Sood, who is also a Professor and Vice Dean for Research at the USC Price School of Public Policy.

"Negotiating on revenues rather than price is the answer. Revenue-based contracting allows us to increase profits and incentives for innovation without limiting access."

Under the proposed model, states would leverage their resources to make a deal with one pharmaceutical company, offering a lump sum payment over a contracted period. The negotiated amount would be higher than the expected revenue for any one company over that timeframe, but still less than the total amount that the Medicaid program would pay to all the drug companies producing the treatment.

In return, the company would agree to provide a 100 percent rebate on drug purchases for the population designated to receive the cure, such as Medicaid patients or prisoners with hepatitis C. The move would make the drug essentially free of additional cost. It also would give the states the opportunity to significantly expand access to the treatment while maintaining their budget.

Vulnerable Populations Still Face Significant Hurdles in Accessing Treatment
According to a 2017 report, less than 3 percent of the 700,000 people with hepatitis C in state Medicaid programs and prisons receive treatment each year. This is due in large part to restrictions that many state programs implemented that limit access to the cure by requiring patients to have reached a certain decline in liver function or have remained sober for a set timeframe.

Though not supported by clinical guidelines, these restrictions are designed to narrow access, thereby limiting the immediate impact on state budgets that might arise from guaranteeing the treatment to everyone.

The consequences of these decisions are especially concerning given the recent rise in heroin use resulting from the opioid epidemic, which has led to a significant increase in new hepatitis C infections.

"Our concern is that the public health burden of hepatitis C infections will continue to grow even though we have a cure if we don't implement innovative financing programs," said Sood.

https://news.usc.edu/143172/how-states-could-be-saving-more-hepatitis-c-patients/