Interview: Express Scripts Talks About AbbVie Hepatitis C Drug Deal

‘The Big Issue Has Not Been Choice, But Access:’ Express Scripts’ Miller Explains
By ED SILVERMAN

Last month, Express Scripts , the nation’s biggest pharmacy benefits manager, and AbbVie reached an exclusive deal that ushered in a price war for hepatitis C treatments. The drug maker offered an undisclosed discount in hopes of breaking the lock that Gilead Sciences has on the burgeoning market. The PBM, which has railed against Gilead pricing, agreed to offer the AbbVie treatment to patients with the most common form of the virus, a population that constitutes some 70% of those infected in the U.S. The AbbVie regimen, however, can be more cumbersome and some physicians worry about patient compliance. We spoke with Steve Miller, the chief medical officer at Express Scripts, about the move. This is an excerpt..

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Gilead exclusive provider of hepatitis C medicine for CVS
By Robert Langreth and Caroline Chen
BLOOMBERG NEWS JANUARY 05, 2015

Gilead’s Harvoni and Sovaldi will be the exclusive drugs for CVS’s standard commercial list of covered medicine, as well as its list for health-care exchanges, Medicare Part D and Medicaid, the benefits manager said today in an e-mail.

“Our goal was to create the lowest net-cost solution for the entire population of patients with all genotypes of hepatitis C,” CVS said. The company didn’t say whether it negotiated a special price for Gilead’s drugs.

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Gilead exclusive provider of hepatitis C medicine for CVS

Gilead exclusive provider of hepatitis C medicine for CVS

By Robert Langreth and Caroline Chen

BLOOMBERG NEWS JANUARY 05, 2015

Gilead Sciences Inc. was chosen over AbbVie Inc. as the main provider of hepatitis C medicine for patients covered through CVS Health Corp., intensifying a rivalry to treat patients with pills that cost $1,000 or more a day.

Gilead’s Harvoni and Sovaldi will be the exclusive drugs for CVS’s standard commercial list of covered medicine, as well as its list for health-care exchanges, Medicare Part D and Medicaid, the benefits manager said today in an e-mail.

“Our goal was to create the lowest net-cost solution for the entire population of patients with all genotypes of hepatitis C,” CVS said. The company didn’t say whether it negotiated a special price for Gilead’s drugs.

The win at CVS helps Gilead recover from a loss to AbbVie at Express Scripts Holding Co., the biggest US drug-benefits manager, which chose last month to favor Viekira Pak in many cases. AbbVie offered an unspecified discount to garner support from Express Scripts, to the dismay of biotech investors who have bet on the industry’s ability to maintain high prices.

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UPDATE 1-CVS to cover Gilead hepatitis C treatment over AbbVie regimen
By Bill Berkrot and Caroline Humer
Jan 5 (Reuters) - CVS Health Corp, one of the largest U.S. managers of drug benefits, said it would give preferred status to the hepatitis C treatments from Gilead Sciences and cover a new competing treatment from AbbVie Inc only as an exception.

The latest salvo in the battle to grab market share for new all-oral treatments for the liver-destroying hepatitis C virus follows a move last month by CVS rival Express Scripts Holding that favored AbbVie's regimen after negotiating a price discount below what Gilead had been charging its commercial customers.

Express Scripts, the nation's largest pharmacy benefit manager, said it would cover AbbVie's Viekira Pak and exclude Gilead's Sovaldi and combination drug Harvoni. The decision had sent Gilead shares sharply lower at the time.

On Monday, Gilead shares were up 2.5 percent following the CVS announcement, while AbbVie shares were down 2.2 percent.

Gilead has come under intense criticism for the high price of its first-to-market all-oral treatment; Sovaldi costs about $1,000 per pill. Harvoni combines Sovaldi with another drug into a one-pill, once-a-day treatment with cure rates well above 90 percent.

A 12-week course of treatment with Harvoni costs about $93,500, although some patients may need just eights weeks of therapy costing about $63,000.

It was not yet known whether Gilead agreed to a substantially discounted price to secure CVS coverage. Gilead did not immediately return a call seeking comment.

Express Scripts said it is still negotiating with Gilead on behalf of its plans. "Our actions have changed how pharmaceutical innovation will be rewarded in the future," spokesman Brian Henry said.

RBC Capital Markets analyst Michael Yee said the CVS move "removes near-term uncertainty for many investors who feared CVS would also strike a deal with AbbVie and put more pressure on Gilead."

AbbVie declined  to say whether it was still in talks with CVS.
CVS said the Gilead drugs would be exclusive on its standard commercial formulary, as well as those for exchanges created under the Affordable Care Act, Medicare Part D and Medicaid.

"Our goal was to create the lowest net-cost solution for the entire population of patients with all genotypes of hepatitis C," CVS spokeswoman Christine Cramer said in a statement.

The recently approved AbbVie regimen has similarly high cure rates, but involves more drugs and pills per day. Many patients must also take the older drug ribavirin, which can cause anemia and other side effects.


Gilead shares were up $2.28 at $97.19, while AbbVie shares were down $1.45 at $64.44. (Reporting by Caroline Humer and Bill Berkrot in New York; Editing by Jeffrey Benkoe and Leslie Adler)

Patient Advocate Foundation Offers New CareLine for Hepatitis C Patients

Patient Advocate Foundation Offers New CareLine for Hepatitis C Patients 

 PAF aims to expand care for Hepatitis C patients by offering a new toll-free CareLine providing personalized case management support.

HAMPTON, Va., Jan. 5, 2015 (GLOBE NEWSWIRE) -- Patient Advocate Foundation (PAF) – a national, non-profit organization providing professional case management services to patients facing healthcare access issues, is pleased to announce the launch of a new Hepatitis C CareLine, providing individualized, sustained assistance to patients diagnosed with Hepatitis C. The CareLine will provide help to patients across the country to resolve healthcare access and insurance issues, at no charge to the patient.

This new program joins Patient Advocate Foundation's existing suite of CareLine programs, furthering PAF's commitment to helping patients with chronic, debilitating or life-threatening illness navigate the healthcare industry. In 2013, Hepatitis diagnoses ranked in PAF's top ten list of diseases reported by patients seeking help through the case management team. Through the Hepatitis C CareLine, dedicated case managers will serve as a direct resource for Hepatitis C patients assisting them with benefit coordination, educational and financial resources, help accessing the latest available treatment, navigation through the appeals and reimbursement processes, as well as other patient services. This new program joins Patient Advocate Foundation's existing copayment support for Hepatitis B and Hepatitis C patients offered through its Co-Pay Relief program.

"Patient Advocate Foundation is committed to helping Hepatitis C patients maintain financial stability while consistently accessing needed treatments and prescribed medical care," says PAF CEO, Alan Balch, Ph.D. "By directly connecting Hepatitis C patients with the correct resources and negotiating on their behalf, we believe PAF can make a difference for patients in the Hepatitis C community."

Any patient or medical provider interested in learning more about Patient Advocate Foundation's Hepatitis C CareLine should call 800-532-5274 or visit hepatitisc.pafcareline.org/. The CareLine will offer live service to patients Monday through Thursday from 8:30 AM – 8:00 PM ET and Friday from 8:30 AM – 7:00 PM ET. Bi-lingual case managers are available to assist Spanish speaking callers.

For more information about Patient Advocate Foundation and their mission to improve healthcare access to all patients, please visit www.patientadvocate.org.

About Patient Advocate Foundation (PAF)
Patient Advocate Foundation is a national non-profit organization that seeks to safeguard patients through effective mediation assuring access to care, maintenance of employment and preservation of their financial stability. PAF services are available to all patients, patient families, and medical professionals without charge. Patient Advocate Foundation serves patients from all 50 states, and has physical locations at many of the top patient referral states including Texas, Florida, California, and Virginia. Erin Singleton, 757-952-0561

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Traditional Chinese Medicine and herbal hepatotoxicity: a tabular compilation of reported cases.

Ann Hepatol. 2015 Jan-Feb;14(1):7-19.

Traditional Chinese Medicine and herbal hepatotoxicity: a tabular compilation of reported cases.

Teschke R1, Zhang L2, Long H3, Schwarzenboeck A1, Schmidt-Taenzer W1, Genthner A1, Wolff A4, Frenzel C5, Schulze J6, Eickhoff A1.

Author information
1Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Medical Faculty of the Goethe University Frankfurt/ Main, Germany. 2Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China.
3Department of Internal Medicine, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China. 4Department of Internal Medicine II, Division of Gastroenterology, Hepatology and Infectious Diseases, Friedrich Schiller University Jena, Germany. 5Department of Medicine I, University Medical Center Hamburg Eppendorf, Germany. 6Institute of Industrial, Environmental and Social Medicine, Medical Faculty of the Goethe University Frankfurt/Main, Germany.

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Traditional Chinese Medicine (TCM) with its focus on herbal use became popular worldwide. Treatment was perceived as safe, with neglect of rare adverse reactions including liver injury. To compile worldwide cases of liver injury by herbal Traditional Chinese Medicine (TCM), we undertook a selective literature search in the PubMed database and searched for the items Traditional Chinese Medicine, TCM, Traditional Asian Medicine, and Traditional Oriental Medicine, also combined with the terms herbal hepatotoxicity or herb induced liver injury. 

The search focused primarily on English-language case reports, case series, and clinical reviews. We identified reported hepatotoxicity cases in 77 relevant publications with 57 different herbs and herbal mixtures of TCM, which were further analyzed for causality by the Council for International Organizations of Medical Sciences (CIOMS) scale, positive reexposure test results, or both. 

Causality was established for 28/57 different herbs or herbal mixtures, 

Bai Xian Pi, Bo He, Ci Wu Jia, Chuan Lian Zi, Da Huang, Gan Cao, Ge Gen, Ho Shou Wu, Huang Qin, Hwang Geun Cho, Ji Gu Cao, Ji Xue Cao, Jin Bu Huan, Jue Ming Zi, Jiguja, Kudzu, Ling Yang Qing Fei Keli, Lu Cha, Rhen Shen, Ma Huang, Shou Wu Pian, Shan Chi, Shen Min, Syo Saiko To, Xiao Chai Hu Tang, Yin Chen Hao, Zexie, and Zhen Chu Cao. 

In conclusion, this compilation of liver injury cases establishes causality for 28/57 different Traditional Chinese Medicine (TCM) herbs and herbal mixtures, aiding diagnosis for physicians who care for patients with liver disease possibly related to herbal Traditional Chinese Medicine (TCM).

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Lawsuit targets army officials claiming HIV, Hepatitis C cure

Lawsuit targets army officials claiming HIV, Hepatitis C cure
 Amira El-Fekki / January 5, 2015

Poor and helpless patients put high hopes on ‘army scam invention’, says lawyer 

High-profile lawyer Khaled Abou Bakr filed a lawsuit against army officials who promoted the controversial cure for AIDS and Hepatitis C curing device in 2014, he announced on his Twitter account on Sunday. 

The lawsuit was submitted on the grounds that they manipulated and failed to deliver their promise to the Egyptian people. 

Abou Bakr demanded investigations against the first administrator of the so-called cure, Maj. Ibrahim Abdel Atty El-Sayed. 

Abou Bakr demanded compensation for the poor, helpless patients, who gave up their original treatment plans following high hopes in light of the army’s announced breakthrough.

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Is there a balm for Gilead?

Is there a balm for Gilead?
By CRAIG A. VAN MATRE

Sunday, January 4, 2015

Doctors and Patients prefer Gilead’s Harvoni because only one pill a day is required. Patients on Viekira Pak must take four pills (or more) — three in the morning and one in the afternoon. Furthermore, patients on Viekira Pak frequently must take ribavirin, which can cause serious side effects. Harvoni causes only “minor” side effects such as nausea, headache and diarrhea. Accordingly, Harvoni was the “drug of choice” in the marketplace until recently. 

Express Scripts negotiated the discount for Viekira Pak but couldn’t get the price of Harvoni down below about $84,000. Gilead thought the superiority of its product deserved no less, apparently. So Express Scripts decided it would only allow patients who get their hepatitis C drugs through an Express Scripts program to receive Viekira Pak. Because Express Scripts has more than 60 percent of the “pharmacy benefit manager” market, this is a big deal and portends many similar deals on the horizon.

Express Scripts helpfully gave patients until Jan. 1, 2015, to adjust to this new regime.

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Liver Cirrhosis More Common Than Previously Thought, Study Finds

Liver Cirrhosis More Common Than Previously Thought, Study Finds

Citations the Journal of Clinical Gastroenterology.

Newswise — MAYWOOD, Il. (Jan. 5, 2014) – Cirrhosis of the liver is more common than previously thought, affecting more than 633,000 adults yearly, according to a study published in the Journal of Clinical Gastroenterology.

And surprisingly, 69 percent of the adults identified as possibly having cirrhosis may not know they have this disease.

“Although some of these individuals may simply have forgotten or been confused about the question, this raises the possibility of a large number of undiagnosed cases of cirrhosis,” first author Steven Scaglione, MD and colleagues reported. Dr. Scaglione is an assistant professor in the departments of Medicine and Public Health Sciences of Loyola University Chicago Stritch School of Medicine.

Alcohol abuse, diabetes and hepatitis C were the most significant contributing factors in more than 50 percent of the cirrhosis cases. All three of these factors are potentially preventable, Dr. Scaglione said.

Cirrhosis is end-stage scarring of the liver. Symptoms include jaundice, fatigue, bleeding or bruising easily, nausea, swelling and confusion. But many patients have no symptoms. Cirrhosis can lead to liver failure and liver cancer. In the United States, cirrhosis is the 12th leading cause of death overall and the fifth leading cause of death for patients aged 45 to 54.

Scaglione and colleagues performed the first ever study to estimate the prevalence of cirrhosis in the general population. They examined data from the National Health and Nutrition Examination Survey (NHANES), an annual survey of a representative sample of U.S. adults conducted by the Centers for Disease Control and Prevention.

The prevalence of cirrhosis was approximately 0.27 percent, which corresponds to 633,323 adults in the United States. Previous best-guess estimates pegged the number of adults with cirrhosis at about 400,000.

Among the study’s other findings:

- People with cirrhosis had a mortality rate of 26.4 percent during a two-year interval, compared with a 8.4 percent two-year mortality rate among similarly matched adults who did not have cirrhosis.

- Compared with the general population, people with cirrhosis tended to be older. Men were more at risk for cirrhosis than women. Prevalence was higher among poor people and people without a domestic partner. Prevalence declined with increasing levels of education.

- A quarter of people with cirrhosis reported they drank alcohol in excess during the prior year, and nearly half tested positive for the hepatitis C virus.

The study has limitations. The technique used to determine whether subjects in the survey had cirrhosis has not been validated in the general population. Thus it’s possible the technique may have misclassified some patients with mild liver disease as cirrhotics. (The technique is called aspartate aminotransferase-to-platelet ratio, or APRI.) The study was cross sectional, meaning it took a snapshot of a representative population at a specific time, rather than following the population over time. And the true prevalence of cirrhosis is likely higher than the study found, because the NHANES survey did not include prisoners, immigrants and military veterans.

The study is titled “The Epidemiology of Cirrhosis in the United States: A Population-Based Study.” Co-authors are Stephanie Kliethermes, PhD, Guichan Cao, MS, David Shoham, PhD, Ramon Durazo, PhD and Amy Luke, PhD, all in the Department of Public Health Sciences of Loyola University Chicago Stritch School of Medicine; and Michael L. Volk, MD of the University of Michigan Health System’s Division of Gastroenterology and Hepatology.

Source Newsroom: Loyola University Health System

New drugs offer hope, barriers for hepatitis C patients

New drugs offer hope, barriers for hepatitis C patients

Laura Weiss, Inquirer Staff Writer
Posted: Sunday, January 4, 2015, 2:50 AM

For patients with hepatitis C, the last year has brought great hope: New drugs that are highly effective with few side effects. But their high cost has led Medicaid officials in Pennsylvania and other states to put up barriers for patients, treating only the sickest ones and leaving many others to wait.

Doctors say they have to go to great lengths to get Medicaid patients approved, generating up to four denials before a final rejection. They say that employees must spend eight to 12 hours to get a patient drug approval.

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