March 10, 2014

Prices of new hepatitis C drugs are tough to swallow for insurers

Peovided by The L.A. Times

Hepatitis C drugs Sovaldi and Olysio offer much better cure rates than other therapies, but they can cost up to $1,000 a pill, a potentially staggering cost to taxpayers and health plans.

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Gilead Sciences says its new hepatitis C therapy, Sovaldi, helps avoid the long-term medical expenses related to liver failure, cancer and transplants. But some pills can cost up to $1,000 each. (Victor J. Blue, Bloomberg / February 11, 2014)

By Chad Terhune and Eryn Brown
March 9, 2014, 5:50 p.m.

A pair of new drugs to treat hepatitis C offer a cure for millions of Americans afflicted with the disease — but at a potentially staggering cost to taxpayers and health plans.

Until now, therapies for hepatitis C helped only about half of patients and posed numerous side effects, such as flu-like symptoms, anemia or depression. In comparison, clinical trials of Sovaldi and Olysio have shown cure rates of 80% to 90% with far fewer complications.

That progress, though, comes at a price.

A 12-week course of Sovaldi can cost $84,000, or about $1,000 a pill, and some patients may require two courses. Treatment with Olysio runs more than $66,000. Using either one, many patients wouldn't require significant treatment again.

"It could be the right thing to do clinically, but at this price, can we afford it?" said Steven Pearson, president of the Institute for Clinical and Economic Review, a nonprofit group in Boston that analyzes the effectiveness and cost of new treatments. "It's a tough ethical and financial quandary."

In a new report, the institute estimates it would cost $6.3 billion to provide the two drugs to Californians with more advanced liver disease from hepatitis C. The annual cost could top $18 billion if half of all California patients with hepatitis C received the medications.

Drugs for some types of cancer, multiple sclerosis and rare illnesses can carry similar price tags. But few of those drugs would be prescribed so widely. And the increased costs for new drugs are often passed along to consumers in the form of higher health insurance premiums.

Left unchecked, some hepatitis C infections result in liver damage, liver cancer or death. Chronic hepatitis C infection affects about 3 million people in the U.S., and it's the leading cause of liver transplants in the nation.

On Monday, a panel of medical experts will meet in San Francisco to examine the use of Sovaldi and Olysio, which federal regulators approved late last year, and to recommend treatment guidelines.

The discussion will revolve around which patients are the best candidates for these medications and whether doctors should advise other patients to wait until their disease worsens, given the high prices.

Those types of restrictions trouble some patient advocates who favor full access. Of the two drugs, Sovaldi is viewed as a potential blockbuster along the lines of the cholesterol-fighting Lipitor.

Employers and health insurers warn that Sovaldi and Olysio are just the beginning of other expensive specialty drugs coming to market. They say that their rapid growth could undermine efforts to rein in medical spending.

The pharmaceutical companies behind the hepatitis C drugs defended their pricing by noting that the medicines represent a major advancement compared with current treatments. Gilead Sciences Inc. in Foster City, Calif., sells Sovaldi, and Olysio comes from Janssen Therapeutics, a unit of healthcare giant Johnson & Johnson.

Both companies said discounts and other financial assistance are available to government health programs and low-income patients.

Gilead said the new therapies also help avoid the long-term medical expenses related to liver failure, cancer and transplants. A liver transplant, for instance, can cost more than $500,000, not including a lifetime of follow-up care.

"Sovaldi is a short-term treatment that results in very high cure rates that can avoid future costs related to disease progression or treatment failure," said Gregg Alton, an executive vice president at Gilead.

Craig Stoltz, a spokesman for Janssen, said the price of Olysio "reflects its value."

Medi-Cal officials said they don't know yet how many patients may need the new drugs. More than 1,500 Medi-Cal patients are prescribed drugs for hepatitis C now.

"These new drugs are expensive," said Medi-Cal spokesman Norman Williams. "Medi-Cal is currently negotiating with the drug manufacturers for a state supplemental rebate."

California said no decision has been made on requests from Medi-Cal managed-care plans to carve out these drugs from already negotiated rates and reimburse insurers separately for them.

Molina Healthcare Inc., a major Medicaid managed-care plan in California and 10 other states, has asked health officials across the country for guidance on how to proceed with patients.

"I'm scratching my head why the American taxpayer is being asked to pay such an enormous price for this drug," said J. Mario Molina, the company's chief executive.

WellPoint Inc., the nation's second-largest health insurer, said it costs nearly 50% more, on average, to treat hepatitis C patients on its state Medicaid plans since the newer drugs were introduced.

"While new drug treatments for hepatitis C have shown to be highly effective, these drugs could have a serious impact on premiums," said Charles Bacchi, executive vice president at the California Assn. of Health Plans, an industry trade group.

As with many new drugs, Medi-Cal is requiring prior authorization before patients can receive them. Some health insurers may require patients to try older, less expensive treatments first.

The potential pool of hepatitis C patients is expected to grow as more screening occurs. Federal officials have recommended that all baby boomers be tested for hepatitis C because researchers have found a higher prevalence of the disease among that group.

Hepatitis C can go undetected for years and many people show no symptoms. The transmission of the disease is often associated with intravenous drug use. But people have contracted it in the past through blood transfusions, transplants or, in some cases, sexual contact.

Thus far, existing patients have been able to receive the new treatments.

Uninsured low-income patients treated in Los Angeles County facilities have been receiving the drugs free under the manufacturers' assistance programs, said Dr. Mitchell Katz, director of the county Department of Health Services.

Project Inform, an HIV and hepatitis advocacy organization in San Francisco, said that callers to its help line have not reported trouble getting the new medicines.

But David Evans, director of research advocacy at Project Inform, said he's concerned that could change if insurers or public programs begin "rationing" therapy for only the sickest patients.

"We should be pushing all of the payers to give access," Evans said. "Don't punish the patients because they have hepatitis."

For many years, the standard treatment for hepatitis C patients was a combination of interferon and a drug called ribavirin. Starting in 2011, doctors added new antiviral drugs to the mix.

Like those medications, Olysio is approved for use with interferon and ribavirin.

But the U.S. Food and Drug Administration approved Sovaldi for use without interferon and ribavirin in certain cases. That has opened up the possibility of treating many patients who couldn't tolerate the side effects of interferon, said Dr. Rena Fox, a professor of medicine at UC San Francisco.

Sovaldi, Fox said, is the "true game changer."

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Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Hiromitsu Kumada MD1, Yoshiyuki Suzuki MD1, Kenji Ikeda MD1, Joji Toyota MD2, Yoshiyasu Karino MD2, Kazuaki Chayama MD3, Yoshiiku Kawakami MD3, Akio Ido MD4, Kazuhide Yamamoto MD5, Koichi Takaguchi MD6, Namiki Izumi MD7, Kazuhiko Koike MD8, Tetsuo Takehara MD9, Norifumi Kawada MD10, Michio Sata MD11, Hidetaka Miyagoshi12, Timothy Eley PhD13, Fiona McPhee PhD13, Andrew Damokosh PhD13, Hiroki Ishikawa12, Eric Hughes MD13,*

DOI: 10.1002/hep.27113

Copyright © 2014 American Association for the Study of Liver Diseasews

Publication History
Accepted manuscript online: 6 MAR 2014 06:10AM EST
Manuscript Accepted: 28 FEB 2014
Manuscript Revised: 21 FEB 2014
Manuscript Received: 10 FEB 2014

Keywords: Direct-acting antiviral; nonresponder; interferon-ineligible; interferon-intolerant; all-oral

Abstract

All-oral combinations of direct-acting antivirals may improve efficacy and safety outcomes for patients with hepatitis C virus (HCV) infection, particularly those who are poor candidates for current interferon/ribavirin-based regimens. In this open-label, phase 3 study, 135 interferon-ineligible/intolerant and 87 nonresponder patients with chronic HCV genotype 1b infection were enrolled at 24 centers in Japan. Patients received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks. The primary end point was sustained virologic response 24 weeks after treatment (SVR24). This study is registered with ClinicalTrials.gov (NCT01497834). SVR24 was achieved by 87.4% of interferon-ineligible/intolerant patients and 80.5% of nonresponder (null and partial) patients; rates were similar in cirrhotic (90.9%) and non-cirrhotic (84.0%) patients, and in patients with IL28B CC (84.5%) or non-CC (84.8%) genotypes. Fourteen patients in each group (12.6%) discontinued dual therapy, mainly due to adverse events or lack of efficacy. Nine nonresponder patients received additional treatment with peginterferon/ribavirin per protocol-defined criteria. The rate of serious adverse events was low (5.9%) and varied among patients. The most common adverse events were nasopharyngitis, increased ALT and AST, headache, diarrhea, and pyrexia.

Conclusion: Interferon-free, ribavirin-free all oral therapy with daclatasvir and asunaprevir for 24 weeks is well tolerated and can achieve a high rate of SVR in patients with HCV genotype 1b who were ineligible, intolerant, or had not responded to prior interferon-based therapy. (Hepatology 2014;)

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Creating a media channel to fight Hepatitis C

Marketing case study 

10 Mar 2014 12:12

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SYDNEY, AUSTRALIA: NSW Health creates an interactive online party experience to give 18-24-year-olds a hard-hitting message about the risks of contracting Hep C.

Insight
Hepatitis C is often misunderstood as only a concern for "junkies", and those who associate with dirty needles. A key audience that had a misconception around hepatitis C was 18-24-year-olds. In fact only 5% saw themselves at any risk. (Source: TNS for NSW Government)

This demonstrated a problem, how can you hope to make a message stick with a famously hard-to-reach group when the message is about something they feel is someone else's problem? A big budget awareness campaign targeting all of the 18-24-year-olds in NSW wasn't an option; the budget was just $200k. Mediacom had to be clever with the money by closely relating the message to occasions where Hep C is contracted. This was the key task.

The agency needed to understand the times and places that young people were most at risk of contracting Hepatitis C. Research showed that an important setting for risk was parties, where people who were not regular drug users got caught up in the heat of the moment and ended up sharing a needle when recreational drug use escalated, as the party evolved.
It was clear that as a party developed they started making decisions based on different parameters.

This led us to a clear insight: Decisions that increase the risk of hepatitis C are made in the heat-of-the-moment, not when in a cold, considered state.

Strategy
Enter The Party. Delivering the Hepatitis C message in the most impactful way meant doing it when they were in a heat-of-the-moment mindset. You can't buy media at parties so the question was, how would the agency get people into a drug-sampling-party-immersed mindset in a government media campaign? It needed to put them in harm's way without being in harm's way.

Mediacom achieved the heat-of-the-moment mindset in a virtual way by basing the whole campaign online. Its audience being internet hungry 18-24-year-olds added further logic to this decision.

The campaign had two parts:

1. An immersive virtual party.

2. Online media and messaging inviting and tempting the audience to the party.
With a spend of just $200k the agency single-mindedly approached just one media partner, Mi9, to deliver the most added value. This media inventory and advertorials all pushed to the main part of the campaign; an interactive party experience that we created at entertheparty.com.au.

Execution
1. An Immersive Virtual Party: The agency created a realistic (Facebook integration so you were there with your friends), interactive (user-defined journey through the party) and appealing (styling, music and locations closely matched to real life parties), to ensure it was a party the audience wanted to go to. The results will show you that it was.

The party-goer had to make decisions that started tame- e.g. "do you want to hang with your friends in the kitchen or backyard"- and then escalated to the more risky and Hep C relevant- e.g. "do you want to get a home tattoo", cumulating with a scene in a bedroom with the question "would you share a needle?".

In this heat-of-the-moment, late-stage party mindset it delivered the key message about the situations in which the viewer would personally be at risk of contracting Hepatitis C. From here the party-goer had the option to re-enter the party, explore different routes, or share the party on Facebook.

2. How to get people to the party: Earned media was key but the Mi9 partnership was used to access relevant environments such as Zoo, Celebrity Fix, Music Fix, Cleo, Cosmo, and behavioural targeting to seek out young partygoers. This consisted of banner ads that were first person, real video shots of the party, as if you were looking right through the window of the house. They invited you to "enter the party".

Results
Brad Kemp, Senior Marketing Officer, NSW Health, said: "We loved the agencies unique thinking in answering this brief. We are currently investigating ways to roll out this idea to a larger audience.

\We look forward to the agency continuing to challenge our thinking, as work such as this really does change the way we think about communications."

The campaign was relevant to the target audience; 27% of NSW 18-24-year-olds agreed with the statement "Hepatitis C is relevant to me" after the activity compared to 5% who viewed themselves as being at risk before the activity. (Source: TNS for NSW Government Campaign Evaluation; January 2013)

It reached a wide audience despite a tiny spend; 20% of NSW 18-24-year-olds participating in the evaluation research recalled seeing the communication. (Source: TNS Campaign Evaluation; January 2013)

It made specific messages stick; 69% of young people exposed to the party reported being more informed of the specific factors to contracting Hep C. (Source: Millward Brown; October 2012)

It created a relevant and memorable environment; 65% said they would refer to this campaign if a friend ever suggested the idea of injecting drugs. (Source: TNS Campaign Evaluation; January 2013).

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By: MARY ANN MOON, Clinical Endocrinology News Digital Network

03/10/14

Among patients with chronic hepatitis C virus infection, viral factors such as viral load and HCV genotype "did not play any significant role in the causation of acute kidney dysfunction events" but known nonviral risk factors did, according to a report published online in the Journal of Clinical and Experimental Hepatology.

In a retrospective cohort study involving 468 patients with chronic HCV (mean age, 50 years) enrolled during a 1-year period at a single hepatology clinic and followed for 6 months to 3 years, 124 episodes of acute kidney dysfunction developed in 63 patients.

Such dysfunction was significantly more likely to develop in those who had comorbid diabetes (47.6% prevalence, compared with 16.5% prevalence in nondiabetic participants), hypertension (69.8% prevalence, compared with 38.8% prevalence in nonhypertensive participants), or a history of IV drug use (44.4% prevalence, compared with 29.4% prevalence in nonusers), said Dr. Sanjaya Kumar Satapathy, who was with the division of gastroenterology at New York Medical College during the study, and his associates.

"Acute volume depletion secondary to nausea, vomiting, diarrhea, and large-volume paracentesis accounted for the major bulk of patients with acute kidney dysfunction. ... In addition, infections (n = 23) and GI bleeding (n = 9), the majority of which occurred in patients with advanced liver disease, appeared to play a significant role in developing acute kidney dysfunction," the investigators wrote (J. Clin. Exp. Hepatol. 2014 [doi:10.1016/j.jceh.2014.01.004]).

In contrast, the prevalence of acute kidney dysfunction showed no relation to baseline viral load; viral genotype; or the patient’s sex, race, body mass index, HIV status, or history regarding alcohol abuse. A total of 68 of the 124 acute kidney dysfunction events (54.8%) resolved completely, with serum creatinine returning to baseline levels; there was partial recovery in another 34.7% of the events, and the remaining 10.5% of cases progressed to either chronic kidney disease or end-stage renal disease.

Although acute kidney dysfunction is a well-known complication of cirrhosis and liver failure, most cases in this study (76%) developed in patients who did not have decompensated or advanced liver disease, noted Dr. Satapathy, who is now with the University of Tennessee, Memphis, and his associates.

No funding sources or potential conflicts of interest were disclosed.

 

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Promising Treatments Herald New Era in Hepatitis C Treatment

Provided by BioNews Texas

Posted by: Irlanda J. Espinosa March 10, 2014

hepatitis-c

Recently, several studies presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, have highlighted promising treatments for serious liver disease, with particular attention being paid to chronic infection caused by the liver-damaging Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection.

For patients who are chronically infected by HCV and HIV simultaneously, there is a substantial increase in the risk of cirrhosis and liver decompression than from being solely infected by HCV. Several companies, such as Boehringer Ingelheim, have been developing oral treatment regimens with durations that are 12 weeks or shorter with lower or absent side-effects for patients with both diseases.

Merck & Co has developed a combination of oral drugs that are highly effective in treating HCV and HIV co-infected patients.  The available data of the ongoing clinical trials for some treatment regimens were presented this Wednesday at CROI, while it is expected more data will be released at the European medical meeting in April.

The regimen consists of the experimental Merck drugs, MK-5172 and MK-8742 (new classes of anti-viral medicines), both with and without ribavirin, in co-infected patients over a 12-week period.

At the end of the period, all 29 patients using the two Merck drugs plus ribavirin presented undetectable levels of HCV (considering this way those patients are cured). On the other hand, 90% of the patients who were under the Merck drugs without ribavirin appeared to have the HCV eliminated from their systems after the 12-week period.

Even when the most common side effects of the treatment were fatigue and headache, no patient discontinued treatment due to side-effects or medication intolerance.

Of course, in a model for addressing HCV infection or co-infection with HIV, the development of new treatments that have the potential to cure effectively 90% of patients with common strains of the virus in a short period of time, is just part of solving the problem. It is necessary to find a way to make these treatments accessible as well..

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