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SPECIALTY DRUG COSTS: HARD PILLS TO SWALLOW

5/30/2015

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Rita Pyrillis is a writer based in the Chicago area. Comment below or emaileditors@workforce.com. Follow Pyrillis on Twitter at @RitaPyrillis and on Google Plus


Employers watch their pharmacy costs skyrocket as specialty drugs to treat diseases like hepatitis C hit the market.

When Stella Armstrong’s doctor told her that she needed to begin treatment for hepatitis C in October 2013 she refused interferon therapy, the only treatment available to her at that time. To Armstrong, the side effects of the anti-viral drug sounded just as bad as the disease — fever, fatigue, depression, hair loss — and the cure rate was low. So when her doctor told her that new and better medicines were on the horizon, she decided to wait.

Three months later, pharmaceutical firm Gilead Sciences Inc. released Sovaldi, a drug with fewer side effects that could cure hepatitis C. In April 2014 she began a three-month treatment course of the new drug. Today she reports that there is no trace of the liver damage that doctors detected two years ago and that she has been cured.

“As it progressed and got worse, I started to worry because it was affecting my work,” said Armstrong, 52, an office worker at a construction firm in San Diego. “I was very tired, and my bones and joints were aching all the time. But I was lucky because my employer was very understanding, and I have good medical insurance through the company.”

The treatment came with a hefty price tag. Sovaldi costs about $84,000 for a 12-week treatment course, or about $1,000 a pill. News of its cost and its efficacy in curing hepatitis C made international headlines and its release was lauded as the most successful launch for any hepatitis C drug, earning Gilead $5.8 billion in its first two quarters on the market.

Hepatitis C From the
'Age of Hippies’


There are an estimated 3.2 million Americans infected with hepatitis C, according to the U.S. Centers for Disease Control and Prevention. The vast majority of those diagnosed — more than 75 percent — are baby boomers, which has prompted the CDC to recommend that everyone born from 1945 through 1965 be screened. Intravenous drug users, recipients of blood transfusions or organ transplants, and those infected with HIV should also get tested, according to the CDC. The virus is spread through infected blood.

“This was the age of hippies experimenting with drugs and sex back in the 1960s,” said Alan Franciscus, founder of the Hepatitis C Support Project, a nonprofit advocacy organization based in San Francisco. “Also, blood was not screened before 1992, and many people contracted it through blood transfusions.”

—Rita Pyrillis

However, Sovaldi’s exorbitant cost provoked an outcry from lawmakers, insurers and health care advocates. One employer — the Southeastern Pennsylvania Transportation Authority in Philadelphia — filed a lawsuit in December 2014 against Gilead for alleged price gouging. The state agency said that it paid more than $2.4 million for Sovaldi prescriptions for its employees that year.

Employers have been watching anxiously as specialty drug costs for chronic conditions like multiple sclerosis and hepatitis C have soared in recent years. Although only 4 percent of patients take specialty drugs, they represent about 20 percent of today’s drug costs, according to a 2013 report by pharmacy benefits manager CVS Health. Industry experts predict that by 2020 specialty drug spending could more than quadruple to about $402 billion a year, according to the report.

While patients and providers hail breakthrough drugs that can cure hepatitis C, like Sovaldi, Harvoni — which Gilead launched last October — and Viekira Pak, which AbbVie launched last December, employers and insurers are scrambling to manage their costs.

Sovaldi is typically prescribed with another hepatitis C drug called Olysio, which costs $66,360 per treatment course, according to published reports. Harvoni costs even more than its predecessor at $94,500 for a typical 12-week course of treatment but is taken alone.

“Ultimately, this type of pricing is unsustainable because it increases costs for employers, premiums for individuals, and its blowing out state budgets across the country,” said Clare Krusing, spokeswoman for America’s Health Insurance Plans, a Washington, D.C.-based trade group.

At 84 Lumber Co. located in Eighty Four, Pennsylvania, specialty drug spending went up by 94 percent between 2013 and 2014, almost entirely because of hepatitis C medications, according to Mark Mollico, the company’s vice president of human resources. The company employs 4,200 people in 30 states.

“Our annual spend on Sovaldi went from zero in 2013, because these drugs hadn’t been approved until 2014, to $178,000 last year,” he said. “Costs for one employee alone were $159,000,” which included Sovaldi and Olysio prescriptions. Mollico added that there isn’t much of an insurance discount on these medications.

The fact that many employees might not know that they have hepatitis C makes it impossible to predict who will need these drugs down the road, according to Mollico. Hepatitis C is a slow-moving disease, and symptoms sometimes take decades to emerge. Armstrong’s symptoms appeared 13 years after her diagnosis. By the time they do, patients show signs of liver damage. Left untreated, the virus can lead to cirrhosis, liver cancer and liver failure.

 “Unlike other conditions like heart disease or diabetes where we know we have so many people with those conditions, hepatitis C is hidden,” Mollico said.

Many employers, like 84 Lumber, were blindsided by the spike in specialty drug costs, according to Shari Davidson, vice president of the National Business Group on Health. In the case of Sovaldi, doctors were advising patients to wait for better or cheaper medication, which created a rush for the drug as soon as it hit the market, catching employers off-guard.

“What’s concerning is that many people were warehoused, meaning they were waiting for Sovaldi to come out,” she said “They were told, ‘If your liver isn’t damaged, wait.’ There was a built-up demand.”

In 2014, prescription drug spending in the United States increased 13.1 percent, the biggest annual increase in over a decade. This increase in overall drug spending is tied to an unprecedented rise in spending on new hepatitis C treatments and compounded medications, according to a report by Express Scripts Holding Co., the nation’s largest pharmacy benefit manager. Compounded drugs are typically used to treat scars, wrinkles and pain.

Before 2014, hepatitis C medications weren’t among the top 10 costliest specialty drugs, but they are now No. 4 in terms of per-patient spending, according to the report.

Price Wars and PBM Deals

The landscape is changing as PBMs, insurers and employers put pressure on drug manufacturers to lower their prices for hepatitis C treatments. Express Scripts led the charge when it made a deal with Gilead’s rival, AbbVie, to exclusively offer its drug Viekira Pak on its largest plan. Gilead saw its stock price tumble as a result. Shortly after that, AbbVie struck a similar deal with CVS to offer Harvoni. Other PBMs, including EnvisionRx and Catamaran Corp. (which is being acquired by UnitedHealth Group Inc.), followed suit in negotiating deals with drugmakers, as have insurance companies including Aetna Inc. and Blue Shield of California.

In February, Gilead shocked investors by announcing expected discounts of 46 percent on Sovaldi and Harvoni for 2015.

The introduction of AbbVie’s Viekira Pak was a game-changer, according to Seth Friedman, vice president of client management at Solid Benefits Guidance, a pharmacy and employee benefit consulting firm.

“Viekira Pak changed the dynamic because it introduced competition,” he said. “Sovaldi spurred a lot of noise because it had no competition, but the landscape is changing.”

Meantime, employers are scrambling to alleviate some of the sticker shock. Some are requiring employees to participate in disease management programs to help them stick to the treatment and using step therapy, which requires patients to try a less expensive medication before moving up to a more expensive one, and by imposing restrictions on who gets treatment. They are also working with their benefits advisers, PBMs and health plans to establish usage criteria, something that the NBGH is advising all of its members to do.

According to a November 2014 survey of 42 NBGH members, nearly 80 percent of employers that offer hepatitis C medications use prior authorization criteria that includes having a specific genotype of the virus, covering only patients who have the active virus, and covering patients who have liver damage.

While the increased competition for hepatitis C drugs and discount deals with PBMs benefit employers, patient advocates say it does little to increase access to treatment.

ON THE WEB

UnitedHealth Group Inc.’s recent proposed acquisition of Catamaran creates a third major pharmacy benefits manager to help employers navigate the pharmacy market.Workforce.com/MergerOptions

Ryan Clary, executive director of the National Viral Hepatitis Roundtable in San Francisco, said that some restrictions are unreasonable, particularly those imposed by state Medicare and Medicaid programs.

“The restrictions placed by private and public payers on hepatitis C treatment can be severe,” he said. “They are blanket restrictions, like you must be sober for six months or you must have advanced liver disease. We believe that somebody with a chronic life-threatening illness like hepatitis C who wants to be cured, should be cured, and insurance should cover it.”

If cost is the impetus for restricting access to medication, employers and insurers must realize that they will have to pay eventually, Clary said.

“You have to weigh that cost against the cost of end-stage liver disease, of a liver transplant and hospitalizations,” he said. “Then, expanding access is not only humane but cost effective.”

Employers fear that as more people get tested for the virus, as the CDC recommends, there will be an increase in patients seeking treatment, according to Alan Franciscus, founder of the Hepatitis C Support Project, a nonprofit advocacy organization. But testing and educating people about hepatitis C are the way to eliminate it, he said.

“One thing I hear is: Why should we test if not everyone can be treated?” he said. “We can give people information about lifestyle changes and tell them how to prevent the spread of hepatitis C, like making sure that your blood doesn’t mingle with others.”

Davidson of the NBGH is hopeful that continued advances in treatment, more testing for the virus and declining costs will mean the end of hepatitis C.

“It’s the hope that we will nip it in the bud and move on,” she said. “If everyone in the U.S. was treated, its possible that we could see the elimination of this disease in our lifetime.”

Until then, concern about the cost of treatment will be weighing on employers, according to Davidson, who said that “hepatitis C comes up in every conversation.”

Nearly 70 percent are tracking the costs of covering these new drugs, reporting costs ranging from zero to $2 million, according to the NBGH survey. But a little more than a quarter have estimated the cost if everyone covered under their health plans with hepatitis C were to be treated. Most have no employees diagnosed with hepatitis C and anticipate no impact, but employers that do estimate costs ranging from $3 million to $56 million.

“We’ll continue to ask our members what kinds of trends they’re seeing, if per-patient costs are going down now with new discounts, how management programs are working and how adherence is impacted,” Davidson said.

She said that finding ways to manage these new hepatitis C drugs could help prepare employers for other new specialty drugs in the pipeline.

 “This is a precursor for other types of drugs as they come out,” she said. “We will see more blockbusters changing lives of people with not just rare diseases, but with high cholesterol or cancer.”

However, that worries Krusing who calls Sovaldi “the canary in a coal mine” when it comes to the future of specialty drug costs.

“We’ve seen tremendous concern that drugs coming to market increasingly may not have a competitor or may be in a market of its own,” she said. “With AbbVie and Gilead, the competition has helped, but it hasn’t addressed the underlying concern, which is that as prescription drug prices increase, you’re starting negotiations at much higher levels. Competition is good, but it doesn’t really help when you begin negotiating from $89,000.”

http://www.workforce.com/articles/21318-specialty-drug-costs-hard-pills-to-swallow
Rita Pyrillis is a writer based in the Chicago area. Comment below or emaileditors@workforce.com. Follow Pyrillis on Twitter at @RitaPyrillis and on Google Plus

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JILLS HEPATITIS POEM

5/27/2015

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BY JILL WOLF,LCSW


My experiences have led me to stand here before you, I promise not to judge ‘cause I ain’t stood in your shoe

But maybe as I stand here you see a White girl with short hair, that’s alright, I’ve gotten it all, blank looks and nothing but stares

But that’s cool cause I got passion and I got time, to come in here and help you refine

Our knowledge and response to Hep C has got to evolve, and that’s my job, to get YOU involved!

I am here to create change one person at a time, the number of undiagnosed people should in itself be a crime

See according to research 75% infected don’t know of their HCV, and those who are positive, they’re looking just like you and me

I’m talking the rich, the poor, blacks, whites, vets, moms and dads, the 1980s drug user, doctors, kids and recent grads

Regardless of what you might think, baby boomers get tested, be ambassadors to your own health cause an interest you need vested

So reach out your hand and give a girl a call, cause your voice needs to be heard by YOU most of all

I’m telling you now you’re worth all your time, there’s a cure for Hep C and the strength you will find

I hope my presence here can create some change, for any of you my schedule I’ll rearrange

My name is Jill and my heart is open, get screened, get tested cause that’s what I’m hoping!

Jill Wolf is the program director for Caring Ambassadors Program.


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 AS INSURERS LIMIT ACCESS TO HEP C DRUGS PATIENTS AND DOCTORS BRISTLE

5/22/2015

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By Virgil Dickson  | May 20, 2015Doctors are finding themselves in tense situations as they try to prescribe new hepatitis C drugs to patients eager for a cure while health plans limit coverage to manage the costs of the medications.

Many health insurers have established prior-authorization criteria generally limiting access to the drugs to patients whose disease has progressed to at least Stage 3 fibrosis (just before the onset of liver cirrhosis). 

The sticker prices of a course of treatment of the drugs range as high as $95,000. To mitigate the burden, major health insurers and pharmacy benefit management companies have entered special pricing agreements with Gilead for its new hepatitis C drugs Harvoni and Sovaldi or AbbVie for its competing drug Viekira Pak. 

The companies have not disclosed the details of those deals, but Gilead executives suggested during a recent call with investors that they exceed 50% for high-prescribing payers. 

Some providers believe infected patients at any stage of the disease should have access to the drugs, which have cure rates exceeding 95%. When they choose to prescribe them, however, they're faced with seeking authorization from payers and pursuing appeals when requests are denied. 

“I'd love to see every patient have a chance to be treated. I am an expert in the infection and would prefer that no one have it,” said Dr. David Thomas, a liver specialist at Johns Hopkins University. “I prescribe the meds for that reason and understand that sometimes it is difficult to get them approved.” Thomas has received grants from Gilead and Merck & Co., which has a hepatitis C drug in development. 

Many people are infected with the hepatitis C virus for decades before the onset of cirrhosis. But patients who suffer from the disease are becoming increasingly frustrated with barriers to coverage as word spreads that the drugs are available. 

This week, a Los Angeles woman sued Anthem Blue Cross for denying coverage for Gilead's Harvoni even though her physician recommended she take it. The Food and Drug Administration approved Harvoni in October 2014. Without insurance coverage for the drug, she would have to pay $95,000 for a 12-week course of treatment, she alleges in the lawsuit. 

Gilead has been tracking this tension between plans and providers. The company found that in 56% of the instances a provider attempted to prescribe one of its hepatitis C treatments in the first three months of 2015, the patients were between zero and Stage 2 on the fibrosis scale.

Gilead CEO John Martin said during an earnings call this year that the company believes a significant number of those prescriptions are not being filled because of health plan restrictions. 

Gilead and AbbVie have enjoyed surging profits since introducing their new hepatitis C drugs. They accounted for about $11 billion of a 13% increase in U.S. drug spending in 2014, according to the IMS Institute for Healthcare Informatics. That report also noted a tenfold increase in the number of patients treated for the disease last year. 

Another patient whose doctor made repeated requests for coverage for Harvoni is Dean Salvani, a 59-year-old resident of Bellmore, N.Y. Salvani has been denied coverage for the drug twice by UnitedHealthcare. 

“There's finally a cure, but I can't get it,” said Salvani, who says he suffers severe muscle and joint pain from the disease. “'You're not sick enough' and 'it's too expensive'” Salvani said, recapping conversations with his health plan's claims staff.

In denial letters provided to Modern Healthcare by UnitedHealthcare, the company confirmed that it denied the authorization because Salvani didn't have at least Stage 3 fibrosis.

“The newer hepatitis C drugs, such as Sovaldi and Harvoni, are effective for patients with the appropriate genetic markers at any stage of disease progression,” United spokesman Tyler Mason said. “Therefore, (we) believe our clinical programs are consistent with clinical evidence to prioritize treatment based upon the progression of the disease, i.e., treating the sickest patients first. Mr. Salvani's current condition may not meet that criteria.”

For every 100 people infected with the virus, Mason noted, only five to 20 will develop cirrhosis over a period of 20 to 30 years, according to the Centers for Disease Control and Prevention. 

“Clinicians tend to be advocates for their patients; they would like the best therapy for their patients as quickly as possible,” said Dr. Henry Masur, chief of the critical care medicine department at the NIH Clinical Center. “But people are realistic and realize that if there is no medical urgency, they have to be patient and treat the higher risk patients first.”

But some experts question the safety of the prior-authorization rules that limit access to the new breed of hepatitis C drugs during moderate and advanced fibrosis. 

“This strategy appears reasonable when one assumes no health impact from delaying treatment,” David Rein, principal research scientist with NORC's Public Health Research Division, an independent research organization at the University of Chicago, wrote in a paper published in the journal Clinical Infectious Diseases in March. 

However, Rein wrote, “doctors know surprisingly little about the health impacts of delaying treatment, and the earliest results from studies examining this issue will not be available for several years.   

”http://www.modernhealthcare.com/article/20150520/NEWS/150519897


Virgil Dickson Virgil DicksonVirgil Dickson reports from Washington on the federal regulatory agencies. His experience before joining Modern Healthcare in 2013 includes serving as the Washington-based correspondent for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's degree from DePaul University in 2007.

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PAINKILLERS ADDICTION SPAWNS NEW HEPATITIS C THREAT

5/15/2015

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Published on NewsOK Modified: May 9, 2015 at 12:51 pm •  Published: May 9, 2015Public health officials are bracing for a new wave of hepatitis C infections, one unleashed by the epidemic of prescription painkiller addiction.

The blood-borne virus, on the decline nationally until a few years ago, is rising rapidly among adolescents and young adults, especially in white, rural communities. Those are the same areas where an epidemic of prescription opioid deaths first showed up over a decade ago, followed by a wave of heroin deaths.

Most of the new hepatitis C patients have contracted the virus by injecting drugs, often crushed pain pills. For infectious disease, that’s riskier.

Scattered studies around the country have detected the patterns, which became clearer on with a report released this past week by the U.S. Centers for Disease Control and Prevention.

Less clear but increasingly expected is a rise in the better-known, more-feared virus that often accompanies hepatitis C: HIV.

In rural southeastern Indiana, 150 cases of HIV have been identified in the past few months, most of them in a town of 4,200 residents. The vast majority injected drugs. Nearly all were also with hepatitis C, which is more easily transmitted by shared needles than HIV.

In the CDC study of disease patterns, the number of new hepatitis C infections among people age 30 and under in Kentucky, Tennessee, Virginia, and West Virginia rose 364 percent from 2006 to 2012; three-quarters of the cases involved injected-drug use. Increases were reported everywhere, but “nonurban areas” — basically rural and suburban counties — went up at double the rate of urban locations, where the virus historically has circulated more.

Jon E. Zibbell, a medical anthropologist and lead author of the study, said in an interview that new infections are rising in older Americans as well — up 150 percent overall between 2010 and 2013, according to CDC data. But the new study looked beyond hepatitis C infections to patterns of admissions for drug treatment.

The findings “indicate a geographic intersection among opioid abuse, drug injecting, and (hepatitis C) in central Appalachia,” Zibbell and his co-authors wrote. The region has among the nation’s highest rates of fatal overdoses caused by prescription painkillers.

Hepatitis C can sit silently in the body for decades before causing liver damage so severe in some cases that only a transplant will prevent death. It was transmitted largely through transfusions, surgeries, and injections before effective screening of blood donations began in 1992, heralding a long decline in infections.

Still, at least 3 million people are believed to be chronically infected today, three-quarters of them baby boomers. Most have no idea, and 2012 federal guidelines called for all 76 million boomers to be tested once. (Longtime guidelines recommend that injection drug users be tested regularly.)

The first medications able to cure hepatitis C with few side effects were approved the next year and marketed to the heavily insured over-50 population. They are so expensive that some Medicaid programs for the poor have balked.

With the blood supply safe, intravenous drug use is now the No. 1 source of infection.

“This notion that it is just a baby boomer problem is not really accurate,” said Stacey B. Trooskin, an infectious diseases doctor and researcher at Drexel University. “With this resurgence in heroin use with syringes, we are going to start seeing an increase in new cases of hepatitis C and maybe HIV, although less so.”

Although estimates vary widely by age, location, and risk behavior, hepatitis C typically is about five times as prevalent as HIV, and it causes more deaths. They often occur in the same people, but the transmission patterns are different.

Hepatitis C is less likely to be passed through sexual contact than HIV. The risk from a dirty needle is the opposite.

Exactly what is in those syringes may be playing a major role in the latest hepatitis C outbreaks in rural areas. Pain pills that are crushed and heated with water are less dissolvable than heroin.

“It’s requiring the users to utilize a higher-gauge needle to inject,” Indiana Health Commissioner Jerome M. Adams said last month. Those needles, if used previously by someone who was infected, will carry more virus than a finer needle used for heroin.

And unlike heroin, a street drug whose potency can’t be predicted, prescription opioids are clearly marked. The user can cut a 5-milligram pill of oxymorphone into quarters and control exactly how much is in the needle. That can mean smaller doses with less opioid (meaning fewer fatal overdoses), but also more injections than the same heroin high would require; that again means more virus.

When the CDC’s Zibbell investigated a cluster of hepatitis C cases in upstate New York, his team found that users who injected crushed pain pills were five times as likely to test positive for hepatitis C antibodies than those who used other drugs.

“The whole phenomenon of injecting pills is much more common in rural areas than in urban areas,” said Stephen Lankenau, who researches prescription drug misuse at Drexel University School of Public Health. When people who have been swallowing pills or perhaps snorting them need a higher dose — to prevent withdrawal symptoms or to save money — they can find heroin more easily in the city, he said. Farther out, they are more likely to inject the liquefied pills directly into the bloodstream.

The hepatitis C virus lives on more than just syringes. It can remain alive in the cookers and filters that are used to prepare drugs for injection, sometimes by different people, again and again.

“If a number of different injectors have pulled from that cooker,” Lankenau said, the risk of infection is high.

http://newsok.com/painkiller-addiction-spawns-new-hepatitis-c-threat/article/feed/837424

——--

©2015 The Philadelphia Inquirer

Visit The Philadelphia Inquirer at www.philly.com

Distributed by Tribune Content Agency, LLC.

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May 15th, 2015

5/15/2015

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HEPATITIS C INFECTIONS FUELED BY PRESCRIPTION PAIN  KILLER ABUSE

5/8/2015

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Liz Szabo, USA TODAY1:59 p.m. EDT May 7, 2015(Photo: Jeffrey Thompson, AP)

(USA Today)--Rates of hepatitis C are soaring, largely driven by an epidemic of prescription pain killer abuse, a new report shows.

The incidence of acute hepatitis C infections among young people in rural areas of four Appalachian states more than tripled from 2006 to 2012, according to a report released today by the Centers for Disease Control and Prevention. New hepatitis cases among people age 30 and younger rose from 1.25 per 100,000 in 2006 people to 4 per 100,000 in 2012 in Kentucky, Tennessee, Virginia and West Virginia.

About 73% of these hepatitis C patients said they injected drugs, which can spread the virus when people share needles. The report is the first CDC study to link the rise in hepatitis C to an increase in injection drug use, says John Ward, director of viral hepatitis prevention at the CDC, who calls the rising infection rates "staggering."

Although the CDC focused this study on the four states with the highest hepatitis C rates, the agency plans to study the disease in other states, as well, Ward says.

"We're in the midst of a national epidemic of hepatitis C," Ward says. Nationwide, more than 20,000 Americans die from hepatitis C a year, which is more than the number who die from AIDS, he says. "The CDC views hepatitis C as an urgen public health problem."

The rate of new hepatitis C infections has risen nationwide, more than doubling from 0.3 cases per 100,000 people in 2010 to 0.7 cases in 2013. Kentucky had the highest rate that year, with 5.1 cases per 100,000, according to the CDC. Delaware and South Carolina had no reported cases that year.

The boom in abuse of prescription pain killers also has been blamed for an outbreak of 149 cases of HIV, the virus that causes AIDS, in rural Indiana. Most of the newly diagnosed HIV cases had injected a powerful prescription painkiller called Opana.

The HIV outbreak led Indiana Gov. Mike Pence to declare a public health emergency in March, allowing for a one-month program allowing injection drug users to exchange their old syringes for new ones. Pence has extended the program to May 24. He signed a law Tuesday allowing Indiana localities with health emergencies to begin their own needle exchanges.

Some acute hepatitis C infections go away without treatment within a few months, but about two-thirds turn into long-term, chronic infections, which can cause liver damage, liver cancer and death.

A newly approved drug, Sovaldi, cures hepatitis C in 90% of patients, but it's very expensive: A 12-week course of treatment costs $84,000.

The CDC estimates that there were nearly 30,000 acute hepatitis C infections nationwide in 2013 and that of 3.2 million Americans are infected.

Many people with hepatitis don't know they're infected, Ward says. The CDC recommends that Baby Boomers get tested for hepatitis C, because many undiagnosed cases of hepatitis C occur in the generation that came of age in the 1960s and 1970s.

Now, with the epidemic of prescription drug abuse, "a new generation of people in this country are getting infected," many of whom are much younger, Ward says.

Hepatitis C infections are concentrated in areas with high rates of opioid abuse. In the new CDC study, rates were twice as high in rural areas as in cities.

About 4.5 million Americans older than 12 abused prescription painkillers in 2013 and 289,000 used heroin, according to the Substance Abuse and Mental Health Services Administration.

Heroin use also has grown as people addicted to prescription painkillers switch to heroin because it's cheaper and easier to get, says Nora Volkow, director of the National Institute on Drug Abuse, part of the National Institutes of Health. About 75% of new heroin users previously abused opioid painkillers.

The number of first-time heroin users grew from 90,000 people in 2006 to 156,000 in 2012, according to the CDC.

Several studies have found that needle exchanges dramatically cut the rate of HIV transmission among injection drug users without increasing illegal drug use, says William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville. Needle exchanges also give public health workers a chance to educate drug users and provide other health services. That's important, because people addicted to drugs may not get any other medical care.

Research shows that needle exchanges have helped to reduce HIV infections.

In New York, 52% of newly diagnosed AIDS patients were injection drug users in 1992. Ten years later, after the implementation of needle-exchange programs, only 3% of new HIV cases were injection drug users, according to the New York State Department of Health AIDS Institute.

The most successful needle exchanges also offer counseling, disease testing and referrals to places where patients can get treatment, Ward says.

There are 225 needle exchange programs in the USA, according to the North American Needle Exchange Network. The exchanges are found in 33 states, the District of Columbia and Puerto Rico.

The USA needs to offer more needle exchanges in order to reduce hepatitis and HIV infections, says Paul Samuels, president and director of the Legal Action Center, which advocates on behalf of people with HIV or substance abuse disorders.

"It is critically important that needle exchange programs like the temporary one in Indiana be replicated across the country, and be permanent," Samuels says. "Studies have repeatedly proven that needle exchange programs reduce HIV, hepatitis and other infections among people who use intravenous drugs without increasing intravenous drug use, and indeed they are a bridge to treatment for some participants. Substance use prevention and treatment, including treatment with medications, and harm reduction -- including needle exchange -- are all necessary components of a comprehensive strategy for combatting the opioid epidemic and addressing the many ways it can harm people with addictions."
http://www.whas11.com/story/news/nation/2015/05/07/infections-pain-killer/70951026/


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CDC Warns of Rise in Hepatitis C Cases Linked to Injection-Drug Use

5/8/2015

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By Jeanne Whalen        The Wall Street Journal           May 7, 2015 1:00 p.m. ET                                  The Centers for Disease Control and Prevention warned about a sharp increase in hepatitis C infections linked to injection-drug abuse in four Appalachian states, and called for better health services to contain the spread.

Reported cases of acute hepatitis C infection in people ages 30 or under more than tripled from 2006 to 2012 in four states—Kentucky, Tennessee, Virginia and West Virginia—according to a new study published by the CDC Thursday. Among patients for whom associated risk factors were reported, more than 70% reported injection-drug abuse.

During the same period, the number of people under 30 admitted to substance-abuse treatment facilities for opioid drugs grew by 21% in those states. A significant proportion of these people identified injection as their main method of drug use

“Taken together, these increases indicate a geographic intersection among opioid abuse, drug injecting, and HCV infection in central Appalachia and underscore the need for integrated health services in substance-abuse treatment settings to prevent HCV infection and ensure that those who are infected receive medical care,” the researchers wrote in the CDC’s Morbidity and Mortality Weekly Report.

The study “provides a call to action,” John Ward, director of the CDC’s division of viral hepatitis, said in an interview. “We have a major problem with hepatitis C,” he said, noting that acute infection reports nationwide rose by 150% between 2010 and 2013.

The sharing of needles among drug users is one of the main ways the blood-borne hepatitis C virus spreads. Injection-drug abuse has soared in Appalachia and other rural areas in recent years amid what health experts call an epidemic of opioid painkiller and heroin addiction.

An outbreak of HIV among injection-drug users in rural Indiana in recent weeks has focused attention on the problem. Health experts say hepatitis C is even more widespread in such communities, as it spreads more easily. Infection can lead to cirrhosis or cancer of the liver and require costly transplants. New drugs are highly effective at curing infections but can cost more than $80,000 per person.

On the heels of the Indiana outbreak, the CDC in April called for all local health departments to take urgent action to prevent further HIV and hepatitis C outbreaks.

The CDC’s new hepatitis C study found that those infected were primarily non-Hispanic white people, with a significant number living in rural areas. The CDC cautioned that hepatitis C is often underreported, because infected people often have no symptoms, and because populations at risk often have limited access to health care.http://www.wsj.com/articles/cdc-warns-of-rise-in-hepatitis-c-cases-linked-to-injection-drug-use-1431018001

Write to Jeanne Whalen at jeanne.whalen@wsj.com

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IMPLEMENTING THE NATION’S FIRST STATE HEPATITIS C TESTING LAW

5/2/2015

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May 1, 2015 • 0 comments • By Colleen Flanigan, R.N., M.S., Director, Viral Hepatitis Section, New York State Department of Health 
https://blog.aids.gov/2015/05/implementing-the-nations-first-state-hepatitis-c-testing-law.html


As the first state hepatitis C testing law in the nation progresses into its second year of implementation, the New York State Department of Health (NYSDOH) is taking steps to educate both healthcare providers and consumers about the importance of HCV screening for individuals born between 1945 and 1965 (often referred to as the “Baby Boomers”) and New York’s related law requiring that healthcare providers offer a one-time HCV screening to patients in this birth cohort as part of routine primary care. Here is an overview of the activities that the NYSDOH has been engaged in to implement and evaluate the new law.

The LawThe NYS Hepatitis C Testing Law was signed into law by the governor on October 23, 2013 and implemented effective January 1, 2014.  This new law mirrors the Centers for Disease Control and Prevention’s (CDC) 2012 expanded hepatitis C virus (HCV) screening recommendations, requiring healthcare providers in the state to offer a one-time HCV screening test to all persons born between 1945 and 1965, and is similar to the 2010 NYS HIV Testing Law .  The law was enacted to increase HCV testing and ensure timely diagnosis and linkage to care.

The two key provisions of the NYS Hepatitis C Testing Law  are:

  • A hepatitis C screening test must be offered to every individual born between 1945 and 1965 receiving services as an inpatient of a hospital or receiving primary care services in the outpatient department of a hospital or in a freestanding diagnostic and treatment center or from a physician, physician assistant, or nurse practitioner providing primary care.
  • If an individual accepts the test and the screening test is reactive, the health care provider must offer or refer for follow-up health care, including a HCV diagnostic test (i.e., HCV RNA).
Educating Providers and ConsumersAll activities related to the testing law implementation and evaluation are being coordinated by the NYS Department of Health’s AIDS Institute.

To inform healthcare providers of the new law, the AIDS Institute:

  • Issued a “Dear Colleague” letter [PDF 76 KB];
  • Developed a “Frequently Asked Questions” document;
  • Conducted stakeholder conference calls and in-person meetings; and
  • Released a web cast .
In April 2015, the AIDS Institute launched a statewide media campaign [PDF 1241 KB] to raise awareness of the law among providers and consumers.  A post card [PDF 1328 KB]  was mailed to providers (i.e., MDs as well as Doctors of Osteopathic Medicine, Physician Assistants, and Nurse Practitioners) across the state making them aware of the recent law.  The post cards included a link to the NYSDOH hepatitis web site where new provider and consumer educational materials are posted and available for download or ordering.  The materials include:

  • Fact Sheets (Provider [PDF 317 KB], Consumer [PDF 302 KB])
  • Consumer Post Card [PDF 1307 KB]
  • Waiting Room Posters [PDF 1277 KB]
Additionally, advertisements were placed in the AARP regional newsletter, and a short video  was created for physician office waiting rooms.

Finally, the law requires the NYSDOH to conduct an evaluation on its impact with respect to the number of persons who are screened for hepatitis C and the number of persons who have accessed care following a positive test.  The final report is due to the Governor by January 2016.  The evaluation activities will include:

  • To determine number of tests conducted
    • Survey of all commercial laboratories in NYS
    • Analysis of Medicaid and HCV surveillance data
  • To determine the number of persons who have accessed care following a positive test
    • Analysis of HCV surveillance data
  • To learn more about how providers have implemented the law, a survey will be mailed to a sample of providers statewide (i.e., MD, DO, PA, and NP).
The NYS HCV Testing Law has a sunset date of 2020. At that time, it will be repealed and will have to be re-introduced if it is still needed.

Contributing to National Viral Hepatitis GoalsThis law is the first of its kind and potentially a model for other states seeking to avoid thousands of illnesses and deaths that would otherwise result from undiagnosed HCV infection. The NYS HCV Testing Law is also the first law that directly supports a key goal of the national Viral Hepatitis Action Plan: the plan calls for increasing the proportion of persons who are aware of their hepatitis C virus infection, from 45% to 66% by 2020. “The support for implementation of the HCV Testing Law from the NYSDOH and its AIDS Institute are substantial contributions toward identifying people who are chronically infected with HCV in New York,” said Dr. Ronald Valdiserri, the U.S. Deputy Assistant Secretary for Health, Infectious Diseases. “We’ll be watching their progress and urging other stakeholders to learn from New York.”

Ms. Flanigan also serves as the CDC-funded Viral Hepatitis Prevention Coordinator in New York.



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