New analysis looks at costly impact of new Hepatitis C treatments in California

A new analysis and infographic released today estimate California's exposure to high-priced Hepatitis C medications could range from hundreds of millions of dollars, even if only 5 percent of Californians infected with Hepatitis C receive treatment through state programs. The analysis, which looks at the costly impact of new Hepatitis C treatments on public programs, comes at a time when state and federal agencies grapple with hefty price tags for drugs like Gilead Sciences' Harvoni and Sovaldi.

California's state agencies have already acknowledged the impact of high-priced Hepatitis C drugs by setting aside hundreds of millions in the state budget and establishing workgroups to address the high-cost drug trend. The analysis released today supports the need for these proactive actions as these highly-effective, but costly, treatments pose a significant threat to the stability of our health care system at a time when health care reform has expanded coverage to millions of Americans.

"With a host of potentially six-figure priced drugs due to hit the market this year, this report shows how just one new treatment can blow a hole in state and federal budgets," said Charles Bacchi, President and CEO of the California Association of Health Plans. "These findings illustrate that this pricing trend is not sustainable for our state, its taxpayers and our public programs."

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Canada: Ontario approves second costly drug for hepatitis C

With provincial approval of a second costly drug that can cure hepatitis C, Ottawa liver specialist Dr. Curtis Cooper is now expecting to see thousands of his patients cured of the disease that, without treatment, had the potential to destroy their lives.

The Ontario government agreed this week to pay for the drug Holkira Pak which, pharmaceutical company AbbVie says had a 97 per cent cure rate in genotype 1 hepatitis C patients during clinical trials. It is the second hepatitis C drug the province has approved this year under the Ontario Drug Benefit exceptional access program. Earlier,the province agreed to pay for the drug Harvoni, which has a similar high cure rate for hepatitis C.

Both drugs cost in the $50,000 to $60,000 range, or more, which, until the province approved them, meant they were out of reach to most patients. Unlike previous treatments for hepatitis C, the drugs are easy to take in daily pill form, are well tolerated by patients and cure the disease in the vast majority of cases.

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FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.38%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened:

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

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National study finds life-threatening barriers in access to breakthrough drugs

Most states violate federal Medicaid law because they deny coverage for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection Program. Taylor's team of researchers examined Medicaid policies for hepatitis C virus treatment using sofosbuvir, more commonly known as Solvadi, and found that most should change policy to improve access to the treatment. The study and its findings were published online in advance of the August issue of the Annals of Internal Medicine.

Hepatitis C virus affects over three million Americans. Worldwide, an estimated 120 to 150 million people have chronic hepatitis C. Left untreated, the infection can lead to cirrhosis, liver failure, and liver cancer. Sofosbuvir is a highly effective pharmaceutical used in combination with other medications to cure the disease.

Taylor's research team, which included the Harvard Law School Center for Health Law and Policy Innovation, Treatment Action Group, Kirby Institute of Australia, and Brown University, found that most Medicaid coverage restrictions for sofosbuvir violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration (FDA) labels.

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What's behind fatigue, elevated liver enzymes?

'I'm more tired than usual, doctor," the patient said, though she really thought nothing was wrong. At 60, she assumed age was catching up with her, and was at the doctor's office for her routine checkup.

Indeed, all her blood work was normal - except for the panel revealing elevated liver enzymes. A liver ultrasound suggested the damage had been going on for some time.

Aside from hypertension, she had no other active medical conditions. The only drugs she took were a diuretic and a multivitamin.

Read more at http://www.philly.com/philly/health/20150628_What_s_behind_fatigue__elevated_liver_enzymes_.html#afUCSI50z4BEYo88.99

Madison County plans 4 sites for needle-exchange program - SFGate

ANDERSON, Ind. (AP) — Health officials are working to open four needle-exchange sites in a central Indiana county after being granted state approval for the program because of disease being spread among intravenous drug users.

The Madison County Health Department wants to have the sites open by late July or early August — two in Anderson and one each in Alexandria and Elwood.

People using the program will have access to other services at each site, such as substance abuse treatment programs and assistance in obtaining food and housing, county public health coordinator Stephanie Grimes told the Herald Bulletin

Madison County plans 4 sites for needle-exchange program - SFGate

ASCO 2015: Does Hepatocellular Carcinoma Differ in People with Hepatitis B and C? | Liver Cancer/HCC

 Liver cancer patients with hepatitis B at a large U.S. cancer center appeared to have worse disease status than those with hepatitis C, including larger tumors and more extensive liver involvement, according to research presented at the American Society of Clinical Oncology (ASCO) annual meeting this month in Chicago. Prognosis for the 2 groups was similar, however.

Over years or decades chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection can lead to serious liver disease including cirrhosis and hepatocellular carcinoma (HCC), a type of primary liver cancer. HCC is a major cause of cancer death worldwide, and hepatitis B and C are leading risk factors. But it is not well understood how liver cancer outcomes differ for people with HBV (a DNA virus in the Hepadnavirus family that integrates its genetic material into host cells) versus HCV (an RNA virus in the Flavivirus family).

hivandhepatitis.com - ASCO 2015: Does Hepatocellular Carcinoma Differ in People with Hepatitis B and C? | Liver Cancer/HCC