One in four hepatitis C patients denied initial approval for drug treatment

Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine study.

The finding, published Aug. 27 in PLOS ONE, identifies a new barrier to caring for patients with this severe condition.

Prior to the FDA approval of novel antiviral therapies for HCV in 2014, treatment options for patients were limited, requiring weekly injections of interferon-based therapy that caused severe side effects. The new regimens revolutionized treatment and offered patients an oral therapy with cure rates exceeding 90%. However, the high cost of care led insurers to impose new restrictions on drug authorization. Read more....

Should We Be Rationing Hepatitis Drugs? Obama Pressured to End Restrictions

Amid mounting evidence that federal and state authorities are rationing costly new wonder drugs for treating people with the potentially lethal hepatitis C virus, public health experts have begun pressing the White House to intervene to expand the use of Sovaldi and other new medications.

An estimated 3.2 million adults are chronically infected with hepatitis C while an estimated 20,000 people die from the serious liver ailment every year, including many military veterans.

The New York Times reported on Tuesday that a group of experts from the Public Health Service and President Obama’s Advisory Council on H.I.V./AIDS wrote a letter to the White House complaining that restrictions on the use of these drugs by many states are inconsistent with prudent and sound medical practices. Read more....

New Zealand: Cost keeps cure out of reach for those with Hepatitis C

Craig Hopkins, 52, nearly died from liver failure after contracting Hepatitis C virus (HCV) from an amateur tattoo. His new liver developed HCV but was finally cured after treatment with a new unsubsidised drug made available on compassionate grounds.

Now Hepatitis C free, the 52-year-old is calling for Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) to be made available in New Zealand.

"I reckon it's really sad the drugs are not available. If they were, it would free up the operating tables and they wouldn't need to do so many liver transplants."

Read more...

Two Current Fronts of the American Health Care Wars: Hepatitis C and Cancer

The Pharmaceutical Industry, Health Insurance and Recurrent Questions of Extortion, Murder and Evil

Asking patients to delay treatment for hepatitis C is like asking patients to delay treatment for diabetes or cancer.

"Waiting for cirrhosis to happen to treat HCV is like waiting for cancer to metastasize or for diabetes to cause complications before treating it. In reality, all cause mortality and per patient per year health care costs are tripled for patients with hepatitis C, whether they have cirrhosis or not."

-- Dr. Douglas Dieterich, leading hepatitis C and liver diseases researcher and specialist at the Mount Sinai Hospital, New York City

My friend John is a retired college professor who lives on a budget. He has hepatitis C, which he acquired from a blood transfusion before the development of blood testing and screening for hep C. He does have health insurance, but like most of those seeking treatment for this condition, he has been told that he must become demonstrably sicker to qualify for treatment coverage. Meanwhile, he must not drink any alcohol and remain vigilant for symptoms, especially fatigue. Since the progression of hepatitis C to cirrhosis of the liver and cancer of the liver can take decades, and John has already had this disease for decades, he is understandably concerned. In fact, he may die sooner from other causes, his untreated hepatitis C playing an indeterminate role. There is, however, an alternative for John. If he had the $100,000+ in cash to pay for the treatment now, he could be fully and safely cured in 8-12 weeks. John does not identify himself as a socialist, and he is willing to pay what he can for treatment, but the cost in this case is overwhelming.

Read more...

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."

Read more...

As insurers limit access to hep C drugs, patients and doctors bristle

Doctors 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.

Read more...

Local Patients Denied Lifesaving Treatment

ALTOONA - Imagine being diagnosed with a deadly disease that can be cured, but you can't get the treatment. More than 100 patients in our region and millions across the country, with Hepatitis C face that frightening situation. Treatments that can reverse the virus  cost about $1,000 a pill.

A tattoo changed a Bedford County man's life. Mike Miller got it done a few years ago by a friend and  last August he found out he'd also gotten the hepatitis C virus. He's tired, he has abdominal pain and his joints ache. He says, "there are just days that I don't feel like getting out of bed."

Fortunately, tests show Mike is still in the early stages of Hep. C.  His blood doesn't show a high number of infected cells and he doesn't have cirrhosis of the liver. So, he doesn't qualify for treatment that could keep the disease from progressing. 

Read more...

$1,000 Pills and the Future of Global Medicine

"In spite of these undoubtedly expensive costs, such an outrageous and unaffordable cost of treatment in the midst of a growing epidemic should not be allowed."

Hepatitis C, a liver-damaging virus, is best known as a “shadow epidemic” suspected of causing precipitous rise in rates of liver cancer, a disease increasing faster than any other cancer in the United States. The disease affects more than four million Americans and is disproportionately found among society’s marginalized populations, including prison inmates and injection drug users. An estimated 130 to 150 million people are infected worldwide.

Though these statistics and stories are worthy of alarm, costs of treating this epidemic are far from urgent. In April 2014, the World Health Organization approved two new oral drugs that fight hepatitis C, but their costs are far from affordable. Gilead Science’s 12-week course of the hepatitis C drug Solvadi costs $84,000, which translates to $1,000 per pill. Johnson & Johnson’s drug Olysio, often prescribed with Solvadi, costs $66,360 for the 12-week regimen.

Pharmaceutical companies oftentimes justify these high costs by simply pointing to the length of time and amount of money that is invested in the research and development process. According to the Pharmaceutical Research Manufacturers of America, research and development for just one medicine takes 10 to 15 years and more than $1 billion.


Read more...

At $594 Per Dose Gilead Sciences, Inc. (GILD) Hepatitis Drug Is Too Costly For Veterans Affairs Department

Gilead Sciences, Inc. (NASDAQ:GILD)‘s hepatitis C drug Sovaldi, which comes at a cost of $1,000 a pill, has proved to be a breakthrough that reduces treatment time to 12 weeks and at reduced risk compared to a year-long treatment option available. However, this heavily-priced therapy has raised concerns and criticisms across the U.S. by payers and consumer support groups.

To consider the impact of Sovaldi’s $84,000 12-week treatment cost, the Veterans Affairs Department provides this therapy only to the sickest patients who need it. The Department is the largest single provider of hepatitis C care in the U.S., which enabled it to negotiate more than 40% discount to the $594 per-dose price with Gilead.

VA and Hepatitis C Care

The Veterans Affairs Department added Sovaldi to its formulary in April 2014. It treated around 5,400 veterans at a cost of $370 million with Sovaldi in fiscal 2014, and has asked Congress for $1.3 billion to treat another 30,000 patients with Sovaldi and other new hepatitis C drugs.

Read more...