How insurance providers deny hepatitis C patients lifesaving drugs - Doctors say up to 80 percent of patients are denied expensive but effective drugs like Harvoni

Amber Rojas was almost eight months pregnant when she learned she had hepatitis C. After her daughter was born on Dec. 23, 2014, Rojas had hoped to start treatment with a newly approved, highly effective drug called Harvoni.

After filing for prior authorization and waiting for months, the 34-year old mother received an unwelcome letter on August 27, 2015 — her treatment request had been denied because her liver was still too healthy. Rojas said that even though she felt very sick with flu-like symptoms, her insurance provider deemed her “not sick enough to qualify.”

Rojas is one of an estimated 3.2 million Americans with hepatitis C, an infection that attacks the liver. In the United States, hepatitis C kills more people every year than HIV. Drugs like Harvoni promise to cure more than 90 percent of patients, yet many insurance providers authorize treatment only if a patient has extensive liver damage, or a fibrosis score of 3 or 4.

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Medicines Patent Pool looks at hepatitis C

Greg Perry, Executive Director of the Medicines Patent Pool, told delegates at the World Hepatitis Summit in Glasgow this week that the organisation was considering how it could act to speed up and expand access to direct-acting antivirals for lower- and middle-income countries, where around 85% of people with hepatitis C are estimated to live.

The Medicines Patent Pool was established with the support of UNITAID, the international drug and diagnostics purchase fund for HIV, tuberculosis and malaria, to negotiate voluntary licensing agreements with pharmaceutical companies that would allow widespread access to low-cost antiretroviral drugs for HIV treatment. The Medicines Patent Pool was also designed as a mechanism to overcome barriers to the development of fixed-dose drug combinations of products from more than one manufacturer, for efficient delivery of treatment in lower- and middle-income countries.

Since its launch in 2010 the Medicines Patent Pool has negotiated voluntary licensing agreements with all the major pharmaceutical companies that allow some or all of their antiretroviral products to be copied by generic manufacturers for sale at greatly reduced prices in lower- and middle-income countries.

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One in four patients with HCV denied initial request for treatment

A new study published in PLoS ONE showed that one in four patients with hepatitis C virus infection who apply for treatment of the infection is initially denied.

“Delay in access may further challenge our ability to cure hepatitis C in this country,” Joseph K. Lim, MD, associate professor of medicine and director of the Yale Viral Hepatitis Program at Yale University, said in a press release. “Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access.”

“This is the first study to our knowledge assessing real-world access to interferon-free [direct-acting antiviral] regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” the researchers wrote. “These results contribute to the limited data available addressing proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors for approval. … Further studies are warranted to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as [sofosbuvir and ledipasvir].” – by Melinda Stevens.

Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645.

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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....

Canada: Hepatitis C treatments skyrocket after pill-based drugs covered by B.C. plan

About 1,400 British Columbians have been treated for hepatitis C in the first four months since new anti-viral medications were covered by the province’s public drug plan — far above predictions.

The Ministry of Health expected 1,500 patients in the first full year for the pill-based medication.
Dr. Mel Krajden, medical head of hepatitis at the B.C. Centre for Disease Control, says the numbers reflect pent-up demand from patients seeking the latest treatments.

“A lot of people who are infected follow the literature on these drugs and they were waiting for the newer ones. It’s a whole group of people who realized these medications are more effective, better tolerated with fewer side effects and work over a shorter period of time,” Krajden said at a World Hepatitis Day event Tuesday in Vancouver.

- See more at: http://www.vancouversun.com/health/Hepatitis+treatments+skyrocket+after+pill+based+drugs+covered+plan/11249876/story.html#sthash.MT3sDoLJ.dpuf

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."

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Canada: Quebec to start reimbursing for 'revolutionary' Hepatitis C treatment

Quebec has decided to reimburse “revolutionary” drugs that can cure Hepatitis C, but only for the sickest patients at first.

According to the rules adopted by the Régie de l’assurance maladie du Québec, some Quebecers with the disease will have to wait three years before getting access to new treatments.

The measures concern two drugs called Harvoni and Holkira Pak that are supposed to cure the condition in 8-12 weeks.

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Area veteran can't get treatment for Hepatitis C

GREENCASTLE : Adam Shaffer, a disabled veteran with two tours in Iraq, discovered that the Department of Veterans Affairs has a cure for one of the things that ails him.

Only thing is: He can't get it.

"With Hepatitis C, the government doesn't have enough money to give veterans the pills," said the 30-year-old Shaffer. "They put you on a waiting list, and it's long. You can't get any treatment. It will kill you."

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2 new hepatitis C drugs to be available in November in Egypt

CAIRO: Minister of Health Adel al-Adawy announced that two new hepatitis C drugs, Harvoni and Viekira, are to be available at the hepatitis treatment centers by next November, youm7 reported Wednesday.

There are 2.3 million hepatitis C patients in Egypt, while 996,642 patients applied on the website of the National Committee for the Control of Viral Hepatitis to be treated by Sovaldi until last June, according to Adawy.

He added that 85,536 patients were provided with the treatment until the end of June.

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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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Ireland: Hepatitis C patients to finally start life-saving treatment

Nearly all 250 sufferers expected to recover after treatment costing up to €55,000 each 

Some 250 seriously ill patients with hepatitis C are to begin receiving a life-saving new treatment after a six-month delay caused by bureaucratic red tape.

The first group of patients with advanced liver disease who have been approved will be treated at one of 10 centres across the State in the coming weeks. Virtually all are expected to be “cured” of the disease following a 12-week programme, which is costing between €45,000 and €55,000 per patient.

Last month, doctors warned that patients were dying because of the failure of the Government to roll out a national treatment programme, even after negotiations with drug companies had ended. Other patients were paying privately for the treatment because of the absence of State support.

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Blue Cross Withholds Cure from Hepatitis C Patients, Lawsuit Claims

LOS ANGELES, May 15, 2015 /PRNewswire/ — Shernoff Bidart Echeverria Bentley LLP filed a lawsuit in Los Angeles Superior Court today accusing Blue Cross of withholding a cure for Hepatitis C based only upon profits, in violation of California law.

The plaintiff, Shima Andre, suffers from Hepatitis C, a contagious liver disease that can lead to complications including severe liver damage, infections, cirrhosis, liver cancer, and even death. But a new treatment is radically changing the lives of those living with Hepatitis C.  The treatment—Harvoni— was just approved by the FDA in 2014 and was even designated as a “breakthrough therapy” for its revolutionary ability to treat and cure Hepatitis C. In clinical trials, Harvoni cured Hepatitis C in 95-99% of patients within only twelve weeks.

But according to the lawsuit, Blue Cross has arbitrarily chosen to give the treatment only to those patients suffering from the worst stages of liver damage. Despite the opinions of other patients’ treating doctors,  they are told by Blue Cross that they must wait for the cure, suffer serious liver damage, and only then will they be eligible for Harvoni. No known medical study supports this decision—and no part of Shima’s insurance policy grants Blue Cross this arbitrary authority.

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UK: NHS denies lifesaving drug to 5,000 patients it gave infected blood: Sofosbuvir has been approved by regulators but victims are STILL waiting for treatment

• Thousands of victims were infected by hepatitis C through imported blood 
• Breakthrough drug Sofosbuvir was approved by regulator NICE in January 
• But NHS England is delaying treatment for patients until at least August 

Thousands of patients who contracted a deadly disease through contaminated blood in the biggest scandal in NHS history are being denied a lifesaving drug.

About 7,500 victims are known to have been infected with hepatitis C in the 1970s and 1980s through imported blood products taken from high-risk donors such as prostitutes and prisoners.

A breakthrough drug called Sofosbuvir was approved in January by drugs regulator NICE and patients were told they would have to wait until April to get the ten-week course of tablets, which costs £45,000. 

But NHS England has decided on a further delay until August to ensure all patients have equal access to treatment.

Read more: http://www.dailymail.co.uk/health/article-3075151/NHS-denies-lifesaving-drug-5-000-patients-gave-infected-blood-Sofosbuvir-approved-regulators-victims-waiting-treatment.html#ixzz3ZhNPqkvn

Egypt: Locally manufactured Sovaldi to be released soon

CAIRO: The Egyptian market will receive a new batch of the hepatitis C treatment medication Sovaldi next June after being manufactured locally, Youm 7 reported Sunday.

Pharmed Healthcare Executive Director, Mohamed Mabrouk, said that his firm will deliver 500,000 bottles after being manufactured with local chemical materials.

“This step will give the Egyptian market an unprecedented motive,” he said.

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Arkansas: State panel OKs more hepatitis-C drug buys

More teachers and state employees with hepatitis-C will be eligible for treatment with expensive drugs under changes adopted by a state board on Tuesday.

The changes approved by the State and Public School Life and Health Insurance Board broadened criteria for the treatment that the board set just over a month ago for coverage of the drugs, which can cost more than $86,000 for a 12-week course of treatment.

The changes will also allow most patients who meet the criteria to take a drug regimen that does not involve injections of interferon, which can cause flulike side effects.

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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. 

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Canada: Drug cure for hep C comes with $95,000 price for Windsor man

Thirty-three years after a van-motorcycle crash put Mike North in hospital for multiple surgeries, he is suffering the devastating health effects from the hepatitis C virus that snuck into his body via blood transfusions.

The virus has attacked his liver, which is now in the most advanced stage of cirrhosis, and he needs a transplant. But before the transplant he must take a recently approved drug that should cure him of hep C, so the virus won’t attack the new liver. Harvoni boasts a cure rate higher than 95 per cent. But there’s a catch: it costs $95,000 for a 12-week treatment, and North has almost no coverage.

“If I don’t get a liver, I’m done,” said North, 62, a former manager at several local automotive plants, who has some savings (including his share of the settlement paid out to victims of Canada’s tainted blood scandal), but only enough to fund his retirement. So his family and medical staff are scrambling to find a way to get him these $1,130 pills as quickly as they can.

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David E. Miller: New hepatitis C treatments save lives, reduce expensive complications

"If Illinois expands access to new hepatitis C medicines, it not only will save lives and relieve untold patient suffering, it dramatically will reduce long-term health care costs resulting from this awful disease."

After decades of research and clinical trials, we have new cures for hepatitis C, the most prevalent and deadliest blood-borne viral disease in the United States.

Until now, hepatitis C treatments have been long, painful and even life-threatening, with low cure rates of 40 to 65 percent. Consequently, up to 85 percent of patients discontinue treatment before they finish.

Still, the Illinois Department of Healthcare and Family Services set tight restrictions on innovative hepatitis C treatments. Only patients with the highest degree of liver damage who meet a set of 25 criteria can have access.

- See more at: http://www.sj-r.com/article/20150305/OPINION/150309693/2011/OPINION#sthash.e3ELmAZa.dpuf

Langford: Doctors prescribe, not insurance companies

"Our legislators have the opportunity this year to support legislation designed to address problems with excessive use of prior authorization and step therapy, that too often let patients in Florida slip through the cracks with no coverage for appropriate therapies."

More than 15 years ago, I was diagnosed with Hepatitis C. While the disease has created a number of challenges, one particularly frustrating and troublesome problem has been obtaining coverage for medications that my physicians have prescribed because I've been forced into “fail first,” or “step therapy,” protocols.

Fail first protocols are management processes used by health plans that require a patient to try the least expensive treatment to address a problem, despite what his or her physician recommends. Only after trying and failing on the least expensive option, and possibly additional treatments, can a patient receive coverage for the medication the physician originally prescribed.

In 1998, my physician advised me to try a recently approved Hepatitis C treatment, Ribavirin, meant to be taken in addition to Interferon. My insurance company required me to fail on Interferon by itself before I could get the superior combination of the two as prescribed by my doctor.

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