Iran: Hepatitis C drug to be released

TEHRAN, Sep. 08 (MNA) – Deputy health minister has reported on the entry of home-made Hepatitis C drug to the country’s pharmaceutical market next week noting that it has been produced by Iranian knowledge-based companies.

“The Sofosbuvir drug is used to treat hepatitis C cases; previously it was imported from other countries and priced at $100 per tablet but the indigenous version will be available at the price of 10 dollars per tablet,” said Reza Malekzadeh at a press conference on knowledge-based companies reminding that, “in terms of quality, this drug fully complies with foreign ones and there is no difference in terms of efficiency or treatment of the disease.”

He also reported the production of two other combination drugs to treat hepatitis C in the country adding that they are currently at laboratory stage and will soon be released. “There are now drugs that can treat hepatitis C and there exists the possibility of eradication of the hepatitis C virus in the country in near future; hepatitis C has a three-month course of treatment and patients should take one tablet per day for full treatment,” added Malekzadeh.

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A Time to Cure: The Growing Case for New Hepatitis C Treatments

One out of every 100 Americans is living with a deadly and communicable virus, yet most can't access the cure which will save their lives and halt the disease's lethal trajectory.

Hepatitis C now kills more Americans each year than HIV/AIDS and is 10 times more infectious. It has become a leading cause of liver failure and liver cancer -- the fastest-rising cause of all cancer-related deaths. For too long this blood-borne virus has silently ravaged communities across the country, often going unnoticed and untreated until it was too late. Until 2013, the only treatments for hepatitis C were painful and effective only half the time, leaving many patients with nowhere to turn, despite their diagnosis.

But now the tide is turning. Multiple treatments for hepatitis C currently offer cure rates of near 100 percent with minimal side effects. Now some of the biggest obstacles facing hepatitis C patients are health insurers.

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Gilead Limits Enrollment in its Hep C Patient Program to Pressure Insurers

In a bid to push back against payers, Gilead Sciences GILD -0.71% is limiting enrollment to its patient assistance program for hepatitis C drugs, which helps people obtain the Sovaldi and Harvoni treatments when they lack sufficient insurance coverage or the financial wherewithal to get the medicines otherwise.

The drug maker is taking this step after finding that some payers, despite receiving discounts in recent months, have continued to restrict patient access to its hepatitis C medicines. As a result, Gilead has been picking up the cost of the medicines for more people it would like seeking patient assistance, according to a July 1 letter sent to patient groups and community health providers, among others.

A Gilead spokeswoman declined to say how many people are enrolled in its Support Path assistance program, how many may be affected by the change or provide actions taken by specific payers.

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UK: NHS accused of delaying access to 'highly tolerable' hepatitis C drugs over cost concerns

The NHS has been accused by leading health charities of attempting to “severely limit” the introduction of new drugs to treat hepatitis C because they are too expensive – despite the cost of them being cleared by officials.

The organisations have called on the Health Secretary to intervene, saying that NHS England has made a series of “unprecedented requests” for patients’ access to new drugs to be delayed because of the price.

Yet Nice has approved the drugs as “cost-effective”, leading to a plea from 14 organisations and senior doctors including the Hepatitis C Trust, the National Aids Trust and The Haemophilia Society to Jeremy Hunt.

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UK: NHS England sets up new £190m hep C fund

NHS England is stumping up £190m to pay for new hepatitis C treatments from AbbVie and Gilead that are yet to receive full funding from the country's health service.

 
The NHS's main commissioning body said that the existing budget for these drugs would be increased to £190m - up from the £40m budget that began last year.

This is the NHS's single largest investment in new treatments this year (except for the £280m Cancer Drugs Fund), but comes after a long delay for this extra funding stream.

The money will go to the roughly 3,500 hepatitis C patients in England and Wales with cirrhosis of the liver, and will gain access by the end of this year to AbbVie's Viekirax, a three-drug combination therapy for the disease, and Exviera (dasabuvir), as well as Gilead's hep C pills Sovaldi and Harvoni.

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The cost of curing hepatitis C

Eradicating hepatitis C
Gilead has said it would like to see the eradication of hepatitis C within 10 to 15 years and with the development of such a cure, experts say it is biologically feasible, at least in theory.

But in practice, many people don’t even know they are infected and more needs to be done to test for the virus and prevent transmission in the first place.

“This is a really historic point in time – any time you make such dramatic leaps in the effectiveness of treatment, it really raises the visibility of the problem,” said WHO’s Wiktor. “But we really need to scale up testing and get the whole health system trained on how to deliver these drugs, how to evaluate patients and how to use these drugs. That’s what we’re trying to work on, but a lot has to happen and it’s not just about reducing the price of the drugs.”

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As Minnesota insurers limit access to hepatitis C drugs, patients chafe

Kelly Krodel thought a miracle had arrived just in time — in a drug that could eliminate the hepatitis C infection she had carried for three decades before it started to wreck her liver.

Turns out, she’s going to have to live with the virus a bit longer. As long as the South St. Paul woman is reasonably healthy, her health insurance won’t pay the drug’s five- or even six-figure cost.

“Now there’s a cure and I can’t even touch it,” she said. “It makes you so angry.”

Krodel is one of a growing number of hepatitis C patients in Minnesota caught in a bind between the exorbitant cost of the year-old medications — Harvoni, Sovaldi and Viekira Pak — and the tight restrictions insurers have used to prevent the drugs from busting their budgets.

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Consumers Sue Anthem for Denying Coverage for a Gilead Hepatitis C Drug

The controversy over the new crop of hepatitis C treatments has taken yet another turn as consumers are starting to file lawsuits against insurers that deny them access to the medicines. Over the past two weeks, two different women alleged that Anthem Blue Cross refused to pay for the Harvoni treatment sold by Gilead Sciences GILD -1.74% because it was not deemed “medically necessary.”

The issue emerges after more than a year of debate over the cost of the medicines and complaints by public and private payers that the treatments have become budget busters. The new hepatitis C treatments, which are sold by Gilead Science and AbbVie, cure more than 90% of those infected and, in the U.S., cost from $63,000 to $94,500, depending upon the drug and regimen, before any discounts.

In response, drug makers have been pressured to offer discounts and some state Medicaid programs, for instance, set restrictions before providing coverage to some hepatitis C patients. By setting restrictions, payers hope to limit the number of patients for whom coverage is provided. And this is the tack that Anthem Blue Cross has pursued, according to court documents.

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Covered California Votes To Cap What Patients Pay For Pricey Drugs

"Starting in 2016, most people will only have to pay a maximum of $150 or $250 per prescription, per month. These caps are for Covered California's so-called silver and platinum plans. Bronze plans will have caps of $500."

In recent years, expensive specialty medicines used to treat cancer and chronic illnesses have forced some very ill Americans to choose between getting proper treatment and paying their rent.

To ease the financial burden, the California agency that governs the state's Obamacare plans issued landmark rules Thursday that will put a lid on the amount anyone enrolled in one of those plans can be charged each month for high-end medicine.

The agency says its rules, set to take effect in 2016, "strike a balance between ensuring Covered California consumers can afford the medication they need to treat chronic and life-threatening conditions while keeping premiums affordable for all."

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Australia: 'Like night and day' – calls for federal government to approve new Hep C drugs

Advocates in Canberra have called on the government to urgently subsidise new, advanced treatments for hepatitis C, saying each month they delay about 50 people die from the condition.

The Pharmaceutical Benefits Advisory Committee recommended on April 24 that three new antiviral medications, designed to treat hepatitis C, be considered for addition to the Pharmaceutical Benefits Scheme.

Canberra Alliance for Harm Minimisation and Advocacy manager Sione Crawford, who lives with hepatitis C, said the difference between the new and old drugs was like "night and day".

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Canada-Ontario decision to cover costly hepatitis C drug a lifesaver, doctor says

Ottawa liver specialist Dr. Curtis Cooper is calling Ontario’s decision to pay for new treatments that can cure hepatitis C a “landmark event” that will change the lives of thousands of people with the disease.

Cooper, director of The Ottawa Hospital and Regional Hepatitis Program, sees thousands of hepatitis C patients, many of whom will benefit from the new drug therapy now that it is covered by the province.

“This is going to mean the difference between health or illness and death,” for many patients, he said.

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Advocates Urge Easier Access To Expensive Drug For Medicaid Patients

Advocates for those living with Hepatitis C are urging the state Department of Social Services to ease new criteria patients must meet in order to have an expensive medication covered by Medicaid.

DSS has issued a bulletin to medical care providers, notifying them that patients with Hepatitis C who are enrolled in HUSKY A, HUSKY C or HUSKY D — parts of the state’s Medicaid program — must have “prior authorization” in order for prescriptions for the medication Sovaldi to be covered.

Prior authorization typically is required by insurers when they want to make sure certain prescription drugs are appropriately used. In essence, it requires enrollees to meet a higher threshold of criteria before insurers will agree to cover the medication’s expense.

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Georgia refuses Hep-C cure for poz guys

News in gay Atlanta of a drug that can eradicate previously incurable Hepatitis-C in 99 percent of cases was tainted last week by the state picking and choosing who can get it, excluding thousands of HIV-positive patients. It’s renewed a clarion call by activists to expand Medicaid.

The 12-week drug regimen known as V-Pak works, but it’s expensive – as much as $80,000 per patient. The National Alliance of State and Territorial AIDS Directors, which includes Georgia, negotiated a discount to about half price, but each state must decide whether or not to offer it under various programs.

In Georgia, that meant Hepatitis C patients under Medicaid will get V-Pak. But HIV-positive people with Hep C on ADAP, the HIV prescription assistance program, can’t. State agencies say they’re hamstrung by the cost to offer life-saving treatment to some and deny it to others, according to WABE.

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Canada: Vancouver man denied access to lifesaving new Hepatitis C drugs

A resident of Vancouver’s Downtown Eastside is speaking out about the cost of treatments for Hepatitis C. Brody Williams says the only effective options left cost close to $100,000.

Brody Williams has battled the disease for years, undergoing numerous treatments. He’s one of 200,000 Canadians struggling with the virus.

But Williams isn’t getting the drugs. They come with a price tag of $75,000 – $100,000 for a course, and neither the federal Ministry of Indian Affairs, nor B.C.’s medical system will pay because he’s had four different drug treatment protocols already.

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Canada: Hepatitis C treatments are 'history in the making' at a high cost

BillyBob McPherson lived on Ottawa’s streets as a young teenager before “running away with the carnival.” The 55-year-old doesn’t know exactly when during his colourful life he contracted hepatitis C — he thinks it might have been in Texas in the 1980s where he had surgery and blood transfusions while working as a carny.

But without treatment, he believes, the disease would have ended his life.

Today, he is disease free, a living testament to the wonders of new drugs developed to cure the liver disease with few or no side effects. But he is also an example of the painful realities of the new treatments.

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