Georgia: New Hepatitis C medicine to enter Georgian market in April

Hepatitis C could soon be "completely eliminated” in Georgia, says the country’s Health Minister.


Georgia is preparing to sign a trilateral agreement that will allow a new medicine to be introduced to the market, which aimed to completely eradicate the infectious disease in Georgia.


Today Georgia’s Minister of Health David Sergeenko held a press conference and said the contract about the new Hepatitis C medication would be signed in April between the Government of Georgia, the United States Disease Control Centre and American biotechnology company Gilead Sciences.

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Worldwide treatment of hepatitis C could be within sight at the right cost

The FINANCIAL -- Lowering the cost of hepatitis C drugs is possible and key to achieving global access to treatment, according to new research by the University of Liverpool and Imperial College London. 

There are an estimated 185 million people infected with the hepatitis C virus worldwide and 160,000 in Britain. Currently there is no vaccine and, if left untreated, infection can lead to cirrhosis and liver cancer, causing up to 500,000 related deaths globally per year.

Hepatitis C is particularly problematic in low to middle income countries; for example 12 million people are infected in Egypt.

A new and effective generation of direct-acting antiviral drugs (DAAs) has been developed to treat hepatitis C. However, at present these drugs are highly expensive. A 12-week course of the new drug sofosbuvir in the US is priced at as much as $84,000 per person and £55,440 in the UK. The NHS has recently delayed introduction of sofosbuvir due to its high price.

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Hepatitis C drug a costly but promising cure

Sallie Wickens’ life followed a death-defying narrative that traced the medical arc of hepatitis C:

A blood-transfusion infection after a car accident in 1959, when she was 5; a positive test for the virus when she was 30; 10 years of deteriorating health; debilitating interferon drug treatments that didn’t work; a liver so damaged she needed a transplant.

And then, her doctor, hepatologist Laura Alba, walked into an exam room last month at St. Luke’s Hospital and gave Wickens, 60, a big smile.

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Spain: Hepatitis C patient feels like a new man

ISIDORO ESCAMILLA was tired of feeling like he always had the flu, an effect of suffering from Hepatitis C that was diagnosed in 2007.

A drug called Sovaldi was hailed as something that would completely change things for him and has been prescribed in Spain for 18 months. Unfortunately, until January 2015 it was not available to patients in Andalucia, where Escamilla lives.

He fought to get the drug to Andalucia, and even tweeted Susana Diaz, president of the Junta de Andalucia regional government.

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Portugal: Hepatitis C treatment 100% subsidised

Innovative drug, Sofosbuvir, to treat hepatitis C is 100% subsidised in Portugal since Tuesday evening and will be given to all patients who need it.

Eurico Castro Alves was speaking at the end of a meeting with the administrators of all hospital that treat hepatitis C in Portugal, Infarmed and the secretary of state of health.

Alves said that an agreement had been signed with the laboratory that makes Sofosbuvir and the drug is now 100% state subsidised.

The Infarmed chairman said that all patients who needed the treatment would receive the drug and added that there are currently 602 receiving Sofosbuvir.

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Portugal: Portugal agrees to treat 13,000 hepatitis C patients

LISBON, Feb. 6 (Xinhua) -- The Portuguese government has agreed to treat up to 13,000 people infected with hepatitis C in the next three years, Portuguese Minister of Health Paulo Macedo said on Friday.

"We will be able to treat more sufferers in a fairer way. We will open way to initiate the eradication, the elimination of the disease," he told a press conference.

He said that the government would pay every treatment undertaken by sufferers of hepatitis C.

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How Hepatitis C Is Shining A Light On Critical Gaps In Payment Reform

In this blog post, we consider alternative payment policies that could help to ensure that—despite their potentially high cost—breakthrough treatments are consistently delivering value to patients and that the health care system is addressing inefficiencies in the delivery and total costs of care.

Paying for Value and Outcomes: Alternative Provider Payment Models
Over the last several decades, payers and providers have taken significant steps to move coverage and reimbursement from fee-for-service (FFS) payments that incentivize higher volume and intensity to a focus on achieving better results and lower overall costs for patients. Such payment reforms have important implications for breakthrough treatments, as they allow treatment access while also ensuring care coordination and more efficient total spending.

Paying for Value and Outcomes: Outcomes-based Reimbursement
A further extension of payment reforms that shift from volume and intensity to value is tying payments for the treatment itself to outcomes or other measures of performance. Outcomes-based contracting, in which manufacturers share the risk of a treatment outcome, could help alleviate concerns that high-cost treatments actually lead to patient improvement or cures in practice. At their most basic, outcomes-based reimbursement agreements establish defined payment for defined outcomes: a manufacturer shares in the cost of failure in practice through larger rebates, discounts, or refunds if a product does not achieve the performance or outcomes goals agreed to by the payer.

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Spain vows hepatitis C action after calls for new drugs

Madrid (AFP) - Spain's government Monday promised new measures to fight hepatitis C, following protests by patients who complained authorities were denying them the latest drugs to treat the deadly liver disease.

A new committee will draw up a proposal within three weeks of examining the extent of the illness and clinical criteria, aiming to "include newly authorised drugs" in treatment plans, the health ministry said in a statement.

But it did not specify whether it would widen access to the latest generation of hepatitis drugs to more patients as campaigners in Spain and other countries are demanding.

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Australia: The miracle cure with a billion-dollar price tag

It's been hailed as a miracle cure for hepatitis C – but comes with a billion-dollar price tag.

The Commonwealth government is under pressure to subsidise Sovaldi, produced by drug company Gilead, that has been approved by the Therapeutic Goods Administration but has been rejected for listing on the Pharmaceutical Benefits Scheme on value-for-money grounds.

The Pharmaceutical Benefits Advisory Committee, the independent expert body that decides which drugs should be subsidised, will consider a second application to list the drug at its March meeting, along with applications to list three other new hepatitis treatments.

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Resolved For 2015: No More Hepatitis C

As we enter 2015, nonprofit organizations that specialize in health advocacy start to compile lists of ambitious resolutions for the New Year. They pledge to spread the word more widely than ever about a particular cause, to exert influence over lawmakers, and to enlist more scientists, advocates and donors in the latest public health crusade.

And I, as executive director of just such a nonprofit, could do the same. I could give you a rundown on our own resolutions to end the infectious disease known as hepatitis C.

Instead, I'm going to be really presumptuous. I'm going to take the liberty of making resolutions on behalf of others. I'll spell out the vows that I believe all the key stakeholders in the fight against hepatitis C should follow in the year ahead.

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Hepatitis C Drug Discount Deals Still Miss Many Patients

Of the estimated three million Americans estimated to have Hepatitis C, about one-third are covered by Medicaid, according to industry reports. About 70 percent of Medicaid recipients are covered by managed care plans, according to Medicaid Health Plans of America, a trade group representing private health plans that contract with health insurance programs for the poor to administer their medical benefits.

Jeff Myers, chief executive officer for Medicaid Health Plans of America called the CVS Health and Express Scripts deals a “fantastic first step in bringing pricing rationality for this population.”

“But unfortunately the prices we’re starting from are at such a ridiculously high level because of the pharmaceutical companies’ pricing model that states still will find it difficult to manage these treatment costs,” Myers said in a statement to Forbes.

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HealthWise: Denied Hepatitis C Treatment? Here is How to Fight Back, by Lucinda K. Porter, RN

Elizabeth Faraone was diagnosed with chronic hepatitis C virus (HCV) in 2001. She is 53 years old and for the past 20 years, she has been battling chronic fatigue and body aches that are increasing in severity. She couldn’t take interferon because of another chronic condition, so when Harvoni was approved by the FDA in October, she called her gastroenterologist. Elizabeth is on Medicaid. Like many patients, she was denied coverage for treatment. However, Elizabeth didn’t take “no” for an answer, and she was able to get Harvoni.

How did Elizabeth do it? First, she found a doctor who was willing to fight for her. She advises, “If a doctor tells you that your medical insurance won't cover the cost of the medicine and he/she refuses to proceed further, tell your doctor that you can walk him/her through the process of getting the medicine. If he/she still refuses to help, find another doctor.” Elizabeth’s doctor “believes it is a medical necessity for all HCV patients to get treatment with the new safe and effective medicines.”

Elizabeth’s doctor sounds like a saint, but actually, he is following the HCV guidelines recommended by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). The guidelines state, “Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non–liver-related comorbid conditions.”

The recommendations to treat HCV patients are clear. However, many insurance companies and Medicaid programs are denying HCV treatment except for those who have stage 3 or 4 fibrosis/cirrhosis of the liver. The State of Connecticut’s Medicaid program is only covering cirrhotic patients. I believe they are doing this because they have selectively chosen to follow this recommendation in the HCV guidelines: “Urgent initiation of treatment is recommended for some patients, such as those with advanced fibrosis or compensated cirrhosis.”

Can you imagine if insurers decided to withhold treatment to diabetics and wait until patients were blind or lost a few toes before they’d cover treatment? This is basically what’s happening, because waiting until someone has cirrhosis is too late to prevent cirrhosis. Cirrhosis is a serious disease, and usually not reversible. Even if the person clears HCV, the insurer now has to take care of someone who has cirrhosis.

How did Elizabeth get Harvoni? She used Gilead Sciences’ prescription assistance program, Support Path (855-769-7284 www.mysupportpath.com). If you have any questions about Harvoni or Sovaldi, start with Support Path. At the risk of sounding like an infomercial, here is what Support Path offers:

 

Help with insurance issues. If you want to know if your insurance plan will cover Harvoni or Sovaldi, call Support Path. They will verify your coverage or tell you if you can expect a denial.

 

Help with denials. If your insurance refuses to pay for your treatment, Support Path will help you with the process of trying to secure low-cost medication. They may refer you to a patient assistance program such as the Patient Access Network Foundation www.panfoundation.org, which provides:

• Assistance with co-payments, often bringing down the cost to $5 a month
• Tips and tools to help you through treatment
• Nursing support for patients

There is also help for Canadians with hepatitis C. Gilead’s Momentum Support Program provides support services for patients via their healthcare providers, along with financial assistance for eligible patients who need help paying for out-of-pocket medication costs. For Harvoni or Sovaldi you need a diagnosis, a prescription, and last year's tax assessment to get assistance. For more information, call (855) 447-7977.

Bobby* has lived with chronic hepatitis C virus (HCV) infection for decades. In 2012, he underwent 24 weeks of triple-therapy with Incivek, peginterferon, and ribavirin. He made it through the challenging regimen, enduring debilitating side effects, but was not cured. When the new HCV medication Harvoni was approved, Bobby talked to his doctor about it. He was denied treatment because his managed care system was only treating those with stage 3 or 4 fibrosis (stage 4 is cirrhosis). Bobby fought back and won. He pointed out that his liver biopsy was three years old, and that his platelets were low. Bobby told his doctor that if he was eligible to be treated in 2012, then he should be treated now. His doctor relented.

Not everyone has a success story. Cindy* has lived with hepatitis C for at least 30 years. She was able to manage the symptoms, but two years ago, intense pain and nausea kept Cindy from sleeping. She was diagnosed with cirrhosis. Her doctor prescribed medication for the pain and nausea, but the side effects were too strong. Cindy said, “It was so strong, you could prop me up in a corner and I would drool.” Desperation drove her to self-medicate with a small amount of marijuana. She never dreamed that this choice, which seemed much more sensible than the pain medication, would interfere with her ability to get access to hepatitis C treatment. Cindy’s health insurance is through the state of Pennsylvania. She was denied treatment when marijuana turned up in the toxicology screen.

Cindy is the victim of injustice. Pennsylvania’s Medicaid program does not require drug and alcohol screening for access to medications for other diseases such as anemia, migraines, or type 2 diabetes. Why this one? There are a number of flimsy explanations:

• HCV is associated with drug use, and it is easy to target drug users (No one in power is going to come to their defense)
• This is leftover from the interferon days when there were concerns about offering a treatment that had severe neuropsychiatric side effects 
• Payers are doing anything they can to restrict access so they can save money

Cindy has not fought back, and remains untreated. However, she could call Support Path and see if she could get coverage. If not, she may be forced to decide between marijuana or six months of pain in order to meet the insurance requirements.

Most of the patients who go through this process are able to get their medications. It takes patience. It can be all too easy to get angry and give up, but you end up hurting yourself. Get support, and never give up. Hold on to this truth: You are worth fighting for.  

Note:  This article went to press prior to the anticipated approval of AbbVie's hepatitis C drugs. The intention of this article is to provide tools to overcome obstacles to hepatitis C treatment, not to promote a specific hepatitis C drug. AbbVie’s patient assistance program is https://www.viekira.com/ 1-844-2proCeed

 *Name changed to protect identities 

Additional Resources

• Help 4 Hep 877-HELP-4-HEP (877-435-7443)
• Hep Forum
  http://forums.hepmag.com   
• Recommendations for Testing, Managing, and Treating Hepatitis C - www.hcvguidelines.org   

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com

http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#4