Hepatitis C drug costing VA, DoD millions

One of the costliest drugs on the market threatens the Veterans Affairs Department's health budget — to the point that VA, which added the medication to its formulary in April, provides it to only the sickest patients who need it.

But treating all of the 174,000 hepatitis C patients in the VA health system is cost-prohibitive. Even with the cost negotiated by VA with the company's maker, Gilead Sciences Inc. of Foster City, California — $594 per dose — treatment would run nearly $12 billion.

So VA has taken a conservative approach to providing the treatment, reserving Sovaldi and its competitor, Olysio, made by Janssen Therapeutics of Titusville, New Jersey (negotiated cost: $413 per pill), for those with advanced liver disease or needing a transplant.

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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

Benitec Advances Hepatitis C Clinical Trial

SYDNEY, Jan. 7, 2015 /PRNewswire/ -- Benitec Biopharma Limited (ASX: BLT, OTC: BTEBY) is pleased to advise that the third patient in its Phase I/IIa clinical trial of TT-034 for hepatitis C was dosed earlier today at the Duke Clinical Research Unit (USA). This is a significant step for this "first in man" study, and follows review of the collective data from the first two patients by the independent Data Safety Monitoring Board (DSMB). The DSMB determined that the patients from the first dosing cohort were clear of any significant treatment-related adverse events.

The newly dosed patient is the first to receive the increased dose of TT-034 (1.25 x 10^11 vg/kg, a concentration that is a half log higher than the doses administered in the first cohort). While TT-034 is designed as a potential "one-shot" cure for hepatitis C, the current dose is still below that expected to inhibit viral replication and data from the second dosing cohort are therefore expected to serve primarily as a further safety assessment.

As with previous patients, the newly dosed patient will be monitored for six weeks and results will be reviewed by the DSMB. Should the results indicate appropriate safety outcomes, the DSMB is expected to recommend that the remaining two patients in the second cohort be dosed. It is aimed to dose both at approximately the same time. The trial sites at Duke Clinical Research Unit and University of California San Diego have identified a number of patients who have passed initial screening who can be prepared in anticipation of this outcome.

About TT-034

TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a "triple therapy" even though it is a monotherapy, and minimizes the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells, it enters the nucleus and produces three separate short hairpin RNAs continuously for the lifetime of the cell. Thus TT-034 has the potential to not only treat the existing HCV infection, but also to guard against reinfection for months to years without the need to re-treat. TT-034 safety and efficacy has been tested extensively in pre-clinical in vivo studies with no adverse effects observed at therapeutic doses.

About Benitec Biopharma Limited

Benitec Biopharma Limited is an ASX-listed biotechnology company (ASX: BLT; OTC: BTEBY), which has developed a patented gene silencing technology called DNA-directed RNA interference (ddRNAi). ddRNAi has the potential to produce 'single-shot' treatments and even cures for a range of chronic and life- threatening human conditions. Based in Sydney, Australia, with labs in Hayward CA (USA) and collaborators and licensees around the world, the company is developing ddRNAi-based therapeutics for diseases including hepatitis C and B, drug resistant lung cancer and wet age-related macular degeneration. Benitec has licensed ddRNAi to other biopharmaceutical companies for human therapeutic applications including HIV/AIDS, Huntington's Disease, cancer, chronic neuropathic pain and retinitis pigmentosa. For more information visit www.benitec.com.  

For further information regarding Benitec and its activities, please contact the persons below, or visit the Benitec website at www.benitec.com.  

Company	Investor relations
Carl Stubbings Chief Business Officer Tel: +61 (2) 9555 6986 Email: cstubbings@benitec.com	Kyahn Williamson Buchan Consulting Tel: +61 (3) 9866 4722 Email: kwilliamson@buchanwe.com.au

SOURCE Benitec Biopharma Limited


RELATED LINKS
http://www.benitec.com

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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Spanish hepatitis C patients to march for access to expensive new drugs

Podemos leader asks sufferers to go with him to Brussels to explain their plight to MEPs 

Hepatitis C patients will march in Madrid on Saturday to demand access to expensive new drugs that the government only offers sparingly through the public health system.

“We will demand to be seen by [Prime Minister Mariano] Rajoy,” said Mario Cortés, president of the support group Plataforma de Afectados por la Hepatitis C, which is organizing the rally.

This group has been staging a sit-in at the capital’s 12 de Octubre hospital for the last 20 days, and is now ready to take its demands right to La Moncloa prime ministerial palace.

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Patients First: HCV and Depression —Alan Franciscus, Editor-in-Chief

People with hepatitis C face many challenges after being diagnosed.  These challenges can occur on a daily basis and seem to last from diagnosis until being cured.  These challenges can lead to increased anxiety and depression.  This article is about the many difficulties that people with hepatitis C face that can lead to depression, how to identify depression and some steps to deal with it. 

HCV and Depression
There are certain times during the hepatitis C journey that people may experience depression:

Diagnosis:  After a diagnosis of HCV, people are in shock, and many feelings may surface.  Some of the fears may include, but are not limited to:

• Becoming sick
• Feeling like you may infect someone else
• Suffering from hepatitis C 
• Being alone if friends and family turn away
• Loss of intimacy—both emotional and physical
• Being unable to start a family, and/or being unable to grow old with a family
• Facing death
• Losing income or not being able to support yourself or loved ones

The list is endless.   An additional issue is that now people are being denied access to treatment.  All of these matters can lead to anxiety and depression.  This time of year is even more difficult because some people experience additional holiday loneliness, isolation, and depression. 

Depression
Depression is a serious disease that affects about 1 in 4 American adults.  It can lead to death.  More importantly, it is a treatable illness.  It is not something that you can just snap out of in spite of what some people think.   Like hepatitis C, it is a silent disease and very stigmatized.  It is finally coming out of the shadows, and it can be successfully treated with counseling and medication.   

Warning Signs:  If you have thoughts of hurting yourself or others, this is an emergency that needs to be taken care of right away.  Call your doctor or nurse or one of the phone numbers listed at the end of this article.  People who work at crisis hotlines have been trained to help people who are in crisis mode. 

Signs and Symptoms of Depression

• Feeling sad, anxious or having an “empty” feeling
• Crying spells with no real explanation
• Feeling hopeless or pessimistic (gloomy or negative symptoms)
• Feeling helpless about life in general
• Not interested in family or social events, hobbies, sex or being with friends
• Constantly fatigued—tired all the time
• Cannot concentrate or make decisions
• Trouble with remembering things
• Having problems sleeping at night
• Losing weight, not eating, or eating too much and gaining weight
• Thinking about killing yourself or just even planning on killing yourself

Getting Help
There is help out there.  Think about talking to a professional.  Ask for help from your family, friends, and medical team.  If you cannot talk to family or friends, start with a support group.  This can be particularly useful if you are dealing with any issue related to hepatitis C. 

There are some general things that people can do to help conquer depression, but with severe depression, nothing replaces professional help.

Alcohol
Everyone with hepatitis C should stay away from alcohol, but if you are suffering from depression it is even more important.  Alcohol can also cause depression. 

Stress
Stress is a killer—that is a no-brainer.  There are many tips to reduce stress—exercise, finding balance, keeping a positive attitude, finding help, meditating, prayer, laughing, watching movies or any other pastime you find pleasurable.  Personally, when I get stressed out, I like to listen to one of my favorite comedians.  It always puts a smile on my face and sends me on my way to enjoy the rest of my day—at least when I have a light case of the blues.   

Realism
Try to get a realistic picture of your life and problems.  It sounds easier than it is but don’t dwell on the negative.  Find things that you enjoy and when you find yourself dwelling on the negative try turning it around and remember what it is positive about your life. 

Exercise
Walking, swimming, Qigong, running or almost any exercise can help to elevate the mood.  Think about joining a gym or a group exercise program.  Go slowly and if you have any physical problems get cleared by your medical provider.  Personally, I exercise every day to chase away the stress and blues. 

Balance
We live in a stressful world and trying to do everything can lead to stress, exhaustion, unrealistic expectations and depression.  Try to find balance – plan activities, build in down time and get plenty of rest. 

Keeping a Positive Attitude
A positive attitude will not cure depression, but it does offer hope for the future.  Remember, the way you feel now will not last forever. However, it is important to get a realistic picture of your physical and mental health.

These are all useful tips for less severe types of depression, but if you feel that you need more help, consider professional help. 

Medications
There are many medications—anti-anxiety and antidepressants—that can help.  Talk to a psychiatrist or your medical provider to find out if this would be a good fit for you.  Everyone is different, and every antidepressant works differently.  You and your medical provider may have to try more than one medication to find the one that works for you.  Most medicines have side effects, and all antidepressants have some side effects.  The most common side effects of antidepressants include headaches, nausea, jitters, nervousness and sexual side effects.  Some of the side effects may diminish over time.  Talk to your medical provider to make sure that the antidepressant is safe for the liver.

One of the best ways to fight depression is through knowledge and actions.  Learn as much about hepatitis C to reduce the fear of the unknown.  If you are depressed because you cannot get approved for a new treatment—check out Lucinda’s HealthWise article for tips to fight back and get approved for the new therapies.    We don’t want to harp on it too much, but get help for depression if you need it. 

Resources:

• Alcoholics Anonymous (AA)
  www.alcoholics-anonymous.org
  To find an AA group near you, look for “Alcoholics Anonymous” in any telephone directory or contact AA
• Hepatitis C Helpline
  877-HELP-4-HEP
  (877-435-7443)
  www.help4hep.org  
• National Institutes of Mental Health
  www.nimh.nih.gov/health/publications/depression
  /index.shtml
• National Suicide Prevention Lifeline, a 24/7 hotline for
  callers in the United States
  1-800-273 – TALK-and 1-800-SUICIDE
• Patient Assistance Programs
  http://www.hcvadvocate.org/hepatitis/factsheets_pdf
  /Patient_Assistance.pdf
  

http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#3

Lawmakers want investigation into VA’s botched treatment of Grand Junction veteran

DENVER — Rodger Holmes served his country in Vietnam.

After he came home to Grand Junction, his struggles with depression and alcoholism left him homeless but he entered treatment programs, worked his way back and spent the last years of his life serving his community, counseling other veterans facing demons he knew well.

He might still be doing so had the 64-year-old not gone to the VA Hospital in Grand Junction last summer to finally treat his Hepatitis C — had the hospital and the system of care he and veterans are supposedly entitled to not failed so spectacularly to serve him.

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