A $1,000-drug used to treat Hepatitis C was a hot-button topic at a California Senate committee hearing Wednesday.
"We are really concerned about the high cost of specialty drugs, which have just continued to increase year after year and are going to end up taking 50 percent of the budget of all of the pharmaceutical costs," Pharmacy and Adult and Family Medicine Executive Director at Kaiser Permanente Dr. Sameer Awsare said.
But drug prices were just one part of the bigger problem of rising healthcare costs. Speakers said that physician fees and hospital facility fees are also a major factor. The growing bill means that consumers, including people with employer-sponsored insurance, are being asked to shoulder more costs out of pocket. In fact, the Health Care Costs Institute released a new report this week finding that people with insurance through work paid 15 percent of their medical expenses out of pocket in 2013, up 6.9 percent year-over-year.
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Thursday, February 5, 2015
Canada: Endoscope didn't cause hepatitis C outbreak at Kitchener clinic
Investigators from Region of Waterloo Public Health are still trying to figure out why five patients who had colonoscopies at a Kitchener clinic on Christmas Eve in 2013 were infected with hepatitis C.
"We know that the endoscope that was used that day was not the cause. All of the clients had different endoscopes. So that wasn't what links those five patients together," said Dr. Liana Nolan, the medical officer of health for Waterloo Region, in a interview with Colin Butler on The Morning Edition Wednesday."This is strong evidence of patient to patient transmission of hepatitis C due to a lapse in infection prevention and control practices at the clinic," the report said.
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Photo gallery: Hepatitis C more curable than ever
New and costly drugs have revolutionized the treatment of hepatitis C. Kansas City Care Clinic (formerly the Kansas City Free Clinic) has been successfully treating patients, many of whom are uninsured. The clinic has also helped patients find financial assistance for the extremely costly medications.
Read the personal stories and see the photos here
Read the personal stories and see the photos here
Predictors of Treatment Response —Alan Franciscus, Editor-in-Chief
In the past, there were many factors that predicted successful treatment outcome. Today, that list is much longer and is somewhat dependent on the particular HCV inhibitor used to treat hepatitis C.
This article is about the negative predictors of treatment response—genotype, subtype, cirrhosis, prior treatment response and viral load.
Genotype:
The most dramatic current negative predictor of treatment response is genotype 3. The current standard of care for treating HCV genotype 3, a combination of sofosbuvir (Sovaldi) plus ribavirin for 24 weeks, has an overall cure rate of 93%. Among those in the group who had never been treated (treatment naïve), the cure rate was 93% for those without cirrhosis compared to 92% for those with cirrhosis. Among treatment experienced patients in this test group, the cure rate was 85% for those without cirrhosis compared to only 60% for those with cirrhosis. Future treatments are needed for people with genotype 3 that have higher cure rates with shorter treatment durations, and which work in cirrhotic patients who have not responded to prior treatment.
Subtype:
Subtype has long been known to affect treatment outcome. In regards to genotype 1, subtype 1a is generally harder to treat. If we look at VIEKIRA PAK to treat HCV genotype 1a without cirrhosis, adding ribavirin is indicated. There is no recommendation to add ribavirin to VIEKIRA PAK for treatment of genotype 1b without cirrhosis.
Cirrhosis:
People with cirrhosis have always been harder to cure than those without it, although now it is not as difficult as in the past. The recommended treatment duration for genotype 1a patients with cirrhosis is 24 weeks with VIEKIRA PAK plus ribavirin. There is a note that 12 weeks can be considered for some patients based on prior treatment history.
Treatment-Experienced:
Patients without cirrhosis can be treated with HARVONI for 12 weeks. Treatment experienced (but not cured) patients with cirrhosis can be harder to cure, so 24 weeks treatment with HARVONI is recommended.
HCV RNA or Viral Load:
In the Full Prescribing Information for HARVONI for genotype 1, there is a footnote about the recommended treatment duration saying that “HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.” This consideration is based on the ION-3 study of 123 patients with baseline viral loads under 6 million IU/mL who were treated for eight weeks. The cure rates were 97% (119 of 123 patients). This is only true with HARVONI. The viral load thresholds need to be studied in all of the newer therapies.
Even now, matching a person’s characteristics to the specifics of the HCV drugs can help cure most people. The future of hepatitis C treatment holds the promise that, when matched with all of a patient’s characteristics, new medicines or combinations of medications will be able to treat and cure everyone with HCV.
http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#4
This article is about the negative predictors of treatment response—genotype, subtype, cirrhosis, prior treatment response and viral load.
Genotype:
The most dramatic current negative predictor of treatment response is genotype 3. The current standard of care for treating HCV genotype 3, a combination of sofosbuvir (Sovaldi) plus ribavirin for 24 weeks, has an overall cure rate of 93%. Among those in the group who had never been treated (treatment naïve), the cure rate was 93% for those without cirrhosis compared to 92% for those with cirrhosis. Among treatment experienced patients in this test group, the cure rate was 85% for those without cirrhosis compared to only 60% for those with cirrhosis. Future treatments are needed for people with genotype 3 that have higher cure rates with shorter treatment durations, and which work in cirrhotic patients who have not responded to prior treatment.
Subtype:
Subtype has long been known to affect treatment outcome. In regards to genotype 1, subtype 1a is generally harder to treat. If we look at VIEKIRA PAK to treat HCV genotype 1a without cirrhosis, adding ribavirin is indicated. There is no recommendation to add ribavirin to VIEKIRA PAK for treatment of genotype 1b without cirrhosis.
Cirrhosis:
People with cirrhosis have always been harder to cure than those without it, although now it is not as difficult as in the past. The recommended treatment duration for genotype 1a patients with cirrhosis is 24 weeks with VIEKIRA PAK plus ribavirin. There is a note that 12 weeks can be considered for some patients based on prior treatment history.
Treatment-Experienced:
Patients without cirrhosis can be treated with HARVONI for 12 weeks. Treatment experienced (but not cured) patients with cirrhosis can be harder to cure, so 24 weeks treatment with HARVONI is recommended.
HCV RNA or Viral Load:
In the Full Prescribing Information for HARVONI for genotype 1, there is a footnote about the recommended treatment duration saying that “HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.” This consideration is based on the ION-3 study of 123 patients with baseline viral loads under 6 million IU/mL who were treated for eight weeks. The cure rates were 97% (119 of 123 patients). This is only true with HARVONI. The viral load thresholds need to be studied in all of the newer therapies.
Even now, matching a person’s characteristics to the specifics of the HCV drugs can help cure most people. The future of hepatitis C treatment holds the promise that, when matched with all of a patient’s characteristics, new medicines or combinations of medications will be able to treat and cure everyone with HCV.
http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#4
Wednesday, February 4, 2015
Pricing wars heat up over hepatitis C drugs
Announcing its first dividend, annual revenue that doubled the prior year's performance and a $15 billion buyback plan wasn't enough to buoy Gilead Sciences' shares when it dropped a bomb during its fourth-quarter earnings conference call: Discounts on the company's hepatitis C drugs this year will be 46 percent, way more than investors and analysts expected.
"That really escalated quickly," Brian Skorney, an analyst with Robert W. Baird, wrote in a note to clients Wednesday. The discount "is meaningfully worse than expectations" in the 25 to 30 percent range, and as a result, Skorney lowered his estimate for Gilead's hepatitis C revenue by 20 percent to $12.9 billion.
Gilead said part of its adjustment reflects a shift toward more patients who are covered by Medicaid and the Veterans Administration receiving the drugs at rebates of more than 50 percent.
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"That really escalated quickly," Brian Skorney, an analyst with Robert W. Baird, wrote in a note to clients Wednesday. The discount "is meaningfully worse than expectations" in the 25 to 30 percent range, and as a result, Skorney lowered his estimate for Gilead's hepatitis C revenue by 20 percent to $12.9 billion.
Gilead said part of its adjustment reflects a shift toward more patients who are covered by Medicaid and the Veterans Administration receiving the drugs at rebates of more than 50 percent.
Read more...
The Five: Fatigue —Alan Franciscus, Editor-in-Chief
- Fatigue or feeling tired is the most common symptom of hepatitis C. It is also the most common extrahepatic (occurring outside of the liver) condition of hepatitis C. It is also one of the most common side effects of HCV therapy. It can range from mild to moderate to so severe that it can affect almost every area of life.
- Causes: Fatigue can be caused by many factors besides hepatitis C. Be sure to talk with your medical provider before jumping to a conclusion that the cause is hepatitis C. Other factors that could be causing fatigue could be other extrahepatic manifestations of hepatitis C (thyroid problems, anemia, HCV treatment, depression, sleep problems, poor diet, lack of exercise, medications, alcohol use and so on).
- Self-help strategies: After you have ruled out any other causes with your medical providers there are many strategies to help improve your energy levels. We have an excellent Guide to Understanding and Managing Fatigue that can walk you through many self-help tips such as information on improving sleep, nutrition, exercise, meditation, complementary medicines and much more.
- HCV Treatment: Severe fatigue is one of the extrahepatic manifestations that can qualify someone for treatment. Curing hepatitis C can also cure fatigue, though fatigue can worsen temporarily during treatment. Be sure to talk with your medical provider about the fatigue you are experiencing and other symptoms. Make sure to document all symptoms in your medical records. For some people, it is hard to complain or even talk about their symptoms. It is critical, however, to make sure that you document your complaints. Medical records are important for treatment and disability records.
One of the best ways to gauge your level of energy or any other factor is to use a scale of 1 to 10 and keep a journal. Let’s say you have a wonderful day, full of energy, and you feel like your old self. That would be a fatigue scale of 1. Now let’s say you have a day where you are feeling sluggish but can still work. Maybe that is a fatigue day of 4. Then there are days when you can hardly get out of bed. Let’s say that is a 10 on the scale of fatigue. I think you get the idea. Log it into a journal every day. Take a copy with you to your medical provider and have them put it in your medical records.
- Support: One way to fight fatigue is to join a support group (either on-line or in-person) and talk with others who are experiencing fatigue. Try to remember to take care of yourself and to practice self-care tips to keep you well and healthy.
http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#3
Cigna Signs Agreement with Gilead to Improve Affordability of Hepatitis C Treatment for Customers and Clients
- Improving customers' health at the most competitive pricing benefits all stakeholders
- Harvoni is the only Cigna preferred hepatitis C drug treatment for genotype 1
BLOOMFIELD, Conn., February 04, 2015 - Cigna (NYSE: CI) has reached an agreement with Gilead Sciences, Inc. (NASDAQ: GILD) to include Harvoni as the only preferred brand prescription drug treatment for customers with hepatitis C genotype 1, the most common form of the disease in the United States. Cigna clients and customers benefit from obtaining breakthrough clinical cure rates for hepatitis C while significantly lowering the cost of drug treatment. “Cigna is committed to offering customers and clients the most affordable solutions that deliver improved health while containing both drug and total medical costs. We have selected Gilead’s Harvoni as the preferred drug treatment for hepatitis C genotype 1. Harvoni’s clinical effectiveness, safety and convenience, coupled with our innovative customer counseling, will deliver material health and financial outcomes for our customers and clients,” said Jon Maesner, chief pharmacy officer for Cigna Pharmacy Management.
Clinical studies have shown that 94% to 99% of individuals with genotype 1 hepatitis C treated with Harvoni achieve a sustained virologic response (SVR). Customers who have an SVR when tested 12 weeks after the completion of treatment are considered cured.
“Cigna continues to invest in analyzing real-world SVR outcomes with the leading hepatitis C treatments across the genotypes as we believe creating alignment around clinical and financial outcomes drives more affordable access to essential medications,” added Maesner. The agreement includes development of an innovative outcomes incentive alignment based on actual SVR results across Cigna's customer population.
Cigna is continuing to:
- Offer therapy support management through Cigna Specialty Pharmacy Services to every customer undergoing hepatitis C treatment.
- Conduct real-world outcomes assessments on existing and new hepatitis C drug treatments, including Harvoni, to further develop outcome-based strategies.
Terms of the agreement are not disclosed.
Read complete press release here
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