Curing the Hepatitis C Virus in the Veteran population

by

Hepatitis C Virus (HCV) is the leading cause of mortality among all causes of hepatitis in the United States (US). It is estimated that 3-4 million people in the US are infected with HCV, with a prevalence of about 1.8% of the general population compared to 5.4% in the Veteran population. Veterans born between 1945-1965 and those in the Vietnam war were at higher risk for HCV due to blood products and the use of air jet guns for mass immunization. About ~175,000 Veterans in 2013 had documented HCV, and is likely underestimated  due to marginalized patients.

Prior to 2012, treatment of HCV was limited to combination therapy with pegylated-interferon and ribavirin, which created several adverse effects. With the introduction of Direct Acting Antivirals (DAAs) to the drug market in 2013, we now have the ability to cure HCV with little to no side effects. These medications inhibit various stages of the virus life cycle, leaving the virus undetectable in the body. Gilead Sciences, Inc., is the pharmaceutical company in in charge of producing most of these novel medications. Some argue that the majority of people with HCV do not require treatment because they can remain in a chronically infected compensated state. The extremely high morbidity and mortality associated with the complications of HCV is reason alone to treat all patients.

Given that the Veterans Health Administration (VHA) is the “largest integrated healthcare system” with the highest proportion of HCV infected individuals, they must create an efficient process for identifying and treating those with HCV by 2017.  The VHA should also create a multidisciplinary team at each Veterans Affairs (VA) consisting of physicians, social workers, hepatologists, midlevel providers, and case managers who follow patients with HCV. The hepatology specialist should educate primary medical providers and the team about initiation and monitoring of HCV treatment for those who require it most. Lastly, while cost is the major barrier to treatment, policy makers must work with Gildead Science to close the gap between the marketing and production drug price. Let’s make it a priority to start taking care of those who took care of us.

Advertisements

11 Responses to “Curing the Hepatitis C Virus in the Veteran population”

  1. atfoxblog Says:

    Thank you for your blog highlighting this common infectious disease that disproportionately affects veterans. The new drug regimens are significantly less toxic than the ribavirin and pegylated interferon that were previously used. However, the costs are staggering when considering the burden of disease. Three million treated at $84K per treatment is 252 billion dollars and 175,000 veterans treated at $84k
    per treatment is 14.7 billion dollars. The total VA budget for 2017 is 182.3 billion dollars which means that treatment for all Hep C patients would take 8% of the budget.

    As you noted in the blog, there is a huge gap between production costs and marketing prices especially in the U.S., Canada, and Australia. However, Egypt, which has the highest HCV prevalence(14.7% of adult population) in the world (WHO Data), is getting a significant discount on the drug. The Egyptian government in conjunction with the CDC is hoping to initiate a mass treatment campaign to combat the HCV epidemic that started due to mass treatment campaign for schistosomiasis due to inadequately sterilized glass syringes and needles. Gilead is providing the drug for approximately $900 per treatment course, about 1% of the cost in the U.S.

    I am in full support of assisting Egypt with management of HCV as they see approximately 160,000 new cases yearly. However, I don’t understand why a similar discount is not offered to the VA and other clinics who manage uninsured, underinsured and marginalized populations. I understand that Gilead is a business and they have to recoup all the costs that went in to developing and testing the medications. Like you, I feel that they can recoup costs and make a profit without such a substantial gap between production cost and medication cost to the public. I applaud you for encouraging policy makers to work with Gilead to close this gap.

    http://esofosbuvir.com/harvoni-cost-in-usa-canada-europe-egypt-india/

    http://www.reuters.com/article/us-hepatitis-egypt-gilead-sciences-idUSBREA2K1VF20140321

  2. atfoxblog Says:

    Thank you for your blog highlighting this common infectious disease that disproportionately affects veterans. The new drug regimens are significantly less toxic than the ribavirin and pegylated interferon that were previously used. However, the costs are staggering when considering the burden of disease. Three million treated at $84K per treatment is 252 billion dollars and 175,000 veterans treated at $84k
    per treatment is 14.7 billion dollars. The total VA budget for 2017 is 182.3 billion dollars which means that treatment for all Hep C patients would take 8% of the budget.

    As you noted in the blog, there is a huge gap between production costs and marketing prices especially in the U.S., Canada, and Australia. However, Egypt, which has the highest HCV prevalence(14.7% of adult population) in the world (WHO Data), is getting a significant discount on the drug. The Egyptian government in conjunction with the CDC is hoping to initiate a mass treatment campaign to combat the HCV epidemic that started due to mass treatment campaign for schistosomiasis due to inadequately sterilized glass syringes and needles. Gilead is providing the drug for approximately $900 per treatment course, about 1% of the cost in the U.S.

    I am in full support of assisting Egypt with management of HCV as they see approximately 160,000 new cases yearly. However, I don’t understand why a similar discount is not offered to the VA and other clinics who manage uninsured, underinsured and marginalized populations. I understand that Gilead is a business and they have to recoup all the costs that went in to developing and testing the medications. Like you, I feel that they can recoup costs and make a profit without such a substantial gap between production cost and medication cost to the public. I applaud you for encouraging policy makers to work with Gilead to close this gap.

  3. atfoxblog Says:

    An interesting link:

    http://esofosbuvir.com/harvoni-cost-in-usa-canada-europe-egypt-india/

  4. atfoxblog Says:

    Another interesting link:

    http://www.reuters.com/article/us-hepatitis-egypt-gilead-sciences-idUSBREA2K1VF20140321

  5. shinsukemuto Says:

    It is very interesting because I didn’t know that so many veterans are unfairly suffering HCV infection. As you pointed out, DAAs dramatically changed the treatment of HCV. Now it is very effective, but so expensive. As you and atfoxblog mentioned,I agree with that Gilead should close the gap between production cost and medication cost to the public.

    However, from my experience as management consultant who served for pharmaceutical companies, the companies invested huge money in drug investment and its success rate to go to market is so tiny.

    Therefore, it is very little chance for them to discount the drug in the U.S. from their own initiative. Your blog is well written and logical. I hope your blog will be shared and give them pressure from public side. Media, patients and doctors should go together to move the company.

    • atfoxblog Says:

      I agree that pharmaceutical companies invest significant money and time in the research and development of medications. They also assume all the risk. It takes years for a drug to go from initial development through clinical trials and FDA approval to reach the market. Many drugs never make it that far. However, Gilead is not losing money and their profit margin in 2015 was in the billions of dollars.

      Gilead fully admits that research and development costs played no role in their pricing policy for the HCV medications. A quote from a research Bloomberg Article (link below) states “Gilead said it didn’t consider research and development expenses in pricing Sovaldi or Harvoni. Instead, it examines prices in “the existing market that we are entering,” spokeswoman Michele Rest said.” Gilead intentionally pushed the pricing envelope on the HCV medications to see what they could get away with, what the market would tolerate, and what insurance companies were willing to pay. They were well aware that they were ‘courting controversy’ and that there would be backlash. Yet, they pushed ahead to set a precedent for future drugs that they would be marketing.

      http://www.bloomberg.com/news/articles/2015-12-10/behind-the-1-000-pill-a-formula-for-profits-inside-gilead

  6. edlinpatrick Says:

    The topic of veteran health is a very interesting one. Although prevalence among veterans is high, I wonder if the VA/VHA is the proper venue for such care to be provided? According to the 2010 National Survey of Active Duty Service Members, Demobilized National Guard and Reserve Members, Family, and Surviving Spouses only 11% of males and 10% of females 65+ report having received healthcare from the VA and only 16% of all respondents plan on using the VA for primary care in the future. Many veterans are comfortable with the services they receive from their current payer/provider and would only use the VA if they did not have access to other healthcare.

    I wonder if teaming up with large payer systems and non profit groups could provide a strong enough lobbying arm to persuade law makers to add service related HCV to the Medicare fee schedules. Although this would not cover those not on Medicare, it is a fiscally sound way to cover a large portion of the infected population. Additionally an intervention which requires little behavior change (such as going from private PCP to VA facility) may have a higher adoption rate than the asking an older veteran to change the location of where he/she seeks care.

  7. jleblan5jhmiedu Says:

    Shabanawalia,
    I was not aware of the proportion of veterans who have been affected with Hepatitis C. What was more shocking to me than the comparison of prevalence in the general population vs. veterans, was the argument about who should be treated. It is also rather repulsive to me when health care professionals, or those in the field of health sciences, argue such things as ‘a person could remain chronically infected but not transmit the disease’. This completely ignores the long-term complications of Hepatitis C infection for each individual who is infected. As you discussed in your post, this infection can now be treated effectively. Hence, there should be no question as to whether or not someone is treated. Acknowledging the potential cost of therapy as one of the potential barriers, no veteran should ever go without treatment. For all that the troops risk, in the name of the country, the least that could be done for them is adequate and effective health care.
    Thank you for your post; I agree with your statements.

  8. hanab_sbfblog Says:

    Thank you for bringing awareness to this issue; as some of the comments mentioned above, I was unaware how disproportionately this infection affects veterans as compared to the general population. I recently worked on a training guide for updating Hepatitis treatment procedures in Mongolia which has one of the highest rates of Hep C infection in the world. In the process of doing the needs analysis, one of the largest barriers was procuring the treatment medication at an affordable price.

    I think it should also be noted that the treatments for acute and chronic hep c differ; also, depending on the severity of chronic infection, the treatment regimen may also be different. Finally, depending on the strain/genotype, the treatment can again differ. However, there was recent news that Gilead received FDA approval for a drug that can successfully control all six major forms of hep C, and is apparently (slightly) more affordable. http://fortune.com/2016/06/29/gilead-hepatitis-c-epclusa-approved/
    I think there has only been one instance in which Gilead gave away Sovaldi – which was to the country of Georgia. But even then, this was in an effort to show governments that their drug was effective at eliminating hep c and therefore a necessary purchase for countries with endemic HCV infection. So, they were not giving this drug away out of the goodness of their hearts; rather, they were trying to boost their own sales for the future. Of course, their own press releases likely spun it to make the company e appear more philanthropic. As another comment mentioned, they are providing the drug at a subsidized cost to endemic countries; why can’t they do the same for U.S.vets?

    Back to this specific case, from a more administrative and logistical perspective, screening and diagnosis may require several tests and possibly several visits, which is likely another limiting factor in terms of resources at VA hospitals. Given the recent news surrounding VA hospitals, wait times for appointments, and overall quality of care provided, this also seems like it could also be a contributing factor. But from a cost perspective alone, I think there needs to be more political and humanitarian pressure put on Gilead, Inc in order to reduce prices for veterans who have protected their country. I don’t want to vilify the pharmaceutical company, but I do want them to consider if their bottom line is worth more than the lives of people who have already sacrificed so much for their country.

  9. ksingh18 Says:

    Excellent post and comments. As a prior VA physician I certainly agree that our vets deserve the best care they can receive, and the significantly higher incidence of certain diseases in this population (like Hep C) is unfortunate. While I am not aware of any national concerted efforts within the VA system to improve screening and treatment for Hep C, at my VA we basically did have a team who worked together to help accomplish this—hospitalists and primary care doctors would try to routinely screen all patients, and those found to be Hep C positive were referred to specialist physicians and pharmacists for more testing, and possibly treatment. So, I definitely think doing this on a larger scale is a goal to strive for.

    Another point worth mentioning is that today, screening for Hep C is considered to be part of best practices (similar to a one time screening for HIV, or age-appropriate screening for colon cancer). Fortunately, the screening test is not overly financially burdensome, and even patients who are Hep C+ as mentioned do not necessarily need immediate treatment (which is usually where the significant costs come in to play); some Hep C+ patients can often be watched for months/years and a portion of them will not progress to having clinical disease, and better yet some of them may even spontaneously clear the virus on their own without any treatment at all. So, I am definitely a big advocate for screening, which I think is very cost-effective. Treatment is usually reserved for those who have certain strains (genotypes) and/or evidence of progressive disease, though nowadays there is a trend to treat all patients if there are no contraindications.

  10. anatheaee Says:

    I also was not aware of high rates of HCV among Vietnam-era veterans, though I was aware that baby boomers in general had high rates of HCV infection. Back when the preferred treatment was of interferon and ribavirin, the side effects of fatigue and depression, along with the 50% or less rate of effectiveness made it a non-option for those not suffering from active and symptomatic infection. See http://www.hepatitis.va.gov/provider/reviews/treatment-side-effects.asp. Now with the new curative option, it makes sense to treat anyone infected with HCV.

    However, I don’t believe that the VA health system, which may be a broken system, and the pharmaceutical industry, which may also be a broken system, are going to work together to solve the problem of the high cost of treatment and the difficulty of identifying those that should be treated.

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s


%d bloggers like this: