June 24, 2013

HCV Care in VA Debated

Provided by NATAP

Download the PDF here

Download the PDF here

Download the PDF here

below are a series of 3 letters to the editor debating the quality of care of HCV for vets in the VA which followed from the publication of this study criticizing HCV care in the VA

from Jules:
This publication in the J of Hepatolog.....led to this letter below to the Journal by Cecil Bennet, which in return led to a response below by David Ross, Director of HCV treatment at the VA, and then again another response below back from Cecil Bennet.

Gaps in the achievement of effectiveness of HCV treatment in national VA practice - "overall effectiveness of HCV therapy is low in a national sample of veterans with chronic HCV"

http://www.natap.org/2012/HCV/012312_03.htm

"There is a chasm between efficacy and effectiveness of antiviral treatment in the VA......The lack of treatment in the remaining patients is potentially concerning......a majority of patients never received a biopsy as part of their evaluation process, and therefore their fibrosis stage remains unknown thus lack of significant fibrosis does not seem to explain the low treatment rates in this population of HCV patients.......Only 11.6% of patients had a liver biopsy in the VA during the two years before and two years after their HCV index date......The study highlights the sporadic testing for viral counts among patients started on antiviral treatment, which does not allow for classifying patients to the conventional randomized trial definition.......39.8% were not tested for genotype......HCV genotype was unknown in 8.8% of the patients who received treatment......Patients who were not tested for genotype were significantly less likely to receive any antiviral treatment (3.3% vs. 25.2%, p <0.0001)......Approximately 43% of patients who did not receive antiviral treatment had none of the contraindications to treatment listed in Materials and methods and in Table 1"

Chronic

Click on picture to enlarge

Why 88% of US military veterans with HCV are not treated

Bennet Cecil
Jnl of Hepatology July 2013
Hepatitis C Treatment Centers, 1009A Dupont Square N, Louisville, KY 40207, USA To the Editor:

The article in the February issue of the Journal of Hepatology reported that less than 12% of American military veterans identified with HCV were treated with antiviral therapy [1]. The Veterans Administration does not want to spend adequate funds to cure patients with hepatitis C. Dr. Kenneth Kizer, Under Secretary for Health in the US Department of Veterans Affairs (VA), gave HCV a high priority but unfortunately he left the VA in 1999. Subsequent leadership has not shown enthusiasm for treating HCV.

The Director of Pharmacy and the Chief of Staff at my local VA hospital told me that I spent too much money treating HCV. Boceprevir and telaprevir are both on the hospital formulary but telaprevir prescriptions are routinely denied because it is more expensive. Patients must jump multiple hurdles before qualifying for antiviral therapy. No one would refuse to give coronary artery stents or bypass grafts to a veteran who smokes but veterans who do not completely abstain from alcohol for three months are refused antiviral therapy. In spite of difficulties, 585 of 1372 (43%) HCV RNA positive patients received antiviral therapy between 1998 and 2010 at our local VA hospital; 226 of 583 treated (39%) achieved SVR [2]. 36% of deaths were from HCC or liver failure. Veterans with sustained viral response had substantially improved survival. Effective antiviral therapy improves prognosis [3], [4]. Less than 2% of Americans die from liver disease, but more than one third of veterans with HCV die prematurely from complications of cirrhosis [2], [5]. According to a 2010 national VA report, deaths in veterans with HCV have more than tripled, "Between 2000 and 2008, the annual number of all cause deaths recorded for Veterans with chronic HCV rose from 1259 (1129 per 100,000 in VHA care) to 5967 (4049 per 100,000 in VHA care), respectively" [6].

Legislation should be passed allowing veterans with HCV to prequalify for their choice of Medicaid or Medicare so that they can obtain antiviral therapy in the private sector. Since Dr. Kizer is no longer in charge of the VA, it is very clear that the VA is not going to treat very many of them.

Treatment of veterans with hepatitis C in the United States Department of Veterans Affairs

Journal of Hepatology
July 2013

David Ross

To the Editor:
As Director of the National Hepatitis C Program for the United States Department of Veterans Affairs [VA], the largest provider of care in the United States for HCV, I would like to respond to the statements by Dr. Bennett Cecil in the October 2012 issue of the Journal of Hepatology about access to and quality of care for HCV-infected Veterans in VA care [1].

1.Dr. Cecil used data from 2005 [2] as the basis for his statement that only 12% of Veterans with HCV in VA care have received anti-viral therapy. However, two of the references he cited explicitly contradict that figure [3], [4]. In fact, the actual proportion treated is more than double that. As of September 30, 2012, internal VA data show over 25% of HCV-infected Veterans in VA care having received such treatment, compared to 17% in non-VA settings [5].

2.Dr. Cecil incorrectly states that both boceprevir and telaprevir are on the VA National Formulary; actually, only boceprevir is, with telaprevir available for use by VA providers as a non-formulary agent [6].

3.Dr. Cecil states that telaprevir is viewed as "too expensive" for use by VA but did not provide any evidence for this contention. In fact, a VHA policy memorandum issued in September 2011 stipulates that cost is not to be a factor in prescribing HCV protease inhibitors. Dr. Cecil did not provide an evidence-based rationale for his preference for prescribing telaprevir.

4.Dr. Cecil implies that he is responsible for anti-viral treatment of almost 600 HCV patients at the Louisville VA; however, multiple providers actually care for the patients with HCV infection at that facility. With regard to use of triple therapy at the Louisville VAMC, as of November 2012, 37 patients had initiated triple therapy (36 boceprevir, 1 telaprevir). Ten were on therapy at that time. Of the remaining 27, six (22.2%) had achieved an SVR, seven were discontinued for lack of efficacy, six were discontinued for toxicity, and eight for non-adherence.

5.The Louisville VAMC's screening/evaluation process includes a review by a clinical pharmacy specialist of drug/ drug interactions, current laboratory results, and monthly monitoring of prescription fills. Patients for whom treatment is appropriate attend a mandatory education class and provided information on HCV, anti-viral therapy, and drug side effects, as well as the importance of drug compliance and obtaining repeat laboratory tests. In addition, a treatment plan and follow-up clinic appointments are reviewed. This class is scheduled weekly, but also has been done at other times at the convenience of individual Veterans (M. Rothschild, personal communication).

Finally, and most importantly, Dr. Cecil's assertions that "VA has not shown enthusiasm for treating HCV patients" and that it is "not going to treat very many of them" are incorrect. Since FDA approved the first direct acting anti-virals in May 2011, VA has treated almost 4500 patients with triple therapy, spent over $100 million in antiviral drug acquisition costs, published updated treatment guidelines recommending use of regimens incorporating direct acting antivirals [7], trained hundreds of VA health care providers to deliver anti-viral therapy, championed integrated models to address treatment-limiting comorbidities [8], added dozens of clinical resources to its HCV Web site (www.hepatitis.va.gov), and moved aggressively to increase access to evaluation and treatment of HCV through teleconsultation models [9].

As a VA clinician who provides care for Veterans with HCV, I am proud of VA's HCV Program, which is recognized as a national leader in the integrated care of patients with this disease [10]. Although there is always room for improvement in any therapeutic service in any health care system, VA has been striving to deliver high-quality, evidence-based care to as many Veterans with HCV as possible, and will continue to do so.

Reply to: "Treatment of veterans with hepatitis C in the United States Department of Veterans Affairs"

Bennet Cecil

To the Editor:

I would like to thank Dr. Ross.

(1)Dr. Ross does not state how many veterans with HCV are currently receiving care at the Department of Veterans Affairs (VA). In 2008, VHA clinicians cared for over 147,000 veterans with chronic HCV [1]. Treating 4500 patients with HCV in 20 months is only 225 patients per month. The VA is currently treating less than 2% of infected veterans per year with boceprevir and telaprevir. It will take more than fifty years for the VA to treat all of their HCV infected patients. Evidence based care of an infectious disease is cure of the infection not the development of integrated models to address comorbidities. If 98% of patients with a curable infection are not treated each year, the VA's response is inadequate.

(2)The VA does a better job with the human immunodeficiency virus (HIV) treating 78% of veterans [2]. The number of patients on antiviral therapy clearly indicates that HIV is a high priority for the VA while HCV treatment is not.

(3)Telaprevir is not available as a non-formulary drug at the Louisville VA. Boceprevir is on the formulary there.

(4)More than 1800 patients with HCV antibodies have been identified at the Louisville VA over 19 years. They had multiple physicians providing care.

(5)$100 million for antiviral therapy over 20 months is $5 million per month. This is clearly inadequate to treat 147,000 veterans with hepatitis C. This is why legislation should be passed so that all veterans with HCV immediately prequalify for their choice of Medicaid or Medicare. They could then obtain antiviral therapy in the private sector instead of waiting for the VA to treat 2% of them each year. Now, many are trapped in the VA system while their curable infection progresses to liver cancer, liver failure and death.

Source

1 comment :

  1. To add insult to injury, I now have had over ten Veterans tell me that in the course of developing their claim for HCV with the VA, they have obtained their VISTA medical records from the Release of Information(ROI) at their VA Medical centers. Every one of them discovered VA had surreptitiously tested them for HCV and "neglected" to tell them they were infected. Some discovered this as much as 8 years afterward. If you don't tell them, they won't come.

    ReplyDelete