VA Overhauls Approach to Care for Veterans With Hepatitis C

By expanding access to effective treatments and increasing education efforts for veterans with hepatitis C virus (HCV) infection, the US Department of Veterans Affairs (VA) is aiming to revolutionize its approach to care for veterans with the disease.

Although the true prevalence of HCV among veterans is unknown, the VA estimates that ~6% of veterans currently using the VA system have HCV—a much higher incidence than for the US population in general.

In the past, financial limitations meant that only the sickest patients were able to receive treatment, said VA under secretary for Health David Shulkin, MD, in a March press release. Now, thanks to increased funding from Congress and a reduction in the prices of HCV drugs, for fiscal year 2016, all veterans with the illness can receive care regardless of the stage of their liver disease.

“We’re honored to be able to expand treatment for veterans who are afflicted with hepatitis C,” Dr Shulkin said. 

 “I think the VA adopting a policy of treating patients with all stages of liver disease is very progressive, very patient-centered, and very forward-thinking,” said Andrew Aronsohn, MD, an associate professor of medicine at the University of Chicago Medical Center, Chicago, IL, and an expert on hepatitis treatment. “They seem to realize that, for a relatively benign treatment course that is highly effective, they are going to be preventing lots of significant health-related issues down the road.”

According to the VA, more than 76,000 veterans infected with HCV have been treated within its health system, and approximately 60,000 have been cured. With its expansion of HCV treatment this year, the VA expects that cure rates for HCV will continue to climb, and rates of complications associated with HCV infection will likely go down in the next couple of years.

“Certainly this is great for patients, and it’s the right thing for patients,” he said. “It’s also the right thing for health systems because those complications cost a lot of money, and this is one of the best models for preventative medicine that we have – fully eradicating a virus that we know can cause a lot of damage.”

Treatment Transformation

Hepatitis C treatment has come a long way over the course of a quarter century since its beginnings with a drug called interferon. “This medicine had lots of side effects,” said Dr Aronsohn. “Patients became very, very ill while taking this medication. It was something that they had to inject, which was also a problem, and response rates were pretty low,” he added. “Even at the best formulation of this interferon-based regimen, the cure rates were only about 50%.”

In 2013 came the first FDA approvals of direct-acting antiviral drugs that directly attack the virus and significantly boost success rates.

These drugs are taken orally, in regimens that last only about 3 months, and, in many cases, are associated with little to no side effects. In addition, the cure rates are over 90% for most patients.

According to the VA, more than 42,000 veterans have been treated with these new, highly effective antiviral treatments since 2014. 

“From a patient perspective, it is all upside,” he said. “The only downside is cost and access.”

Addressing the costs associated with antiviral therapy for HCV remains a major challenge. To date, the market for HCV drugs has been dominated by Gilead Sciences Inc with its drugs Sovaldi (sofosbuvir) and Harvoni (edipasvir/sofosbuvir), introduced in 2013 and 2014, respectively. Thus, Gilead has been the target of criticism from lawmakers, who have accused the company of price gouging: a typical course of Sovaldi runs about $84,000, and Harvoni costs $94,500.

AbbVie was the first to challenge Gilead when it launched the Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets) in late 2014; however, the pricing was comparable, at about $83,000 per patient for a standard course. 

Increased competition may be beginning to drive the price down, however. Merck & Co joined the fray in early 2016, offering a new hepatitis C treatment called Zepatier (elbasvir and grazoprevir) at a list price of $54,600 for a 12-week regimen.

Dr Aronsohn predicts that, as new hepatitis C regimens are released onto the market, competition will drive prices down, making the costs associated with HCV treatment more sustainable for systems like the VA.

In the meantime, although the bulk use of these medications has allowed the VA to negotiate discounted pricing, it still spent $696 million on new hepatitis C drugs (17% of the VA’s total pharmacy budget) last year alone. 

In fiscal year 2015, the total cost to the VA of treating 30,936 veterans with HCV was $1.2 billion, according to David Ross, MD, PhD, MBI, director of HIV, Hepatitis, and Public Health Pathogens Programs for the Veterans Health Administration. Based on current treatment rates, the VA expected to treat between 42,000 and 50,000 veterans in fiscal year 2016, and the drug costs alone would have totaled between $753 and 880 million.

As of the March expansion in HCV coverage, VA says that it anticipates that spending on hepatitis C drugs will total ~$1 billion as many more veterans will be started on HCV treatment. Fortunately, Congress has increased funding to the VA to support this spending increase for the current fiscal year. But whether this support from Congress will continue into the next fiscal year remains to be seen. The VA has reportedly requested $1.5 billion in its budget for 2017 to support HCV treatments and clinical resources.

Remaining Challenges

According to Dr Aronsohn, there are other difficulties that need to be addressed beyond just cost of care to ensure sustainable access to HCV treatment among veterans. For one, a lack of disease awareness means that many adults in the US, including veterans, may have been infected with HCV but are not aware of it. Therefore, improved efforts to identify and diagnose the virus in these individuals are crucial. 

To overcome the challenges associated with lack of awareness, Dr Aronsohn said, the model of success is HIV. The one thing that has been done well is creating awareness of the disease over time. “That needs to happen with hepatitis C,” he said, “and that’s one of the ways to get patients to understand their risk factors and to know when they need to be advocates for themselves.” For its part, VA is working to improve disease awareness for HCV through educational resources for veterans provided on its website.

The second key challenge is the linkage from diagnosis to care. Patients who have been diagnosed need to be able to find providers equipped to treat the illness. Yet, the dramatic increase in the numbers of those receiving or seeking treatment makes this a tall order. The rate of new treatment starts in the VA was about 100 per week prior to 2014, according to Dr Ross. One year ago, the rate had increased to approximately 570 per week. Currently, the rate is approximately 1130 per week. 

To address this increase in demand, beginning in 2014, the VA deployed Veterans Integrated Service Network (VISN) Hepatitis C Innovation Teams (HITs). Through the implementation of systems redesign strategies, these teams have assessed and worked to address local gaps in care for veterans with the disease.

The VA also offers the Veterans Choice Program, which allows eligible veterans to receive care from non-VA facilities and providers. Eligible individuals include those who have been waiting more than 30 days for medical care within the VA system or who live more than 40 miles away from the nearest VA medical care facility or face another travel burden that prevents them from receiving care at a VA medical care facility.

To address geographic constraints for those who choose to receive treatment within the VA health system, the VA has adopted a model developed by Sanjeev Arora, MD, at the University of New Mexico called Project ECHO (Extension of Community Health Outcomes). The VA’s version is called SCAN (Specialty Care Access Network)/ECHO. 

This tele-consultation model uses case-based learning to train primary care providers at outpatient clinics to evaluate and treat patients, allowing veterans in rural locations to receive treatment at a VA facility close to where they live, rather than to travel for hours to a VA medical center. 

SCAN/ECHO has been highly successful, according to Dr Ross. Wait times for treatment decreased by 75%, and cure rates for patients treated through this program are equivalent to the rates for patients treated by specialists.

Dr Aronsohn, who leads the ECHO-Chicago Hepatitis C management team, pointed out that programs like this are going to be essential moving forward because of the high rates of HCV infection—both among veterans and among the general population. “It’s just not feasible that they’re all going to get in to see specialists and be managed by specialists,” he said. “That care is going to have to be shifted to the primary care setting.”

Even with improved efforts to connect veterans with the care they require, many veterans with HCV have conditions that may limit the ability to be treated effectively, such as substance use that impairs adherence, serious mental illness, documented non-adherence to medical appointments or treatment, unstable/uncontrolled medical comorbidities, or a lack of engagement in care, Dr Ross pointed out. Still others choose to decline treatment.

The VA is taking steps to increase the availability of treating providers and outreach staff and is scaling up efforts to reach out to patients who fall into these categories so that they, too, can benefit from treatment when appropriate.

Lessons To Be Learned

According to Dr Ross, the success of the VA, in large part, has been due to the utilization of interdisciplinary clinical teams that integrate treatment, aggressive case management, mental health support, and clinical pharmacy expertise.

The use of a population health cascade of care model to determine which patients have been tested, diagnosed, linked to care, evaluated, treated, or cured, allows targeted interventions to improve access and quality at each stage of the cascade. In addition, electronic registries and dashboards allow near real-time reporting and analysis on various access and quality measures.

Bringing care to the patient through SCAN/ECHO and other telehealth initiatives improves access, and evidence-based standards with flexibility for clinical judgment enhance outcomes. Last, but certainly not least, Dr Ross added, the thorough integration of clinical pharmacists at all levels is critical for ensuring appropriate therapy.

So what can other health care systems potentially learn from the VA’s large-scale approach to expanding HCV treatment to all veterans? 

“There are huge disparities in our country as far as access to these medications, so the VA is a really nice model,” Dr Aronsohn said, noting that the VA is accomplishing what the medical community, patient advocates, and patients have hoped would take place across the country and around the world. “Whatever way they’ve been able to do this to make [the expanded coverage] happen is something that other systems should really pay a lot of attention to,” he added.

At the same time, Dr Aronsohn acknowledges the challenges for systems outside the VA. The cost benefits associated with HCV tend to pay off over the course of years, he explained, because savings are achieved through the prevention of the complications that arise during the end stages of liver disease. But patients tend to change payers and insurance policies fairly often, so why would a payer want to spend $100,000 for a beneficiary’s treatment when that same individual could very well be covered by someone else in 5 years? 

“The VA is a little bit of a different population: because people tend to stay in the VA for a longer period of time, they are actually able to realize the cost benefits down the road with this population.”