Tarek Hassanein, MD

 are increasingly looking to accountable care and population health initiatives to control rising health care costs, with a primary focus on chronic conditions such as diabetes, heart disease, and asthma.

Specialty drug spending is also a significant driver of costs across all populations, and nowhere is this more evident than in the management of hepatitis C. Although the cost of new hepatitis C virus (HCV) therapies dominates the headlines, few of these discussions focus on a “big picture” perspective of improving outcomes and reducing costs associated with HCV management.

Patients with HCV have an increased incidence of comorbidities and more frequent issues with substance abuse and/or mental health that lead to significant, costly health care utilization. For these reasons, it’s clear that new models of care should be zeroing in on this unique opportunity to improve care quality and better manage costs.

Understanding the Costs Associated with HCV 

A recent study developed by Milliman and sponsored by Primrose Healthcare reinforces the cost profile of the HCV population.

According to the study, the average allowed cost per patient per month for the adult Medicaid population with HCV is more than 2.5 times greater than for a similar population not diagnosed with HCV.

Annualizing this cost difference results in a total of over $12,000. These costs are significant when you consider that this analysis did not include the costs associated with new interferon-free drug regimens.

These costs included medical utilization, such as emergency department (ED) visits and hospitalizations. In fact, adult patients with HCV who are enrolled in Medicaid have twice as many ED visits and 3.5 times the rate of inpatient admissions.

Within a commercially insured population, the impact on utilization is even more pronounced: adults with HCV in this group, on average, experience 3 times more ED visits and 5 to 6 times the rate of hospital admissions.

Eradicating the Virus Doesn’t Eliminate Other Risk Factors 

Even with the advent of new drug therapies that can eliminate HCV, costs are an ongoing challenge because of the comorbidities that accompany HCV and the liver damage that has already occurred. Treating the virus does not fully restore liver health or alleviate these other risk factors that can lead to the need for acute care utilization.

Studies like the Milliman analysis show that adults diagnosed with HCV have higher rates of diabetes and HIV than a similar population not diagnosed with HCV. In addition, adults with Medicaid who have HCV are diagnosed with mental health disorders at a rate of 3 to 4 times that of a similar population not diagnosed with the HCV.

Commercially insured adults who have HCV and advancing liver disease can have up to 20 times the rate of substance abuse compared with a similar population not diagnosed with HCV. Together, these comorbid conditions create a “perfect storm” of high utilization rates, poor outcomes, and skyrocketing costs attributed to adults infected with HCV.

Antiviral drug therapy alone cannot address all of these issues. To understand the true impact of these challenges, it helps to examine the most important predictors of mortality in patients with HCV.

A recent study shows that chronic HCV actually has a limited impact on mortality, unless a patient has other severe comorbidities such as HIV or alcohol abuse.

Developing an Approach that Addresses These Challenges 

Today’s collaborative care models provide an ideal avenue to incorporate strategies that can alleviate the true cost burden presented by patients with HCV. Pharmacists, providers, and payers must work together to develop a thoughtful, holistic, and data-driven approach to improving HCV-related care and reducing costs.

Like individuals with other chronic illnesses, patients with HCV require more intensive outreach, personalized treatment, and support. This includes care delivery designed to address all of the patient’s risk factors and not just a particular disease state.

As a result, care management for patients with HCV must incorporate clinical best practices, data sharing, and engagement resources. It must also empower physicians to drive treatment decisions and coordinate care for each patient across the continuum.

One way to incorporate these best practices is through a technology-based approach. Whereas data sharing is a key element of new accountable care models, data sharing through the health information exchange has been slow and cumbersome.

To that end, utilizing web-based and mobile-enabled software that allow for exchange of clinical information and more informed, coordinated treatment decisions can be a strong solution.

However, these systems must be designed to support the complex needs of patients with HCV, as opposed to a “one-size-fits-all” care management approach. They must also incorporate clinical pathways that are designed to address the full spectrum of care needs in this population—from pretreatment to treatment, and beyond.

The benefits of this more comprehensive approach include:

		Pretreatment support ensures that patients who aren’t “sick enough” to receive drug therapy are still receiving support that can optimize their liver health and address other health issues. For example, providers can offer assistance with substance abuse issues and help patients stay abstinent from drugs and alcohol prior to treatment. This same support may also be available through a technology-based system that connects patients with community outreach and substance abuse recovery services. Another benefit of this strategy is that providers can identify patients who are ideal candidates for drug treatment based on their ability to abstain from alcohol and drug use.

		Treatment support helps optimize cure rates by engaging patients and ensuring better medication adherence. Although new interferon-free drugs have extremely high cure rates, patients not adhering to the specifics of each regimen might suffer from viral relapse and resistance to available therapies. Given the high incidence of substance abuse and mental health issues in HCV populations (both of which can be tied to low adherence), it stands to reason that adherence challenges must be addressed as part of any treatment plan. This stage in the process involves a close collaboration between providers and pharmacists—with both parties utilizing the tools and data provided through advanced technology and making informed decisions based on these insights.

		Posttreatment support is essential to consolidate the benefits of viral eradication and helps patients restore and maintain liver health and resolution of fibrosis. It can also continue to address substance abuse recovery and drive good lifestyle choices, while helping to prevent reinfection with HCV and reducing the risk for other health conditions including diabetes and alcohol use, both of which are known to lead to cirrhosis in the absence of HCV. 

A technology-enabled approach to managing HCV begins with an understanding of the complexity of treatment. Effective care doesn’t just eliminate HCV, it also empowers patients to make good lifestyle decisions and better manage their care so their liver can recover from the damage caused by years of HCV infection.

Each patient also has unique needs based on his or her health status and risk factors that must be accounted for by providers in developing a personalized treatment approach. For these reasons, the importance of utilizing clinical pathways as a foundation for an effective treatment plan cannot be underestimated.

Clinical pathways have been used successfully in managing complex health conditions, such as cancer. Now, companies like Primrose Healthcare are incorporating them into HCV management solutions.

These pathways are driven by claims and/or clinical data loaded into the system. Advanced analytics built into these systems use these data to develop a customized pathway to optimize patient health.

For example, a clinical pathway will set specific monitoring intervals during treatment, such as timing of blood tests and patient follow-up. These clinical pathways can be accessed by providers, care managers, and pharmacists, effectively ensuring that care is coordinated, consistent, and effective.

In addition to supporting clinical decision making at the point of care, systems like these must also incorporate tools and resources available directly to patients. These may include apps designed to drive recovery from substance abuse issues, educational articles and videos, adherence tools, nutrition planning, and other engagement resources.

Finally, technology-based resources, like those found in the Primrose Healthcare system, can help providers manage patients “in the white space” between office visits. Secure patient—provider communication can be enabled online, eliminating time-consuming follow-up by phone and ensuring that patients can receive timely answers to questions and guidance, as needed.

It will empower the patients and engage them in their health care.

By leveraging a single system designed to meet this full range of needs, providers and pharmacists across the continuum of care can ensure that treatment is more personalized, targeted, and evidence-based. Payers can also use data and reporting from these tools to monitor performance.

For example, they may track provider performance and tie it to value-driven incentives in a patient-centered medical home (PCMH) or accountable care model. This holistic approach gives payers an important strategy in reducing the true cost burden of HCV.

More coordinated, targeted care can reduce ED visits, eliminate the need for hospital admissions, and prevent costs associated with disease progression and liver damage. In the long term, it might even eliminate the need for significant acute care, such as liver transplants.

Most importantly, it promotes better health and improved quality of life for people diagnosed with this condition. This type of targeted population health approach is much more than a care management program.

It is a fully integrated strategy that aligns ideally with the goals of value-based care. As a result, it can be easily incorporated into PCMH practices, Centers of Excellence for HCV care, or across a broad set of providers participating in today’s innovative quality-driven care efforts. 

		Johnson RL, Blumen HE, Ferro C. The burden of hepatitis C virus disease in commercial and managed Medicaid populations. Seattle, WA: Milliman; July 8, 2015.

		Alcohol use disorders—stronger predictors of mortality than chronic hepatitis C virus infection [news release]. Science Daily. www.sciencedaily.com/releases/2015/04/150425215742.htm. Published April 25, 2015.

 is a Bon Secours physician at the Liver Institute of Virginia Mary Immaculate Hospital. He is the Bon Secours expert on liver disease and liver treatments for Virginia. Dr. Shiffman is recognized as one of the world’s leaders in the field of hepatology and is ranked among the top 1% of gastroenterologists in the country. Prior to Bon Secours, Dr. Shiffman was a professor of medicine at Virginia Commonwealth University. During his 20 years at VCU Medical Center, he directed the hepatology program and trained numerous physicians in caring for patients with liver disease. He focuses on helping patients living with hepatitis C, hepatitis B, liver cancer, and other diseases of the liver. Dr. Shiffman holds a master of science in physiology from the University of New Mexico School of Medicine and a Doctor of Medicine from State University of New York Upstate Medical Center. 

, is vice chairman/chief medical officer at Primrose Healthcare. Dr. Tarek Hassanein is board-certified in gastroenterology and hepatology and is a professor of medicine at the UCSD School of Medicine. A leading expert in liver diseases, Dr. Hassanein is renowned for management of viral hepatitis, fatty liver, cirrhosis, liver cancer, and pre/post liver transplant care. Dr. Hassanein earned his medical degree from Alexandria University in Egypt and completed a residency in internal medicine at Wayne State University in Detroit, Michigan. He completed a research and clinical fellowship in gastroenterology, hepatology, and transplantation at the University of Pittsburgh.

Articles

New models of collaboration can guide providers in optimizing care for patients with HCV.

Hepatitis C Management: How Payers, Providers, and Pharmacies Can Work Together to Stem Costs

Patients with hepatitis C benefit from a collaborative approach that involves specialty pharmacists and other care providers working with patients to promote patient engagement, adherence to therapy, and management of comorbidities.

There is certainly cause to celebrate the launch of the latest direct-acting antiviral drugs for hepatitis C, as they provide an easier, faster treatment plan with fewer side effects. This is especially good news for patients who have faced such limited and challenging treatment options over the past decades. However, new interferon-free regimens like Sovaldi, Harvoni, and Viekira Pak are presenting their own challenges, including—but not limited to&mdash;their $100,000-plus per course of treatment price tags. The clinical and economic reality is that these drugs cannot realistically be available to every patient infected with the hepatitis C virus (HCV) today.

However, even those patients who do receive access to these therapies aren’t automatically “cured” in terms of their liver health. Specifically, eradicating HCV is just 1 step along an entire spectrum of treatment and support that must be provi- ded to improve patient outcomes. This process includes better pretreatment before antivirals are needed, and perhaps most importantly, active management of liver disease in the later stages of HCV. That’s because HCV and liver disease are not one and the same. While there is obviously a relationship between the 2 conditions, eliminating HCV won’t heal a patient’s liver. As such, a more integrated approach is needed to tie an optimal treatment plan together for each patient while considering their unique needs, with efforts to achieve HCV eradication, increase treatment adherence, improve/maintain liver health, and reverse long years of liver injury and scarring (fibrosis).

Examining the Challenges Inherent in Management of Liver Disease 

It is essential that the entire health care industry—payers, providers, specialty pharmacies, and patients&mdash;be aligned with this goal of achieving more holistic treatment that considers the management of liver disease as a separate and important objective. This will require models of care that promote greater provider collaboration, information sharing across the continuum of care, and promotion of consistent clinical best practices. A collaborative, outcomes-based approach is key, because HCV-related liver disease is complex and can be impacted by a variety of factors. These factors include the patient’s disease progression, genetics, comorbidities, and lifestyle.

To understand which patients are most at risk and how liver disease impacts outcomes, it helps to look at current research. According to the Centers for Disease Control and Prevention, for every 100 people infected with HCV, 75 to 85 will develop chronic infection. Of those individuals, 60 to 70 will develop chronic liver disease, with up to 20 progressing to cirrhosis. Finally, an estimated 1 to 5 individuals will actually die of cirrhosis or liver cancer.

Those are devastating statistics for the millions of Americans infected with HCV.

The question is why liver disease strikes the vast majority of people infected with chronic HCV. To answer that question, it’s important to note that many patients have no initial symptoms of HCV infection and, therefore, are not tested until liver damage has occurred. In these cases, the virus has already caused liver cells to die, inflammation to set in, and fibrosis to form. This scarring may initially be mild, but over time it becomes severe, ultimately developing into cirrhosis, which may lead to cancer.

Liver disease may also be impacted by a patient’s comorbidities, which tend to be commonplace in this population. Studies show that hepatitis B, insulin resistance, and diabetes, for example, can increase the liver damage that occurs when patients suffer from 1 or more of these issues in combination with HCV.

Finally, a patient’s lifestyle, such as continued drug and alcohol use, can also advance liver disease, even after receiving drug therapy.

Creating a Multidimensional Strategy to Manage Liver Disease 

Collaboration across the continuum of care, as mentioned earlier, is a first step in the process of creating a more effective approach to managing liver disease. This includes the sharing of insights and data between a health plan’s care managers, specialty pharmacists, primary care providers (PCPs), specialists, and everyone else directly involved in an HCV patient’s treatment. Providers and pharmacists must also be able to manage patients “in the white space” between office visits in order to effectively support these at-risk individuals. All of these elements can be accomplished through technology that already exists today—Web-based platforms that can serve to connect patients and their entire care team. Secure messaging features, access to health care data, and other tools can also be incorporated into these secure platforms.

However, given all of the unique characteristics of these patients—from genotype to disease progression and comorbidities&mdash;it isn’t enough to simply share patient data among the care team. Instead, health care organizations will need to look to a proven technology-enabled approach that combines data sharing with the incorporation of proven, evidence-based clinical pathways. Clinical pathways define the optimal care process, sequence, and timing of interventions for a particular diagnosis. They were originally introduced in the oncology field, where the multitude of treatment protocols and options are highly complicated. The same approach is now being applied as a means to help HCV providers select the most effective treatment plan for each patient based on an analysis of their unique health care needs. This includes their health status, lifestyle, coexisting disease states, and the extent of their fibrosis/scarring.

Clinical pathways can also take into account a patient’s distinct level of involvement or engagement when recommending a treatment approach. For example, is a patient adherent with treatment? Do they show up for doctor’s appointments and refill their medications on time? Do they make emergency department visits instead of their regular PCP visits? All of these factors must be considered as an effective treatment plan is developed. Patients with lower adherence levels may need additional care and support from physicians, pharmacists, and care managers.

Engagement levels also play an important role in the last aspect of this integrated approach. Patients themselves need to have access to understandable, meaningful, and customized educational materials and adherence tools. They must gain an advanced understanding of the impact of their choices—from alcohol and drug abstinence to taking medications as directed&mdash;and how these decisions affect their liver health. This is especially important in individuals for whom liver damage has progressed to a point where cirrhosis could occur or liver transplant could ultimately be required if left unmanaged.

Patients with mental health and substance abuse issues must also be closely managed and assessed, especially if they are being considered as candidates for expensive drug therapy. That’s because research has shown that active use of illicit substances is often associated with reduced adherence to medical interventions.

 Reduced adherence in the world of costly new antiviral drugs could mean lower cure rates for payers investing millions in these therapies. In addition, another clinical study shows that reducing alcohol use in people with HCV can slow disease progression and provide important health benefits.

One Solution that Brings All of These Aspects Together 

One case in point that could ultimately showcase the power of these integrated elements is the HCV management solution developed by Primrose Healthcare. Primrose has developed a Web-based software platform specifically designed to address the full continuum of treatment and support needed in HCV patients. While the system can complement drug therapy, it can also more effectively manage patients beyond this aspect of treatment, including:

		Driving more effective management of liver disease itself through clinical pathways

		Pinpointing a patient’s level of interest/engagement and offering strategies to address low levels of engagement

		Providing tools to patients that improve self-management, including medication adherence devices and reminder packaging, educational videos, and access to their medical data and treatment plan

		Offering secure messaging between physicians, pharmacists, and patients, allowing them to stay connected in between office visits

		Enabling access to clinical recommendations and patient data across a patient’s entire care team—including adherence data supplied directly by a specialty pharmacy

		Providing a clear picture of patients’ condition and management to payers 

This solution has recently been introduced in the United States and has already established a partnership with one of the nation’s largest specialty pharmacies. The Primrose leadership team has broad experience in the management of liver disease and viral hepatitis as well as patient engagement and clinical management.

The Specialty Pharmacy’s Role in These Efforts

Specialty pharmacies are literally on the “front lines” of patient care, and yet these organizations are often overlooked as vital members of the overall health care team. Solutions like the one outlined above put specialty pharmacies in a strong position to improve their collaboration with providers while expanding on the valuable services they already offer to patients today. These include:

		Serving as a valuable point of contact for patients desiring high-touch education and support

		Sharing valuable adherence data with providers

		Collaborating with providers and care managers to improve engagement levels

		Seeking financial assistance for patients who qualify for manufacturer and nonprofit programs

In closing, HCV-related liver disease can only be managed by a multidisciplinary approach that involves all stakeholders across the health care industry. These individuals must be empowered with the right tools and technology to make the very best, most informed decisions for every unique patient. Part of this treatment plan may indeed include today’s antiviral therapies for patients who are ideal candidates—those who are engaged in self-management behaviors and are further along the continuum of disease progression. However, optimal treatment doesn’t simply come in pill form. Instead, it requires a rethinking of today’s care models and a fully coordinated approach to improving patient health. 

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		El-Zayadi A-R. Hepatitis C comorbidities affecting the course and response to therapy. 

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 is board certified in gastroenterology and hepatology and is a professor of medicine at the UCSD School of Medicine. A leading expert in liver diseases, Dr. Hassanein is renowned for management of viral hepatitis, fatty liver, cirrhosis, liver cancer, and pre/post liver transplant care. Dr. Hassanein earned his medical degree from Alexandria University in Egypt and completed residency in internal medicine at Wayne State University in Detroit, Michigan. He completed a research and clinical fellowship in gastroenterology, hepatology, and transplantation at the University of Pittsburgh.

 oversees all of the company’s finance, operations, business development, strategic planning, sales, and marketing efforts. He brings more than 15 years of health plan management expertise to this position, including executive roles at CIGNA Corporation. At CIGNA, Mr. Cournand was responsible for strategic oversight of critical business functions, including sales, clinical management, actuarial, finance, and corporate venture capital efforts. Mr. Cournand received his MBA from Nova Southeastern University after earning his undergraduate degree in marketing.