Sarjit Patel, PharmD

Breakthrough hepatitis C drugs promise cure rates upwards of 90%, and specialty pharmacy can play an important role in their success by addressing obstacles to adherence.

With breakthrough drugs for the treatment of the hepatitis C virus (HCV) now promising cure rates upwards of 90%, the specialty pharmacy’s role in ensuring the effectiveness of these medications is now more important than ever. That’s because patients with HCV often have complex needs and issues with treatment adherence that must be addressed in tandem with these therapies. Nonadherence has a distinct impact on patient health as it can lead to treatment failure and possibly even drug resistance in certain rare cases where the virus mutates and begins to produce antiproteases.

In addition, drug therapy alone is often not enough to drive positive outcomes. A study published in a leading hepatology journal tracked patients with early stage HCV over a 4-year period. In spite of receiving drug therapy, some patients still experienced disease progression and decompensated cirrhosis, leading to a 5% mortality rate.

As a result of these issues, adherence and support strategies must be tailored to each unique individual in order to improve liver health and ensure sustained virological response to medication. To better understand these issues, it helps to first examine the unique and diverse characteristics of this population which can lead to medication nonadherence, poor liver health, and ultimately, treatment failure.

HCV infection is a significant problem among individuals who have injected illicit drugs. As such, this population is also more likely to have comorbidities including mental health issues, addiction, and other conditions such as HIV/AIDS that are related to high-risk behaviors. According to the Centers for Disease Control and Prevention, baby boomers are also disproportionately affected by this condition. Some were infected by contaminated blood and blood products before widespread screening of the blood supply began in 1992. Others could have been infected through past use of intravenous drugs or other means. These individuals may also have unrelated health conditions related to aging that must be managed alongside hepatitis C.

It stands to reason that medication adherence can be challenging in such populations. Aging individuals or patients with comorbidities may be taking many different drugs and have complex treatment regimens. As a result, they may have logistical or mental barriers to adherence, such as forgetfulness, or financial challenges related to the cost of multiple medications. Individuals infected with HCV may also be more likely to have social barriers to adherence, such as poor literacy or a lack of overall health literacy. Lastly, individuals with complex health needs will require additional support and guidance with regard to taking their medication properly and avoiding safety issues, such as drug interactions.

In the past, the side effects of interferon-based regimens certainly played a distinct role in high rates of medication nonadherence in these populations. New drugs, especially those not used in combination with interferon, are much more manageable from this perspective. However, as they become more readily available to patients in high-risk categories, including those mentioned above, the pharmacist must be an active participant in addressing other adherence issues. This involves working in tandem with a patient’s entire health care team, especially the physician and insurance company where applicable, and providing intensive support to patients themselves.

Addressing Logistical Challenges to Adherence: Cost and Access to Therapy

New FDA-approved therapies such as Sovaldi, Harvoni, and Olysio are all over the news lately—not just because of their incredible potential for curing HCV, but also because of their high cost. However, specialty pharmacies are uniquely positioned to help patients gain access to affordable medications through a variety of channels. If a patient has insurance, whether through commercial payers or Medicaid/Medicare, the complex prior authorization (PA) process can be difficult and time-consuming for physicians to manage. Pharmacies can streamline this process, serving as a point of contact between physician office staff and insurance carriers, ensuring that the proper documentation is submitted in a timely manner. In this way, patients can gain rapid access to the appropriate therapy and ensure it is covered by their health plan.

To accomplish this goal, pharmacies must be educated on the intricacies of each health insurer’s guidelines. The PA process is becoming increasingly complex as new high-cost therapies emerge, and these guidelines vary greatly by payer and region. The specialty pharmacy can assist the physician practice in the PA process to decrease potential confusion and ensure that all appropriate clinical information is submitted to the payer.

However, not all patients are insured, and even individuals with health coverage may have difficulty paying for the new HCV drugs if their cost share is significant. That’s why pharmacy teams must also pursue financial assistance from other means, such as programs sponsored by pharmaceutical manufacturers and nonprofit groups. Fortunately, the manufacturers of Harvoni, Sovaldi, and Olysio all have made co-pay and patient assistance programs available at this time. Following is a comparison of the average out-of-pocket costs per fill that patients of Avella Specialty Pharmacy experienced during the first quarter of 2014, including those who received financial assistance support:

		Sovaldi cost share with Medicare and foundation assistance $.33

		Sovaldi cost share with commercial insurance: $774

		Sovaldi cost share with commercial and copay card assistance: $33

Employing Patient Education Strategies to Break Down Perceptual and Social Barriers 

Perceptual barriers to medication adherence include a lack of understanding about the requirements and benefits of a given therapy or a lack of belief in its treatment advantages. While a patient’s own physician may be the first line of defense against these issues, pharmacists also play a very important ongoing role. Specialty pharmacies should have the time and resources available to administer personalized education about medication requirements and what patients can expect from their unique treatment program. This includes helping patients understand the importance of taking their medication as directed and in the proper dosage, guiding them toward health literacy resources, and providing strategies for dealing with any unwanted side effects and safety issues. Specialty pharmacies may also provide additional guidance to reinforce a physician’s efforts to help patients understand the need to make positive lifestyle changes that promote good liver health.

Leveraging a High-Tech and High-Touch Approach to Help Address Mental Barriers to Adherence 

Mental barriers to adherence, including forgetfulness and mental health or substance abuse issues, can be particularly difficult to manage in regard to promoting treatment adherence. As such, a patient’s entire health care team should be working together toward the same goal. Physicians may need to refer these patients to behavioral health support and resources. However, pharmacy staff can also reinforce these efforts through 2 very distinct strategies.

The first, which can be especially helpful in addressing issues related to forgetfulness, is leveraging tools and new technology to offer adherence solutions that remind patients when it is time to refill or take medications. Given the prevalence of mobile devices, especially in younger populations, these programs should be mobile-optimized in addition to being available for desktop users. As an added advantage, many such apps and portals also include patient education tools and resources, such as access to medication history and drug interaction data. And while reminder packaging has not yet become commonplace for HCV drugs, it stands to reason that this may be the next frontier in adherence strategies—especially since these devices have already demonstrated early results in improving adherence. In fact, a recent study conducted by the University of Arizona, the National Institutes of Health, and Avella Specialty Pharmacy demonstrated that using behavioral contracting and reminder tools, including refill and medication reminders, improves medication adherence.

The second strategy involves close collaboration with a patient to reinforce the efforts of physicians and care team members in driving adherence. This requires that clinical support be available to individuals around the clock and that regular educational sessions between patients and pharmacy staff are maintained, especially if patients have complex physical or mental health issues. This is especially important since many payers and specialists themselves are leaning more heavily on primary care providers to help manage these patients on an ongoing basis.

 Primary care providers may be less familiar with the world of specialty medications and could lack some of the key resources required to help effectively manage these patients.

A Unique Opportunity for Specialty Pharmacies to Deliver Value Across a Wide Range of Services 

The management of HCV is set to be completely transformed by the availability of powerful new specialty drugs. However, specialty pharmacies must do more than just dispense these therapies to help ensure that cure rates are achieved and that good liver health is sustained among patients. This will involve a combination of patient education, financial assistance, adherence to best practices, collaboration with care team members, and data sharing where needed. As a result of these efforts, pharmacies can drive adherence and cure rates comparable to those experienced within the ideal environment of clinical trials. For example, Avella Specialty Pharmacy has experienced a medication possession ratio of 88% for Sovaldi and has achieved sustained virologic response rates of 89% in the first quarter of 2014 for HCV patients with all genotypes and Metavir scores receiving this therapy.

It is clear that the future of HCV eradication is not only in the hands of physicians and pharmaceutical manufacturers, it is also a key responsibility of pharmacy professionals skilled in dealing with a wide range of adherence and treatment-related obstacles. Fortunately, these are all areas where specialty pharmacies have shown strong capabilities in the past, as they dedicate their resources to supporting hard-to-manage patients with highly complex therapies. 

		Larrey D, Ripault MP, Pageaux GP. Patient adherence issues in the treatment of hepatitis C. 

		Moorman AC, Xu F, Tong X, et al. Mortality and progression to decompensated cirrhosis in chronic hepatitis C (CHC) patients with liver biopsy confirmed fibrosis in the Chronic Hepatitis Cohort Study (CHeCS) [abstract]. 

		Chisholm-Burns MA, Spivey CA, Graff Zivin J, Lee JK, Sredzinski E, Tolley EA. Improving outcomes of renal transplant recipients with behavioral adherence contracts. 

		Thomas Hertz B. Treating hepatitis C means expanded role for primary care. 

. Modern Medicine Network website. April 24, 2014.

, is a graduate of the University of Arizona College of Pharmacy. He joined Avella Specialty Pharmacy in 2010 and is currently a clinical pharmacist. He has a strong focus on customer service following intensive internships with Albertsons/Osco Pharmacy and Express Scripts, Inc, and a position as an Albertsons/Osco staff pharmacist. Sarjit has served as a diabetes educator, providing in-depth education and coaching for diabetes patients, and he brings these coaching skills to the specialty realm. With his passion for educating and coaching patients, Sarjit has found working with patients with hepatitis to be very rewarding.

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Breakthrough hepatitis C drugs promise cure rates upwards of 90%, and specialty pharmacy can play an important role in their success by addressing obstacles to adherence.  