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Strategies for Hepatitis C in Managed Care
San Diego—With the availability and future approval of novel agents for the treatment of hepatitis C virus (HCV), managed care organization (MCO) de- cision makers must consider many factors as they develop drug management strategies and tactics, including drug costs, patient management needs, adherence, comparative safety and efficacy, and appropriate utilization management controls. Appropriate management strategies are critical for MCOs focused on ensuring that HCV patients receive optimal benefit from these therapies.
“I am hard pressed to find another area with such extraordinary advances recently than hepatitis C,” said Paul Kwo, MD, professor of medicine, division of gastroenterology and hepatology, Indiana University. Dr. Kwo and Vanita K. Pindolia, PharmD, BCPS, vice president, ambulatory clinical pharmacy programs, Henry Ford Health System/ Health Alliance Plan of Michigan, discussed balancing cost and cure rates in a managed care environment for HCV during a satellite symposium at the AMCP meeting. The symposium was supported by educational grants from AbbVie, Inc. and Merck & Co., Inc.
Dr. Kwo opened the session with a discussion on HCV infection and associated complications. More than 4.5 million Americans are infected with HCV, which causes inflammation of the liver that can lead to diminished liver function or liver failure. Baby boomers account for 76.5% of HCV infections in the United States. An estimated 35% of undiagnosed baby boomers with HCV currently have advanced fibrosis (F3-F4 bridging fibrosis to cirrhosis).
Risk factors associated with fibrosis progression in HCV include immune status, host response to the virus, and associated factors such as age, gender, alcohol intake, diabetes, obesity, HIV, and immune system compromise. The rate of fibrosis progression differs depending on several factors, including fibrosis stage and the time since the infection [Antivir Ther. 2010;15(3):281-291]. HCV infec- tion is also associated with significantly higher prevalence of comorbidities including neoplasm, metabolic abnormality, mental disorder, and systemic disorders.
Dr. Kwo noted that HCV genotype 3 infection is the most difficult to treat of the other genotypes. He cited a recent study published in Hepatology [2014;60(1):98-105] that found HCV genotype 3 is associated with significantly higher risk of cirrhosis and hepatocellular carcinoma (HCC). The researchers conducted an analysis using the VA Clinical Case Registry of patients with active HCV viremia (N=110,484). At a mean follow-up of 5.4 years, patients with HCV genotype 3 had a 31% higher risk of cirrhosis and HCC compared with HCV genotype 1, independent of age, diabetes, body mass index, and antiviral treatment.
“We need better therapy for genotype 3,” said Dr. Kwo. “A genotype 3 patient is someone who needs to be treated.”
He said that achievement of sustained virologic response (SVR) decreases complications associated with HCV management as observed in a study by Hsu and colleagues that investigated whether antiviral therapy for HCV infection was associated with improved clinical outcomes related to diabetes [Hepatology. 2014;59:1293-1302]. The study found that antiviral treatment was associated with improved renal and cardiovascular outcomes in diabetic patients.
“We can make hepatitis C a rare disease by 2026,” he said. “When you cure hepatitis C, the complications associated with hepatitis C also decrease.”
Screening and Treatment Guidelines
In January 2014, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) released a hepatitis C guidance report titled Recommendations for Testing, Managing, and Treating Hepatitis C. The guidelines recommend 1 time HCV testing for individuals born between 1945 and 1985. Other persons should be screened for risk factors for HCV infection, and 1 time testing should be performed for all persons with behaviors, exposures, and conditions associated with an increased risk of HCV infection.
Evidence supports treatment in all HCV-infected persons except those with limited life expectancy due to nonliver-related comorbidities. The guidelines also outline current treatment recommendations:
• Pegylated interferon is no longer recommended for first-line therapy of any patient
• 3 FDA-approved pegylated inter- feron-free regimens are available for treatment of HCV genotype 1
• No differences in treatment recommendations for HCV mono-infected versus HCV/HIV co-infected pa- tients; drug–drug interactions must be assessed
As for emerging therapies, Dr. Kwo said several additional therapies are in late phase development. “Wouldn’t it be nice if in 10 to 15 years, we don’t have to talk about [hepatitis C] anymore,” he said.
Challenges for Payers
The unprecedented evolution of the HCV treatment armamentarium presents challenges for payers, according to Dr. Pindolia. She referenced a 2014 analysis published by Milliman Inc. that looked at the economic impact of new HCV drug therapy in Medicare Part D in 2015. The estimated cost of new HCV drug therapies will increase 2015 federal spending on the individual Medicare Part D program by approximately $2.9 billion to $5.8 billion. The estimated cost of HCV drug therapies will increase total annual individual Medicare Part D beneficiary premiums by $481 million to $965 million in 2015, according to the report.
Dr. Pindolia reviewed management strategies, including specialty pharmacy services and disease management, that MCOs can implement to improve overall patient outcomes for HCV patients. HCV drug management strategies include utilizing prior authorization, identifying and encouraging use of preferred tiers, encouraging collaborative and coordinated care, and contracting with pharmaceutical manufacturers. HCV pharmacy management strategies include coordinating with specialty pharmacy providers, filling partial prescriptions to decrease waste, and coordinating next prescription fill with timely HCV RNA test results.
She also said opportunities exist for specialty pharmacies. Specialty pharmacy services can achieve evidence-based and patient-centered approaches to evaluating and managing HCV therapies to both improve patient outcomes and facilitate cost savings. A multifaceted approach is needed to support the patient, including education, clinical outreach, ongoing adherence messaging and reminders, and technology-based tools to create a sense of patient connection.
“Various technologies are available for improving adherence,” she said, including medication reminders, email, and online tracking.
A partnership between specialty pharmacy and health plans can also improve outcomes. As many as 75% of plans now mandate specialty pharmacy use to access to HCV products. One-on-one counseling by pharmacists (Table) with expertise specifically in managing HCV patients will enhance the collaboration that is needed to continually monitor adherence, side effects, and drug in- teractions, and communicate with the treating physician when adjustments are needed, explained Dr. Pindolia.—Eileen Koutnik-Fotopoulos
