Between 2010 and 2018, the rate of hepatitis C virus (HCV) infection in the United States more than quadrupled.1 More than 2 million Americans are estimated to be living with HCV, many unaware they are infected.
The latest viral hepatitis surveillance report from the CDC indicated that infections rose again during 2019. Hepatitis C is a leading cause of liver cancer and primary cause of liver transplants,2 and despite widely available curative, direct-acting antiviral treatments, it remains a major public health issue. Viral hepatitis costs the government, health systems, and patients billions of dollars every year.3 But the US Department of Health and Human Services (HHS) has a strategic plan to eliminate viral hepatitis in the United States, and 340Bs can play a role.
Road Map to Elimination
HHS has laid out a national strategic plan to eliminate viral hepatitis over the next 10 years. The plan has adopted the World Health Organization’s definition of elimination: a 90% reduction in acute infections and a 65% reduction in mortality compared with a 2015 baseline. The strategy provides an actionable framework and key performance indicators to eliminate viral hepatitis by 2030 in the United States.
HHS identifies several disproportionately affected populations and challenges related specifically to HCV. Populations at greater risk for HCV infection include American Indian/Alaskan Natives, Black individuals, non-Hispanic individuals, those who inject drugs or have HIV, and those born between 1945 and 1965. Challenges include access to and cost of HCV treatments, injection drug use, lack of awareness regarding infection status, lack of an HCV vaccine; perinatal transmission of HCV; and testing and linkage to care.
The strategy has 5 primary goals with supporting objectives to achieve elimination. These include achieving integrated coordinated efforts across stakeholder groups to collectively address the viral hepatitis epidemic, decreasing hepatitis disparities, establishing more comprehensive national viral hepatitis surveillance and data usage, improving viral hepatitis–related health outcomes, and reducing infections.3
HCV, High-Impact Settings, 340B
The plan identifies “high-impact settings,” in which large portions of at-risk populations receive care. Included in these settings are many 340B-eligible covered entities (CEs), such as community health centers, Federally Qualified Health Centers, Ryan White clinics, and sexually transmitted infection clinics. The proximity of these CEs to disproportionately affected communities makes the 340B program an extremely effective resource in the plan to eliminate viral hepatitis in the United States.
The National Alliance of State and Territorial AIDS Directors is a nonpartisan nonprofit agency representing a coalition of public health officials involved with the administration of HIV and viral hepatitis programs in the United States.4
The organization affirms 340B as “an instrumental tool in ending the viral hepatitis epidemic, enabling viral hepatitis programs to expand and improve services, address health equity, and reduce health disparities.”5
One of the challenges identified in the strategic plan is access to medication. On average, 340B health systems provide a higher number of medication access programs than non-340B hospitals.6 The cost savings generated by 340Bs provide critical funding for mission-driven organizations to expand health services and improve health outcomes. A 2019 peer-reviewed study conducted a budgetary impact analysis on a multidisciplinary primary care–based HCV treatment program. The findings showed that for every referral of a patient with HCV, the health system would lose $370 without the 340B program and gain $930 in cost savings with the program.7
Across the country, CEs use 340B cost savings to expand resources, facilitate access to treatment, improve health outcomes for at-risk populations, and increase testing. In Philadelphia, Pennsylvania, a community health center used cost savings to significantly expand linkage to care for at-risk community members and testing.8 The United States faces a mounting shortage of health care workers,9 and data show that expanding the role of the clinical pharmacist can successfully fill the HCV provider gap and facilitate positive outcomes.10 340B cost savings are often used to integrate clinical pharmacists into care teams. After a significant increase in local HCV infections, a health system in Maine used 340B savings to create a pilot program integrating pharmacists alongside physicians to manage HCV by providing education, medication therapy management, monitoring, and ongoing follow-up. The program increased the number of patients starting treatment for HCV, and 100% of those enrolled in the program completed posttreatment laboratory tests compared with 58.8% of those without pharmacist involvement.11 Pharmacists have also been successful in extending the reach of rural clinics by providing HCV clinical services for disproportionately affected Alaskan Native and Native American populations.12
Although the 340B program maintains bipartisan support, there are shortcomings. Critics contend that some health systems are not using cost savings generated through the program to increase care for at-risk or low-income populations.13 Sixteen drug manufacturers have moved to restrict discounts through 340B contract pharmacy arrangements with many health systems, citing lack of oversight in addition to an increase in duplicate discounts and diversion.14 Also, some CEs have come to rely on the cost savings generated through 340B programs to keep their doors open. As lower-cost generics enter the market, 340B cost savings decrease and leave many mission-driven entities at financial risk.
Program integrity has fallen on the shoulders of the CEs. Now more than ever, health systems must draw a clear line showing how 340B cost savings are applied to expand services, improve outcomes, and stretch resources. CEs should also consider financial contingency plans, as generics erode cost savings and leave overleveraged CEs at risk.
Working together with contract pharmacy partners, CEs should also be prepared to provide increased visibility and claims level data demonstrating program integrity to their manufacturer partners.
“Covered entities should critically evaluate and review the compliance processes in place with their contract pharmacy partners,” said Ted Traurig, BioMatrix vice president of specialty pharmacy operations. “Aggressive mock auditing, physically segregated inventories, separate wholesale accounts, and prospective identification of Medicaid claims can go a long way in helping CEs avoid duplicate discounts and diversion.”
Envisioning a Future Free of HCV
The elimination of HCV will require engagement from a wide range of health stakeholders and organizations. The clinical pharmacist role continues to evolve in the health care environment, and pharmacists will play an increasingly active part in overcoming HCV. Although it is not perfect, the 340B program provides significant opportunities and resources to achieve many goals outlined in the HHS plan. Health systems in high-impact settings should critically review the action plan and consider how to best use 340B cost savings to help achieve the goal of eliminating HCV.
ABOUT THE AUTHOR
Justin Lindhorst, MBA, is marketing director/regional care coordinator at BioMatrix Specialty Pharmacy in Plantation, Florida.
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2. Know more hepatitis. CDC. Updated June 14, 2021. Accessed April 26, 2022. https://www.cdc.gov/knowmorehepatitis/index.htm
3. Viral hepatitis. U.S. Department of Health and Human ServicesHHS. Accessed April 26, 2022. https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf
4. About us. NASTAD. Accessed April 26, 2022. https://nastad.org/about
5. 340B drug pricing program guidance for viral hepatitis programs. NASTAD. November 2021. Accessed April 26, 2022. https://nastad.org/sites/default/files/2021-11/PDF-340B-Viral-Hepatitis.pdf
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8. Case study: how BioMatrix 340B services helped Philadelphia FIGHT increase HCV testing and linkage to care. BioMatrix Specialty Pharmacy. October 2020. Accessed April 26, 2022. https://static1.squarespace.com/static/58d944d2ebbd1aac620cfead/t/6025b182a95517221882cf0d/1613083010534/BMX057.2+%7C+340B+FIGHT+Case+Study+Case+Study-tk-v1.4.pdf
9. Fact sheet: strengthening the health care workforce. American Hospital Association. November 2021. Accessed April 26, 2022. https://www.aha.org/fact-sheets/2021-05-26-fact-sheet-strengthening-health-care-workforce
10. Koren DE, Zuckerman A, Teply R., Nabulsi NA, Lee TA, Martin MT. Expanding hepatitis C virus care and cure: national experience using a clinical pharmacist–driven model. Open Forum Infectious Diseases. 2019;6(7):ofz316. doi:10.1093/ofid/ofz316
11. Meeting varied community needs with 340B savings. 340B Health. October 2021. Accessed April 26, 2022. 2021. https://www.340bhealth.org/files/Meeting_Varied_Community_Needs_with_340B_Savings.pdf
12. Geiger R, Steinert J, McElwee G, et al. A regional analysis of hepatitis C virus collaborative care with pharmacists in Indian health service facilities. J Prim Care Community Health. 2018;9:2150132718807520. doi:10.1177/2150132718807520
13. Minemyer P. Pioneer Iinstitute report calls 340B an ‘increasingly dysfunctional’ program. Fierce Healthcare. March 22, 2022. Accessed April 26, 2022. https://www.fiercehealthcare.com/hospitals/pioneer-institute-report-calls-340b-increasingly-dysfunctional-program
14. King R. J&J to cut off 340B discounts to contract pharmacies starting in May despite lingering legal fight. Fierce Healthcare. March 22, 2022. Accessed April 26, 2022. https://www.fiercehealthcare.com/providers/jj-cut-340b-discounts-contract-pharmacies-starting-may-despite-lingering-legal-fight