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Treating Medicaid Patients With Hepatitis C: Clinical and Economic Impact
Zobair Younossi, MD; Stuart C. Gordon, MD; Aijaz Ahmed, MD; Douglas Dieterich, MD; Sammy Saab, MD; and Rachel Beckerman, PhD
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Treating Medicaid Patients With Hepatitis C: Clinical and Economic Impact

Zobair Younossi, MD; Stuart C. Gordon, MD; Aijaz Ahmed, MD; Douglas Dieterich, MD; Sammy Saab, MD; and Rachel Beckerman, PhD
Hepatitis C virus treatment is often restricted in Medicaid patients. This analysis evaluates the clinical and cost impacts of treating all Medicaid patients versus the current status quo.
Although the largest cost savings were attributable to downstream medical cost offsets, pharmacy costs attributable to LDV/SOF treatment decreased 2%, from $4.84 billion to $4.75 billion; this is due in part to the 9618 patients potentially eligible for LDV/SOF 8W treatment under Medicaid at the onset of the model who age into Medicare as compensated cirrhotics and can only receive treatment with the 12W regimen. Additional LDV/SOF cost savings result from treating a larger number of patients under Medicaid and the lower price for LDV/SOF under this scheme versus Medicare ($31,500 vs $83,108.18 [inflation-adjusted future price] for LDV/SOF 8W).

Under the current scenario of Medicaid LDV/SOF restrictions, the aggregate cost per SVR across the entire patient cohort—patients treated in Medicaid, patients treated in Medicare, and patients unable to be treated—was $51,809. Treating all Medicaid patients with LDV/SOF led to a 19.8% ($10,282) savings per SVR and was dominant from a cost-effectiveness (cost per life-year gained, cost per QALY gained) standpoint, given that earlier treatment with LDV/SOF resulted in better health and cost outcomes (eAppendix Tables F and G).

DISCUSSION

Access to HCV treatment under current state Medicaid programs is highly heterogeneous. Although HCV treatment qualification has become less stringent in some states, others refuse coverage, have instituted criteria for only treating patients with advanced fibrosis, or have not yet considered adding DAAs to their formularies.23,34 This strategy is flawed: first, patients with advanced fibrosis are more difficult to treat;35 second, fibrosis is a surrogate for liver-related mortality and fails to account for other negative impacts of HCV on patients and their well-being. In fact, evidence suggests that patients with early-stage fibrosis experience at least equivalent PROs and work productivity benefits from an HCV cure compared with those with more severe disease.36

The confluence of high HCV prevalence in the Medicaid population and lack of access to treatment may result in individual and societal harm and has cost implications beyond Medicaid. Although full coverage is possible as patients with HCV age in to Medicare, Medicaid-level drug discounts are not offered, thereby increasing the acquisition cost of HCV drugs for the population not treated earlier in their disease. Further, these policies disproportionately affect economic disadvantaged populations that rely on Medicaid, creating significant health disparities for aging and minority populations.

To our knowledge, this is the first study to estimate the HCV burden to both Medicare and Medicaid resulting from Medicaid HCV treatment restrictions. This study provides evidence that the current Medicaid strategy is flawed in providing treatment to different patients based on their state of residence. The current Medicaid strategy is estimated to result in 27,000 excess cases of cirrhosis and almost 10,000 excess cases of decompensated cirrhosis, leading to over 1700 liver transplants, over 8000 cases of HCC, and over 16,000 HCV-related deaths. This analysis likely underestimates the burden of HCV infection because it does not account for the negative impact of HCC-related extrahepatic diseases and PROs.37

Curing Medicaid patients with HCV using an extended “treat all” strategy could reduce the risk of complications, cirrhosis, HCC, the need for liver transplantation, and liver-related deaths. Given the large number of patients with HCV, we acknowledge that such a strategy would require up-front investment in the context of state Medicaid budget constraints; however, this strategy would ultimately lead to cost savings for CMS by reducing the future burden to Medicare and the costs associated with HCV morbidity and mortality. Additionally, we believe that an HCV cure will lead to substantial improvement in PROs and work productivity. Most critically, a “treat all” strategy will reduce the health disparities caused by the current Medicaid strategy, which primarily affects minorities and baby boomers who are approaching Medicare age.

This analysis was conducted conservatively, excluding 15% of Medicaid patients for whom the restriction status of LDV/SOF was not publically available; this potentially underestimates the full impact of lifting Medicaid coverage restrictions. The restriction status of LDV/SOF was inferred from published restrictions of SOF, which may lead to uncertainty. This analysis used clinical trial data rather than real-world data as model inputs for SVR rates; however, recent studies (ie, HCV-TARGET38) have shown that real-world and clinical trial SVR rates with all-oral ribavirin-free regimens like LDV/SOF are similar. Our model structure only allowed for patients to receive treatment in Medicaid once as they entered the model and did not allow for potential treatment at subsequent time points in Medicaid as patients continued to be monitored and progress to more severe fibrosis stages; thus, the number of patients ineligible to receive treatment in Medicare may be overestimated. Finally, this analysis assumed that all chronic HCV Medicaid patients eligible for treatment were aged 43 years and aged into Medicare at 65 years, which may not reflect real-world demographics and coverage dynamics (eg, dual-eligible patients).

CONCLUSIONS

Institution of a less restrictive “treat all” strategy in Medicaid patients was associated with clinical outcome and cost benefits. Based on these data, we believe it is time to develop a national strategy to eradicate HCV from the United States regardless of payer status. Such a strategy requires collaboration among private payers, governmental payers (including Medicaid), healthcare providers, drug manufacturers, and patients.

Acknowledgments

The authors thank John R. Ferguson for editorial assistance in preparing this manuscript.

Author Affiliations: Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital (ZY), Falls Church, VA; Betty and Guy Beatty Center for Integrated Research, Inova Health System (ZY), Falls Church, VA; Henry Ford Hospital (SCG), Detroit, MI; Stanford University School of Medicine (AA), Stanford, CA; Icahn School of Medicine at Mount Sinai (DD), New York, NY; University of California–Los Angeles (SS), Los Angeles, CA; Maple Health Group, LLC (RB), New York, NY.
 
Source of Funding: This study was funded by Gilead Sciences, Inc.
 
Author Disclosures: Dr Younossi is a consultant for Gilead, Abbvie, and Bristol-Myers Squibb (BMS), and has also received honoraria from each. Dr Ahmed has served as a consultant for Gilead, Abbvie, and Janssen, and has received a grant from Gilead. Dr Dieterich has been a consultant for and received honoraria and lecture fees for speaking from Gilead, BMS, Abbvie, Merck, and Janssen. Dr Saab has served as a consultant for Abbvie, BMS, Gilead, and Merck; and has received lecture fees for speaking at the invitation of a commercial sponsor and honoraria from Abbvie, BMS, Gilead, and Merck. Dr Gordon has served on ad-hoc advisory boards for Abbvie Pharmaceuticals, BMS, Intercept, CVS Caremark, Gilead Pharmaceuticals, and Merck; and has received grants/research support from Abbvie Pharmaceuticals, BMS, Conatus, CymaBay, Exalenz, Gilead Pharmaceuticals, Intercept Pharmaceuticals, and Merck. Dr Beckerman reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.
 
Authorship Information: Concept and design (RB, SCG, SS); acquisition of data (RB); analysis and interpretation of data (RB, SCG, SS, ZY); drafting of the manuscript (AA, DD, RB, SS, ZY); critical revision of the manuscript for important intellectual content (AA, RB, SCG, SS, ZY); statistical analysis (RB); obtaining funding (RB); administrative, technical, or logistic support (RB); and supervision (ZY).
 
Address Correspondence to: Zobair Younossi, MD, Beatty Center for Integrated Research, 3300 Gallows Rd, Falls Church, VA 22042. E-mail: zobair.younossi@inova.org.
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