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The American Journal of Managed Care Special Issue: HCV
Real-World Outcomes of Ledipasvir/Sofosbuvir in Treatment-Naïve Patients With Hepatitis C
Zobair M. Younossi, MD, MPH, FACG, AGAF, FAASLD; Haesuk Park, PhD; Stuart C. Gordon, MD; John R. Ferguson; Aijaz Ahmed, MD; Douglas Dieterich, MD; and Sammy Saab, MD, MPH
Sofosbuvir Initial Therapy Abandonment and Manufacturer Coupons in a Commercially Insured Population
Taruja D. Karmarkar, MHS; Catherine I. Starner, PharmD; Yang Qiu, MS; Kirsten Tiberg, RPh; and Patrick P. Gleason, PharmD
Improving HCV Cure Rates in HIV-Coinfected Patients - A Real-World Perspective
Seetha Lakshmi, MD; Maria Alcaide, MD; Ana M. Palacio, MD, MPH; Mohammed Shaikhomer, MD; Abigail L. Alexander, MS; Genevieve Gill-Wiehl, BA; Aman Pandey, BS; Kunal Patel, BS; Dushyantha Jayaweera, MD; and Maria Del Pilar Hernandez, MD
Does Patient Cost Sharing for HCV Drugs Make Sense?
Darius N. Lakdawalla, PhD; Mark T. Linthicum, MPP; and Jacqueline Vanderpuye-Orgle, PhD
A Way Out of the Dismal Arithmetic of Hepatitis C Treatment
Jay Bhattacharya, MD, PhD, Center for Primary Care and Outcomes Research, Stanford University School of Medicine; Guest Editor-in-Chief for the HCV special issue of The American Journal of Managed
Value of Expanding HCV Screening and Treatment Policies in the United States
Mark T. Linthicum, MPP; Yuri Sanchez Gonzalez, PhD; Karen Mulligan, PhD; Gigi A. Moreno, PhD; David Dreyfus, DBA; Timothy Juday, PhD; Steven E. Marx, PharmD; Darius N. Lakdawalla, PhD; Brian R. Edlin, MD; and Ron Brookmeyer, PhD
The Wider Public Health Value of HCV Treatment Accrued by Liver Transplant Recipients
Anupam B. Jena, MD, PhD; Warren Stevens, PhD; Yuri Sanchez Gonzalez, PhD; Steven E. Marx, PharmD; Timothy Juday, PhD; Darius N. Lakdawalla, PhD; and Tomas J. Philipson, PhD
Costs and Spillover Effects of Private Insurers' Coverage of Hepatitis C Treatment
Gigi A. Moreno, PhD; Karen Mulligan, PhD; Caroline Huber, MPH; Mark T. Linthicum, MPP; David Dreyfus, DBA; Timothy Juday, PhD; Steven E. Marx, PharmD; Yuri Sanchez Gonzalez, PhD; Ron Brookmeyer, PhD; and Darius N. Lakdawalla, PhD
Currently Reading
Coverage for Hepatitis C Drugs in Medicare Part D
Jeah Kyoungrae Jung, PhD; Roger Feldman, PhD; Chelim Cheong, PhD; Ping Du, MD, PhD; and Douglas Leslie, PhD

Coverage for Hepatitis C Drugs in Medicare Part D

Jeah Kyoungrae Jung, PhD; Roger Feldman, PhD; Chelim Cheong, PhD; Ping Du, MD, PhD; and Douglas Leslie, PhD
This study analyzes the current coverage designs for hepatitis C virus drugs by Medicare Part D plans.
These findings are consistent with recent reports on Part D coverage for high-price rheumatoid arthritis and cancer drugs.20,21 This implies that the strategies of high cost sharing and use of prior authorization are not unique to HCV drugs but are applied to many high-price drugs. It is discouraging that the effectiveness or the therapeutic values of drugs are not considered in benefit decisions. New HCV drugs are highly efficacious, but Part D plans’ coverage for them differs little from coverage for less-effective HCV drugs, such as the first DAAs. It is also surprising that integrated MAPDs charge slightly higher cost sharing on average for new HCV drugs than do standalone PDPs, although they could expect potential cost savings from reduced use of medical services by offering generous coverage for those drugs.
 
Cost sharing is commonly used to contain healthcare expenditures, so plans may have naturally turned to high cost sharing for all costly drugs as drug spending rose. Although not surprising, this raises a concern that patients’ access to needed medications may be limited, which can lead to worsened health outcomes. It also raises an important but difficult question of how to design benefits for high-price drugs. One approach would be to selectively lower cost sharing for high-value drugs—particularly for beneficiaries with financial difficulties—to ensure patients’ access to effective drugs.
 
Linking cost sharing to value is not a new strategy. It has been adopted for drugs used to treat common chronic conditions, such as diabetes or hypertension.22,23 Applying it to new drugs can be challenging, however, because defining and measuring value is difficult, and evidence on real-world effectiveness or cost-saving effects has not yet been established for new HCV drugs. Little is known about their impact on patients’ health outcomes, such as incidence or progress of liver diseases, and on posttherapy healthcare utilization. A value-based approach based on clinical efficacy (using currently available information) would be limited, but it could be a good starting place while implementing procedures to update information on value/effectiveness as more evidence is gathered.
 
In addition, reducing financial stress on beneficiaries who need expensive but effective drugs can help improve patients’ access to those drugs. As discussed above, the current Part D coverage may not offer adequate financial protection to some beneficiaries because high prices of recently introduced drugs far exceed the initial coverage limit and OOP maximum thresholds in Part D. Expanding eligibility for low-income cost-sharing subsidies for certain costly, yet effective, drugs might be an option to explore.
 
Limitations
Our analysis is limited to examining coverage for HCV drugs without assessing its impact on drug utilization. It does not tell us how many patients would not initiate new drug therapies or discontinue therapies due to financial burdens. We could not examine protocols for prior authorization and how many cases are denied. Future research should address those questions as utilization data for the post-Sovaldi period become available.
 
CONCLUSIONS
Our analysis is the first to describe the current Part D benefits for HCV drugs and examine their financial implications for HCV patients. It indicates that Part D enrollees using new HCV drugs with no subsidy face sizable financial burdens, even with catastrophic coverage and the recent in-gap discount for brand name drugs. As baby boomers—the group most likely to have HCV—join Medicare, efforts should be made to ensure patients’ access to needed drugs. 


Author Affiliations: Department of Health Policy and Administration, College of Health and Human Development, The Pennsylvania State University (JKJ, CC), University Park, PA; Department of Public Health Sciences (PD), Division of Health Services and Behavioral Research (DL), Penn State University College of Medicine, The Pennsylvania State University, Hershey, PA; Division of Health Policy and Management, School of Public Health, University of Minnesota (RF), Minneapolis MN.

Source of Funding: This work was supported by NIH/NIA grant number 1R01AG047934-01, and NIH grant number R24 HD041025. No conflicts of interest exist.

Author Disclosures: The authors report 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 (JKJ, RF, PD); acquisition of data (JKJ); analysis and interpretation of data (JKJ, RF, CC, DL); drafting of the manuscript (JKJ, PD, DL); critical revision of the manuscript for important intellectual content (RF, CC, PD, DL); statistical analysis (JKJ, CC); obtaining funding (JKJ); administrative, technical, or logistic support (CC).

Address correspondence to: Jeah Kyoungrae Jung, PhD, Department of Health Policy and Administration, College of Health and Human Development, The Pennsylvania State University, 601E Ford Building, University Park, PA 16802. E-mail: kuj11@psu.edu.
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