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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
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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
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Darius N. Lakdawalla, PhD; Mark T. Linthicum, MPP; and Jacqueline Vanderpuye-Orgle, PhD
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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
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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
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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
Member cost negatively affects initial medication adherence and manufacturer coupons can decrease member share by up to 98%.
Our study has several limitations. First, we did not analyze member characteristics such as health literacy, treatment preferences, or prior treatment failures. We also assumed the members who abandoned therapy did so because of their insurer-required sofosbuvir member cost share, while other unmeasured factors—such as side effects of therapy, stigma of the disease, or a provider’s decision to change a course of therapy—may all influence initial sofosbuvir abandonment. This, along with data availability and study design, limits our ability to conclude causality between the insurer-required member cost share and sofosbuvir therapy abandonment. Second, our study was conducted within a commercially insured population, limiting generalizability nationally and to publicly insured populations. The impact of sofosbuvir coupons on member cost share was limited to members who filled their initial sofosbuvir claim at a specialty pharmacy. This further limits the generalizability to populations filling their prescriptions elsewhere.
Additionally, we only examined a single product within the HCV class, although more than 90% of new HCV treatment regimens included sofosbuvir during the analysis period.13 The coupon analysis is also subject to bias, as we did not have information on the utilization of manufacturer coupons unless the claim was filled at the specialty pharmacy. For 71.9% of members, we do not know if a coupon was applied to their sofosbuvir claim. Finally, we did not evaluate the impact of sofosbuvir abandonment on health outcomes. Further research is necessary in this area to understand the long-term impact of HCV treatment on the clinical, healthcare cost, and societal cost outcomes associated with adherence to HCV therapy.
Manufacturer coupons have increased dramatically in the past 5 years. The pharmaceutical industry will have spent about $7 billion on coupons and discount cards in 2015—a significant increase from the $1 billion spent in 2010.15 Although we found evidence that sofosbuvir coupons significantly reduced member cost, understanding the long-term impact of coupons on how insured members purchase and utilize prescription drugs is important. The cost-saving benefits that manufacturer coupons provide to members may only be experienced in the short term.16 Manufacturer coupons offset the difference in member cost share between generic and brand-name drugs available to them by their insurer.17 By doing so, manufacturer coupons could alter incentives of both patients and providers away from utilizing low-cost alternatives that are equally safe and effective. This altering of incentives and the subsequent impact on costs is why the HHS issued a ruling banning coupons in Medicare.18 The negative impact of manufacturer coupons can be twofold: increased direct healthcare costs,16 when a manufacturer ends a coupon program and the costs fall back onto the member, and increased indirect costs, such as rising insurance premiums.16,19
When a sofosbuvir manufacturer coupon was used, it dramatically lowered a member’s cost share by an average of $1321, lowering the member’s true amount paid for their initial sofosbuvir prescription to an average of $28. The manufacturer coupon for HCV therapy can potentially assist in preventing new therapy abandonment, as our findings suggest that an insurer-required member cost share of greater than $2500 was associated with higher sofosbuvir abandonment rates. However, coupons for nonpreferred drugs may result in higher premiums, due to loss of formulary management capabilities that are essential to keep premiums low.

The authors would like to thank G. Caleb Alexander, MD, MS, for his time, critical review, expertise, and insight.

Author Affiliations: Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health (TDK), Baltimore, MD; Center for Drug Safety and Effectiveness, Johns Hopkins University (TDK), Baltimore, MD; Prime Therapeutics LLC (CIS, YQ, KT, PPG), Eagan, MN; College of Pharmacy, Department of Pharmaceutical Care and Health Systems, University of Minnesota (CIS, PPG), Minneapolis, MN.

Source of Funding: Prime Therapeutics LLC funded the study internally. Ms Karmarkar is supported by the T32 NRSA Training Grant from the Agency for Healthcare Research and Quality. The funding source had no role in the design and conduct of the study, analysis, or interpretation of the data; and preparation or final approval of the manuscript prior to publication.

Author Disclosures: Ms Qiu and Drs Starner and Gleason are employees of Prime Therapeutics, which is a pharmacy benefit management company and funded the study. Ms Tiberg was of Prime Therapeutics at the time the manuscript was accepted for publication; she also presented at the Pharmacy Benefit Management Institute conference in March 2015 on “Hepatitis C Forecasting and Management.” The remaining 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 (TDK, CIS, YQ, KT, PPG); acquisition of data (CIS, PPG); analysis and interpretation of data (CIS, YQ, PPG); drafting of the manuscript (TDK, CIS, KT, PPG); critical revision of the manuscript for important intellectual content (TDK, CIS, KT, PPG); statistical analysis (YQ); and supervision (PPG).

Address correspondence to: Patrick P. Gleason, PharmD, Prime Therapeutics LLC, 1305 Corporate Center Dr, Eagan, MN 55121. E-mail:

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