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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
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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
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
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

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%.

To describe rates of sofosbuvir initial medication adherence as a function of the insurer-required member cost (ie, out-of-pocket cost) and to determine how manufacturer coupons affect insurer-required member cost.

Study Design: Observational cross-sectional analysis.

Methods: Administrative pharmacy claims data from 13 million commercially insured members were used to identify sofosbuvir new starts between January 2014 and September 2014. Members were categorized as either sofosbuvir initial adherence or as abandoning therapy. A multivariate logistic regression model adjusting for sociodemographic characteristics, severity of illness, and total drug costs (health insurer plus member amount) for non-sofosbuvir pharmacy claims in 2014 was used to evaluate the association between insurer-required member cost and initial medication adherence. In a sub-analysis, sofosbuvir index claims with coupon data available were analyzed to determine how coupon use impacted insurer-required member cost.

Results: A total of 67.3% of members had a pre-coupon member cost of <$250 for their index sofosbuvir claim. Just 201 (5.0%) members were exposed to a member cost of more than $10,000. The logistic regression model demonstrated an association between member cost and abandonment starting at $2500 to <$5000 (odds ratio: 1.9; 95% CI, 1.01-3.43; P = .0393). The average member sofosbuvir index claim cost was $1349 before coupon was applied, and $28 after. Overall, coupons offset the member amounts paid by 98%: $771,593 of the $787,860 member cost requested by the insurer.

Conclusions: These findings indicate that a 30-day supply sofosbuvir member cost of >$2500 was associated with increased initial therapy abandonment, and that manufacturer coupons substantially reduced sofosbuvir insurer-required member cost. Insurers and policy makers should consider the impact of member cost on medication adherence and the impact coupons have on the actual member cost.

Am J Manag Care. 2016;22(5 Spec Issue No. 6):SP191-SP197
Take-Away Points
The member cost share, coupon use, and impact of member cost share (ie, out-of-pocket cost) on adherence are unknown among members with hepatitis C virus that have been prescribed sofosbuvir. This study of more than 13 million commercially insured members in 2014 found: 
  • Increasing member cost share is significantly associated with lower initial sofosbuvir adherence. A sofosbuvir member cost share between $2500 and <$5000 was associated with 1.9 higher odds of new sofosbuvir therapy abandonment compared with the abandonment when member cost share was <$50. 
  • The average member cost share on the initial sofosbuvir 30-day supply claim was $1349 and coupons covered $1321 (98%), meaning a member actually paid $28 on average.
Chronic hepatitis C virus (HCV) infection can lead to cirrhosis, liver failure, hepatocellular carcinoma, and liver transplantation.1,2 In 2013, there were more than 29,000 reported cases of acute HCV in the United States, and more than 2.7 million individuals  estimated to be chronically infected with the virus.3 As the population continues to age, the burden of disease is expected to increase along with the economic burden on patients and the healthcare system.2
In 2013, the FDA approved simeprevir (Olysio) and sofosbuvir (Sovaldi) for the treatment of HCV. In contrast to earlier treatments, these products yield substantially higher cure rates—as high as 84% to 96%4—lower risks of side effects, and shorter treatment course. Since then, additional interferon-free therapies, such as ledipasvir/sofosbuvir (Harvoni) and dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira Pak), have also been approved.
The new products are costly for patients and third-party payers alike. CMS has defined drugs that cost more than $600 per month as specialty drugs.5 HCV drugs are an example of extremely high-cost specialty drugs. Ledipasvir/sofosbuvir costs $94,500 for a 12-week course, or about $1125 per day. A 12-week course of sofosbuvir, when used in combination with ribavirin, costs about $84,000, or about $1000 a day. The potential costs of treating all Americans infected with the virus6 has thus generated a great deal of controversy. In addition to the issue of societal affordability, is the question of how much a member should contribute, as their cost share (ie, out-of-pocket cost), when they have insurance. There are many different pharmacy benefit designs, ranging from a fixed cost share per prescription—$50 per month, for example—to a fixed percentage coinsurance—20%, for example, which, for sofosbuvir, would result in thousands of dollars in insurer-required member cost share.
Previous research has identified a negative association between a member’s cost share and starting or re-initiating therapy—also called initial medication adherence.7 For multiple sclerosis (MS), oral oncology, and biologic anti-inflammatory drug therapies, member cost shares above $250 per month supply were associated with significantly lower initial medication adherence rates.8-11 As member cost sharing rose to more than $2000 a month, initial medication adherence was less than 50%, meaning that more than half of members abandoned their newly prescribed therapy for MS or an autoimmune disease when they were asked to pay more than $2000 monthly.
To help members avoid cost shares, most manufacturers of brand-name drugs for any condition offer coupons that reduce the insurer-required member’s cost share to less than $50 per month. For the HCV drugs, pharmaceutical manufacturer coupons are available to lower a member’s cost to “$5 per prescription fill, up to a maximum of 25% of the catalog price of a 12-week regimen. The offer is valid for 6 months from the time of first redemption.”12,13 However, we know little about the extent to which HCV drug coupons are used, or about their potential impact on initial medication adherence.
The primary objectives of this study were to describe member cost sharing for sofosbuvir, to quantify sofosbuvir initial medication adherence rates as a function of the insurer-required member cost, and, in a subset of members, to determine how member cost for sofosbuvir is lowered by manufacturer coupons.
The methods applied in this analysis are identical to those found in previous research.7,8 We used administrative pharmacy claims data from a pharmacy benefit manger with more than 13 million commercially insured members from 14 different plans. We identified members for our analytic sample as those newly initiating HCV therapy with sofosbuvir between January and September 2014; members with a sofosbuvir claim in December 2013 were excluded. Only sofosbuvir was chosen because it was recently approved and it was the primary HCV specialty drug treatment during the treatment initiation analysis period of January through September 2014. Members were eligible for the analysis if they were continuously enrolled for 90 days after the first sofosbuvir transaction. The first sofosbuvir transaction was the index claim for a member. For a sensitivity analysis, we required 180 days of continuous enrollment after the first transaction.

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