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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
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Does Patient Cost Sharing for HCV Drugs Make Sense?
Darius N. Lakdawalla, PhD; Mark T. Linthicum, MPP; and Jacqueline Vanderpuye-Orgle, PhD
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

Does Patient Cost Sharing for HCV Drugs Make Sense?

Darius N. Lakdawalla, PhD; Mark T. Linthicum, MPP; and Jacqueline Vanderpuye-Orgle, PhD
Despite the high cost of novel hepatitis C treatments and patients' apparent willingness to bear part of it, high patient cost sharing is both inefficient and inequitable.
Am J Manag Care. 2016;22(5 Spec Issue No. 6):SP188-SP190
The launch of novel direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) in 2013 brought the ever-present tension among innovation, drug pricing, and patient access into the media and policy-making spotlight. Although the clinical value of these drugs is clear, their high cost raised protests from insurers and health systems concerned that treating HCV patients with these highly effective new drugs would bankrupt the healthcare system. As a result, some insurers have shifted the cost burden partly onto patients with HCV by placing these therapies on high-cost specialty drug tiers within their formularies. This approach might seem appealing and “equitable” at some level, but closer reflection reveals that it would expose patients with HCV to potentially significant financial burdens at a time when they are least able to cope with them. There are better options for sharing the costs of HCV treatment among beneficiaries.
Effects of Cost Sharing on Adherence in HCV
Opponents of high cost sharing commonly argue that it reduces patient adherence and leads to worse health outcomes. Indeed, there is considerable evidence to suggest that high levels of cost sharing have such effects in a wide variety of disease areas1: on average, 10% greater cost sharing reduces pharmaceutical spending by 2% to 6% but is also associated with lower initiation and adherence.2 However, this pattern does not appear to hold in the case of HCV therapies. Although adherence data for new DAAs remain scarce, we can assess the relationship between cost sharing and adherence to older, less-effective regimens, such as pegylated interferon (Peg-IFN) alone, Peg-IFN plus ribavirin (RBV), or so-called “triple therapy”—Peg-IFN plus RBV plus older generation DAAs boceprevir or telaprevir (BOC/TPV).
The Figure illustrates the relationship between adherence and cost sharing for employer-insured patients with HCV who were prescribed older HCV regimens between 2004 and early 2014. Adherence is measured by the proportion of days covered (PDC), which measures the fraction of days on which the patient had the medication on hand—the lower the PDC, the more days of therapy patients are forced to miss. The degree of cost sharing is measured as the proportion of total drug costs, paid out of pocket, for each insurance plan and year in the data; it is broken into 4 quartiles: 1 (lowest cost-sharing plan-years) to 4 (highest).
The Figure also demonstrates how average adherence across plan-years varies across cost-sharing quartiles for different HCV regimens. It shows no economically or statistically meaningful effects of cost sharing on adherence; the only factor possibly affecting adherence appears to be regimen type, where patients may be slightly less adherent to regimens that include BOC/TPV. However, higher cost sharing does not seem to discourage adherence to earlier HCV regimens. Patients were willing to bear higher out-of-pocket costs for the older generation of drugs. Economic theory would suggest that they would be just as, if not more, willing to bear higher out-of-pocket costs for the newer, more effective and more tolerable generation of drugs.
Does High Cost Sharing for DAAs Make Sense?
In light of this, it would be tempting to conclude that high cost sharing for new DAAs is unlikely to discourage adherence. Although this might be the case, new DAAs are very expensive and likely to be considered specialty drugs for reimbursement purposes. Subsequently, patients’ actual out-of-pocket costs under high cost-sharing arrangements could be quite large, even with private insurance. High cost-sharing arrangements for these therapies would therefore impose a significant financial burden on patients who are already bearing the burden of a potentially life-threatening disease.

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