chronic hepatitis b (chb) causes significant liver-related morbidity and mortality. chb treatment is profitable in the united states; however, high out-of-pocket costs for first-line therapy can be a barrier to treatment.
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entecavir, a generic drug that is one of the first-line agents used for the treatment of chb, has seen a sharp drop in the average price that pharmacies pay for the drug (i.e., the national average cost of acquisition of drugs [nadac]) due to competition from the manufacturer. however, the list price, which correlates with out-of-pocket spending, has remained high. We evaluated trends in the number of manufacturers, average wholesale price, nadac, and out-of-pocket spending for entecavir among a commercially insured population with chb between 2014 and 2018.
For this cross-sectional study, annual Nadac prices of entecavir 0.5 mg tablets were obtained from the Medicaid publicly available Nadac database for the last week of December 2014 to December 2018.1 We calculated the price average annual wholesale price based on a weighted average calculation of medicaid spending and the average wholesale price were derived from a criteria standard drug database (prospectorx).2 we used the state food and drug administration orange book united to determine the annual number of drug manufacturers. We analyzed a commercial database of health claims using a cloud-based analytical interface (ibm corp) from 2014 (the year of entry of generic entecavir) to 2018 (the most recent data available). we limit our analysis to continuously enrolled members with private insurance and a chb diagnosis code associated with a visit within 2 years of the analysis period and a claim for entecavir 0.5 or 1 mg tablets (and appendix in the supplement) . we obtained entecavir refill and utilization data and calculated the average number of refills per member, the average number of days of supply per member, and the average annual out-of-pocket expense, as well as the total spend per member, refill, and 30 days. supply stratified by use of a high deductible health plan. We follow the Strengthening Reporting of Observational Studies in Epidemiology (Stroboscopic) reporting guideline for observational studies. The protocol for this study was reviewed by the US Centers for Disease Control and Prevention and granted waiver status. the study used data from an anonymous database. all results are presented in aggregate form and no specific patients were identified; therefore, informed consent was not required under 45 cfr §46. data was analyzed using stata se version 16.1 (statacorp).
Between 2014 and 2018, there were more than 1,000 annual fills of entecavir and a mean (of) 6.7 (3.8) annual fills per member. As the number of entecavir manufacturers increased from 1 to 11, Nadac decreased from $30.12 to $1.93 per 0.5 mg tablet. the average wholesale price remained constant at $44.43. among commercially insured members, the mean (sd) out-of-pocket cost per 30-day supply of generic entecavir was $41 ($81) in 2014 and $52 ($97) in 2018. mean (sd) out-of-pocket cost per 30-day supply of brand-name entecavir was $118 ($180) in 2014 and $165 ($178) in 2018. Among members with a high-deductible health plan, the average (sd) out-of-pocket expense per 30-day supply of generic entecavir was $103 ($167) in 2014 and $133 ($122) in 2018. The mean (sd) total spend per 30-day supply of generic entecavir was $981 ($154) in 2014 and $591 ($332) in 2018 (table). Trends in number of manufacturers, nadac, average wholesale price, and out-of-pocket expense per 30-day supply of generic entecavir are shown in the figure.
Out-of-pocket spending on generic entecavir increased between 2014 and 2016 and remained high through 2018 despite strong generic competition and a marked decline in the price that pharmacies paid for entecavir. in 2018, despite 11 approved manufacturers, patients in high-deductible health plans spent an average of $133 per 30-day supply, a threshold associated with a greater than 50% prescription abandonment rate.3 the average wholesale price The artificially high price for entecavir is a likely factor in such high out-of-pocket costs, as the drugs are often paid for at a discount from the average wholesale price, benefiting supply chain intermediaries such as pharmacy benefit managers and wholesalers, while contributing to drug price inflation.4 in 2017, so-called differential pricing from pharmacy benefit managers caused indiana medicaid to spend more than $800 on a 30-day supply of entecavir that it cost pharmacies less than $140.5 and how out-of-pocket spending can influence prescription abandonment among people living with chb, a population tion predominantly born outside the United States and disproportionately affected by social determinants of health.6
Limitations of this study included the lack of health plan reimbursement or patient coupons in the cost calculations. In addition, we did not take into account other strategies, such as the division of 1 mg tablets, which could reduce out-of-pocket costs. Our findings highlight the need for policies that improve transparency around generic drug financing and pharmacy benefit management practices.
Accepted for publication: November 28, 2021.
Published: January 21, 2022. doi:10.1001/jamanetworkopen.2021.44521
Correction: This article was corrected on March 10, 2022 to correct errors in the figure.
open access: This is an open access article distributed under the terms of the cc-by license. © 2022 alpern jd et al. never open network.
corresponding author: jonathan d. alpern, md, healthpartners infectious diseases, 8170 33rd ave s, mailstop 23301a, minneapolis, mn 55425 (email@example.com).
Author contributions: drs. Alpern and Joo had full access to all study data and took responsibility for the integrity and accuracy of the data. analysis.
concept and design: alpern, joo, link, stauffer, bahr, leventhal.
data acquisition, analysis or interpretation: alpern, joo, link, ciaccia, stauffer, leventhal.
manuscript writing: alpern, joo, leventhal.
critical review of the manuscript for important intellectual content: all authors.
statistical analysis: wow.
administrative, technical or material support: alpern, link, bahr.
supervision: ciaccia, stauffer, leventhal.
Conflict of Interest Disclosures: dr. Alpern reported receiving funding from Arnold Ventures during the writing of the manuscript for an unrelated study. Mr. Ciaccia reported that he has clients that include the American Pharmaceutical Association, the Ohio Pharmaceutical Association and the American Pharmaceutical Cooperative Incorporated; He reported previous work for Capital RX, a transparent pharmaceutical administrator that uses the National Average Cost of Drug Acquisition methodology to price pharmacy claims. The doctor. stauffer reported receiving fees from fishawack health/emergent biosolutions and royalties for updating off of submitted work. The doctor. bahr reported receiving research funding from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (#k23ns110470) for unrelated work. no other disclosures were reported.
Disclaimer: The results and conclusions in this article are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.