National Trends in Drug Payments for HIV Preexposure Prophylaxis in the United States, 2014 to 2018

BACKGROUND Use of HIV preexposure prophylaxis (PrEP) has increased nationwide, but the magnitude and distribution of PrEP medication costs across the health care system are unknown. OBJECTIVE To estimate out-of-pocket (OOP) and third-party payments using a large pharmacy database. DESIGN Retrospective cohort study. SETTING Prescriptions for tenofovir disoproxil fumarate with emtricitabine (TDF-FTC) for PrEP in the United States in the IQVIA Longitudinal Prescriptions database, which covers more than 90% of retail pharmacy prescriptions. MEASUREMENTS Third-party, OOP, and total payments were compared by third-party payer, classified as commercial, Medicaid, Medicare, manufacturer assistance program, or other. Missing payment data were imputed using a generalized linear model to estimate overall PrEP medication payments. RESULTS Annual PrEP prescriptions increased from 73 739 to 1 100 684 during 2014 to 2018. Over that period, the average total payment for 30 TDF-FTC tablets increased from $1350 to $1638 (5.0% compound annual growth rate) and the average OOP payment increased from $54 to $94 (14.9% compound annual growth rate). Of the $1638 in total payments per 30 TDF-FTC tablets in 2018, OOP payments accounted for $94 (5.7%) and third-party payments for $1544 (94.3%). Out-of-pocket payments per 30 tablets were lower among Medicaid recipients ($3) than among those with Medicare ($80) or commercial insurance ($107). Payments for PrEP medication in the IQVIA database in 2018 totaled $2.08 billion; $1.68 billion (80.7%) originated from prescriptions for persons with commercial insurance, $200 million (9.6%) for those with Medicaid, $48 million (2.3%) for those with Medicare, and $127 million (6.1%) for those with manufacturer assistance. LIMITATION The IQVIA database does not capture every prescription nationwide. CONCLUSION Third-party and OOP payments per 30 TDF-FTC tablets increased annually. The $2.08 billion in PrEP medication payments in 2018 is an underestimation of national costs. High costs to the health care system may hinder PrEP expansion. PRIMARY FUNDING SOURCE Centers for Disease Control and Prevention.

[1]  R. Walensky,et al.  Medicare Part D and Cost-Sharing for Antiretroviral Therapy and Preexposure Prophylaxis , 2020, JAMA network open.

[2]  R. Walensky,et al.  Comparative Pricing of Branded Tenofovir Alafenamide–Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate–Emtricitabine for HIV Preexposure Prophylaxis , 2020, Annals of Internal Medicine.

[3]  V. Patel,et al.  Evaluation of Algorithms Used for PrEP Surveillance Using a Reference Population From New York City, July 2016–June 2018 , 2020, Public health reports.

[4]  D. Smith,et al.  Vital Signs: Status of Human Immunodeficiency Virus Testing, Viral Suppression, and HIV Preexposure Prophylaxis — United States, 2013–2018 , 2019, MMWR. Morbidity and mortality weekly report.

[5]  C. Orkin,et al.  Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TA , 2019, Antiviral research.

[6]  R. Redfield,et al.  Ending the HIV Epidemic: A Plan for the United States. , 2019, JAMA.

[7]  A. Siegler,et al.  Persistence on HIV preexposure prophylaxis medication over a 2‐year period among a national sample of 7148 PrEP users, United States, 2015 to 2017 , 2019, Journal of the International AIDS Society.

[8]  L. Waters,et al.  Are new antiretroviral treatments increasing the risks of clinical obesity? , 2019, Journal of virus eradication.

[9]  Michael R. Kramer,et al.  Trends in the use of oral emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis against HIV infection, United States, 2012-2017. , 2018, Annals of epidemiology.

[10]  D. Smith,et al.  HIV Preexposure Prophylaxis, by Race and Ethnicity — United States, 2014–2016 , 2018, MMWR. Morbidity and mortality weekly report.

[11]  A. Pozniak,et al.  How safe is TDF/FTC as PrEP? A systematic review and meta-analysis of the risk of adverse events in 13 randomised trials of PrEP , 2018, Journal of virus eradication.

[12]  R. Gandhi.  Preexposure Prophylaxis for the Prevention of HIV , 2018 .

[13]  M. Chartier,et al.  Accessibility and Uptake of Pre-Exposure Prophylaxis for HIV Prevention in the Veterans Health Administration. , 2018, Federal practitioner : for the health care professionals of the VA, DoD, and PHS.

[14]  Dawn K. Smith,et al.  Estimated Coverage to Address Financial Barriers to HIV Preexposure Prophylaxis Among Persons With Indications for Its Use, United States, 2015 , 2017, Journal of acquired immune deficiency syndromes.

[15]  M. Clark,et al.  Potential Healthcare Insurance and Provider Barriers to Pre‐Exposure Prophylaxis Utilization Among Young Men Who Have Sex with Men , 2017, AIDS patient care and STDs.

[16]  P. Sullivan,et al.  Optimal costs of HIV pre-exposure prophylaxis for men who have sex with men , 2017, PloS one.

[17]  K. Mayer,et al.  Impact of insurance coverage on utilization of pre-exposure prophylaxis for HIV prevention , 2017, PloS one.

[18]  M. Mimiaga,et al.  Defining the HIV pre-exposure prophylaxis care continuum , 2017, AIDS.

[19]  P. Sullivan,et al.  Willingness to use pre-exposure prophylaxis among Black and White men who have sex with men in Atlanta, Georgia , 2016, International journal of STD & AIDS.

[20]  Raffaele Vardavas,et al.  A Cost-effectiveness Analysis of Preexposure Prophylaxis for the Prevention of HIV Among Los Angeles County Men Who Have Sex With Men. , 2016, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[21]  K. Humphreys,et al.  Cost-Effectiveness of HIV Preexposure Prophylaxis for People Who Inject Drugs in the United States , 2016, Annals of Internal Medicine.

[22]  Leemore S. Dafny,et al.  When Discounts Raise Costs: The Effect of Copay Coupons on Generic Utilization , 2016 .

[23]  A. Phillips,et al.  What do we know about the cost–effectiveness of HIV preexposure prophylaxis, and is it affordable? , 2016, Current opinion in HIV and AIDS.

[24]  David Thompson,et al.  On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. , 2015, The New England journal of medicine.

[25]  C. Hendrix,et al.  Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial , 2013, The Lancet.

[26]  John T Brooks,et al.  Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. , 2012, The New England journal of medicine.

[27]  James D. Campbell,et al.  Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. , 2012, The New England journal of medicine.

[28]  Sally Galbraith,et al.  Applied Missing Data Analysis by Craig K Enders , 2012 .