Cost-Effectiveness Analysis of Lenacapavir Compared to Cabotegravir and Generic Oral FTC/TDF for HIV Pre-Exposure Prophylaxis for Cis-Gender Women in the United States
Author(s)
Devyani Bhatnagar, MS1, Swarnali Goswami, PhD2, Prajakta P. Masurkar, PhD3, David W. Hutton, PhD1.
1University of Michigan, Ann Arbor, MI, USA, 2HEOR, University of Mississippi, Department of Pharmacy Administration,, University, MS, USA, 3Associate Director, HEOR, UCB, Milton, GA, USA.
1University of Michigan, Ann Arbor, MI, USA, 2HEOR, University of Mississippi, Department of Pharmacy Administration,, University, MS, USA, 3Associate Director, HEOR, UCB, Milton, GA, USA.
OBJECTIVES: Lenacapavir (LEN) is a bi-annual injectable HIV Pre-exposure Prophylaxis (PrEP) drug that has shown promising results in clinical trials among cis-gender women in terms of HIV prevention. This study assessed the lifetime cost-effectiveness of LEN compared to the two other FDA-approved PrEP options for cis-gender women: the bi-monthly injectable cabotegravir (CAB) and the daily oral generic emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) from a US Payer Perspective
METHODS: A four-state Markov model simulated PrEP initiation with CAB, LEN, or FTC/TDF in eligible adults. Individuals could continue initial PrEP or discontinue. Efficacy data were drawn from the HPTN 083/084 trials for CAB-LA, FTC/TDF, and the PURPOSE 1 trial for LEN. Other model inputs were referred from published literature. Lifetime HIV-related costs, transmissions, and resistance risks were modeled. Outcomes included infections prevented, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Model outcomes were discounted at 3%. One-way and probabilistic sensitivity analyses (PSA) were performed to test the model’s robustness.
RESULTS: The model estimated that LEN prevented 3.7 more HIV-1 infections per 100 PrEP users compared to FTC/TDF and 0.2 more infections compared to CAB. CAB-LA and LEN both reduced QALY losses versus FTC/TDF, with incremental lifetime costs of $42,761.82 and $69,039.08 per person, respectively. The ICERs were $261,127.09 and $240,938.39 per QALY gained for FTC/TDF and CAB-LA, respectively, compared to LEN exceeding traditional cost-effectiveness thresholds. Results remained consistent in sensitivity and scenario analyses.
CONCLUSIONS: LEN is not cost-effective compared to generic FTC/TDF or CAB-LAI for HIV PrEP. However, LEN offers a viable alternative with reduced administration frequency for individuals at risk of acquiring HIV infection.
METHODS: A four-state Markov model simulated PrEP initiation with CAB, LEN, or FTC/TDF in eligible adults. Individuals could continue initial PrEP or discontinue. Efficacy data were drawn from the HPTN 083/084 trials for CAB-LA, FTC/TDF, and the PURPOSE 1 trial for LEN. Other model inputs were referred from published literature. Lifetime HIV-related costs, transmissions, and resistance risks were modeled. Outcomes included infections prevented, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Model outcomes were discounted at 3%. One-way and probabilistic sensitivity analyses (PSA) were performed to test the model’s robustness.
RESULTS: The model estimated that LEN prevented 3.7 more HIV-1 infections per 100 PrEP users compared to FTC/TDF and 0.2 more infections compared to CAB. CAB-LA and LEN both reduced QALY losses versus FTC/TDF, with incremental lifetime costs of $42,761.82 and $69,039.08 per person, respectively. The ICERs were $261,127.09 and $240,938.39 per QALY gained for FTC/TDF and CAB-LA, respectively, compared to LEN exceeding traditional cost-effectiveness thresholds. Results remained consistent in sensitivity and scenario analyses.
CONCLUSIONS: LEN is not cost-effective compared to generic FTC/TDF or CAB-LAI for HIV PrEP. However, LEN offers a viable alternative with reduced administration frequency for individuals at risk of acquiring HIV infection.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE22
Topic
Economic Evaluation
Topic Subcategory
Value of Information
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Infectious Disease (non-vaccine), SDC: Reproductive & Sexual Health