Study Supports Pricing Long-Acting Injectable Cabotegravir to Compete With Oral HIV PrEP

The value of the highly effective long-acting injectable HIV prevention medication cabotegravir (CAB-LA) will depend on how much it is priced, according to the results of a study led by investigators at Massachusetts General Hospital (MGH).¹

The findings, published in the Annals of Internal Medicine, show that the superiority of long-acting injectable cabotegravir (CAB-LA) to prevent HIV over oral alternatives among high-risk men who have sex with men (MSM) and transgender women (TGW) in the United States would not justify a large price difference for the new medication.¹

“While an injection given every 2 months to prevent HIV is an exciting option, unless priced to reflect its actual value above newly available generic pills, the people who need it most may be left behind,” Anne Neilan, MD, MPH, investigator in the Divisions of General Academic Pediatrics and Infectious Diseases at MGH, said in a statement.¹

Investigators teamed up with the HIV Prevention Trials Network 083 study on efficacy of CAB-LA compared with daily oral emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIVE pre-exposure prophylaxis (PrEP) among MSM and TGW.¹

They used widely published computer microsimulation models to examine the cost-effectiveness of long-acting injectable PrEP compared with oral alternatives.¹

The results of the analysis show that at a range of willingness-to-pay thresholds, CAB-LA for PrEP among MSM and TGW who were at high risk for HIV would only provide good value if its annual price was less than $6600 higher than generic F/TDF.¹

CAB-LA’s pricing was announced after the study was accepted for publication, and its annual price is actually more than 3 times higher than is estimated in the study.¹

“The current pricing of CAB-LA has the potential to worsen existing disparities in PrEP uptake, rather than improve them,” Kenneth Freedberg, MD, MSc, director of the Medical Practice Evaluation Center at MGH, said in the statement. “This has clear implications in the U.S. and even more important implications in lower-resourced settings where CAB-LA for PrEP is highly anticipated but has not yet been introduced.”¹

Additionally, investigators highlight the opportunities for improved implementation if CAB-LA could be priced to be cost-saving when compared with generic F/TDF.¹

Additional investments could be made in other approaches, like innovative delivery, which could also promote equitable access to the drug, Neilan said.¹

Recently, the FDA approved Cabenuva (ViiV Healthcare) CAB-LA combined with long-acting injectable rilpivirine (Janssen), for every-2-month dosing for adult individuals with HIV.²

In January 2021, the FDA approved Cabenuva for a once-monthly injection.³

Cabenuva is the first and only complete long-acting HIV treatment regimen that contains ViiV Healthcare’s cabotegravir extended-release (ER) injectable suspension in a single-dose vial and rilpivirine ER injectable suspension in a single-dose vial.²

Both monthly and twice-a-month injections showed similar effectiveness, as well as similar rates of virologic suppression, and most respondents preferred the every-2-month injection over an oral version of the drug that was taken as the required lead-in.²

References

1. New study supports pricing long-acting injectable cabotegravir to compete with generic oral HIV pre-exposure prophylaxis. EurekAlert. News release. February 1, 2022. Accessed February 2, 2022. https://www.eurekalert.org/news-releases/942006

2. Gallagher A. FDA approves Cabenuva for 2-month dosing to treat HIV-1. Pharmacy Times. February 1, 2022. Accessed February 3, 2022. https://www.pharmacytimes.com/view/fda-approves-cabenuva-for-2-month-dosing-to-treat-hiv-1

3. Hippensteele A. FDA approves rilpivirine, cabotegravir as the first long-acting regimen for HIV treatment. January 22, 2021. Accessed February 3, 2022. https://www.pharmacytimes.com/view/fda-approves-rilpivirine-cabotegravir-as-the-first-long-acting-regimen-for-hiv-treatment