Cost-Effectiveness of Brexanolone Versus Selective Serotonin Reuptake Inhibitors for the Treatment of Postpartum Depression in the United States

Eldar-Lissai, Adi; Cohen, Joshua T.; Meltzer‐Brody, Samantha; Gerbasi, Margaret E.; Chertavian, Elizabeth; Hodgkins, Paul; Bond, Julia C.; Johnson, Scott J.

doi:10.18553/jmcp.2020.19306

Cited by 12 publications

(25 citation statements)

References 72 publications

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“…53 A recent cost-effectiveness analysis also indicates that treatment of adults with PPD using BRX is cost-effective compared to SSRIs over an 11-year time horizon, particularly for patients with severe symptoms, based on a United States health care payer perspective. 54 There are limitations to this study. As this analysis was conducted on clinical trial data, estimating MCT values was not an objective at study onset, therefore the estimates reported here should be validated on an external dataset, and ideally additional anchors, including patient-reported anchors, should also be included.…”

Section: Discussionmentioning

confidence: 90%

Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making

Gerbasi

Meltzer‐Brody

Acaster

et al. 2021

Journal of Women's Health

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Background: Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two Phase 3 clinical trials. Materials and Methods: Data from the three trials were combined. PPD-specific 17-item Hamilton Rating Scale for Depression (HAMD-17) group-level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT]) were estimated and applied to differences in BRX versus placebo (PBO) at hour 60 (primary endpoint) and day 30 (end of trial follow-up). Likelihood of HAMD-17 response and remission and Clinical Global Impression of Improvement (CGI-I) response for BRX versus PBO were assessed at hour 60 and as sustained through day 30 using relative risk. Associated number needed to treat (NNT) and number needed to harm (NNH) values were also estimated. Results: Two-hundred nine patients were included. The average HAMD-17 MID estimate was −2.1; the least-squared mean difference between BRX and PBO exceeded this at hour 60 and day 30. Minimal, moderate, and large MCTs were estimated to be −9, −15, and −20 points, respectively. Significantly more BRX-treated than PBO-treated patients achieved minimal, moderate, and large change (all p s < 0.05) at hour 60 and large meaningful response at day 30 ( p < 0.05). BRX-treated patients were more likely to sustain HAMD-17 remission and CGI-I response through day 30 versus PBO. NNTs ranged from 4 to 8, with NNH of 97. Conclusions: BRX provided meaningful changes relative to PBO, rapid (hour 60), and sustained improvements (day 30) in PPD symptoms, low NNT, and large NNH. These results may help inform treatment decision-making. Clinicaltrials.gov registration numbers: NCT02614547, NCT02942004, and NCT02942017.

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Section: Discussionmentioning

confidence: 90%

Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making

Gerbasi

Meltzer‐Brody

Acaster

et al. 2021

Journal of Women's Health

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“…However, its use is currently restricted to certified healthcare facilities and must be infused over 60 hours. These factors, along with its cost of approximately $39,000 for the drug and its administration, have significantly limited its access [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

A Novel Treatment of Postpartum Depression and Review of Literature

Yoon¹,

Martin²

2022

Cureus

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Early-onset postpartum depression has been shown to have a unique neurobiological basis compared to major depressive disorder, implying a need for targeted treatments such as the recent Food and Drug Administration (FDA)-approved brexanolone. In this case report, a woman with a past medical history of major depressive disorder was diagnosed with postpartum depression due to worsening mood with suicidal and homicidal ideations. She was treated with vilazodone and aripiprazole with good effect after consideration of her past medication trials. Her regimen is unique in clinical practice and not reported in current literature for the treatment of postpartum depression. It may represent a safe and effective medication choice, especially in the context of current first-line treatments that have a high treatment failure rate. More research is needed to find treatments that address the unique challenges of postpartum women.

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“…The continuous infusion, the need for an inpatient facility, requiring continuous pulse oximetry monitoring, and side effects such as sedation leading to the discontinuation of this treatment all add to the challenges of brexanolone becoming a real-world practical treatment for PPD [51]. Further adding to the barriers is the total cost of USD 34,000 (USD 7450 per vial and about 4.58 vials on average), excluding the inpatient facility cost [50,51]. This makes its use as the treatment of choice cost 36 times more in contrast to mainstream therapy.…”

Section: Discussionmentioning

confidence: 99%

Treating Postpartum Depression: What Do We Know about Brexanolone?

et al. 2021

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Postpartum depression (PPD) is defined as the onset of major depressive disorder in mothers, occurring during pregnancy or within 4 weeks post-delivery. With 7% of pregnancy-related death in the United States owing to mental health conditions, including PPD, and a global prevalence of 12%, PPD is a growing public health concern. In 2019, the Food and Drug Administration (FDA) approved brexanolone, an exogenous analog of allopregnanolone, as the first ever drug to be specifically indicated for treating patients with PPD. This approval was preceded by an open-label study and three randomized placebo-controlled trials, each assessing the safety, tolerability, and efficacy of brexanolone, using mean Hamilton Rating Scale for Depression (HAM-D) score reduction as the primary outcome. In each randomized controlled trial, the drug was administered as an intravenous infusion given over 60 h. Enrolled participants were followed up on days 7 and 30 to evaluate the sustained effect. A statistically significant reduction in mean HAM-D score compared to placebo was observed in all three studies, supporting brexanolone’s use in treating moderate-to-severe PPD. Therefore, this article attempts to briefly review the pharmacology of brexanolone, evaluate the latest available clinical data and outcomes concerning its use, reevaluate its position as a ‘breakthrough’ in managing PPD, and review the cost-related barriers to its worldwide standardized use.

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Cost-Effectiveness of Brexanolone Versus Selective Serotonin Reuptake Inhibitors for the Treatment of Postpartum Depression in the United States

Cited by 12 publications

References 72 publications

Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making

Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making

A Novel Treatment of Postpartum Depression and Review of Literature

Treating Postpartum Depression: What Do We Know about Brexanolone?

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