lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Cost-Effectiveness of Oral Cannabinoid-Rich THC:CBD Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting

34 Pages Posted: 22 Jul 2024

See all articles by Mbathio Dieng

Mbathio Dieng

The University of Sydney - NHMRC Clinical Trials Centre

Peter Grimison

The University of Sydney - NHMRC Clinical Trials Centre

Antony Mersiades

The University of Sydney - NHMRC Clinical Trials Centre

Adrienne Kirby

The University of Sydney - NHMRC Clinical Trials Centre

Anna Walsh

The University of Sydney - NHMRC Clinical Trials Centre

Martin R. Stockler

The University of Sydney - NHMRC Clinical Trials Centre

Rachael L. Morton

The University of Sydney - NHMRC Clinical Trials Centre

More...

Abstract

​Background: Chemotherapy-induced nausea and vomiting frequently occurs in cancer patients undergoing moderately or highly emetogenic intravenous chemotherapy. The Cannabis CINV randomized trial showed the incorporation of THC:CBD (tetrahydrocannabinol: cannabidiol) cannabis extract compared with placebo, in addition to usual guideline-recommended antiemetic prophylaxis, improved refractory chemotherapy-induced nausea and vomiting, however its cost-effectiveness is unclear.

Methods: A within-trial cost-effectiveness analysis was performed from a health system perspective, utilising prospectively collected trial data with linked Medicare records.  The economic outcome was cost ($AUD) per additional complete responder, defined as ‘no emesis and no use of rescue medications’ during the treatment phase (0-120 hours). One-way sensitivity analyses and non-parametric bootstrapping with 1000 replications assessed robustness of findings.

Findings: Of 147 participants randomized, 60 of 73 assigned THC:CBD and 66 of 74 assigned placebo consented to Medicare data linkage. The average total costs (for hours 0 to 120) were $1,464 in the THC:CBD group versus $2,725 in the usual care group. The THC:CBD group demonstrated mean cost savings of $1,261 per patient (95%CI -$3,550 to $1,029), and  additional 19% of participants with complete response (95%CI 12% to 26%). THC:CBD was cost-effective per additional complete responder (i.e. dominant) over placebo. At a cost-effectiveness threshold of $15,000 per complete responder, the incremental net monetary benefit was $11,610 (95%CI −$4,667 to $17,615), with a 90% probability of THC:CBD being cost-effective. THC/CBD remained cost-effective up to a maximum price of $4,260, based on a cost-effectiveness threshold of $15,000 per complete responder. Study findings remained robust across all sensitivity analyses.

Interpretation: Addition of oral THC:CBD was cost-saving for refractory chemotherapy-induced nausea and vomiting despite guideline-consistent anti-emetic prophylaxis, supporting its use in clinical practice and reimbursement by funders.

Trial Registration: The trial’s economic evaluation was prospectively registered in the Australian and New Zealand Clinical Trials Registry (ACTRN12616001036404).

Funding: This study was supported by the Department of Health, New South Wales Government, Australia. Tilray Brands, Inc. supplied and covered the cost of study treatments but had no role in data analysis. RL Morton was supported with an Australian National Health and Medical Research Council (NHMRC) Emerging Leader Fellowship #1194703.

Declaration of Interest: We declare no competing interests.

Ethical Approval: Approval to conduct the trial was granted by Sydney Local Health District Ethics Review Committee (RPAH Zone) (EC00113) and by the Australian Department of Human Services (now Services Australia) for linkage to Medicare claims data (RMS2850). Informed consent for participation and access to Medicare data was obtained from each participant. We followed the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) for reporting this study. A health economic analysis plan was developed before the data analysis was conducted.

Keywords: cost-effectiveness, medicinal cannabis, chemotherapy induced nausea and vomiting, reimbursement, cancer, treatment

Suggested Citation

Dieng, Mbathio and Grimison, Peter and Mersiades, Antony and Kirby, Adrienne and Walsh, Anna and Stockler, Martin R. and Morton, Rachael L., Cost-Effectiveness of Oral Cannabinoid-Rich THC:CBD Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting. Available at SSRN: https://ssrn.com/abstract=4898474 or http://dx.doi.org/10.2139/ssrn.4898474

Mbathio Dieng (Contact Author)

The University of Sydney - NHMRC Clinical Trials Centre ( email )

Peter Grimison

The University of Sydney - NHMRC Clinical Trials Centre ( email )

Antony Mersiades

The University of Sydney - NHMRC Clinical Trials Centre ( email )

ABN 15 211 513 464
Locked Bag 77
Camperdown, NSW 1450
Australia

Adrienne Kirby

The University of Sydney - NHMRC Clinical Trials Centre ( email )

ABN 15 211 513 464
Locked Bag 77
Camperdown, NSW 1450
Australia

Anna Walsh

The University of Sydney - NHMRC Clinical Trials Centre ( email )

ABN 15 211 513 464
Locked Bag 77
Camperdown, NSW 1450
Australia

Martin R. Stockler

The University of Sydney - NHMRC Clinical Trials Centre ( email )

ABN 15 211 513 464
Locked Bag 77
Camperdown, NSW 1450
Australia

Rachael L. Morton

The University of Sydney - NHMRC Clinical Trials Centre ( email )

ABN 15 211 513 464
Locked Bag 77
Camperdown, NSW 1450
Australia

Click here to go to TheLancet.com

Paper statistics

Downloads
42
Abstract Views
249
PlumX Metrics