Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial

Jinshuo Li; Steve Parrott; Ada Keding; Omara Dogar; Rhian Gabe; Anna-Marie Marshall; Rumana Huque; Deepa Barua; Razia Fatima; Amina Khan; Raana Zahid; Sonia Mansoor; Daniel Kotz; Melanie Boeckmann; Helen Elsey; Eva Kralikova; Anne Readshaw; Aziz Sheikh; Kamran Siddiqi; TB & Tobacco Consortium

doi:10.1136/bmjopen-2021-049644

Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial

Jinshuo Li^*, Steve Parrott, Ada Keding, Omara Dogar, Rhian Gabe, Anna-Marie Marshall, Rumana Huque, Deepa Barua, Razia Fatima, Amina Khan, Raana Zahid, Sonia Mansoor, Daniel Kotz, Melanie Boeckmann, Helen Elsey, Eva Kralikova, Anne Readshaw, Aziz Sheikh, Kamran Siddiqi, TB & Tobacco Consortium

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries.

DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation.

SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan.

PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472).

INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence.

PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping.

RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm.

CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS.

TRIAL REGISTRATION NUMBER: ISRCTN43811467.

Original language	English
Article number	e049644
Number of pages	9
Journal	BMJ Open
Volume	12
Issue number	8
DOIs	https://doi.org/10.1136/bmjopen-2021-049644
Publication status	Published - 26 Aug 2022

Keywords

Adolescent
Adult
Alkaloids
Azocines
Cost-Benefit Analysis
Humans
Quinolizines
Smoking Cessation
Tuberculosis, Pulmonary

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10.1136/bmjopen-2021-049644Licence: CC BY

Cite this

Li, J., Parrott, S., Keding, A., Dogar, O., Gabe, R., Marshall, A.-M., Huque, R., Barua, D., Fatima, R., Khan, A., Zahid, R., Mansoor, S., Kotz, D., Boeckmann, M., Elsey, H., Kralikova, E., Readshaw, A., Sheikh, A., Siddiqi, K., & TB & Tobacco Consortium (2022). Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial. BMJ Open, 12(8), Article e049644. https://doi.org/10.1136/bmjopen-2021-049644

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title = "Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial",

abstract = "OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries.DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation.SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan.PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472).INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence.PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping.RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm.CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS.TRIAL REGISTRATION NUMBER: ISRCTN43811467.",

keywords = "Adolescent, Adult, Alkaloids, Azocines, Cost-Benefit Analysis, Humans, Quinolizines, Smoking Cessation, Tuberculosis, Pulmonary",

author = "Jinshuo Li and Steve Parrott and Ada Keding and Omara Dogar and Rhian Gabe and Anna-Marie Marshall and Rumana Huque and Deepa Barua and Razia Fatima and Amina Khan and Raana Zahid and Sonia Mansoor and Daniel Kotz and Melanie Boeckmann and Helen Elsey and Eva Kralikova and Anne Readshaw and Aziz Sheikh and Kamran Siddiqi and {TB & Tobacco Consortium}",

note = "{\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.",

year = "2022",

month = aug,

day = "26",

doi = "10.1136/bmjopen-2021-049644",

language = "English",

volume = "12",

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Li, J, Parrott, S, Keding, A, Dogar, O, Gabe, R, Marshall, A-M, Huque, R, Barua, D, Fatima, R, Khan, A, Zahid, R, Mansoor, S, Kotz, D, Boeckmann, M, Elsey, H, Kralikova, E, Readshaw, A, Sheikh, A, Siddiqi, K & TB & Tobacco Consortium 2022, 'Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial', BMJ Open, vol. 12, no. 8, e049644. https://doi.org/10.1136/bmjopen-2021-049644

Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial. / Li, Jinshuo; Parrott, Steve; Keding, Ada et al.
In: BMJ Open, Vol. 12, No. 8, e049644, 26.08.2022.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis

T2 - an economic evaluation of a multicentre randomised controlled trial

AU - Li, Jinshuo

AU - Parrott, Steve

AU - Keding, Ada

AU - Dogar, Omara

AU - Gabe, Rhian

AU - Marshall, Anna-Marie

AU - Huque, Rumana

AU - Barua, Deepa

AU - Fatima, Razia

AU - Khan, Amina

AU - Zahid, Raana

AU - Mansoor, Sonia

AU - Kotz, Daniel

AU - Boeckmann, Melanie

AU - Elsey, Helen

AU - Kralikova, Eva

AU - Readshaw, Anne

AU - Sheikh, Aziz

AU - Siddiqi, Kamran

AU - TB & Tobacco Consortium

PY - 2022/8/26

Y1 - 2022/8/26

N2 - OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries.DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation.SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan.PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472).INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence.PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping.RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm.CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS.TRIAL REGISTRATION NUMBER: ISRCTN43811467.

AB - OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries.DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation.SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan.PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472).INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence.PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping.RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm.CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS.TRIAL REGISTRATION NUMBER: ISRCTN43811467.

KW - Adolescent

KW - Adult

KW - Alkaloids

KW - Azocines

KW - Cost-Benefit Analysis

KW - Humans

KW - Quinolizines

KW - Smoking Cessation

KW - Tuberculosis, Pulmonary

U2 - 10.1136/bmjopen-2021-049644

DO - 10.1136/bmjopen-2021-049644

M3 - Article

C2 - 36028279

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 8

M1 - e049644

ER -