Insurance Coverage, Smoking Cessation
Conditions
Keywords
Smoking cessation, quit rates, reimbursement, drug coverage, effectiveness, cost-effectiveness, health policy, drug utilization, adherence, urine cotinine.
Brief summary
This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.
Interventions
OTHERFull Smoking Cessation Treatment Coverage (100%)
This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.
OTHERNo Smoking Cessation Treatment Coverage (0%)
None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Daily smokers (10 cigarettes per day or more); * Smokers motivated to make a quit attempt within the next 14 days; * Potential subjects must be outpatients; * A subject must have a stable mental and physical medical condition (as per investigator's judgment).
Exclusion criteria
* A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance; * A subject with an unknown drug insurance status; * A subject living in a household where there is someone already recruited in the study; * A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product; * A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence | Week 26 | Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment \[SCT\]) in the last 7 days? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco | Week 26 | PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days? confirmed by negative urine cotinine test results (defined as cotinine levels less than \[\<\]200 nanograms per milliliter \[ng/mL\]). |
| Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 26, Week 39, and Week 52 | CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions Have you smoked any cigarettes (even a puff) since the last contact/visit? at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit? and (b) urine cotinine test results were neither positive (greater than or equal to \[≥\]200 ng/mL) nor missing. |
| Percentage of Participants With 7-Day PP of Abstinence at Week 13 | Week 13 | PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? |
| Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 26 to Week 52 | LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reimbursement for Smoking Cessation Therapy (SCT) Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization. | 696 |
| No Reimbursement for SCT Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket. | 684 |
| Total | 1,380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 0 |
| Overall Study | Death | 3 | 5 |
| Overall Study | Lost to Follow-up | 160 | 146 |
| Overall Study | Multiple reasons | 11 | 12 |
| Overall Study | Withdrawal by Subject | 42 | 104 |
Baseline characteristics
| Characteristic | Reimbursement for Smoking Cessation Therapy (SCT) | No Reimbursement for SCT | Total |
|---|---|---|---|
| Age Continuous | 46.5 Years STANDARD_DEVIATION 12.3 | 46.7 Years STANDARD_DEVIATION 12.3 | 46.6 Years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 342 Participants | 347 Participants | 689 Participants |
| Sex: Female, Male Male | 354 Participants | 337 Participants | 691 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 335 / 696 | 246 / 684 |
| serious Total, serious adverse events | 35 / 696 | 25 / 684 |
Outcome results
Primary
Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence
Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment \[SCT\]) in the last 7 days?
Time frame: Week 26
Population: Intent to Treat (ITT) Population: all randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence | 20.8 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence | 13.9 Percentage of Participants |
Comparison: Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.p-value: 0.000795% CI: [1.23, 2.18]Regression, Logistic
Secondary
Percentage of Participants With 7-Day PP of Abstinence at Week 13
PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?
Time frame: Week 13
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With 7-Day PP of Abstinence at Week 13 | 34.1 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With 7-Day PP of Abstinence at Week 13 | 23.7 Percentage of Participants |
Comparison: Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.p-value: <0.000195% CI: [1.35, 2.2]Regression, Logistic
Secondary
Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco
PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days? confirmed by negative urine cotinine test results (defined as cotinine levels less than \[\<\]200 nanograms per milliliter \[ng/mL\]).
Time frame: Week 26
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco | 15.7 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco | 10.1 Percentage of Participants |
Comparison: Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.p-value: 0.001895% CI: [1.21, 2.33]Regression, Logistic
Secondary
Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52
CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions Have you smoked any cigarettes (even a puff) since the last contact/visit? at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit? and (b) urine cotinine test results were neither positive (greater than or equal to \[≥\]200 ng/mL) nor missing.
Time frame: Week 26, Week 39, and Week 52
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 26 | 15.7 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 39 | 7.8 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 52 | 6.6 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 26 | 10.1 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 39 | 6.3 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 | Week 52 | 5.6 Percentage of Participants |
Comparison: Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.p-value: 0.297995% CI: [0.82, 1.9]Regression, Logistic
Comparison: Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.p-value: 0.438895% CI: [0.76, 1.87]Regression, Logistic
Secondary
Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52
LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52
Time frame: Week 26 to Week 52
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 34 | 17.4 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 44 | 13.7 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 30 | 19.7 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 48 | 12.5 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 39 | 14.9 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 52 | 11.2 Percentage of Participants |
| Reimbursement for Smoking Cessation Therapy (SCT) | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 26 | 20.8 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 52 | 9.9 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 26 | 13.9 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 30 | 12.6 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 34 | 12.3 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 39 | 11.3 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 44 | 11.0 Percentage of Participants |
| No Reimbursement for SCT | Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 | Week 48 | 10.8 Percentage of Participants |
Comparison: Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.p-value: 0.455195% CI: [0.81, 1.62]Regression, Logistic