Prescription Smoking-Cessation Medication Fills and Spending, 2009–2019

Abstract

Introduction:

Smoking is the leading cause of preventable disease and death. However, effective medicines, including prescription medications often covered by health insurance, are available to aid cessation.

Methods:

Trends of 7 U.S. Food and Drug Administration–approved prescription medications for smoking cessation during 2009–2019 (before and during Affordable Care Act implementation), including fill counts and spending (total and patient, adjusted to 2019 dollars), were assessed among U.S. adults aged ≥18 years. Symphony Health’s Integrated Dataverse combines data on >90% of outpatient prescription fills with market purchasing data to create national estimates. Analyses were conducted in 2021.

Results:

Annually, total fills (spending) decreased from 3.7 million ($577 million) in 2009 to 2.5 million ($465 million) in 2013 and increased to 4.5 million ($1.279 billion) in 2019; patient spending decreased from $174 million (30% of total annual spending) in 2009 to $54 million (4%) in 2019. Comparing 2009 with 2019, the total spending per fill increased by 80% (from $157 to $282), whereas patient spending per fill decreased by 75% (from $47 to $12). The total spending per fill for branded products increased by 175% (from $166 to $459), and decreased by 41% (from $75 to $44) for generic products. Branded product percentage decreased from 89% to 57%.

Conclusions:

Total fills and spending decreased from 2009 to 2013 and then increased through 2019, whereas patient spending decreased. Earlier studies suggest possible reasons for these trends, such as gradual implementation of federal requirements for insurance coverage of cessation medications, and reduced cost sharing and financial barriers.

INTRODUCTION

Smoking is the leading cause of preventable disease and death in the U.S.^1,2 Quitting smoking yields rapid cardiovascular health improvement, and greatly reduces risks of cancer, stroke, coronary event recurrence, and death.^1-6 Effective treatments to help quit include counseling and 7 cost-effective U.S. Food and Drug Administration (FDA)-approved medications.⁷ Although tobacco use has declined,^2,7 the prevalence of cigarette smoking is currently 14% (and tobacco use overall, 21%), with higher rates among male individuals, people aged ≤65 years, people with lower income, and uninsured individuals and those with Medicaid.⁸ Of those who smoke, most report interest in quitting,⁷ but prescription cessation medication use is only 6%, and did not change significantly from 2006 to 2015.⁹

Prior research has shown that removing cost sharing and other barriers to coverage of cessation treatments can increase quit rates.^7,10,11 Insurance coverage of cessation treatments has improved over the past decade.^12,13 For example, the Affordable Care Act (ACA), enacted in 2010, prohibits all state Medicaid programs from excluding FDA-approved cessation medication from enrollees’ pharmacy coverage.^14,15 The ACA also requires Medicaid expansion plans and many group and individual health plans to provide in-network coverage without patient cost sharing for certain preventive services, including counseling and FDA-approved tobacco-cessation medicines.¹⁴ This study examines trends in fills and spending for prescription cessation medications during the period before (2009) and during ACA implementation (2010–2019), by patient- and payer-related characteristics.

METHODS

Smoking-cessation medication trends were assessed from 2009 to 2019, before and during ACA implementation, among U.S. adults aged ≥18 years (2018 data were unavailable because they were not purchased by the Centers for Disease Control and Prevention). Symphony Health’s Integrated Dataverse combines data on >90% of outpatient prescription fills from retail and mail-order pharmacies with market purchasing data to create national estimates. Medications captured all FDA-approved prescription cessation medications, including 2 non-nicotine medications (bupropion and varenicline) and 5 prescribed versions of nicotine-replacement therapies (nicotine gum, oral inhaler, lozenge, nasal spray, and patch). Bupropion was limited to the 150-mg formulation, which is most commonly recommended for smoking cessation.^10,16

Measures, calculated annually, included: total fills, total spending (including both payer and patient spending), total spending per fill, patient spending, and patient spending per fill.^17,18 Spending was adjusted to 2019 dollars.¹⁹ Results were stratified by patient age group (18–44, 45–64, ≥65 years) and sex, branded versus generic medications, and payer (commercial, managed Medicaid, traditional Medicaid, and Medicare). This study was considered exempt from IRB approval as public health surveillance. Analyses were completed in 2021 using SAS, version 9.4 and Microsoft Excel.

RESULTS

Total prescription fills of cessation medications decreased from 2009 to 2013, from 3.7 to 2.5 million, and then increased through 2019, reaching 4.5 million (Table 1). Percentage of branded product fills decreased from 89% in 2009 to 57% in 2019. Fill percentage by sex remained relatively constant, with approximately 55% by women. Fill percentage among those aged 18–44 years decreased from 38% to 30%, whereas fill percentage increased among older groups.

Table 1.

Smoking-Cessation Prescription Medication Fills and Spending, 2009–2019^a

Category	2009	2010	2011	2012	2013	2014	2015	2016	2017	2018a	2019
Total fills (millions)	3.69	3.01	2.72	2.56	2.47	2.61	2.99	3.62	4.05	–	4.54
Fills by sex, %
Female	55.4	55.2	55.2	55.5	55.6	55.3	55.2	55.6	55.3	–	55.1
Male	44.6	44.8	44.8	44.5	44.4	44.7	44.8	44.4	44.7	–	44.9
Fills by age group, years, %
18–44	38.3	38.0	37.1	37.7	36.4	34.9	34.1	32.9	31.7	–	30.0
45–64	52.3	52.5	52.5	52.3	53.2	55.1	56.6	57.4	57.8	–	58.1
≥65	9.4	9.5	10.4	10.0	10.4	10.0	9.3	9.7	10.5	–	11.8
Fills by brand, %
Branded	89.2	88.2	84.5	79.8	76.9	72.1	64.2	61.5	60.8	–	57.3
Generic	10.8	11.8	15.5	20.2	23.1	27.9	35.8	38.5	39.2	–	42.7
Mean therapy days per fillb
Branded	28.3	28.2	28.4	28.6	28.7	28.7	28.6	28.7	28.9	–	29.9
Generic	23.0	22.3	23.5	23.5	23.4	23.3	23.9	24.2	24.4	–	24.8
Total spending per fill (average), $	156.5	160.8	167.7	174.6	188.2	195.5	205.1	225.1	250.5	–	281.8
Branded, $	166.4	174.2	187.9	205.1	229.3	251.6	290.4	334.2	381.6	–	458.5
Generic, $	74.6	60.6	57.3	54.3	51.6	50.2	52.1	51.0	47.4	–	44.1
Commercial, $	153.5	162.6	173.7	188.5	206.4	222.0	238.6	263.5	291.9	–	322.4
Managed Medicaid, $	106.9	102.8	107.5	103.2	107.0	115.5	120.5	131.0	150.7	–	178.3
Traditional Medicaid, $	116.5	114.0	119.5	119.1	121.6	131.2	130.9	144.9	156.3	–	173.4
Medicare, $	151.6	163.8	179.3	196.3	220.9	242.9	273.1	311.0	357.5	–	421.1
Patient spending per fill (average), $	47.2	44.4	40.0	36.4	32.8	24.5	16.3	14.2	12.8	–	11.8
Branded, $	51.6	48.8	45.1	42.9	39.3	30.4	20.5	18.2	16.5	–	16.0
Generic, $	11.6	11.6	12.3	11.1	11.1	9.3	8.6	7.8	7.1	–	6.2
Commercial, $	44.6	46.6	44.8	41.4	34.6	22.0	13.7	11.8	10.9	–	10.6
Managed Medicaid,c $	4.5	8.3	7.6	6.3	6.4	5.6	5.2	4.3	4.1	–	3.1
Traditional Medicaid,c $	2.6	2.7	2.8	3.8	4.0	4.6	4.2	4.2	2.8	–	2.7
Medicare, $	18.3	20.1	22.4	23.4	22.7	22.0	23.1	23.8	22.7	–	22.5

^a2018 data were unavailable. Spending was adjusted to 2019 dollars.

^bMean therapy days per fill was calculated as total days of therapy made available to patients divided by total fills.

^cUnder managed Medicaid, participants are enrolled in a private health plan, which receives payments from the state; under traditional fee-for-service Medicaid, providers receive payments from the state for covered services.

Total spending followed a similar pattern as fills, falling from $577 million in 2009 to $465 million in 2013 and increasing to $1.279 billion in 2019 (Figure 1). Comparing 2009 with 2019, total spending per fill increased by 80% ($157 to $282) (Table 1). Total spending per fill for branded products increased by 175% ($166 to $459), but decreased by 41% ($75 to $44) for generic products. All payers showed increased spending per fill, with the highest percentage increase in Medicare (178%, $152 to $421), and the lowest in traditional Medicaid (49%, $117 to $173).

Figure 1. Smoking-cessation prescription medication fills, in thousands (A), and spending, in millions (B).

Notes: Figure A shows the number of fills (in thousands) from 2009 to 2019^a, overall and by branded and generic fills. Figure B shows the spending (in millions of dollars) from 2009 to 2019^a, overall and by branded products, generic products, and patient spending.

^a2018 data were unavailable. Spending was adjusted to 2019 dollars.

In contrast to total spending, patient spending decreased from $174 to $54 million from 2009 to 2019 (from 30% of total annual spending on cessation medications to 4%) (Figure 1 and Appendix Table 1), and patient spending per fill decreased by 75% ($47 to $12) (Table 1). Patients with commercial insurance had the highest decrease in patient spending per fill (76%, $45 to $11), patients with managed Medicaid decreased 31% ($4.50 to $3.10), patients with traditional Medicaid spent the least and experienced little change ($2.60 to $2.70), and patients with Medicare increased 23% ($18 to $23).

DISCUSSION

From 2009 to 2013, prescription cessation medication fills declined, but then increased from 2013 to 2019, and patient spending per fill decreased by 75% overall (Table 1). Researchers have hypothesized that an observed decline in fills may have been caused by the addition of safety warnings for non-nicotine cessation medications in 2009 and 2011.¹³ Trends since 2013 align with the potential outcomes anticipated by gradual implementation of federal requirements for insurance coverage of cessation medications.¹⁴ By January 2016, approximately 2.3 million adults who smoked were newly enrolled in ACA-expanded Medicaid.²⁰ By July 1, 2016, all 32 states that expanded Medicaid covered at least some cessation treatments for enrollees, including 19 states that covered all 7 FDA-approved medications.²⁰ Broader traditional Medicaid coverage of cessation medications has been shown to be weakly associated with higher use,²¹ and Medicaid expansion under the ACA has been associated with increased smoking cessation among low-income younger adults.²² Some researchers have hypothesized that requirements for non-grandfathered private insurance plans to cover tobacco cessation with no cost sharing could potentially reduce patient spending for cessation medications in private plans¹⁴; this may partially explain the observed 76% decrease in patient spending per fill among those with commercial payers. In addition, some states expanded pharmacists’ authority to prescribe cessation medications, which may have increased access,²³ whereas other state policies and programs, such as tobacco taxes, smoke-free air laws, and awareness campaigns,¹² may have increased demand.

During 2009–2019, cessation medication spending more than doubled, from $577 million to $1.279 billion (Figure 1). Despite increases in the percentage of generic fills, large increases in the total spending per fill for branded products led to an increase in overall spending. However, costs for cessation medications are small compared with other smoking-related health expenses,¹⁶ and cessation services are estimated to be potentially cost saving from the perspective of Medicare, Medicaid, states, employers, and commercial plans.^24-27

Limitations

This study had limitations. First, data did not capture over-the-counter nicotine-replacement therapies (patch, gum, and lozenge); thus, results likely underestimated total purchases and spending for cessation medications. Second, diagnoses for which medications were prescribed could not be assessed; bupropion can be prescribed for uses other than smoking cessation, such as depression, which may have introduced misclassification.¹⁶ Third, 2018 data were unavailable. Finally, this study was descriptive and could not assess whether observed changes in prescribing patterns could be attributed to changes in policy or insurance coverage.

CONCLUSIONS

Prescription fills for smoking-cessation medications declined from 2009 to 2013 and then increased through 2019. Data suggest that lower out-of-pocket costs can increase cessation treatment use, quit attempts, and smoking abstinence,¹¹ and the 2020 Surgeon General’s report highlighted barrier-free insurance coverage of cessation treatment as an important evidence-based intervention.⁷ However, cessation medications remain underutilized,^13,16,28,29 and, in addition to coverage, improvements are needed in factors such as pharmacy availability for same-day fills³⁰ and physician training and provision of cessation counseling and recommendations.^6,31 Resources are available to help health professionals integrate cessation treatment into routine clinical care, such as the HHS Million Hearts Tobacco Cessation Change Package.²⁸ Future research could explore state-level variation in policies and trends for fills and spending, as well as potential differences by medication type.

Appendix Table 1. Smoking-Cessation Prescription Medication Total Annual Spending, in Millions, 2009–2019^a

Variable	2009	2010	2011	2012	2013	2014	2015	2016	2017	2018a	2019
Total spending ($, in millions)	577.0	483.7	455.6	447.6	464.9	509.5	614.2	814.4	1014.6	–	1278.7
Branded ($, in millions)	547.2	462.1	431.5	419.4	435.4	473.1	558.3	743.4	939.2	–	1193.4
Generic ($, in millions)	29.8	21.6	24.1	28.2	29.4	36.4	55.9	71.0	75.3	–	85.3
Patient spending ($, in millions)	174.2	133.5	108.6	93.5	81.0	63.9	48.7	51.3	51.9	–	53.8
Branded ($, in millions)	169.5	129.4	103.5	87.7	74.7	57.1	39.5	40.4	40.7	–	41.7
Generic ($, in millions)	4.6	4.1	5.2	5.8	6.4	6.8	9.2	10.9	11.2	–	12.0
Patient % of total spend	30%	28%	24%	21%	17%	13%	8%	6%	5%	–	4%

^a2018 data were unavailable. Spending was adjusted to 2019 dollars.