ABSTRACT
Purpose
Several new respiratory inhalers have recently entered the market, including combination therapy products and generic alternatives. Therefore, we examined the cost and utilization of publicly dispensed respiratory inhalers in Ontario, Canada, and the impact of new market entrants on these trends.
Methods
We conducted a repeated cross‐sectional study among provincial drug program beneficiaries dispensed a respiratory inhaler between January 1, 2003, and March 31, 2023. We estimated per‐beneficiary spending on respiratory inhalers per quarter, defined as the cost (2022 Canadian dollars) of respiratory inhalers reimbursement divided by the number of beneficiaries dispensed a respiratory inhaler. Joinpoint regression models were used to characterize changes in the trend.
Results
Between Q1 of 2003 and Q1 of 2023, public payer spending rose 160% ($26 206 322 to $68 054 816), while the number of beneficiaries dispensed a respiratory inhaler increased 92% (155 893 to 299 418). Reimbursement of ICS/LABA inhalers accounted for half the cost ($33 844 484 in Q1 of 2023). The trend for per‐beneficiary spending was marked by six joinpoints, with periods of increasing and decreasing quarterly costs. Between 2003 and 2015, per‐beneficiary spending increased, reaching $248/beneficiary in Q1 of 2015. In Q2 of 2015, the trend decreased for the first time and continued to decline until Q2 of 2018 ($206/beneficiary). The trend increased again after Q3 of 2018 and reached a plateau in Q3 of 2019 ($216/beneficiary).
Conclusions
Public formulary listing of combination therapy inhalers, namely LAMA/LABA in Q2 of 2015, coincided with a significant decline in per‐beneficiary spending on respiratory inhalers.
Keywords: medication costs, respiratory disease, respiratory inhalers
Summary.
Between Q1 2003 and Q1 2023, public payer spending on respiratory inhalers increased by 160%, while the number of beneficiaries increased by 92%.
Reimbursement of inhalers from the ICS/LABA drug class accounted for one‐half of public payer spending on respiratory inhalers in Q1 of 2023.
Public formulary listing of brand name combination therapy inhalers from the LAMA/LABA drug class coincided with a significant decline in per‐beneficiary spending on respiratory inhalers.
Public formulary listing of generic alternatives for Advair and Flovent did not coincide with shifts in per‐beneficiary spending, likely due to the delay between patent expiry and generic product availability.
1. Introduction
Chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) are leading causes of morbidity and mortality worldwide [1]. While chronic treatment with respiratory inhalers can enhance lung function and prevent respiratory exacerbations [2, 3], the cost of treatment has imposed a financial strain on both patients and public payers [4]. In 2018, public payers in the United States (U.S.; Medicare Part D) spent $6.5 billion U.S. dollars (net spending, after accounting for confidential rebates) on respiratory inhalers, with long‐acting combination therapy inhalers accounting for a majority of the total cost [5]. Similarly, in Canada, combination therapy inhalers containing an inhaled corticosteroid and long‐acting beta‐agonist (ICS/LABA) accounted for 2.3% of all pharmaceutical sales in 2018, amounting to $577 million Canadian dollars (CAD) [6]. Despite being on the market for decades, the limited availability of generic alternatives due to ongoing brand name patents has kept the cost of respiratory inhalers high [7, 8]. A practice known as ‘device hopping’ has allowed manufacturers to prolong market exclusivity by reformulating the same active ingredient into new delivery devices, with each inhaler product covered by multiple different patents. In light of the high costs and limited generic alternatives, the cost of respiratory inhalers is recognized as a public health concern [4, 9].
In Ontario, Canada, the Ontario Drug Benefit (ODB) program provides prescription drug coverage to approximately 25% of the Ontario population [10]. Over the past 10 years, several new respiratory inhaler products have been listed on the ODB provincial drug formulary [11]. This includes novel formulations that deliver combined doses of medications from the long‐acting muscarinic agents (LAMA), LABA, and ICS drug class, initially listed on the ODB formulary in May 2015 (LAMA/LABA) and September 2019 (ICS/LAMA/LABA) [11]. Furthermore, after nearly 20 years of market exclusivity, generic alternatives for Advair (ICS/LABA) and Flovent HFA (ICS) were listed on the ODB formulary in March 2020 and March 2021, respectively [11]. Generic inhalers offer a 50% price reduction compared to their brand‐name counterparts; however, only four brand‐name inhalers have competing generic alternatives in Canada [11]. Considering the changing availability of respiratory inhaler products, it is important to evaluate how this has affected public payer spending on these products. Therefore, the objective of this study was to describe trends in the cost and utilization of respiratory inhalers reimbursed by the public payer in Ontario, Canada, and assess whether changes in spending aligned with the listing of new market entrants on the provincial drug formulary.
2. Methods
2.1. Study Design Setting
We conducted a population‐based, repeated cross‐sectional study among all individuals dispensed a respiratory inhaler with a prior diagnosis of asthma or COPD between January 1, 2003, and March 31, 2023, through the ODB program.
2.2. Data Sources
We used Ontario's health administrative databases, which are securely linked using unique encoded identifiers and analyzed at ICES (formerly known as the Institute for Clinical Evaluative Sciences), an independent, non‐profit research institute whose legal status under Ontario's health information privacy law allows it to collect and analyze health care and demographic data, without consent, for health system evaluation and improvement. We used the ODB Database to identify prescriptions for publicly funded respiratory inhalers dispensed at a community pharmacy and the Registered Persons Database to verify all individuals included in this study had a valid Ontario Health Insurance Plan (OHIP) number. We used ICES‐derived Asthma and COPD datasets to confirm prior diagnosis of either asthma or COPD among respiratory inhaler recipients. These databases use administrative healthcare data (e.g., outpatient and inpatient healthcare interactions) to identify patients with physician‐diagnosed asthma [12] (sensitivity: 83.8% and specificity: 76.5%) or COPD [13] (sensitivity: 85.0% and specificity 78.4%). Access to data used in this project is authorized under section 45 of Ontario's Personal Health Information Protection Act, which does not require review by a Research Ethics Board.
2.3. Population and Measures
We identified all claims for respiratory inhalers (see Table S1 for full list of respiratory inhalers included in our study) reimbursed by the ODB program among individuals with a prior diagnosis of asthma or COPD between January 1, 2003, and March 31, 2023. Eligibility for ODB coverage includes unemployment, disability, high prescription drug costs relative to net household income, receipt of home care services, residence in a long‐term care facility, being < 25 years old without private insurance, and age ≥ 65 years old. Additionally, between January 1, 2018, and March 31, 2019, the OHIP+ program extended ODB coverage to individuals < 25 years old, regardless of insurance status. For each quarter over our study period, we identified the first respiratory inhaler dispense date for each unique individual and restricted our study population to those with a prior diagnosis of asthma or COPD. The date of diagnosis may have occurred at any point on or between the ICES‐derived COPD or Asthma dataset inception and the respiratory inhaler dispense date. Lastly, we excluded those without a valid OHIP number for the purpose of data linkage to the ICES data repository.
Our primary outcome was a quarterly measure of per‐beneficiary ODB spending on respiratory inhalers among those diagnosed with asthma or COPD. Here, the denominator was defined as the number of unique ODB beneficiaries dispensed at least one respiratory inhaler in each calendar year quarter (i.e., measure of utilization). For the numerator, total ODB spending on respiratory inhalers (dollar amount reimbursed by ODB towards the cost of the respiratory inhaler and any associated pharmacist dispensing fees) was calculated for each individual identified in the denominator per quarter.
As a secondary analysis, we stratified our primary outcome by drug class and history of diagnosis (asthma versus COPD; stratification not mutually exclusive). Single therapy drug class inhalers (i.e., delivery of medication from a single drug class) were classified as: ICS, LABA, LAMA, short‐acting muscarinic agonist (SAMA) and short‐acting beta‐agonist (SABA). Whereas combination therapy inhalers (i.e., delivery of medications from two to three drug classes) were classified as SAMA/SABA, ICS/LABA, LAMA/LABA, and ICS/LAMA/LABA. Lastly, as a sensitivity analysis for our primary outcome, we restricted our study population to those 65 years or older on the respiratory inhaler dispense date, as provincial drug coverage for individuals under 65 years varied over the course of our study period.
2.4. Analysis
We used joinpoint regression models (e.g., joined linear regression segments on a logarithmic scale) to characterize changes in the trend for per‐beneficiary spending on respiratory inhalers. A “joinpoint” is a time point where two linear segments meet, signifying a statistically significant change in the slope of the trend [14]. We assessed whether identified joinpoints coincided with the initial listing of new market entrants on the ODB formulary (see Table S2 for list of key dates for new market entrants). This included brand name products from the LAMA/LABA and ICS/LAMA/LABA drug classes, along with generic alternatives for Advair and Flovent. Joinpoints are identified without preconceived notions regarding the location of breakpoints in the trend, which is necessary due to the varied shifts in product availability and drug price fluctuations over the study period. The optimal model was selected by comparing the weighted Bayesian Information Criterion values for different models with “k” joinpoints [14]. We calculated the quarterly percent change (QPC) and corresponding 95% confidence intervals (CIs) for each linear trend segment, along with the average quarterly percent change (AQPC) and accompanying 95% CI for the overall trend across the study period. Estimated trends with a 95% CI containing zero were deemed statistically insignificant (e.g., trend stable over time). Costs were inflation‐adjusted to 2022 CAD using the Health and Personal Care Consumer Price Index—Medicinal and pharmaceutical products [15]. All analyses were conducted in SAS Enterprise Guide statistical software version 8.3 (SAS Institute) or the Joinpoint Regression Program (v. 5.0.2).
3. Results
3.1. Respiratory Inhaler Cost and Utilization
Between Q1 of 2003 and Q1 of 2023, ODB spending on respiratory inhalers increased by 159.7% (from $26 206 322 to $68 054 816), while the number of ODB beneficiaries dispensed a respiratory inhaler increased by 92.1% (from 155 893 to 299 418) (Figure 1). Approximately three‐quarters of public payer spending and beneficiaries dispensed a respiratory inhaler were 65 years or older (Figure S1). When stratified by drug class, ICS/LABA inhalers accounted for approximately one‐half of ODB spending, representing 49.7% ($33 844 484) of public payer spending on respiratory inhaler costs in Q1 of 2023 (Figure 2). The second most expensive drug class in Q1 of 2023 was LAMA ($10 827 905 [15.9%]), followed by ICS/LAMA/LABA ($9 489 853 [13.9%]), LAMA/LABA ($5 563 309 [8.2%]) and ICS ($4 333 650 [6.4%]). Spending on the remaining drug classes, which predominantly included shorter‐acting agents, represented 5.9% ($3 995 615) of overall ODB spending on respiratory inhalers in Q1 of 2023. In contrast to ODB spending, the most commonly dispensed respiratory inhalers according to drug class in Q1 of 2023 were SABA (N = 170 683 [57.0%]), ICS/LABA (N = 135 046 [45.1%]), LAMA (N = 66 835 [22.3%]) (Figure 3). Uptake of novel combination therapy inhalers was lower in comparison to pre‐existing long‐acting inhalers. After ODB listing of the first LAMA/LABA inhaler in Q2 of 2015, utilization initially increased but peaked at 29 850 (8.6%) beneficiaries in Q1 of 2020. Additionally, while only 8.1% (N = 24 203) of ODB beneficiaries were dispensed a respiratory inhaler from the ICS/LAMA/LABA drug class in Q1 of 2023, uptake has remained on an increasing trend since initial listing on the ODB formulary in Q3 of 2019. In parallel to the uptake of LAMA/LABA and ICS/LAMA/LABA inhalers, utilization of LAMA inhalers declined by 31.8% since the initial listing of the first LAMA/LABA respiratory inhaler (N = 97 980 in Q2 of 2015 versus N = 66 835 in Q1 of 2023).
FIGURE 1.
Ontario Drug Benefit Program spending on respiratory inhalers and number of beneficiaries dispensed at least one respiratory inhaler per quarter between Q1 of 2003 and Q1 of 2023 (2022 CAD). The OHIP+ time period refers to the provision of extended provincial drug coverage to all individuals < 25 years old, regardless of insurance status.
FIGURE 2.
Ontario Drug Benefit Program spending on respiratory inhalers per quarter between Q1 of 2003 and Q1 of 2023 (2022 CAD), stratified by drug class. The OHIP+ time period refers to the provision of extended provincial drug coverage to all individuals < 25 years old, regardless of insurance status.
FIGURE 3.
Number of Ontario Drug Benefit Program beneficiaries dispensed a respiratory inhaler per quarter between Q1 of 2003 and Q1 of 2023, stratified by drug class. The OHIP+ time periods refer to the provision of extended provincial drug coverage to all individuals < 25 years old, regardless of insurance status.
3.2. Per‐Beneficiary ODB Spending on Respiratory Inhalers
Between Q1 of 2003 and Q1 of 2023, per‐beneficiary spending on respiratory inhalers increased from $168 to $227 (AQPC 0.38% per quarter; 95% CI: 0.34 to 0.43); (Figure 4; Table 1). The trend fluctuated considerably over the study period and was marked by six joinpoints. Between Q1 of 2003 and Q1 of 2015, quarterly per‐beneficiary spending increased from $168 to $248. This time period was marked by two joinpoints, representing an increasing trend overall, although estimated QPCs declined with each successive joinpoint. Specifically, between Q1 of 2003 to Q1 of 2004, Q2 of 2004 (first joinpoint) to Q3 of 2007, and Q1 of 2008 (second joinpoint) to Q1 of 2015, the QPC was estimated to be 3.74% (95% CI: 2.80 to 5.46), 1.10% (95% CI: 0.85 to 1.38) and 0.31% (95% CI: 0.22 to 0.40), respectively. The third joinpoint, identified in Q2 of 2015, which coincided with ODB listing of the first LAMA/LABA inhaler, was the first observed decline in per‐beneficiary spending on respiratory inhalers over the study period. Following Q2 of 2015, the trend decreased by 1.36% per quarter (95% CI: −1.85 to −0.59) and decreased to $235 in Q2 of 2017. The decline in per‐beneficiary spending continued to accelerate, marked by a 4.10% (95% CI: −5.97 to −2.55) decrease per quarter from Q3 of 2017 ($218 per beneficiary; fourth joinpoint) to Q2 of 2018 ($206 per beneficiary). However, in Q3 of 2018 (fifth joinpoint) the trend increased once again, this time by 4.41% (95% CI: 2.81 to 6.59) per quarter until Q2 of 2019. The fourth and fifth joinpoints also encompassed implementation and termination of the OHIP+ program. The sixth and final joinpoint was identified in Q3 of 2019, which coincided with ODB formulary listing of ICS/LABA/LAMA inhalers. Following Q3 of 2019, the trend plateaued (QPC: −0.12%; 95% CI: −0.37 to 0.11) and remained unchanged for the remainder of the study period despite the introduction of generic alternatives for Advair and Flovent in Q1 of 2020 and Q1 of 2021, respectively.
FIGURE 4.
Per‐beneficiary Ontario Drug Benefit (ODB) Program spending on respiratory inhalers between Q1 of 2003 and Q1 of 2023 (2022 CAD). Dashed vertical lines represent joinpoints, which signify a statistically significant change in the slope of the trend; A = Joinpoint; B = ODB listing of LAMA/LABA inhalers; C = ODB Listing of ICS/LAMA/LABA inhalers; D = ODB listing of generic Advair; E = ODB listing of generic Flovent.
TABLE 1.
Estimated quarterly percent changes, Ontario Drug Benefit Program spending on respiratory inhalers per beneficiary dispensed a respiratory inhaler from Q1 2003 to Q1 2023 (2022 Canadian Dollars).
| Overall, per‐capita spending | |||
|---|---|---|---|
| Segment | Lower endpoint | Upper endpoint | QPC (95% CI) |
| 1 | Q1, 2003 | Q1, 2004 | 3.74 (2.80 to 5.46) |
| 2 | Q2, 2004 | Q3, 2007 | 1.10 (0.85 to 1.38) |
| 3 | Q1, 2008 | Q1, 2015 | 0.31 (0.22 to 0.40) |
| 4 | Q2, 2015 | Q2, 2017 | −1.36 (−1.85 to −0.59) |
| 5 | Q3, 2017 | Q2, 2018 | −4.10 (−5.97 to −2.55) |
| 6 | Q3, 2018 | Q2, 2019 | 4.41 (2.81 to 6.59) |
| 7 | Q3, 2019 | Q1, 2023 | −0.12 (−0.37 to 0.11) |
Note: Average quarterly percent change (AQPC) = 0.38 (95% CI: 0.34 to 0.43).
Results from our sensitivity analysis varied slightly when compared to the overall trend for per‐beneficiary spending. Specifically, per‐beneficiary spending was slightly greater among those 65 years or older compared to the overall trend. The trend for those 65 years or older fluctuated slightly over the study period, increasing from $181 to $236 (AQPC 0.40% per quarter; 95% CI: 0.35 to 0.45; Figure S2 and Table S3) and was marked by four joinpoints over the study period. Similar to the overall trend, the first decline in per‐beneficiary spending was noted in Q1 of 2015, which occurred in close proximity to the ODB formulary listing of the first LAMA/LABA inhaler (listed in Q2 of 2015). Between Q1 of 2015 and Q1 of 2017, the trend continued to decrease (QPC: −1.43; 95% CI: −3.27 to −0.94). The last joinpoint was noted in Q2 of 2017, after which the trend plateaued for the remainder of the study period. When stratified by diagnosis type, the trend for per‐beneficiary spending among those diagnosed with COPD closely followed those 65 years or older (Figure S3 and Table S4). Whereas the trend among beneficiaries diagnosed with asthma diverged from the trend noted among those with COPD in 2017. Specifically, a significant yet short‐term decline was noted between Q3 of 2017 and Q1 of 2019, which coincided with the OHIP+ time period (Figure S4 and Table S5). Following Q2 of 2019, the trend for per‐beneficiary spending among individuals diagnosed with asthma remained generally stable.
When stratified by drug class, per‐beneficiary spending was highest among recipients of longer acting combination therapy inhalers (Figure S5). In Q1 of 2023, per‐beneficiary spending was highest for those dispensed a respiratory inhaler within the ICS/LAMA/LABA ($392), ICS/LABA ($251) and LABA/LAMA ($218) drug classes. Per‐beneficiary spending on single agent inhalers was much lower in comparison, with the most expensive drug class being LAMA ($162 in Q1 of 2023), followed by LABA ($157), ICS ($99), SAMA ($54) and SABA ($19). Joinpoint regression analysis results for per‐beneficiary spending stratified by drug class are outlined in Table S6. The trend significantly increased over the study period for most drug classes, except for ICS/LABA recipients, which remained stable, and ICS, SAMA, and SABA, which decreased.
4. Discussion
In this repeated cross‐sectional population‐based study, which examined trends in the cost and utilization of publicly dispensed respiratory inhalers in Ontario, Canada, we found that spending on respiratory inhalers outpaced the rise in the number of beneficiaries dispensed a respiratory inhaler. Public payer spending was primarily driven by the cost of ICS/LABA inhalers, which accounted for approximately half of ODB spending on respiratory inhalers. Per‐beneficiary spending on respiratory inhalers increased slightly and was marked by a period of increasing and decreasing costs. Public formulary listing of brand name combination therapy inhalers from the LAMA/LABA drug class coincided with a significant decline in per‐beneficiary spending on respiratory inhalers. In contrast, the introduction of generic alternatives for Advair (ICS/LABA; first listing in Q1 of 2020) and Flovent (ICS; first listing in Q1 of 2021) did not impact the trend. Further expansion of generic product availability is likely required to decrease public payer spending on respiratory inhalers.
Despite the high cost of combination therapy respiratory inhalers, the addition of these products to the public formulary in Ontario, Canada, coincided with significant declines in the trend for per‐beneficiary spending on respiratory inhalers, given the use of a single combination therapy inhaler is less expensive than the cost of multiple single drug class brand name inhalers (e.g., LAMA and LABA separately). Our findings align with past research, which has demonstrated that in comparison to the use of multiple single therapy inhalers, a combination therapy inhaler is associated with reduced treatment costs and improved healthcare outcomes [16, 17]. A 2020 systematic review of studies examining clinical and economic outcomes associated with the use of combination‐versus single‐therapy inhalers found a reduction in emergency room visits, hospitalizations, and use of rescue medications among combination therapy recipients with asthma and COPD [16]. These findings are likely attributed to improved treatment adherence with combination therapy products, in comparison to the use of multiple single therapy inhalers, which may have varying requirements for dosing frequency and device administration techniques.
Although the cost of a combination therapy inhaler is generally less expensive than the concurrent use of multiple single therapy inhalers, they remain expensive treatments, nonetheless. Multiple organizations have made calls to pharmaceutical companies to reduce respiratory inhaler pricing and release generic alternatives, as patients without insurance are at times forced to discontinue treatment due to increasing unaffordability [4, 18, 19]. In response to public and political pressure, three pharmaceutical companies (i.e., Boehringer Ingelheim, GlaxoSmithKline plc and AstraZeneca) have declared a $35 cap on out‐of‐pocket expenses for select respiratory inhalers dispensed in the U.S. It is currently unknown whether this policy will be implemented in Canada. In Ontario, Canada, reimbursement for ICS/LABA inhalers contributed to nearly 50% of overall public payer spending on respiratory inhalers. Although a generic alternative for Advair (ICS/LABA product) was listed on the public formulary on March 31, 2020, this did not coincide with any significant shifts in per‐beneficiary spending overall or among ICS/LABA inhaler recipients. Advair is one of four brand‐name respiratory inhalers within the ICS/LABA drug class that is available in Canada. Although Advair was once the most commonly dispensed ICS/LABA inhaler, its market share has declined over the past decade [6]. Whereas market share for Symbicort, another brand‐name respiratory inhaler within the ICS/LABA drug class, increased [6] following the release of the 2019 GINA guidelines, which recommended Symbicort as first‐line treatment for asthma [2]. In fiscal year 2021/22, Symbicort was also ranked as the third most expensive publicly dispensed single‐source non‐patented medication in Canada [20]. While the introduction of a generic alternative for Advair likely resulted in significant cost savings for those using Advair, a similar benefit was not observed at the population level because this product no longer holds significant market share in the Canadian pharmaceutical market [6].
Given the high cost of brand name respiratory inhalers, it is reassuring that after 17 years of market exclusivity a generic alternative for Symbicort was made available in the U.S. in July 2023 [21]. Lengthy periods of market exclusivity are attributed to tactics employed by drug manufacturers to extend the patent lifecycle, namely the procurement of secondary patents on inhaler devices and engagement in patient litigation against potential generic manufacturers [7]. Due to differences in the Canadian versus U.S. drug market, generic medications are generally approved and launched in the U.S. first, leading to an even longer delay between patent expiration and availability of generic alternatives in Canada. For instance, although the Canadian patent for Advair expired in 2014 [22], a generic alternative (e.g., Wixela Inhub) was not made available until March 2020 [11], compared to February 2019 in the U.S. [23] Moreover, although a generic alternative to Symbicort has been available in the U.S. since 2023, no such product is currently available in Canada, despite the expiration of Symbicort's Canadian patent in 2019 [22].
Strengths of our study include the use of a large, population‐based database of prescription dispensing records. However, our study has limitations. First, causal inferences cannot be established based on our joinpoint models due to the possibility of additional events occurring in close proximity to formulary listing dates of interest. Specifically, apart from the introduction of new products to the ODB formulary, various changes took place over the study period. This includes changes to formulary listing price, eligibility criteria for the provincial drug program (e.g., OHIP+ program from Q1 of 2018 to Q1 of 2019), emergence of declaration for the SAR‐CoV‐2 pandemic, and release of new treatment guidelines for asthma and COPD. For example, although a short‐term decline in overall per‐beneficiary spending on respiratory inhalers is noted between Q3 of 2017 and Q3 of 2019, a similar decline is not observed among those 65 years or older or diagnosed with COPD. However, it was observed among those with an asthma diagnosis. This likely indicates that observed changes between Q3 of 2017 and Q3 of 2019 in overall per‐beneficiary spending were driven by beneficiaries diagnosed with asthma and implementation of the OHIP+ program, which caused a temporary increase in the number of beneficiaries with asthma. As a result, the decline in overall per‐beneficiary spending noted in Q3 of 2019 (sixth joinpoint) may have been influenced by formulary listing the first ICS/LAMA/LABA inhaler and termination of the OHIP+ program. Second, our analysis was restricted to individuals eligible for the ODB program and costs incurred by the public payer for the reimbursement of respiratory inhalers. As a result, we were unable to determine cost implications of changing respiratory inhaler product availability for those not eligible for provincial drug coverage or any out‐of‐pocket expenses incurred by the patient. Third, requirements for ODB eligibility may limit the generalizability of our results, as the majority of ODB beneficiaries are 65 years or older or require disability/social support. Fourth, we may have overestimated public payer spending on respiratory inhalers as we relied on the listing price for all our calculations, which did not include confidential manufacturers' rebates received by the public payer. However, while this may affect absolute cost estimates, we expect that trends over time may be less impacted by this limitation. Lastly, our study was conducted in a single Canadian province, which may further limit the generalizability of our findings to jurisdictions across and outside of Canada due to differences in public payer reimbursement of prescription medications.
In summary, between 2003 and 2023, public payer spending on respiratory inhalers increased considerably in Ontario, Canada, with $68 million CAD spent in Q1 of 2023 alone. Despite the high cost of novel combination therapy respiratory inhalers (e.g., LAMA/LABA), their listing on the public formulary coincided with a significant reduction in per‐beneficiary spending on respiratory inhalers. While the availability of generic alternatives for Advair and Flovent likely resulted in cost‐savings at the patient‐level, the addition of these products to the public drug formulary did not impact the trend for per‐beneficiary spending overall or by drug class. This was likely due to the lengthy delay between patent expiry and the eventual entry of a generic alternative, by which time these products no longer held significant market share. Overall, implementation of drug policies that support the expedited entry of generic inhalers, particularly products that hold market share and disincentivize patent prolongation, should be considered to decrease the cost of respiratory inhalers.
4.1. Plain Language Summary
The cost of chronic treatment with respiratory inhalers has imposed a financial strain on both patients and public payers, becoming recognized as a public health concern worldwide. Over the past 10 years, several new products have become available, including new combination therapy respiratory inhalers and generic alternatives for long‐standing brand name inhalers. Considering the changing availability of respiratory inhaler products, we examined trends in cost and utilization of respiratory inhalers reimbursed by the government in Ontario, Canada, along with the impact of new market entrants on these trends. We found that public payer spending on respiratory inhalers outpaced the rise in the number of beneficiaries dispensed a respiratory inhaler. Reimbursement of inhalers from the ICS/LABA drug class accounted for approximately one‐half of public payer spending on respiratory inhalers. Per‐beneficiary spending on respiratory inhalers increased slightly with periods of increasing and decreasing quarterly per‐beneficiary spending. Listing of new combination therapy respiratory inhalers coincided with significant declines in per‐beneficiary spending. In contrast, the introduction of generic alternatives did not impact the trend. Further expansion of generic product availability is likely required to decrease public payer spending on respiratory inhalers.
Ethics Statement
The use of data in this project was authorized under section 45 of Ontario's Personal Health Information Protection Act, which does not require review by a Research Ethics Board.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: Supporting Information.
Acknowledgments
This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long‐Term Care (MLTC). This study also received funding from the MOH (Grant #0691). Parts of this material are based on data and information compiled and provided by the MOH and the Canadian Institute for Health Information (CIHI). This document used data adapted from the Statistics Canada Postal CodeOM Conversion File, which is based on data licensed from Canada Post Corporation, and/or data adapted from the Ontario Ministry of Health Postal Code Conversion File, which contains data copied under license from Canada Post Corporation and Statistics Canada. We thank IQVIA Solutions Canada Inc. for the use of their Drug Information File. The analyses, conclusions, opinions, and statements expressed herein are solely those of the authors and do not reflect those of the funding or data sources; no endorsement is intended or should be inferred.
Funding: This work was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH) and the Ministry of Long‐Term Care (MLTC). This study also received funding from the MOH (Grant #0691). Parts of this material are based on data and information compiled and provided by the MOH and Canadian Institute for Health Information (CIHI).
Data Availability Statement
The dataset from this study is held securely in coded form at ICES. While legal data sharing agreements between ICES and data providers (e.g., healthcare organizations and government) prohibit ICES from making the dataset publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1: Supporting Information.
Data Availability Statement
The dataset from this study is held securely in coded form at ICES. While legal data sharing agreements between ICES and data providers (e.g., healthcare organizations and government) prohibit ICES from making the dataset publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS.