When Colombia updated its Health System Benefit Plan in 2022, the change opened coverage to a new generation of respiratory medicines, including long-acting bronchodilators and inhaled combination therapies that had previously been outside the standard package. A new observational study now reports what happened next: dispensing of the newly included therapies rose sharply, and the direct pharmaceutical costs of these medications nearly doubled within 18 months.
The study was conducted by a team led by Manuel Enrique Machado-Duque and Jorge Enrique Machado-Alba, drawing on the dispensing database of Audifarma SA, a pharmaceutical manager whose records cover approximately 9.2 million members of the Colombian Health System. That population corresponds to roughly 30 percent of the active affiliated population of the contributory regime and 6 percent of the state-subsidized regime, together comprising about 17 percent of the Colombian population. The researchers analyzed dispensing records from the same data source using the same procedures throughout the observation period, and the health status of the evaluated population remained stable during the study window.
The policy backdrop is essential to understanding the findings. Under Resolution 2292 of 2021, issued by the Colombian Ministry of Health and Social Protection, the Benefit Plan took effect in 2022 with an expanded list of respiratory medications. Before the update, only short-acting bronchodilators such as salbutamol, a short-acting beta agonist; ipratropium bromide, a short-acting antimuscarinic; and beclomethasone, an inhaled glucocorticoid, were used for managing respiratory conditions under the plan. The resolution incorporated long-acting beta agonists (LABAs) alone or combined with inhaled glucocorticoids (ICSs), such as salmeterol/fluticasone or formoterol/budesonide, as well as long-acting antimuscarinics (LAMAs), additional LAMA molecules, long-acting ICSs, and monoclonal antibodies such as omalizumab. With their inclusion, these therapies became accessible to patients in both the contributory and subsidized regimes without additional mandatory authorizations or permits.
The study population was large and demographically broad. By the final month of follow-up, in June 2023, the study medications had been dispensed to a total of 42,370 patients, whose average age was 60.8 years, with a standard deviation of 26.2 years. The majority were female, at 24,054 patients, or 56.8 percent. A total of 5,632 patients, or 13.3 percent, were between 0 and 17 years old, while 24,053 patients, or 56.8 percent, were over 65. Most patients lived in the Bogota-Cundinamarca region, at 30.6 percent, followed by the Central region at 28.9 percent and the Caribbean region at 21.4 percent, and most participated in the contributory scheme, at 72.0 percent.
The dispensing trends showed substantial growth beginning in January 2022, when the new Benefit Plan took effect. The greatest increases in the percentages of patients receiving the newly included medications were observed for the combination vilanterol/umeclidinium, which rose 292.1 percent, followed by vilanterol/fluticasone at 239.7 percent and formoterol/budesonide at 156.1 percent. Increases were not limited to combination products. The number of patients dispensed budesonide rose 364.6 percent, fluticasone rose 289.1 percent, tiotropium bromide rose 143.9 percent, benralizumab rose 134.0 percent, and roflumilast rose 111.6 percent during the 18-month follow-up period after the new plan took effect. Percentage changes for the leading combination therapies ranged between 103.4 and 292.1 percent.
The financial consequences were equally pronounced. The total estimated cost for the October-December quarter of 2021, the last complete quarter before implementation, was USD 2,404,035, or 9,570,463,987 Colombian pesos. By the April-June quarter of 2023, the figure had reached USD 4,651,828, or 19,495,810,574 pesos, an increase of 93.5 percent in the invoiced value. The researchers attributed this rise primarily to increased turnover of LABA/ICS combinations, which grew 190.4 percent, and LABA/LAMA combinations, which grew 119.4 percent, along with a 35.6 percent increase in biotechnology products such as benralizumab, which itself rose 149.9 percent and ranked among the groups with the highest net costs to the health system. Measured as cost per thousand insured inhabitants per day, expenditure climbed from USD 2.84 to USD 5.48, an increase of 103.7 percent.
To check whether these increases simply reflected a general rise in dispensing across all medications, the team analyzed comparator drugs. Related comparators, salbutamol and ipratropium bromide, which were already included in the Benefit Plan before the update, showed only modest changes during the observation period. Unrelated comparators, including enalapril, atorvastatin, and omeprazole, which treat conditions not directly related to the new respiratory therapies, showed relatively stable or slight increases in dispensation. The authors concluded that the marked increases observed for the newly included respiratory medicines cannot be explained simply by a generalized increase in medication dispensation across all therapeutic groups, although they emphasized that this comparator analysis should be interpreted as exploratory.
The findings align with international treatment recommendations that motivated the policy change. Clinical guidance indicates that LABA/ICS combinations should be the first-line and mainstay treatment for managing asthma in a wide variety of patients, from intermittent to persistent disease, with the goals of controlling symptoms, reducing chronic airway inflammation, and reducing the probability of severe and life-threatening exacerbations. For chronic obstructive pulmonary disease, LABA/LAMA combinations are the therapy of choice for patients with symptoms, intended to control symptoms, slow the progression of lung damage, and reduce the occurrence of new exacerbations. The authors note that the release of the new Benefit Plan aligns with these international recommendations, eliminating difficulties associated with patient access to ideal therapies, and that previous management strategies in Colombia were generally not in accordance with the recommendations, so the recommended therapies were often started as adjunct treatments rather than replacements.
A study conducted in 2015 in Colombia found that the inclusion of new medicines in the 2011 Benefit Plan led to a general increase of 830 percent in the number of new therapies by June 2013, particularly losartan/hydrochlorothiazide, esomeprazole, and atorvastatin. An Italian study by Braido and colleagues similarly found that the emergence of new respiratory medications and their inclusion by health systems were associated with increased dispensing and direct pharmaceutical costs of combination therapies such as vilanterol/umeclidinium and salmeterol/fluticasone in 2015. The authors of the current study also point to fiscal pressures in Colombia, noting that the annual increase in the value of the capitation payment unit, which corresponds to the amount covered by the Health System to the insurer for each patient, has not grown sufficiently to match or exceed annual inflation, raising concerns about resource scarcity.
The researchers are careful about what the data can and cannot show. They emphasize that this is a descriptive medication use and cost analysis, and that the study design does not allow causal inferences regarding the effect of the policy change; the observed trends may have been influenced by other factors, including changes in clinical practice, disease burden, prescriber behavior, medication availability, market dynamics, or broader nonclinical trends in dispensation. Clinical details of the patients, such as the severity of respiratory pathology and the effectiveness of therapy, are unknown, out-of-pocket expenses could not be determined, and the results cannot be extrapolated to other insurers in the country, particularly those affiliated with the subsidized scheme. No global assessment of potential symptom improvement or reductions in exacerbations was conducted. The authors recommend that future studies employ quasi-experimental designs, such as interrupted time-series or segmented regression analyses, to formally estimate the causal impact of Benefit Plan updates, and that new cost-effectiveness studies assess these therapies against disease exacerbations and other outcomes of interest.
Subject of Research: Trends in the dispensing and direct pharmaceutical costs of respiratory medications included in Colombia's 2022 Health System Benefit Plan update
Article Title: Trends in the Use and Costs of Medications for Respiratory Management Included in the 2022 Benefit Plan of the Colombia Health System
Article References: Machado-Duque, M. E., Valladales-Restrepo, L. F., Gaviria-Mendoza, A., Albanes-Beltrán, J. P., Mesa-Escobar, G., Delgado-Araujo, A. C., Oyuela-Gutiérrez, M. C., Rubio-Londoño, S., & Machado-Alba, J. E. (2026). Trends in the Use and Costs of Medications for Respiratory Management Included in the 2022 Benefit Plan of the Colombia Health System. Drugs – Real World Outcomes. https://doi.org/10.1007/s40801-026-00581-7
Image Credits: AI Generated
DOI: 10.1007/s40801-026-00581-7
Keywords: Colombia, Benefit Plan, respiratory medications, COPD, asthma, LABA/ICS, LABA/LAMA, pharmaceutical costs, drug dispensing, health policy, observational study, Audifarma
News Source: Ophelia Keating. (October 29, 2026). Respiratory Drug Dispensing and Costs Nearly Doubled in Colombia After 2022 Benefit Plan Update. Scienmag.
