Medical Unmet Needs in Uncontrolled Asthma Despite GINA Step 4/5 Treatment in Poland

Abstract

Background

Asthma is a heterogeneous chronic respiratory disease characterized by symptoms such as wheezing, shortness of breath, cough, and bronchial obstruction confirmed in spirometry. According to the Polish National Health Fund (NHF), in 2023 there were 2.07 million patients with asthma (International Classification of Diseases, ICD-10 codes J45, J46) in Poland. Despite guideline-based treatment recommended by the Global Initiative for Asthma (GINA) at steps 4 and 5, a substantial proportion of patients remain uncontrolled, leading to significant clinical and societal burden.

Objective

This study aimed to identify the prevalence of uncontrolled asthma among adults receiving GINA step 4/5 therapy in Poland and to characterise the most common medical unmet needs (MUNs).

Methods

We analyzed prescription data from the IQVIA™ Longitudinal Prescription Data (LRx) database covering approximately 55% of Polish pharmacies between November 2023 and October 2024. Adult patients (≥20 years) with GINA step 4/5 asthma were identified based on treatment patterns, including inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), long-acting muscarinic antagonists (LAMA), oral corticosteroids (OCS), and biologics. MUNs were defined as: (1) annual OCS exposure >500 mg, (2) ≥2 exacerbations requiring high-dose OCS rescue medication, and (3) excessive short-acting beta-agonist (SABA) use (>3 packs/year).

Results

Among 1.44 million adult asthma patients, 372,905 (26%) were classified as GINA step 4/5. Of these, 64,235 (17.2%) exhibited at least one MUN. High OCS exposure was most frequent (54% of MUN patients), followed by ≥2 exacerbations (38%) and SABA overuse (45%).

Conclusion

Despite advanced therapy, a significant proportion of GINA step 4/5 asthma patients in Poland remain uncontrolled. Addressing these unmet needs requires optimized treatment strategies, improved patient education, and broader access to biologic therapies.

Introduction

Asthma is a heterogenous disease with pulmonary symptoms such as wheezing, shortness of breath, cough of different duration or intensity level, and bronchial obstruction confirmed in spirometry.¹ According to Polish National Health Fund (NHF) data, in 2023 there were 2.07 million of patients with asthma (J45, J46 International Classification of Diseases, 10th Revision (ICD-10) codes) in Poland.² In previous years (2013–2019) this number was approximately at the same level.²

Notably, severe asthma imposes a significant societal burden, largely because the condition is inadequately controlled in over half of patients’ population. Consequently, these individuals experience frequent exacerbations and a greater need for rescue medication. This lack of control, in turn, elevates the risk of comorbidities and mortality, necessitates frequent hospitalizations and doctor visits, and significantly contributes to lost workdays, diminished productivity, and substantial economic losses for both individuals and the healthcare system.³

Asthma treatment is focused on disease control and disease stability through symptom management, as well as mitigating the side effects of the treatment.² Conventionally, the level of asthma severity is determined based on the treatment advancement that the patient is responsive to and that ensures proper asthma control. Treatment include inhaled corticosteroid (ICS), inhaled corticosteroid combined with long-acting beta-agonist (ICS-LABA, preferably formoterol), long-acting muscarinic agonist (LAMA) or a leukotriene receptor agonist (LTRA), oral corticosteroids (OCS) and finally biologic therapies, such as mepolizumab, targeted to specific asthma phenotypes.⁴ In Poland, the treatment might be administered by both general practitioners (GP) or specialists, especially in the field of allergology and pulmonology, hence rigorous education of both groups on the subject of asthma management is crucial for patient safety.⁵ On the other hand, limited patient education might result in low therapy adherence and compliance leading to worsening of their condition, which consequently results in the occurrence of medical unmet needs.⁵ The definition of the three most common medical unmet needs (MUNs) used in this study was developed in collaboration with clinical experts and GSK. In this paper the three most common medical unmet needs of patients with Global Initiative for Asthma (GINA) 4/5 stage asthma were defined as:

• High OCS exposure – above 500 mg per year.

• More than 2 exacerbations per year.

• Excessively high short-acting beta-2 agonist (SABA) extemporal usage – more than 3 packs purchased per year.

Patients meeting these criteria may be eligible for biologic therapies available within drug programs reimbursed by the NHF in Poland. The purpose of this analysis is to identify major errors and inefficiencies in the current standard of care in Poland, map their prevalence across the country, and review potential remedies aimed at enhancing care of asthma patients.

Patients and Methods

Study Design and Materials

The study used data from November 2023 to October 2024, capturing seasonal variations (eg, pollen surges, respiratory infections, air pollution) and ensuring consistent treatment evaluation based on current guidelines. Annual data was chosen due to the stable number of asthma patients treated each year. Polish respiratory medicine experts contributed valuable insights, and the study was conducted in collaboration with GSK Commercial. It involved a multi-stage analysis of pharmacy data to identify adult GINA 4/5 patients with unmet medical needs, following this sequence:

1. Identification of regular patients taking therapeutic medications classified under ATC code R03.

2. Selection of patients with asthma.

3. Patients with asthma defined as age 20 and above.

4. Identification of GINA stage 4/5 asthma.

5. Identification of patients with Medical Unmet Needs (MUN).

6. Categorization of MUN patients by specific need.

Data Sources

The primary data source for this study was the IQVIA™ Longitudinal Prescription Data (LRx) database, which is based on a pharmacy panel covering approximately 55% of Poland’s 12,429 pharmacies (as of November 2024). The data comprised claimed prescriptions from retail pharmacies. A third-party entity anonymized patient and physician data using advanced cryptographic methods prior to integration into IQVIA databases. Patient data retained age group and gender, with the Personal Identification Number (PESEL) replaced by unique codes. Physician data included specialization and practice type, with the Polish Medical License Number (PWZ) similarly anonymized.

To validate results and support population-level inferences, blood eosinophil levels—a key marker for type 2 asthma phenotype—were analyzed.⁶ Levels were categorized as: hypereosinophilia (>1500 cells/µL), severe (500–1500 cells/µL), moderate (300–500 cells/µL), elevated (150–300 cells/µL), and normal (<150 cells/µL). This laboratory data, provided by Diagnostyka S.A., underwent the same anonymization process as the IQVIA LRx data.

Selection of Pulmonary Patients

The baseline inclusion criterion was patients who purchased at least one prescribed respiratory drug (ATC code R03) at any IQVIA panel pharmacy during the 12-month study period. To enhance the accuracy of inferences, a regularity rule was applied: patients were required to have purchased a prescription drug at least once every six months over the preceding three years in any panel pharmacy. This ensured consistent visibility in the IQVIA LRx database, supporting accurate asthma identification and GINA-based severity assessment. Patient residential data were approximated using the primary postal code, derived from the location of the majority of pharmacy purchases spanning a three-year period. This methodology provided a valuable geographic dimension for identifying therapeutic needs. Our analysis subsequently presents these results stratified by Poland’s 16 administrative voivodeships, the country’s highest-level administrative divisions.

Determination of Pulmonary Indication

In the second phase, an Artificial Intelligence Machine Learning (AIML) model developed by IQVIA Germany was used to predict the likelihood of asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary diseases based on treatment history and demographics (age, gender).⁷ The gradient boosted tree model was trained on German electronic medical records (EMRs) containing age group, sex, prescriptions, lab tests, and confirmed diagnoses. The model was subsequently validated in other countries, including Poland, meeting predefined performance criteria and demonstrating reliable discrimination between asthma, COPD, and other pulmonary conditions.

Selection of Patients with Asthma

Pulmonary diagnoses predicted by the German AIML model were validated using GINA 2023 and Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guidelines, focusing on asthma and COPD. While these conditions share overlapping symptoms and mechanisms, their treatment differs significantly. LABA and/or LAMA are recommended as initial therapy for COPD but are contraindicated in asthma unless combined with ICS, due to the potential risk of severe exacerbations.⁴ Conversely, high-dose ICS is discouraged in COPD. To refine diagnosis assignment, Poland-specific rules were applied using reimbursement and registration data for products with a single reimbursable indication or only one registered indication, respectively. IQVIA LRx data, which includes prescription details and patient co-payment levels, was cross-referenced with national reimbursement lists to narrow down likely indications. For COPD classification, an additional age criterion of over 40 years was applied.

Projection Methodology

Patient data with assigned respiratory diagnoses, sourced from a pharmacy panel covering approximately 55% of Polish pharmacies, was projected to the national level to assess respiratory disease epidemiology. This projection employed a cloning algorithm that matched attributes—sourced from public and IQVIA datasets—to both panel and non-panel pharmacies. Publicly available attributes included demographic factors (eg, salary, population density), nearby healthcare facilities, and pharmacy characteristics. By integrating these variables with IQVIA’s comprehensive sell-in and sell-out data, national-level estimates were generated with high accuracy—an estimated error of 1% nationally and up to 2% at the voivodeship level.

Selection of Patients with GINA Stage 4/5 Asthma

At this stage of the analysis, we narrowed the study population of patients with asthma to adults (aged 20 years and older). Patients with GINA stage 4/5 asthma were identified based on the GINA 2024 treatment guidelines. Specifically, adults receiving medium to high dose inhaled corticosteroids (ICS) alone or with long-acting beta-agonists (LABA) were classified as 4 or 5 stage asthma. Additional criteria for identifying patients with GINA steps 4 or 5 asthma included the presence of any of the following:

• ICS nebulizer prescription in addition to ICS inhaler (concluding ICS inhaler standalone is not enough to control asthma),

• OCS prescription (regardless of amount and dosage),

• dispensing of at least three packs of LAMA per year, whether as monotherapy or in combination with ICS, or ICS and LABA.

Identification of GINA 4/5 Stage Asthma Patients with Medical Unmet Needs (MUN)

All patients with GINA 4/5 stage asthma were evaluated for MUN according to the following criteria:

1. Patients with a total annual OCS exposure encompassing medications such as prednisone, prednisolone, and methylprednisolone exceeding 500 mg, regardless of rescue or maintenance therapy, measured as the total dose of OCS purchased within 12 months.

2. Patients experiencing two or more exacerbations per year, indicated by the purchase of high-dosage OCS rescue medication at least 2 times in 12 months period. High-dose OCS rescue medication was defined as follows (refer to Table 1):

   • Dexamethasone – any dispensed quantity,
   • Prednisolone and prednisone all packages with 20 mg dose or more and packages with 10 mg dose if the dispensed quantity was less than 50 tablets,
   • Methylprednisolone all packages with 16 mg dose or higher and packages less than 50 tablets with 8 mg dose.

3. Patients with high amounts of SABA prescribed, indicating extemporal usage – more than 3 packs purchased per year.

Table 1.

Definition of High Dose OCS Rescue Medication

Molecule	Dose	Pack Size
Dexamethasone	All	All
Prednisone/Prednisolone	Strength ≥ 20 mg	All
	10 mg	< 50
Methylprednisolone	≥ 16 mg	All
	8 mg	< 50

It was possible for each patient to be categorized into more than one group. The number of patients in each of the MUN groups was subsequently tallied, considering any overlaps.

Results

Patients with Asthma

During the period from November 2023 to October 2024 in Poland, 11.7 million patients treated for pulmonary diseases were identified and categorized into asthma, COPD, or other respiratory diseases based on their prescription profiles. Among these patients, 17% were classified as having asthma, while COPD accounted for 9%, and other respiratory diseases comprised the remaining 74%. The estimated total number of identified asthma patients was 1.97 million, representing an approximate 5% underestimation compared to the 2.07 million reported by the National Health Fund (NHF). Results of the analysis showed that 42% of patients with asthma were male and 58% were female. Notably, a higher prevalence of asthma was observed in males within the youngest age group (≤19 years). Conversely, in older age cohorts, females exhibited a greater proportion of asthma cases. Geographical variations in asthma morbidity rates across Polish voivodeships, expressed per 100,000 population, are presented in Figure 1.

Figure 1.

Number of asthma patients in Poland per 100,000 population by voivodeships. Greater Poland voivodeship was the leader with 6,347 asthma patients per 100,000 population. The lowest morbidity rate of asthma per 100,000 residents was observed in the Lower Silesian voivodeship – 3,854 patients.

Patients with GINA 4/5 Stage Asthma

The total number of patients with asthma was then narrowed down to 1.44 million of adult asthma patients. 372,905 (25.8%) of those were classified as GINA stage 4/5 due to prescriptions pattern found, including OCS prescription, ICS nebulizer beside ICS inhaler, at least 3 packs of LAMA or ICS yearly pack level corresponding to maximum daily dose ICS in GINA 4/5 stage treatment according to GINA 2023 recommendations. The number of GINA 4/5 stage asthma cases in the female adult population (246,676) was nearly twice as high as in males (126,228). These results, including the prevalence per 100,000 adult population by voivodeship, are presented in Figure 2.

Figure 2.

Number of patients with GINA 4/5 stage asthma in Poland per 100,000 population by voivodeships. The highest incidence of 4/5 stage asthma per 100,000 adult population was found in central regions of Poland: 1,589 in Łódź voivodeship, 1,567 in Greater Poland and 1,495 in Pomeranian voivodeship.

Medical Unmet Needs Among Patients with GINA 4/5 Stage Asthma

Following the identification and assessment of the most common MUNs within the defined adult GINA stage 4/5 asthma population, 64,200 patients, representing 17.2% of this group, were further classified as having uncontrolled asthma, with the largest proportion of these patients exhibiting a yearly oral corticosteroid (OCS) exposure exceeding 500 mg. In this study, patients with high OCS exposure constituted 54% of all MUN patients (34,660 patients) and 9% of GINA stage 4/5 asthma patients. Highest morbidity occurred among the 60–74 age group for both genders. Figure 3 illustrates the prevalence of high OCS exposure across different voivodeships.

Figure 3.

Number of GINA stage 4/5 asthma patients with high OCS exposure in Poland per 100,000 population by voivodeships. Voivodeships with the highest prevalence of high OCS exposure were Kuyavian-Pomeranian, Łódź and Greater Poland.

As for second group of MUN, there were 24,558 patients experiencing 2 or more exacerbations per year, using high dose OCS as a rescue medication. Over 1/3 of all patients were in the 60–74 age group – 8,956 patients. The geographically segmented results are presented in Figure 4.

Figure 4.

Number of patients with GINA 4/5 stage asthma using ≥2 high dosage of OCS as rescue medication in analyzed period in Poland per 100,000 population by voivodeships. The highest prevalence of two and more exacerbations per 100,000 population was found in Kuyavian-Pomeranian and Pomeranian voivodeships.

45% of MUN patients (8% of patients with GINA 4/5 stage asthma) were classified as ones with high amounts of SABA prescribed, indicating extemporal usage. This translates to 28,780 asthma patients in Poland with SABA overuse. The geographical distribution of this condition’s morbidity is presented in Figure 5. Demographically, women represented the majority of the study population (57%), with the 60–74 age group being the most numerous (10,775 patients).

Figure 5.

Number of GINA 4/5 stage asthma patients with high SABA usage in analyzed period in Poland per 100 thousand population by voivodeships. A higher morbidity of this condition was observed in the central Poland voivodeships and West Pomeranian compared with other regions.

Share of each MUN patients’ group in total adult asthma population in Poland is depicted on Figure 6. Among all adult asthma patients, 4% experienced at least one of the analyzed MUN. Specifically, 2.4% of adult asthma patients consumed more than 500 mg of OCS in 12-months period, regardless of a single dose size. Furthermore, 1.7% of all adult asthma patients experienced two or more exacerbations in 12-months period resulting in high-dose OCS consumption. The final MUN group, characterized by high SABA usage, comprised 2% of the total adult asthma population. Beside assignment to each MUN group, the overlaps were analyzed to identify patients with more than one MUN. The number of patients within each cohort is detailed in Table 2.

Figure 6.

Share of patients with GINA stage 4/5 asthma and patients with MUNs among all adult asthma patients. 26% of all adult asthma patients are classified as GINA stage 4/5. 4% of all adult asthma patients are GINA stage 4/5 patients who also exhibit at least one identified MUN. 2.4% of all adult asthma patients are GINA stage 4/5 patients with high oral corticosteroid (OCS) exposure. 1.7% of all adult asthma patients are GINA stage 4/5 patients experiencing two or more exacerbations per year. 2.0% of all adult asthma patients are GINA stage 4/5 patients with high short-acting beta-agonist (SABA) extemporal usage.

Table 2.

Number of Patients in MUN Overlap Cohorts. Group 1 Defined as Patients with Total OCS Exposure per Year More Than 500 mg Regardless of Rescue or Maintenance Therapy as Total Dose of OCS Purchased Within 12 Months. Group 2 Defined as Patients Experiencing Two or More Exacerbations per year, Indicated by the Purchase of High-Dosage OCS Rescue Medication at Least 2 Times in 12 months Period. Group 3 Defined as Patients with High Amounts of SABA Prescribed, Indicating Extemporal Usage – More Than 3 Packs Purchased per Year

Overlaps Between Groups	Projected no. of Patients	% GINA stage 4/5 Asthma Patients
Group 1 and Group 2	18,956	5,1%
Group 1 and Group 3	4,273	1,1%
Group 2 and Group 3	3,176	0,9%
Group 1and Group 2 and Group 3	2,642	0,7%
Any of Group 1, Group 2 or Group 3	64,235	17,2%

The largest group of patients with overlap, consisting of 18,956 patients, who experienced both high OCS exposure and 2 or more exacerbations per year, represents 5.1% of the GINA stage 4/5 asthma patient population.

Figure 7 sums up the multi-stage process of identifying the study cohort, starting from a broad group of regular prescription users of medications classified under ATC code R03 and culminating in the selection of GINA stage 4/5 asthma patients with specific MUN, who will be the focus of further analysis.

Figure 7.

Cohorts of respiratory patients in Poland.

An analysis of prescription patterns among GINA stage 4/5 asthma patients revealed that general practitioners (GPs) were the most frequent prescribers (62%), followed by pulmonologists (22%) and allergists (7%). GPs were the most frequent prescribers for GINA stage 4/5 asthma patients across all three MUN groups (62–71%) (Figure 8). Pulmonologists represented the second most frequent prescribing specialty (15–21%). Allergists prescribed medication for 4–7% of patients (Figure 8). Prescribers classified as “Other” represent physicians from less frequently occurring medical specialties aggregated into a one category.

Figure 8.

GINA stage 4/5 asthma patients (N=372,905) with 3 types of medical unmet needs by main physician specialties. Group 1 N=34,660, Group 2 N =24,558, Group 3 N = 28,780 patients.

Blood Eosinophil Levels in GINA Stage 4/5 Asthma Patients

Further analysis conducted among GINA stage 4/5 asthma patients involved examining the distribution of blood eosinophil levels based on laboratory test results. Among all patients with GINA stage 4/5 asthma, we were able to verify a result for 33% of the cohort. GINA stage 4/5 asthma patients were categorized based on their blood eosinophil levels, utilizing a standard classification of eosinophilia. Among the tested GINA 4/5 asthma patients, 66% exhibited blood eosinophil counts within the normal range or elevated. Moderate eosinophil levels were observed in 20% of patients, while 13% presented with severe eosinophilia (Figure 9). Hypereosinophilia, defined as a blood eosinophil count exceeding 1500 cells/µL, was observed in less than 1% of patients (Figure 9).

Figure 9.

Distribution of eosinophil (eosinophilia) test results among patients with GINA stage 4/5 asthma (N=124,177).

Discussion

Despite receiving guideline-recommended GINA step 4/5 treatment, a substantial proportion of GINA step 4/5 asthma patients experience medical unmet needs as reflected in high oral corticosteroid use, frequent exacerbations, and excessive SABA use. This study aims to characterize and estimate the prevalence of GINA step 4/5 asthma patients in whom standard high-intensity therapies fail to achieve adequate disease control, highlighting a gap in health management.

According to polish NHF data, in 2023 there were 2.07 million of asthma patients (J45, J46 ICD-10 codes) in Poland.² Based on our study results, the estimated number of patients in Poland receiving asthma-related treatment purchased in retail pharmacies during the period from November 2023 to October 2024 was 1.97 million (5% less compared to the NHF report²). This discrepancy is likely attributable to the patient regularity criteria implemented in our analysis, which required individuals to have purchased a prescription medication at least once every six months over the preceding three years. This methodological approach enables the identification of patients consistently represented within the IQVIA LRx database, thereby enhancing the accuracy of asthma identification and supporting the determination of disease severity according to GINA classification. Furthermore, our underestimation may be attributed to the exclusion of patients receiving specialized care and treatment within hospitals or long-term care facilities, where collective prescriptions are frequently dispensed.

Applying the GINA 2024 treatment guidelines, which include OCS prescription, ICS nebulizer alongside ICS inhaler, and at least 3 packs of LAMA drugs or an ICS yearly pack level corresponding to the maximum daily dose ICS for GINA stage 4/5 asthma, our estimation based on prescription patterns found in IQVIA™ Longitudinal Prescription Data (LRx) indicates that the number of adults with GINA stage 4/5 asthma is 372,905 (26% among adults with asthma). By further restricting this GINA stage 4/5 asthma population to include those with at least one identified MUN, such as high total OCS exposure, two or more exacerbations or high amounts of SABA prescribed, indicating extemporal usage, we estimated 64,235 patients (4.3% of the total adult asthma population) as experiencing inadequate asthma control. Data from the AstmaZero project indicated that 6% of patients with asthma used OCS at least once annually, with most receiving prescriptions for 200–1800mg, corresponding to 1–5 courses of exacerbation treatment. In well controlled asthma exacerbations shall not occur at all.⁸ In comparison, a population-based study conducted in the Netherlands, based on data from the PHARMO Database Network, which links outpatient pharmacy dispensing records with general practitioner and hospital data, and covering the period from 2009 to 2013, estimated the prevalence of severe asthma to be approximately 3.7% among patients with asthma. This estimation was based on individuals prescribed high-dose inhaled corticosteroid-long-acting beta-agonist (ICS-LABA), or medium- or high-dose ICS-LABA plus long-term oral corticosteroids (OCS), who also exhibited poor symptom control (as assessed by the Asthma Control Questionnaire) and demonstrated good adherence and correct inhaler technique.⁹ While the Polish study utilized prescription patterns, the Dutch study employed a more comprehensive definition incorporating symptom control and adherence. Nevertheless, the comparable prevalence estimates for severe/uncontrolled asthma in Poland and the Netherlands (4.3% and 3.7%, respectively) suggest a potentially similar proportion of severely affected patients with asthma in both countries.

The treatment of asthma in Poland presents with several areas requiring improvement, including: delayed diagnosis (averaging over 7 years), poor adherence to prescribed therapies, frequent errors in inhalation technique during the use of inhaled medications, and consequently, poor disease control in a significant proportion of patients.¹⁰ Crucially, the physician–patient relationship plays a vital role, influencing patient motivation and their ability to correctly use prescribed medications. Low adherence rates (ranging from 8–13% at one year) and prevalent inhalation errors lead to an increased risk of asthma exacerbations and elevated healthcare costs.¹⁰ Therefore, it is critical to systematically monitor adherence to treatment recommendations and provide support in overcoming individual challenges, potentially leveraging interactive communication methods such as smartphone applications.¹⁰

One of the key problems is over-reliance on SABAs by patients with asthma, which is associated with a nearly two-fold increased risk of severe asthma exacerbations.¹⁰ Consistent with the GINA 2024 report, SABA-only treatment and higher average use of SABA over a year is a significant risk factor for exacerbations and in shorter periods increased use of as-needed SABA is linked with higher probability of severe exacerbation in subsequent days or weeks.⁴ In presented study, 28,780 patients, representing 8% of all GINA stage 4/5 asthma patients, exhibited excessive SABA usage.

Organizational factors and reimbursement criteria also significantly influence asthma treatment approaches. The lack of current specialist confirmation regarding asthma treatment details impacts the therapeutic decisions made by general practitioners (GPs). The conducted analysis showed that 62% of all GINA stage 4/5 asthma patients are primarily managed by GPs. The absence of valid specialist documentation (or its expiration after one year, as per Polish regulations) may lead primary care physicians to hesitate in prescribing reimbursed medications, thereby limiting treatment accessibility. Furthermore, a significant error observed among patients is the self-discontinuation of inhaled corticosteroids (ICS), frequently perceived as insufficiently effective due to the lack of immediate broncho dilatory effects and the absence of an immediate, discernible symptom exacerbation upon cessation.¹⁰ The use of OCS, even at low doses, is significantly associated with an increased risk of serious side effects, including pneumonia, type 2 diabetes mellitus, osteoporosis, cardiovascular diseases, depression, and cataracts.¹⁰ GINA guidelines recommend that OCS use should be restricted to only the most severe forms of asthma.⁴ A principle should be adopted whereby the necessity for even a short course of OCS for asthma should trigger a specialist consultation to consider the patient’s eligibility for biologic treatment within the drug programs offered by the NHF. As demonstrated in the study, 34,660 patients (9%) with GINA stage 4/5 asthma experienced OCS exposure exceeding 500 mg per year, and 24,558 patients (7%) experienced two or more exacerbations requiring high-dose OCS rescue medication annually. These findings strongly suggest that many patients with severe asthma are over-relying on OCS when they could benefit from biologics. Given that many of these patients likely present with T2 inflammation (evidenced by elevated blood eosinophil count), they represent ideal candidates for these advanced therapies. The significant OCS burden observed is a clear indicator of the under-prescription of biologics for eligible patients. This under-treatment could be due to various factors, including the systemic issues with specialist documentation, insufficient awareness of biologic criteria among some providers, or administrative hurdles in the reimbursement process. Prioritizing specialist referrals for OCS-dependent patients and simplifying access to biologic therapies is crucial to mitigate OCS-related harm and provide more effective, targeted treatment.

Comprehensive patient education regarding asthma pathophysiology and the correct administration of inhaled medications is crucial. A notable issue is the insufficient availability of written asthma action plans (possessed by only about 20% of patients) and the lack of peak flow meters for patients experiencing symptomatic asthma.¹⁰ The educational procedures recommended by GINA are implemented by only 31% of specialists. This suggests that the population of patients lacking a fundamental understanding of their disease aetiology and the proper technique for using inhaled medications is increasing rather than progressively diminishing.¹¹ Factors contributing to suboptimal treatment adherence include the complexity of therapeutic regimens, difficulties encountered with inhaler devices, and a lack of clear understanding regarding treatment objectives. Consequently, robust educational interventions and effective communication strategies involving healthcare professionals – primarily general practitioners (GPs) alongside specialist pulmonologists and allergists – are critical to mitigating the risks associated with poor patient engagement and non-adherence.

Limitations of the Study

• The data were extrapolated to a national level from a limited patient population, which may affect generalizability.

• Due to the age groupings within the IQVIA™ Longitudinal Prescription Data (LRx), precise delineation of the adult population was not feasible. Consequently, for the purposes of our analyses, adults were defined as individuals aged 20 years and older.

• Patient diagnoses were inferred based on treatment patterns, which may introduce diagnostic inaccuracies due to comorbidities or suboptimal treatment regimens.

• There is a potential for misclassification of non-MUN patients as MUN, as some individuals may be receiving treatments for coexisting conditions that align with our assumptions.

• Eosinophil level ranges were defined in collaboration with GSK, incorporating additional categories of elevated and moderate eosinophilia. These categories may include values that some sources consider within normal limits.

• The medical unmet need groups were defined in collaboration with GSK, based on common treatment errors reported in the literature. Assumptions for each group were made in light of data limitations, which include information on prescribed and purchased medications but not on actual patient adherence or dosing.

Conclusion

The estimated prevalence of GINA step 4/5 asthma patients in Poland is 372,905 as determined through analysis of IQVIA™ Longitudinal Prescription Data (LRx). Approximately 17.2% of these individuals experience medical unmet needs, characterized by high oral corticosteroid (OCS) exposure, frequent exacerbations, and/or excessive short-acting beta-agonist (SABA) use, highlighting a critical gap in their management within standard outpatient care. While the observed prevalence of uncontrolled asthma within this Polish cohort demonstrates a potentially comparable scale to severe asthma estimates reported in other European countries, further research incorporating patient-reported outcomes such as symptom control and treatment adherence is essential for a more nuanced and complete understanding of the patient experience. These findings underscore the critical importance of identifying and addressing unmet needs in the management of uncontrolled severe asthma in Poland. Enhancing patient outcomes may require expanded access to drug programs, implementation of optimized treatment strategies, and the reinforcement of comprehensive educational initiatives targeting both patients and healthcare professionals.

Funding Statement

This study was undertaken by IQVIA and funded by GSK.

Abbreviations

NFZ, National Health Fund (Polish: Narodowy Fundusz Zdrowia); ICS, Inhaled corticosteroid; LABA, Long-acting beta2-agonist; LAMA, Long-acting muscarinic antagonist; LTRA, Leukotriene Receptor Agonist; OCS, Oral Corticosteroids; GP, General Practicioner; SABA, Short-acting beta2-agonist; LRx, IQVIA™ Longitudinal Prescription Data; PWZ, Medical License Number (Polish: Prawo Wykonywania Zawodu); GINA, Global Initiative for Asthma; AIML, Artificial Intelligence Machine Learning; COPD, Chronic Obstructive Pulmonary Disease; EMR, Electronic Medical Records; GOLD, Global Initiative for Chronic Obstructive Lung Disease; MUN, Medical Unmet Need.

Data Sharing Statement

For requests for access to anonymized subject level data, please contact the corresponding author.

Ethics Approval and Informed Consent

This study was conducted using anonymized prescription data obtained from the IQVIA™ Longitudinal Prescription Data (LRx) database, accessed with explicit permission from IQVIA Solutions Poland. In accordance with the Act of 29 August 1997 on the Protection of Personal Data (Journal of Laws 2016, item 922, as amended), research utilizing fully anonymized data is exempt from the requirement for ethics committee approval and informed consent.

Furthermore, the LRx database undergoes regular independent audits to assess the risk of re-identification, all of which have been successfully completed.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

K. Sosnowska, A. Grabowicz are employees of IQVIA. P. Ciesielczyk is employed by GSK. The funding source, GSK, supported the preparation and approved the study design. The funding source had no effect on the data collection, analysis, interpretation, writing of the report, and the decision to submit the article for publication. G. Bochenek received lecture fees from GSK, Astra Zeneca, Novartis and consulting fees from Sanofi, Astra Zeneca. R. Dobek received honoraria for lectures from: AstraZeneca, Chiesi, GSK, Teva. A. Kucharczyk declares a potential conflict of interest. She has delivered lectures sponsored by GSK, AstraZeneca, Novartis, and Sanofi. She has served on advisory boards for GSK, AstraZeneca, Novartis, and Sanofi. She has received support for conference attendance from AstraZeneca, Novartis, and Sanofi. She also served as National Coordinator and Principal Investigator for the Aurora (XALOC) clinical trial sponsored by AstraZeneca, for which both she and her institution received financial compensation. P. Kuna received honoraria for lectures from Adamed, AstraZeneca, Berlin-Chemie/Menarini, Celon Pharma, FAES, Glenmark, Polpharma, GSK, Teva, Sanofi and support for attending the Scientific Congress form Berlin-Chemie/Menarini and AstraZeneca. M. Kupczyk declares receiving grants from 3TR and ClimAir for EU Horizon 2020, lecture and consultation fees for Abbvie, Adamed, AstraZeneca, HAL, Chiesi, GSK, Novartis, Teva, Emma, LEK-AM, Celon, Zentiva, Sunpharm, and HVD, support form Chiesi, AstraZeneca, and Stallergens for attending ATS, ERS, EAACI. He also participated on Advisory Boards for AstraZeneca, Chiesi, Almirall, Sanofi, GSK, and Novartis. He is a former president of the Polish Society of Allergology. I. Poziomkowska-Gęsicka received payment for lectures from GSK, AstraZeneca, Novartis, Sanofi and support for attending meeting from GSK, AstraZeneca, Sanofi. She participated in Advisory Board for AstraZeneca. R. Gawlik received payment for lectures from Sanofi, GSK, AstraZeneca, Chiesi, Berlin-Chemie/Menarini, and Allergopharma. P. Dąbrowiecki declares no conflict of interest.