Inhaled Corticosteroids for asthma treatment in India: An urgent and radical rethink needed.

Asthma is a common chronic respiratory disease characterised by airway inflammation, which is a major global cause of morbidity and mortality.[1]

Inhaled corticosteroids (ICSs) are a highly effective treatment for patients with asthma, which, if used regularly, reduce the risk of asthma attacks and resultant asthma deaths.[2] Unfortunately, despite their key role in controlling airway inflammation and prevention of the worst consequences of asthma ICS are under-prescribed and under-used worldwide.

Given the troubling asthma morbidity and mortality statistics from India in the 2019 Global Burden of Disease (GBD) report the study by Salvi et al.[3] in this issue of the journal is a timely and welcome attempt to quantify levels of ICS use in India. The study authors used GBD data to estimate the number of asthma cases in India and hence expected sales of ICS and compared these with actual ICS sales (data provided through Cipla Ltd., a pharmaceutical company, from IQVIA, a contract research organisation that works closely with the pharmaceutical industry).

The key message from the study is that sales of ICS in India are much lower than expected ‘ideal’ sales based on international recommendations and this reinforces the need for urgent action to improve this situation.

There are a few issues with the study. First, the assumption that only 10% of asthma patients in India have mild intermittent (i.e. GINA Step 1) asthma is surprising given previous estimates from other countries are markedly higher than this.[45] The resultant high percentage of those ‘expected’ to require higher amounts of ICS may have led to accentuation of the disparity between expected and actual ICS sales. The basis of the authors’ (‘worst case scenario’) estimate that up to one-third of the ICS units sold were to patients with chronic obstructive pulmonary disease (COPD) is also unclear. Returning to the article’s title ‘Is underuse of Inhaled corticosteroids for Asthma in India contributing to 42% of global asthma deaths’? the answer is almost undoubtedly yes, but there are a number of other potential contributing and confounding factors requiring consideration not referenced by the authors. These include poverty (or perhaps more accurately ability and willingness to spend on healthcare[6]), level of education and health beliefs,[7] population density, pollution[8] (especially biofuel exposure[9]) and access to healthcare.[10]

Potential causes of ICS underuse in India are well covered and clearly there are many urgent issues to address here. Education of healthcare professionals about the critical role of ICS and improvement in the availability of ICS medications are clearly important. The most crucial and likely most difficult issue to tackle here though is the education of patients about the importance of adhering with ICS treatment, reducing stigma and dispelling myths about inhaled asthma treatment.

Another important point discussed by Salvi et al. is over-the-counter (OTC) purchase of asthma medications, mostly oral or inhaled bronchodilators and oral steroids. Given recognition of the potentially dangerous effects of unopposed short-acting β-agonist (SABA) use in patients with deteriorating asthma,[11] this raises the question of whether SABA inhalers should have a Black Box warning or even going one step further, should OTC sales of SABA be banned? The other side of this equation would be to ensure easy and wide availability of ICS in all healthcare settings—particularly in outpatient settings and promotion of cheaper ICS that are covered under Drug Price Control Order (DPCO) Act. A nationwide campaign by the Indian Medical Association, Indian Chest Society and other relevant bodies to promote awareness among the population and healthcare providers could also have a positive impact.

Even in countries where training of healthcare professionals about the importance of ICS in asthma and ICS prescription rates are much higher there are persistent problems with ICS underuse and SABA overuse.[12] Recent RCT and ‘real-world’ trial evidence has demonstrated marked reductions in asthma exacerbation risk using combined ICS/long-acting β-agonist (LABA) inhalers as reliever therapy in comparison with SABA reliever.[1314] Since 2019 the Global Initiative for Asthma (GINA) guidelines have recommended as needed ICS/formoterol as a preferred reliever therapy over SABAs in patients with mild (Step 1 or 2) asthma.

This raises the question of whether India could, in fact, ‘skip a step’ of concentrating purely on increased prescription of fixed dose ICS maintenance regimes for asthma (with SABA as reliever therapy) and instead take the opportunity to push ahead with widespread prescription of ICS/LABA for reliever (± maintenance) therapy. ICS/formoterol is already recommended as an option for reliever therapy in the Indian Medical Association (IMA) guidelines for asthma management in primary care[15] and its use as a reliever coupling ICS with symptom relief from fast-acting formoterol instead of SABA avoids the danger of unopposed SABA use.[11] In view of the pressing global need to reduce the carbon footprint of inhaled therapy ICS/formoterol dry powder inhaler (DPI) devices (which are widely commercially available) should preferentially be prescribed over metered dose inhaler (MDI) devices.[16] Challenges to this approach remain including a lack of safety and efficacy data regarding addition of an ICS/formoterol reliever inhaler to a different maintenance ICS/LABA inhaler.[17] Another barrier to this approach would be higher unit price of combined ICS/formoterol inhalers over ICS and SABA inhalers. This could be helped by bringing ICS/formoterol inhaler under DPCO.

In summary, the work by Salvi et al. supports the conclusion that ICS are markedly underused in India. Given the current level of concern regarding adverse asthma outcomes in India urgent coordinated action on all fronts including education for patients and healthcare providers to improve attitude and practice regarding asthma management as well as controlling environmental and biomass pollution is required to ensure good lung health.