Chronic Obstructive Pulmonary Disease (COPD) is a progressive condition that places a significant burden on patients and healthcare systems. Guidelines recommend triple therapy for patients with moderate-to-severe COPD whose disease remains inadequately controlled despite receiving dual therapy. This can be delivered either via multiple inhalers (MITT) or a single inhaler (SITT).
SITT has been shown in RCTs to reduce exacerbations, potentially lower mortality, and improve adherence compared to MITT, leading to reduced healthcare resource use and costs. However, despite these benefits, access to SITT in primary care varies across Europe due to payer-driven restrictions; regulations typically designed to control costs, but often limiting PCPs’ ability to prescribe guideline-recommended care.
To explore the real-world impact of these access criteria, we conducted a three-part study: a targeted literature review (TLR), qualitative interviews with 14 experts across nine countries, and a consensus workshop. The TLR revealed limited evidence on SITT access variation and no studies quantifying the impact of prescribing restrictions. Interviews highlighted five key themes: country-level variation, unintended consequences of prescribing restrictions, over-reliance on specialist prescribing, persistent access challenges, and patient inequalities.
The expert panel validated the findings from the TLR and provided some country-specific insights into how payer-imposed requirements for specialist sign-off constrain access to triple therapy. The panel found that these restrictions disproportionately apply to SITT, suggesting a disconnect between clinical guidelines and prescribing policy.
These findings provide the first cross-national, expert-informed account of the unintended consequences of payer-driven access criteria on the management of COPD with SITT in primary care. In the absence of peer-reviewed publications quantifying this issue, the study offers an important perspective for health policy discussions aimed at aligning access with guidelines, improving outcomes, and ensuring more equitable care.
Acknowledgements: this work was commissioned and funded by AstraZeneca. The work was carried out independently by Aquarius Population Health.
Link to publication:
DOI: 10.2147/COPD.S503726
To learn more about our work at Aquarius, please visit our website or email us at info@aquariusph.com
Article by Ellie Moran – July 2025