Variations in the pharmacological management of COPD due to payer-driven access criteria for triple therapy: Pan-European cross-expertise qualitative insights

Background: Triple therapy (TT) is authorised in Europe for maintenance treatment in moderate-severe Chronic Obstructive Pulmonary Disease (COPD) patients who are inadequately treated by dual therapies. Its delivery through single-inhalers (SITT) is recommended as the more convenient and cost-effective option than multiple-inhalers (MITT). TT may be subject to access criteria imposed by payers to ensure prescription appropriateness or contain costs, mainly affecting SITT. This study aims to explore the payer-driven variations in access to TT in primary care across Europe to understand their implications. Methods: This qualitative research used 14 in-depth, semi-structured interviews: seven pulmonologists, three general practitioners (GPs), two PAG representatives and one health-economist. Purposive sampling was used to identify participants from nine European countries to provide a balanced comparison. Thematic content analysis was used, employing a deductive approach and line-by-line coding in NVivo®. Results: We identified five themes: 1-Variations between countries; 2-Unintended consequences; 3-Specialist access; 4-Remaining challenges; 5-Access inequalities for patients. Most national payers do not apply access criteria for TT (Belgium, England, Germany, Netherlands and Portugal) or lifted them recently (France and Spain). These criteria are still in place in Italy and Austria, mostly about SITT, and affect GPs by limiting the right to initiate triple therapy. While the management of COPD in primary care needs strengthening, the interviewees perceived the payer-driven criteria as reducing GPs’ autonomy and preventing timely treatment, inadvertently creating barriers and inequalities. Even in countries without access criteria, GPs could benefit from improved training around SITT as therapeutic inertia and issues with spirometry persist. Conclusion: Payer-driven access criteria for SITT are perceived as having unintended consequences that undermine GPs’ role in managing COPD. This can potentially prevent timely access to guideline-directed medical therapy for moderate-severe COPD patients, hinder equitable care, and potentially further impact health and cost outcomes for patients and healthcare systems.