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Review
. 2025 May 22:20:1595-1612.
doi: 10.2147/COPD.S503726. eCollection 2025.

Single-Inhaler Triple Therapy in Primary Care Across Europe: Expert Panel Consensus on the Consequences of Payer-Driven Access Rules and Call to Action

Fabiano Di Marco  1 , Orjola Shahaj  2 , Arschang Valipour  3 , Bertrand Legrand  4 , Claudio Jommi  5 , Claudio Micheletto  6 , Claus Franz Vogelmeier  7 , Daryl Freeman  8 , Janwillem W H Kocks  9 , Luis Alves  10 , Myriam Calle Rubio  11 , Rudi Peché  12 , Susanna Palkonen Snr  13 , Tonya Winders  14 , Nicolas Roche  15
Affiliations
Review

Single-Inhaler Triple Therapy in Primary Care Across Europe: Expert Panel Consensus on the Consequences of Payer-Driven Access Rules and Call to Action

Fabiano Di Marco et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a prevalent condition characterized by persistent airflow obstruction and respiratory symptoms. Single-Inhaler Triple Therapy (SITT) has been shown to improve patient adherence, reduce exacerbations, and lower healthcare resource utilization in patients who are not controlled despite being on dual therapy or Multiple-Inhaler Triple Therapy (MITT). Despite evidence supporting SITT, payer-driven access rules across Europe sometimes limit its use in primary care, creating barriers to optimal COPD management.

Purpose: Through expert consensus, the study seeks to generate a shared understanding of the unintended consequences of payer-driven access criteria for SITT in managing moderate-to-severe COPD in primary care.

Methods: A targeted literature review (TLR) was conducted to assess SITT initiation in primary care across Europe and examine the impact of access criteria. Semi-structured interviews were held with 14 experts from nine European countries, including clinicians, health economists, and patient advocacy representatives. A consensus generation workshop was conducted, where experts evaluated the findings and developed position statements to highlight the challenges posed by payer-driven access criteria.

Results: The TLR identified variability in access to SITT in Europe, with several countries restricting its initiation to specialists, thus limiting primary care physicians' (PCPs) ability to prescribe SITT. The expert panel generated seven consensus points stating that enabling PCPs to step up or switch eligible patients to SITT has the potential to support care continuity, enhance clinical autonomy for PCPs, reduce reliance on potentially less effective treatment options, improve patient and healthcare system outcomes, avoid unnecessary referrals to specialists, enable prompt initiation of guideline-directed medical therapy for COPD in primary care and reduce access inequalities.

Conclusion: Restrictions for SITT initiation in primary care may need to be revisited to mitigate their unintended health and cost consequences and improve equitable access to treatment. This should take into consideration each country's unique healthcare system.

Keywords: COPD; access; expert consensus; payer; primary care; reimbursement; single-inhaler triple therapy.

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Conflict of interest statement

FDM has received honoraria for lectures at national and international meetings, served as a consultant, and received financial support for research funds and fees from AstraZeneca, Boehringer Ingelheim, Novartis, Pfizer, Chiesi Farmaceutici, Guidotti/Malesci, GLAXOSMITHKLINE., and fees (advisory boards, consultation, education, presentations) from Austral, Biosency, MSD., AstraZeneca, Chiesi, Menarini, Nuvaira, Neopharmed Gentili, Novartis, Sanofi, and Zambon. OS declare no conflicting interests in relation to this work. AV has received honoraria for lectures at national and international meetings and served as a consultant for Astra Zeneca, Boehringer Ingelheim, Chiesi, GLAXOSMITHKLINE, Menarini, Sanofi, and Zentiva. CJ reports serving as an advisory board member and a paid speaker for Amgen, AstraZeneca, BMS, CSL, Behring, Gilead, Incyte, MSD, Roche, Sanofi, and Takeda. Outside the submitted work CJ has carried out research projects in the last 3 years funded by AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Biogen, B.M.S., Boehringer Ingelheim, Daiichi Sankyo, Egualia, Gilead, Incyte, Janssen Cilag, Lundbeck, MSD, Novartis, Roche, Pfizer, Sandoz, Sanofi, Takeda, and Teva. BL reports personal fees from ASTRA ZENECA, GSK, and CHIESI. CM received fees as a speaker from AstraZeneca, GLAXOSMITHKLINE, Sanofi, Chiesi, Menarini, Guidotti, Novartis, Zambon, and Boehringer. GP has received lecture and consultancy fees from Alfasigma, AstraZeneca, Chiesi, GlaxoSmithKline, Guidotti-Malesci, Menarini, Mundipharma, Novartis, Sanofi, and Zambon. CFV has given presentations at symposia and/or served on scientific advisory boards sponsored by Aerogen, AstraZeneca, Boehringer Ingelheim, Chiesi, CSL, Behring, Grifols, GLAXOSMITHKLINE, Insmed, MedUpdate, Menarini, Novartis, Nuvaira, Roche, and Sanofi. DF has received honoraria for lectures from AstraZeneca, GLAXOSMITHKLINE, and Chiesi, provided funded consultant support to AstraZeneca and received support for local healthcare projects from AstraZeneca. JWHK reports grants, personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from Boehringer Ingelheim, grants and personal fees from Chiesi, grants, personal fees and non-financial support from GLAXOSMITHKLINE, non-financial support from Mundi Pharma, grants and personal fees from Teva, personal fees from MSD, personal fees from COVIS Pharma, personal fees from ALK-Abello, grants from Valneva outside the submitted work; and JWHK holds <5% shares of Lothar Medtec GmbH and 72.5% of shares in the General Practitioners Research Institute. LA has served as an advisor or consultant for AstraZeneca, GlaxoSmithKline, and Merck Sharp & Dohme; served as a speaker or a member of a speakers bureau for AstraZeneca, GlaxoSmithKline, BIAL, Viatris, and Novartis Pharmaceuticals Corporation. He is also a member of the Education Subcommittee of the International Primary Care Respiratory Group and a member of the GRESP, the Portuguese Primary Care Study Group for Respiratory Diseases. MCR has received speaker fees from AstraZeneca, Boehringer Ingelheim, Bial, Chiesi, CSL, Behring, GlaxoSmithKline, Menarini, Novartis, Pulmox, Zambón and Grifols, and consulting fees from GlaxoSmithKline and Bial. RP has received consulting fees from AstraZeneca, Chiesi, GlaxoSmithKline, MSD and Sanofi and has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, Chiesi and GlaxoSmithKline. SP reports grants from AbbVie, AstraZeneca, Aimmune, Boehringer Ingelheim, Chiesi, DBV Technologies, OM Pharma, GlaxoSmithKline, Novartis, Pfizer, Regeneron, Roche, and Sanofi. SP reports employment at the European Federation of Allergy and Airways Diseases Patients Associations (EFA). EFA receives unrestricted grants from corporate entities, as mentioned above. SP serves as EFA representative in the following advisory groups of these entities: AstraZeneca (COPD Advisory Committee, Global Respiratory Taskforce), GlaxoSmithKline (Health Advisory Board), Novartis (European Patient Advisory Group and Steering Committee of European Patient Innovation Summit), and Sanofi (Severe Asthma Working Group). TW received paid speaker and advisor fees for AstraZeneca, GSK, Merck/MSD, Novartis, and Sanofi Regeneron outside the submitted work. NR reported receiving grant funding from Boehringer Ingelheim, Novartis AG, Pfizer Inc, and GlaxoSmithKline and personal fees from Boehringer Ingelheim, Novartis AG, Pfizer Inc, GlaxoSmithKline, Austral Pharma, Biosency, MSD, AstraZeneca, Chiesi Farmaceutici SpA, Menarini Group, Nuvaira, Sanofi SA, and Zambon outside the submitted work. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Final position statements (seven) emerging from the expert consensus panel on the need to revisit payer-drive access rules that prevent primary care physicians from prescribing single-inhaler triple therapy to moderate-to-severe COPD patients that meet clinical criteria according to the guidelines.
See this image and copyright information in PMC

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