BACKGROUND Stakeholder consultation is an integral part of the NICE clinical guideline development process. Comments received are a vital part of the robust quality-assurance and peer-review processes. The NICE guideline for Atrial Fibrillation underwent consultation (September–November 2020) giving stakeholders such as clinical and patient experts the opportunity to comment on a draft recommendation for the direct-acting oral anticoagulants (DOACs) for the management of patients with atrial fibrillation (AF).

OBJECTIVES Review and categorise stakeholder comments on the relative effectiveness and cost-effectiveness of DOACs received during consultation and final NICE NG196 guideline to assess the impact that stakeholder comments had in the guideline development process.

METHODS Stakeholder responses were extracted (from publicly available material on the NICE website) if they commented on the draft DOAC recommendations. Responses were categorised based on whether they were supportive/neutral/advocated changes; frequency of mention of specific concerns were captured. Final NICE guideline NG196 was reviewed to determine the extent to which stakeholder comments received during consultation was reflected.

RESULTS 43 stakeholders commented on the DOAC recommendations: 1 stakeholder supportive, 2 neutral, majority (n=40; 93%) expressed concern. Key objections included: limiting patient choice (mentioned by 22 stakeholders) and excluding treatment adherence considerations (21), DOAC trials heterogeneity (18), lacking head-to-head trial data (17), cost-effectiveness findings inaccurate/do not consider national/local drug cost rebates (15), criticism of the network meta-analysis (NMA) (11), errors within the health economic model code (1). The NICE committee agreed with concerns raised particularly those regarding the comparative clinical effectiveness, model uncertainty and cost-effectiveness conclusions, reverting to parity recommending any licensed DOAC as first-line anticoagulation option in eligible AF patients based on the NHS List prices.

CONCLUSIONS Our analyses show the strong impact that stakeholder consultation has within the NICE guideline process and the willingness of NICE to consider its stakeholders views when developing evidence-based guidelines.