The National Centre for Pharmacoeconomics (NCPE) has issued a recommendation on Roche’s Vabysmo (faricimab), a bispecific antibody for neovascular (wet) age-related macular degeneration (nAMD), following its regulatory approval in other major markets. The decision evaluates Vabysmo’s clinical performance, safety, and cost-effectiveness compared to existing therapies, impacting access and reimbursement in Ireland.

  • The NCPE reviewed Vabysmo (faricimab) for reimbursement in Ireland for nAMD.
  • Vabysmo is the first bispecific antibody targeting both VEGF-A and Ang-2, offering a novel mechanism of action.
  • FDA and other approvals were based on Phase III studies showing non-inferiority to aflibercept with extended dosing intervals.
  • Flexible dosing may reduce injection burden.
  • Positive recommendations can accelerate adoption and shape pricing negotiations across Europe.

The National Centre for Pharmacoeconomics (NCPE) recommends Vabysmo (faricimab), Roche’s bispecific antibody for neovascular (wet) age-related macular degeneration (nAMD), marking a significant advancement in both clinical management and payer reimbursement models for retinal vascular diseases. As payers and market access strategists closely watch NCPE recommendations, this move positions Vabysmo at the forefront of Ireland’s ophthalmology formulary, joining a cohort of next-generation anti-VEGF therapies that are reshaping the standard of care. NCPE recommends Vabysmo for adoption, and this decision reflects a careful balance of clinical innovation, safety, and the value proposition for public health funds.

Vabysmo stands out as the first FDA-approved treatment for nAMD and diabetic macular edema (DME) that simultaneously inhibits VEGF-A and Ang-2. Approved in the US and Japan and under review in the EU, Vabysmo’s flexible dosing, potentially allowing intervals between injections to extend up to four months, reduces the logistical and resource burden for providers and patients compared to the monthly or bi-monthly regimens historically required by older anti-VEGF agents.

“Our commitment to advancing retinal care is reflected in Vabysmo’s dual-pathway innovation, offering patients sustained benefits with fewer injections—an outcome that supports both clinical and payer goals.”

– Levi Garraway, MD, PhD, Chief Medical Officer, Genentech (Roche Group)

NCPE recommends Vabysmo in a context where payers globally are scrutinizing not just the clinical efficacy but also the long-term cost-effectiveness of high-cost specialty medicines. The positive Irish recommendation closely follows Vabysmo’s launches in other major markets. The FDA based its approval on four Phase III trials, showing Vabysmo’s non-inferiority to aflibercept and its potential to increase dosing intervals.

Evaluations in the UK and Germany have also acknowledged the dual-path mechanism and extended dosing capabilities of Vabysmo. Although price negotiations reflect ongoing tensions between clinical need and health system budgets. NICE fast-tracked Vabysmo for NHS use, citing the same extended dosing data and potential to alleviate clinic burdens.

Vabysmo’s dual targeting of VEGF-A and Ang-2 continues to drive R&D interest in bispecifics and multi-targeted biologics for ophthalmology. The positive reception and expanding reimbursement footprint signal an accelerating shift from traditional single-pathway agents toward combination mechanisms. Companies such as Novartis (with Beovu) and Regeneron (Eylea HD) are updating their market access strategies to emphasize real-world outcomes, durability, and economic value as NCPE recommends, and similar HTA agencies increasingly favor therapies that optimize both efficacy and operational efficiency.

Clinical development for faricimab in new retinal indications, as well as post-launch real-world studies, will further inform payer value frameworks. The adoption of Vabysmo following NCPE’s recommendation underscores the importance of aligning clinical innovation with evidence of economic and societal benefit, a trend that will shape future reimbursement landscapes in ophthalmology.