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New HTA Decisions in England
March 2021
Drug name
BEOVU® (brolucizumab)
Company
Novartis
Decision date
16/12/2020
Therapeutic area
Eye conditions
Therapeutic sub area
Macular degeneration
Decision
Recommended with restrictions
Indication
Brolucizumab is recommended as an option for treating wet age-related macular degeneration in adults.
Decision Detail
It is recommended only if, in the eye to be treated: • the best-corrected visual acuity is between 6/12 and 6/96; • there is no permanent structural damage to the central fovea; • the lesion size is less than or equal to 12 disc areas in greatest linear dimension and; • there is recent presumed disease progression (for example, blood vessel growth, as shown by fluorescein angiography, or recent visual acuity changes). It is recommended only if the company provides brolucizumab according to the commercial arrangement (there is a simple discount patient access scheme for brolucizumab). If patients and their clinicians consider brolucizumab to be one of a range of suitable treatments, including aflibercept and ranibizumab, choose the least expensive (taking into account administration costs and commercial arrangements). Only continue brolucizumab in people who maintain an adequate response to therapy. Criteria for stopping should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy.
Summary
The HAWK and HARRIER trials provided the clinical evidence, comparing the safety and effectiveness of brolucizumab with aflibercept; primary outcome was change in best-corrected visual acuity (BCVA). The committee concluded that brolucizumab is non-inferior to aflibercept. Meta-analysis assessed the relative effectiveness of brolucizumab, aflibercept and ranibizumab across 6 outcomes, concluding that the effectiveness of brolucizumab is similar to aflibercept and ranibizumab. Adverse events were also likely to be similar to aflibercept and ranibizumab. The total costs (including administration) of brolucizumab are the same or less than those of aflibercept and ranibizumab. The committee therefore recommended brolucizumab, in line with the previous recommendations for aflibercept and ranibizumab, as a cost-effective use of NHS resources for treating wet age-related macular degeneration in adults.