Faricimab for treating wet age-related macular degeneration

Evidence-based recommendations on faricimab (Vabysmo) for wet age-related macular degeneration in adults.

# Recommendations
Faricimab is recommended as an option for treating wet age-related macular degeneration in adults, only if:
the eye has a best-corrected visual acuity between 6/12 and 6/96
there is no permanent structural damage to the central fovea
the lesion size is 12 disc areas or less in greatest linear dimension
there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes)
the company provides faricimab according to the commercial arrangement.
If patients and their clinicians consider faricimab to be 1 of a range of suitable treatments (including aflibercept and ranibizumab), choose the least expensive treatment. Take account of administration costs, dosage, price per dose and commercial arrangements.
Only continue faricimab if an adequate response to treatment is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.
These recommendations are not intended to affect treatment with faricimab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Wet age-related macular degeneration is usually treated with aflibercept or ranibizumab, which are already recommended by NICE for treating wet age-related macular degeneration. Faricimab is another treatment option that works in a similar way.
Evidence from clinical trials shows that faricimab is as effective as aflibercept. An indirect comparison of faricimab with ranibizumab also suggests similar clinical effectiveness.
A cost comparison suggests faricimab has similar costs and overall health benefits to aflibercept or ranibizumab. So, faricimab is recommended for treating wet age-related macular degeneration if it is used in the same population as aflibercept and ranibizumab.# Information about faricimab

# Marketing authorisation indication
Faricimab (Vabysmo, Roche) is indicated for 'the treatment of adults with neovascular (wet) age-related macular degeneration'.

# Dosage in the marketing authorisation
The dosage schedule is available in the summary of product characteristics for faricimab.

# Price
Faricimab costs 857 for 1 vial of 120 mg per 1 ml solution for injection (excluding VAT; company submission, accessed April 2022).
The company has a commercial arrangement. This makes faricimab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.# Committee discussion
The appraisal committee considered evidence submitted by Roche, a review of this submission by the evidence review group (ERG), and responses from stakeholders. See the committee papers for full details of the evidence.

# Comparators

## Aflibercept and ranibizumab are appropriate comparators
Aflibercept and ranibizumab are anti-vascular endothelial growth factor (anti-VEGF) injections recommended by NICE for treating wet age-related macular degeneration. Faricimab is another anti-VEGF injection that works in a similar way to aflibercept and ranibizumab, but it also targets the Ang2 pathway. The company proposes that faricimab will extend the time needed between injections compared with aflibercept and ranibizumab. The ERG suggested aflibercept was the most appropriate comparator for faricimab. Clinical experts said that the 2 treatments are both used. But they said aflibercept may be used more than ranibizumab. The ERG's clinical experts suggested that 65% of people have aflibercept. The committee concluded that aflibercept and ranibizumab were both appropriate NICE-recommended comparators.

# Clinical evidence

## Evidence from 2 clinical trials, TENAYA and LUCERNE, shows similar clinical effectiveness of faricimab and aflibercept
Clinical evidence for faricimab compared with aflibercept came from 2 clinical trials. These were TENAYA and LUCERNE. Both were phase 3 randomised controlled trials that compared faricimab with aflibercept in 1,329 adults. After the initial loading doses specified in the summary of product characteristics, aflibercept was given every 8 weeks and faricimab was administered every 8, 12 or 16 weeks based on an assessment of disease activity at weeks 20 and 24. The assessment was based on objective prespecified criteria (best corrected visual acuity and optical coherence tomography) and physician's clinical assessment. People stayed on the fixed dosing intervals until week 60 without having any other treatment. The primary outcome measure was the mean change in best corrected visual acuity from baseline averaged over 40, 44 and 48 weeks. The difference in adjusted mean best corrected visual acuity from baseline at weeks 40, 44 and 48 was 0.4 letters, 95% confidence interval -0.9 to 1.6. The results were also reported averaged over 52, 56 and 60 weeks (these are considered confidential by the company and cannot be reported here). The evidence suggested that both treatments were similarly effective and had similar adverse events. Because there is only data up to 112 weeks, there is some uncertainty about how many faricimab injections are needed beyond the first 2 years. Despite the uncertainty, the committee considered that faricimab is likely to be similarly clinically effective as aflibercept.

## Faricimab is likely to have similar clinical effectiveness as ranibizumab
The company did a network meta-analysis comparing faricimab with ranibizumab and aflibercept. The ERG considered that the network meta-analysis showed that faricimab has similar clinical effectiveness and had similar adverse events to aflibercept and ranibizumab. Also, clinical opinion suggests that the treatments are similar. The committee concluded that there was sufficient evidence of similar clinical efficacy for faricimab compared with ranibizumab.

# Cost comparison

## Faricimab is likely to be cost saving or have similar costs compared with aflibercept or ranibizumab
The company base case assumed there would be fewer injections and monitoring visits needed for faricimab compared with the comparators. But the committee was aware that in NHS clinical practice faricimab may have a similar dosing regimen as aflibercept and ranibizumab. This is to reduce inconsistencies in clinical practice and chance of error in busy clinical settings. Because of this, along with the lack of long-term data, the committee considered scenarios in which the number of injections and monitoring visits was the same for faricimab, aflibercept and ranibizumab after the initial loading doses. The committee acknowledged that if the time needed between injections is lengthened, then the cost of faricimab would reduce. When taking account of the commercial arrangements for all treatments, the committee was satisfied that the total cost associated with faricimab was similar or lower than aflibercept or ranibizumab (the exact results are confidential and cannot be reported here). The committee therefore recommended faricimab for treating wet age-related macular degeneration in line with the previous recommendations for aflibercept and ranibizumab.

# Other factors

## There are no equality issues relevant to the recommendations
The committee did not identify any equality issues.