NICE issues Final Appraisal Determination (FAD) recommending Novartis’ novel eye treatment Beovu® (brolucizumab) for wet age-related macular degeneration

NICE issues Final Appraisal Determination (FAD) recommending Novartis’ novel eye treatment Beovu® (brolucizumab) for wet age-related macular degeneration

• Beovu® (brolucizumab) can improve sight and slow down the deterioration caused by wet AMD, a condition developed by nearly 40,000 people in the UK each year1,2

• Eye injections are a source of fear for people living with wet AMD, with nearly 55% regularly feeling anxious before treatment3

• Brolucizumab could help minimise treatment burden, with more than 50% of patients maintained on 12-weekly dosing intervals immediately after the loading phase to week 482

London, UK, 16 December, 2020 — Novartis today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD), the final draft guidance recommending Beovu® (brolucizumab) for use on the NHS for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.

Sight loss has a significant financial impact, costing the UK economy a staggering £25.2 billion a year, due to the costs of informal care by family and friends, productivity losses, and quality of life impacts4. Macular disease, including wet AMD, is the biggest cause of sight loss in the UK5 with up to 40,000 people developing wet AMD every year1. It is a long-term, degenerative disease that can cause changes in vision, often experienced as gaps or dark spots in the centre of a person’s sight6.

NICE’s FAD recommendation was based on findings from the Phase III HAWK and HARRIER clinical trials, in which brolucizumab met the primary endpoint, demonstrating gains in best-corrected visual acuity (BCVA) from baseline that were non-inferior to aflibercept at week 482,7. Approximately 30% of patients treated with brolucizumab gained at least 15 letters at week 482,7. Vision gain was seen as early as four weeks into the trial and sustained over the remainder of the trial2,7.

Results from HAWK and HARRIER also showed that more than 50% of patients on brolucizumab were maintained on a 12-weekly dosing interval (56% in HAWK and 51% in HARRIER) immediately after the loading phase through year one2,7.

“Eye injections are a source of fear and anxiety for people with wet AMD and in these exceptional times, they are more anxious than ever about hospital visits,” said Cathy Yelf, Chief Executive of the Macular Society. “We are delighted that a new treatment option, which has the potential to maintain vision and help minimise the number of hospital visits for people living with this devastating condition, is now available in England and Wales.”

In wet AMD, faulty blood vessels leak fluid and blood in the back of the eye, which can permanently scar the macula8,9. If this fluid is left untreated, central vision will gradually get worse9. Brolucizumab works by suppressing the growth of these abnormal blood vessels, reducing the potential for fluid and blood leaking into the retina2.

“Wet AMD can progress rapidly and cause significant visual loss in as little as 3 months. Wet AMD can be managed with effective, consistent treatment and regular monitoring of fluid in the back of the eye,” said Mr Robin Hamilton, Consultant Ophthalmic Surgeon at Moorfields Eye Hospital and UK Chief Investigator for the HARRIER study. “Results from HAWK and HARRIER clinical studies showed that brolucizumab offers greater retinal fluid resolution versus the comparator. Today’s recommendation offers patients access to a treatment option that has the potential to minimise the treatment burden and hospital visits, while improving their vision and slowing down the progression of their wet AMD. This should give them more time to do the things that matter most to them.”

In fluid-related secondary clinical endpoints, significantly fewer brolucizumab-treated patients had intra-retinal and/or sub-retinal fluid (IRF/SRF) compared to aflibercept at week 48 (31% for brolucizumab 6 mg vs. 45% for aflibercept in HAWK [P<0.001]; 26% vs. 44%, respectively, in HARRIER) [P<0.001]2. Presence of IRF and SRF may disrupt the normal retinal structure and cause damage to the macula2.

Additionally, brolucizumab showed significantly greater reductions in central subfield thickness compared with aflibercept at week 16 and at week 48. In both trials, 30% fewer patients had signs of disease activity with brolucizumab versus aflibercept as early as week 16 (24% for brolucizumab 6mg vs. 35% for aflibercept in HAWK [P=0.001]; 23% vs. 32%, respectively, in HARRIER) [P=0.002]2. Brolucizumab exhibited an overall well tolerated safety profile in treated patients2.

“Today’s positive NICE recommendation represents an important advancement for people in England and Wales living with wet AMD. This decision not only means people with wet AMD have access to a treatment option that has the potential to maintain their vision, but also offers to minimise treatment burden and hospital visits,” said Chinmay Bhatt, Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals. “This is more vital than ever to help relieve pressure on healthcare systems. We are working closely with the NHS to ensure eligible patients can start benefiting from brolucizumab as soon as possible.”