NICE recommends Novartis Beovu® (brolucizumab) for thousands with sight loss due to diabetes

NICE recommends Novartis Beovu^® (brolucizumab) for thousands with sight loss due to diabetes

•    Beovu^® (brolucizumab) can improve visual impairment due to diabetic macular oedema¹

•    Brolucizumab can help minimise treatment burden with evidence suggesting it may be administered less frequently and in clinical trials showed potential for fluid resolution in numerically more diabetic macular oedema patients than aflibercept³

•    Brolucizumab was approved through NICE’s expedited process

London, July 28, 2022 — Novartis today announced that the National Institute for Health and Care Excellence (NICE) recommended Beovu^® (brolucizumab) in a final appraisal document (FAD) as a treatment option in the NHS for a leading cause of visual impairment due to diabetic macular oedema (DMO) in adults with a central retinal thickness of 400 micrometres or more¹.

More than 3.4 million people were living with diabetes in England in 2021⁴. Around 22,733 people are expected to be eligible for treatment with brolucizumab⁵.

“A diagnosis of diabetic macular oedema can leave people feeling anxious or worried about the future, but, with the right treatment and support, we know people can cope well,” said Cathy Yelf, chief executive of leading sight loss charity the Macular Society. “Current treatments mean patients have to make frequent trips to hospital which can take its toll on them and their friends and family, who they often rely on to take them to appointments. It is great that patients will have another treatment option available to them which can help retain their sight and potentially reduce the burden of the number of visits to hospital.”

The NICE appraisal is based on evidence from the Phase III KESTREL and KITE trials investigating brolucizumab versus currently approved treatment, aflibercept. These were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting brolucizumab may offer fewer injections from the start of treatment through year one versus afilbercept. In the first year of both trials, following the loading phase, brolucizumab 6 mg patients were treated on 12-week intervals, with those demonstrating disease activity moved to every eight weeks; all aflibercept patients were dosed on eight-week intervals following the loading phase, in line with its label. Over half of patients (55.1% in KESTREL and 50.3% in KITE) treated with brolucizumab 6 mg remained on a 12-week dosing interval through year one³.

Although there are other available anti-VEGF therapies, there is a need for alternative options that offer better anatomical outcomes around greater fluid resolution. In clinical trials, a proportion of patients receiving currently approved treatments aflibercept or ranibizumab had incomplete fluid resolution a year after treatment^6,7,8. In KESTREL and KITE, Beovu showed potential for fluid resolution in numerically more DMO patients than aflibercept³.

“Diabetic macular oedema affects central vision, making it difficult for the individual to do simple things like read, watch TV or recognise the faces of people around them. Even with regular screening, thousands of people with diabetes will unfortunately go on to develop sight loss or visual impairment,” said Professor Winfried Amoaku, Associate Professor & Reader in Ophthalmology and Visual Sciences, University of Nottingham, and Consultant Ophthalmologist at the Queens Medical Centre, Nottingham University Hospitals Trust. “The evidence for brolucizumab is encouraging, and adds another treatment option that will help manage this condition, with less frequent injections, that will be of great help to the NHS services.”

Diabetic macular oedema occurs because poor blood sugar/insulin control can damage blood vessels around the eye causing them to leak fluid in the macula – an area at the back of the eye that helps you see colour and details⁹. Brolucizumab works by blocking the effects of a molecule called vascular endothelial growth factor (VEGF), which stops the leaking blood vessels. It is administered by injection into the back of the eye¹⁰.

Diabetic macular oedema is the leading cause of sight loss in people with diabetes¹¹. Sight loss has a significant financial impact. In 2010, the total health and social care costs of DMO in the UK were estimated to be over £116 million, with direct medical costs

accounting for 80% of the total cost².

Brolucizumab has been recommended as part of a new expedited process at NICE within which decisions are made by a subgroup of committee members. Brolucizumab will be available for prescribing on the NHS 30 days after the publication of the final technology appraisal guidance (TAG). Brolucizumab is already approved in England for the treatment of wet age-related macular degeneration.

“To help the NHS recover from the pandemic, we need to offer bold solutions and partner like never before. We have worked in close collaboration with NICE and welcome their decision to expedite the recommendation of brolucizumab to help even more people maintain their sight, and improve their care for the future,” said Marie-Andrée Gamache, Country President, Novartis UK and Ireland. “With brolucizumab we can offer people with visual impairment due to diabetic macular oedema another option without putting undue pressure on already stretched NHS services.”

About Beovu (brolucizumab)

Beovu (brolucizumab, also known as RTH258) 6 mg is approved for the treatment of wet age-related macular degeneration (AMD) in more than 70 countries, including in the US and EU ^10,12. In March 2022, brolucizumab was also approved by the European Commission (EC) to treat diabetic macular oedema (DMO), applying to all 27 European Union member states as well as Iceland, Norway and Liechtenstein.

About the KESTREL and KITE clinical trials³

KESTREL and KITE are global, randomized, double-masked, Phase III, two-year studies comparing the safety and efficacy of brolucizumab with aflibercept in the treatment of patients with visual impairment due to DMO.

In the loading phase of both trials, patients in the brolucizumab arms were treated every six weeks for a total of five doses; patients in the aflibercept arms were treated every four weeks for a total of five doses, in line with its label. In the first year of the study, following the loading phase, patients in the brolucizumab arms were subsequently treated every 12 weeks, with those demonstrating disease activity moved to dosing every eight weeks. After the loading phase, patients in the aflibercept arms were treated every eight weeks.

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we strive to use innovative science and digital technologies to create treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk.Novartis UK is on Twitter. Sign up to follow @NovartisUK at www.twitter.com/novartisuk

References

1.      Data on file. NICE Final Draft Guidance. NICE, 2022.

2.      Data on file. NICE FDG Committee Papers. NICE, 2022.

3.      Brown D, Wolf S, Garweg JG, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL & KITE studies. Presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. May 2021.

4.      NHS Digital Quality and Outcomes Framework 2020-2021. Available at: https://digital.nhs.uk/data-and-information/data-tools-and-services/data-services/general-practice-data-hub/quality-outcomes-framework-qof.  Accessed July 2022

5.      Browning DJ, Glassman AR, Aiello LP, Beck RW, Brown DM, Fong DS, et al. Relationship between optical coherence tomography-measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology. 2007;114(3):525-36.

6.      Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615-25.

7.      Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-54.

8.      Roberts PK, Vogl WD, Gerendas BS, Glassman AR, Bogunovic H, Jampol LM, et al. Quantification of Fluid Resolution and Visual Acuity Gain in Patients With Diabetic Macular Edema Using Deep Learning: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Ophthalmol.2020;138(9):945-53.

9.      National Eye Institute. Macular Edema. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema. Accessed March 2022.

10.   Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.

11.   Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011;2(6):98-104.

12.   Beovu [US prescribing information] East Hanover, NJ. Novartis: 2020.