NICE gives EYLEA a provisional green light to treat patients with visual impairment due to DMO

NICE gives EYLEA a provisional green light to treat patients with visual impairment due to DMO

The National Institute for Health and Care Excellence (NICE) draft decision recommends EYLEA for the majority of patients with visual impairment due to diabetic macular oedema (DMO) but denies access to patients with early stage disease1

Newbury, Thursday 19th February, 2015 -Bayer HealthCare is pleased that NICE has recognised the benefits of EYLEA(aflibercept solution for injection) for the treatment of visual impairment due to diabetic macular oedema (DMO) according to a draft decision released today.1 However, Bayer is disappointed that a core group of patients diagnosed with early stage DMO (central retinal thickness <400 micrometres) would be denied treatment until their disease has progressed to a stage where permanent damage to the eye has already begun.  Bayer is committed to working with NICE throughout the appraisal process to ensure all DMO patients have access to EYLEA when the decision is finalised; expected in June 2015.

Dr Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King's College Hospital London added: "It is good news that we may potentially have Eylea as a further effective treatment option for many patients experiencing visual impairment due to DMO; however it is frustrating that whilst we are able to diagnose the disease early through the diabetic retinal screening programme we are still unable to effectively treat patients until their DMO progresses. The level of vision in patients who are diagnosed early tends to be good and prompt treatment will help maintain this vision by preventing further damage due to DMO. Another treatment option available for those with early stage DMO includes laser therapy which is not very effective and can even lead to deterioration of vision, meaning the decision is often made to leave patients and monitor them for disease progression until they can receive alternative treatment options."

DMO occurs in some people that have diabetic retinopathy, a complication of diabetes affecting the eye. Approximately 50,000 people could be affected by DMO,2 however this is set to increase significantly with the expected growth of the diabetes population; adding to what is already a major public health issue.3,4 If not treated effectively, DMO can result in vision loss and this can have an impact on the day-to-day lives of patients, carers and their families. It can jeopardise financial security, due to the loss of employment and dependence on benefits, and impact a patient's psychological well-being due to depression and social isolation.1 It can also significantly impact a patient's ability to manage their glucose levels.It is therefore vitally important that this disease is diagnosed and treated early to minimise its impact on a patient's health and well-being.

EYLEA was licensed in the UK for the treatment of wet age related macular degeneration (wAMD), an eye condition affecting the elderly, in November 20125 and was accepted by the SMC for this use within NHS Scotland in April 2013.6 It was recommended by National Institute for Health and Care Excellence (NICE) for the treatment of wAMD on the NHS in England and Wales in July 2013.7

EYLEA was also licensed in the UK for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO), a serious condition affecting the main vein in the eye, in August 20138 andNICE recommended it for this use in February 2014.9 It was accepted by the SMC for use within NHS Scotland for the treatment of visual impairment due to macular oedema secondary to CRVO in April 2014.10 Funding for EYLEA is now mandated across England and Wales for the treatment of eligible patients with wAMD and visual impairment due to macular oedema secondary to CRVO.7,9

The UK licence for EYLEA for the treatment of visual impairment due to DMO was granted in August 2014,8 with the SMC accepting it for restricted use in this indication in November 2014.11

About diabetic macular oedema (DMO)

DMO, a serious eye condition affecting people with diabetes, is the commonest cause of blindness among people of working age in the developed world.12 The number of people with DMO is set to increase significantly with the expected growth of the diabetes population, adding to what is already a major public health issue.4

DMO occurs in some patients that have diabetic retinopathy, a complication of diabetes. DMO occurs when fluid leaks from damaged blood vessels beneath the macula, a small part of the retina at the back of the eye, and results in the distortion of central vision where straight lines appear crooked or wavy.3

About EYLEA

EYLEAis made up of two human proteins fused together to interfere with two growth factors, vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF). These growth factors affect the blood vessels beneath the macula by increasing inflammation and fluid leakage (macular oedema) and promoting the growth of abnormal and fragile blood vessels. By interfering with these growth factors EYLEA blocks their effect on blood vessels beneath the macula, preventing further damage to sight.5

Like other injections into the eye for the treatment of visual impairment due to DMO, EYLEA needs to be given by a trained ophthalmologist. Treatment starts with one injection per month for five consecutive doses, followed by one injection every two months without the need to visit the hospital for monitoring between injections. After the first 12 months of treatment, the time between injections may be extended based on how well the treatment is working.5

About the phase III DMO Programme13-18

The licence for EYLEA for the DMO indication was granted based on data from the VIVID-DME and VISTA-DME studies which showed that it is capable of delivering sustained visual acuity gains compared to laser photocoagulation after two years of receiving EYLEA 2 mg every other month, after five initial monthly injections (VIVID-DME: mean gain from baseline in best corrected visual acuity (BCVA) of 9.4 letters (10.7 letters at one year; p<0.0001) with EYLEA and 0.7 letters (1.2 letters at one year; p < 0.0001) with laser photocoagulation. VISTA-DME: mean gain from baseline in BCVA of 11.1 letters (10.7 letters at one year) with EYLEA and 0.9 letters (0.2 letters at one year) with laser photocoagulation.

In both studies, EYLEA was well tolerated with a similar overall incidence of adverse events (AEs), serious ocular (relating to the eye) AEs, and serious non-ocular (not relating to the eye) AEs compared to laser photocoagulation. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME studies included conjunctival haemorrhage (bleed in the eye), eye pain, and floaters in the eye. The most frequent non-ocular TEAEs included hypertension and cold symptoms. Arterial thromboembolic events (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates with EYLEA compared to laser photocoagulation.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries.

The Global Ophthalmology Awards Program (GOAP), currently in its third year, is an integral part of Bayer's long-term commitment to ophthalmology. Through grants, the GOAP supports research and training in retinal ophthalmology with the aim of advancing the scientific understanding and clinical management of ophthalmic disorders.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

References

1.NICE. Appraisal Consultation Document - Aflibercept for treating diabetic macular oedema. February 2015

2.Diabetes UK. NICE recommends use of Lucentis for NHS treatment of vision loss. Available at: http://www.diabetes.org.uk/About_us/News_Landing_Page/NICE-recommends-us... (Last accessed: February 2015)

3.RNIB. Understanding eye conditions relating to diabetes. Available at: http://www.rnib.org.uk/eye-health-eye-conditions-z-eye-conditions/unders... (Last accessed: February 2015)

4.Help Diabetes, National Institute for Health Research, Rising obesity causes number of diabetes to double in 20 years. Available at: http://www.researchforthefuture.org/2013/09/rising-obesity-causes-number-of-diabetes-cases-to-double-in-20-years/ (Last accessed: July 2014)

5.Eylea® (VEGF Trap-Eye) summary of product characteristics (SmPC)

6.Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: http://www.scottishmedicines.org.uk (Last accessed: February 2015)

7.National Institute for Health and Care Excellence. Technology Appraisal 294. Aflibercept solution for injection for treating wet age related macular degeneration. July 2013

8.European Medicines Agency. Eylea (Aflibercept). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/002392/WC500148632.pdf (Last accessed: February 2015)

9.National Institute for Health and Care Excellence. Final Appraisal Determination. Aflibercept for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion. February 2014

10.Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®). April 2014. Available at: http://www.scottishmedicines.org.uk 

11.Scottish Medicines Consortium. aflibercept, 40mg/mL solution for injection (Eylea®) SMC No. (1003/14). Available at: http://www.scottishmedicines.org.uk  (Last accessed: February 2015)

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

13.Midena, E. and Korobelnik, J-F. 2014. Intravitreal Aflibercept for Diabetic Macular Edema (DME): 100-Week Results from the VIVID-DME and VISTA-DME Studies. Free Paper Session: Vascular Diseases and Diabetic Retinopathy I. EURETINA 14th Congress. September 2014

14.U.Schmidt-Erfurth. Efficacy and Safety of Intravitreal aflibercept in DME: Results of two phase III studies (VIVID-DME and VISTA-DME). Free Paper Session: New drug treatment and technology. EURETINA 13th Congress. September 2013. Available at: http://www.euretina.org/hamburg2013/programme/free-papers-details.asp?id=2732&day=0 (Last accessed: February 2015)

15.Bayer HealthCare. VEGF Trap-Eye in Vision Impairment Due to DME (VIVID-DME) phase III trial. Available at: http://www.clinicaltrials.gov/ct2/show/study/NCT01331681?term=VIVID-DME&rank=1 (Last accessed: February 2015)

16.Bayer HealthCare. Study of Intravitreal Administration of VEGF Trap-Eye (BAY86-5321) in Patients With Diabetic Macular Edema (VISTA DME) phase III trial. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01363440?term=VISTA-DME&rank=1 (Last accessed: February 2015)

17.Bayer HealthCare. Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema) (VIVID-Japan) phase III trial. Available at:  http://www.clinicaltrials.gov/ct2/show/NCT01512966?term=VIVID-Japan&rank=1 (Last accessed: February 2015)

18.Bayer HealthCare. Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement (VIVID EAST). Available at: http://clinicaltrials.gov/show/NCT01783886 (Last accessed: February 2015)

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