NHS patients in England and Wales will have access to three new treatment options from Bayer, GSK and Otsuka after the drugs received final backing from the National Institute for Health and Care Excellence (NICE).
The headline recommendation is for Bayer’s Eylea (aflibercept) in the treatment of wet age-related macular degeneration (AMD) – an eye condition that affects the macula and can lead to problems with vision and blindness.
There are estimated to be about 26,000 new cases of wet AMD in the UK each year and patients already have access to Novartis’ Lucentis (ranibizumab), which has become the current standard therapy since its NICE recommendation in 2008.
The approval of Eylea means Bayer will now offer serious competition to Novartis’ domination of the wet AMD market, although there is little to separate the two products.
Under NICE’s recommendation, Eylea is restricted to the same use as Lucentis, which includes limiting the available patient population to those who show signs the condition has been getting worse and for whom there is no permanent damage to the part of the eye called the fovea.
According to the cost-effectiveness body, the two drugs – both of which are provided at a discount through a patient access scheme – are closely matched on both price and efficacy.
Frequency of treatment is likely to be the main area that Bayer will attempt to capitalise on, considering Eylea is recommended to be given monthly for three consecutive doses, followed by one injection every two months.
This compares to the recommendation for Lucentis, treatment with which should start with one injection per month for three consecutive months, followed by a phase in which patients are monitored for visual acuity every month at a hospital, where a further dose can be administered if needed.
“The approval of Eylea may well help to ease the enormous pressure on eye clinics and, bearing this in mind, we hope that this decision will be implemented quickly by the NHS,” said Helen Jackman, chief executive of the patient group Macular Society.
“Demand for this sort of treatment is rising, especially as some patients are opting out of going to their monthly appointments due to the physical, mental and, sometimes, financial strain,” she added.
NICE backs GSK’s Revolade
Elsewhere, NICE also gave a final recommendation to GlaxoSmithKline’s (GSK) Revolade (eltrombopag) in the treatment of adults with the bleeding disorder chronic immune (idiopathic) thrombocytopenic purpura, which drastically affects quality of life and can lead to serious haemorrhaging.
The recommendation only covers a limited group of patients, however, including those who have had their spleen removed and whose condition does not respond to other treatments, such as corticosteroids or immunoglobulins.
It is also available as a second-line treatment in adults who have not had a splenectomy because surgery is not advisable.
As with Eylea, GSK’s Revolade is only available for NHS if the company provides the drug at a discount through a patient access scheme.
Abilify available for children with bipolar disorder
The trio of final approvals published today from NICE also covers the use of Otsuka’s Abilify (aripiprazole) in the treatment of adolescents aged 13 and over with bipolar disorder.
The drug is already recommended for people aged 15 or over with bipolar disorder, but this recommendation brings the drug to an even younger group of patients.
“Acute manic episodes not only have a huge impact on the young person in terms of school, work and social life, but also on those around them – particularly their family or carers,” explained Professor Carole Longson, director of the Centre for Health Technology Evaluation.
“Because of this it is really important that manic episodes are treated quickly and effectively so that young people and their families can return to normal in terms of schooling, work and family life as quickly as possible.”