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NICE GUIDLINE
TA298
Ranibizumab for treating choroidal neovascularisation
associated with pathological myopia
Dr.Muhammad Hamza
North Devon District NHS Hospital
 CNV is a common cause of vision loss in people with
pathological myopia.
 There are approximately 200,000 people with pathological
myopia in the UK. The prevalence or incidence of CNV
associated with pathological myopia in the UK is not known.
However, approximately 30% of people who develop CNV in
one eye will develop it in the other eye within 8 years
Indication
 Patients of any age undergoing treatment for choroidal
neovascularisation (CNV) secondary to pathological myopia
(PM), including patients with concomitant ocular disease
Dosage
 Ranibizumab is administered as a single 0.5 mg intravitreal injection. Each vial
of ranibizumab contains 2.3 mg in 0.23 ml; overfilling is considered necessary
to achieve an injectable dose of 0.5 mg. The summary of product
characteristics states that monitoring is recommended monthly for the first
2 months and at least every 3 months thereafter during the first year. If
monitoring reveals signs of disease activity, for example, reduced visual acuity
and/or signs of lesion activity, further treatment is recommended
Major Outcomes Considered
 Clinical effectiveness
 Best corrected visual acuity in the studied eye
 Adverse effects of treatment
 Health related quality of life
 Cost-effectiveness
 The approval was supported by data from the Novartis-
sponsored clinical trial, RADIANCE, which showed
ranibizumab provides superior improvement in visual acuity
compared with the current licensed standard of care,
verteporfin PDT (Visudyne®), in patients with CNV
secondary to PM. These new data showed around 40 percent
of ranibizumab treated patients compared with 15 percent of
verteporfin PDT treated patients gained 15 or more letters
of visual acuity at month three ( 4). Mean visual acuity gains
of approximately 14 letters at one year were demonstrated
with ranibizumab; this was with a median of 2.0 injections
(1,2).
Contraindications
 Contraindications to ranibizumab include known
hypersensitivity to the active substance or to any of its
excipients, active or suspected ocular or periocular
infections, and active severe intraocular inflammation.
Current practice
 The Committee heard that the current standard treatment
for choroidal neovascularisation secondary to pathological
myopia is vPDT. However, it is not effective in most patients
and its use is diminishing because of anti-VEGF treatments.
Risk of Complication
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Vitreous floaters,
Conjunctival haemorrhage
Sensation of a foreign body in the eye
Eye pain,
Ocular hyperaemia,
Increased intraocular pressure,
Vitritis,
Vtreous detachment.
The Committee agreed that the evidence suggested manageable
adverse events with ranibizumab, and concluded that ranibizumab
was safe and well tolerated in patients with visual impairment
caused by choroidal neovascularisation associated with
pathological myopia.
Followup
 Pivotal trial shows average visual acuity improvement of up to 14
letters at one year with a median of only two injections with Lucentis
treatment
Implementation
 When NICE recommends a treatment 'as an option', the
NHS must make sure it is available for the patients .
The key drivers of cost effectiveness
 The manufacturer's sensitivity analyses showed that the cost
effectiveness of ranibizumab was sensitive to changes in the
unit cost of ranibizumab and vPDT, the number of
ranibizumab injections in the first and second year, the
starting age of the patient group, the discount rate for
benefits, and the maximum utility gain in the worse-seeing
eye.
Future
 The Committee noted that the primary end point of RADIANCE
was the mean average change in BCVA between baseline and
months 1–3. The Committee heard from a clinical specialist that 3
months was not a long timeperiod to assess the longer term
benefits of ranibizumab.The Committee concluded that, because
the clinical effectiveness of ranibizumab was not compared with
vPDT after 3 months, there is uncertainty about the long-term
efficacy of ranibizumab for choroidal neovascularisation associated
with pathological myopia.
 Review of guidance 7.1 The guidance on this technology will
be considered for review in March 2016.
References
 1 Bandello F. Twelve-month efficacy and safety of
ranibizumab 0.5 mg versus verteporfin photodynamic
therapy in the treatment of visual impairment due to
choroidal neovascularization secondary to pathologic myopia.
Association for Research in Vision and Ophthalmology 2013
 2 Novartis data on file: LUCDOF13-009
 3 NICE, 2012, available online:
http://www.nice.org.uk/nicemedia/live/14019/63645/63
645.
 4 Novartis data on file: LUCDOF 13-010 pdf accessed July
2013