NICE has published its findings after exploring the feasibility of advising the NHS on the clinical and cost effectiveness of bevacizumab (Avastin, Genentech/Roche) to treat wet age-related macular degeneration (AMD), the leading cause of blindness in the UK, and other conditions affecting the eye. NICE was asked to undertake this work by the Department of Health, who also asked the NHS Health Technology Assessment programme to commission work to identify the existing and expected evidence on the use of bevacizumab in the eye. This work also fed into the NICE report.
The pre-scoping briefing report takes into account comments received from invited stakeholders, most of whom also attended a pre-scoping workshop at NICE in July 2010.
The main conclusion of the report is that there is support for an appraisal of intravitreal[1] bevacizumab for eye conditions. Stakeholders agreed that an appraisal would need to be conditional on, or incorporate the assessment of, the safety and quality of intravitreal bevacizumab by a regulatory body or through the involvement of regulatory expertise. Furthermore, arrangements for safety monitoring / pharmacovigilance[2] will need to be explored.
The next step is for the Department of Health to decide whether or not to refer bevacizumab to NICE for consideration as part of its technology appraisal programme.
Notes
1. The report can be found on the NICE website.
2. Although NICE does not normally appraise drugs outside of their licensed indications it can happen at request of the Department of Health. For example, the Department of Health has previously asked NICE to look at off-label immunosuppressive drugs for renal transplantation in children and adolescents.
3. Wet age-related macular degeneration (AMD) is an eye condition that affects the macula (a tiny part of the retina at the back of the eye). AMD causes problems with central vision, but does not lead to total loss of sight and is not painful.
4. Macular degeneration is diagnosed as either dry (non-neovascular) or wet (neovascular). Neovascular refers to growth of new blood vessels in an area, such as the macula, where they are not supposed to be.
5. Bevacizumab works by stopping tumour growth by preventing the formation of new blood vessels. It does this by targeting and inhibiting the function of a natural protein called vascular endothelial growth factor that stimulates new blood vessel formation.
6. Bevacizumab is currently being used as a treatment for eye conditions by some NHS trusts as an alternative to ranibizumab (Lucentis), which is licensed for AMD and which NICE recommended for use in August 2008 (guidance.nice/TA155).
Footnotes
[1] When drugs are administered through the eyes.
[2] This is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.
Source:
National Institute for Health and Clinical Excellence (NICE)
View drug information on Avastin; Lucentis.