Macular degeneration affects 1 in 7 people over 50 and is the leading cause of blindness in Australia. It is believed to have a hereditary link.
Aflibercept (EYELEA) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). This new chemical entity is a recombinant fusion of proteins which bind to vascular endothelial growth factor (VEGF) to block the abnormal growth and leakage of blood vessels which leads to vision loss through thickening and oedema of the retina.
The TGA found the risk-benefit profile to be comparable with the current preferred treatment, LUCENTIS (ranibizumab), despite having evaluation data for only 12 months. The optimal dosing schedule may prove to be less frequent than LUCENTIS, although the evidence is not yet convincing.
It will be difficult for ophthalmologists to achieve cost-minimisation against the existing treatments as proposed by the PBS with the authority restriction to treatment-naive patients only. Bayer may yet present the PBAC with clinical evidence of a benefit in patients who have failed or are unable to continue treatment with verteporfin (VISUDYNE) or ranibizumab (LUCENTIS), possibly by demonstrating that withdrawal due to an adverse reaction, should not preclude access to treatment!