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The National Institute for Health and Clinical Excellence (NICE) in England produced its first Appraisal Consultation Document (ACD) regarding the use of anti-vascular endothelial growth factor (anti-VEGF) drugs for the treatment of wet age-related macular degeneration (AMD) recently. Essentially, the document recommended that the new anti-VEGF inhibitor Lucentis (ranibizumab; Novartis Ophthalmics) may be used only to treat predominantly classic subfoveal choroidal neovascularization (CNV) which shows evidence of progression in the second affected eye, provided the visual acuity is between 6/12 and 6/96.1 After considering feedback from formal consultees, the Appraisal Committee will prepare a Final Assessment Document (FAD) for submission to NICE who will then issue guidance.
This preliminary ruling also recommended a total block on a second anti-VEGF drug, Macugen (pegaptanib sodium; Pfizer), in England and Wales.
The implications of this ACD are that CNV of other lesion types should receive 'usual care', and that individuals must lose vision in one eye in order to qualify for anti-VEGF treatment for CNV in the other eye. One would have thought that, after a similar ACD was issued in the past on the use of photodynamic therapy (PDT) in second eyes only of patients with CNV, such a ruling as this would not have been contemplated again. This ruling was eventually overturned.
Patient outcomes have improved considerably with anti-VEGF therapy. Several years ago we hailed PDT as a significant improvement in the management of wet AMD. And, it was when it was launched in 2000. However, the percentage of patients or eyes whose vision is stabilized or improved is significantly higher with anti-VEGF therapy, especially Lucentis, than with PDT. At worse, vision loss is reduced. From my experience, a significant number of patients treated with anti-VEGF therapies walk into the consulting room with beaming smiles. Every clinician who uses these drugs knows that they work, albeit not all the time; some work better than others. Surely, 70 to 95% disease stabilization is better than 0 to 65%!
There are currently about 90 patients in my clinic who receive anti-VEGF therapy, either paid for privately, on named patient funding by primary care trusts (PCTs), or as part of clinical trials. The majority are new cases whilst some are PDT failures undergoing salvage therapy.
Putting a price on sight
In my view, the NICEs Appraisal Committee has based its opinion purely on drug costs and cost-effectiveness. I agree it is (theoretically) useful to evaluate the cost-effectiveness of new treatments in the climate of ever increasing treatment costs. This is done by determination of cost per quality adjusted life years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) - the cost of a new treatment compared with that of standard or usual care for the particular disease or condition. NICE apparently uses a cut-off point of £30,000/QALY (approximately €45,000/QALY) for ICERs such that therapies are considered cost-effective if the ICER is £30,000/QALY or less.
The ICER for Lucentis is below this cut-off point for predominantly classic CNV, whilst that for other lesion types treated with Lucentis, and for all lesion types treated with Macugen, are above the magic cut-off ICER. Hence it appears that they are not cost-effective.
How do you explain to a patient that, although these drugs which will help stop their loss of vision, are available, they are too expensive in comparison to any benefits they may experience, according to NICE?
Then you continue: 'However, if you are unlucky enough to develop a similar problem in your other eye later, I might treat you, provided the leaking pattern in that second eye has a particular pattern which makes it progress rapidly. And if I cannot treat your second eye, I'll register you as visually impaired so that you may get help from government Social Services. Of course, this help comes from a different budget from health and is means tested!'
The unenviable task of having to explain to a patient why they can't receive these new therapies has been consequently delegated to the clinician by NICE.
Did NICE get it wrong?