Scottish cost regulators have rejected National Health Service funding for Alimera Science's eye implant Iluvien in patients with diabetic macular oedema, on grounds that it is too expensive.
Iluvien (fluocinolone acetonide intravitreal implant) sits at the back of the eye and delivers tiny levels of active substance continuously for up to three years, its anti-vascular endothelial growth factor (anti-VEGF) properties helping to lessen the build up of fluid in the eye, thereby limiting sight loss and/or improving vision.
The product was given the all clear in Europe last year after clinical trial data showed that 38% of patients with chronic DMO experienced a significant improvement in their visual acuity 30 months after receiving the implant.
However, despite conceding that Iluvien is indeed clinically effective, the SMC concluded that its high incremental cost ratio - which exceeded £40,000 per QALY in certain circumstances - as well as uncertainties in key variables, meant that its cost-effectiveness had not been demonstrated.
The SMC's sister body, the National Institute for Health and Care Excellence, also rejected the drug for use on the NHS in England and Wales earlier this year.
Restricted use for IBS drug
Elsewhere, the news was much more positive for Almirall, which saw its first-in-class irritable bowel syndrome (IBS) drug Constella (linaclotide) granted SMC approval.
Specifically, use of the drug has been approved in patients with moderate-to-severe IBS with constipation who have not responded adequately to or cannot tolerate all other suitable treatment options.
In a revised base case, the company estimated the cost per QALY to be £7,370, and the SMC noted that threshold analysis indicated the effectiveness of the drug could be reduced by 22% before the cost per QALY increased to £30,000.
Almirall has estimated that 306 patients would be treated with its drug in the first year leaping to 3,133 patients after five years, resulting in a gross impact on the medicines budget or £94,000 and £959,000, respectively.