Iluvien may get UK NHS listing

pSivida (ASX:PVA) licensee Alimera has scored a win in efforts to gain UK acceptance for the Iluvien micro-insert as a treatment for chronic diabetic macular edema (DME).

The UK's National Institute for Clinical Excellence (NICE), which had previously proposed not to recommend the reimbursement of Iluvien by the NHS, has agreed to accept additional clinical data that may change its mind.

NICE is evaluating the cost-effectiveness of Iluvien – Alimera's name for an insert developed by pSivida – as a treatment for chronic DME.

Alimera has now been cleared to provide data from a subgroup of patients within a clinical study that had already had cataract surgery and received an artificial lens prior to entering the trial.

A side-effect of exposure to the corticosteroid delivered through the Iluvien insert is increased vulnerability to developing cataracts, and this may be one reason why NICE initially proposed not to recommend the treatment.

But patients with artificial lenses will never develop another cataract, so will not have to bear the additional costs of cataract surgery. This makes Iluvien a more cost-effective treatment for this cohort, so the additional data could help with the application.

NICE in fact has a policy of not accepting new data unless it is likely to effect its decision on a product. The body will make the final ruling on its recommendation in November.

According to Brian Leedman, Vice President of Investor Relations at pSivida, as DME is already a cause of cataracts, it is likely that candidates for Iluvien treatment would also be candidates for the surgery regardless.

Alimera has already received a nod for Iluvien from the UK's Medicines and Healthcare products Regulatory Agency. But company has faced setbacks receiving FDA approval in the US.

pSivida is meanwhile attempting to bring essentially the same insert to market – under the name Medidur – to deliver a treatment for another back-of-eye disease, posterior uveitis. In July, the company received the OK to include data from Alimera's trials in its own FDA application.

pSivida (ASX:PVA) shares were trading 1.85% higher at $1.650 as of around 2:30pm on Thursday.