pSivida licensee expects NHS listing in November

pSivida (ASX:PVA) licensee Alimera Sciences is on track to achieve NHS reimbursement for eye disease treatment Iluvien in a subgroup of diabetic macular edema (DME) patients.

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending Iluvien for the treatment of chronic DME that is insufficiently responsive to available therapies in eyes that have undergone cataract surgery.

Iluvien uses a sustained-release intravitrial micro-insert designed by pSivida.

NICE is due to issue final guidance on Iluvien to the UK’s National Health Service (NHS) in November. A positive recommendation would mean NHS reimbursement in England and Wales for the patient subgroup.

NICE had previously recommended that Iluvien not be approved for reimbursement on the grounds that the evidence provided did not show that the benefits justify the price. But Alimera subsequently developed a Patient Access Scheme targeting the subgroup.

The agency issued a draft decision recommending Iluvien for the subgroup in June.

pSivida CEO Dr Paul Ashton noted that “Alimera plans to continue to work with NICE in an effort to broaden access to Iluvien to include all chronic DME patients who could benefit from the treatment.”

Iluvien is already available in the UK for private pay patients and in Germany. It has marketing approval in Austria, Portugal, France and Spain, and Alimera is seeking approval in the US.

pSivida is developing a treatment for posterior uveitis using the same insert and has secured approval to use data from Alimera’s clinical trials in its own FDA application.

pSivida (ASX:PVA) shares were trading 0.69% higher at $4.35 as of around 1.30 pm on Tuesday.