pSivida’s Iluvien close to UK reimbursement

pSivida (ASX:PVA) licensee Alimera Sciences is a step closer to finally securing limited National Health Service reimbursement for ocular insert Iluvien in the UK.

The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft decision recommending Iluvien for the subgroup of chronic macular edema (DME) patients who have undergone prior cataract surgery and are insufficiently responsive to available treatments.

After being twice denied reimbursement for Iluvien as a general DME treatment on the grounds that the benefits of the treatment do not justify the proposed price, Alimera submitted a revised application and patient access scheme (PAS) arguing that it is cost-effective in this subgroup.

The draft recommendation concludes that the treatment meets the cost-effectiveness threshold in this cohort.

pSivida CEO Dr Paul Ashton said DME patents who have undergone cataract surgery (pseudophakic patients) represent a large subgroup.

“Patients with DME have a far higher incidence of cataract than the overall population,” he said. “In the phase III FAME trials of Iluvien, over 50% of control patients were pseudophakic at the end of the trial.”

Alimera has already launched Iluvien in the UK for private pay patients, as well as in Germany, and is seeking FDA approval to launch in the US.

pSivida’s licence agreement entitles the company to a 20% cut on any of Alimera’s net sales of the product in all three markets.

pSivida shares were trading unchanged at $3.62 as of around 1 pm on Monday.