The US drugmaker contracted Quintiles to provide commercial services support for Iluvien – a sustained release intravitreal implant – in Germany in late November, prompting the contract research organisation’s (CROs) services unit to start hiring staff.
At the time Alimera CEO Dan Myers described the agreement as a “multi country, European commercialization project” and both firm’s said they expect to sign additional project orders for similar services in the France and the UK.
The first part of the project appears to be straightforward. German authorities approved the implant back in July and – according to Alimera – the product is on track for market launch early in 2013.
In the UK Quinitles is likely to face more of a struggle. In May, the Medicines and Healthcare products Regulatory Agency (MHRA) deemed the product as a clinically effective treatment for vision loss associated with diabetic macular edema.
However, late last month the National Institute for Health and Clinical Excellence (NICE) – the agency that assesses the cost effectiveness of medical treatments in England and Wales – said that while it is effective, Iluvien’s price tag is too high and rejected it.
NICE recommended that Alimera conduct further research focused “on a group of patients whose condition is unresponsive to other available therapies and include measures of efficacy and health-related quality of life.”
In response the drugmaker said it had developed a patient access scheme to “determine the appropriate pricing for Iluvien in order to ensure that treatment decisions are based on patient need, rather than cost."
Whether Quintiles will be part of the PAS was not disclosed, however senior VP of Commercial Solutions Chris Pepler’s suggestion that: “It is increasingly important to engage with multiple stakeholders across the patient pathway” may indicate some involvement.