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pSivida Corp. (NASDAQ: PSDV) announces that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has published final guidance indicating that ILUVIEN® is not cost effective for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. This final guidance is consistent with the final draft guidance issued on November 29, 2012.
pSivida’s licensee for ILUVIEN for DME, Alimera Sciences, Inc., reported that it has chosen to pursue a Patient Access Scheme (PAS) for ILUVIEN for DME that is intended to allow treatment decisions to be based on patient need, rather than cost. Alimera further reported that the PAS is currently under review by the Patient Access Schemes Liaison Unit (PASLU) at NICE and that, if approved by the Department of Health, the PAS will be available to the Appraisal Committee for review and consideration. Alimera stated its belief that the PAS could be considered under NICE’s rapid review facility should the PAS be accepted.
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