Scotland Approves Novartis / ThromboGenics’ Jetrea and Roche’s RoActemra

Scotland Approves Novartis / ThromboGenics’ Jetrea and Roche’s RoActemraThe Scottish Medicines Consortium (SMC) has announced their latest set of recommendations approving regulatory submissions for Novartis and ThromboGenics’ eye therapy Jetrea and Roche’s RoActemra.

The SMC have also announced rejections for the chronic obstructive pulmonary disease (COPD) drugs submitted for approval by Boehringer Ingelheim and GlaxoSmithKline (GSK).

The cost regulator for Scotland endorsed Jetrea for vitreomacular traction, an eye condition that can result in blindness. Jetrea involves a single injection and is already available in England on the NHS.

The recommendations also included a subcutaneous formulation of Roche’s RoActemra for rheumatoid arthritis. The decision to approve RoActemra was aided by the convenience of self-administration in addition to cost savings, thanks to a patient access scheme proposed by Roche.

However, it wasn’t all positive news, with the Scottish Medicines Consortium rejecting Boehringer’s Striverdi for COPD, noting that there were “uncertainties in the clinical evidence and weaknesses in the analysis.”

GlaxoSmithKline’s Anoro also received negative regulatory guidance, with the SMC commenting that although Anoro offers cost savings, “there was some uncertainty around the appropriateness of the comparators” used in clinical studies. GSK has since confirmed that they plan to resubmit the drug.


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