While some modifications in the HTA process for orphan drugs have had some positive impacts, manufacturers still face key hurdles due to inconsistent reimbursement assessments in the EU markets, the authors of a recent study suggest.
The authors, Chales River Associates’ Steven Kelly, Ioanna Stefani, Charlotte Poon and Nimisha Raj, reviewed all 80 treatments cleared by the EMA between 2013-2019 with an orphan drug designation at launch.
“Overall, the concessions and modifiers introduced in the HTA process for ODs have a positive impact on minimising rejections and accelerate the T2R,” the study states. “However, obstacles remain to capture the full value of ODs within the HTA process.”
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