European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
EUnetHTA 21, the EU health technology assessment network that will soon hang up its hat has defended the methodologies it developed to support the EU HTA Regulation in the wake of criticism from industry.
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A report published by the European Medicines Agency highlights milestones reached under its collaboration with EUnetHTA over recent years and outlines areas for further development once the initiative changes hands under the new HTA Regulation.
More clarity is needed on how member states plan to adapt their health technology appraisal procedures once the requirement kicks in for them to factor in EU-level joint clinical assessments.
Proposed Methodologies For EU Joint Clinical Assessment Are Threat To ATMPs and Rare Disease Patients
Sixteen out of 18 EU-approved advanced therapy medicinal products would fail to pass an EU-wide joint clinical assessment because proposed methodologies are unsuitable for such products, according to the Alliance for Regenerative Medicine.