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Health Technology Assessment
The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.
Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.
New rules on health technology assessments in Spain make room for real-world evidence and early dialog.
A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.
The UK government should remove a cost-neutrality restriction on England’s health technology assessment institute, NICE, that limits the value it places on medicines for severe conditions, says industry body the ABPI.
High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.
New guidance from the European Commission on clinical trial validity for forthcoming joint clinical assessments has eased some concerns about the generation of evidence for rare disease treatments and advanced therapies.
HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The EU HTA Regulation will see clinical comparisons of medical products conducted at an EU level. However, the needs of some smaller nations may not be represented, experts from Cencora explain in this second of two articles on the new EU joint clinical assessments.
Manufacturers should undertake scenario planning exercises and simulations to prepare for questions that will be asked under the upcoming EU HTA Regulation, but unpredictable questions are likely to arise, experts from Cencora caution in this first of two articles on the new EU joint clinical assessments.