Abstract:PROs were also presented in the HTA submissions of 8 drugs with no EMA PRO data. In HTA submissions, PROs assessing QoL (51/57, 89.4%) and pain (18/57, 31.6%) were the most common. Statistical significance was observed in 59.6% of the 52 submissions with available results. In the final HTA decision, PROs were mentioned for 43.9% of submissions, not mentioned in 35.1% and were not reviewed by the HTA body in 21.0% of submissions due mainly to methodological issues. ConClusions: Demonstrating a statistically sig… Show more
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