Aligning Cancer Therapeutic Evidence Between EMA and EU HTAs

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Many of the health technology assessment agencies (HTAs) of EU member nations have evidence requirements for cancer drugs that are different than those of the European Medicines Agency (EMA). This disparity often delays patient access. In a new article in Value in Health, authors break down these different requirements to highlight the need for alignment between EMA and EU HTA requirements.

According to the authors, “Despite the growing awareness of the differences in assessment, no study has yet described what these differences are for oncology drugs. This study, performed in collaboration with the European Federation of Pharmaceutical Industries and Associations, analyzes the differences in the acceptability of evidence (evidentiary requirements) for oncology drugs between EMA and national HTA bodies. Subsequently, recommendations on potential further alignment to minimize and optimally manage these differences according to the authorities will be provided.”

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(Source: Value in Health, December 9^th, 2022)