Efforts to ease competition concerns could be having a positive impact on pharmaceutical companies’ willingness to make submissions for combination therapies to England’s health technology assessment (HTA) institute, NICE, according to a Pink Sheet analysis of NICE data.
Has Competition Reassurance Helped Counter Combination Woes In The UK?
The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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