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Blurring the boundaries between regulatory approval and HTAs

This article was originally published in Scrip

Executive Summary

Once there was a clear distinction between the scientific evaluation of new drugs and the assessment of their value for use in reimbursement decisions. The latter was often referred to as the “fourth hurdle”, and took place after quality, safety and efficacy had been assessed and the product approved. Now things are changing, though, and relative value assessments are becoming more closely allied to the drug approval process itself.

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