LONDON — A major shakeup in how the benefits of medicines are assessed in Europe is looming, and developers of treatments like gene therapies are already arguing that what they see as flaws in the new system could entrench the issues they’ve had getting their products to patients.
Starting next year, there will be a new, continent-level review of a drug’s effectiveness compared to what else is on the market. It’s a wonky policy shift in the arcane world of HTA — that is, “health technology assessment,” which is when authorities review a new drug and determine what price is cost-effective — that has drugmakers big and small racing to adapt. Some have even been running dress rehearsals of the new procedures.
“This is probably the biggest change to HTA in the last 20 to 30 years,” James Ryan, a health economist at AstraZeneca, said at a recent industry conference.
