In most countries with publicly funded health systems, a medicine’s approval by the regulator is not the end of the road. An HTA body then assesses how much benefit it adds compared with existing options, and often whether that benefit justifies its cost. The result shapes whether the medicine is funded, for which patients, and at what price.
Well-known HTA bodies include NICE in England, the G-BA with IQWiG in Germany, the HAS in France, Canada’s Drug Agency (formerly CADTH), and the PBAC in Australia. Their methods differ. Some focus on cost-effectiveness, others on added clinical benefit, and some negotiate price directly or feed into a separate negotiation.
In the European Union, the HTA Regulation introduced joint clinical assessments at EU level. They have applied since January 12, 2025 to new cancer medicines and advanced therapy medicinal products, are due to extend to orphan medicines in 2028, and to all new medicines in 2030. National bodies still make their own decisions on value and pricing.
For market access and HEOR teams, following HTA decisions, including what assessors asked for and how competitors were judged, is part of planning any submission.