New guidelines on direct and indirect comparisons for generating evidence for forthcoming EU-level joint clinical assessments (JCAs) will likely jeopardize national level implementation of the EU Health Technology Assessment (HTA) Regulation and put at risk swifter access to medicines, ARM, the Alliance for Regenerative Medicines, has warned.
The alliance said that together with what it considers to be a flawed draft Implementing Act, the guidelines mean the “JCA