Posted by Michael Wonder on 25 Jul 2017
ICER seeks public comment on proposed value assessment framework for treatments that represent a potential major advance for serious ultra-rare conditions
25 July 2017 - ICER’s fundamental approach to value assessment remains constant with proposed changes for special circumstances.
The ICER has released an outline of proposed adaptations to its value framework to be applied in the assessment of certain treatments for ultra-rare conditions. ICER proposes that its fundamental approach to value assessment remain constant; however, several key changes are proposed to provide decision-makers with information reflecting the distinctive practical and ethical challenges associated with potential major advances for serious ultra-rare conditions.
To qualify for a distinctive assessment approach, ICER proposes that a treatment must be expected to affect a patient population of fewer than 10,000 individuals, with little chance of future expansion of indication or population, and it must offer a major gain in quality and/or length of life for patients with a serious condition. The proposed updates will be open to public comment for 60 days until Monday, 25 September 2017.
