PharmacoEconomics & Outcomes News 784, p5 - 12 Aug 2017 ICER seeks input on assessment for serious ultra-rare conditions The Institute for Clinical and Economic Review (ICER) is seeking public comment on proposed changes to its value assessment framework for treatments for serious ultra-rare conditions. Although the ICER’s fundamental approach to value assessment is unchanged, these adaptations reflect the particular ethical and practical considerations associated with treatments that could potentially offer major advances for ultra-rare conditions. Treatments will qualify if they offer a significant gain in quality or length of life for serious conditions that affect a population of less than 10 000 patients, with little chance of future increases in patient population or indication. Discussion on the need to distinguish ways to assess treatment for rare conditions was prompted by an ICER white paper, followed by an all-stakeholder meeting held in May 2017 in Washington, DC, during which the proposed adaptations were developed. The changes include consideration of the potential challenges of generating evidence for treatments for ultra-rare conditions, as well as inclusion of a broader range of cost-effectiveness thresholds, from $US50 000 to $500 000 per quality-adjusted life-year. The adaptations will also include wider consideration of the effects of new treatments on family, school and community, as well as the impact on infrastructure for patient screening and care. The ICER aims to collaboratively design a template for the provision of information on research, development and other costs relevant to new treatments for serious ultra-rare conditions. In the meantime, the ICER will work with individual treatment manufacturers to decide what cost information is shared for public deliberation. The proposed adaptations are open for public comment until Monday, 25 September 2017. Institute for Clinical and Economic Review. ICER Seeks Public Comment on Proposed Value Assessment Framework for Treatments That Represent a Potential Major Advance for Serious Ultra-Rare Conditions. Internet Document : 25 Jul 2017. Available from: URL: https://icer-review.org/announcements/proposed-vaf- changes-ultra-rare/ 803263659 1173-5503/17/0784-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved PharmacoEconomics & Outcomes News 12 Aug 2017 No. 784
PharmacoEconomics & Outcomes News – Springer Journals
Published: Aug 12, 2017
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