BRIEF -- ICER to evaluate cystic fibrosis treatments in upcoming report

The USA-based Institute for Clinical and Economic Review (ICER), a non-profit organization, will develop a report assessing the comparative clinical effectiveness and value of treatments for cystic fibrosis.

The report is tentatively expected to include Vertex Pharmaceuticals’ tezacaftor used in combination with the firm’s Kalydeco (ivacaftor), a combination therapy currently under review by the Food and Drug Administration, with an approval decision expected in February of 2018.

The report is also expected to review combination therapy lumacaftor/ivacaftor, marketed by Vertex as Orkambi, after approval in 2015.

An “Open Input” period began yesterday, and comments on the topic will be accepted from all interested stakeholders until October 27, 2017.

The Open Input period is intended to allow stakeholders to share key information relevant to the development of the evidence report. During this time, ICER will also contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of this new treatment option.

All input can be emailed to publiccomments@icer-review.org and must be received by October 27 in order to be considered. Patients are also invited to submit input via our online form.