The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining its planned review of the comparative clinical effectiveness and value of tezacaftor (Vertex Pharmaceuticals) used in combination with ivacaftor (Kalydeco, Vertex Pharmaceuticals). The 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 (Orkambi, Vertex Pharmaceuticals), approved in 2015, as well as ivacaftor monotherapy, approved in 2012.
The scoping document will be open to public comment for three weeks until 5 p.m. EST Nov. 20. It will inform development of a report that will be subject to public deliberation during a May 2018 meeting of the Midwest Comparative Effectiveness Public Advisory Council, one of ICER’s three independent evidence appraisal committees.