The Institute for Clinical and Economic Review (ICER) is planning to evaluate and compare the clinical effectiveness and value of cystic fibrosis treatments now available or awaiting approval, with a tentative focus on several by Vertex Pharmaceuticals.
According to information provided in an ICER press release, the institute intends to include in its evaluation the combination therapy tezacaftor and Kalydeco (ivacaftor) being developed by Vertex. This combination is under review as a potential CF treatment, with aU.S. Food and Drug Administration (FDA) decision expected by February 2018.
The report also plans to review Orkambi (lumacaftor and ivacaftor), a combo therapy also by Vertex that was approved in the U.S. in 2015.
ICER welcomes comments or input from stakeholders, including clinical experts and patients, that may be relevant to the development of its evidence report. All information collected will be incorporated into the report.
For additional information, including explanations about the types of information that may be most helpful in developing the report, visit ICER’s Manufacturer Engagement Guide, Patient Participation Guide, and Patient Guide to Open Input.
During this period, ICER will also be in contact with CF patient groups and clinical experts for insights into the patient’s perspective and clinical context regarding treatments.
An initial draft report is expected to be released on Oct. 31, 2017. This Draft Scoping Document will inform on ICER’s proposed scope of the review, and will be open to public comments for three weeks, from Oct. 31 until Nov. 20. A Final Scoping Document will then be proposed.
A Draft Evidence Report is expected to be available for review by March 15, 2018, and open to public evaluation through April 12. The final report will tentatively be posted on May 3.
That report will be the subject of a meeting planned for May 17, 2018, of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). There, an independent panel will evaluate, and vote on, the comparative clinical effectiveness, benefits, and disadvantages of the different cystic fibrosis therapies.