ICER to Review Drug Treatments for Osteoporosis in Upcoming Report

Boston, Mass., November 11, 2016 – The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emerging drug therapies for the treatment of osteoporosis to inform a meeting of the California Technology Assessment Forum (CTAF) in June 2017. While awaiting further discussion with patient groups, clinical experts, and other stakeholders to help develop a formal scope for this review, our preliminary intent is to evaluate the emerging treatments abaloparatide and romosozumab, with potential comparisons to denosumab and teriparatide. We do not currently envision including within the scope of this review other drugs or forms of treatment such as exercise, dietary supplements, vitamins or calcium, hormones, selective estrogen receptor modulators, or bisphosphonates.

Additional information on the preliminary list of treatments to be reviewed will be posted as part of a draft scoping document scheduled to be released for public comment on December 5, 2016.

An “Open Input” period begins today, and comments on the topic will be accepted from all interested stakeholders. The Open Input period is intended to allow stakeholders to comment and share key information relevant to the development of ICER’s scope and evidence report. During this time, ICER will contact key patient groups and clinical experts to gain further insights.

For more information about the Open Input period, including a further explanation of the types of information that may be most helpful to development of the report, visit ICER’s website. There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to publiccomments@icer-review.org and must be received by 5 PM ET on December 1, 2016 in order to be considered.

The report will be the subject of a June 30, 2017 meeting of CTAF. During the meeting, the independent Panel will deliberate and vote on the comparative clinical effectiveness and value of the treatments included in the review. The Panel will discuss the implications of the votes for policy and practice with a roundtable of clinical experts and patients to provide guidance to patients, clinicians, insurers, and policymakers confronted with decisions on how best to treat osteoporosis to ensure optimal patient outcomes.

Key Dates for ICER’s Report and Public Meeting:

Open Input Period: November 11 – December 1, 2016
Draft Scoping Document Posted: December 5, 2016
Public Comments on Draft Scoping Document: December 5 – December 23, 2016
Final Scoping Document Posted: January 9, 2017
Draft Evidence Report Posted: April 28, 2017
Public Comments on Draft Evidence Report: April 28 – May 25, 2017
Evidence Report Posted: June 16, 2017
Meeting Date: June 30, 2017
Final Report Posted: On or about July 14, 2017

More information on the review of treatments for osteoporosis will be posted to the ICER website as it becomes available.