– Abaloparatide recently approved by FDA, romosozumab under FDA review; Public comment and requests to give oral comment now being accepted until May 31st-
Boston, Mass., May 3, 2017 – The Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the comparative clinical effectiveness and value of three treatments for osteoporosis in postmenopausal women: abaloparatide (TymlosTM, Radius Health, Inc.), romosozumab (Amgen, Inc. and UCB, Inc.), and teriparatide (Forteo®, Eli Lilly and Co.). Abaloparatide was approved by the FDA last week, and romosozumab is currently under FDA review, with an with approval decision expected in July of 2017. ICER’s report and accompanying draft voting questions are now open to public comment for four weeks.
ICER is committed to engaging with all stakeholders in a thorough and transparent manner. Before completing this Draft Evidence Report, ICER reached out to key stakeholders, including patient groups, clinical experts, and the manufacturers of the drugs to engage them in the process. ICER also accepted public comments on a Draft Scoping Document prior to conducting the review. The current draft report incorporates input received from patients, clinicians, manufacturers, and other stakeholders during each of these opportunities for engagement.
The Draft Evidence Report, as well as the accompanying voting questions, will be open to public comment until May 31, 2017 at 5 PM ET. All stakeholders are invited to submit written comments by email to email@example.com. Guidelines for submitting public comments, including formatting specifications, are available on the ICER website. ICER’s Manufacturer Engagement Guide and Patient Participation Guide provide further guidance for these groups. ICER will review all comments received and incorporate any necessary changes in the Evidence Report and revised voting questions that will be posted on or about June 16, 2017. All comments received will be posted publicly along with the Evidence Report.
The Evidence Report, which will include value-based price benchmarks for the treatments under review, will be the subject of a public meeting of the California Technology Assessment Forum (CTAF) on June 30, 2017 in Los Angeles, CA. During the meeting, the independent Council will publicly deliberate the evidence and vote on key questions raised in the report, and an expert policy roundtable will discuss recommendations to apply the evidence to policy and practice. Register now to attend the meeting in person, or watch the live webcast.
Register to Make an Oral Comment
During the public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Beginning today, requests to submit oral comment are being accepted. All requests must be emailed to firstname.lastname@example.org by 5 PM ET on May 31, 2017. For more information about registering for oral comment, please visit our website.
Visit ICER’s website for more information on engagement.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.