ICER Posts Draft Scoping Document on Treatments for Osteoporosis

Document will be open to public comment until December 23, 2016

December 5, 2016– The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document that will shape an upcoming report on treatments for osteoporosis. ICER’s report is expected to review the evidence on three anabolic agents: abaloparatide (Radius Health, Inc.), romosozumab (Amgen, Inc. and UCB, Inc.), and teriparatide (Forteo®, Eli Lilly and Co.). It is also anticipated that analyses in the report will provide information on the cost-effectiveness of each of these three agents, as well as potential short-term budget impact of the two emerging therapies. The Draft Scoping Document will be open to public comment for three weeks until December 23, 2016 at 5pm ET.

The draft scoping document was developed with input from key stakeholders, including relevant patient organizations and clinical experts, which provided important insights into the context of treatment decisions. For example, patient groups highlighted concerns about rare but serious adverse events of some commonly used first-line therapies that may deter treatment. While clinical societies and patient groups have noted that these events are much less common than the fractures that osteoporosis treatment can prevent, patients are eager to learn whether additional treatment options carry fewer risks. ICER will continue to engage with patient groups, clinicians, drug manufacturers, and other stakeholders to assess appropriate outcomes and comparators and to enrich the evidence available from clinical trials.

The report is expected to evaluate the comparative clinical effectiveness of abaloparatide, teriparatide, and romosozumab for preventing fractures associated with osteoporosis in post-menopausal women with an indication for treatment. Both abaloparatide and romosozumab are currently under review by the Food and Drug Administration. Approval decisions are expected in March and July of 2017, respectively. While ICER had initially proposed plans to include denosumab (Prolia®, Amgen, Inc.) in the review, it was decided based on feedback received during the open input period that ICER would review only anabolic therapies (those that stimulate bone formation), thus excluding denosumab, an anti-resorptive agent aimed at decreasing bone breakdown. The proposed treatments for review are subject to change based on feedback received through public comment and continued discussion with subject matter experts.

All interested stakeholders, including patients, providers, payers, and manufacturers, are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by December 23, 2016 at 5pm ET. Comments can be submitted by email to publiccomments@icer-review.org. More information about submitting a public comment, including formatting specifications, is available on ICER’s website. Following the public comment period, a revised scoping document will be posted on or about January 9, 2017.

The California Technology Assessment Forum (CTAF) will evaluate the report assessing therapies for osteoporosis at a public meeting on June 30, 2017. The CTAF Panel is an independent, regional body of practicing physicians, methodological experts, and leaders in patient advocacy and engagement that provides objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions.

During the June 2017 public meeting, the Panel will vote on key questions raised in the report, and a policy roundtable of patient, clinical, payer, and policy experts will discuss recommendations for how best to apply the evidence to policy and practice.

Additional information regarding the report and meeting are available on ICER’s website.

About ICER

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.