March 23, 2016 – The Institute for Clinical and Economic Review (ICER) has posted draft scoping documents that outline key areas of interest for an upcoming report assessing the comparative clinical effectiveness and value of obeticholic acid (Intercept Pharmaceuticals, Inc.). This drug is currently being considered for approval by the FDA for treatment of the rare liver condition of primary biliary cirrhosis/cholangitis (PBC). It is expected, however, that there will be significant interest in using obeticholic acid for treatment of patients with nonalcoholic steatohepatitis (NASH), a liver condition that can lead to liver failure and affects as many as 3-4% of all Americans. A separate scoping document has been developed for each of the two clinical areas.
In addition to a systematic review of the comparative clinical effectiveness and cost-effectiveness of obeticholic acid for use in PBC and NASH, ICER’s report will also include value-based price benchmarks that represent price ranges reflective of the comparative benefits of the drug and its affordability for the overall health care system.
The report will be the subject of the July 15, 2016 public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) where the Council will vote on key questions raised in the report and a policy roundtable will discuss recommendations to apply the evidence to policy and practice.
Members of the public are encouraged to submit suggested refinements or additions to the scope via email to email@example.com. The scoping document will be open to public comment for a period of one week. Comments must be received by 5:00 PM EDT on Wednesday, March 30, 2016 and must adhere to guidelines described in the public comment guide.
Additional key dates for the draft report are included below:
March 23: Scoping document posted
March 23 – March 30: Public comment period for scoping document
April 21: Revised scoping document posted
May 25: Draft report and voting questions posted
May 25 – June 9: Public comment period for draft report and voting questions
On or about June 23: Revised draft report posted
June 23 – July 14: New England CEPAC reviews revised draft report
July 15: Public meeting in Portland, ME
More information will be posted to the New England CEPAC website as it becomes available.
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.