The Institute for Clinical and Economic Review (ICER) has released two Draft Evidence Reports assessing the comparative clinical effectiveness and value of obeticholic acid (Ocaliva™, Intercept Pharmaceuticals): one examining its use for primary biliary cholangitis (PBC), and the other examining its use for nonalcoholic steatohepatitis (NASH). Both reports, as well as accompanying draft voting questions, will be open to a public comment period of two weeks.
Obeticholic acid is currently being considered for approval by the FDA for treatment of PBC, a rare liver disease. There is also expected to 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.
The two reports are draft versions of the Evidence Reports that will serve as the basis for deliberation and discussion at the next public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on July 15, 2016.
ICER is committed to engaging with all stakeholders in as thorough and transparent a manner as possible. Before completing this Draft Evidence Report, ICER reached out to key stakeholders, including patient groups and the manufacturer of the drug, to engage them in the process.
The Draft Evidence Report, as well as the accompanying voting questions, will be open to public comment until June 9, 2016 at 5PM ET. All stakeholders are invited to submit formal comments. Comments should be emailed to publiccomments@icer-review.org. Guidelines for submitting public comments, including formatting specifications, are available on the ICER website. ICER will review all comments received and incorporate any needed changes in the Evidence Reports that will be posted on or about June 23, 2016.
The Evidence Reports, including a value-based price benchmark, will be discussed during the July 15th New England CEPAC public meeting. The independent Council will vote on key questions raised in the reports, and a policy roundtable will discuss recommendations to apply the evidence to policy and practice.
During the public meeting there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Requests to make oral comments should be submitted to publiccomments@icer-review.org by 5PM ET on Friday, July 8, 2016.
More information on our methods for public engagement can be found here.
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.