July 18, 2016– The Institute for Clinical and Economic Review (ICER) has released an addendum to the Draft Scoping Document on disease-modifying therapies (DMTs) for multiple sclerosis. The addendum will be subject to a special public comment period of four weeks to provide stakeholders the opportunity to comment on the modifications.
With this addendum, ICER has expanded the draft scope to include the use of ocrelizumab and rituximab for patients with primary-progressive multiple sclerosis (PPMS). Previously, the scope was limited to include only relapsing-remitting multiple sclerosis (RRMS). The decision to expand the scope of the MS review reflects feedback from patients, clinicians, and other stakeholders that an analysis of all DMTs for MS would be of greatest utility, as well as the Food and Drug Administration’s (FDA) June 27th announcement that it had granted Priority Review Designation to ocrelizumab for both PPMS and RRMS indications. An approval decision is expected in December 2016.
The addendum will be open to public comment until Friday, August 12, at 5:00 pm PT. All comments on the addendum can be emailed to firstname.lastname@example.org, and must adhere to the same style requirements as comments on a draft scoping document, as outlined in our methods for Patient, Manufacturer, and Other Stakeholder Engagement. The public comment period for the Draft Scoping Document released on July 1 has now ended and will not be re-opened.
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.