Preliminary list of drugs to be reviewed includes rucaparib (Rubraca™, Clovis), niraparib (Tesaro), and olaparib (Lynparza™, AstraZeneca)
Boston, Mass., February 8, 2017 – The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of emerging therapies for treatment of ovarian cancer. The report will include a systematic review of the clinical effectiveness and cost-effectiveness of selected treatments. While awaiting further discussion with patient groups, clinical experts, and other stakeholders to help develop a formal scope for this review, our preliminary intent is to evaluate the emerging treatments rucaparib (Rubraca™, Clovis), niraparib (Tesaro), and olaparib (Lynparza™, AstraZeneca). This list may change as the scope develops. Additional information on the preliminary list of treatments to be reviewed will be posted as part of a draft scoping document scheduled to be released for public comment on March 6, 2017.
A three-week “Open Input” period begins today, and comments on the topic will be accepted from any and all interested stakeholders. The Open Input period is intended to allow stakeholders to share key information relevant to the development of ICER’s scope and evidence report. During this time, ICER will also contact key patient groups and clinical experts to gain further insights.
For more information about the Open Input period, including a further explanation of the types of information that may be most helpful to development of the report, visit ICER’s website. ICER’s Manufacturer Engagement Guide includes specific information for manufacturers, and the Patient Participation Guide and Patient Guide to Open Input provide information for patients and patient groups. There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to firstname.lastname@example.org and must be received by 5PM CT on March 6, 2017 in order to be considered.
A Draft Scoping Document, which will provide more detail on ICER’s proposed scope for the review, will be available on or about March 6, 2017 and will be open to public comment for three weeks.
The report will be the subject of a September 2017 meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). During the meeting, the independent Council will deliberate and vote on the comparative clinical effectiveness and value of the treatments included in the review. The Council will discuss the implications of the votes for policy and practice with a roundtable including clinical experts and patients to provide guidance to patients, clinicians, insurers, and policymakers confronted with decisions on how new treatments will fit into current practice to ensure optimal patient outcomes.
The key dates for ICER’s review of treatments for ovarian cancer are included below:
- Open Input Period: February 8, 2017-March 6, 2017
- Draft Scoping Document Posted: March 6, 2017
- Public Comment on Draft Scope: March 6- March 27, 2017
- Final Scoping Document Posted: April 4, 2017
- Draft Evidence Report and Draft Voting Questions Posted: July 12, 2017
- Public Comment on Draft Evidence Report and Voting Questions: July 12, 2017- August 9, 2017
- Evidence Report and Revised Voting Questions Posted: August 30, 2017
- Public Meeting of the Midwest CEPAC: September 14, 2017
- Final Report Posted: On or about September 27, 2017