Document will be open to public comment until March 27, 2017
March 6, 2017– The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document that will shape an upcoming report on poly (ADP-ribose) polymerase (PARP) inhibitors for treatment of ovarian cancer. ICER’s report is expected to review the evidence on rucaparib (Rubraca™, Clovis Oncology), niraparib (Tesaro, Inc.), and olaparib (Lynparza™, AstraZeneca). Report analyses will also provide information on the cost-effectiveness and potential short-term budget impact of the therapies. The Draft Scoping Document will be open to public comment for three weeks until March 27, 2017 at 5pm CT.
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, patients emphasized depression and anxiety as critically important factors to the patient experience, and noted the importance of considering financial burdens when evaluating the impact of treatment. 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 rucaparib, niraparib, and olaparib. All three of the drugs are PARP inhibitors intended for use in ovarian cancer. Both rucaparib and olaparib have been approved by the FDA for ovarian cancer associated with deleterious BRCA genetic mutations. Niraparib has a proposed indication for maintenance treatment of patients with ovarian cancer who are in response to platinum-based chemotherapy; an approval decision is expected for niraparib in late June of 2017. 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 March 27, 2017 at 5pm CT. Comments can be submitted by email to email@example.com. More information about submitting a public comment, including formatting specifications, is available on ICER’s website. Specific guidance for manufacturers and patients or patient groups is available in ICER’s Manufacturer Engagement Guide and Patient Participation Guide. Following the public comment period, a revised scoping document will be posted on or about April 4, 2017.
The Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) will evaluate the report assessing therapies for ovarian cancer at a public meeting on September 14, 2017. The Midwest CEPAC 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 September 2017 public meeting, the Council 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.