FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.
In July 2017, the Institute for Clinical and Economic Review (ICER) released a draft evidence report titled, “Poly ADP-ribose polymerase (PARP) Inhibitors for Ovarian Cancer: Effectiveness and Value.” FORCE has concerns about the conclusions drawn by this report as there are significant differences in the patient populations used for comparative data and gaps in the costs used for the value analysis. Additionally, the design of the analysis does not adequately represent the interests of patients, clinicians, or the hereditary cancer community. FORCE expressed these concerns via written comments and testified at the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) meeting on September 14, 2017, in St. Louis, MO.
The Institute for Clinical and Economic Review (ICER) is an independent nonprofit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Its reports may impact access to care. As such, its review of PARP Inhibitors is of great interest to the hereditary cancer community.
ICER’s draft report reviews evidence on the comparative clinical effectiveness and value of PARP inhibitors for treatment of ovarian cancer. Currently, these therapies include Rucaparib (Rubraca™, Clovis Oncology), Niraparib (Zejula™, Tesaro, Inc.) and Olaparib (Lynparza™, AstraZeneca). These treatments represent significant progress and provide hope to those impacted by hereditary cancer.
PARP inhibitors offer a number of benefits over traditional chemotherapy including the fact that they are taken orally, so there is no need to commute to an infusion center; they have minimal adverse effects compared to those typically experienced with cytotoxic chemotherapy regimens and invasive surgeries; and, dosing flexibility allows patients and their health care team to manage such symptoms.
ICER admits, “Although substantial uncertainty remains about the impact of PARP inhibitors on overall survival and quality of life, these agents appear to provide additional benefit over existing ovarian cancer therapies that may not be adequately captured in the clinical literature.”
The draft report indicates that "these agents are much more expensive than existing therapies." However, to evaluate cost, we must also consider savings in productivity, quality-of-life, and the ability to keep patients from wasting precious time on agents that won’t work for them. For personalized medicine to succeed, it is critical that these agents, upon FDA-approval, are accessible to patients and incorporated into clinical practice. This is the large-scale societal benefit of personalized or precision medicine.
As such, FORCE asks ICER to take a closer look at the research methods and data utilized in this report to ensure that they adequately represent those who stand to benefit most from PARP inhibitors. Restricting coverage and reimbursement for these agents will set back progress and send a discouraging message to scientists, patients, families, biotech companies, and society.
ICER Draft Report Assesses Value of 3 PARP Inhibitors for Ovarian Cancer, American Journal of Managed Care
PARP Inhibitor Therapy, FORCE website
Updates on PARP Inhibitor Research, FORCE website
PARP Inhibitor Research Update, Be Empowered Webinar, FORCE