Advocacy

FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Advocacy > Issues > ICER Review of PARP Inhibitors for Ovarian Cancer


Newsflash

6/27/2019
We played a lead role in drafting coalition comments on the FDA's proposed mammography guideline updates.

6/21/2019
FORCE recommendations regarding genomics were accepted and will be integrated into the Healthy People 2030 objectives.

6/3/2019
Today, the FDA announced a new pilot program called Project Facilitate to assist oncologists in requesting access to unapproved therapies for cancer patients. 

5/7/2019
We signed onto coalition letters to the House and Senate regarding FY20 funding for the Defense Health Research programs. 

4/8/2019
FORCE submitted a letter of support for TX legislation that would mandate coverage of fertility preservation prior to cancer-related surgery or treatment.

ICER Review of PARP Inhibitors for Ovarian Cancer

Treatments & Therapies

Overview

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 expressed significant concerns about the report's conclusions via written comments and testified at the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) meeting on September 14, 2017, in St. Louis, MO. ICER released its final report later that month. Despite our efforts and those of many others, the final report does not reflect the value of PARP inhibitors to the broader ovarian cancer community, or to the hereditary cancer community we serve. 

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 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 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. 

FORCE hopes ICER will revisit its analysis and 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.

Search Policy Issues by Keyword

FORCE:Facing Our Risk of Cancer Empowered