ASCO developed a Decision Aid to assist physician-investigators and research staff in determining whether an AE should be reported to the sponsor as an SAE and attributed to the investigational drug.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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Today the Pennsylvania Society of Oncology and Hematology (PSOH) and the American Society of Clinical Oncology (ASCO) came out in strong support of HB 1194, proposed legislation to promote transparency in prior authorization and step therapy policies, which would put in place important safeguards to ensure that patients get the care they need.
On October 23, 2019, the Food and Drug Administration approved niraparib (ZEJULA®, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.
The Quality Oncology Practice Initiative (QOPI®) Certification Program continues to expand its reach, certifying the first system within the U.S. Department of Veterans Affairs, the Salisbury VA Health Care System, on October 9.
Rising health care costs, including escalating drug prices, have led to an increased focus by payers on strategies to guide the use of health care resources. As payers search for ways to control the rising cost of care, they often employ “utilization management" (UM) policies, which are payer-imposed practices that may restrict, limit, or deny coverage for certain treatments.
ASCO has submitted comments to the Food and Drug Administration (FDA) applauding its proposed rule to implement the use of new graphic warning labels on cigarette packaging and advertisements. The comments were sent through a letter from ASCO President Howard A. Burris III, MD, FACP, FASCO, to FDA Acting Commissioner Ned Sharpless, MD, on September 19.
A new JCO Precision Oncology article co-authored by CancerLinQ® Deputy Medical Director Wendy Rubinstein, MD, PhD, FACMG, FACP, and CancerLinQ LLC Medical Director Robert S. Miller, MD, FACP, FASCO, published October 1 examines next-generation sequencing in relation to how it can be implemented into the clinical workflow in a practice setting.
On September 26, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).
Researchers from around the country joined together for two days of learning and collaboration at ASCO’s headquarters in the greater DC metro area for the 2019 ASCO Research Community Forum (RCF) Annual Meeting. On September 22-23, 2019, experts in the field led timely presentations and discussions that coincided with the meeting’s theme of Working Smarter. Working Together.
On September 30, President Trump signed into law a Continuing Resolution (CR), which would provide flat funding for federal agencies, including the National Institutes of Health (NIH) and the National Cancer Institute (NCI), through November 21, 2019. ASCO encourages Congress to take action to include the highest increase possible in a full Fiscal Year (FY) 2020 funding package.
At the 2019 ASCO Advocacy Summit, ASCO members from 35 states held more than 160 Congressional meetings, urging Members of Congress to take action to advance policy priorities which improve patient access to cancer care, including clinical trials.
Senators Lisa Murkowski (AK), Doug Jones (AL), and Bill Cassidy (LA) introduced S. 2546, the Safe Step Act of 2019, in the U.S. Senate. If enacted into law, the bill would ensure patients with private insurance have reasonable protections against harmful step therapy practices.
In a letter to the Centers for Medicare & Medicaid Services (CMS), ASCO President Howard A. “Skip” Burris III, MD, FACP, FASCO, commented on provisions in the proposed 2020 Medicare Physician Fee Schedule (MPFS) and Quality Payment Program (QPP) proposed rule that would impact cancer care for Medicare beneficiaries.
The National Cancer Institute (NCI) is sponsoring a quarterly webinar series honoring the legacy of Arti Hurria, MD, in improving the treatment of older adults with cancer. The first webinar titled, Perspectives on Cancer and Aging: Arti Hurria Memorial Webinar Series, will be held on October 7, 2019, from 1:00-2:00 pm ET.