ASCO recently submitted two comment letters from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, to the Food and Drug Administration (FDA) Commissioner Scott Gottlieb related to the modernization of clinical trials.
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.
To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.
This year we celebrate Healthcare Quality Week October 21–26, a time dedicated to celebrating the contributions professionals have made to improve health care quality. For 2018, ASCO is using this time to recognize practices—and the individuals on their oncology care teams—that have participated in offerings and expansions in several Society programs aimed at improving the quality of cancer care.
In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis highlights key studies from this year’s ASCO Quality Care Symposium, an annual meeting that brings together oncology leaders and members of the cancer care team to share strategies and methods for improving measurement and implementation of quality and safety activities in oncology.
ASCO’s Policy Issue Briefs provide succinct overviews and relevant data on major policy issues impacting patients with cancer and the physicians who care for them. These briefs are designed to be especially helpful for journalists, offering background information on key issues across health policy today.
A bipartisan group of more than 100 members of the U.S. House of Representatives signed a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma urging the Agency to review and improve prior authorization practices under Medicare Advantage (MA). The letter, led by Rep. Ami Bera, MD (CA-7), and Rep. Phil Roe, MD (TN-1), cites concerns that MA beneficiaries may be encountering barriers to care due to “onerous and often unnecessary prior authorization requirements.”
ASCO and the Society for Immunotherapy of Cancer (SITC) have released a joint statement with twelve clinical trial reporting recommendations that address the unique efficacy, toxicity, and combination/sequencing aspects of immuno-oncology (IO) treatments. These recommendations, jointly published in the Journal of Clinical Oncology (JCO) and Journal for ImmunoTherapy of Cancer (JITC), will lead to better IO trial reporting and assessment.
Richard L. Schilsky, MD, FACP, FSCT, FASCO, Senior Vice President and Chief Medical Officer of ASCO will moderate a panel at an upcoming public meeting of the Reagan-Udall Foundation for the Food and Drug Administration (FDA) on November 19, 2018, at the FDA main campus at White Oak.
On October 17, the Journal of the National Cancer Institute published a manuscript summarizing the action items coming out of the joint ASCO/U.S. Food and Drug Administration Geriatric Oncology Workshop, held Nov. 6, 2017.
Applications are now being accepted for the West Coast session of ASCO’s Quality Training Program, which will be held off-site near City of Hope in California, beginning in January. Applications are due Wednesday, December 5, 2018.
On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA®, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
President Trump recently signed a pair of bills into law aimed at increasing transparency with regard to drug prices in the United States. The Patient Right to Know Drug Prices Act (S. 2554) and the Know the Lowest Price Act (S. 2553) prohibit so-called "gag clauses," which prevent pharmacists from telling customers if they could save money by buying prescription drugs out-of-pocket rather than using their health insurance. S. 2554 applies to private health plans, while S. 2553 targets Medicare Part D and Medicare Advantage plans.
Clifford A. Hudis, MD, FACP, FASCO, CEO of ASCO and Robert S. Miller, MD, FACP, FASCO, Medical Director of CancerLinQ LLC, will be speaking at the upcoming Association for Value-Based Cancer Care 2018 Summit in New York, NY from October 30-31, 2018.
As Hurricane Michael poses a threat to Florida and other states, ASCO has assembled a list of resources and information to support cancer care providers and patients.
In the latest ASCO in Action Podcast, Dr. Ray Page, DO, PhD, FACOI joins ASCO CEO Dr. Clifford A. Hudis to discuss the impact that Pharmacy Benefit Managers (PBMs) are having on cancer care delivery and ASCO’s recent position statement on PBMs.
On October 4, 2018, the Food and Drug Administration approved emicizumab-kxwh injection (HEMLIBRA®, Genentech, Inc.) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors.