ASCO's delegates to the American Medical Association’s (AMA) House of Delegates (HOD) will propose several resolutions during the policy-making body’s interim meeting, which will be held November 16-19, 2019. ASCO currently sends three delegates to the AMA HOD: Edward P. Balaban, DO, FACP, FASCO; Thomas A. Marsland, MD, FASCO; and Ray D. Page, DO, PhD, FACOI, FASCO. The society also has two alternate delegates to the HOD: Kristina L. Novick, MD and Steve Y. Lee, MD. ASCO’s Resident Fellow Section Delegate is Erin L. Schwab, MPH, BS, MD.
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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The MEDS Act takes important steps toward ending the drug shortage crisis we are experiencing today, ASCO Board of Directors member Peter C. Adamson, MD stated during a briefing on Capitol Hill. Dr. Adamson spoke in support of Senate bill S. 2723, “The Mitigating Emergency Drug Shortages (MEDS) Act,” at the November 5 briefing.
The U.S. Food and Drug Administration (FDA) recently announced a reorganization and renaming of the office responsible for reviewing applications for new and existing cancer therapies.
The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been renamed the Office of Oncologic Diseases (OOD). Richard Pazdur, MD, will serve as the acting director of OOD and continue his role as director of the FDA Oncology Center of Excellence (OCE).
On November 1, the Centers for Medicare & Medicaid Services (CMS) released its final rule for reimbursement under the Hospital Outpatient Prospective Payment System (HOPPS) in 2020. ASCO is still analyzing the rule and will provide in-depth analysis for members as soon as possible. Based on a preliminary evaluation, key provisions in the proposed rule include:
Health insurers, employers, and pharmacy benefit managers (PBMs) have shifted a growing share of the costs for specialty prescription medicines to their patients and beneficiaries. Since insurer cost-sharing requirements for prescription medications (such as high coinsurance and deductible amounts) can be uniquely burdensome compared to other types of health care, pharmaceutical manufacturers regularly offer co-pay assistance—which can include co-pay cards or coupons—to help patients afford their prescriptions.
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.
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.
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.
On September 17, 2019, the Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (KEYTRUDA®, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
On September 17, 2019, the Food and Drug Administration approved apalutamide (ERLEADA®, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.
ASCO joined 370 health care groups in urging members of the U.S. House of Representatives to support the Improving Seniors’ Timely Access to Care Act (H.R. 3107). The bipartisan bill would help protect patients from unnecessary care delays by streamlining and standardizing prior authorization under Medicare Advantage (MA) and providing program oversight and transparency for MA beneficiaries.
New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study demonstrate that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A mutated or deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma.
On August 16, 2019, the Food and Drug Administration approved fedratinib (INREBIC®, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover Food and Drug Administration (FDA)-approved Chimeric Antigen Receptor T-cell (CAR T-cell) therapy for certain patients with cancer.
ASCO recently submitted comments to the Food and Drug Administration (FDA) regarding the agency’s draft guidance recommending specific approaches for sponsors of clinical trials to broaden eligibility criteria, redesign clinical trials, and remove patient barriers to increase enrollment of underrepresented populations in their clinical trials.