ASCO leaders recently met with representatives from the Trump Administration to discuss the delivery of high-quality, high-value cancer care as the Administration implements its “blueprint to lower drug prices and reduce out-of-pocket costs.”
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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In a new position statement, the American Society of Clinical Oncology (ASCO) warns that some of the practices of pharmacy benefit manager (PBM) companies use could hinder patient access to timely, high-quality cancer care. ASCO describes a range of PBM practices that, while they may be intended to help control costs in cancer care, might compromise physicians’ ability to provide the right treatment at the right time for people with cancer.
ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered drugs under Medicare Part B and Part D.
ASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration that the Risk Evaluation and Mitigation Strategy communication plan for ICLUSIG® (ponatinib) is no longer required.
ASCO submitted a response to the Request for Information (RFI) that was included in the Trump Administration's “blueprint to lower drug prices and reduce out-of-pocket costs.” In a letter to Secretary of the U.S. Department Health and Human Services (HHS) Alex Azar, ASCO recommends a value-based approach to address rising drug costs and makes specific recommendations regarding the 340B Drug Pricing Program, reviving the Competitive Acquisition Program (CAP), moving drugs from Medicare Part B to Part D, and site neutrality proposals.
In the latest ASCO in Action Podcast, Dr. Edward Kim, Chair of the Department of Solid Tumor Oncology at the Levine Cancer Institute, joined ASCO CEO Dr. Clifford A. Hudis to discuss eligibility criteria for cancer clinical trials.
On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. The FDA also accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
During the American Medical Association (AMA) House of Delegates (HOD) annual meeting, delegates approved several ASCO-led resolutions and incorporated them into the AMA’s policy agenda.
Right-to-try is the latest topic addressed in the ASCO in Action podcast series. ASCO CEO Dr. Clifford Hudis recently interviewed ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky to examine RTT legislation—now enacted as federal law—and discuss the Food and Drug Administration’s (FDA) expanded access program.
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda®, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
From June 9 – 13, ASCO’s delegates will participate in the American Medical Association’s (AMA) Annual Meeting of the House of Delegates (HOD). The AMA HOD is the principal policy-making body of AMA, and meets twice a year to discuss pressing issues and establish association policies. 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.
Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have been developed and marketed as competitive, lower-cost alternatives to newer biologic treatments. This pathway was established to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. Biosimilars are among the fastest-growing class of drugs in the United States, a class called biological products.
On May 15, ASCO submitted comments to Congressional committees applauding their commitment to addressing the opioid crisis but urged them to ensure that such efforts do not prevent patients with cancer from receiving appropriate opioid therapy.
ASCO has been notified about a recent safety update relating to the drug BLINCYTO® (blinatumomab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.
In the newest ASCO in Action podcast, Dr. Gary H. Lyman, MPH, FASCO, FRCP, joins ASCO CEO Dr. Clifford A. Hudis to discuss biosimilars and ASCO’s recent statement on biosimilars published in the Journal of Clinical Oncology. Dr. Lyman is chair of the ASCO Biosimilars Work Group and lead author of the ASCO statement, which aims to educate cancer care providers on the use and regulation of biosimilars.