ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to a Request for Information (RFI) on Direct Provider Contracting (DPC) Models published on the Center for Medicare and Medicaid Innovation’s (CMMI) website in April 2018.
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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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.
Sexual and gender minority (SGM) populations face unique challenges in accessing health services, including discrimination and greater risk of anxiety and depression, that can result in disparate care. SGM populations have low rates of cancer screening for reasons that include lower rates of insurance coverage, exclusion from traditional cancer screening campaigns, and previous experiences of discrimination when interacting with health care systems and providers.
On Tuesday, May 15, five ASCO volunteers represented the society as part of One Voice Against Cancer’s (OVAC) annual Hill Day, where 100 participants from 25 non-profit organizations met with Members of Congress and their staff to highlight the need for the government’s continued investment in the fight against cancer.
The U.S. House of Representatives passed the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act (H.R. 820/S. 292), which will help improve care for the nearly 16,000 children diagnosed with cancer in the United States every year.
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.
On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet®, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
On May 18, 2018, the U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
On May 17, the Senate Appropriations Committee held a hearing to discuss the budget request for the National Institutes of Health (NIH) for Fiscal Year (FY) 2019. NIH Director Francis Collins, MD, PhD, and National Cancer Institute (NCI) Director Ned Sharpless, MD, both gave testimony at the hearing, where Dr. Sharpless underscored the need for adequate funding to strengthen the cancer research infrastructure.
The agenda has been set for the June 22 ASCO/Food and Drug Administration (FDA) “Core Outcome Assessments in Cancer Clinical Trials” workshop.
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.
The Food and Drug Administration (FDA) is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam because of outbreaks of the Burkholderia cepacia complex (commonly called B. cepacia) in three states. The
On May 15, 2018, the Food and Drug Administration approved Retacrit™ (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study now provides a full list of patient cohort expansions and closures on its website. Based on treatment responses in Stage I, patient cohorts are either expanded to Stage II for further study and identification of a signal or permanently closed. ASCO’s TAPUR Study offers a clinical trial opportunity for patients with advanced cancer who have not responded or are no longer responding to standard treatment and who have genomic alterations in their tumors that can be targeted with a TAPUR Study drug.