The American Society of Clinical Oncology and the European Society for Medical Oncology today published a joint analysis comparing the results of both organizations’ value frameworks in ASCO’s Journal of Clinical Oncology. The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined
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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On December 14, 2018, the Food and Drug Administration approved romiplostim (NPLATE®, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
On December 14, 2018, the Food and Drug Administration approved Herzuma (trastuzumab-pkrb, Celltrion Inc.) as a biosimilar to Herceptin (trastuzumab, Genentech Inc.) for patients with HER2-overexpressing breast cancer.
The latest issue of the Journal of Oncology Practice (JOP) features a new Special Series focusing on Real-World Approaches to Quality Improvement in Oncology. The issue includes research and commentary that share practical examples of approaching quality measurement and improvement that can guide physicians and others in the oncology field.
ASCO recently hosted a webinar outlining important changes to Medicare reimbursement starting Jan. 1, 2019. The event, 2019 Medicare Reimbursement – Final Rules Update, provided details on how provisions in the Hospital Outpatient Prospective Payment System (HOPPS), as well as the Medicare Physician Fee Schedule (MPFS) and Quality Payment Program (QPP) final rules will impact cancer care in the year ahead.
ASCO has submitted a statement for the record from ASCO Chief Executive Officer Clifford Hudis, MD, FACP, FASCO, to the House Energy and Commerce Committee’s Subcommittee on Health related to its recent hearing, “Implementing the 21st Century Cures Act: An Update from the Office of the National Coordinator.”
On Friday, December 7, President Trump signed into law a two-week Continuing Resolution (CR) to prevent a partial government shutdown.
While Congress was able to pass some of its Fiscal Year (FY) 2019 appropriations bills before the end of the 2018 fiscal year, it has not yet come to agreement on seven remaining appropriations bills, which fund a variety of federal departments and agencies, including the Food and Drug Administration (FDA). The CR will provide flat funding for those agencies until December 21, 2018, when Congress will need to take further action to fund them.
ASCO submitted comments to the United States Pharmacopeia Convention (USP) concerning a proposed chapter on pharmaceutical compounding. ASCO is concerned that proposed chapter, General Chapter <797> Pharmaceutical Compounding– Sterile Preparations (USP <797>), as it is currently written, could create unnecessary confusion for providers, interfere with patient access to potentially life-saving drugs, and undermine FDA drug approval requirements.
On December 6, 2018, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.
In the latest ASCO in Action Podcast, Dr. Beverly Moy, a medical oncologist at the Massachusetts General Hospital, joined ASCO CEO Dr. Clifford A. Hudis to discuss patient participation in clinical trials and how policymakers, trial sponsors, and other stakeholders can help remove and overcome financial barriers.
On November 28, 2018, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA®, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
Over the past two years, the National Cancer Institute (NCI) has worked to implement the Cancer Moonshot Initiative, including recommendations of the Cancer Moonshot Blue Ribbon Panel (BRP) that highlighted 10 areas of cancer research ripe for innovation.
While ASCO supports efforts to control drug prices, we are keenly aware that optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence.