ASCO submitted comments to Senate Health Education, Labor and Pensions (HELP) Committee leadership regarding draft legislation to address rising out-of-pocket costs for patients in the United States. ASCO’s comments focus on improving patient access to cancer care by reducing prescription drug prices, improving transparency around pharmacy benefit manager (PBM) practices, and improving public health and the exchange of health information.
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 June 10, 2019, the Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (POLIVY™, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
As part of the collaboration that lead to the recent CDC clarification on its guideline on prescribing opioids to manage pain from certain conditions, leadership from the organizations came together to write an op-ed for ASCO Connection. That commentary from ASCO CEO Clifford A. Hudis, MD, FACP, FASCO; NCCN CEO Robert W. Carlson, MD; and ASH President Roy Silverstein, MD, fully outlines the groups’ concerns about how efforts to address the opioid crisis in the United States could inadvertently create a new crisis through the misguided application of well-intentioned clinical guidelines.
On May 29, 2019, the Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA®, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
On May 28, 2019, the Food and Drug Administration approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).
On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
On May 24, 2019, the Food and Drug Administration approved alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Positive findings from fully enrolled cohorts in non-small cell lung cancer and metastatic breast cancer from ASCO's Targeted Agent and Profiling Utilization Registry (TAPUR™) Study will be presented in poster sessions at the 2019 ASCO® Annual Meeting. In addition, the study is being expanded to include patients with active brain metastases and three new drug therapies. Pharmaceutical company Boehringer Ingelheim has also joined the study and, later this year, will provide afatinib (Gilotrif®) to participants who enroll in a tissue-agnostic cohort of patients with an NRG1 gene fusion. That same month, the TAPUR Study also will add two new drugs from existing pharmaceutical company collaborators: abemaciclib (Verzenio®, Eli Lilly and Company) and talazoparib (Talzenna®, Pfizer).
On May 16, the Centers for Medicare & Medicaid Services (CMS) released a final rule on drug coverage policies. After receiving feedback from the American Society of Clinical Oncology (ASCO) and other stakeholders, CMS did not finalize a proposal that would have impeded access to drugs within Medicare Part D’s Six Protected Classes. The agency did, however, finalize a proposal to allow the use of step therapy for protected class prescription drugs under Medicare Advantage and Part B—despite stakeholder concerns.
ASCO submitted comments to a U.S. House Energy & Commerce health subcommittee hearing entitled, “Improving Drug Pricing Transparency and Lowering Prices for American Consumers." The hearing focused on several bills aimed at increasing transparency around drug prices and lowering out-of-pocket costs for patients. ASCO’s comments offer the oncology community’s perspective on several of the bills discussed during the hearing and focus on improving access to affordable cancer care.
The American Society of Clinical Oncology (ASCO) applauds the Centers for Medicare & Medicaid Services (CMS) for listening to ASCO and other stakeholders by not finalizing a proposal that would have significantly impacted access to drugs within the Six Protected Classes.
On May 16, 2019, the Food and Drug Administration approved dalteparin sodium (FRAGMIN®, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.
On May 15, 2019, the Food and Drug Administration approved venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
On May 14, 2019, the Food and Drug Administration approved avelumab (BAVENCIO®, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).
On May 10, 2019, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.