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.
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 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.
On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA®, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
On May 2, 2019, the Food and Drug Administration approved ivosidenib (TIBSOVO®, Agios Pharmaceuticals, Inc.) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.
As part of ASCO’s State of Cancer Care in America™ initiative, the Journal of Oncology Practice published an infographic about opioids and cancer pain, which highlights the specific needs of patients with cancer and some of the hurdles they face in trying to access prescribed opioids to manage cancer-related pain.
On April 19, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The Food and Drug Administration granted accelerated approval to erdafitinib (BALVERSA™, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
ASCO submitted testimony to the U.S. House and Senate Appropriations Committees urging them to increase funding for the National Institutes of Health, National Cancer Institute, and Food and Drug Administration.
On April 11, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.
ASCO submitted its position statement on the impact that Pharmacy Benefit Managers (PBMs) have on cancer care to a U.S. Senate Finance Committee hearing, “Drug Pricing in America: A Prescription for Change, Part III.” PBM representatives testified in-person during the hearing, which was held as part of Congress’ ongoing efforts to address rising prescription drug costs in the United States. In its submission, ASCO reiterated the society’s concerns about the negative effects of certain PBM practices on patients and the cancer care system.
ASCO recently submitted comments to the Department of Health and Human Services (HHS) in response to a proposed rule that would eliminate protection for manufacturer rebates on prescription drugs in the Medicare and Medicaid programs. The society’s comments express a shared concern over rising prescription drug costs and urge HHS to implement policies that make rebate arrangements transparent, while ensuring that efforts to address the problem don’t inadvertently lead to higher out-of-pocket costs for people with cancer.
The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) has added a new guide for companies regarding use of the Expanded Access Navigator. This guide is intended to provide small and emerging biopharmaceutical companies with assistance in understanding the procedures for expanded access, developing an expanded access policy for their company, and responding to requests for single-patient expanded access.