On July 18, 2018, the Food and Drug Administration expanded the indication for ribociclib (Kisqali®, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
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.
To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.
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.
"I Live to Conquer Cancer" is a new national outreach and awareness initiative that builds on ASCO’s continued advocacy activities in support of the National Institutes of Health (NIH) and the National Cancer Institute (NCI), and aims to underscore the critical importance of federally funded cancer research.
On July 13, 2018, the Food and Drug Administration approved enzalutamide (XTANDI®, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
The Centers for Medicare & Medicaid Services (CMS) released its proposed rule for 2019 Medicare physician reimbursement. CMS estimates that in 2019, overall impact for the hematology/oncology specialty will be a -4 percent reduction in reimbursement and -2 percent for radiation/oncology. These overall impacts reflect statutory adjustment factors, related to the Medicare Access and CHIP Reauthorization Act and Relative Value Units of CPT codes. It is important to note that the actual impact on individual physician practices will depend on the mix of services the practice provides.
ASCO strongly opposes provisions in the 2019 Medicare Physician Fee Schedule (MPFS) proposed rule that could significantly cut cancer care resources that are needed to provide high-quality care to individuals with cancer
A new study in the Journal of Oncology Practice (JOP) used ASCO’s Quality Oncology Practice Initiative (QOPI)® to identify five determinants of successful implementation of Survivorship Care Plans (SCPs) to improve the care and outcomes for cancer survivors.
ASCO submitted comments to U.S. House of Representatives Energy and Commerce Committee leadership in conjunction with a subcommittee hearing on the 340B Drug Pricing Program, “Opportunities to Improve the 340B Drug Pricing Program.” In writing to Committee leadership, ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, underscored ASCO’s appreciation for the committee’s continued efforts “to ensure the program addresses the needs of underserved patients—particularly their ability to access cancer care.”
On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY®, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
ASCO President Monica M. Bertagnolli, MD, FACS, FASCO joined ASCO CEO Dr. Clifford A. Hudis in the most recent ASCO in Action Podcast to discuss her presidential theme and the vision she has for ASCO this coming year.
The Centers for Medicare & Medicaid Services (CMS) is advancing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration proposal to a public comment period and consideration for formal approval. If approved, the demo would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who sufficiently participate in certain Medicare Advantage (MA) plans that involve assuming greater financial risk.
Data abstraction for ASCO’s Quality Oncology Practice Initiative (QOPI®) Round 2 of reporting opened on July 5 and will close on Tuesday, Dec. 4. Round 2 final reports will be available on Dec. 18.
In June 2018, ASCO President Monica M. Bertagnolli, MD, FACS, FASCO authored To Conquer Cancer, Our Nation Must Continue to Invest in Research, which focuses on the need for robust federal funding of cancer research.
ASCO and the European Society for Medical Oncology (ESMO), are calling on leaders and health ministers of the 193 United Nations (UN) member countries to reduce the burden of all non-communicable diseases (NCDs), including cancer. The two organizations issued a joint statement in advance of the third High-level Meeting of the United Nations (UN) General Assembly on the Prevention and Control of NCDs, taking place on September 27, 2018, in New York.
FDA has limited the use of Tecentriq (atezolizumab) and Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. This is due to decreased survival associated with these drugs as single therapy (monotherapy) compared to platinum-based chemotherapy 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).