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Oncology Newsfeed

  • FDA Approves Azedra for Treatment of Rare Adrenal Tumors

    On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site, and require systemic anticancer therapy. This is the first FDA-approved drug for this use.

    Pheochromocytomas are rare tumors of the adrenal glands. These glands are located right above the kidneys and make hormones including stress hormones called epinephrines and norepinephrines. Pheochromocytomas increase the production of these hormones, leading to hypertension (high blood pressure) and symptoms such as headaches, irritability, sweating, rapid heart rate, nausea, vomiting, weight loss, weakness, chest pain or anxiety. When this type of tumor occurs outside the adrenal gland, it is called a paraganglioma.

    Read the FDA announcement.

    Posted 7/31/2018


  • CMS Issues CY 2019 Proposed OPPS Rule

    On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule for calendar year 2019. The deadline for submitting comments on the proposed rule is September 24, 2018.

    ACCC is currently analyzing the rule and will provide an update to members soon.

    Read the CMS fact sheet.
    View the proposed CY 2019 OPPS rule.

    Posted 7/25/2018


  • GAO Report Compares Characteristics of 340B and non-340B Hospitals

    On July 18, the Government Accountability Office (GAO) issued a report that compares characteristics of hospitals participating in the 340 Drug Pricing Program with those not participating in the 340B Program. The report focuses on three types of hospitals that made up more than 95 percent of 340B participants in 2016. 

    The report examines the effects of Medicaid expansion on 340B participation and other characteristics such as rates of charity care provided.

    Because for certain types of hospitals 340B eligibility is partially based on the number of Medicaid patients served, the report finds that 340B participation increased for those particular hospitals in states that expanded Medicaid.

    Read the report summary.
    View the full report.

    Posted 07/25/18



  • House of Representatives Passes PCHETA, Three Other Workforce Bills

    On July 23, the House of Representatives passed four Energy and Commerce Committee bills to authorize critical health workforce programs:

    • H.R. 1676, The Palliative Care and Hospice Education and Training Act (PCHETA), directs the Department of Health and Human Services (HHS) to award grants to train healthcare workers in palliative care. It would also create a national awareness campaign about the benefits of palliative care. ACCC strongly advocated for PCHETA during its 2018 ACCC Capitol Hill Day.
    • H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act, reauthorizes workforce programs that support loan repayment and provider training experiences in primary care, dentistry, rural or underserved areas, and in community-based settings. It will also restructure the geriatric health professional grant program to reflect changes by the Health Resources and Services Administration (HRSA).
    • H.R. 959, the Title VIII Nursing Workforce Reauthorization Act, reauthorizes nursing workforce development programs. It also extends advanced education nursing grants, defines nurse-managed health clinics, adds clinical nurse specialists to the National Advisory Council on Nurse Education, and reauthorizes loan repayments, scholarships, and grants for education, practice, quality, and retention.
    • H.R. 5385, the Dr. Benjy Frances Brooks Children's Hospital GME Support Reauthorization Act, reauthorizes the Children's Graduate Medical Education (CHGME) program for five years.
    Posted 7/24/2018


  • FDA Approves Filgrastim Biosimilar for AML

    On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015.

    Read the Pfizer corporate press release here.

    Posted 7/23/2018


  • CMS to Host Webinar Series on 2017 MIPS Feedback; 2018 Performance Categories

    The Centers for Medicare & Medicaid Services (CMS) will be hosting two "Office Hours" sessions over the next few weeks to provide a brief overview of the Merit-based Incentive Payment System (MIPS 2017) performance feedback and targeted review, answer frequently asked questions, and highlight available resources on performance feedback and targeted review. The two webinars will be held at the following times:

    If you are interested in submitting a question to be considered, please email CMSQualityTeam@ketchum.com. This email address is only for office hours questions; do not use this to submit a targeted review request. Space for these sessions is limited; register now to reserve your spot. The audio portion of the sessions will be broadcast through the web. Questions? Contact the Quality Payment Payment program at qpp@cms.hhs.gov.

    CMS is also hosting a series of webinars on the MIPS Performance Categories for Year 2 (2018) of the Quality Payment Program. The webinars will provide an overview on the Cost, Improvement Activities, and Quality performance categories for Year 2. CMS subject matter experts will cover topics including category requirements, scoring details, and data submission mechanisms. Below are details for these webinars:

    MIPS Cost Performance Category for Year 2 (2018) Overview Webinar

    MIPS Improvement Activities Performance Category for Year 2 (2018) Overview Webinar

    MIPS Quality Performance Category for Year 2 (2018) Overview Webinar

    The audio portion of these webinars will be broadcast through the web; you can listen to the presentation through your computer speakers. CMS will open the phone line for the Q&A portion, but if you are unable to hear audio through your computer speakers, please contact CMSQualityTeam@ketchum.com.

    Posted 7/20/2018



  • FDA Approves Ivosidenib for R/R AML

    On July 20, the Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. It is the first FDA-approved therapy for patients with R/R AML and an IDH1 mutation.

    Read the Agios corporate press release here.

    Posted 7/20/18


  • FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer

    On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

    The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

    Read the full FDA press release here.

    Posted 7/18/18


  • ACCC Submits Comments to Administration's Drug Pricing Blueprint

    On July 16, the Association of Community Cancer Centers (ACCC) submitted comments to the Request for Information (RFI) included in the administration's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. The plan was released in May. 

    In its comments, ACCC expresses support for the overarching goal to "bend the cost curve by improving care, providing the right care at the right time, reducing over-treatment and under-treatment, and reducing hospital admissions and readmissions." However, ACCC cautions that "any policy solution to rein in drug costs must preserve patients' access to—and ability to afford—quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer providers."

    In brief, ACCC comments on the following concerns:

    • If HHS goes forward with revitalization of the Competitive Acquisition Program (CAP), there must be sufficient modifications to the program to preserve patient access to drugs, maintain provider flexibility, and permit providers to choose whether to participate based on whether participation in CAP will help them best serve their patients' needs, and not in response to punitive reimbursement cuts.
    • HHS should not impose Medicare Part D utilization management requirements on Medicare Part B drugs or move these drugs into Medicare Part D as doing so would reduce patient access and could increase costs to the Medicare program and patients. In addition, HHS should clarify how these changes would work in practice.
    • HHS should ensure that payment rates reflect the true costs of providing care at a particular site of service.
    • HHS should ensure that any proposals related to modifying the 340B Drug Pricing Program encourage all oncology providers to treat underserved patient populations.
    Read the ACCC Comment letter for a full discussion of these issues.

    Posted 7/16/2018

     



  • FDA Approves Enzalutamide for Castration-resistant Prostate Cancer

    On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).

    This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC.

    Read FDA announcement.

    Posted 7/16/2018