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Oncology Newsfeed

  • FDA Approves Ibrutinib Plus Obinutuzumab for CLL/SLL

    On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

    Read the Janssen press release here.

     Posted January 28, 2019


  • ACCC Joins in Letter to CMS Expressing Concerns with Proposed Part D & MA Rule

    The Association of Community Cancer Centers (ACCC) joined more than 30 stakeholder organizations in a January 25 letter to the Centers for Medicare & Medicaid Services (CMS) outlining concerns over the impact of the administration's proposed rule on Modernizing Part D and Medicare Advantage. The letter addresses the following issues addressed in the proposed rule:
    • Providing plan flexibility to manage protected classes
    • Application of step therapy for Part D drugs by Medicare Advantage plans
    • Explanation of benefits requirements
    • Changes to the definition of negotiated price
    • Pharmacy price concessions in negotiated price.
    Read the letter.

    Posted 1/25/19


  • Medicare Coverage Established for MRD Testing for ALL, Multiple Myeloma

    On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing.

    Read the Adaptive Biotechnologies press release here
    .

    Posted 1/23/2019


  • FDA Approves Third Biosimilar to Trastuzumab

    On January 18, the FDA approved trastuzumab-dttb (Ontruzant, Samsung Bioepis), a biosimilar to trastuzumab (Herceptin), for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

    Read the OncLive news coverage here.

    Posted 1/18/19


  • CMMI to Test Part D Payment Model & Update to MA VBID Model

    On January 18, the Centers for Medicare & Medicaid Services (CMS) announced that its Center for Medicare and Medicaid Innovation (CMMI) will test a new model for Part D plans and an update to the Medicare Advantage Value-Based Insurance Design (VBID) model that the agency launched in 2017. 

    The Part D model, titled the Part D Payment Modernization model, is voluntary as is the MA VBID update model, meaning that certain Medicare Advantage and Part D plans can choose to participate, and patients can choose to enroll in participating plans. 

    The Part D Payment Modernization model will begin in January 2020. The model is intended to test the impact of a revised Part D program design and incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs.

    The voluntary, five-year Part D Modernization model will be open to eligible standalone Prescription Drug Plans (PDPs) and Medicare Advantage-Prescription Drug Plans (MA-PDs) that are approved to participate. 

    The CMS fact sheet on the Part D Modernization model states:
    "Through this model, CMS is testing the impact of a modernized Part D payment structure that increases and better aligns Part D plan sponsor liability with the costs paid for by CMS and Medicare beneficiaries. Ultimately, this model will allow CMS to address the high list price of drugs covered by Medicare Part D and evaluate the impact on cost and quality for Medicare beneficiaries."

    Read CMS fact sheet on Part D Modernization Model here.

    More information is available on the CMMI website here.

    The CMS press release is available here

    Posted 1/18/19



  • FDA Approves Cabozantinib for Previously Treated HCC

    On January 14, Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

    Read the full Exelixis, Inc. press release here.

    Posted 1/15/2019


  • U.S. Cancer Death Rate Continues 25-Year Decline, ACS Report Finds

    Over the past 25 years, the U.S. has seen a steady decline in the death rate from cancer, according to "Cancer Statistics, 2019," the annual report from the American Cancer Society (ACS) published online January 8, in CA: A Cancer Journal for Clinicians.

    Between 1991 and 2016, the U.S. saw an overall 27 percent decrease in cancer deaths. The decrease is attributed to reduction in smoking and advances in early detection and treatment of cancer. However, the ACS report finds that not all of the U.S. population is benefiting equally. While the historic racial disparities in cancer death rates are lessening, socioeconomic gaps are widening.

    A companion version of the report, "Cancer Facts & Figures 2019," includes a special section on the oldest old population in the U.S., which includes incidence, mortality rates, trends, survival, treatment, and challenges affecting this growing segment of the population.

    Learn more.

    Posted 1/8/19



  • CMS Opens Data Submission Period for MIPS from 1/2 to 4/2

    The Centers for Medicare & Medicaid Services (CMS) has officially opened the data submission period for Merit-based Incentive Payment System (MIPS)-eligible clinicians who participated in Year 2 (2018) of the Quality Payment Program. With the exceptions noted in the paragraph below, data can be submitted and updated any time from January 2, 2019 to April 2, 2019.

    CMS Web Interface users need to report their Quality performance category data between January 22 and March 22, 2019. Also, for clinicians who reported Quality measures via Medicare Part B claims throughout the 2018 performance year, we’ll receive your quality data from claims processed by your Medicare Administrative Contractor, and claims for services furnished during 2018 must be processed within 60 days after the end of the 2018 performance period.

    Clinicians will follow the steps outlined below to submit their data:

    1. Go to the Quality Payment Program website.
    2. Log-in using your QPP access credentials (see below for directions).
    3. Submit your MIPS data for Year 2 (2018).

    To log in and submit data, clinicians will need to use the new HCQIS Authorization Roles and Profile (HARP) system. Previously, clinicians received their credentials through the Enterprise Identity Management (EIDM) system. Clinicians are encouraged to log in early to familiarize themselves with the system.

    • Previous EIDM Accounts: For all clinicians who previously had an EIDM account, you were automatically transitioned to HARP, and will use your existing EIDM user ID and password to sign in to the QPP website.
    • New Clinicians: For all clinicians who didn’t have an EIDM account, you’ll need to enroll with HARP. For a step-by-step guide to signing up for a HARP account, refer to the QPP Access User Guide.

    Clinicians who are not sure if they are eligible to participate in the Quality Payment Program can check their eligibility status using the QPP Participation Status Tool.

    To learn more about how to submit data, please review the 2018 MIPS Data Submission FAQs and other resources available in the QPP Resource Library.

    If you have questions about how to submit your 2018 MIPS data, contact the Quality Payment Program by phone: (1-866-288-8292 / TTY: 1-877-715-6222) or email QPP@cms.hhs.gov.

    Posted 1/2/2019



  • FDA Approves Tagraxofusp-erzs for Blastic Plasmacytoid Dendritic Cell Neoplasm

    On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris, Stemline Therapeutics), a CD123-directed cytotoxin, for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.

    Read the FDA announcement here.
    Read the Stemline Therapeutics press release here.

    Posted 12/26/18



  • FDA Approves Calaspargase Pegol-mknl for Pediatric/AYA ALL

    On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.

    Read the full FDA press release here.

    Posted 12/20/2018