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Oncology Newsfeed

  • FDA Approves Kymriah to Treat Certain R/R Patients with Large B-Cell Lymphoma

    On May 1, 2018, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

    Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma. 

    Read the company press release.

    Read FDA announcement.

    Posted 5/1/2018



  • CMS to Host Webinar on Participation Criteria for Year 2 of QPP

    The Centers for Medicare & Medicaid Services (CMS) is hosting a webinar on Wednesday, May 9 at 1:00 PM ET to provide an overview of participation criteria used to determine inclusion in the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs).

    Attendees will learn about:

    • How CMS determines a clinician’s participation status in MIPS at the individual and group level
    • Advanced APMs and criteria for how to become a Qualifying APM Participant (QP)
    • Advanced APMs All-Payer Combination Option
    • APM Scoring Standard benefits for participation in a MIPS APM
    • Checking your participation status for the 2018 Performance Year

    CMS will address questions from participants at the end of the webinar, as time allows.

    Webinar Details
    Title:     Participation Criteria for Year 2 of the Quality Payment Program
    Date: Wednesday, May 9, 2018
    Time:     1:00-2:15 p.m. ET
    Registration Link:     https://engage.vevent.com/rt/cms/index.jsp?seid=1091


    Posted 5/1/2018



  • NASEM Publishes Workshop Proceedings on Cancer Survivorship Care, Health Professional Education

    The National Academies of Sciences, Engineering, and Medicine (NASEM) has published the proceedings of several new workshops, including a workshop held by the National Cancer Policy Forum on long-term cancer survivorship care.

    Long-Term Survivorship Care After Cancer Treatment summarizes the proceedings of a July 2017 workshop held in Washington, D.C., to examine progress made in cancer survivorship care since the publication of the 2006 consensus study report From Cancer Patient to Cancer Survivor: Lost in Transition. Workshop participants highlighted potential opportunities to improve the planning, management, and delivery of cancer survivorship care.

    The Global Forum on Innovation in Health Professional Education also published the proceedings of their Improving Health Professional Education and Practice Through Technology workshop held in November 2017. Participants explored effective use of technologies as tools for bridging identified gaps within and between health professions education and practice in order to optimize learning, performance and access in high-, middle-, and low-income areas while ensuring the well-being of the formal and informal health workforce.

    Posted 5/1/2018



  • FDA Approves Dabrafenib and Trametinib for Treatment of Melanoma

    On April 30, 2018, the Food and Drug Administration granted regular approval to dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.

    Read the full FDA announcement here.

    Posted 5/1/2018


  • CMS Issues Proposed FY2019 Hospital IPPS Rule

    On April 24, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System.  

    Among the proposed changes, CMS seeks to overhaul the Medicare and Medicaid EHR Incentive Programs to “focus on interoperability, improve flexibility, relieve burden and place emphasis on measures that require the electronic exchange of health information between providers and patients,” according to the agency’s fact sheet. To reflect this new focus, CMS proposes to change the EHR incentive program name from the “Meaningful Use” program to “Promoting Interoperability.”

    In addition to payment and policy proposals, CMS is releasing a Request for Information (RFI) to gain stakeholder input on the possibility of revising Conditions of Participation related to interoperability as a way to increase electronic sharing of data by hospitals. 

    The deadline for submitting comments on the proposed rule and the RFI is June 25, 2018.

    Read the full rule here, and access the CMS fact sheet here.

    Posted 4/25/2018



  • An Update from CMS on New Direction for Innovation Center

    Earlier this week, the Centers for Medicare & Medicaid Services (CMS) announced the release of the more than 1,000 comments the agency received in response to its “New Direction” RFI for the Innovation Center. In a statement, the agency said that it is sharing the feedback “to promote transparency and facilitate further discussion” on ways to move the Innovation Center in a new direction. Learn more.

    CMS also opened a new RFI for a “potential model in the area of direct provider contracting” as a next step. The agency is seeking input on a possible direct provider contracting care model between payers and primary care or multispecialty groups.The model might be tested within the Medicare fee-for-service (FFS) program (Medicare Parts A and B), Medicare Advantage program (Medicare Part C), and Medicaid. Read more on the RFI.

    Posted 4/24/2018



  • President Trump's Speech on Drug Pricing Postponed

    On April 22, the White House stated that President Donald Trump's planned speech on lowering drug costs has been postponed. Originally planned for April 26, the speech has been postponed to an undetermined date in the "near future," according to Hogan Gidley, deputy White House press secretary.

    Source: Bloomberg BNA

    Posted 4/23/2018


  • FDA Approves Fostamatinib Tablets for ITP

    On April 17, 2018, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate tablets (Tavalisse, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Read FDA announcement.

    4/18/18


  • FDA Approves Nivolumab and Ipilimumab for Treatment of Renal Cell Carcinoma

    On April 16, 2018, the Food and Drug Administration granted approval to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk previously untreated advanced renal cell carcinoma.

    Read the full press release here.

    Posted 4/16/2018



  • HHS Secretary Names New Leader of CMMI

    On April 6, Secretary of Health and Human Services (HHS) Alex Azar announced that Adam Boehler would assume leadership of the Center for Medicare & Medicaid Innovation (CMMI) on the week of April 9. Boehler, the founder and chief executive officer of Landmark Health, replaced acting leader Amy Bassano as the head of CMMI, the office responsible for testing Medicare and Medicaid payment innovations.

    Read more here.

    Posted 4/13/2018