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Oncology Newsfeed

  • ACS: More than Half of Americans Report Medical Financial Hardship

    A new study by researchers from the American Cancer Society (ACS) finds that approximately 137 million adults in America (56 percent) reported having medical financial hardship in the past year. Highlights of the report include:

    • Adults aged 18 to 64 reported higher material (i.e. trouble paying medical bills), psychological (i.e. concern about medical bills), and behavioral (delaying or forgoing care because of cost) medical financial hardship than those aged 65 and older.
    • Among adults aged 18 to 64, those with less education and more health conditions reported greater intensity of hardship.
    • Women were more likely to report multiple domains of hardship than men.
    • Uninsured adults were more likely to report multiple domains of hardship than those with public or private insurance.
    2017 ACCC Annual Achievement Award winner Barbara McAneny, MD, president of the American Medical Association, says of the study in the Los Angeles Times, "People are trying hard to do the right thing, but care is being prices out of their reach."

    Read the ACS press press release.
    Read the Los Angeles Times article.
    Read "Prevalence and Correlates of Medical Financial Hardship in the USA" in the Journal of General Internal Medicine.

    Posted 5/2/2019


  • AHA Releases Scientific Statement on Cardio-Oncology Rehabilitation

    The American Heart Association (AHA) has published a scientific statement in the journal Circulation outlining the need to develop and test cardio-oncology rehabilitation programs for patients at high risk for cardiac dysfunction during and after cancer treatment. The statement outlines the process for identifying at-risk patients and the infrastructure needed to address the unique exposures and complications related to cardiac rehabilitation.

    Read the AHA journal article here.

    Posted 4/25/2019


  • CMS Releases IPPS Proposed Rule

    On April 23, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year (FY) 2020.

    In the IPPS proposed rule, the agency proposes to:

    • increase the wage index of low wage index hospitals
    • support broad access to "transformative technologies" by proposing several payment policy changes, including increasing the new technology add-on payment
    • modernize payment policies for medical devices that meet FDA Breakthrough Devices designation
    The agency fact sheet specifically addresses CAR-T therapy in the context of applications for new technology add-on payments for FY 2020. In the proposed rule, CMS presents 17 new applications for new technology add-on payment for FY 2020, and proposes to continue the new technology add-on payments for 10 of the 13 technologies currently receiving the add-on payment (3 technologies will no longer be in their newness period in FY 2020). Two of the technologies CMS is proposing to continue payments for are types of chimeric antigen receptor (CAR) T‑cell therapy.

    The ACCC policy team is analyzing the proposed rule and will provide a more in-depth analysis to members shortly.

    Read the agency fact sheet.
    Access the proposed rule.

    Posted 4/23/2019



  • FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

    On April 19, the FDA approved pembrolizumab (Keytruda, Merck & Co. Inc.) plus axitinib (Inlyta, Pfizer Inc.) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

    Read the full FDA press release here.

    Posted 4/22/2019


  • FOA: Optimizing Management & Outcomes for Survivors Moving Into Follow-Up Care

    The National Institutes of Health (NIH)/National Cancer Institute (NCI) have announced a funding opportunity RFA-CA-19-035, titled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-Up Care (RO1 Clinical Trial Required)"

    The Funding Opportunity Announcement (FOA) solicits applications that develop and test models of care for adult survivors of cancer who are transitioning from active treatment to follow-up care. Through this FOA, the NCI intends to support multi-level interventions that enhance communication, collaboration, and coordination among oncology and non-oncology providers to improve cancer survivor outcomes.

    Interventions that focus on the needs of racial/ethnic minority or medically underserved adult survivors and/or those receiving care in community settings (including, but not limited to, community-based cancer centers) are not required but strongly encouraged. NCI seeks to fund applications that represent a broad spectrum of cancer survivors (e.g., variability in demographics, cancer type, clinical characteristics) and care delivery settings (e.g., community settings, integrated healthcare settings).

    KEY DATES 

    Open Date (Earliest Submission Date): May 28, 2019

    Letter of Intent Due Date(s): 30 days prior to the application due date

    Application Due Date(s): June 28, 2019, by 5:00 PM local time of applicant organization.

    DATE FOR PRE-APPLICATION WEBINAR for RFA-CA-19-035
    May 3, 2019
    1:00 PM - 2:00 PM (ET)  

    On Friday, May 3, 2019 from 1:00 - 2:00 PM (ET), NCI will hold a pre-application webinar for RFA-CA-19-035 entitled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care (R01 Clinical Trial Required)."

    NCI staff members involved in this FOA will provide orientation and technical assistance to potential applicants to the above-referenced FOA by explaining the goals and objectives for the proposed FOA and answer questions from webinar attendees. Potential applicants are encouraged to submit their questions to NCIHDRP@mail.nih.gov by 12 pm ET on May 1, 2019.

    To join the webinar, pre-registration is required through Webex. Specific webinar information will be provided upon registration.

    Posted 4/17/19



  • ASCO and ASH Updated Guidelines for Managing Biosimilar ESAs

    The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have issued an updated practice guideline on the use of erythropoiesis-stimulating agents (ESAs) in cancer care, in which they state that the available literature suggests that biosimilars of epoetin alfa have similar efficacy and safety to reference agents. The update also suggests that both biosimilars and their references may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent.

    Read the ASCO and ASH press release here.
    Read the updated ESA guideline here.

    Posted 4/17/2019


  • FDA Approves Erdafitinib for Metastatic Urothelial Carcinoma

    On April 12, 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.

    The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication.

    Read the full FDA press release here.

    Posted 4/12/2019


  • FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment

    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.

    Read the FDA press release here.

    Posted 4/12/2019


  • FDA Expands Palbociclib Use to Include Male Breast Cancer Patients

    On April 4, the U.S. Food and Drug Administration extended the indication of palbociclib (Ibrance, Pfizer Inc.) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

    Read the full FDA press release here.

    Posted 4/5/2019


  • FDA Proposes Policy Changes to Update Mammography Services

    The U.S. Food and Drug Administration issued a proposed rule on March 27 that would make amendments to the regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 that seek to improve the quality of mammography services. The proposed rule would expand the information mammography facilities are required to provide to patients and healthcare professionals to allow for more informed medical decision-making, the agency said in a statement. It also modernizes mammography quality stands and strengthens the FDA’s ability to enforce regulations that apply to the safety and quality of mammography services.

    Under the proposed rule, breast density information would be added to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.

    The amendments would also expand the information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.

    Under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications, the agency said.

    The proposed rule will be open for public comment for 90 days after publication.

    Read the FDA press release.
    View the proposed rule.

    Posted 3/27/2019