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Oncology Newsfeed

  • AUA Updates Guideline on Castration-Resistant Prostate Cancer

    On May 17, 2018, the American Urological Association (AUA) announced updates to its castration-resistant prostate cancer (CRPC) guideline. The guideline was updated to incorporate new published research related to the treatment of patients with asymptomatic non-metastatic CRPC.

    Read the newly amended guideline here.

    Posted 5/18/2018


  • FDA Approves Biosimilar to Epoetin Alfa for Anemia

    On May 15, 2018, the Food and Drug Administration approved epoetin alfa-epbx (Retacrit, Hospira Inc.) as a biosimilar to epoetin alfa (Epogen/Procrit, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

    Read the FDA announcement here.

    Posted 5/15/2018


  • HHS Issues Formal RFI for Drug Pricing Blueprint

    On May 14, the Department of Health and Human Services (HHS) issued a formal request for information (RFI) regarding the Trump Administration’s proposed drug pricing blueprint. HHS seeks “all suggestions to improve the affordability and accessibility of prescription drugs, including reflections and answers to questions not specifically asked.” Questions specifically posed by HHS are:

    • What other regulations or government policies may be increasing list prices, net prices, and out-of-pocket drug spending?
    • What other policies or legislative proposals should HHS consider to lower drug prices while encouraging innovation?
    • What data or evidence should HHS consider when developing proposals to lower drug prices?
    • HHS is actively working to reduce regulatory burdens. To what extent do current regulations or government policies related to prescription drug pricing impose burden on providers, payers, or others?
    • To what extent do the planned actions described in this document impose burden, and do these burdens outweigh the benefits?

    ACCC will be submitting comments, but we also encourage our member programs to weigh in on this important document. Comments must be submitted on or before July 15, 2018. To submit electronically, go to http://www.regulations.gov.

    Posted 5/14/2018


  • President Trump Unveils Blueprint to Lower Drug Prices

    On Friday, May 11, President Trump and U.S. Department of Health and Human Services Secretary Alex M. Azar II announced the administration's plan to lower drug prices.

    Access "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs."

    ACCC is continuing to look at the policies' implications for our members and their patients. Stay tuned for updates.

    Posted 5/11/2018



  • CMS Releases Rural Health Strategy

    On May 8, 2018, the Centers for Medicare & Medicaid Services (CMS) announced the launch of its first Rural Health Strategy. The strategy is intended to address access to quality, affordable healthcare in rural communities, the viability of rural hospitals, and the effects of CMS rules and regulations on healthcare in rural areas.

    Read the full Rural Health Strategy here, and read the fact sheet here.


    Posted 5/8/2018



  • USPSTF Issues Final Recommendation on Screening for Prostate Cancer

    On May 8, 2018, the U.S. Preventive Services Task Force (USPSTF) released a final recommendation statement and evidence summaries on screening for prostate cancer. The USPSTF final recommendation provides clinicians and patients with important new information about the benefits and harms of prostate-specific antigen (PSA)-based screening. 

    For men 55 - 69 years of age, the USPSTF final recommendation calls for informed individual decision-making based on the individual's values and specific clinical circumstances. This is a C recommendation.

    The USPSTF recommends against PSA-based screening for prostate cancer in men age 70 and older.

    Read the USPSTF Recommendation Statement and access the evidence summary and FAQs.

    Posted May 8, 2018


  • FDA Approves Daratumumab for Newly Diagnosed, Transplant Ineligible MM Patients

    On May 7, 2018, the Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).

    Read the Johnson & Johnson press release here.

    Posted 5/8/2018


  • FDA Approves Dabrafenib and Trametinib for Treatment of Thyroid Cancer

    On May 4, 2018, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

    Read the full FDA announcement here.

    Posted 5/1/2018



  • 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