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Oncology Newsfeed

  • Administration Slows Timeline for IPI, Rebate Regulatory Action

    The Trump Administration's spring regulatory agenda, released on May 22, shows a slow down of next steps for regulatory action on two pivotal drug-pricing reform measures: the International Pricing Index (IPI) model and the revamping of the rebate system.

    The IPI model was outlined last fall in an advance notice of proposed rulemaking from the Department of Health and Human Services (HHS). The rule, originally expected this spring, is now slated to be proposed in August.

    The regulatory agenda also indicates that Administration's proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system are now scheduled to be released later than originally anticipated.

    Source: Inside Health Policy
    Posted 5/23/2019

  • Verma: CAR-T NCD "New Ground" for CMS, Agency Needs More Time

    On May 17, the Centers for Medicare & Medicaid Services (CMS) abruptly announced a delay in its release of a Medicare National Coverage Determination (NCD) for CAR T-cell therapy, which was due to be published that same day. The agency statement did not provide an explanation for the delay.

    In a meeting with reporters on Wednesday, May 22, CMS Administrator Seema Verma said that the agency is taking care with the NCD because not only is the technology "new ground" for CMS, but also application of CAR-T therapy is expected to expand to other types of cancer beyond lymphoma. “So we want to make sure that we’re doing this appropriately, dotting our i’s and crossing our t’s. It’s just taking a little bit more time because it’s not a routine type of decision,” Verma said.

    Source: Inside Health Policy
    Posted 5/23/2019

  • CMS Releases Finalized Medicare Advantage & Part D Rule

    On May 16, the Centers for Medicare & Medicaid Services (CMS) released their final rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Highlights from this final rule include:

    • Reversal from the outlined proposed rule that would have allowed for significant change to the Medicare Part D six protected classes and coverage of these important therapies.
    • Part D plan sponsors will be required to implement an electronic real-time benefit tool (RTBT) with the goal of increasing price transparency. This tool seeks to be capable of integrating with at least one prescriber's electronic prescribing system or electronic health record.

    The ACCC policy team will continue to analyze this rule and provide a more detailed analysis at a later date.

    Read the CMS final rule here.

    Posted 5/17/2019

  • FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

    On May 15, AbbVie Inc. and Genentech Inc. announced that the U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA had previously granted Breakthrough Therapy designation to this chemotherapy-free combination.

    Read the Genentech press release

    Posted 5/15/2019

  • FDA Approves Avelumab Plus Axitinib for Advanced RCC

    On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib.

    Read the Pfizer press release.

    Posted 5/15/2019

  • FDA Issues Final Guidance to Manufacturers on Biosimilars' Pathway to Interchangeability

    On May 10, the U.S. Food and Drug Administration (FDA) released its final guidance to drug manufacturers with direction on what studies need to show the agency in how a biosimilar is interchangeable with a biologic. The healthcare community, and specifically, the oncology community, has called upon the FDA and Congress to increase the availability and competition of biosimilars.  

    Read statement from acting FDA Commissioner Ned Sharpless, MD.

    Posted 5/13/2019

  • FDA Approves Ramucirumab for HCC

    On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.

    Read the FDA press release here.

    Posted 5/10/2019

  • FDA Approves Ado-Trastuzumab Emtansine for HER2+ Breast Cancer

    On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1) (Kadcyla, Genentech Inc.) for use as an adjuvant treatment option for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (Herceptin) and chemotherapy.

    Read the TargetedOnc article here.

    Posted 5/3/2019

  • FDA Approves Ivosidenib for AML

    On May 2, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

    Read the FDA press release here.

    Posted 5/3/2019

  • AUA Releases New Guidance for Testicular Cancer, Radiotherapy after Prostatectomy

    On May 2, the American Urological Association (AUA) released a new clinical guideline for the diagnosis and treatment of early-stage testicular cancer, the most common cancer among men aged 20 to 40. The new clinical guideline makes 45 recommendations, including recommendations for scrotal ultrasound, obtaining serum tumor markers, and sperm banking prior to orchiectomy.

    Read the AUA press release.
    Read Diagnosis and Treatment of Early State Testicular Cancer: AUA Guideline (2019).

    On April 30, AUA and the American Society for Radiation Oncology (ASTRO) announced updates to their joint clinical guideline on adjuvant and salvage radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence to include new published research related to adjuvant radiotherapy.

    Read the AUA press release.
    Read Adjuvant and Radiotherapy after Prostatectomy: ASTRO/AUA Guideline.

    Posted 5/2/2019