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Oncology Newsfeed

  • FDA Approves Entrectinib for ROS1-Positive, Metastatic NSCLC

    Roche announced August 16 that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

    The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

    Read corporate press release.

    8/16/2019


  • CMS Finalizes NCD for CAR T-Cell Therapy

    On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.  

    Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia.

    The NCD 
    continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

    In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible." 


    Read the CMS Decision Memo.

    Download CMS Decision Memo.

    Posted 8/07/2019


  • New NCCN Guidelines Address Small Intestine Cancers

    On August 1, the National Comprehensive Cancer Network (NCCN) announced release of new NCCN Guidelines for Small Bowel Adenocarcinoma. These are the first clinical guidelines in the U.S. to address this rare but growing cancer type, which is sometimes associated with hereditary causes like Lynch syndrome.

    NCCN also recently released Updated NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer and Colorectal Cancer Screening, which clarify how to use genetic testing and screening to detect cancer in high-risk individuals at an earlier stage.

    Read NCCN press release. 

    Posted 8/1/2019



  • HHS Issues Plan Outlining 2 Paths for Prescription Drug Importation

    The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.

    Pathway 1: A Notice of Proposed Rulemaking (NPRM) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada.

    Pathway 2: Manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. 

    Read the HHS press release.
    Read the administration's Action Plan.

    Posted 7/31/2019


  • FDA Approves Pembrolizumab for PD-L1 Positive Advanced SCC of Esophagus

    On July 31, Merck announced U.S. Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    Read the corporate press release
    .

    Posted 7/31/2019


  • FDA Approves Darolutamide for Non-metastatic Castration-resistant Prostate Cancer

    On July 30, Bayer announced U.S. Food and Drug Administration (FDA) approval of Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa was approved under the FDA's Priority Review designation.

    Read corporate press release.

    Posted 7/31/2019


  • CMS Releases Proposed 2020 OPPS and PFS Rules

    On Monday, July 29, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) proposed rule and the CY 2020 Physician Fee Schedule (PFS) and Quality Payment Program proposed rule.

    CMS states that the OPPS proposed rule puts forward price transparency requirements that will increase competition among all hospitals by requiring them to make pricing information publicly available.

    According the agency, the policy changes included under the proposed 2020 PFS rule align with the administration's aims to reduce providers' paperwork burden, remove unnecessary reporting measures, and reward clinicians for time spent with patients.

    The ACCC policy team is currently reviewing both proposed rules and will provide a more in-depth summary for ACCC members shortly.

    Posted 7/29/2019



  • FDA Requests Recall of Certain Textured Breast Implants

    To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders.

    The company agreed and is removing these products from the global market.

    The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

    These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. 
    A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found here

    The FDA notes that the macro-textured implants, like the BIOCELL textured implants manufactured by Allergan, represent less than 5% of breast implants sold in the U.S. 

    Read the full FDA announcement, which includes recommendations for patients and providers.

    Posted 7/24/2019



  • Senate Finance Committee Reveals Drug-Pricing Legislation

    On July 23, the U.S. Senate Finance Committee released a long-anticipated drug-pricing bill. The legislation, which is slated for mark up on Thursday, July 25, includes significant changes to drug-pricing policy in Medicare and Medicaid. As written, the bill calls for restructuring of the Part D benefit, imposing much-debated inflationary rebates in Medicare Parts B and D, and increasing the rebate cap in Medicaid.

    New Structure for Part D
    The bill restructures Part D, eliminating the donut hole and shifting manufacturer liability to the catastrophic phase. Beneficiaries would pay costs up to $415 deductible. After meeting their deductible, during an initial coverage phase, beneficiaries would pay 25% of drug costs and plans would cover 75%. The out-of-pocket spending cap for beneficiaries would be $3,100. 

    During the catastrophic phase, Medicare would pay 20% for brand drugs, plans would cover 60%, and drug makers would pay 20%. For generics, Medicare would pay 40% and plans would pay 60%. As written, the legislation calls for this new structure to be phased in starting in 2022, and be in full effect by 2024.

    Part B
    The drug-pricing bill includes the following changes to Part B: 

    • Establishes requirement that manufacturers pay rebates when drugs and biologicals prices increase faster than inflation, as measured by the CPI-U. (Biosimilars or vaccines paid under Part B are excluded from this measure.)
    • Sets a new maximum add-on payment for drugs, biologics and biosimilars. 
    • Increases payments for biosimilars to encourage their use over brand biologics.
    • Requires drug, biologic and biosimilars makers to exclude the value of coupons provided to privately insured individuals when they report a drug’s ASP to HHS. However, the bill would not include contributions to patient assistance programs or foundations.
    • Requires that patients be better informed about cost sharing.
    The Senate is not slated to vote on the legislation until September.

    Concurrently, the House is working on its own drug-pricing legislation that is due for release in September. ACCC's policy team will be following developments on Capitol Hill closely and providing updates to its membership.

    Source: Inside Health Policy
    Posted 07/24/2019


  • FDA Approves Ruxience (rituximab-pvvr) for Adult NHL, CLL, Some Auto-Immune Conditions

    Pfizer Inc. announced on July 23, the U.S. Food and Drug Administration (FDA) approval of Ruxience™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

    Read the corporate press release.

    Posted 7/24/2019