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  • FDA Approves Tazverik for Advanced Epithelioid Sarcoma in Patients Aged 16 Years & Older

    On Jan. 23, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.

    Tazverik blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing.

    Read FDA announcement.

    Posted 1/24/2020

  • GAO Report Calls for More Oversight of 340B Hospital Eligibility

    A recent report from the Government Accountability Office (GAO) published Jan. 10, 2020, calls on the Health Resources and Services Administration (HRSA) to improve processes to reasonably assure that participating non-governmental hospitals meet 340B Drug Pricing Program eligibility requirements.

    The 340 Drug Pricing Program (340B Program) is administered by the U.S. Department of Health and Human Services' (HHS) Health Resources and Services Administration (HRSA). Under the 340B Program, certain hospitals and other qualified entities that care for many low-income and uninsured individuals receive discounted prices on outpatient drugs from drug manufacturers. About two-thirds of hospitals participating in the 340B Program (approximately 1,700) are non-governmental hospitals (i.e., private, nonprofit hospitals).

    The GAO makes several recommendations for achieving greater oversight of hospital eligibility. Among these, the report recommends that HRSA:

    • Implement a process to verify that all non-governmental hospitals have contracts in place, including throughout hospitals’ audit periods;
    • Amend its contract reviews to include an assessment of whether contracts meet statutory requirements;
    • Provide better guidance on contract reviews.

    HHS agreed with all of the GAO’s recommendations except the recommendation to implement a process to verify that all non-governmental hospitals have contracts in place. HHS says that HRSA does not have the resources to carry out the recommended verification process and it would over-burden the agency.

    Read the full report.
    Read GAO recommendations.

  • Update to ASCO/CAP Guideline on ER and PgR Testing in Breast Cancer

    On Jan. 13, an updated guideline for estrogen and progesterone receptor (ER/PgR) testing in breast cancer was released jointly by the College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO). The updated guideline reaffirms much of the original guidance and includes more specific recommendations for handling and reporting cases with low ER expression. The updated guideline was posted as online early release to the Archives of Pathology & Laboratory Medicine (Jan. 13, 2020, doi: 10.5858/arpa.2019-0904-SA).

    A CAP press release highlights the following changes:
    "Cases with 1-10% of cells staining for ER expression will now be reported as ER-low positive. Pathology reports for these cases should include a recommended comment that acknowledges the more limited data on endocrine responsiveness in this group. Also in such cases, pathologists should report the status of internal controls, with a special comment for specimens that lack internal positive controls."

    The CAP press release also notes that the new guideline more clearly recommends that:
    ". . . ER be tested in cases of newly diagnosed DCIS (without invasion) to help estimate potential benefit of endocrine therapy to reduce the risk of a future breast cancer event. But, specifically, PgR testing in DCIS is optional."

    Read the CAP press release.
    Access the updated Estrogen and Progesterone Receptor Testing in Breast Cancer guideline

    Posted 1/14/2020

  • FDA Approves Avapritinib for GIST Subset

    On Jan. 9, 2020, the U.S. Food and Drug Administration (FDA) announced approval of avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keep the cancer cells from growing.

    Read the FDA approval announcement.

    Posted 1/9/2020.

  • ACS Report Finds Largest One-Year Drop in Cancer Deaths

    The American Cancer Society’s annual report on U.S. cancer statistics, released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.  

    In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.

    The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.

    The American Cancer Society estimates for 2019, the U.S. saw approximately 1,762,450 cancers diagnosed.

    Read the full report.
    Read Facts & Figures 2020.

    Posted 1/9/2019

  • FDA Approves Pembrolizumab for Treatment of Subset of Bladder Cancer Patients

    On Jan. 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

    Read the FDA announcement.

    Posted 1/8/2020

  • FDA Approves Olaparib for Pancreatic Cancer

    On Dec. 30, 2019, AstraZeneca and Merck announced U.S. Food and Drug Administration (FDA) approval of olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

    Read the corporate press release.

    Myriad Genetics, Inc., announced Dec. 30, 2019, FDA has approved the company's BRACAnalysis CDx® for use as a companion diagnostic test by healthcare professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza® (olaparib). 

    Read the corporate press release.

    Posted 12/30/2019

  • FDA Approves Enhertu for Previously Treated Unresectable or Metastatic HER2+ Breast Cancer

    On December 20, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

    Read FDA announcement.

    Posted 12/20/2019

  • ACCC Responds to CMMI RFI on Oncology Care First Model

    On Dec. 12, 2019, the Association of Community Cancer Centers (ACCC) provided comments to the Center for Medicare and Medicaid Innovation's informal Request for Information on its potential Oncology Care First Model. Applauding CMMI for making the OCF Model voluntary and envisioning a multi-payer model, ACCC urged CMMI to:

    • make significant changes to the risk tracks for purposes of performance-based payment episodes,

    • structure the prospective payment for care management and certain other services as a supplemental payment,

    • provide more detail on the methodology for the novel therapy adjustment and ensure that the final adjustment adequately accounts for the cost of innovative and often life-saving new therapies, and

    • provide more details and future opportunities to comment on the OCF before finalizing the Model.
    Learn more and read comment letter

    Posted 12/19/2019


  • FDA Approves Padcev (enfortumab vedotin-ejfv) for Advanced Urothelial Cancer

    On Dec. 18, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.

    Padcev is indicated for the treatment of locally advanced or metastatic urothelial cancer in adults who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. Platinum-containing chemotherapy, PD-1 and PD-L1 inhibitors are standard treatments for patients with bladder cancer, the sixth most common cancer in the U.S. Urothelial cancer, which accounts for more than 90% of bladder cancers, begins in cells that line the bladder and nearby organs. Padcev is a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.

    Read FDA announcement.

    Posted 12/19/2019 

  • Trump Administration Issues Proposed Rule on Importation of Prescription Drugs

    On Dec. 18, 2019, President Trump, along with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow states to import certain prescription drugs from Canada. In addition, the administration announced a new draft guidance for industry that allows drug manufacturers to important their own prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

    The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)

    Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.

    Read the HHS press release.
    Read Importation of Prescription Drugs Proposed Rule.
    Read new draft guidance for industry.

  • FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

    On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).

    FDA previously approved enzalutamide for patients with castration-resistant prostate cancer.

    Read the FDA announcement

    Posted 12/17/2019

  • CMS Extends Open Enrollment Deadline to Dec. 18

    On Dec. 16, 2019, a spokesperson for the Centers for Medicare & Medicaid Services (CMS) issued the following statement:

    "In an abundance of caution, to accommodate consumers who attempted to enroll in coverage during the final hours of Open Enrollment but who may have experienced issues, starting at 3:00 PM EST today, December 16 we are extending the deadline to sign up for January 1 coverage until 3:00 AM EST December 18."

    The website and the call center were open for business on Sunday, December 15, CMS says. However, due to the high volume of consumers (more than half a million) calling to enroll in health insurance on the exchange, some consumers were asked to leave their name at the call center. The agency states: "Those consumers who have already left their contact information at the call center do not need to come back and apply during this extension because a call center representative will follow up with them later this week.”

    Read CMS statement on Health Insurance Exchange Open Enrollment Extension.

    Posted 12/16/2019

  • Senate Confirms Dr. Stephen Hahn as U.S. FDA Commissioner

    On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).

    Posted 12/12/2019  

  • Inside Health Policy Reports: CMS to Repay Hospitals for 2019 Site-Neutral Pay Cut

    On Dec. 11, 2019, Inside Health Policy reported that the Centers for Medicare & Medicaid Services (CMS) "plans to repay hospitals that sued over 2019 pay cuts from the agency’s so-called site-neutral policy. The agency has also updated the 2019 pay rates for clinic visits at certain off-campus hospital facilities to remove the cut in light of a federal court decision that said the agency didn’t have the authority to implement it."

    In September 2019, a Federal Washington, D.C., District Court judge found that CMS exceeded its authority in introducing these cuts in the 2019 Hospital Outpatient Prospective Payment System (HOPPS) rule. Several stakeholder organizations filed suit against CMS in response to the final 2019 (HOPPS) rule's provision that established a new reimbursement rate for off-campus hospital outpatient department clinic visits that aligned the payment rate with that under Medicare's Physician Fee Schedule. The 2019 HOPPS rule extended these payment cuts to providers that were specifically exempted from these site-neutrality reimbursement reductions by the Bipartisan Budget Act of 2015.

    Inside Health Policy reports that the "American Hospital Association, Association of American Medical Colleges and others that sued CMS over the cuts say in a Dec. 9 court notice that some hospitals 'recently received payments for claims processed over the past few weeks at the pre-2019 OPPS Rule payment rates for challenged services.' "

    Inside Health Policy further reports that: "the [court] notice says that hospitals haven’t been reimbursed for claims from previous months in 2019 and the government has not 'receded from its stated intention to continue to implement in 2020 the same plan this court already vacated.' "

    CMS told Inside Health Policy that it began paying hospitals the higher reimbursement rate as of Nov. 4, and that Medicare Administrative Contractors will reprocess claims previously subject to the cut during the first few months of 2019.

    ACCC's policy team will provide more information when it becomes available.

    Posted 12/12/2019

  • ASTRO Issues New Clinical Guideline for Radiation Therapy for BCC and cSCC

    On Dec. 10, 2019, the American Society for Radiation Oncology (ASTRO) issued a new clinical guideline on the use of radiation therapy to treat patients diagnosed with basal cell and cutaneous squamous cell carcinomas (BCC, cSCC). The guideline suggests dosing and fractionation for these treatments.

    An executive summary and full-text version of ASTRO's first guideline for skin cancer are published online in Practical Radiation Oncology.

    Read ASTRO press release.

    Posted 12/10/2019

  • NCCN Updates Genetic Testing Guidelines for Assessing Breast, Ovarian, and Pancreatic Cancer Risk

    On Dec. 4, 2019, the National Comprehensive Cancer Network (NCCN) announced publication of updated genetic risk assessment recommendations for breast, ovarian and pancreatic cancers. Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Version 1.2020 include new and expanded sections on risk assessment and management related to these cancer types, but retains a conservative approach toward testing practices where evidence is still lacking. 

    Read NCCN press release.

    Posted 12/6/2019

  • FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC

    On Dec. 3, 2019, the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

    Read the corporate announcement.

    Read FDA announcement.

    Posted 12/04/2019; updated 12/06/2019

  • ACCC Dec. 5 Webinar on CY2020 Medicare Final Payment Rules

    On Thursday, Dec. 5 the Association of Community Cancer Centers (ACCC) will host a members-only webinar on the Centers for Medicare & Medicaid Services (CMS) CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) final rules.

    ACCC's summaries of the CY 2020 OPPS final rule  MPFS final rule are available here [login required].

    CMS CY2020 OPPS & PFS Final Rules: What You Need to Know
    Thursday, December 5, 2019
    2:00 – 3:00 PM EST

    REGISTER HERE. [Login required]

    Posted 11/27/2019

  • FDA Approves Reblozyl for Anemia in Adults with Beta Thalassemia

    On Nov. 8, 2019, the U.S. Food and Drug Administration (FDA) granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

    REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

    Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.

    Read the FDA announcement.

    Posted 11/25/2019