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Oncology Newsfeed

  • FDA Approves Levoleucovorin for Injection for mCRC, Osteosarcoma

    On October 23, the FDA approved levoleucovorin for injection (Khapzory, Spectrum Pharmaceuticals, Inc.) for three indications:
    • Rescue after high-dose methotrexate therapy in patients with osteosarcoma
    • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
    • The treatment of patients with metastatic colorectal cancer (mCRC) in combination with fluorouracil.
    Read the Spectrum Pharmaceuticals press release here.


  • HHS Secretary Azar Provides Updates to Drug Pricing Blueprint

    Health and Human Services Secretary Alex Azar yesterday outlined updates to HHS’s “four strategies” for addressing prescription drug pricing in remarks delivered during the National Academy of Medicine’s President’s Forum on Affordable Medicines: Access, Innovation, and the Public Interest.

    In his address, Secretary Azar called attention to the proposed rule issued yesterday by the Centers for Medicare & Medicaid Services (CMS) that would require manufacturers to include in their direct-to-consumer TV advertising the list price of drugs paid for by Medicare & Medicaid. While acknowledging a pharmaceutical industry announcement yesterday of an initiative to improve price transparency, Secretary Azar stated that HHS “will not rely on voluntary action to accomplish our goals.” 

    Secretary Azar’s speech centered on HHS’ four areas of drug-pricing focus under the Administration's blueprint for lowering drug prices released last May: negotiation, reducing consumer out-of-pocket costs, improving competition, and creating incentives for lower list prices. In his remarks, Secretary Azar highlighted specific actions the administration has taken to date and outlined possible future steps in each of the four areas.

    The full text of Secretary Azar's address is available here.

    ACCC policy staff will provide a more in-depth look at Secretary Azar's remarks shortly. 

    Posted 11/16/18 


     


  • FDA Approves Talazoparib for gBRCAm HER2- Breast Cancer

    On October 16, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.) for the treatment of patients with deleterious or suspected germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on the use of the FDA-approved companion diagnostic BRACAnalysis CDx (Myriad Genetics, Inc.).

    Read the full FDA press release here.

    Posted 10/16/18


  • CMS Issues Drug Pricing Transparency Proposed Rule

    On Oct. 15, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would revise the Federal Health Insurance Programs for the Aged and Disabled by amending the Medicare Parts A, B, C, and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or “list price”) of that drug or biological product. 

    According to a CMS statement, under the proposed rule, the price required to be posted would be for a typical course of treatment for an acute medication like an antibiotic, or a 30-day supply of medication for a chronic condition that is taken every month. The posting would take the form of a legible textual statement at the end of the ad, the agency said. The HHS Secretary would maintain a public list of drugs that were advertised in violation of this rule. CMS would provide an exception to the requirement to post prices for prescription drugs with list prices of less than $35 per month.

    Read the proposed rule here.

    CMS will accept comments on the proposed rule until Dec. 17, 2018.

    ACCC policy staff is currently analyzing the proposed rule.

    Posted 10/15/18



  • New Clinical Guideline Issued for Early-Stage Prostate Cancer Patients Treated with EBRT

    On Oct. 12, the American Society for Radiation Oncology (ASTRO), American Society of Clinical Oncology (ASCO) and American Urological Association (AUA) issued a new clinical guideline for physicians treating men with early-stage prostate cancer using external beam radiation therapy (EBRT). Experts from the three medical societies developed the new guideline which recommends offering patients hypofractionated radiation therapy as an alternative to longer, conventional courses of radiation. The new guideline reflects evidence showing similar early cancer control and side-effect rates with hypofractionated treatment, compared to longer courses of conventional radiation. ASTRO, ASCO and AUA published the guideline in their respective journals, Practical Radiation OncologyJournal of Clinical Oncology, and The Journal of Urology.

    Posted 11/12/18


  • CMS Acts to Support Georgia in Response to Hurricane Michael

    On Oct. 11, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that the agency has acted to support Georgia in response to Hurricane Michael. The agency is temporarily waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare immediately; and taking steps to ensure dialysis patients obtain critical life-saving services. 

    Key administrative actions CMS is taking in response to the public health emergency declared in Georgia:

    • Waivers for Hospitals, Healthcare Facilities, and Clinicians: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. The CMS Regional Offices will be granting other provider-specific requests for specific types of hospitals and other facilities in Georgia. These waivers work to provide continued access to care for beneficiaries. For more information, visit: www.cms.gov/emergency.
    • Special Enrollment Opportunities for Individuals Impacted by the Hurricane: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries. This gives people impacted by the hurricane the opportunity to gain access to health coverage on the Exchange or change their Medicare health and prescription drug plans immediately if eligible for the special enrollment period. For more information, visit:
    • Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, click here.  
    • Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated and is working with IPRO End Stage Renal Dialysis Network of the South Atlantic (NW 6) to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility; the ESRD NW hotline number; and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The toll-free hotline for NW 6 is 1-800-524-7139 and the KCER hotline is 866-901-3773. Additional information is available on the NW website  or the KCER website
    • Medical equipment and supplies replacements: CMS will temporarily suspend certain requirements necessary for Medicare beneficiaries who have lost or sustained damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.
    • Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in the affected areas of Georgia, but will continue to investigate allegations of immediate threat to patient health and safety.
    • Ensuring Access to Care in Medicare Advantage and Part D.  During a PHE, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

    CMS will continue to work with all geographic areas impacted by Hurricane Michael. Beneficiaries and providers of healthcare services that have been impacted are encouraged to seek help by visiting CMS’ emergency webpage.

    Posted 10/11/18



  • CMS Announces Steps to Support Florida in Response to Hurricane Michael

    On October 10, the Centers for Medicare & Medicaid Services (CMS) announced steps taken by the agency to support Florida in response to Hurricane Michael. The actions include temporarily waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare immediately; and taking steps to ensure dialysis patients obtain critical life-saving services.

    Below are key actions CMS is taking in response to the Public Health Emergency (PHE) declared in Florida:

    • Waivers for Hospitals, Healthcare Facilities, and Clinicians: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will be issuing a number of waivers as necessary, which will be listed on the website below, and the CMS Regional Offices will be granting other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. For more information on the waivers CMS will grant, visit the CMS website.

    • Special Enrollment Opportunities for Individuals Impacted by the Hurricane: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries. This gives people impacted by the hurricane the opportunity to gain access to health coverage on the Exchange or change their Medicare health and prescription drug plans immediately if eligible for the special enrollment period. For more information on these special enrollment periods, visit:

    • Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, visit the Medicaid website.

    • Dialysis Care:  CMS is helping patients obtain access to critical services. The Kidney Community Emergency Response (KCER) program has been activated and is working with Quality Insights Renal Network 7, ESRD NW 7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility; the ESRD NW hotline number; and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. Additional information is available on the NW’s websites (1, 2, and 3) or the KCER website.

    • Medical equipment and supplies replacements: CMS will temporarily suspend certain requirements necessary for Medicare beneficiaries who have lost or sustained damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.

    • Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in the affected areas of Florida, but will continue to investigate allegations of immediate threat to patient health and safety.

    • Ensuring Access to Care in Medicare Advantage and Part D.  During a PHE, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

    CMS will continue to work with all geographic areas impacted by Hurricane Michael. Beneficiaries and providers of healthcare services that have been impacted are encouraged to seek help by visiting CMS’ emergency webpage.




  • NCCN Releases New Guidelines for Neuroendocrine Tumors

    On October 9, the National Comprehensive Cancer Network (NCCN) announced the publication of a new set of Guidelines for Patients focused on neuroendocrine tumors. This cancer type can originate in many different parts of the body, has variable symptoms, and requires individualized and complicated treatment approaches.

    Read the new NCCN Guidelines for Patients here
    .

    Posted 10/10/18


  • FDA Expands Approval of HPV Vaccine to People Aged 27 to 45

    On October 5, the U.S. Food and Drug Administration expanded the approved use of Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant, Merck & Co.) to include individuals aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by nine types of HPV. Gardasil 9 was previously approved for individuals aged 9 through 26 years.

    Read the full FDA press release here.

    Posted 10/8/2018


  • MedPAC Suggests Expansion of DVP to Inpatient Setting

    The Medicare Payment Advisory Committee (MedPAC), in its comments to CMS on the proposed 2019 Hospital Outpatient Prospective Payment System rule, suggests expansion of the proposed Drug Value Program (or, DVP, a revamped version of the agency's Competitive Acquisition Program) as a possible approach for "certain high-priced products regardless of the setting in which they are administered." 
     
    Citing CAR T-cell therapy as an example, the commission's comment letter states:

    "The recent development of CAR-T immunotherapy, which is extraordinarily expensive and can be furnished in inpatient and outpatient hospital settings, has drawn attention to the issue of very high cost drugs across settings. The DVP model, with its management tools such as a formulary and binding arbitration, may be well suited for addressing very high priced drugs across settings."


    Association of Community Cancer Centers (ACCC) comments to the Drug Value Plan proposal included within the 2019 OPPS rule urge that:  

    "Any policy solution to rein in drug costs must preserve patients’ access to – and ability to afford – quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer care providers." 

    Further, ACCC requests that the agency ensure that any model based on Competitive Acquisition Program (CAP) authority is:

    • voluntary for all participants,
    • preserves patient access to treatment and provider flexibility, and
    • promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.
    Read MedPAC comments to the proposed 2019 OPPS rule.

    Read ACCC comments to the proposed 2019 OPPS rule.

    MedPAC is an independent congressional agency established to advise the U.S. Congress on issues affected the Medicare program. 

    Posted 10/5/18