FDA Approves Tucatinib in Combination for Advanced HER2-Positive Breast Cancer
On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.
Read FDA announcement.
White House Guidance Suggests Phased-In Approach for Easing COVID-19 Restrictions
On Thursday, April 16, the White House released guidance for a phased-in approach for easing social distancing and stay-at-home restrictions instituted in response to the novel coronavirus-19. In a call with state governors on Thursday, President Trump said that each state can determine its own plan for reopening, and that the White House three-phase plan titled, "Guidelines: Opening Up America Again," was intended to serve as general guidance and was not a mandate.
Some state governors are starting to lay out forward-looking scenarios. However, state governors remain concerned about relaxing stay-at-home restrictions too early, before there is the capacity to clearly identify who is sick and where.
BMS Expands Patient Support Programs for Newly Uninsured Patients in the U.S.
Bristol Myers Squibb (BMS) is expanding its patient support programs to help unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. Patients will be able to immediately access their medicines through one single point of entry and all BMS-branded medicines will be free (see list). The program will be in effect for six months, after which, patients who are currently enrolled may continue on the program until they have insurance.
Read the press release.
FDA Approves Eltrombopag 25-mg Powder for Suspension Package Size
Novartis Pharmaceuticals Corporation has announced that the US Food and Drug Administration approved Promacta® (eltrombopag) 25-mg powder for suspension package size on March 23, 2020.
Read corporate announcement.
COVID-19 Program on Vidscrip Platform
Video Platform for COVID-19 Patient Communications is now available, sponsored by AstraZeneca.
In an effort to support healthcare professionals during this unprecedented time and provide an efficient way, to address the overwhelming influx of calls and emails from patients with questions and concerns about COVID-19, AstraZeneca is sponsoring a healthcare technology company called Vidscrip, through June 30, 2020, or until such time as the COVID-19 virus is no longer a US public health emergency.
This program enables healthcare professionals to use their own computer to record short videos that answer questions to common COVID-19 questions and then share those videos with their patients through their web page, or through direct links to their patient’s phone via a personalized email or text message.
For more information visit www.vidscrip.com/COVID19 or text “COVIDAZUS” to 73771.
Trastuzumab-dttb, Biosimilar of Herceptin, Launches on U.S. Market
On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials, according to the company press release.
Read company announcement.
CMS Issues Guidance on Payer COVID-19 Coverage
On April 11, the Centers for Medicare & Medicaid Services (CMS) released guidance for implementation of the requirement for group health plans and group and individual health insurance to cover both COVID-19 diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
The guidance also ensures that COVID-19 antibody testing will be covered. When a COVID-19 antibody test becomes widely available, it could become a key element in fighting the pandemic.
Access the guidance.
ASCO Launches COVID-19 Registry
The American Society of Clinical Oncology (ASCO) has announced the launch of the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry) to help the cancer community learn about the pattern of symptoms and severity of COVID-19 among patients with cancer. The registry will also aim to gain insight into how COVID-19 infections impact the delivery of cancer care and patient outcomes. The registry will collect both baseline and follow-up data throughout the pandemic and into 2021.
HHS Starts Distribution of $30 Billion in Provider Relief Funds
The bipartisan CARES Act, signed into law March 27, provides for $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response. On April 10, the U.S. Department of Health and Human Services (HHS) announced the immediate start to distribution of $30 billion
in relief funds to providers. HHS states that eligible providers will begin receiving payment via direct deposit starting April 10, 2020.
Full details including who is eligible, how payment distributions are determined, what to do if you are an eligible provider, and more here.
CMS Adds New COVID-19 Workforce Flexibility Waivers
On April 9, the Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules so that hospitals, clinics, and other healthcare facilities can boost their frontline medical staffs during the novel Coronavirus (COVID-19) pandemic.
These changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.
Access CMS fact sheet on detailing Blanket Waivers for Healthcare Providers (includes information on the new waivers and those announced previously).