Industry News

CMS Re-evaluating Accelerated Payment Program; Halting Advance Payment Program
On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately.

CMS states that significant additional funding will continue to be available to hospitals and other healthcare providers through other programs such as the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136) and the Paycheck Protection Program and Health Care Enhancement Act (PL 116-139) for healthcare providers. The U.S. Department of Health and Human Services (HHS) is distributing these funds through the Provider Relief Fund, and these payments do not need to be repaid.

View CMS' updated fact sheet on the Accelerated Payment Program and Advance Payment Program here.

Posted 4/27/2020

Pfizer Oncology Announces Transition of IBRANCE® (palbociclib) from Capsules to Tablets

Pfizer Oncology is pleased to announce that IBRANCE^® (palbociclib) is transitioning from capsules to tablets. The new film-coated tablets will be dispensed in blister packs, whichh are designed to enable patients to track where they are in their treatment cycle. The tablet formulation is bioequivalent to the capsule formulation.

IBRANCE® is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced, or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or
- fulvestrant in patients with disease progression following endocrine therapy.
Read the trade sheet for the tablet formulation.

Posted 4/24/2020

FDA Approves KOSELUGO™ for Neurofibromatosis-1 with Plexiform Neurofibromas

On April 10, the U.S. Food and Drug Administration (FDA) approved KOSELUGO™(selumetinib) for the treatment of children two years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cannot be completely removed by surgery.

Read corporate announcement.

Read product fact sheet.

Posted 4/23/2020

CMS Launches COVID-19 Workforce Virtual Toolkit
On April 22, the Centers for Medicare & Medicaid Services (CMS) released a new toolkit to help state and local healthcare decision-makers in managing healthcare workforce challenges in response to the COVID-19 emergency. The online toolkit, developed by the Healthcare Resilience Task Force, includes a full suite of available resources to aid in response based on state and local needs.

Access the COVID-19 Workforce Virtual Tookit.

Posted 4/22/2020

FDA Approves Sacituzumab Govitecan-hziy in Previously-Treated Metastatic Triple Negative Breast Cancer
On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy™) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

Read FDA announcement.

Read corporate press release.

Posted 4/22/2020

CMS Issues Guidance for Some Facilities to Re-Start Non-Essential Services
On April 19, the Centers for Medicare & Medicaid Services (CMS) released guidance for facilities in areas with a low, or relatively low and stable incidence of COVID-19, to resume providing non-emergent, non-COVID-19 healthcare services. Many non-essential surgeries and procedures have been curtailed since March 18 when the agency recommended that facilities limit non-essential care to preserve personal protective equipment (PPE) and prepare for potential surge areas.

The CMS guidance references the White House plan for Opening Up America, released on Friday, April 17. The agency's guidance titled, Opening Up America Again, Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I, notes that "if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I."

Access the CMS guidance.

Posted 4/20/2020

FDA Approves Pemigatinib for Certain Unresectable Advanced Cholangiocarcinomas

On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

The FDA also approved the FoundationOne^® CDX (Foundation Medicine, Inc.) as a companion diagnostic for patient selection.

Read FDA announcement.

Posted 4/20/2020

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.

Posted 4/17/2020

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.

Posted 4/17/2020

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.

4/17/2020

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