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FDA Approves
Carfilzomib for SecondLine Multiple Myeloma
The U.S. FDA has approved expanded
use of carfilzomib for the treatment of
multiple myeloma when used in combination with lenalidomide and dexamethasone. The regimen is approved in
patients who have received one to three
prior lines of therapy. The expanded
approval was based on the results of the
phase III ASPIRE trial, published in The
New England Journal of Medicine, which
included 792 patients. Patients treated
with carfilzomib plus lenalidomide and
dexamethasone had longer progressionfree survival, overall survival, and overall
response rates than those treated with
lenalidomide and dexamethasone alone.
The trial also found that the carfilzomib
combination group reported superior
health-related quality of life. Carfilzomib
has been previously approved by the U.S.
FDA as a single agent for treatment of
multiple myeloma in patients who have
received at least two prior therapies,
including bortezomib and an immunomodulatory agent, and in those who have
progressed on or within 60 days of the
last therapy.
family satisfaction
• Inform new payment systems for the
Medicare and Medicaid programs
The program will affect the care of
approximately 150,000 Medicare beneficiaries over the next four years, including
patients with advanced cancers, chronic
obstructive pulmonary disease, congestive heart failure, and HIV/AIDS.
Services under this new model will
begin on January 1, 2016, for the first
phase of participating hospices, with
more than 140 Medicare-certified hospices included in the trial. Services will
be available around the clock every day
of the year, and CMS will pay a per-beneficiary per-month fee ranging from $200
to $400 to participating hospices under
this new model.
Patrick Conway, MD, MSc, the
principal deputy administrator and chief
medical officer at CMS said in a New
York Times article, “If [the program] is
successful, and we think it will be, it is a
strong evidence base to potentially scale
it to the entire Medicare population.”
CMS is also monitoring the cost
of patients in the program compared
with those receiving traditional medical
benefits.
Sources: U.S. Department of Health and Human Services; The New
York Times
Source: U.S. FDA press release
Medicare Testing
New Model that
Combines Hospice
and Treatment
The Centers for Medicare & Medicaid
Services (CMS) launched a new pilot
program, the Medicare Care Choices
Model, to provide a new option for dually eligible Medicare beneficiaries (those
who are also eligible for Medicaid) to receive palliative care services