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DOJ Approves the
$69 Billion CVS
Health–Aetna Merger
The U.S. Department of Justice (DOJ)
approved the merger of the pharmacy
and health-care provider CVS Health
with insurer Aetna, paving the way for
the two companies to create one of the
largest health companies in the U.S. The
$69 billion merger’s approval is condi-
tional on Aetna’s sale of its Medicare Part
D prescription drug plan to the insurer
WellCare Health Plans. This provision
“would fully resolve the Department’s
competition concerns,” according to a
news release from the DOJ.
This merger
continues the
trend of health-
care company
consolidations,
which state
regulators and
advocates
worry will
make it difficult
for smaller
companies to
compete.
CVS and Aetna, which had revenues
of $185 billion and $60 billion in 2017,
respectively, said that the new company
will provide an improved experience for
customers. “Care will be coordinated
among the health-care providers, caregiv-
ers and their health-care teams, leveraging
the connectivity CVS will provide,” said
CVS Health CEO Larry J. Merlo.
This merger continues the trend of
health-care company consolidations, fol-
lowing the DOJ’s approval of Cigna’s buy-
out of Express Scripts, another pharmacy
benefit manager, earlier this year. State
regulators and advocates worry that these
mergers, along with other large insurers’
acquisitions of pharmacy operations, will
make it difficult for smaller competitors to
compete in either industry.
In a statement released by George
Slover of advocacy group Consumers
Union, the group reiterated its opposition
42
ASH Clinical News
to the merger. “This type of consolidation
in a market already dominated by a few,
powerful players presents the very real
possibility of reduced competition that
harms consumer choice and quality.”
Sources: Department of Justice news release, October 10, 2018; The New
York Times, October 10, 2018.
FDA Approves
DNA-Based Blood
Compatibility Test
The FDA granted approval to ID CORE
XT, a molecular-based assay that can
be used to determine blood donor and
patient compatibility. ID CORE XT is the
second molecular assay approved for use
in transfusion medicine, and the first to
report genotypes as final results.
Human blood is classified based on
the antigens on the surface of red blood
cells, including the ABO blood group
antigens and non-ABO antigens, which
are more likely to develop in patients who
receive multiple blood transfusions. When
these patients, such as those with sickle
cell disease, receive blood transfusions
with poorly matched non-ABO antigens,
cell destruction and a transfusion reaction
are likely to occur.
Red blood cell antigens have tradition-
ally been identified by testing antisera,
a blood serum containing antibodies.
However, when antisera is scarce or un-
available, performing this type of testing is
difficult, creating the need for alternative
testing methods like DNA analysis.
The agency’s decision was based on
results of a study showing that the test
performed comparably to antisera-based
tests.
“The approval of the ID CORE XT test
can streamline blood compatibility testing
and provides an additional alternative to
testing blood with antisera,” said Peter
Marks, MD, PhD, director of the FDA’s
Center for Biologics Evaluation and Re-
search. “We know that DNA testing holds
great promise – to provide more informa-
tive, accurate and cost-effective methods
that can enhance patient care.”
consumer-directed television ads to dis-
close drugs’ list prices.
HHS Secretary Alex Azar revealed
the proposed rule in a speech before the
National Academy of Medicine (NAM).
Under the rule, companies’ television ads
would have to disclose the price of a 30-
day supply of any drug covered through
Medicare and Medicaid if the cost was
more than $35 per month. By making
consumers more aware of the costs of
medicines, HHS believes that manufactur-
ers will be incentivized to lower prices, a
major goal of the Trump administration.
Members of the health-care com-
munity remain skeptical that includ-
ing prices would alter consumers’ and
health-care providers’ prescribing habits.
Responding to the announcement, the
American Medical Association reiter-
ated its opposition to direct-to-consumer
advertising but noted that “as long as the
practice is allowed, the ads should come
with at least a small dose of transpar-
ency.” (For more about the prevalence of
direct-to-consumer drug advertising and
its affect on drug prices, see our August
2018 article, “Ad Nauseam.”)
The draft rule also encountered resist-
ance from drug manufacturers, which
argue that the requirement could mislead
patients and deter them from seeking
medical care, noting that the list price is
rarely what a consumer pays for a drug.
Hours before Mr. Azar unveiled his
proposal, the trade group Pharmaceutical
Research and Manufacturers of America
announced that drug companies would
voluntarily direct consumers to websites
with pricing and other information. Mr.
Azar, however, dismissed the group’s pro-
posal as ineffective, suggesting that it was
only an attempt to forestall government
regulation.
“Sometimes it takes government to
make the first move, to disrupt a broken
system, and to lay down new rules of the
road,” Mr. Azar told the audience at NAM,
adding that “placing information on a
website is not the same as putting it right
in an ad.”
The rule is expected to be debated
throughout the fall before it is formally
adopted or rejected.
Source: The Washington Post, October 15, 2018.
Source: FDA news release, October 11, 2018.
New Guidelines Call
HHS Considering
for “Seismic Shift” in
Requiring
Palliative-Care
Pharmaceutical Ads to
Delivery
Include Prices
In new guidelines published by the Na-
To provide incentives for pharmaceuti-
cal companies to lower drug prices, the
U.S. Department of Health and Human
Services (HHS) proposed requiring certain
integrate palliative care into the routine
services they provide to people living
with cancer or other serious illnesses. The
guidelines also include tools, resources,
and practice examples to assist with their
implementation.
“Palliative care should be provided
throughout the community wherever
people living with serious illness receive
care, including outpatient clinics, cancer
centers, long-term care facilities, office
practices, homeless shelters, dialysis
units, and at home,” said Martha L.
Twaddle, MD, co-chair of the guidelines
panel. “To reach that goal, the guidelines
promote consistent criteria and encour-
age continuity of palliative care across
settings.”
The guidelines (“Clinical Practice
Guidelines for Quality Palliative Care,
Fourth Edition”) were developed by the
National Consensus Project for Quality
Palliative Care, a coalition of 16 national
organizations with extensive expertise
with palliative care and hospice.
New recommendations appearing in
this edition include:
• providing each person living with
serious illness a comprehensive assess-
ment to determine his or her needs
and priority goals
• assessing the needs of families and
caregivers for support and education
• integrating palliative care principles
and best practices in various settings
• improving coordination of care, espe-
cially as the person living with serious
illness transitions from one place to
another
“We realize it may be overwhelming for
providers to offer palliative care if they
haven’t previously,” said Betty Ferrell,
PhD, MA, co-chair of the guidelines
panel. “That’s why the guidelines provide
extensive real-world practice examples to
illustrate what quality palliative care can
and should look like in the community.”
The guidelines have been endorsed
by more than 80 national organiza-
tions, including the American Heart
Association/American Stroke Associa-
tion, the American Board of Internal
Medicine, and the American Cancer
Society.
Source: National Coalition for Hospice and Palliative Care press release,
October 31, 2018
tional Coalition for Hospice and Palliative
Care, the National Consensus Project for
Quality Palliative Care urges all health-
care providers and organizations to
December 2018