WOONSOCKET, R.I., Aug. 10,
2015 /PRNewswire/ -- In a commentary published online first
today in the Journal of the American Medical Association
(JAMA), CVS Health (NYSE: CVS) Research Institute experts
encouraged the cardiology community to review and reconsider
current treatment guidelines for the management of high
cholesterol. As a new class of high-cost cholesterol lowering
drugs, known as PCSK9 inhibitors, comes to market, current American
College of Cardiology/American Heart Association (ACC/AHA)
guidelines, could complicate treatment choices and inhibit
utilization management tools to manage costs.
"As PCSK9 inhibitors become available, the current cholesterol
management guidelines do not provide clarity as to how these
expensive new medications could fit in the treatment paradigm,
potentially resulting in some scenarios where a prescriber could
consider a PCSK9 inhibitor for a low-risk patient," said Dr.
William H. Shrank MD, MSHS, Chief Scientific Officer at CVS Health.
"There is a need for consensus around management strategies for
patients with high cholesterol given that the cost differential
between proven older therapies and this new class of drugs is
substantial. In fact, if used broadly, PCSK9 inhibitors would
likely be the most costly class of medications we've seen thus
far."
In 2013, ACC/AHA guidelines abandoned the longstanding principle
that physicians should treat patients to a specific cholesterol
target based on their cardiovascular risk and instead recommended
more aggressive management of cholesterol with high-dose,
high-potency medications if a patient was at elevated risk for
cardiovascular disease. The guidelines were established when
statins, a highly effective, low-cost treatment option, were the
primary treatment for high cholesterol and the only treatment with
proven improved outcomes, so budgetary effects of the guidelines on
patients and payors was limited. However, the CVS Health authors
write that there is likely to be substantial enthusiasm about
PCSK9s in the marketplace and caution that the current guidelines
do not provide clarity on how to choose the best evidence-based
therapy to achieve cost-effective clinical outcomes.
"As we work to encourage cost-effective use of these new
cholesterol-lowering medications for our PBM clients, guidelines
that incorporate specific LDL targets would be important to help
determine where PCSK9 inhibitors best fit," added co-author Troyen
A. Brennan, MD, Chief Medical Officer at CVS Health. "Given the
changing market dynamics, we are encouraging an evaluation of
treatment guidelines that will provide clear guidance for
clinicians and will also enable effective utilization management
programs to help control health care costs while achieving desired
health outcomes."
The U.S. Food and Drug Administration (FDA) recently approved
Praluent® (alirocumab), the first PCSK9 inhibitor, for treatment of
high cholesterol in July 2015 and
approval of a second therapy is expected soon. In the U.S., more
than 73 million adults have elevated LDL-C, a major contributor to
cardiovascular disease, a leading cause of death and
disability. Praluent will cost more than $14,000 annually per patient and will most likely
be taken chronically, for the duration of a patient's life,
amplifying strain on the health care system. The FDA advisory
panels, which met earlier in the year, noted the lack of outcomes
data for this new class of medicines and the need for more broad
evaluation to assess potential adverse effects, and large-scale
clinical trials are under way that will provide greater insight
into the long-term clinical outcomes.
The CVS Health Research Institute is focused on contributing to
the body of scientific knowledge related to pharmacy and health
care through research collaborations with external academic
institutions, participation in federally-funded research, analysis
and sharing of CVS Health data sources and coordination of pilot
programs and initiatives. CVS Health Research Institute findings
support a continuous quality improvement environment, which
encourages product innovation and development to benefit CVS Health
patients, clients and their members.
To read the commentary in JAMA, click the following link:
http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2015.10017
About CVS Health
CVS Health (NYSE: CVS) is a pharmacy
innovation company helping people on their path to better health.
Through its 7,800 retail drugstores, nearly 1,000 walk-in medical
clinics, a leading pharmacy benefits manager with more than 70
million plan members, and expanding specialty pharmacy services,
the Company enables people, businesses and communities to manage
health in more affordable, effective ways. This unique integrated
model increases access to quality care, delivers better health
outcomes and lowers overall health care costs. Find more
information about how CVS Health is shaping the future of health at
www.cvshealth.com.
Media
Contacts:
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|
Christine
Cramer
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Christina
Beckerman
|
CVS Health
|
CVS Health
|
(401)
770-3317
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(401)
770-8868
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christine.cramer@cvshealth.com
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christina.beckerman@cvshealth.com
|
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SOURCE CVS Health