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Global Healthy Living Foundation Celebrates New FOURIER trial …

Healthy Living Foundation (GHLF)
, a non-profit organization whose
mission is to improve the quality of life for people with chronic
illness, strongly advocates that patients and physicians, together, be
the primary drivers of health care decisions, particularly as it relates
to medication prescribing. GHLF is hopeful that positive outcomes study
results for evolocumab, a PCSK9 inhibitor for the lowering of LDL
cholesterol will help in justifying expanded access to this innovative
form of treatment. The FOURIER Outcomes Study, presented today at the
American College of Cardiology (ACC) 66th Annual Scientific
Session found that evolocumab reduces the risk of cardiovascular events,
including death, non-fatal myocardial infarction, non-fatal stroke and
hospitalization for unstable angina or coronary revascularization.

GHLF believes the FOURIER trial provides additional evidence that this
medicine, one of two available PCSK9 inhibitors, is an important
treatment option for appropriate patients who have not responded to
maximally tolerated statin therapy. Unfortunately, despite earlier
efficacy and safety studies leading to the FDA approval of PCSK9
inhibitors, many patients cannot obtain their prescriptions due to
insurance company denials. For example, recent data from The Institute
for Patient Access finds that in Florida health plans reject 45 percent
of patients submitted for coverage of prescribed PCSK9 inhibitors.

“No one can appreciate a patient’s medical condition better than his/her
physician. The PCSK9 inhibitors are approved for two very
specific indications, patients with familial hypercholesterolemia (FH)
or patients with clinically evident atherosclerotic cardiovascular
disease (ASCVD) who have had an inadequate response to maximally
tolerated statin therapy,” said Dr. Seth J. Baum, MD, FACC, FACPM, FAHA,
FNLA, FASPC, Preventive Cardiology, Inc. and President of the American
Society for Preventive Cardiology (ASPC). “It’s incredibly frustrating
and potentially risky for patients to be denied access to PCSK9
inhibitors, which I think are the greatest advance in lipid modifying
therapy in three decades.”

Barriers to Treatment Common
Biologic drugs, the PCSK9
inhibitors are monoclonal antibodies (MABs) that inactivate the protein,
PCSK9. They work by targeting and inactivating PCSK9 that has been
released by the liver into the blood.i By inactivating PCSK9
via inhibition, more LDL receptors are available to capture LDL
cholesterol for removal from the blood. Despite proven efficacy and
safety, insurance companies often require prior authorization and step
therapy (“fail first”) prescribing in order to first demonstrate that a
patient will not succeed on a much less expensive statin (or several
statins) before approving access to a PCSK9 inhibitor.

“My father and my brother died because of complications related to
familial hypercholesterolemia and I’ve spent my entire life trying to
lower my cholesterol,” said Craig Davis, a decorated airman and retired
Chief Information Officer who now advocates for chronic disease patients
on behalf of the Global Healthy Living Foundation. “After my second
quadruple bypass, it was exciting when PCSK9 inhibitors became
available, but also very stressful because I spent months fighting my
insurance company to approve my claim. I even risked my health by going
off an exorbitantly expensive orphan drug to prove that my cholesterol
was in dire need of treatment. Insurance company ‘fail first’ policies
disregard the well-being of patients.”

According to a recent analysis of a commercial insurance plan with 13.1
million members, the average rate of approved PCSK9 inhibitor
prescriptions was a measly 1.2 per 100,000.ii Notably, the
predicted rate was 112 per 100,000, but number fell far short due to
their profitable utilization management practices. Another study
documented a nearly 90 percent (88.4%) denial rate for PCSK9 inhibitor

“Despite providing comprehensive records, we find that health insurance
companies routinely deny claims for appropriately selected high-risk
patients as their first response. Efforts to appeal that decision
require hours of additional time and multiple administrative hurdles
that effectively restrict access to these medications,” said William
Cromwell, MD, Chief of the Lipoprotein and Metabolic
Disorders Institute, Discipline Director for Cardiovascular Disease at
Laboratory Corporation of America (LabCorp), and Adjunct Associate
Professor at Wake Forest University School of Medicine, USA. “PCSK9
inhibitors are indicated for high-risk patients with an inadequate
response to statins. By blocking access to this potentially life-saving
medication, payors are inappropriately placing my patients at risk.”

Call to Action
If repeatedly denied access, patients
should contact their state’s insurance commissioner
to ask for
assistance. Patient advocacy groups, like the Global
Healthy Living Foundation
and its related 50
State Network
, a grassroots advocacy organization comprised of
chronic disease patients who proactively connect with state and federal
health policy stakeholders to share their perspective and influence
change, can help patients understand their rights and seek help in
gaining access to medications.

“PCSK9 inhibitors are proven to be effective in some of our most
difficult casesiv,” stated Seth Ginsberg, Co-Founder and
President of Global Healthy Living Foundation. “While they are more
expensive than traditional statin treatment, long term PCSK9 Inhibitor
therapy, as demonstrated by the FOURIER study, should reduce healthcare
utilization costs by reducing the incidence of serious cardiovascular

About Global Healthy Living Foundation
The Global
Healthy Living Foundation
is a 501(c)(3) non-profit organization
whose mission is to improve the quality of life for people living with
chronic illnesses, such as arthritis, osteoporosis, migraine, diabetes,
psoriasis, cardiovascular disease and chronic pain, by advocating for
improved access to care at the community, state, and federal levels, and
amplifying education and awareness efforts within its social media
framework. GHLF is also a staunch advocate for vaccines. The Global
Healthy Living Foundation is the parent organization of CreakyJoints,
the go-to source for more than 100,000 arthritis patients and their
families world-wide who are seeking education, support, advocacy and
patient-centered research and ArthritisPower,
the first ever patient-led, patient-centered research registry for
arthritis, bone, and inflammatory skin conditions.

Prime Therapeutics. April 2016
iii Symphony Health
Solutions. “PCSK9 Inhibitors: Payer Dynamics”

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