Global Healthy Living Foundation Celebrates New FOURIER trial results presented at American College of Cardiology (ACC) 66th Annual Scientific Session

Enthusiasm Tempered by Barriers Patients Face Accessing Evolocumab As Health Insurers Repeatedly Deny Prescription Claims

UPPER NYACK, N.Y.--()--The Global 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 prescriptions.iii

“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 events.”

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.

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


Global Healthy Living Foundation
Jessica Daitch, 917-816-6712

Release Summary

Global Healthy Living Foundation (GHLF) hopes the FOURIER results presented at the ACC 66th Annual Scientific Session will justify expanded access by insurance to this innovative form of treatment.


Global Healthy Living Foundation
Jessica Daitch, 917-816-6712