Nav: Home

Insurance company requirements place heavy administrative burden on physicians seeking to prescribe new cholesterol-lowering drugs

January 16, 2018

PHILADELPHIA -- A rare glimpse into the prior authorization requirements implemented by public and private insurance providers across the country has found substantial administrative burden for a new class of medications for patients with high cholesterol that places them at high risk for heart attack or stroke, according to new research from the Perelman School of Medicine at the University of Pennsylvania. So-called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are self-injected medications approved for individuals with a genetic condition called familial hypercholesterolemia (FH) and those with atherosclerotic cardiovascular disease (ASCVD) who have high cholesterol despite receiving traditional statin medications and other treatments. Results of the study are published today in Circulation: Cardiovascular Quality and Outcomes.

"As innovative yet often expensive new drugs come on the market to treat serious and/or chronic medical conditions, insurers have turned to policies aimed at ensuring appropriate use in order to manage costs," said the study's lead author Jalpa A. Doshi, PhD, a professor of General Internal Medicine. "Prior authorization - which requires a prescriber to demonstrate that a prescription is medically necessary for the patient before it is approved by the insurer - has been used for many years and is a fairly common strategy, but we found that the burden of the requirements for PCSK9 inhibitors were so high that they raise real concerns about access barriers."

The researchers analyzed data from a proprietary database containing information on prior authorization policies covering more than 275 million Americans, or more than 95 percent of those with prescription coverage. The data, which spanned 3,872 plans in the commercial, health insurance exchange, Medicare, and Medicaid segments, showed that between 82 and 97 percent of Americans were enrolled in the plans implementing prior authorization for PCSK9 inhibitors. Many required health care providers to submit actual medical records rather than simply answer questions on a form, which is more common, and to provide documentation on patient histories that may not be available if a patient has switched doctors over time.

"Of particular concern was that patients with FH, where the need for PCSK9 inhibitors is more straightforward, faced the same cumbersome requirements as did patients with ASCVD," said Michael Parmacek, MD, chair of Medicine at the Perelman School of Medicine at the University of Pennsylvania.

In addition, insurance companies often required confirmation of the FH diagnosis through genetic testing, which is not a standard test in clinical practice and typically not covered by insurance. This could place additional financial burden on patients, beyond the substantial out-of-pocket costs many would face when filling a PCSK9 inhibitor prescription.

To place these findings in context, the researchers compared prior authorization criteria for PCSK9 inhibitors to those for two other medications that would be prescribed by the same types of physicians and that shared other key characteristics (such as being more expensive than alternate treatment options). They found that prior authorization requirements for PCSK9 inhibitors were substantially more burdensome than those for the comparator drugs, involving three to 11 times the number of required items to be filled out on the prior authorization form and more frequent demand to justify responses to individual items with medical record submissions.

Prior studies have found very high rejection rates for PCSK9 inhibitor authorization requests, and the new study may shed light on some contributing factors.

"More paperwork means more risk of errors or omissions, and the forms weren't consistent across insurance plans, so it's also juggling multiple sets of requirements and appeals when initial requests are rejected. This places particular burden on physicians in smaller practices without dedicated staff or resources to assist and could take time away from patient care. It raises the question of whether patients seen by physicians with greater administrative capacity, rather than those with the greatest medical need, are more likely to receive approval," Doshi said.

Approved in 2015, data on long-term outcomes and cost-effectiveness for PCSK9 inhibitors is still accumulating.

"It remains to be seen how payers will respond to additional evidence, and whether they will modify the prior authorization requirements," said Daniel Rader, MD, chair of Genetics at the Perelman School of Medicine. "While the concerns over the budget impact of prescribing PCSK9 inhibitors are certainly valid, there ultimately needs to be a balance between appropriate pre-approval requirements and ensuring those most in need have access to treatment."
-end-
Additional Penn authors on this study include Justin Puckett, BA. This study was supported by Regeneron and Sanofi.

Editor's Note: Doshi has served as a consultant for Sanofi.

Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise.

The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 20 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $405 million awarded in the 2017 fiscal year.

The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center -- which are recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report -- Chester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; Penn Wissahickon Hospice; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine, and Princeton House Behavioral Health, a leading provider of highly skilled and compassionate behavioral healthcare.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2017, Penn Medicine provided more than $500 million to benefit our community.

University of Pennsylvania School of Medicine

Related Heart Attack Articles:

Top Science Tip Sheet on heart failure, heart muscle cells, heart attack and atrial fibrillation results
Newly discovered pathway may have potential for treating heart failure - New research model helps predict heart muscle cells' impact on heart function after injury - New mass spectrometry approach generates libraries of glycans in human heart tissue - Understanding heart damage after heart attack and treatment may provide clues for prevention - Understanding atrial fibrillation's effects on heart cells may help find treatments - New research may lead to therapy for heart failure caused by ICI cancer medication
Molecular imaging identifies link between heart and kidney inflammation after heart attack
Whole body positron emission tomography (PET) has, for the first time, illustrated the existence of inter-organ communication between the heart and kidneys via the immune system following acute myocardial infarction.
Muscle protein abundant in the heart plays key role in blood clotting during heart attack
A prevalent heart protein known as cardiac myosin, which is released into the body when a person suffers a heart attack, can cause blood to thicken or clot--worsening damage to heart tissue, a new study shows.
New target identified for repairing the heart after heart attack
An immune cell is shown for the first time to be involved in creating the scar that repairs the heart after damage.
Heart cells respond to heart attack and increase the chance of survival
The heart of humans and mice does not completely recover after a heart attack.
A simple method to improve heart-attack repair using stem cell-derived heart muscle cells
The heart cannot regenerate muscle after a heart attack, and this can lead to lethal heart failure.
Mount Sinai discovers placental stem cells that can regenerate heart after heart attack
Study identifies new stem cell type that can significantly improve cardiac function.
Fixing a broken heart: Exploring new ways to heal damage after a heart attack
The days immediately following a heart attack are critical for survivors' longevity and long-term healing of tissue.
Heart patch could limit muscle damage in heart attack aftermath
Guided by computer simulations, an international team of researchers has developed an adhesive patch that can provide support for damaged heart tissue, potentially reducing the stretching of heart muscle that's common after a heart attack.
How the heart sends an SOS signal to bone marrow cells after a heart attack
Exosomes are key to the SOS signal that the heart muscle sends out after a heart attack.
More Heart Attack News and Heart Attack Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Listen Again: The Power Of Spaces
How do spaces shape the human experience? In what ways do our rooms, homes, and buildings give us meaning and purpose? This hour, TED speakers explore the power of the spaces we make and inhabit. Guests include architect Michael Murphy, musician David Byrne, artist Es Devlin, and architect Siamak Hariri.
Now Playing: Science for the People

#576 Science Communication in Creative Places
When you think of science communication, you might think of TED talks or museum talks or video talks, or... people giving lectures. It's a lot of people talking. But there's more to sci comm than that. This week host Bethany Brookshire talks to three people who have looked at science communication in places you might not expect it. We'll speak with Mauna Dasari, a graduate student at Notre Dame, about making mammals into a March Madness match. We'll talk with Sarah Garner, director of the Pathologists Assistant Program at Tulane University School of Medicine, who takes pathology instruction out of...
Now Playing: Radiolab

What If?
There's plenty of speculation about what Donald Trump might do in the wake of the election. Would he dispute the results if he loses? Would he simply refuse to leave office, or even try to use the military to maintain control? Last summer, Rosa Brooks got together a team of experts and political operatives from both sides of the aisle to ask a slightly different question. Rather than arguing about whether he'd do those things, they dug into what exactly would happen if he did. Part war game part choose your own adventure, Rosa's Transition Integrity Project doesn't give us any predictions, and it isn't a referendum on Trump. Instead, it's a deeply illuminating stress test on our laws, our institutions, and on the commitment to democracy written into the constitution. This episode was reported by Bethel Habte, with help from Tracie Hunte, and produced by Bethel Habte. Jeremy Bloom provided original music. Support Radiolab by becoming a member today at Radiolab.org/donate.     You can read The Transition Integrity Project's report here.