***PRESS RELEASE*** Statement from Cardiovascular Patient Advocates on Troubling ICER Report on PCSK9 Inhibitors

STATEMENT FROM KEITH FERDINAND, MD, CARDIOLOGIST:

“ICER’s report is a disappointment for patients and physicians and other practitioners who have seen expected results with these drugs. For patients suffering with extremely high cholesterol, these medications can reduce the risk of heart attack and stroke. Unfortunately, ICER’s report could jeopardize many patient’s ability to access the life-saving medication they and their physicians and other providers have determined is the best course of care.”

One Step Forward, Two Steps Back for Heart Patients

A money-back deal for cholesterol-lowering PCSK9 inhibitors doesn’t cut costs enough, claims a new analysis from a University of Pittsburgh researcher.  The drug’s manufacturer says the numbers used to calculate her cost figures don’t reflect reality.  But the voice that’s missing from this public debate is the one that arguably has the most to lose – patients, who already struggle to access breakthrough cardiovascular therapies.

Access to PCSK9 Inhibitors

Approved by the FDA to treat patients with genetic high cholesterol and those who have already experienced a cardiac event, PCSK9 inhibitors can lower stubborn “bad” cholesterol for patients who’ve found few results with existing treatments.  But the drugs’ price point has led health plans to establish extensive prior authorization processes to limit costs.  A national IfPA health plan report card found that 43 percent of patients are denied access to the PCSK9 inhibitor their doctor prescribes.  

Read more at Institute for Patient Access. 

***PRESS RELEASE*** Cardiovascular Health Forum to Highlight Access Barriers to Groundbreaking, Cholesterol-Lowering Therapies

Florida health plans reject nearly 50 percent of claims for treatment

WASHINGTON – On Saturday, August 5, the Partnership to Advance Cardiovascular Health will host a health forum, “Advancing Cardiovascular Health & Patient Access to Innovative Therapies.” The lunchtime event in Orlando at the Florida Medical Association’s annual meeting will bring together patient advocates, clinicians, and policymakers to discuss innovations in cardiovascular therapies, high rates of cardiovascular disease in Florida and barriers that patients face in accessing new cholesterol-lowering drugs. Seth Baum, MD, founder of Excel Medical Clinical Trials and president of the American Society for Preventive Cardiology, will lead the forum.

STATEMENT FROM SETH BAUM, MD, BOCA RATON CARDIOLOGIST/LIPIDOLOGIST AND PRESIDENT OF THE AMERICAN SOCIETY FOR PREVENTIVE CARDIOLOGY:

“As a physician, there is nothing more frustrating than working with a patient to make a diagnosis and recommend a course of treatment, only to have that treatment denied by unreasonable outside forces. Trust between a patient and physician is sacrosanct and must be protected. We have new, groundbreaking, highly effective medications that can lower cholesterol and reduce the risk of heart attack and stroke, yet Florida insurers’ rates of rejection for these potentially life-saving medications is alarming. Working together we must find a solution that ensures patients have access to the medicines their physicians prescribe.”

In a February Florida Health Plan Coverage Report Card from the Institute for Patient Access, data shows Florida health plans reject nearly 50 percent of claims for breakthrough cholesterol-lowering medicines known as PCSK9 inhibitors.

PCSK9 inhibitors work by extending the lifespan of a receptor on the liver that clears LDL, or “bad” cholesterol. Patients, some with a genetic condition called familial hypercholesterolemia, or FH, are at increased risk for cardiac events such as heart attack and stroke because of extremely high levels of LDL. Clinical trials data show that PCSK9 inhibitors can lower LDL cholesterol more than statins alone and can also reduce the associated risks of heart attack and stroke.

The Florida Health Plan Coverage Report Card data, collected from August 2015 to July 2016, reflects PCSK9 inhibitor claims for Florida managed care organizations, including commercial plans, Medicare and managed Medicaid.

Key Florida Findings:

·  45% average rejection rate

·  3,784 total rejections

·  1,197 appeals

·  Highest rates of rejection: Federal Employee Benefit Plan (77%), Express Scripts (76%), Cigna Healthcare (63%)

·  Lowest rates of rejection: Aetna US Healthcare (29%), Freedom Health FL (29%), Humana Health Plan (29%)

The least patient-friendly plans were the Federal Employee Benefit Plan, with a rejection rate of 77%, and Express Scripts at 76%. Also denying claims at a far higher rate than the state average were Cigna Healthcare, 63%, and Florida Blue, 61%. Humana Health Plan, Aetna and Freedom Health Florida denied fewer than 30% of claims. 

The Partnership to Advance Cardiovascular Health launched a national change.org petition in June to the National Association of Insurance Commissioners to raise awareness about the alarming rejection rates that qualifying patients face across the country. To date, the petition has garnered nearly 3,000 signatures.

 

Saturday, August 5

Noon – 1:30 p.m.

Loews Sapphire Falls at Universal Orlando

Room: Grand Caribbean 3

6601 Adventure Way

Orlando, FL

 

The event is open to the press. Press interested in attending should RSVP to Susan Hepworth at shepworth@allianceforpatientaccess.org no later than Friday, August 4.

 

Resources

Partnership to Advance Cardiovascular Health                             http://www.advancecardiohealth.org

 

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ICER Report Could Intensify Barriers for Heart Patients

Accessing innovative cardiovascular drugs may soon get harder.

A new publication from the Institute for Clinical and Economic Review, a drug price analysis group, assigns a C+ effectiveness grade to cholesterol-lowering drugs known as PCSK9 inhibitors.  The lukewarm valuation sets the stage for increased health plan barriers, despite the drugs’ effectiveness in reducing heart attack and stroke risk.

PCSK9 inhibitors work by preventing the PCSK9 protein from destroying a receptor on the liver that clears bad cholesterol. The receptor “lives” longer, clearing more LDL cholesterol for the patient.  For some patients who don’t sufficiently respond to traditional statin therapy, the drugs have offered unprecedented improvement.

Read more at Institute for Patient Access

***MEDIA ADVISORY*** Cardiovascular Health Forum to Highlight Access Issues to Groundbreaking, Cholesterol-Lowering Therapies

WASHINGTON – Tomorrow, Friday June 23, the Partnership to Advance Cardiovascular Health, along with Mended Hearts, will host “The Status of Cardiovascular Health in Alabama: A Forum.” The lunchtime event in Birmingham will bring together patient advocates, clinicians, and policymakers to discuss innovations in cardiovascular therapies, high rates of cardiovascular disease in Alabama and barriers that patients face in accessing new cholesterol-lowering drugs. In an Alabama Health Plan Coverage Report Card from the Institute for Patient Access, data shows Alabama health plans reject more than 50 percent of claims for PCSK9 inhibitors. Alabama has the second highest death rate from cardiovascular disease in the country. The event is open to the press.

WHO: Cardiovascular patient advocates, clinicians, policymakers, Alabama Department of Health, Mended Hearts, Legislative staff

WHAT: Cardiovascular health forum to highlight access issues to new cholesterol-lowering therapies

WHERE: The American Heart Association

1449 Medical Park Drive S.

Birmingham, Alabama

WHEN: Friday, June 23

11:00am

RSVP: Press interested in attending should RSVP to Susan Hepworth at shepworth@allianceforpatientaccess.org.

A patient currently struggling to get access to these medications will be available for interviews.

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***PRESS RELEASE*** Cardiovascular Health Advocates to Launch Change.org Petition to National Association of Insurance Commissioners Regarding Access to Cholesterol-Lowering Therapies

Petition launch coincides with cardiovascular health forum in Alabama.

WASHINGTON – On Friday, June 23, the Partnership to Advance Cardiovascular Health (PACH) will launch a petition on Change.org directed at the National Association of Insurance Commissioners in response to the alarming rejection rates that qualifying patients across the country face in accessing new, groundbreaking, cholesterol-lowering medications known as PCSK9 inhibitors. The petition will be promoted at a series of health forums on the status of cardiovascular health in states where there is an enhanced need for access to cholesterol-lowering therapies but health plan barriers remain high. Many health plans around the country are using restrictive plan designs and utilization management tools to force patients onto less effective therapies in spite of physicians’ recommendations and compelling data.

The petition’s initial launch will occur on Friday at the first cardiovascular health forum in Birmingham, Alabama, which will focus on high rates of cardiovascular disease in Alabama and barriers that patients face in accessing cholesterol-lowering drugs. Data from the Institute for Patient Access (IfPA) shows Alabama health plans reject more than 50 percent of claims for PCSK9 inhibitors. The least patient-friendly Alabama plans were the Federal Employee Benefit Plan, with a rejection rate of 87 percent, and Blue Cross Blue Shield Alabama at 60 percent. 

A National Health Plan Coverage Report Card from IfPA highlights the rates at which insurers nationwide deny patients coverage for PCSK9 inhibitors. The report card reveals that health plans reject 43 percent of claims submitted for coverage. The data, collected from July 2015 to July 2016 by a national data supplier, reflects PCSK9 inhibitor claims from all 50 states for managed care organizations, including commercial plans, Medicare and managed Medicaid.

Research shows that PCSK9 inhibitors can reduce the risk of heart, stroke and cardiovascular death by 20 percent, yet many qualifying patients do not have access to the therapies prescribed by their physician.

National Health Plan Coverage Report Card Key Findings:

  • 43% average rejection rate
  • 80,775 claims
  • 34,459 total rejections
  • 12,108 appeals
  • Highest rates of rejection: Federal Employee Benefit Plan (85%), Express Scripts (62%), Anthem (62%), Cigna Healthcare (51%) 
  • Lowest rates of rejection: Health Care Services Corporation HCSC (39%), Humana Health Plan (27%), Rite Aid (27%), Aetna US Healthcare (26%)
  • Highest volume of rejection: United Health Group (5,453 rejections), Humana Health Plan (4,542 rejections), CVS Health (2,990 rejections), Express Scripts (2,515 rejections)

Some states had even higher rejections rates than the national average.

  • Alabama, 53%
  • Mississippi, 53%
  • Georgia, 50%
  • South Carolina, 48%
  • Kentucky, 48%
  • Michigan, 47%
  • Texas, 46%
  • Florida, 45%
  • Ohio, 45%

PCSK9 inhibitors work by extending the lifespan of a receptor on the liver that clears LDL, or “bad” cholesterol. Patients, some with a genetic condition called familial hypercholesterolemia, or FH, are at increased risk for cardiac events such as heart attack and stroke because of extremely high levels of LDL. Clinical trials data show that PCSK9 inhibitors can lower LDL cholesterol more than statins alone and can also reduce the associated risks of heart attack and stroke.

Resources

Partnership to Advance Cardiovascular Health                               http://www.advancecardiohealth.org

 

***PRESS RELEASE*** Cardiovascular Health Forum to Highlight Access Issues to Groundbreaking, Cholesterol-Lowering Therapies; Launch National Petition for Greater Access

Alabama has the second highest death rate from cardiovascular disease in the country yet state health plans reject more than 50 percent of claims for treatment

WASHINGTON – On Friday, June 23, the Partnership to Advance Cardiovascular Health, along with Mended Hearts, will host “The Status of Cardiovascular Health in Alabama: A Forum.” The lunchtime event in Birmingham will bring together patient advocates, clinicians and policymakers to discuss innovations in cardiovascular therapies, high rates of cardiovascular disease in Alabama and barriers that patients face in accessing new cholesterol-lowering drugs. In an Alabama Health Plan Coverage Report Card from the Institute for Patient Access, data shows Alabama health plans reject more than 50 percent of claims for PCSK9 inhibitors.

The Alabama Department of Health, along with Mended Hearts, the largest patient-to-patient heart health advocacy organization in the country, and Birmingham cardiologists will participate in the forum.

PCSK9 inhibitors work by extending the lifespan of a receptor on the liver that clears LDL, or “bad” cholesterol. Patients, some with a genetic condition called familial hypercholesterolemia, or FH, are at increased risk for cardiac events such as heart attack and stroke because of extremely high levels of LDL. Clinical trials data show that PCSK9 inhibitors can lower LDL cholesterol more than statins alone and can also reduce the associated risks of heart attack and stroke.

The Alabama Health Plan Coverage Report Card data, collected from August 2015 to July 2016 by a national data supplier, reflects PCSK9 inhibitor claims for Alabama managed care organizations, including commercial plans, Medicare and managed Medicaid.

Key Alabama Findings:

  • 53% average rejection rate
  • 976 total rejections
  • 238 appeals
  • Highest rates of rejection: Federal Employee Benefit Plan (87%), BCBS AL (60%), Express Scripts (59%), Cigna Healthcare (59%)
  • Lowest rates of rejection: CVS Health (51%), Tricare Military Health SVC SYS (47%), United Health Group (46%), Humana Health Plan (28%)

The least patient-friendly plans were the Federal Employee Benefit Plan, with a rejection rate of 87%, and BCBS AL at 60%. Also denying claims at a higher rate than the state average were Express Scripts, 59%, and Cigna Healthcare, 59%. Humana Health Plan had the lowest rejection rate, though it still denied almost a third of claims.

In conjunction with the forum, the Partnership to Advance Cardiovascular Health this week will launch a national change.orgpetition to the National Association of Insurance Commissioners to raise awareness about the alarming rejection rates that qualifying patients face in Alabama and across the country.

Friday, June 23

11:00am

The American Heart Association

1449 Medical Park Drive S.

Birmingham, AL

The event is open to the press. Press interested in attending should RSVP to Susan Hepworth at shepworth@allianceforpatientaccess.org no later than Thursday, June 22.

Resources

Partnership to Advance Cardiovascular Health                         http://www.advancecardiohealth.org

 

RELEASE: New PACH Video Highlights Patient Stories of PCSK9 Inhibitor Barriers

***VIDEO RELEASE***

New Video “PCSK9 Inhibitors: Access Barriers Affect Real People” Highlights Barriers to New, Breakthrough Cholesterol-Lowering Drugs

 WASHINGTON – Today the Partnership to Advance Cardiovascular Health released a new web video, “PCSK9 Inhibitors: Access Barriers Affect Real People.” The video, featuring patient testimonials, explores access issues to new, breakthrough cholesterol-lowering drugs known as PCSK9 inhibitors. 

 

 

CLICK HERE TO WATCH THE VIDEO

These patients, some with a genetic condition called Familial Hypercholesterolemia, or FH, are at increased risk for cardiac events such as heart attack and stroke because of extremely high levels of LDL or “bad” cholesterol. While new clinical trials data have definitively linked the drugs to improved outcomes such as lowered stroke and heart attack risk, health plan barriers exist. Data released by the Institute for Patient Access in a series of Health Plan Coverage Report Cards show that health plans in many states are denying a majority of PCSK9 claims, sometimes at rates as high as 90 percent. 

 

The video, filmed at a town hall hosted by the American Society for Preventive Cardiology (ASPC) in Washington, D.C., highlights not only patient testimonials, but also the concerted effort by health care providers to overcome these remarkable denial rates. At the town hall, ASPC announced uniform prior authorization and appeal forms to help make the process easier for patients and physicians to get PCSK9 coverage. 

PCSK9 inhibitors work by extending the lifespan of a receptor on the liver that clears LDL, or “bad” cholesterol. Clinical trials data show that PCSK9 inhibitors can lower LDL cholesterol more than statins alone and can also reduce the associated risks of heart attack and stroke.

 

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Alabama Health Plans deny treatment for high cholesterol

The Institute for Patient Access released a new Health Plan Coverage Report Card claiming that Alabama insurers deny patients coverage for advanced cholesterol-lowering drugs known as PCSK9 inhibitors 53 percent of the time. The report card reveals that health plans reject more than one out of every two claims submitted for coverage of prescribed PCSK9 inhibitors. The data, collected from August 2015 to July 2016 by a national data supplier, reflects PCSK9 inhibitor claims for Alabama managed care organizations, including commercial plans, Medicare and managed Medicaid.

Read more at the Alabama Political Reporter

Cholesterol-Slashing Drug Can Protect High-Risk Heart Patients, Study Finds

The first rigorous test of an expensive new drug that radically lowers cholesterol levels found that it significantly reduced the chance that a high-risk patient would have a heart attack or stroke. These were men and women who had exhausted all other options.

The results of the study, which cost about $1 billion and was paid for by Amgen, maker of the drug, were published on Friday in The New England Journal of Medicine and presented at the annual meeting of the American College of Cardiology.

Read more at The New York Times. 

***PRESS RELEASE*** Texas Health Plans Reject Nearly Half of Claims for High Cholesterol Treatment

New health plan report card analyzes PCSK9 inhibitor claims for managed care organizations

 WASHINGTON – The Institute for Patient Access released a new Health Plan Coverage Report Card highlighting the rates at which Texas insurers deny patients coverage for advanced cholesterol-lowering drugs known as PCSK9 inhibitors. The report card reveals that health plans reject nearly one out of every two claims submitted for coverage of prescribed PCSK9 inhibitors. The data, collected from July 2015 to July 2016 by a national data supplier, reflects PCSK9 inhibitor claims for Texas managed care organizations, including commercial plans, Medicare and managed Medicaid.

Key Texas Findings:

  • 46% average rejection rate
  • 2,877 total rejections
  • 745 appeals
  • Highest rates of rejection: Federal Employee Benefit Plan (91%), Express Scripts (73%), Teacher Retirement System of Texas TRS (64%)
  • Lowest rates of rejection: Humana Health Plan (31%), Tricare Military Health SVC SYS (31%), Aetna US Healthcare (28%)

 

“This is a very troubling and frankly dangerous finding,” said Alliance for Patient Access Executive Director Brian Kennedy. “The patients prescribed this medicine have extremely high LDL cholesterol, and statins alone are not sufficient to reduce their risk of heart attack. With these new cholesterol-lowering drugs, patients’ risk of heart attack decreases, yet insurance companies are too often refusing to cover the medicine.”

PCSK9 inhibitors work by extending the lifespan of a receptor on the liver that clears “bad” cholesterol.  Clinical trials data show that PCSK9 inhibitors can lower LDL cholesterol more than statins alone and can also reduce the associated risks of heart attack and stroke.

The Institute for Patient Access report card highlights the 13 Texas health plans that process the most PCSK9 inhibitor claims, ranking them based on the number of rejections issued. The least patient-friendly plans were the Federal Employee Benefit Plan, with a rejection rate of 91%, and Express Scripts at 73%. Also denying claims at a far higher rate than the state average were Teacher Retirement System of Texas TRS, 64%, and Wellcare Management Group, 61%. Humana Health Plan, Tricare Military Health SVC SYS and Aetna had the lowest rejection rates, though they still denied roughly 30% of claims.

This report card is one in a series to be released by the Institute for Patient Access in 2017 to highlight barriers to patient access.

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BACKGROUND

Institute for Patient Access

PCSK9 Inhibitors Texas Report Card

Alliance for Patient Access

New Collaboration Improves Access to Treatment for Familial Hypercholesteremia (FH) Patients Most at Risk for Early Heart Attacks and Death

PASADENA, Calif., March 15, 2017 /PRNewswire-USNewswire/ -- The FH Foundation, a patient-centered non-profit dedicated to research, advocacy, and education of all forms of familial hypercholesterolemia (FH), today announced its collaboration with Express Scripts, a leading pharmacy benefit manager, to improve pharmacy coverage for patients with FH, an inherited genetic disorder that causes high LDL-cholesterol from birth. With a more comprehensive set of diagnostic criteria, a broader group of patients will have access to cutting-edge PCSK9 inhibitor treatment, as appropriate.

Read more at PRNewswire. 

Dr. Keith Ferdinand: Together, We Can Save Hearts

Good health is the cornerstone of progress, and since 1974, the Association of Black Cardiologists (ABC) has been dedicated to lowering the high rate of cardiovascular disease, including stroke, especially in minority populations.  As an ABC member and Chairman of the ABC Access to Healthcare Working Group, I have spent my career pursuing a central goal of ABC—to eliminate the disparities related to cardiovascular disease in all people regardless of race, ethnicity, gender, geography, or socioeconomic status.

Read more at The New Orleans Tribune. 

Report: Florida HMOs slammed for denying cholesterol drugs

Florida health plans on average reject 45 percent of the claims claims submitted for coverage of prescribed advanced cholesterol lowering drugs, according to the advocacy group known as Institute for Patient Access.

The institute released a report card highlighting the rates at which Florida insurers deny patients coverage for the medications, known as PCSK9 inhibitors.

More at Politico. 

***PRESS RELEASE*** Florida Health Plans Reject Nearly Half of Claims for High Cholesterol Treatment

New health plan report card analyzes PCSK9 inhibitor claims for managed care organizations.

WASHINGTON – The Institute for Patient Access today released a new Health Plan Coverage Report Card highlighting the rates at which Florida insurers deny patients coverage for advanced cholesterol-lowering drugs known as PCSK9 inhibitors. The report card reveals that health plans reject nearly one out of every two claims submitted for coverage of prescribed PCSK9 inhibitors. The data, collected from August 2015 to July 2016 by a national data supplier, reflects PCSK9 inhibitor claims for Florida managed care organizations, including commercial plans, Medicare and managed Medicaid.

Key Florida Findings:

  • 45% average rejection rate
  • 3,784 total rejections
  • 1,197 appeals
  • Highest rates of rejection: Federal Employee Benefit Plan (77%), Express Scripts (76%), Cigna Healthcare (63%)
  • Lowest rates of rejection: Aetna US Healthcare (29%), Freedom Health FL (29%), Humana Health Plan (29%)

 

“This is a very troubling and frankly dangerous finding,” said Alliance for Patient Access Executive Director Brian Kennedy. “The patients prescribed this medicine have extremely high LDL cholesterol, and statins alone are not sufficient to reduce their risk of heart attack. With these new cholesterol-lowering drugs, patients’ risk of heart attack decreases, yet insurance companies are too often refusing to cover the medicine.”

PCSK9 inhibitors work by extending the lifespan of a receptor on the liver that clears “bad” cholesterol.  Clinical trials data show that PCSK9 inhibitors can lower LDL cholesterol more than statins alone and can also reduce the associated risks of heart attack and stroke.

The Institute for Patient Access report card highlights the 15 Florida health plans that process the most PCSK9 inhibitor claims, ranking them based on the number of rejections issued. The least patient-friendly plans were the Federal Employee Benefit Plan, with a rejection rate of 77%, and Express Scripts at 76%. Also denying claims at a far higher rate than the state average were Cigna Healthcare, 63%, and Florida Blue, 61%. Humana Health Plan, Aetna and Freedom Health Florida denied fewer than 30% of claims.

This is the first in a series of state report cards that the Institute for Patient Access will release in 2017 to highlight barriers to access.

“Accessing Cholesterol Treatments” is No Simple Task, Explains New Video

On the heels of recent research confirming breakthrough drugs’ impact on patients with high cholesterol, the Partnership to Advance Cardiovascular Health has released a quick-draw videoexploring obstacles for patient access.

In “Accessing Cholesterol Treatments,” narrator and cardiologist Seth Baum, MD, describes a hypothetical patient with a family history of extremely high cholesterol. “He’s not the typical cholesterol patients,” Dr. Baum explains, “And the typical medications, known as ‘statins,’ don’t lower his cholesterol enough.”

More at Institute for Patient Access

Will New Evidence on PCSK9 Inhibitors Improve Patient Access?

For patients with extremely high cholesterol, the promise of new PCSK9 inhibitors just keeps growing. Data presented at this month’s American Heart Association meeting confirms that the breakthrough drugs lower LDL cholesterol – as anticipated. But it also reveals that the treatments can reduce the buildup of heart attack-causing plaque on the walls of coronary arteries.

Now the study’s results beg the question: Will new evidence of PCSK9 inhibitors’ impact lead to improved health plan coverage?

More at Institute for Patient Access

Cholesterol Drug Shows Promise to Help Reverse Heart Disease

For the first time, a new drug given along with a cholesterol-lowering statin medicine has proved able to shrink plaque that is clogging arteries, potentially giving a way to undo some of the damage of heart disease.

The difference was very small but doctors hope it will grow with longer treatment, and any reversal or stabilization of disease would be a win for patients and a long-sought goal.

More at US News & World Report

The PCSK9 Inhibitor Conundrum

Medicine is at a crossroads; cardiology in particular. I saw this fact magnified at the American Society for Preventive Cardiology’s recent town hallon access barriers to PCSK9 inhibitors. The event was entitled, “Unraveling a Therapeutic Conundrum,” and the conundrum is this: Will we embrace the potential that these innovative drugs hold for patients, or will we use them as a scapegoat for soaring health care costs?

A guest blog by Seth Baum, MD, at Institute for Patient Access