{"id":14748,"date":"2019-09-05T06:00:59","date_gmt":"2019-09-05T11:00:59","guid":{"rendered":"http:\/\/www.paristn.net\/articles\/?p=14748"},"modified":"2019-09-05T00:52:31","modified_gmt":"2019-09-05T05:52:31","slug":"rejected-unfilled-prescriptions-for-new-more-expensive-cholesterol-drugs-tied-to-higher-heart-stroke-risk","status":"publish","type":"post","link":"https:\/\/www.paristn.net\/articles\/2019\/09\/05\/rejected-unfilled-prescriptions-for-new-more-expensive-cholesterol-drugs-tied-to-higher-heart-stroke-risk\/","title":{"rendered":"Rejected, Unfilled Prescriptions for new, more expensive Cholesterol Drugs tied to higher Heart, Stroke Risk"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-56563\" title=\"American Heart Association\" src=\"https:\/\/www.clarksvilleonline.com\/wp-content\/uploads\/2010\/12\/American-Heart-Association-new-logo-480x230.jpg\" alt=\"American Heart Association\" width=\"240\" height=\"115\"><strong>Dallas, TX<\/strong> &#8211; Patients appear to be at higher risk of heart problems or stroke when prescriptions for the newest cholesterol-lowering drugs are rejected by insurance companies or unfilled by patients, according to new research in <i>Circulation:<\/i> <i>Cardiovascular Quality and Outcomes<\/i>, an<i> <\/i>American Heart Association journal.<\/p>\n<p>The drugs, PCSK9 inhibitors (PCSK9i), can substantially lower levels of&nbsp;<a href=\"https:\/\/www.heart.org\/en\/health-topics\/cholesterol\/hdl-good-ldl-bad-cholesterol-and-triglycerides\" title=\"https:\/\/www.heart.org\/en\/health-topics\/cholesterol\/hdl-good-ldl-bad-cholesterol-and-triglycerides\"  target=\"_blank\" rel=\"noopener noreferrer\">low-density lipoprotein (LDL, the \u201cbad\u201d cholesterol)<\/a>&nbsp;in the blood.<\/p>\n<div id=\"attachment_462681\" style=\"width: 490px\" class=\"wp-caption aligncenter\"><a target=\"_blank\" href=\"https:\/\/www.clarksvilleonline.com\/wp-content\/uploads\/2019\/09\/Prescription-Drug-Bottles-Closeup.jpg\"  class=\"thickbox no_icon\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-462681\" class=\"wp-image-462681 size-medium\" title=\"Prescriptions for the newest \u2013 but more expensive - cholesterol-lowering drugs called PCSK9 inhibitors that are not covered by insurance companies or unfilled by patients are related to higher risk of cardiovascular problems for high risk patients. (American Heart Association)\" src=\"https:\/\/www.clarksvilleonline.com\/wp-content\/uploads\/2019\/09\/Prescription-Drug-Bottles-Closeup-480x320.jpg\" alt=\"Prescriptions for the newest \u2013 but more expensive - cholesterol-lowering drugs called PCSK9 inhibitors that are not covered by insurance companies or unfilled by patients are related to higher risk of cardiovascular problems for high risk patients. (American Heart Association)\" width=\"480\" height=\"320\"><\/a><p id=\"caption-attachment-462681\" class=\"wp-caption-text\">Prescriptions for the newest \u2013 but more expensive &#8211; cholesterol-lowering drugs called PCSK9 inhibitors that are not covered by insurance companies or unfilled by patients are related to higher risk of cardiovascular problems for high risk patients. (American Heart Association)<\/p><\/div>\n<p><!--more--><\/p>\n<p>But they are also more expensive than other prescription treatments \u2013 costing about $14,000 a year at the time this study was conducted in 2015 &#8211; 2017.<\/p>\n<p>Last fall, the American Heart Association <a href=\"https:\/\/newsroom.heart.org\/news\/the-american-heart-association-applauds-corporate-commitment-to-expanding-access-to-lifesaving-medicine-6725823\" title=\"https:\/\/newsroom.heart.org\/news\/the-american-heart-association-applauds-corporate-commitment-to-expanding-access-to-lifesaving-medicine-6725823\"  target=\"_blank\" rel=\"noopener noreferrer\">encouraged drug companies to lower prices to improve patient access<\/a>.<\/p>\n<p>The study reviewed the medical records and pharmacy claims of about 139,000 high risk adults over a 29-month period after the drugs were first made available in 2015. On average patients\u2019 outcomes were tracked for 11.5 months from the prescription date.<\/p>\n<h3>Researchers found:<\/h3>\n<ul>\n<li>Insurers rejected about two-thirds of prescriptions for those at highest risk.<\/li>\n<li>Patients were 16% more likely to have a cardiovascular event (such as <a href=\"https:\/\/www.heart.org\/en\/health-topics\/heart-attack\/about-heart-attacks\" title=\"https:\/\/www.heart.org\/en\/health-topics\/heart-attack\/about-heart-attacks\"  target=\"_blank\" rel=\"noopener noreferrer\">heart attacks<\/a>, unstable angina, angioplasty, coronary bypass surgery, <a href=\"https:\/\/www.heart.org\/en\/health-topics\/cardiac-arrest\/about-cardiac-arrest\" title=\"https:\/\/www.heart.org\/en\/health-topics\/cardiac-arrest\/about-cardiac-arrest\"  target=\"_blank\" rel=\"noopener noreferrer\">cardiac arrest<\/a>, and heart disease or <a href=\"https:\/\/www.strokeassociation.org\/en\/about-stroke\" title=\"https:\/\/www.strokeassociation.org\/en\/about-stroke\"  target=\"_blank\" rel=\"noopener noreferrer\">stroke<\/a> attributed to clogged arteries) if their prescription was rejected than if it was covered and filled for almost a year of treatment.<\/li>\n<li>Patients were 21% more likely to have a cardiovascular event if they had a prescription approved but did not fill it.<\/li>\n<\/ul>\n<p>\u201cOur study shows that when high-risk groups of individuals with familial hypercholesterolemia or already established atherosclerotic disease are rejected for prescribed PCSK9i therapies it can have consequences,\u201d said lead author Kelly D. Myers, B.S., chief technology officer for <a href=\"http:\/\/www.thefhfoundation.org\/\" title=\"http:\/\/www.thefhfoundation.org\/\"  target=\"_blank\" rel=\"noopener noreferrer\">The FH Foundation<\/a>, a leading research and advocacy non-profit organization focused on reducing heart disease by driving scientific understanding and evidence-based care of familial hypercholesterolemia (FH).<\/p>\n<p>\u201cWe have both treatment guidelines and available medications to help reduce cholesterol and associated cardiovascular events in the most vulnerable high-risk patients, and yet barriers in the healthcare system \u2013 such as higher treatment costs, tight restrictions on approvals, Medicare rules against co-payment assistance, and lack of coverage \u2013 are delaying treatment.\u201d<\/p>\n<p>[320left]PCSK9i drugs are typically given as injections once or twice a month, often with other cholesterol-lowering drugs including statins. The newer medication is approved to treat two groups of high-risk patients: &nbsp;those with an inherited condition defined by a defect in how the body processes LDL called <a href=\"https:\/\/www.heart.org\/en\/health-topics\/cholesterol\/causes-of-high-cholesterol\/familial-hypercholesterolemia-fh\" title=\"https:\/\/www.heart.org\/en\/health-topics\/cholesterol\/causes-of-high-cholesterol\/familial-hypercholesterolemia-fh\"  target=\"_blank\" rel=\"noopener noreferrer\">familial hypercholesterolemia<\/a> (FH) &nbsp;and those with arterial plaque buildup who have high LDL despite other treatments.<\/p>\n<p>Donald Lloyd-Jones, M.D., a member of the writing committee for the American Heart Association\u2019s 2018 cholesterol guidelines, noted&nbsp; this study reviewed data from 2015-2017, prior to several positive steps that have been taken to make this medication more relevant, available and affordable for the people who can best benefit from it.<\/p>\n<p>\u201cFollowing a thorough review of the science, the American Heart Association guidelines now support the use of PCSK9 inhibitors for certain populations &#8211; after use of statins and ezetimibe &#8211; and we encourage clinicians and payors to take this into consideration in determining prescription approvals,\u201d said Lloyd-Jones, chair of the Department of Preventive Medicine at Northwestern University.<\/p>\n<p>&#8220;Additionally, the Association has taken bold action in working directly with pharmaceutical companies to address the considerable costs that can hinder access to life-saving medications. So, we hope to see this trend turning and for future data to show that people have access to the medications they need and are using them to their greatest benefit,\u201d Lloyd-Jones stated.<\/p>\n<h3>Among other findings in the study:<\/h3>\n<ul>\n<li><a name=\"_Hlk14238899\"><\/a>Prescriptions written for women were more likely to be rejected than those for men.<\/li>\n<li>Rejections were more common among both blacks and Hispanics than whites.<\/li>\n<li>15% of prescriptions were abandoned by patients, a rate that researchers suspect was driven by high co-payments. The average copayment for abandoned prescriptions was $233.30 \u2013 more than $100 higher than for prescriptions that were covered.<\/li>\n<li>About two-thirds of abandoned prescriptions were among Medicare patients.<\/li>\n<\/ul>\n<p><a name=\"_Hlk487448505\"><\/a>The authors noted that the use of a large data set and length of time studied are key strengths of the research. But the data did not capture why claims were rejected, individuals\u2019 LDL levels, drug samples patients were given, patient deaths, and missed diagnoses of cardiovascular disease. They also noted potential biases of the study team \u2013 employees and advisers for the FH Foundation \u2013 adding that their research questions were rooted in patients\u2019 health concerns and experiences with prescription claim denials.&nbsp;<\/p>\n<p>Co-authors are Niloofar Farboodi, M.Sc., M.P.H.; Mkaya Mwamburi, M.D., Ph.D., M.A.; William Howard, Ph.D.; David Staszak, Ph.D.; Samuel Gidding, M.D.; Seth J. Baum, M.D.; and Daniel J. Rader, M.D. and Katherine Wilemon, B.S., CEO and founder of The FH Foundation. Author disclosures are on the manuscript.<\/p>\n<p>The <a href=\"http:\/\/www.thefhfoundation.org\/\" title=\"http:\/\/www.thefhfoundation.org\/\"  target=\"_blank\" rel=\"noopener noreferrer\">FH Foundation<\/a> funded the study.<\/p>\n<p><b>Additional Resources:<\/b><\/p>\n<ul>\n<li>View the <a href=\"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCOUTCOMES.118.005404\" title=\"http:\/\/\"  target=\"_blank\" rel=\"noopener noreferrer\">manuscript<\/a> and <a href=\"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCOUTCOMES.119.005910\" title=\"http:\/\/\"  target=\"_blank\" rel=\"noopener noreferrer\">editorial<\/a> online and <a href=\"https:\/\/healthmetrics.heart.org\/rejected-or-abandoned-cholesterol-drug-prescriptions-tied-to-more-heart-events\/\" title=\"https:\/\/healthmetrics.heart.org\/rejected-or-abandoned-cholesterol-drug-prescriptions-tied-to-more-heart-events\/\"  target=\"_blank\" rel=\"noopener noreferrer\">AHA commentary<\/a> by American Heart Association volunteer expert Donald Lloyd-Jones, M.D.<\/li>\n<li>AHA News Release: <a href=\"https:\/\/newsroom.heart.org\/news\/less-than-half-of-patients-prescribed-new-cholesterol-drug-receive-insurance-approval\" title=\"https:\/\/newsroom.heart.org\/news\/less-than-half-of-patients-prescribed-new-cholesterol-drug-receive-insurance-approval\"  target=\"_blank\" rel=\"noopener noreferrer\">Less than half of patients prescribed new cholesterol drug receive insurance approval<\/a><\/li>\n<li>AHA News Release: <a href=\"https:\/\/newsroom.heart.org\/news\/the-american-heart-association-applauds-corporate-commitment-to-expanding-access-to-lifesaving-medicine-6725823\" title=\"https:\/\/newsroom.heart.org\/news\/the-american-heart-association-applauds-corporate-commitment-to-expanding-access-to-lifesaving-medicine-6725823\"  target=\"_blank\" rel=\"noopener noreferrer\">The American Heart Association applauds corporate commitment to expanding access to lifesaving medicine<\/a><\/li>\n<li>Follow AHA\/ASA news on Twitter <a target=\"_blank\" href=\"https:\/\/twitter.com\/HeartNews\" title=\"@HeartNews\" >@HeartNews<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Dallas, TX &#8211; Patients appear to be at higher risk of heart problems or stroke when prescriptions for the newest cholesterol-lowering drugs are rejected by insurance companies or unfilled by patients, according to new research in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal. The drugs, PCSK9 inhibitors (PCSK9i), can substantially lower levels [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[86],"tags":[2538,3833,88,6774,4030,2542,10817,2557,2543],"class_list":["post-14748","post","type-post","status-publish","format-standard","hentry","category-health","tag-american-heart-association","tag-cardiac-arrest","tag-cholesterol","tag-circulation","tag-dallas-tx","tag-heart-attack","tag-hypercholesterolemia","tag-lipoprotein","tag-stroke"],"_links":{"self":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts\/14748","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/comments?post=14748"}],"version-history":[{"count":1,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts\/14748\/revisions"}],"predecessor-version":[{"id":14749,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts\/14748\/revisions\/14749"}],"wp:attachment":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/media?parent=14748"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/categories?post=14748"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/tags?post=14748"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}