[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-279436-105":3,"detail-sidebar-cat-1-en-105":81,"doc-detail-279436-en":126},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","nexlizet-letter-of-medical-necessity-sample","Nexlizet Letter of Medical Necessity - Sample","","Sample medical necessity letter for Nexlizet® (bempedoic acid and ezetimibe) tablets to support prior authorization submissions or appeals after denials. The template frames the FDA-approved indication for LDL-C reduction in adults with hypercholesterolemia, including HeFH, and for reducing major adverse cardiovascular events in statin-ineligible patients. It includes key safety notes such as contraindications, hypersensitivity risk, hyperuricemia and gout monitoring, and tendon rupture warnings, plus adverse reaction highlights and drug-interaction cautions.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/letters/","Letters",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/nexlizet-letter-of-medical-necessity-sample/279436/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/nexlizet-letter-of-medical-necessity-sample/279436.png","ImageObject",442,249,{"name":42,"@type":43},"Logic","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-21","2026-09-16",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",12,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"How should this Nexlizet medical necessity letter be used?","Question",{"text":63,"@type":64},"Use the template as an example when submitting prior authorization or appealing a denial of coverage for Nexlizet to a patient’s health plan.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What clinical situations does Nexlizet’s indication cover in the letter?",{"text":68,"@type":64},"It covers adjunct use to diet and exercise to reduce LDL-C in adults with hypercholesterolemia (including HeFH) and use of bempedoic acid to reduce major adverse cardiovascular events in adults at increased risk who cannot take recommended statin therapy.",{"name":70,"@type":61,"acceptedAnswer":71},"What key safety information should be included or considered?",{"text":72,"@type":64},"The letter highlights contraindications to ezetimibe or bempedoic acid hypersensitivity, monitoring for hyperuricemia and gout risk, and increased risk of tendon rupture, along with common adverse reactions and interaction precautions with certain statins and fibrates.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},279436,1790443018,{"code":4,"msg":82,"data":83},"success",[84,89,93,98,103,108,113,117,122],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":55,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":22,"doc_module_name":25,"category_name":110,"show_sort_weight":111,"slug":112},17,"Forms",40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":115,"slug":116},18,30,"letters",{"id":118,"doc_module":22,"doc_module_name":25,"category_name":119,"show_sort_weight":120,"slug":121},21,"Paper Templates",5,"papers-templates",{"id":123,"doc_module":22,"doc_module_name":25,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158",{"code":4,"msg":82,"data":127},{"doc_id":79,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":114,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":30,"language":135,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":12,"update_tm":139,"read_time":22},1099513958762,"https://ap-avatar.wpscdn.com/avatar/1000023916a998db790?x-image-process=image/resize,m_fixed,w_180,h_180&k=1784791008015729253","This is a sample letter of medical necessity for Nexlizet® (bempedoic acid and ezetimibe) tablets. This sample is provided foryour guidance only. Use of information in this letter does not guarantee that the health plan will provide reimbursement for NEXLIZET, and is not intended to substitute for or influence your independent medical judgment as a healthcare provider.  \nBased on your clinical judgement, you may use this letter as an example of the type of information that may be helpful when submitting a prior authorization or appealing a denial of coverage for NEXLIZET from a patient’s health plan.  \nINDICATION  \nNEXLIZET is indicated:  \n• as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH.  \n• bempedoic acid, a component of NEXLIZET, is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin) .  \nIMPORTANT SAFETY INFORMATION  \n• NEXLIZET is contraindicated in patients with a prior hypersensitivity to ezetimibe or bempedoic acid or any of the excipients. Serious hypersensitivity reactions, such as anaphylaxis, angioedema, rash, and urticaria have been reported with ezetimibe or bempedoic acid.  \n• Hyperuricemia: Bempedoic acid, a component of NEXLIZET, may increase blood uric acid levels, which may lead to gout. Monitor as clinically indicated and initiate treatment with urate-lowering drugs as appropriate.  \n• Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. Tendon rupture occurred in 0.5% of patients treated with bempedoic acid in primary hypercholesterolemia trials, versus 0% on placebo. In the cardiovascular outcomes trial, the rates were 1.2% for bempedoic acid and 0.9% for placebo. Discontinue NEXLIZET atthe first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.  \n• The most common adverse reactions in the primary hypercholesterolemia trials of bempedoic acid in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.  \n• Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.  \n• The most common adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.  \n• The most common adverse reactions in the cardiovascular outcomes trial of bempedoic acid, at an incidence of ≥2% and 0.5% greater than placebo, were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.  \n• Concomitant use of NEXLIZET with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided due to the potential for increased risk of simvastatin-or pravastatin-related myopathy. Concomitant use with fibrates may increase triglycerides and decrease high-density lipoprotein cholesterol. Monitor and adjust therapies as recommended.  \n• Discontinue NEXLIZET when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. The benefits of breastfeeding should be considered along with the mother’s clinical need for NEXLIZET and any potential adverse effects on the breastfed infant from NEXLIZET or from the underlying maternal condition.  \nReport pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.  \nPlease see th","cbCail8TVtQzNau3","https://ap.wps.com/l/cbCail8TVtQzNau3","pdf",2777421,"English","# Insurance Company Information\n## Patient and Policy Details\n## Letter Recipient and Greeting\n# Statement of Medical Necessity\n## FDA-Approved Indication Basis\n## Statin Intolerance Documentation Options\n# Important Safety Information\n## Contraindications and Hypersensitivity\n## Hyperuricemia and Tendon Rupture\n## Common Adverse Reactions\n## Drug Interactions and Pregnancy Considerations","[{\"question\":\"How should this Nexlizet medical necessity letter be used?\",\"answer\":\"Use the template as an example when submitting prior authorization or appealing a denial of coverage for Nexlizet to a patient’s health plan.\"},{\"question\":\"What clinical situations does Nexlizet’s indication cover in the letter?\",\"answer\":\"It covers adjunct use to diet and exercise to reduce LDL-C in adults with hypercholesterolemia (including HeFH) and use of bempedoic acid to reduce major adverse cardiovascular events in adults at increased risk who cannot take recommended statin therapy.\"},{\"question\":\"What key safety information should be included or considered?\",\"answer\":\"The letter highlights contraindications to ezetimibe or bempedoic acid hypersensitivity, monitoring for hyperuricemia and gout risk, and increased risk of tendon rupture, along with common adverse reactions and interaction precautions with certain statins and fibrates.\"}]","Nexlizet Letter of Medical Necessity - Sample | PDF",1789520754]