{"id":22304,"date":"2021-03-31T16:28:59","date_gmt":"2021-03-31T20:28:59","guid":{"rendered":"https:\/\/avalere.com\/?p=22304"},"modified":"2023-03-03T16:08:38","modified_gmt":"2023-03-03T21:08:38","slug":"majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/insights\/majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics","title":{"rendered":"Majority of Part D Spending Is on Brand Drugs in Classes with Generics"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text]Medicare establishes standards to ensure that plan formularies in Part D cover treatments across conditions and diseases. Coverage standards are based on guidelines published by the United States Pharmacopeia (USP) that group drugs into categories and classes designed to include a range of therapeutic agents for diseases and conditions. While a small number of classes may have only a single drug, other classes may include a large number and a mix of brand and generic products. Part D spending patterns may reflect these differences in classes.<\/p>\n<p>In most cases, Part D plans must cover at least 2 drugs per category and class. Additionally, the Centers for Medicare &amp; Medicaid Services (CMS) requires more generous coverage in the classes of clinical concern, or the \u201cprotected classes,\u201d which include drugs for certain mental health conditions, seizures, HIV, cancer, and immune suppression after transplants.<\/p>\n<p>In 2019, brand drugs accounted for 79% of total Part D spending ($143.1 billion) while generics accounted for 21% ($38.7 billion). Similarly, a prior Avalere <a href=\"https:\/\/advisory.avalerehealth.com\/insights\/avalere-analysis-examines-drug-spending-in-medicare-part-d\">analysis<\/a> conducted in 2017 revealed that brand drugs accounted for 77% of total Part D spending ($117.1 billion), while generics accounted for the remaining 23% of spending ($34.4 billion). Specifically, single-source brand drugs, which do not have an equivalent generic drug available on the market, accounted for about 70% of total Part D spending ($128 billion) in 2019 compared to 72% in 2017. The remaining 8% of brand spending in 2019 was on multi-source brand drugs with generic equivalents.<sup>1<\/sup>\u00a0While single-source brand drugs accounted for a significant share of 2019 Part D spending, the vast majority of single-source brand drug spending was in USP classes that included other generic or brand drugs. In fact, far less than 1% (~$2 million) of Part D spending in 2019 was on brand medicines that were the only product available in their therapeutic class.[\/vc_column_text][vc_single_image image=&#8221;22302&#8243; add_caption=&#8221;yes&#8221; img_caption=&#8221;Figure 1. Part D Spending by Class and Type of Drug, 2017 vs. 2019&#8243; css=&#8221;.vc_custom_1617220483964{margin-top: 50px !important;margin-bottom: 20px !important;}&#8221;][vc_column_text]<em>Funding for this research was provided by the Pharmaceutical Research and Manufacturers of America. Avalere Health retained full editorial control.<\/em><\/p>\n<p>To receive Avalere updates,\u00a0<a href=\"https:\/\/info.avalere.com\/LP=46\">connect with us<\/a>.<\/p>\n<h2>Methodology<\/h2>\n<p>Avalere mapped Part D drugs listed under USP Medicare Model Guidelines (MMG) Formulary Reference File (FRF) to MediSpan to identify single-source and multi-source drugs, as well as brand and generic products. The USP MMG-FRF maps the USP MMG v8.0 to the CMS 2019 FRF to create a comprehensive list of drugs that fall under each class of the USP MMG v8.0. Drugs listed as having \u201cno USP class\u201d in the USP MMG-FRF were analyzed as a separate \u201cclass\u201d under their respective therapeutic categories. MediSpan\u2019s determination of a generic product requires that a product be pharmaceutically equivalent but not necessarily bioequivalent. Avalere used MediSpan\u2019s determinations but did not assess products\u2019 therapeutic equivalence. Avalere used the 2019 Part D Public Use File (PUF) to identify the Part D spending associated with each drug. Notably, 156 drugs in the 2019 Part D PUF file accounting for 0.7% of total Part D spending were not found in the USP MMG v8.0 Alignment File.<\/p>\n<h2>Notes<\/h2>\n<ol>\n<li>Drugs that do not face competition from equivalent generics are referred to as \u201csingle-source\u201d brand drugs. Once a drug loses its intellectual property protection, 1 or more manufacturers can make a generic version of the drug. Brand drugs with generic equivalents are called \u201cmulti-source drugs.\u201d<\/li>\n<\/ol>\n[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text]Medicare establishes standards to ensure that plan formularies in Part D cover treatments across conditions and diseases. Coverage standards are based on guidelines published by the United States Pharmacopeia (USP) that group drugs into categories and classes designed to include a range of therapeutic agents for diseases and conditions. While a small number of classes&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3],"tags":[],"content-categories":[129],"class_list":["post-22304","post","type-post","status-publish","format-standard","hentry","category-insights","content-categories-drug-pricing","entry","no-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Majority of Part D Spending Is on Brand Drugs in Classes with Generics | Avalere Health Advisory<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/advisory.avalerehealth.com\/insights\/majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Majority of Part D Spending Is on Brand Drugs in Classes with Generics | Avalere Health Advisory\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_column_text]Medicare establishes standards to ensure that plan formularies in Part D cover treatments across conditions and diseases. 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Coverage standards are based on guidelines published by the United States Pharmacopeia (USP) that group drugs into categories and classes designed to include a range of therapeutic agents for diseases and conditions. While a small number of classes&hellip;","og_url":"https:\/\/advisory.avalerehealth.com\/insights\/majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics","og_site_name":"Avalere Health Advisory","article_published_time":"2021-03-31T20:28:59+00:00","article_modified_time":"2023-03-03T21:08:38+00:00","author":"avalere_wp","twitter_card":"summary_large_image","twitter_creator":"@avalerehealth","twitter_site":"@avalerehealth","twitter_misc":{"Written by":"avalere_wp","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/advisory.avalerehealth.com\/insights\/majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics#article","isPartOf":{"@id":"https:\/\/advisory.avalerehealth.com\/insights\/majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics"},"author":{"name":"avalere_wp","@id":"https:\/\/advisory.avalerehealth.com\/#\/schema\/person\/6cea6678c016753ac38b9aad6cff71aa"},"headline":"Majority of Part D Spending Is on Brand Drugs in Classes with Generics","datePublished":"2021-03-31T20:28:59+00:00","dateModified":"2023-03-03T21:08:38+00:00","mainEntityOfPage":{"@id":"https:\/\/advisory.avalerehealth.com\/insights\/majority-of-part-d-spending-is-on-brand-drugs-in-classes-with-generics"},"wordCount":575,"commentCount":0,"publisher":{"@id":"https:\/\/advisory.avalerehealth.com\/#organization"},"articleSection":["Insights &amp; 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