{"id":407,"date":"2023-05-22T23:45:34","date_gmt":"2023-05-22T23:45:34","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/?page_id=407"},"modified":"2025-01-28T11:13:44","modified_gmt":"2025-01-28T11:13:44","slug":"eligibility","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/","title":{"rendered":"Eligibility"},"content":{"rendered":"<div id=\"acf-block-64b808ce4ba1b\" class=\"simple-hero\">\n            <div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2024\/11\/2.0_1_Header-Image.png?v=1.17);\"><\/div>\n\t    <div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2024\/11\/2.0_1_Header-Image.png?v=1.17);\"><\/div>\n        <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"hero-content\">\n\t\t\t\t\t\t\t\t\t\t\t\t    <h1>Eligibility\n<\/h1>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-646ca8c2cd072\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-646ca8c2cece2\" class=\"block-wysiwyg\">\n            <h2>Clinical requirements<\/h2>\n<h3>The following eligibility criteria must be met before a patient can be considered for ROCTAVIAN<\/h3>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"new\" class=\"block split-content equal-bias bottom-border\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block first-block\">\n                                                            \t\t                            \t\t                                                                    <ul class=\"icon-list\">\n                                                                                                                                                                                            <li style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/1.1_CheckMark-icon-450-ow-100x100.png);\">\n                                                    <strong>Adult<\/strong> (\u226518 years of age)\n                                                <\/li>\n                                                                                                                                                                                            <li style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/1.1_CheckMark-icon-450-ow-100x100.png);\">\n                                                    <strong>Severe hemophilia A <\/strong> (congenital Factor VIII deficiency with Factor VIII activity &lt; 1U\/dL)\n\n                                                <\/li>\n                                                                                                                                                                                            <li style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/1.1_CheckMark-icon-450-ow-100x100.png);\">\n                                                    <strong>No active inhibitors<\/strong> to Factor VIII\n                                                <\/li>\n                                                                                                                                                                                            <li style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/1.1_CheckMark-icon-450-ow-100x100.png);\">\n                                                    <strong>No active infections,<\/strong> either acute (such as acute respiratory infections or acute hepatitis) or uncontrolled chronic (such as chronic active hepatitis B), or known hypersensitivity to mannitol\n                                                <\/li>\n                                                                                    <\/ul>\n                                                                                                                        <\/div>\n                    \n                                            <div class=\"content-block second-block\">\n                                                            \t\t                            \t\t                                                                    <ul class=\"icon-list\">\n                                                                                                                                                                                            <li style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/1.1_CheckMark-icon-450-ow-100x100.png);\">\n                                                    <strong>No known significant hepatic fibrosis or cirrhosis<\/strong> as determined by a baseline assessment of liver health (liver function tests, ultrasound and elastography or laboratory assessments for liver fibrosis)\n                                                <\/li>\n                                                                                                                                                                                            <li style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/1.1_CheckMark-icon-450-ow-100x100.png);\">\n                                                    <strong>No antibodies to AAV5.<\/strong> The AAV5 DetectCDx\u2122 test is a required, FDA-approved, validated blood test that detects antibodies to AAV5\n                                                <\/li>\n                                                                                    <\/ul>\n                                                                                                                        <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-646ca8c2d0e46\" class=\"block accordion block-tight-bottom\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                                <div class=\"accordion-item\">\n                        <div class=\"accordion-title\">\n                            <div class=\"accordion-trigger\">\n                                <span><\/span>\n                                <span><\/span>\n                            <\/div>\n                            <h2>Safety considerations\n<\/h2>\n                        <\/div>\n                        <div class=\"accordion-content\">\n                                                            <ul>\n<li>Patients should be evaluated before and after administration of ROCTAVIAN for risk factors for <strong>thrombosis<\/strong> and general cardiovascular risk factors<sup>1<\/sup><\/li>\n<li>The integration of liver-targeting AAV vector DNA into the genome may carry the theoretical risk of hepatocellular carcinoma development. ROCTAVIAN can also insert into the DNA of other human body cells<sup>1<\/sup><\/li>\n<li>The majority of patients treated with ROCTAVIAN experienced ALT elevations and required <strong>corticosteroids<\/strong>. Assess patient&#8217;s ability to receive corticosteroids and\/or other immunosuppressive therapy that may be required for an extended period<sup>1<\/sup><\/li>\n<\/ul>\n                                                    <\/div>\n                    <\/div>\n                                                                            <div class=\"accordion-item\">\n                        <div class=\"accordion-title\">\n                            <div class=\"accordion-trigger\">\n                                <span><\/span>\n                                <span><\/span>\n                            <\/div>\n                            <h2>Lifestyle considerations\n<\/h2>\n                        <\/div>\n                        <div class=\"accordion-content\">\n                                                            <ul>\n<li>It is recommended that patients abstain from consuming<strong> alcohol<\/strong> for at least 1 year after administration of ROCTAVIAN, and thereafter limit alcohol use<sup>1<\/sup><\/li>\n<li>For 6 months after receiving ROCTAVIAN, men of reproductive potential and their female partners must prevent or postpone <strong>pregnancy<\/strong> using an effective form of contraceptive, and men must not donate semen<sup>1<\/sup><\/li>\n<\/ul>\n                                                    <\/div>\n                    <\/div>\n                            \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"Test-and-assess\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-646ca8c2d0f18\" class=\"block-wysiwyg\">\n            <h2>Test and assess<\/h2>\n<h3>Take the first steps to treatment. Test your patients to confirm eligibility, and assess if ROCTAVIAN gene therapy is right for them<\/h3>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-646ca8c2d11e9\" class=\"block boxed-content top-border block-tight-bottom\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\">\n\t\t\t\t\t\t\t\t\n<div id=\"acf-block-646ca8c2d1513\" class=\"image-text-block content-align-center bottom-border\">\n            <div class=\"image-block small\">\n            <figure>\n                <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.1_Step-1-icon.png?v=1.17\" alt=\"Step 1\" \/>                <\/div>\n            <\/figure>\n        <\/div>\n        <div class=\"content-block\">\n                            <p><strong>Conduct required eligibility testing<sup>1<\/sup>:<\/strong><\/p>\n<ul>\n<li>Bloodwork (AAV5 DetectCDx<sup>TM<\/sup>, liver function tests, Factor VIII inhibitor titer test)<\/li>\n<li>Liver ultrasound and elastography or laboratory assessments for determining hepatic fibrosis<\/li>\n<\/ul>\n<p><em>Visit <a href=\"https:\/\/www.biomarin-rareconnections.com\/hcp\/\" target=\"_blank\" rel=\"noopener\">biomarin-rareconnections.com<\/a> to see if your patient is eligible for financial support services.<\/em><\/p>\n                    <\/div>\n<\/div>\n\n<div id=\"acf-block-646ca8c2d1592\" class=\"image-text-block content-align-center bottom-border\">\n            <div class=\"image-block small\">\n            <figure>\n                <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.1_Step-2-icon.png?v=1.17\" alt=\"Step 2\" \/>                <\/div>\n            <\/figure>\n        <\/div>\n        <div class=\"content-block\">\n                            <p><strong>Discuss lifestyle, monitoring, and safety considerations<\/strong> with your patients. Confirm the decision to treat with ROCTAVIAN<\/p>\n                    <\/div>\n<\/div>\n\n<div id=\"acf-block-646ca8c2d1605\" class=\"image-text-block content-align-center bottom-border\">\n            <div class=\"image-block small\">\n            <figure>\n                <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.1_Step-3-icon.png?v=1.17\" alt=\"Step 3\" \/>                <\/div>\n            <\/figure>\n        <\/div>\n        <div class=\"content-block\">\n                            <p><strong>Fill out the <a href=\"https:\/\/www.biomarin-rareconnections.com\/hcp\/roctavian\/enroll-your-patients\/\" target=\"_blank\" rel=\"noopener\">Patient Enrollment Form<\/a><\/strong> to initiate the prescription for ROCTAVIAN<\/p>\n                    <\/div>\n<\/div>\n\n<div id=\"acf-block-64b124c48250f\" class=\"block-wysiwyg\">\n            <p><small>AAV5 DetectCDx\u2122 is a trademark of ARUP Laboratories.<\/small><\/p>\n    <\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-646f863d76ca2\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-646ca8c2d1984\" class=\"block call-to-action call-to-action-no-overlay block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/06\/HCP-CTA-Background.png?v=1.17);\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t    \t\t\t\t\t<div class=\"cta-content-main\">\n                        <div class=\"content-block\">\n\t\t\t\t\t        \t\t\t\t\t        \t\t\t\t\t\t        <h2 class=\"h3\">Do you have questions about eligibility testing?\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t    <\/div>\n\t\t\t\t\t                                <div class=\"content-block\">\n                                <p><a class=\"button button-ghost button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/connect-with-us\/\" target=\"_self\">Connect with us<\/a><\/p>\n                            <\/div>\n\t\t\t\t\t                        <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-646ca9e2102b7\" class=\"block references\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>Reference:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox). Prescribing Information. BioMarin Pharmaceutical Inc.; 2023.\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-407","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Eligibility &amp; Steps to Treatment | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) for Healthcare Professionals<\/title>\n<meta name=\"description\" content=\"Eligibility for ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eligibility &amp; Steps to Treatment | ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) for Healthcare Professionals\" \/>\n<meta property=\"og:description\" content=\"Eligibility for ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria\" \/>\n<meta property=\"og:url\" content=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/\" \/>\n<meta property=\"og:site_name\" content=\"BioMarin Roctavian HCP EN-US\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-28T11:13:44+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"Eligibility &amp; Steps to Treatment | ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) for Healthcare Professionals\" \/>\n<meta name=\"twitter:description\" content=\"Eligibility for ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/\",\"url\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/\",\"name\":\"Eligibility & Steps to Treatment | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) for Healthcare Professionals\",\"isPartOf\":{\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/#website\"},\"datePublished\":\"2023-05-22T23:45:34+00:00\",\"dateModified\":\"2025-01-28T11:13:44+00:00\",\"description\":\"Eligibility for ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria\",\"breadcrumb\":{\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Eligibility\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/#website\",\"url\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/\",\"name\":\"BioMarin Roctavian HCP EN-US\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Eligibility & Steps to Treatment | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) for Healthcare Professionals","description":"Eligibility for ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/","og_locale":"en_US","og_type":"article","og_title":"Eligibility & Steps to Treatment | ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) for Healthcare Professionals","og_description":"Eligibility for ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria","og_url":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/","og_site_name":"BioMarin Roctavian HCP EN-US","article_modified_time":"2025-01-28T11:13:44+00:00","twitter_card":"summary_large_image","twitter_title":"Eligibility & Steps to Treatment | ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) for Healthcare Professionals","twitter_description":"Eligibility for ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria","schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/","url":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/","name":"Eligibility & Steps to Treatment | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) for Healthcare Professionals","isPartOf":{"@id":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/#website"},"datePublished":"2023-05-22T23:45:34+00:00","dateModified":"2025-01-28T11:13:44+00:00","description":"Eligibility for ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) can be determined through a few tests. Patients must be free from antibodies to AAV5 and have no hepatic impairment, among other criteria","breadcrumb":{"@id":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/eligibility\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/"},{"@type":"ListItem","position":2,"name":"Eligibility"}]},{"@type":"WebSite","@id":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/#website","url":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/","name":"BioMarin Roctavian HCP EN-US","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/pages\/407","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/comments?post=407"}],"version-history":[{"count":215,"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/pages\/407\/revisions"}],"predecessor-version":[{"id":3230,"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/pages\/407\/revisions\/3230"}],"wp:attachment":[{"href":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-json\/wp\/v2\/media?parent=407"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}