{"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                                                    <p><strong>Adult<\/strong> (\u226518 years of age)<\/p>\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                                                    <p><strong>Severe hemophilia A <\/strong> (congenital Factor VIII deficiency with Factor VIII activity &lt; 1U\/dL)\n<\/p>\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                                                    <p><strong>No active inhibitors<\/strong> to Factor VIII<\/p>\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                                                    <p><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<\/p>\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                                                    <p><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)<\/p>\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                                                    <p><strong>No antibodies to AAV5.<\/strong> The AAV5 DetectCDx\u2122 test is a required, FDA-approved, validated blood test that detects antibodies to AAV5<\/p>\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 v26.0 - 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. 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