{"id":17619,"date":"2023-04-27T06:03:35","date_gmt":"2023-04-27T06:03:35","guid":{"rendered":"https:\/\/d36deud6t4mnhi.cloudfront.net\/?page_id=17619"},"modified":"2024-04-12T11:41:31","modified_gmt":"2024-04-12T09:41:31","slug":"access","status":"publish","type":"page","link":"https:\/\/www.ipsen.com\/us\/patients\/access\/","title":{"rendered":"Early Access Public Policy"},"content":{"rendered":"    <section class=\"sub-page-banner bg-img\" style=\"background-image:url(https:\/\/www.ipsen.com\/websites\/ipsen_com_v2\/wp-content\/uploads\/sites\/2\/2023\/05\/02111317\/Module-1_Subpage-Patients-Responsibility_Banner_1920x280pix.jpeg)\">\n        <div class=\"container content-sec\">\n            <nav aria-label=\"breadcrumb\">\n            <ol class=\"breadcrumb\">\n                <li class=\"breadcrumb-item\"><a href=\"https:\/\/www.ipsen.com\/us\">Home<\/a><\/li><li class=\"breadcrumb-item visible\"><a href=\"https:\/\/www.ipsen.com\/us\/patients\/\">Patients<\/a><\/li><li class=\"breadcrumb-item active\" aria-current=\"page\">Early Access Public Policy<\/li><\/ol>\n            <\/nav>            <h1 class=\"visible\">Early Access Public Policy<\/h1>\n            <p class=\"visible\">Ipsen commits to enable Early Access to patients to Ipsen Products which are not yet approved by local Health Authorities<\/p>\n        <\/div>\n    <\/section>\n\n\n\n<div class=\"wp-block-columns alignfull is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\t<!-- Hero Carousel Start Here-->\n\t<section class=\"hero-section blue-filter\">\n\t\t<div class=\"hero_gridwidth container\"><!-- container class shown if gridlayout choosen -->\n\t\t\t<div id=\"heroCarousel\" class=\"carousel slide\" data-bs-ride=\"carousel\" data-enableplaybtn=\"\" data-autoplay= \"\"  data-autospeed= \"\" >\n\t\t\t\t<!-- Slider Indicator-->\n\t\t\t\t<div class=\"carousel-indicators hidden\">\n\t\t\t\t<button type=\"button\" data-bs-target=\"#heroCarousel\" data-bs-slide-to=\"0\" class=\"active\" aria-current=\"true\" aria-label=\"Slide 0\"><\/button>\t\t\t\t<\/div>\n\t\t\t\t<!-- Items -->\n\t\t\t\t<div class=\"carousel-inner\">\n\t\t\t\t\t\t\n\t\t\t\t\t\t<!-- Hero Banner with carousel HTML -->\n\t\t\t\t\t\t<div class=\"carousel-item active\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" class=\"bd-placeholder-img visible\" width=\"100%\" height=\"100%\" src=\"https:\/\/www.ipsen.com\/websites\/ipsen_com_v2\/wp-content\/uploads\/sites\/2\/2023\/02\/02113522\/MicrosoftTeams-image-19-2.png\" aria-hidden=\"true\" title=\"Hero Banner\" alt=\"Hero Banner\" \/> \n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t\t\t<div class=\"container align-left\">\n\t\t\t\t\t\t\t\t<div class=\"carousel-caption\">\n\t\t\t\t\t\t\t\t\t<h2 class=\"visible text-start\">Early Access Public Policy<\/h2>\n\t\t\t\t\t\t\t\t\t<div class=\"visible text-start\">Ipsen\u2019s vision is to be a leading global biopharmaceutical company focused on innovation and Specialty Care and our mission is to improve patients\u2019 lives through innovative new medicines<\/div>\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/section>\n\t<!-- Hero Carousel End Here-->\n  <\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">    <section class=\"title-text \">\n        <div class=\"container\">\n            <div class=\"title-text-inner\" style=\"background-color:#e7faff;\">\n                <div class=\"text-head-dash visible\">\n                                            <span class=\"dash\"><\/span> \n                        <p class=\"heading-para\">\n                            ABOUT EARLY ACCESS                        <\/p>\n                                    <\/div>\n                <div class=\"text-parbase visible\">\n                    <p><p>Ipsen defines \u201cEarly Access\u201d<sup>1<\/sup>\u00a0as access to:<\/p>\n<ol>\n<li>Unapproved medicine for the requested indication in the country where the request comes from<\/li>\n<li>For life-threatening or serious medical conditions<\/li>\n<li>Where there is no satisfactory alternative therapy available for the given medical condition<\/li>\n<li>Where there is no alternative option for the patient to participate in an ongoing clinical trial in the given indication<\/li>\n<li>Where the medicine has reasonable medical evidence of the positive balance of benefits\/risks in the given indication and the medicinal product has started the regulatory process of approval in the US and\/or the EU<\/li>\n<\/ol>\n<p>Early Access can only take place if it is allowed within the local laws, rules and regulations or specifically approved in writing by local authorities.<\/p>\n<p>The physician and the patient should discuss the expected benefits, known and potential unknown risks before seeking Early Access to a medicinal product.<\/p>\n<p>In some cases, Ipsen may set up a program designed to provide Early Access to several patients in defined countries.<\/p>\n<p>The list of Ipsen\u2019s Early Access Programs in the United States is available on\u00a0<strong><a href=\"http:\/\/www.clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener\">www.clinicaltrials.gov<\/a><\/strong>.<\/p>\n<p>Physicians can contact Ipsen and make a request for Early Access to\u00a0<a href=\"mailto:medinfo.usa@ipsen.com\"><strong>medinfo.usa@ipsen.com<\/strong><\/a>.<\/p>\n<\/p>\n                <\/div>\n                            <\/div>\n        <\/div>\n    <\/section>\n\n\n\n<!--Alert Card Layout Start Here-->\n<section class=\"alertcard-section\">\n      <div class=\"container\">\n        <!--Alert Box HTML Start Here-->\n        <div class=\"alert-box general-box\">\n                    <div class=\"info-icon\">\n              <span class=\"info-circle\"><img decoding=\"async\" src=\"https:\/\/www.ipsen.com\/us\/wp-content\/themes\/ipsen-main\/dist\/images\/alert-general-icon.png\" alt=\"Alert Icon\" title=\"Alert Icon\" \/><\/i>\n            <\/div>\n                    <div class=\"info-contents\">\n            <p class=\"info-head hidden\"><\/p>\n            <p class=\"info-sub-head-para hidden\"><\/p>\n            <div class=\"alert-content visible\"><p><em><sup>1<\/sup>Other terms commonly used: Compassionate Use, Early Access, Expanded Access Program, Managed Access Program, Patient Access Program, Special Access Program, Scheme Access Program, Temporary Use Authorization and Pre-approval access.<\/em><\/p>\n<\/div>\n          <\/div>\n        <\/div>\n        <!--Alert Box HTML Start Here-->\n      <\/div>\n    <\/section>\n<!--Alert Card Layout End Here-->\n\n\n\n    <!--Accordion Cards Start Here-->\n    <section class=\"accordion\" data-according-id=\"534761926\">\n        <div class=\"container\">\n            <div class=\"row\">\n                <!--Accordion info section-->\n                <div class=\"column-1 col-xl-12 col-md-12 col-sm-12\">\n                    <div class=\"accordian-info\">\n                        <h2 class=\"accordian-heading visible\">Request for Early Access to an Ipsen Product<\/h3>\n                        <p class=\"accordian-summary hidden\"><\/p>\n                    <\/div>\n                <\/div><!--Accordion info section over here -->\n\n                <div class=\"col-xl-12 col-lg-12 col-md-12 col-sm-12\">\n                    <div class=\"accordion accor-group\" id=\"accordionExample534761926\">\n                         \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading0\">\n                                            <button class=\"accordion-button accor-btn \" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading5347619260\" aria-expanded=\"true\" aria-controls=\"expHeading5347619260\">\n                                                Who can request Early Access?                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading5347619260\" class=\"accordion-collapse collapse show\" aria-labelledby=\"expHeading0\" data-bs-parent=\"#accordionExample534761926\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Only qualified Physicians can make requests for Early Access to an Ipsen Product once they have exhausted all other appropriate and available options to treat the medical condition of their patient, including enrollment in a clinical trial.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading1\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading5347619261\" aria-expanded=\"true\" aria-controls=\"expHeading5347619261\">\n                                                How can the Physician contact Ipsen and make a request?                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading5347619261\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading1\" data-bs-parent=\"#accordionExample534761926\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Physicians can contact Ipsen and send a request for Early Access to <a href=\"mailto:medinfo.usa@ipsen.com\"><strong>medinfo.usa@ipsen.com<\/strong><\/a>.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading2\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading5347619262\" aria-expanded=\"true\" aria-controls=\"expHeading5347619262\">\n                                                What will happen to the request?                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading5347619262\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading2\" data-bs-parent=\"#accordionExample534761926\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>When the request is received by Ipsen, Ipsen will send an acknowledgement of receipt of the request within 48 business hours. The request will be assessed by Ipsen medical affairs fairly, as promptly as possible and after a thorough discussion with the Physician as necessary.<\/p>\n<p>&nbsp;<\/p>\n<p>The decision will be based on at least the following criteria:<\/p>\n<ol>\n<li>The conditions for Early Access are met<\/li>\n<li>Patient\u2019s individual medical conditions<\/li>\n<li>Ipsen product availability<\/li>\n<li>Regulatory and health system environment where the request has come from (e.g. to make sure a Pharmacovigilance structure is in place)<\/li>\n<\/ol>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading3\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading5347619263\" aria-expanded=\"true\" aria-controls=\"expHeading5347619263\">\n                                                What will happen if the request is approved?                                             <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading5347619263\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading3\" data-bs-parent=\"#accordionExample534761926\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>If the request for Early Access is approved by Ipsen, the Physician must collect and complete all necessary documents to comply with appropriate rules and regulations \u2013 as quickly as possible. Once collected, Ipsen will send the Physician the requested Ipsen Product for Early Access to treat their patient.<\/p>\n<p>&nbsp;<\/p>\n<p>The physician must commit to the regulatory obligations including reporting of adverse events during the entirety of the Early Access.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading4\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading5347619264\" aria-expanded=\"true\" aria-controls=\"expHeading5347619264\">\n                                                What will happen if the request is not approved?                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading5347619264\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading4\" data-bs-parent=\"#accordionExample534761926\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Ipsen is committed to Early Access but the company cannot guarantee approval and regrets that there are occasions where it is not appropriate for the company to provide Early Access to its medicine or where the request does not fall within the definition of Early Access. In these circumstances we commit to provide a timely response and clear rationale for the decision.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                <\/div>\n                <\/div> \n            <\/div>\n        <\/div>\n    <\/section>\n    <!--Accordion Cards End Here-->\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":0,"parent":29977,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized 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