{"id":10868,"date":"2018-09-14T22:32:23","date_gmt":"2018-09-14T20:32:23","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=10868"},"modified":"2023-09-27T16:32:22","modified_gmt":"2023-09-27T14:32:22","slug":"antimicrobial-resistance-fda-discusses-reimbursement-reforms","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/antimicrobial-resistance-fda-discusses-reimbursement-reforms\/","title":{"rendered":"Antimicrobial Resistance: FDA Discusses Reimbursement Reforms"},"content":{"rendered":"<p>Reimbursement reforms for antimicrobial treatments could include \u201ca mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multi-drug resistant organisms and linked to proven clinical outcomes,\u201d US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said in a speech at Pew Charitable Trusts on Friday.<\/p>\n<p>He also offered the idea of using a \u201csubscription-based model\u201d that could see hospitals paying a flat rate for access to a certain number of doses of a new antimicrobial.<\/p>\n<p>Currently, the Centers for Disease Control and Prevention (CDC) estimates that the direct cost of antimicrobial resistance on the U.S. economy is $20 billion annually.<\/p>\n<p>\u201cThese subscription fees could be priced at a level to create a sufficient return on the investment to develop drugs with a certain profile,\u201d Gottlieb said. \u201cThis should have the effect of creating a natural market for drugs that meet certain important specifications.\u201d<\/p>\n<p>FDA is also discussing payment pilots with other federal agencies, including the Centers for Medicare and Medicaid Services (CMS), noting interest in doing such pilots in concert with the private sector as well.<\/p>\n<p>New approaches to reimbursement that could be explored might \u201calso include new technology add-on payments for certain new antibacterial drugs that meet critical patient and public health needs,\u201d he said.<\/p>\n<p>Meanwhile, earlier this week, FDA released a new\u00a0<a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-FD-18-016.html\">request for information<\/a>\u00a0(RFI) to obtain external input into developing an annual list of regulatory science initiatives specifically for antimicrobial products. Part of such a list will be a focus on the \u201cdelay in availability of information regarding the identification and antibacterial susceptibility of the causal pathogen, when isolated.\u201d<\/p>\n<p>Responses to the RFI will be accepted until 31 October 2018.<\/p>\n<p>Source: <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2018\/9\/antimicrobial-resistance-fda-discusses-reimbursem\"><strong>RAPS<\/strong><\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Reimbursement reforms for antimicrobial treatments could include \u201ca mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multi-drug resistant organisms and linked to proven clinical outcomes,\u201d US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said in a speech at Pew Charitable Trusts on [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[59,39],"tags":[],"class_list":["post-10868","post","type-post","status-publish","format-standard","hentry","category-gezondheid-op-maat","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - 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