[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-254859-105":53,"doc-detail-254859-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","coverage-modification-checklist-drug-submission","Coverage Modification Checklist - Drug Submission","","Coverage modification checklist for drug submission sponsors requesting the Ministry of Health to modify a drug’s current coverage status. The process applies to non-Common Drug Review (CDR) drugs when new clinical information becomes available. Review is limited to submission packages that meet the checklist criteria and include all required documents. Requirements cover cover letter signatures, drug product request forms, product monographs, patents documentation, regulatory and clinical evidence, pharmacoeconomic materials, budget impact analysis, pricing and distribution, and multiple signed consent and communication letters.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/coverage-modification-checklist-drug-submission/254859/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/coverage-modification-checklist-drug-submission/254859.png","ImageObject",442,249,{"name":88,"@type":89},"Margaret","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-18","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Who can request modification of a drug’s coverage status, and who must receive the request?","Question",{"text":109,"@type":110},"Drug submission sponsors may request a modification of the current coverage status from the Ministry of Health to change the drug’s current coverage.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"When do coverage modification requests generally apply?",{"text":114,"@type":110},"They generally apply to non-Common Drug Review (CDR) drugs when new and relevant clinical information becomes available.",{"name":116,"@type":107,"acceptedAnswer":117},"What determines whether a drug submission package will be reviewed?",{"text":118,"@type":110},"Only packages that follow the checklist criteria and include all checklist documents are reviewed.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},254859,1790716855,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":76,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":9},137451207643,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","Coverage modification checklist  \nDrug submission sponsors may request a modification of current coverage status from the Ministry of Health to change the current coverage of a drug. Requests to modify the coverage status of a drug generally apply to non-Common Drug Review (CDR) drugs when new and relevant clinical information has become available.  \nOnly drug submission packages that follow the checklist criteria and that include all checklist documents will be reviewed. If you have questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management [team at:](team at: DrugReviewProcess@gov.bc.ca)[ ](team at: DrugReviewProcess@gov.bc.ca)[DrugReviewProcess@gov.bc.ca](team at: DrugReviewProcess@gov.bc.ca)  \nAll letters, unless otherwise stated, must be prepared on company letterhead and signed by an appropriate senior official. Documents may be signed with an e-signature.  \n\n| BC Ministry of Health documentation |\n| --- |\n| ❏ Cover letter – signature required |\n| ❏ Drug product request form for patented drug products and biosimilars\u003Cbr>Applies to Non-Common Drug Review (CDR) submissions only:\u003Cbr>Access and complete the Ministry of Health Drug Product Request Form for non-CDR Submissions (DOCX) as a Word document. In the template, include the following:\u003Cbr>• Each indication, strength and the Drug Identification Number (DIN) to be reviewed\u003Cbr>• The name of the drug manufacturer and each vendor/associate company working on the submission\u003Cbr>• Contact information for the primary and backup person who can be contacted regarding the submission\u003Cbr>• A high-level executive summary describing the submission |\n| ❏ Product monograph\u003Cbr>• A copy of the most recent product monograph approved by Health Canada with the company, drug brand, and non-proprietary names that correspond to the Notice of Compliance (NOC)\u003Cbr>• A copy of the clean and dated product monograph approved by Health Canada |\n| ❏ Letter confirming that written notification of any future changes will be provided – signature required |\n| ❏ Letter confirming the availability of the drug pre-NOC – signature required |\n| ❏ Letter confirming ability to supply for anticipated demand – signature required |\n| Patents documentation |\n| ❏ Summary list of the drug product’s associated patents and the patent expiry dates as documented on Health Canada Patent Register |\n| Health Canada documentation |\n| ❏ NOC or Notice of Compliance with Conditions (NOC/c) |\n| ❏ Drug Identification Number(s) (DIN) |\n| Efficacy, effectiveness, and safety documentation (including supplementary appendixes) |\n| ❏ Supporting clinical evidence |\n\n\n| ❏ Pharmacoeconomic evidence |\n| --- |\n| ❏ All other information the drug submission sponsor would like the Ministry of Health to consider |\n| ❏ Reference list of key clinical studies and errata |\n| ❏ Copies of key clinical studies and errata |\n| ❏ Reference list of editorial articles (or statement that there are no editorials) |\n| ❏ Copies of editorial articles |\n| ❏ Literature search strategies |\n| ❏ Reference list of studies included in submission |\n| ❏ Copies of studies included in submission |\n| ❏ Letter declaring that all known unpublished studies have been disclosed – signature required |\n| ❏ Table of all known ongoing trials for indications that are different than the indication being submitted for review |\n| Budget Impact Analysis (BIA) |\n| ❏ A Provincial Budget Impact Analysis (BIA) for B. C. that is consistent with the standards published by the Patented  Medicines Prices Review Board (PMPRB) |\n| Pricing and distribution information |\n| ❏ Summary list and/or table on unit price or all dosage forms, strengths and package sizes, to four decimal places |\n| ❏ Method of distribution\u003Cbr>Please provide wholesaler name and contact information |\n| ❏ Letter of commitment to honour the submitted price – signature required |\n| Sharing of information |\n| ❏ Letter of consent authorizing the unrestricted","cbCainmig1hwyVKU","https://ap.wps.com/l/cbCainmig1hwyVKU","pdf",170827,"English","# Coverage modification request\n## Submission scope and review criteria\n## Required documents by section","[{\"question\":\"Who can request modification of a drug’s coverage status, and who must receive the request?\",\"answer\":\"Drug submission sponsors may request a modification of the current coverage status from the Ministry of Health to change the drug’s current coverage.\"},{\"question\":\"When do coverage modification requests generally apply?\",\"answer\":\"They generally apply to non-Common Drug Review (CDR) drugs when new and relevant clinical information becomes available.\"},{\"question\":\"What determines whether a drug submission package will be reviewed?\",\"answer\":\"Only packages that follow the checklist criteria and include all checklist documents are reviewed.\"}]","Coverage Modification Checklist - Drug Submission | PDF",1789282597]