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Confidential information handling must comply with the template guidance in Appendix 2, and all pages across the submission, including appendices, require numbering. Submissions must use specified file naming rules and secure electronic delivery via the NCPE provided link. A complete package includes the template in .docx and .pdf, a budget impact model .xlsm, reference materials, RIS files, and relevant product documentation such as draft SmPC or PAR copy where applicable.","NCPE Rapid Review Applicant Submission Template\n\u000f\nVersion Control\n\u000f\nThis document outlines the content and format of the written submission to the NCPE as part of a Rapid Review.  The submission should be concise, consisting of summary information, with more detailed information provided in supplementary appendices, if necessary. Inclusion of confidential information should follow guidance outlined in Appendix 2 of this Template. This document may be updated periodically. Please refer to \u0013 HYPERLINK \"http://www.ncpe.ie\" \u0014www.ncpe.ie\u0015  to obtain the most recent version prior to submission.\nAll pages in the submission, including appendices, should be numbered. Do not alter the heading/table structure provided, unless otherwise specified.\nAll files included in the submission should be named in accordance with the specified file-naming convention and saved in the specified format, as outlined below. The international non-proprietary name (INN) should be included at the start of all filenames. Please do not use all capital letters or use underscores in the filename.\nFile naming convention and format\n\u000f\nSubmission Checklist\nPrior to starting the Rapid Review assessment, the NCPE Review Group will ensure that the Applicant submission includes:\na completed Rapid Review Submission Template in both .docx and .pdf format, including all Appendices\na NCPE Budget Impact Model Template in.xlsm format using the \u0013 HYPERLINK \"https://www.ncpe.ie/submission-process/submission-templates/budget-impact-model-template/\" \u0014standard NCPE template\u0015\nfull text copies of all references in .pdf format\na RIS file of all references\nthe draft SmPC, if the rapid review is submitted at CHMP positive opinion, as the SmPC and EPAR will not be published\na copy of the PAR from the reference country for products authorised via mutual recognition procedure.\nIf the submission is incomplete, the Applicant will be requested to submit the missing element(s). If errors are identified in the drug cost and/or budget impact calculations, the Applicant will be requested to correct the errors and resubmit the relevant files within three working days of the request.\nAll electronic files must be submitted using a secure link provided by the NCPE. Please contact the NCPE at \u0013 HYPERLINK \"mailto:ncpe@stjames.ie\" \u0014ncpe@stjames.ie\u0015 for instructions on secure online submission.\n\u000f\nTable of Contents\n\u0013 TOC \\o \"1-4\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc110526639\" \u00141.\tDetails of the Intervention\t\u0013 PAGEREF _Toc110526639 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526640\" \u00142.\tThe Disease and Place in Therapy\t\u0013 PAGEREF _Toc110526640 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526641\" \u00142.1.\tThe disease/condition\t\u0013 PAGEREF _Toc110526641 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526642\" \u00142.2.\tEpidemiology of the disease in Ireland\t\u0013 PAGEREF _Toc110526642 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526643\" \u00142.3.\tClinical guidelines and standard of care in Ireland\t\u0013 PAGEREF _Toc110526643 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526644\" \u00142.4.\tPlace in therapy\t\u0013 PAGEREF _Toc110526644 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526645\" \u00142.5.\tComparators\t\u0013 PAGEREF _Toc110526645 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526646\" \u00143.\tClinical evidence\t\u0013 PAGEREF _Toc110526646 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526647\" \u00143.1.\tStudy Design\t\u0013 PAGEREF _Toc110526647 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526648\" \u00143.2.\tClinical efficacy\t\u0013 PAGEREF _Toc110526648 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526649\" \u00143.3.\tClinical safety\t\u0013 PAGEREF _Toc110526649 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526650\" \u00144.\tComparative costs\t\u0013 PAGEREF _Toc110526650 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526651\" \u00145.\tBudget Impact Analysis\t\u0013 PAGEREF _Toc110526651 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526652\" \u00146.\tInternational HTA\t\u0013 PAGEREF _Toc110526652 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526653\" \u00147.\tReferences\t\u0013 PAGEREF _Toc110526653 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526654\" \u00148.\tAppendices\t\u0013 PAGEREF _Toc110526654 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526655\" \u0014Appendix 1: Clinical opinion\t\u0013 PAGEREF _Toc110526655 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc110526656\" \u0014Appendix 2: Confidential informa","cbCaimBlVB93eJai","https://ap.wps.com/l/cbCaimBlVB93eJai","docx",426010,21,"English","en",105,"# Details of the Intervention\n## Submission Checklist\n## Table of Contents\n## List of Abbreviations\n## Details of the Intervention - Table 1\n## The Disease and Place in Therapy","[{\"question\":\"What is the overall purpose and structure of the NCPE Rapid Review submission template?\",\"answer\":\"The template defines the required content and format for a written NCPE Rapid Review submission, encouraging concise summary information with more detailed material placed in supplementary appendices when necessary.\"},{\"question\":\"Which items must be included in the submission checklist before the Rapid Review assessment starts?\",\"answer\":\"The checklist requires a completed Rapid Review Submission Template in .docx and .pdf (with appendices), a NCPE Budget Impact Model Template in .xlsm, full text reference copies in .pdf, a RIS file for references, and additional product documentation such as a draft SmPC or PAR copy where applicable.\"},{\"question\":\"How should confidential information be handled in the submission?\",\"answer\":\"Confidential information must follow the guidance described in Appendix 2 of the template.\"}]","Details of the Intervention - 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