5.5 Major submissions
Refer to the document table in the Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee for a checklist of some required documents for major submissions.
The electronic documents should be lodged in a series of folders labelled:
- Main body of the submission. This is a Microsoft Word document presenting the required information specified in the PBAC Guidelines, comprising an executive summary and up to five sections. A checklist for the executive summary can be downloaded from the checklists and templates section of the PBAC Guidelines webpage.
- TGA documents. The following documents (where available) should be provided in this folder:
- TGA clinical evaluator’s report
- TGA delegate’s overview
- minutes of the Advisory Committee on Prescription Medicines
- TGA risk management plan
- confirmation of registration in the Australian Register of Therapeutic Goods
- the most recent Product Information
- Australian Public Assessment Report for prescription medicines (AusPAR).
Refer to Section 6.3 for additional information about providing documents where major submissions are being evaluated under TGA parallel processing.
- Key documents. The following completed documents are required by the department:
- submission cover letter on company letterhead signed by an authorised company representative. This should include an index list of all documents provided, to help check that all documents are present
- PB11 (‘Application to list a Drug or Medicinal. Preparation as a Pharmaceutical Benefit’)
- PB11b (‘Cost of Goods Information’), available on the PBS website
- Part B of the Application Form for Submission Services
- restriction template (if applicable)
- complete and approved Australian Digital Health Agency AMT Mapping form (in Microsoft Word).
The request for a specific restriction is included in Section 1 of the main body of the submission. Information on how PBS restrictions are created in the current format and a template is available on the ‘Checklists and templates’ page of the PBAC Guidelines website.
- References. Separate electronic copies of all papers referenced in the submission, including all published copies of the relevant trials. The references must include the main published paper (where available), together with adequate details of the trial methods, analyses and all trial results presented in the submission for use in the economic evaluation; or the main published paper alone if the applicant has no access to any more detailed report. These materials must be legible and in English (or be accompanied by a reputable translation).
- Appendixes. Copies of supporting material, such as supporting studies for Sections 3 and 4, market research reports, and expert advice surveys.
- Attachments. Provide any required attachments as separate documents or files, such as:
- any clinical study reports, trial protocols and amendments. The attachments for clinical trial reports must provide the full clinical trial report and a synopsis or summary of the trial report. The list of appendixes for the clinical study report should be provided, but the appendixes are not required in the submission.
- Section 3 models or cost-minimisation spreadsheets
- Section 4 financial estimates workbook.
Where an analysis requires a computer program to generate information for Section 3 or 4 of the submission, provide sufficient information (input data, description of methods used to conduct the analysis, outputs and electronic copy), so that the analysis results can be independently verified, and the validity of the methods of analysis can be assessed.
If any of the analyses in the submission used specific computer software, provide a copy of all relevant electronic files of the statistical analyses and economic evaluation presented in Section 3 or 4 of the submission, and a technical document or an attachment to the submission to give details of calculations. Provide clear cross-references, as appropriate, between the technical document or attachment, and the relevant item in the main body of the submission and for the extraction of data from each source (to the level of the page, table or figure number of the source document).
Where possible, supply the dataset in the form that was used for the analysis. This might be:
- Microsoft Excel files
- flat files (ie relatively unformatted ASCII files; typically with file extension txt or dat) with little or no formatting beyond comma or tab separation of values (which are accessible by most widely used statistical programs)
- SAS datasets.
If any intermediate file processing, reformatting and/or file concatenation is required for the preparation of the input data for the actual statistical analysis, provide the computer code(s) required to do this.
Provide the full details of the variable names, order and format (eg whether a data value is a date or time in a certain format, a string or a numerical value with a particular precision) if these are not clearly apparent from the data input section of the analysis code.