Making a Submission
- Common Submission Form [Word 253KB]
- Information Pack [PDF 105KB]
- Formulary Submissions
- Process for Submissions
- Submission Deadlines and WADEP Meeting Dates
- Process Following Submission
Before commencing the preparation of a submission, please contact WATAG for updated information.
Formulary Submissions
A Common Submission Form [Word 189KB] is used for formulary submissions to both hospital Drugs and Therapeutics Committee, and to WADEP when a submission is considered to be for a high-cost drug. Drug submissions meeting the criteria of anticipated annual expenditure of greater than $300,000 within WA, or $100,000 per tertiary institution, or $10,000 per patients are referred by the hospital Drugs and Therapeutics Committee to WADEP.
The Common Submission Form is a template for required information when making an submission for hospital formulary listing to either a hospital Drugs and Therapeutics Committee or WADEP and is to be completed by applicants.
Drugs listed under the PBS Highly Specialised Drug Program (Section 100) do not require submission to WADEP and will be listed on the hospital formulary for use strictly in accordance with the indication approved by the PBS.
The Information Pack [PDF 188KB] contains general information regarding WADEP and is a guide for applicants making a submission.
All submissions to list a drug or indication on the hospital formulary should made to the local hospital DTC in the first instance. High cost drug submissions may be returned to the applicant if addition information is required and will then be directed to WATAG and WADEP. If uncertain, or to anticipate a high-cost drug classification, the applicant should check with the hospital DTC.
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Process for Submissions
The process for submitting an application to WADEP is:
- Determine if the submission meets the criteria for a high-cost drug submission to WADEP (Contact the local DTC if there is uncertainty as documentation for WADEP submissions differ from standard formulary submissions). The criteria for a WADEP submission is drugs with a cost of:
- more than $10,000 annually for an individual patient;
- more than $100,000 annually for an individual health service; or
- more than $300,000 annually within the WA public health system.
- For high-cost drug submissions to WADEP, complete sections A and C of the Common Drug Submission Form (provide supporting documentation as indicated on the form) and submit to the local DTC.
- The local DTC will then check and sign the submission and return it to the applicant for submission to WADEP.
- Five printed copies (including the signed original) of all submission documents should be sent to:
Executive Officer (WATAG)
Royal Perth Hospital
PO Box X2213
Perth WA 6847
- An electronic copy of the completed Common Submission Form should be sent via email to:
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Submission Deadlines and WADEP Meeting Dates
High-cost drug submissions to WATAG should be made 1 month before the next scheduled meeting of WADEP to allow adequate time for the evaluation of the submission and preparation of reports for consideration by WADEP at its next meeting.
| Deadline for Submission | WADEP Meeting Date |
23 December 2009 |
11 February 2010 |
22 March 2010 |
22 April 2010 |
3 May 2010 |
3 June 2010 |
5 July 2010 |
5 August 2010 |
4 October 2010 |
4 November 2010 |
15 December 2010 |
February 2011 |
| * 2011 dates to be confirmed | |
WADEP meetings are held in private and are normally scheduled bi-monthly.
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Process Following Submission
The lead clinician (or deputy) making a submission may be invited to attend the meeting to support an application. Presenters attending a WADEP meeting will be required to declare any conflicts of interest.
On completion of an evaluation, the following categories of recommendation are made by the WADEP:
- Recommended for general inclusion in the hospital formulary
- Recommended for inclusion in the hospital formulary with restrictions (to be specified)
- Not recommended for use at present, as further evidence of clinical effectiveness and/or acceptable cost effectiveness is required.
- Not recommended (reason then given).
WADEP makes its recommendations to WATAG which are then reviewed. Final recommendations are sent to the Operations Review Committee (ORC) of the State Health Executive Forum (SHEF) to consider affordability and provide corporate oversight. Upon ORC acceptance of a recommendation, WATAG will issue an Advisory Note detailing the outcome of the submission for the attention of hospital Drugs and Therapeutics Committees and also communicates this information to the applicant(s). Applicants are also advised if a submission is unsuccessful, and may appeal to WATAG against a negative final recommendation on the basis of procedural unfairness or substantial new evidence. Authors may wish to seek further clarification concerning the recommendations, and will have an opportunity to express alternative views. The Panel will consider correspondence of this kind.
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File Formats
The documents for download on this website are in a Portable Document Format (PDF). To read these files you might need to download Adobe® Acrobat Reader.
