DDHHS Non-LAM Application

You are about to commence an application for an item that is not on the List of Approved Medications.

Once started, the application cannot be saved. It must be completed in a single session.

To complete the application you will need:

1. Patient details, including name, UR number and date of birth.

2. Urgency and reason why an urgent assessment is reqiuired.

3. Medication details, including generic name, form and strength, dosing regime and potential costs.

4. Requested indication.

5. Registration status with TGA, PBS, and LAM.

6. Clinical details including detailed reasons for the choice of medication and why alternatives are not suitable, other clinical details including test results, and any issues that non-approval may have on patient care.

7. How efficacy will be measured. Additionally, if the medication was used previously, what effect has it had.

8. Evidence. Provision of evidence is critical to success of any application. Electronic copies of papers etc must be attached to the final email.

9. Any other relevant details including any potential conflicts of interest.

10. Your details, the treating consultant, departmental director and financial delegate. Their authorization is required prior to the application being assessed.

Submission is via email. Once the form is completed, an email page will open with the recipient address pre-populated. You will be required attache a PDF of the application, attach evidence documents, and send it to Pharmacy.

Constant dosing

Individual Dosage:	(enter typical dose and indicate dose range in notes below)
Cost per dose:
Dosing frequency:	doses per

Variable dosing

Detail regimen:
Detail cost for each dosage proposed:

Insert TGA indications here:

Insert PBS indications here:

Insert LAM indications here:

Results of previous treatment:

Expected treatment outcomes from future treatment:

Detail any potential or actual conflicts of interest here:

Your Name:
Department:
Position:
Your Email:
Consultant
Name:
Department:
Position:
Clinical Director:
Name:
Department:
Email address:
Financial Approval:
Name:
Cost Centre:
Position:
Email address:

Note. Changes cannot be made after this.

You are about to submit this application by email. Three steps are required.

1. Clicking on the button below will open an email window and a printer dialog.

2. You must print the application using 'Microsoft Print to PDF' printer option.

3. You must attach the PDF application generated in step 2 to the email.

4. You must attach the evidence documents to that email.

Applications recieved without accompanying evidence will be returned.

Thank you for your application. You will be notified of the decision soon.

Last Name:		First Names:
UR Number:		Date of Birth:
		Gender:

Generic Name:
Trade Name:
Form and Strength:	(eg 100mg tabs, 250mcg ampoules)
Medication dosing:	Constant Variable

Duration of this application:
Overall planned duration of therapy:
Planned (or actual) start date:
Additional notes:

1. Patient Details:	Yes No	I have completed all patient details required.
2. Urgency:	Yes No	Application urgency entered including reasons for requesting urgent review.
3. Medication Details:	Yes No	All medication details entered.
4. Requested Indication:	Yes No	A concise indication has been entered.
5. Registration Status:	Yes No	I have completed TGA, PBS and LAM registration details.
6. Clinical Details:	Yes No	I have completed all relevant clinical details.
7. Outcome measures:	Yes No	I have completed outcome measures.
8. Evidence:	Yes No	I have completed details of supporting evidence and will attach electronic copies to the final email..
9. Conflict of Interest Statement:	Yes No	I have completed the conflict of interets statement and detailed any actual or potential conflicts if present.
10. Applicant's Details:	Yes No	All details are complete
11. Acknowledgement:	Yes No	The information entered above is correct at the time of application.
12. Consent:	Yes No	I commit to obtaining informed consent for the use of this medication. This will include details of its registration status when it is not TGA registered for the requested indication. It will also include that an approval does not create an obligation for ongoing supply.
13. Reporting:	Yes No	I agree to reporting any suspected or actual adverse drug reactions to the committee.

Indicate urgency of application:
If urgent, why:

DDHHS Non-LAM Application Form