Appendix 2 - Standard Submission to Add a Medicine, or
Make Any Other Major Change, to the Queensland Health
List of Approved Medicines (LAM)
The Queensland Health Medicines Advisory Committee (QHMAC) has determined that applications for the
addition of a medicine, or a major change in restriction to an included medicine in the LAM should contain the
following information, to allow an informed decision to be made: Please type/write responses in the boxes
provided.
Details of Medicine Requested (If you are requesting a deletion, please give a brief summary of
reasoning and complete as much of this form as is appropriate).
Generic Name
Trade Name
Dosage Form
Strength
Pack Size
Manufacturer/Supplier
TGA Registration
Is the medicine registered by the Therapeutic Goods Administration for marketing in Australia? YES / NO
If YES, list the indications that the medicine is registered for:
PBS Availability
Is the medicine listed as a benefit under the Pharmaceutical Benefits Scheme?
If YES: Is it a Section 100 item?
YES / NO
YES / NO
If YES, list its PBS indications:
Reasons for the Request
(Please state why the medicine is required for further indications or preferred to alternative medicine(s)
currently available in the LAM in terms of efficacy, safety, advantages, etc.).
Indication Requested and specific patient group(s) likely to benefit from its availability
Appendix 2 - 1
Suggested Prescribers
Should the medicine be restricted to a particular group of prescribers?
YES / NO
If YES, please indicate (eg. Restricted to Specialist Oncology Staff).
Suggested LAM restriction (please indicate appropriate wording)
Medicine(s) currently available in the LAM for the above indication(s):
Medicine(s) that could be deleted from the LAM (or usage reduced) if this request is
approved:
Safety
Please list the nature and incidence of side effects for the new medicine / indication:
The source of this information is:
Manufacturer’s product information
Other (please specify below)
How do these differ from the nature and incidence of side effects for the LAM medicines(s) in current use for
this indication?
The source of this information is:
Manufacturer’s product information
Other (please specify below)
Appendix 2 - 2
Evidence Supporting the Proposed Therapy (list all relevant references)
Reference
Randomised Trial
Yes
No
Title:
Non-Randomised Trial
Yes
No
Case study with no controls
Yes
No
Yes
No
Absolute Risk Reduction c.f. control
Statistically Significant P<0.05
Author(s):
95% Confidence Interval
Number Needed to Treat
Evidence of clinical improvement
Journal:
% Active vs
A
%Control
Date/Year:
Grading
B
C
Reference
Randomised Trial
Yes
No
Title:
Non-Randomised Trial
Yes
No
Case study with no controls
Yes
No
Yes
No
Absolute Risk Reduction c.f. control
Statistically Significant P<0.05
Author(s):
95% Confidence Interval
Number Needed to Treat
Evidence of clinical improvement
Journal:
% Active vs
Date/Year:
Grading
A
%Control
B
C
Level of Evidence supporting the proposed therapy
Grade A
Supported by at least one, and preferably more large randomised trials with clear-cut results
and low risk of error,(statistically significant results P<0.05), and the results of such studies published
in peer-reviewed journals. It would be expected that the results would demonstrate substantial clinical
benefit.
Grade B
Supported by at least one small randomised trial with uncertain results and moderate to high risk of
error (statistically not significant P>0.05), ie randomised trials with positive trends but of low power due
to small sample size to reach statistically significant results. It would be expected that the results would
demonstrate substantial clinical benefit.
Grade C
Supported by only non-randomised concurrent cohort comparisons between contemporaneous
patients, or non-randomised historical cohort comparisons between current patients and former
patients, or case studies with no controls. It would be expected that the results would demonstrate
substantial clinical benefit.
Appendix 2 - 3
Benefits in Safety and Efficacy (include references)
New
Current
Main Benefit in Safety
Incidence of main adverse event expressed as a percentage. Please specify
(eg stroke, mortality, allergic reaction, etc.)
%
%
Main Benefit in Effectiveness
Incidence of effectiveness outcome expressed as a percentage. Please specify
(eg main outcome achieved, cure, relapse rate, etc)
%
%
New
Current
Additional Benefits
Please specify (eg surgery or procedure averted, admission averted, reduced
length of stay, etc)
Treatment Costs (b, c, e, g must be completed – contact QHMAC Secretariat if assistance required)
Requested
item
LAM
comparator
$
$
d. Cost per standard course (a x b x c)
$
$
e. Additional costs or savings per patient per course. Please specify (incl
monitoring, drug administration costs, additional equipment required,
etc)
$
$
f.
$
$
a. Cost per dosage unit. (Indicate source)
b. Average number of dosage units administered per patient per day
c.
Average duration of treatment in days (if continuous write ‘365’)
Total annual cost per patient (d + e)
g. Expected number of patients per year (in your clinic / hospital / HHS)
Financial Implications (complete if possible)
Requested item
Annual cost (f x g)
$
LAM comparator
$
Likely number of patients in Qld
Any other cost reductions, apart from those considered in (e) above
Appendix 2 - 4
Difference
$
Potential Conflict of Interest Statement
All relevant potential conflicts must be declared, regardless of whether the applicant considers them
to be significant, or not.
I certify that I am not aware of any potential conflict of interest which may arise in respect of this
application.
(Please note that it is not assumed that any of the activities listed necessarily constitute a conflict of
interest which would disqualify the applicant from making submissions to QHMAC).
OR
I may have a potential conflict of interest for the following reason/s:
[eg Receipt of research funds from a sponsoring company; Receipt of ex-gratia payments or
consultancy fees from a sponsoring company; Overseas/interstate trips funded or subsidised by a
sponsoring company; Personal or family shares in the company sponsoring the product/s (or
competing product/s) for which application is made].
Please identify any potential conflicts of interest
Requested by
Name of
Applicant:
Signature:
Appointment:
Hospital:
Contact Phone
Number/Pager:
Email
address:
Date:
I give permission for this application to be shared with other QH clinicians.
OR
I do not give permission because:
Please provide copies of all materials cited above.
Use of promotional materials from Pharmaceutical companies is inappropriate. Please note that you may be
requested to provide follow-up review or audit after the application is approved.
It is recommended that the application be typed, rather than handwritten. A request can only be made by a
staff member of Queensland Health.
An electronic copy of this form is available in Word format on the Medication Services Queensland (MSQ)
QHEPS site at http://qheps.health.qld.gov.au/medicines/ [Click on “List of Approved Medicines (LAM)”] or
http://www.health.qld.gov.au/qhcss/mapsu/ Guidelines on “How to Make a Submission for a Change to the
Queensland Health List of Approved Medicines” are also available from this site.
Appendix 2 - 5
Comments
Medical Superintendent / Executive Director of Medical Services:
Name:
Signature:
Date:
Signature:
Date:
E-mail address:
Director of Pharmacy:
Name:
E-mail address:
Local Medicines Advisory Committee (MAC):
Name:
Signature:
Date:
Email address:
Submission of the Application
(1) If your hospital has a local Medicines Advisory Committee (MAC), the completed submission form
and supporting information should be sent to them. The local MAC will consider your request and
forward it on to the Queensland Health Medicines Advisory Committee (QHMAC) with their
recommendation.
(2) If your hospital does not have a local MAC, then the completed form should be sent to your local
Medical Superintendent and Director of Pharmacy for their comments, PRIOR to sending it to QHMAC
(see address below).
Checklist for Application
Please satisfy each of the following before you submit the application. Failure to do so will delay review of
the application.
(a)
(b)
(c)
(d)
(e)
(f)
Have you answered every question or indicated not applicable?
Have you provided costing data?
Have you included a Prescribing Guideline/Protocol?
Have you included supporting documentation for your submission?
Have you obtained comments from Medical Superintendent, Director of Pharmacy?
Is there a recommendation from the local MAC?
Once the local Medicines Advisory Committee (or Medical Superintendent and Director of Pharmacy) has
considered the request, they should forward it to QHMAC.
The submission should only be sent to QHMAC after completing either (1) or (2) above.
Address:
Executive Secretary, QHMAC
Medication Services Queensland
PO Box 126, RBWH PO
HERSTON QLD 4029
Email:
QHMAC-Secretariat@health.qld.gov.au
QHMAC Secretariat:
Date Submission
Received:
Date applicant emailed/ phoned
to acknowledge receipt:
Appendix 2 - 6