STATEWIDE MEDICINES FORMULARY - SUBMISSION FORM Pharmaceutical Benefits Scheme (PBS) listed medications

What is this form for?

This form is to apply to list a new, Pharmaceutical Benefits Scheme (PBS) listed medication on the Statewide Medicines Formulary (SMF). For applications of non-PBS listed medications please use the SMF Submission Form (non-PBS). Requests to amend wording of a current SMF restriction should be emailed to WADEP@health.wa.gov.au.

Who can apply?

Submissions may be made by a senior health professional working for the WA health system (i.e. from a Health Service Provider (HSP) or contracted health entity). The SMF is applicable to all public health services.

Application process:

Prior to the application being commenced, notice of intent to submit should be given to the WADEP Secretariat to ensure applications are not duplicated.

Once a submission is received, the WADEP secretariat will inform relevant Heads of Departments and Drug and Therapeutics Committees (DTC) for open comment regarding submission content and to prevent duplication of submissions.

The submission form should be completed in full.

Applicants should garner comments from peers and/or support for the application within and across departments and other HSPs. This will strengthen the application and shorten the review process.

Applicants should consider the medicine’s place in therapy, particularly if a treatment guidelines needs to be amended or developed. High-cost or complex medicines will most likely require a treatment algorithm. Submission of an algorithm may also help to shorten the review/post-review process.

Applicants must have the support of their line manager (e.g. Heads of Department, Clinical Service Director) for the submission after discussing cost, affordability and strategic / service delivery implications.

The submission cannot proceed without a signed conflict of interest declaration. Electronic signatures or HE numbers are accepted in place of physical signatures

Completed applications or questions may be forwarded to the WADEP secretariat; WADEP@health.wa.gov.au

Pharmaceutical Benefits Scheme (PBS) Submission Form

Complete ALL shaded boxes.

Details of the medicine
Approved (generic) name:	Click here to enter text.
Trade (brand) name(s):	Click here to enter text.
Pharmaceutical sponsor:	Click here to enter text.
Dosage form(s):	Click here to enter text.
Strength(s):	Click here to enter text.
Standard dose:	Click here to enter text.
Usual duration of treatment:	Click here to enter text.

New PBS Listing Details
Requested PBS indication:
Click here to enter text.
Related prescribing criteria:
Click here to enter text.
If the medication is not yet available on the PBS please provide the expected list date.
Click here to enter text.

Population
All adult applications should consider if paediatric use is likely to be required; if you do not regularly work in paediatrics seek the advice of a relevant paediatrician/paediatric specialist.
A	Adult	☐	Paediatric	☐	Both	☐
B	Tertiary services	☐	Other hospital/services	☐	All	☐
C	Inpatient	☐	Outpatient	☐	Both	☐
What proportion of patients will be initiated on this medication as an inpatient statewide per annum? NOTE: Hospitals do not receive PBS reimbursement for medicines dispensed to admitted inpatients. Where possible, consider if your patients can be initiated on the medication on discharge or as an outpatient.	Click here to enter text.

Rationale for submission
Tick the box that best describes the rationale for this submission:
Treatment need: Prevention or treatment of medical condition inadequately covered by currently listed options	☐
Improved efficacy: More effective than and as safe as currently listed options	☐
Improved safety: Safer than and as effective as currently listed options	☐
Improved cost: Less expensive than and as effective and safe as currently listed options	☐
In your own words outline the rationale for this submission:
Click here to enter text.

Place in therapy
When is the new medicine to be used in therapy?
First – line ☐	Subsequent – line ☐	At any stage ☐	Preventative use ☐
What PBS listed medications are currently used for this indication?
Click here to enter text.

Comparators
What non-PBS treatments are currently used for this indication (include non-medicine alternatives i.e. surgery)?
Click here to enter text.
With the addition of this new medication, to what degree will patients have treatment changed (e.g. totally replace comparator’s place in therapy)?
Click here to enter text.
Can any of the above be delisted or rationalised?
Click here to enter text.

Supporting evidence: All submission must have the pivotal trial(s) attached.

Benefits and outcomes
Outcomes
What is the desired outcome(s) of therapy from the new medicine (e.g. cure, relief from symptoms, relapse rate, survival, prevention of complication etc.)?
Click here to enter text.
How is this outcome measured? Is this a validated test? Is this the outcome measure used in practice?
Click here to enter text.

Safety
Are there safety concerns pertaining to this medication’s use in hospitals (i.e. administration, potential for medication errors)?
Click here to enter text.
Are there concerns with continuity of care and/or equity of access pertaining to this medication?
Click here to enter text.

Cost and utilisation
Comparative cost / patient It is recommended that you ask the pharmacy department for the purchase price of medications. This is the cost to the hospital for inpatient use and may differ from the PBS price.
The comparator used for this section should be the same as 1.5. If a different comparator is used state the name, dose and rationale.
Click here to enter text.
Requested medicine (purchase price)	Comparator (purchase price)
Cost per standard dose (if weight based use 70 kg)	$ text	$ text
Treatment course (continuous, cyclical / intermittent, finite)	text	text
Average number of days of treatment / treatment course	text Days	text Days
Average estimated cost / patient / annum	$ text	$ text
Additional costs identified (specify below)	$ text
Click here to enter text.
Additional savings identified (specify below)	$ text
Click here to enter text.
Total cost / patient / annum	$ text	$ text
Other relevant cost information
Click here to enter text.
State the source of the above information
Click here to enter text.

Utilisation
Total number of patients expected to start treatment at your hospital per annum	text
Total number of patients expected to start treatment across WA per annum It is advisable to speak with colleagues from other sites likely to treat the requested indication. The WADEP EO may be able to provide you names of the relevant clinicians.	text
Total number of patients expected to cease treatment across WA per annum	text

Applicant and applicant support details
Input from others
It is highly recommended that the applicant consult with all Departments within and external to their hospital relevant to this application (including other specialties likely to prescribe the medicine).
Provide details of the people consulted and had input in this application.
Click here to enter text.
Was a pharmaceutical company representative involved in the preparation of this submission?	Yes ☐	No ☐

Authorisation
This submission requires authorisation by the applicant’s Head of Department. Applicants that are HODs should have a peer or authority above themselves (i.e. Medical Services Director) sign-off.
HoD Name and position:
Signature (or HE number):	Date:

Applicant details
Name:
Position:
Clinical unit and practicing hospital(s):
Primary email:

Conflict of interest All relevant potential conflicts must be declared, regardless of whether the applicant considers them to be significant, or not. Please note conflict of interests declared may not disqualify the applicant from making submissions to the SMF. The following are examples of COI: paid positions, honoraria, sponsorship of research, travel/conference funding, shares or commercial dealings, gifts, or entertainment.
With reference to the WA Health Code of Conduct regarding conflict of interests:
I certify that I am not aware of any potential conflict of interest which may arise in respect of this application.	☐
OR
I may have a potential conflict of interest (complete the question below).	☐
Briefly describe each potential conflict:

Applicant declaration I declare, that to the best of my knowledge, all the information contained in this application is true and accurate.
Applicant Name:
Signature (or HE number):	Date:

The WADEP and the Statewide Medicines Formulary Team does not take responsibility for any delay in the application process where this form is not completed in full or to the best of the applicant’s ability. Whilst WADEP and the SMF Team will attempt to contact and assist the applicant, gaps in relevant information may hinder the process or may attribute to a negative outcome. If you have any questions or concerns, or for advice and tips on how to complete this form please contact the SMF Team.

Please email the completed form and/or questions to WADEP@health.wa.gov.au