Resources for evaluation of new medicines
DTC Formulary Submission and IPU Application Templates
NSW TAG has developed templates and accompanying tools to assist hospital Drug and Therapeutics Committees in systematic, evidence-based review and decision-making about applications for new medicines or new indications in accordance with NSW Health Policy Directive PD2008_037: Evaluation of Medicines for Use in Public Hospitals.
The formulary submission and IPU application template were updated in December 2009 based on feedback from the NSW TAG membership and clinicians working in NSW public hospitals. The updates included prompts for the inclusion of PBAC public summary documents, where relevant, and the acknowledgement of the multidiscplinary nature of these forms.Evaluation of these documents is ongoing and modifications will be considered as required. Feedback about the tools and suggestions for improvement are very welcome.
Templates and Tools
- Information for DTCs about the use of the tools and templates
PDF ~ 30 KB | MS_Word ~ 65 KB
- Formulary Submissions:
- Formulary submission template
PDF ~ 98 KB | MS_Word ~ 118 KB
- Prescribing protocol template
PDF ~ 22 KB | MS_Word ~ 61 KB
- DTC decision algorithm for evaluation of medicines
PDF ~ 33 KB | MS_Word ~ 53 KB
- Device containing Medicines Submissions:
- IPU Applications:
- IPU application template
PDF ~ 692 KB | MS_Word ~ 84 KB
- Decision Algorithm for evaluation of medicines for IPU approval
PDF ~ 29 KB | MS_Word ~ 44 KB
- For all submissions/applications to DTC:
- Supplementary information template (for use by DTC delegate)
PDF ~ 15 KB | MS_Word ~ 67 KB
- NPS questions to ask when evaluating a new medicine
PDF ~ 89 KB
- High Cost Medicines:
High Use IPU Medicines
In general, hospitals have been recommended to consider adding to formulary those medicines which have had more
than three IPU applications approved. However many of these medicines are expensive and use requires ongoing monitoring
to ensure there are no cost blowouts. Some hospitals have developed streamlined IPU forms to facilitate DTC approval processes
for these medicines but ensure that outcomes are monitored and DTC continues to have oversight of the medicines use.
Below are examples of steamlined IPU forms from St Vincentâ€™s Hospital:
Other Resources for DTC decision makers
- Achieving effective medicines governance: Guiding Principles for the roles and responsibilities of Drug and Therapeutics Committees in Australian public hospitals, November 2013.
- Managing Medicines Access Programs : Guiding Principles for the governance of Medicines Access Programs in Australian hospitals, May 2015.
- Overseeing biosimilar use: Guiding Principles for the governance of biological and biosimilar medicines in Australian hospitals. Version 2, September 2016.
- Position Statement for the use of Complementary and Alternative Medicines, May 2015.
- Rethinking Medicines Decision Making : Guiding Principles for the quality use of off-label medicines.
- Achieving Effective Medicines Governance: Guiding Principles for the roles and responsibilities of Drug and Therapeutics Committees in Australian public hospitals.
- Appendix 6: Drug and Therapeutics Committees Checklist (version 1).
In addition the NPC has released an e–Learning package that considers the legal and ethical aspects of local decision-making about the funding of medicines and treatments.