Hospitals play a significant and important role in funding high-cost medicines so patients can access treatments they need. High-cost medicines are often specialty medicines, which contribute to a significant and increasing portion of the hospital budget. It is imperative that these expensive medicines are governed and managed with a fair, standardized evidence-based process. We aim to provide a framework for Drugs and Therapeutics Committees (DTCs).

During 2021, Guiding Principles were developed following a literature review and survey of current practices by DTCs in Australia. An Expert Advisory Group (EAG) was convened, comprising individuals with expertise in quality use of medicines, evidence-based medicine and medicines governance. The guiding principles were drafted by the EAG, in consultation with a range of stakeholders and relevant external organizations. All feedback was collated, reviewed and discussed to refine the content of the final Guiding Principles released in January 2022.

Seven overarching principles provide key recommendations for the governance of high-cost medicines:

1. (i) A definition of high‑cost medicines should be determined and clearly articulated for use by each medicines governance committee.

2. (ii) Review of high-cost medicines requires members with relevant expertize to facilitate good and effective decision-making.

3. (iii) The committee should engage directly with the applicant prior to review to ensure a full understanding of the rationale for the request.

4. (iv) consistent, robust and transparent procedure for the assessment of high-cost medicine applications should be defined and implemented for use by each medicines governance committee to ensure fair process.

5. (v) Ethical considerations fundamentally underpin deliberations around high-cost medicines.

6. (vi) The decisions and outcomes of the decision making should be transparent and appropriately communicated to the various audiences.

7. (vii) The high-quality assessment of high-cost medicines requires appropriate training and resourcing.

These national Guiding Principles promote consistent, evidence-based use of high-cost medicines and provide a framework for DTCs to assess and achieve effective governance for the quality use of high‑cost medicines.