Medicines for multiple myeloma

Overview

The Department is undertaking a research project to examine Pharmaceutical Benefits Scheme (PBS) arrangements for medicines used in the treatment of multiple myeloma (MM), including relapsed or refractory multiple myeloma.

The objective of the project is to contribute to a better understanding of the issues associated with expanding access to PBS-listed medicines for MM, with consideration of treatment pathways across the full disease course. The project will develop evidence-informed options for consideration by the Pharmaceutical Benefits Advisory Committee (PBAC) regarding future PBS settings.

This project was identified in the August 2026 Post-market Review Workplan and is being undertaken as a staged research project. The Department has engaged the Centre for Health Economics at Monash University to undertake this work.

Why are we undertaking this work?

Stakeholder meetings on PBS subsidy arrangements for multiple myeloma medicines were held between members of the PBAC and representatives from the Department, industry and consumer organisations, including Myeloma Australia, in July 2025 and February 2026.

Issues raised by stakeholders during these meetings included that achieving the preferred treatment landscape may require amendments to current PBS restriction settings. Stakeholders identified several areas where PBS arrangements may no longer fully reflect contemporary clinical practice, treatment sequencing or emerging therapies.

This research project will build on:

• outcomes of the PBAC multiple myeloma stakeholder meetings held in July 2025 and February 2026;
• correspondence from Myeloma Australia's Medical and Scientific Advisory Group;
• principles discussed with sponsors of multiple myeloma medicines during stakeholder engagement activities.

The project aims to support transparent, consistent and sustainable decision-making regarding access to PBS-subsidised multiple myeloma treatments.

Project objectives

The project seeks to:

• examine how current PBS restrictions align with indications approved by the Therapeutic Goods Administration (TGA), contemporary clinical guidelines and treatment pathways in clinical practice;
• assess issues associated with access to PBS-listed treatments for people with multiple myeloma;
• support PBAC consideration of evidence-informed options for future PBS settings; and
• where appropriate, assess the economic and financial implications of options recommended by the PBAC for further analysis.

Key issues being explored

The project will examine a range of issues raised through stakeholder engagement activities, including:

• movement from PBS restrictions based on line of therapy to approaches based on previous medicine and/or medicine-class exposure;
• the ongoing relevance of transplant eligibility distinctions within PBS restrictions;
• simplification of PBS restriction structures;
• broader access to generic medicines where appropriate;
• access to important treatment regimens, including daratumumab-containing regimens;
• optimisation of treatment sequencing and treatment duration;
• positioning of chimeric antigen receptor (CAR) T-cell therapies and bispecific antibodies within treatment pathways; and^*
• the potential future role of minimal residual disease in treatment decision‑making.^*

The identification of these issues does not indicate any predetermined outcome and is intended to support the PBAC’s evidence-based consideration of potential future PBS settings.

*As myeloma treatment and testing extend beyond the PBS, the outcomes of this research project will also be provided to the Medical Services Advisory Committee and state and territory governments for consideration, where relevant.

Approach

The project is being undertaken in stages.

Stage 1: Review and options development

The initial stage will examine:

• current PBS restrictions for multiple myeloma medicines;
• TGA-approved indications;
• contemporary Australian and international clinical guidelines;
• treatment pathways in clinical practice; and
• available evidence relating to future PBS settings and restriction structures.

This work will inform the development of options for PBAC consideration regarding future PBS arrangements for multiple myeloma medicines.

Stage 2: Economic and financial analysis

Subject to PBAC advice on the options developed in Stage 1, selected options may undergo further economic evaluation and financial impact analysis.

This work will support subsequent PBAC consideration of potential changes to PBS settings for multiple myeloma medicines.

Stakeholder engagement

Stakeholder engagement will occur throughout the project.

The draft Stage 1 report will be released for public consultation, which is anticipated to take place from December 2026 to January 2027. Stakeholders, including consumers, clinicians, pharmaceutical sponsors and other interested parties, will be invited to provide feedback on the report to inform the development of options for PBAC consideration.

In addition to public consultation activities, sponsors and other stakeholders may have opportunities to provide input through established PBAC processes, including pre-PBAC responses and, where applicable, pre-subcommittee responses.

Further information regarding stakeholder engagement opportunities will be published on this webpage as the project progresses.

Process and indicative timeline

The project is expected to progress through a number of stages. Please note that the timeframes below are indicative only and may change as the project progresses.

Related information

• August 2026 Post-market Review Workplan
• Multiple Myeloma Stakeholder Meeting Outcome Statement (July 2025)
• Multiple Myeloma Stakeholder Meeting Outcome Statement (February 2026)

Further information

Updates will be published on this webpage as the project progresses, including information about stakeholder engagement opportunities and consultation activities.

Please direct any enquiries to the Quality Use of Medicines Reviews and Programs Section.

Subscribe to PBS News for updates regarding reviews, consultations and publication of project outcomes.

Read more about post-market reviews on the Reviews webpage.