In Australia, a government advisory committee* determines whether to recommend that a medicine should be subsidised.

As part of its decision-making process, this committee invites people with the condition, as well as their carer/s and family, to have their say on how this medicine would benefit them.

Once this committee provides a positive recommendation, it is then up to the Federal Government to list the medicine on the Pharmaceutical Benefits Scheme (PBS).

This is a separate process to how medicines are registered for use in Australia. Medicines that are registered are deemed to be effective and safe for use, but medicines often need to be publicly funded before they are affordable to most Australians.

*PBAC = Pharmaceutical Benefits Advisory Committee

The Pharmaceutical Benefits Advisory Committee (PBAC) is considering whether Darzalex (also known as daratumumab) in combination with lenalidomide and dexamethasone, should be publicly funded for Australians newly diagnosed with multiple myeloma who are unable to have a stem cell transplant.

However, overseas Darzalex is considered the gold standard of care for this group of patients.1 Currently, Darzalex is listed on the PBS as a second-line of therapy. This means that to receive subsidised access to Darzalex, Australians with myeloma need to have already received first-line therapy and their myeloma has progressed.

Myeloma Australia would like to see more treatments available for Australians with myeloma in line with the clinical benefit shown in clinical studies.

Many Australians do well when treated with a stem cell transplant. However, more than half (60%) of Australians2 – 1,500 people – are considered unable to have a stem cell transplant when they are first diagnosed with myeloma.

Research indicates that 57% of those who are unable to have a stem cell transplant do not progress to a second line of therapy.3 This highlights the need for more effective treatments to be used earlier in this group of patients and it is important that the most effective treatments are used upfront.4.

In clinical studies, people with newly diagnosed myeloma who were unsuitable for transplant have been shown to benefit from significantly improved progression free survival and overall survival when treated with Darzalex in combination with lenalidomide and dexamethasone, compared to lenalidomide and dexamethasone alone.1

Anyone living with myeloma can respond to this consultation. The committee also welcomes submissions from carers and family members of those living with myeloma.

Myeloma Australia is advocating for treatments to be made available for people with newly diagnosed myeloma. We believe that the choice of treatment should be a decision for the treating clinician in discussion with the person undergoing treatment.

The committee asks for you to be as specific as possible in your submission. The consultation asks about your experience of living with myeloma, your experience of treatments, and your expectations regarding the impact that new treatments will have on your life, including what you see as the advantages and disadvantages of the new treatment. The committee disregards submissions that are duplicative and simply call for access to new therapies.

7. How can I have my say?

  • To have your say, go to the following link before 25 January
  • Select ‘DARATUMUMAB (Darzalex®): Multiple myeloma’ from the drop-down menu in Question 7

References

  1. Facon T, et al. Treatment Regimens for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: A Systematic Literature Review and Network Meta-analysis. Adv Ther. 2022 May;39(5):1976-1992.
  2. Bergin K, et al. Australian and New Zealand Myeloma and Related Diseases Registry. The Myeloma Landscape in Australia and New Zealand: The First 8 Years of the Myeloma and Related Diseases Registry (MRDR). Clin Lymphoma Myeloma Leuk. 2021 Jun;21(6):e510-e520.
  3. Fonseca, R., et al. Frontline treatment patterns and attrition rates by subsequent lines of therapy in patients with newly diagnosed multiple myeloma. BMC Cancer 20, 1087 (2020).
  4. Zhao J, et al. Real-world treatment patterns in relapsed/refractory multiple myeloma in Australia: results from the Myeloma and Related Diseases Registry. Presented at, BLOOD 2019, Perth, Australia, October 2019