PBS listing timelines for new checkpoint inhibitors

MAESTrO Database

1 October 2018 - The PBAC examined their PBS listing timelines at its recent special meeting.

The PBAC conducted a special meeting in August to consider a request from the Minister of Health to provide him with advice on options for listing PD-1 and PD-L1 checkpoint inhibitors for the treatment of multiple cancer indications on the PBS. Specifically, the PBAC was asked to advise the Minister on 1) the current status of PD-1 and PD-L1 checkpoint inhibitors for the treatment of cancer; 2) on any issues around access to medicines for people with rare cancers, particularly where there are no existing effective therapies, and 3) options that could broaden or lead to faster PBS listing for cancer indications.

"The PBAC was reassured that the time from registration to reimbursement for checkpoint inhibitors in Australia, which ranged from 111 to 1,055 days (median 320 days) was consistent with the average time for PBS listing of other medicines and the timelines of international bodies. The PBAC noted the Strategic Agreement between Government and Medicines Australia initiatives aimed at improving the efficiency, transparency and timeliness of PBS listing processes, and agreed this work should further improve timeliness of access."

The following checkpoint inhibitors have been listed on the PBS as at 1 October 2018:

Pembrolizumab (Keytruda)

  • Malignant melanoma
  • Hodgkin's disease

Nivolumab

  • Malignant melanoma
  • Renal cell carcinoma
  • Non-small cell lung cancer (squamous cell)
  • Non-small cell lung cancer (non-squamous cell)
  • Head and neck cancer

Atezolizumab

  • Non-small cell lung cancer

MAESTrO has attempted to validate the PBS listing timelines cited above; they cannot be replicated. The range  is 115 days (nivolumab; malignant melanoma) to 572 days (nivolumab; non-small cell lung cancer) using the date of the delegate's decision, rather than ARTG start date, as date of TGA approval.

Michael Wonder

Posted by:

Michael Wonder