15 December 2017 - The recommendations from the November 2017 PBAC meeting are now available.

Submissions

• 69 submissions were considered; all 69 related to the listing of a medicine, medicinal preparation or gene therapy on the Pharmaceutical Benefits Scheme

• 64 of the 69 submissions were for a medicine, four were for a medicinal preparation and one was for a gene therapy (nusinersen sodium)

• All were lodged by a sponsor/pharmaceutical company (i.e. there were no third-party submissions)

• 39 (57%) were major submissions

• 48 (70%) were initial submissions and 21 (30%) were resubmissions

• 21 (30%) submissions were for ‘new medicines’

• 19 (28%) submissions included a CEA/CUA. The economic evaluation in some submissions is as yet unknown.

• 33 (48%) submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 12 (17%) were for medicines in WHO ATC Group A (alimentary tract and metabolism) and 8 (12%) were for medicines/medicinal preparations in WHO ATC Group V (various)

• Three submissions appear to have been withdrawn; one was for a new medicine

• The PBAC considered a few minor submissions that were not included in the published agenda

Outcomes

• The 69 submissions yielded 98 outcomes; 54 (55%) recommendations, 31 (32%) rejections, 8 (8%) deferrals and 5 (5%) no outcomes. Insofar as some submissions included multiple requests; the number of outcomes exceeds the number of submissions.

• 11 of the 21 submissions for new medicines considered by the PBAC were recommended

• The 19 submissions that are known to have included a CEA/CUA yielded 22 outcomes; 2 (9%) recommendations, 18 (82%) rejections and 2 (9%) deferrals.

• 16 of the 31 rejections were for medicines in WHO ATC Group L (3 of these 16 rejections are for a medicine that is not used by patients with cancer)

• The 21 resubmissions yielded 28 outcomes of which 14 (50%) were recommendations

Additional analyses of the PBAC outcomes will be published in the coming days.

Read November 2017 PBAC outcomes