24 April 2020 - The recommendations from the March 2020 PBAC meeting are now available.

Submissions

45 submissions were considered by the PBAC; all relate to the listing of a medicine or medicinal preparation on the Pharmaceutical Benefits Scheme. Two submissions, which appeared in the published agenda (version 1), were not considered by the Committee.

• 18 (45%) were major submissions
• 29 (63%) were initial submissions and 16 (37%) were resubmissions
• 14 (31%) submissions were for a ‘new (single entity) medicine’
• 14 (31%) submissions were for a cancer medicine
• 4 (9%) submissions included a CEA/CUA. The type of economic evaluation in some submissions is as yet unknown.
• One submission was withdrawn (siponimod hemifumarate, Mayzent)
• The PBAC considered one minor submission that was not included in the published agenda

Outcomes

The 45 submissions considered by the PBAC yielded 66 outcomes;46 (70%) recommendations, 14 (21%) rejections, 5 (7%) deferrals and 1 (2%) no outcome. Insofar as some submissions included multiple requests; the number of outcomes exceeds the number of submissions.

• 8 (57%) of the 14 submissions for a new medicine were recommended
• The 14 submissions for a cancer medicine yielded 18 outcomes; 11 recommendations and 7 rejections

Insights

• No medicine appears to have been recommended on the basis of a comparison with a lowest cost alternative
• As expected, most of the medicines recommended by the PBAC have an associated requirement for there to be a risk sharing agreement
• The PBAC considered seven submissions for a PD-1/PD-L1 inhibitor; five were recommended
• The PBAC has recommended the PBS (Authority required) listing of dupilumab (Dupixent) on the third attempt. The PBAC had some concerns about the appropriate target patient population for dupilumab; it has finally settled on ‘patients aged 12 years and older with severe atopic dermatitis who are inadequately controlled on topical therapies.’ More on this in tomorrow’s edition of MAESTrO Daily.
• The PBAC has recommended the PBS (Authority required) listing of romosozumab (Evenity) for ‘patients with severe osteoporosis who have experienced a prior fracture while on anti-resorptive therapy.’ Like dupilumab, it was a case of ‘third time/submission lucky’.
• The PBAC did not consider a minor resubmission for siponimod hemifumarate (Mayzent). Whilst it appears as an agenda item (version 2), it was subsequently removed from the agenda by the Department of Health in the basis that it should have been a major submission. It is unclear if the PBAC will consider another submission at its next scheduled meeting in July. The agenda for the July meeting is due to be published this week.
• The PBAC did not consider EUSA Pharma’s submission for dinutuximab beta (Qarziba). It was EUSA Pharma’s first ever PBAC submission. It was determined during the evaluation process that dinutuximab beta was likely to be predominantly administered to inpatients in tertiary public hospitals. As such, it is more it suited to be funded jointly by the Commonwealth and the States through the National Health Reform Agreement (NHRA). The submission has been referred to the Medical Services Advisory Committee, who has assessed all previous applications for funding through the NHRA. This appears to be the first time this has happened.
• More insights from the March meeting will be published in MAESTrO Daily this week, including an interesting finding for MSD’s Keytruda

Read PBAC outcomes