Summary of submissions and outcomes from the November 2014 PBAC meeting
Michael Wonder, Wonder Drug Consulting Pty Ltd
www.maestrodatabase.com
Submissions
·
61 submissions were considered by the November 2014 PBAC
meeting. 59 of the 61 submissions were prepared
and lodged by the pharmaceutical industry.
·
59 of the 61 submissions related to the Pharmaceutical
Benefits Scheme (PBS), two to the PBS (Section 100); the remaining two submissions
related to the National Immunisation Program (NIP)
·
52 of the 61 submissions were for medicines, two were for a
medicinal preparation (nutritional supplement/blood glucose indicator strip)
and the remaining two were for a vaccine
· 49 were initial submissions and 12 were
resubmissions
·
16 submissions were for new medicines
·
24 submissions were for medicines in WHO ATC Group L (anti-neoplastic
and immunomodulating agents), 9 were for medicines in WHO ATC Group V (various)
and 6 were for medicines in WHO ATC Group A (alimentary system)
Outcomes
·
The 61 submissions yielded 84 definitive outcomes;
62 (74%) recommendations, 12 (14%) rejections and 10 deferrals (12%)
·
10 of the 16 submissions for new medicines
were recommended (63%)
·
Nine (70%) of the 13 submissions that were supported by a
CEA or CUA were recommended. This result
needs to be interpreted with caution as two submissions were recommended on a
different basis and others with recommended with ‘conditions’ that the sponsors
concerned may consider to be unacceptable in their present form.
·
Three of the 12 rejections were for medicines in WHO ATC
Group L
·
The 12 resubmissions yielded 13 outcomes of which 10 were
recommendations (77%)
·
The applicants that fared well this meeting
were Roche (10 recommendations), MSD (8 recommendations) & Novartis (5
recommendations). The applicants that
fared poorly this meeting were Janssen-Cilag (2 rejections), GSK (2 rejections)
& Specialised Therapeutics (4 deferrals).
·
The PBAC recommended a price reduction for the
following medicines:
· Crizotinib
(Xalkori) – recommendation
· Ocular
lubricants – recommendation (the specific medicines that are subject to a price
reduction have not been identified)
· Pomalidomide
(Pomalyst) – recommendation
· Trametinib dimethyl
sulfoxide (Mekinist) – recommendation
· Elosulfase
alfa (Vimizim) – rejection
· Ponatinib
hydrochloride (Iclusig) - deferral
For more details, go
to www.maestrodatabase.com
