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

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