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How can this be? Don’t bother asking because privacy laws shield the drug company applications for PBS listing from public scrutiny.

by Dr Martin Whitely

ADHD drug Concerta is a slow release form of methylphenidate (the active ingredient in Ritalin) that can be taken once daily.  It was first licensed for use in Australia by the Therapeutic Goods Administration (TGA) in 2003 and subsidised via the Pharmaceutical Benefits Scheme (PBS) for use by children in 2007.

Recently Concerta’s manufacturer Janssen-Cilag (a subsidiary of Johnson and Johnson) applied to “extend the current Authority required listing” on the Pharmaceutical Benefits Scheme for Concerta “to include use in patients diagnosed with attention deficit hyperactivity disorder (ADHD) after the age of 18 years”. The Pharmaceutical Benefits Scheme Advisory Committee (PBAC) “rejected the application on the basis of uncertain efficacy and safety in the proposed PBS population and hence uncertain cost-effectiveness, and high and highly uncertain cost to the PBS.”[1] In response Janssen Cilag commented that “Concerta is already available on the PBS for use in adults who were diagnosed with ADHD ≤ 18 years. This submission requested the same access for all adult patients regardless of the age at which they were diagnosed. We will consult with the PBAC with regards to a future resubmission.”[2]

Janssen Cilag raise a valid point; How can Concerta be ok for children and yet have “uncertain efficacy and safety” for adults? Read the rest of this entry »

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