Readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Prescriber publishes selected questions from readers, together with answers from the PBAC. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and withdrawals. This exclusive arrangement helps Australian Prescriber readers understand how the contents of the Pharmaceutical Benefits Scheme (PBS, see are determined. Letters and responses are reviewed by the Editorial Executive Committee and may be edited before publication. It may not be possible to reply to all individual questions.

Availability of methylphenidate

What is the Pharmaceutical Benefits Advisory Committee's justification for not including methylphenidate on the Pharmaceutical Benefits Scheme for attention deficit hyperactivity disorder, while allowing dexamphetamine?

G. Shakkal
By e-mail

PBAC response:

The Pharmaceutical Benefits Advisory Committee (PBAC) has considered whether methylphenidate 10 mg tablet should be recommended for listing for the treatment of attention deficit hyperactivity disorder. Data submitted by the manufacturer indicated that although this drug may be superior to dexamphetamine in some patients, the reverse is true in others, i.e. there is no difference in overall effectiveness between the two drugs. As a consequence, the PBAC recommended that methylphenidate be listed at a price equivalent to that currently applying to the listing of dexamphetamine. However, implementation of a recommendation depends on the negotiation, between the Government and the manufacturer, of a mutually acceptable price for the product. In the case of methylphenidate the negotiations have not been successful.

The National Health Act 1953 under which the PBAC operates does not provide for merit appeals against the recommendations of the Committee. Rather, the applicant may address the issues by re-submission to the PBAC. A re-submission may include new data, new circumstances, new argument and new approaches to provide a basis for any change in the Committee's earlier decision.