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The Working Occasion also requested adjustments to the diagnostic standards for narcolepsy included in the current restriction for modafinil. Nevertheless the factors in the current restriction have been based mostly upon internationally accepted standards and no information or references have been provided in support of the claims made within the pre-Sub-Committee response relating to the proportion of narcolepsy patients currently being denied modafinil therapy on account of requirements associated to the MSLT. The trial by Black (2006) differed in design to the trials previously thought of by the PBAC as patient eligibility criteria included that patients be on stable doses of modafinil (i.e., a responder population) and the dose of modafinil used ranged between 200 and 600 mg/day (the TGA accepted doses had been 200-four hundred mg/day). The Committee indicated its willingness to hold additional dialogue with the working occasion and other relevant stakeholders on the restriction’s diagnostic standards.
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