Approval of proposals for atomoxetine, sugammadex and baclofen injection

SAXXXX Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has ADHD (Attention Deficit and Hyperactivity Disorder) diagnosed according to DSM-IV or ICD 10 criteria; and
2. Once-daily dosing; and
3. Any of the following:
   1. Treatment with a subsidised formulation of a stimulant has resulted in the development or worsening of serious adverse reactions or where the combination of subsidised stimulant treatment with another agent would pose an unacceptable medical risk; or
   2. Treatment with a subsidised formulation of a stimulant has resulted in worsening of co-morbid substance abuse or there is a significant risk of diversion with subsidised stimulant therapy; or
   3. An effective dose of a subsidised formulation of a stimulant has been trialled and has been discontinued because of inadequate clinical response; or
   4. Treatment with a subsidised formulation of a stimulant is considered inappropriate because the patient has a history of psychoses or has a first-degree relative with schizophrenia; and
4. The patient will not be receiving treatment with atomoxetine in combination with a subsidised formulation of a stimulant, except for the purposes of transitioning from subsidised stimulant therapy to atomoxetine.

The restrictions applying to sugammadex (Bridion) inj 100 mg per ml, 2 ml and 5 ml vials, will be amended in the HML from 1 February 2014 as follows (additions in bold):

Any of the following:

1. Patient requires reversal of profound neuromuscular blockade following a rapid sequence induction that has been undertaken using rocuronium (i.e. suxamethonium is contraindicated or undesirable); or
2. Severe neuromuscular degenerative disease where the use of neuromuscular blockade is required; or
3. Patient has an unexpectedly difficult airway that cannot be intubated and requires a rapid reversal of anaesthesia and neuromuscular blockade; or
4. The duration of the patient’s surgery is unexpectedly short; or
5. Neostigmine or a neostigmine/anticholinergic combination is contraindicated (for example the patient has ischaemic heart disease, morbid obesity or COPD); or
6. Patient has a partial residual block after conventional reversal.

• Baclofen inj 0.05 mg per ml, 1 ml ampoule and inj 2 mg per ml, 5 ml ampoule (Lioresal Intrathecal) will be listed in Section B of the Pharmaceutical Schedule from 1 February 2014, fully funded at a price and subsidy of $11.55 and $209.29 per injection, respectively, subject to the following prescription endorsement for subsidy:

Subsidy by Endorsement
Subsidised only for use in a programmable pump in patients where oral antispastic agents have been ineffective or have caused intolerable side effects and the prescription is endorsed accordingly.