Proposal to open list montelukast tablets

Special Authority for Subsidy

Initial application — (Pre-school wheeze) from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria:

Both:

1.  To be used for the treatment of intermittent severe wheezing (possibly viral) in children under 5 years; and
2. The patient has had at least three episodes in the previous 12 months of acute wheeze severe enough to seek medical attention.

Renewal — (Pre-school wheeze) from any relevant practitioner. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.

Initial application — (exercise-induced asthma) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

1. Patient has been trialled with maximal asthma therapy, including inhaled corticosteroids and long-acting beta-adrenoceptor agonists; and
2. Patient continues to receive optimal inhaled corticosteroid therapy; and
3. Patient continues to experience frequent episodes of exercise-induced bronchoconstriction.

Initial application — (aspirin desensitisation) only from a clinical immunologist or allergist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

1. Patient is undergoing aspirin desensitisation therapy under the supervision of a Clinical Immunologist or Allergist; and
2. Patient has moderate to severe aspirin-exacerbated respiratory disease or Samter’s triad; and
3. Nasal polyposis, confirmed radiologically or surgically; and
4. Documented aspirin or NSAID allergy confirmed by aspirin challenge or a clinical history of severe reaction to aspirin or NSAID where challenge would be considered dangerous.

Part II of Section H of the Pharmaceutical Schedule

Restricted

Initiation – Pre-school wheeze

Both:

1. To be used for the treatment of intermittent severe wheezing (possibly viral) in children under 5 years; and
2. The patient has had at least three episodes in the previous 12 months of acute wheeze severe enough to seek medical attention.
   

Initiation – Exercise-induced asthma

All of the following:

1. Patient has been trialed with maximal asthma therapy, including inhaled corticosteroids and long-acting beta-adrenoceptor agonists; and
2. Patient continues to receive optimal inhaled corticosteroid therapy; and
3. Patient continues to experience frequent episodes of exercise-induced bronchoconstriction.
   

Initiation – Aspirin desensitisation

Clinical immunologist or allergist

All of the following:

1. Patient is undergoing aspirin desensitisation therapy under the supervision of a clinical immunologist or allergist; and
2. Patient has moderate to severe aspirin-exacerbated respiratory disease or Samter's triad; and
3. Nasal polyposis, confirmed radiologically or surgically; and
4. Documented aspirin or NSAID allergy confirmed by aspirin challenge or a clinical history of severe reaction to aspirin or NSAID where challenge would be considered dangerous.

The price and subsidy for Apo-Montelukast tablets would remain unchanged.  These are supplied by Apotex under a sole supply arrangement which ends on 30 June 2019.