Decision to open list montelukast tablets

Medicines

Decision

PHARMAC is pleased to inform you about our decision to remove the Special Authority and Hospital Medicine restrictions on montelukast 4 mg, 5 mg, and 10 mg tablets and to apply the dispense all-at-once (stat dispensing) rule from 1 April 2018.

What we’re doing

We’re pleased to inform you about our decision to remove the Special Authority and Hospital Medicine restrictions on montelukast 4 mg, 5 mg, and 10 mg tablets and to apply the dispense all-at-once (stat dispensing) rule from 1 April 2018.

What would the effect be?

Montelukast tablets are currently funded for the treatment of pre-school wheeze, exercise induced asthma, and aspirin desensitisation.

This decision widens access to funded montelukast tablets from 1 April 2018 by removing the current Special Authority and restrictions.

For patients

From 1 April 2018, eligible patients would be able to access fully funded montelukast tablets from their community pharmacies with a prescription, regardless of the disease or condition that this medicine is being used to treat.

For prescribers

From 1 April 2018, prescribers no longer need to apply for a Special Authority approval for their patients to access fully funded montelukast tablets.

Montelukast tablets may be particularly suitable as an add-on treatment, with oral antihistamines, for patients with severe or refractory allergic rhinitis (hay fever) that is not currently being adequately controlled with antihistamines alone, or when used for the treatment of asthma in certain patient populations. These are brand new indications that montelukast tablets may be used to treat.

All medicines have risks and benefits. This decision widens access of montelukast tablets to a large number of patients for a number of new indications. Prescribers should monitor patients for any signs of adverse events (if any), and report these to the Centre for Adverse Reactions Monitoring (CARM). CARM’s contact details are:

CARM
NZ Pharmacovigilance Centre
University of Otago Medical School
PO Box 913, Dunedin
Telephone: 03 479 7247

Fax:            03 479 7150

Website: http://carm.otago.ac.nz(external link)

Who we think will be most interested

This proposal will be of interest to:

  • People with asthma, parents of children with asthma
  • Prescribers (General Practitioners, immunologists, nurse prescribers)
  • Suppliers and wholesalers
  • Community and hospital pharmacists

Details about this decision

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule (deletions in strikethrough).

Section B changes 

 

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.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made is below.

Theme PHARMAC Staff Comment
Supportive of open listing montelukast tablets, noting particular benefits to children with asthma, and to Māori populations. Noted.
Recommended awareness campaign for prescribers of montelukast tablets to monitor for rare adverse neuro-psychiatric issues or Churg-Strauss Syndrome. Noted. Information around adverse events monitoring and CARM reporting details are provided above.