Proposal to open list montelukast tablets

Medicines

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to widen funded access to montelukast tablets by removing all Special Authority criteria and restrictions applying to montelukast 4 mg, 5 mg, and 10 mg tablets (Apo-Montelukast) in Section B and in Part II of Section H of the Pharmaceutical Schedule, from 1 April 2018. 

The proposed change would enable prescribing of fully funded montelukast tablets to any eligible patients that the prescriber considers would clinically benefit from treatment for a number of new indications.

We are particularly interested in views and feedback around the need for new funded treatments for allergic rhinitis in New Zealand, and whether prescribers are likely to require additional educational material or support with prescribing montelukast tablets.

Consultation closes at 5pm on Tuesday, 27 February 2018 and feedback can be emailed to: tony.wang@pharmac.govt.nz.

Please share this information with any other groups or people you think may be interested in providing feedback.

What would the effect be?

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

This proposal seeks to widen access to funded montelukast tablets from 1 April 2018 by removing the current Special Authority and restrictions.

For patients

The effect of this proposal would mean that 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

The effect of this proposal would mean that from 1 April 2018, prescribers would no longer need to apply for a Special Authority approval for 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.

Who we think will be 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

Why we're proposing this?

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

Montelukast tablets are registered with Medsafe for the treatment of a broad range of indications including the prophylaxis and chronic treatment of treatment of asthma, prevention of day and night time symptoms of asthma, the prevention of exercise induced bronchospasm, and the relief of symptoms associated with seasonal and perennial allergic rhinitis.

It is expected that this proposal would benefit over 10,000 patients in the first 12 months.

Asthma

Asthma is a disease that disproportionately affects Māori and populations in areas of high rates of socioeconomic deprivation, with measures of prevalence, hospitalization, and mortality all higher than lesser deprived populations(external link). The open listing of montelukast would add another funded treatment option to enable patients to better manage and control their asthma. Montelukast may be particularly suitable for the prevention and control of asthma in children.

Allergic rhinitis (hay fever)

Season and perennial allergic rhinitis is a condition that affects a significant proportion of New Zealanders. Approximately 10% of patients taking oral antihistamines still experience the symptoms of allergic rhinitis. Use of montelukast as add-on treatment for seasonal and perennial allergic rhinitis is well established overseas, and the open listing of montelukast tablets is expected to bring significant benefits to those New Zealanders with severe or refractory allergic rhinitis.

Clinical advice

The Respiratory Subcommittee in April 2014 had recommended that access to montelukast be widened by removing the Special Authority entirely, and gave this recommendation a low priority.

The Pharmacology and Therapeutics Advisory Committee (PTAC) at its August 2014 meeting however considered that the increased use of montelukast tablets in allergy therapy could pose a fiscal risk to PHARMAC, and did not endorse the Respiratory Subcommittee’s recommendation to remove the Special Authority at that time.

The fiscal risk identified by PTAC is now significantly reduced due to lower pricing of montelukast tablets, achieved through PHARMAC’s annual multi-product tendering process. This means we are now comfortable with progressing this proposal.

Details about our proposal

PHARMAC is seeking feedback on a proposal to widen access to montelukast 4 mg, 5 mg, and 10 mg tablets by removing all restrictions in Section B and Part II of Section H of the Pharmaceutical Schedule (open list), from 1 April 2018.

It is proposed that the following changes be made to the Special Authority and restrictions applying to montelukast tablets in Section B and Part II of Section H of the Pharmaceutical Schedule, from 1 April 2018 (deletions in strikethrough):

Section B of the Pharmaceutical Schedule

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.

To provide feedback

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Tuesday, 27 February 2018 to:

Tony Wang
Therapeutic Group Manager
PHARMAC
PO Box 10254
Wellington 6143 

Email: tony.wang@pharmac.govt.nz

Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.