This is the text extract for Proposal to list montelukast sodium and ivermectin; Closing Date: CLOSED; Contact: Christine Chapman, browse documents here.

---

15 June 2012

Proposal to list montelukast sodium and ivermectin.

PHARMAC is seeking feedback on a proposal to fund montelukast sodium (Singulair) and ivermectin (Stromectol) through a provisional agreement with Merck Sharp and Dohme (New Zealand) Limited. In summary, this proposal would result in:  Montelukast sodium (Singulair) tablets and chewable tablets being funded, subject to Special Authority restrictions, for patients with pre-school wheeze and exerciseinduced asthma. Ivermectin (Stromectol) tablets being funded, subject to Special Authority restrictions, for the treatment of scabies.



Details of the proposal and background information can be found on the following pages.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5.00 pm Friday, 29 June 2012 to: Christine Chapman Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: Christine.chapman@pharmac.govt.nz Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.

A514984514984 Page 1 of 5

---

Details of the proposal Montelukast sodium  It is proposed that, from 1 August 2012, montelukast sodium be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST) follows:

Chemical Montelukast sodium Montelukast sodium Montelukast sodium Presentation Tab 10 mg Tab chewable 4 mg Tab chewable 5 mg Brand Singulair Singulair Singulair Pack size 28 28 28 Price and subsidy $18.48 $18.48 $18.48



Montelukast sodium would be subject to the following Special Authority restrictions:

Prescribing Guideline: Clinical evidence indicates that the effectiveness of montelukast is strongest when used intermittently. Special Authority for Subsidy Initial application (Pre-school wheeze) from any relevant practitioner. Approvals valid for one year for applications meeting the following criteria: All of the following: 1 2 3 To be used for the treatment of intermittent severe wheezing (possibly viral) in children under 5 years; and The patient has trialled inhaled corticosteroids at a dose of up to 400µg per day beclomethasone or budesonide, or 200 µg per day fluticasone for at least one month; and The patient continues to have at least three severe exacerbations at least one of which required hospitalisation (defined as in-patient stay or prolonged Emergency Department treatment) in the past 12 months.

Renewal (pre-school wheeze) - only from a relevant practitioner. Approvals valid for two years where the treatment remains appropriate and the patient is benefitting 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 2 Patient is being treated with maximal asthma therapy, including inhaled corticosteroids and long-acting beta-adrenoceptor agonists; and Patient continues to experience frequent episodes of exercise-induced bronchoconstriction.



Montelukast sodium would have subsidy and delisting protection until 30 June 2014; and A confidential rebate would apply from 1 August 2013. Page 2 of 5



A514984514984T11-575

---

Ivermectin  It is proposed that, from 1 August 2012, ivermectin be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST) follows:

Chemical Ivermectin Presentation Tab 3 mg Brand Stromectol Pack size 4 Price and subsidy $17.20



Ivermectin would be subject to the following Special Authority restrictions:

Special Authority for Subsidy Initial application (Scabies) from any relevant practitioner. Approvals valid for one month for applications meeting the following criteria Applying clinician has discussed the diagnosis of scabies with a Dermatologist, Infectious Disease physician or clinical microbiologist; and 1 The patient is in the community; and 2 Any of the following: (i) Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or (ii) The community patient is physically or mentally unable to comply with the application instructions of topical therapy; or (iii) The patient has previously tried and failed to clear infestation using topical therapy Or 3 The Patient is a resident in an institution and 4 All residents of the institution with scabies or at risk of carriage are to be treated for scabies concurrently; and 5 any of the following: (i) Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or (ii) The patient is physically or mentally unable to comply with the application instructions of topical therapy; or (iii) previous topical therapy has been tried and failed to clear the infestation Renewal application (Scabies) from any relevant practitioner. Approvals valid for one month for applications meeting the following criteria Applying clinician has discussed the diagnosis of scabies with a Dermatologist, Infectious Disease Physician or Clinical Microbiologist; and 1 The patient is in the community; and 2 Any of the following: (i) Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or (ii) The community patient is physically or mentally unable to comply with the application instructions of topical therapy; or (iii) The patient has previously tried and failed to clear infestation using topical therapy Or 3 The Patient is a resident in an institution and 4 All residents of the institution with scabies or at risk of carriage are to be treated for scabies concurrently; and 5 any of the following: (i) Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or (ii) The patient is physically or mentally unable to comply with the application instructions of topical therapy; or (iii) previous topical therapy has been tried and failed to clear the infestation Note: Ivermectin is no more effective than topical therapy for treatment of standard scabies infestation. Initial application (Other parasitic infections) from Infectious Disease Specialist or Clinical Microbiologist. Approvals valid for one month for applications meeting the following criteria

A514984514984T11-575

Page 3 of 5

---

Patient has either 1 Filaricides: or 2 Cutaneous larva migrans (creeping eruption); or 3 Strongyloidiasis

 

Ivermectin would have subsidy and delisting protection until 30 June 2014 For institutional patients a Special Authority would be required for one patient and then a Bulk Supply Order (BSO) for the institution could be used to claim for all of the patients requiring treatment in the institution. The Special Authority number would need to be included in the BSO

Background to the proposal Montelukast sodium Montelukast sodium is a leukotriene receptor agonist indicated for the treatment of asthma. The Pharmacology and Therapeutics Advisory Committee (PTAC) and the Respiratory Subcommittee of PTAC have reviewed montelukast sodium on several occasions. In relation to pre-school wheeze, the most recent recommendation from PTAC was that montelukast sodium be funded subject to Special Authority restrictions for the treatment of patients with pre-school wheeze who have trialed inhaled corticosteroids at recommended dose levels for at a least one month and continue to experience severe exacerbations. In relation to exercise-induced asthma the most recent recommendation from the Respiratory Subcommittee of PTAC was that montelukast be funded subject to Special Authority for exercise-induced asthma for patients who have been treated with maximal asthma therapy and continues to experience frequent episodes of exercise-induced asthma. The most recent published PTAC and Respiratory Subcommittee minutes relating to montelukast sodium can be found on PHARMAC’s website at: http://www.pharmac.govt.nz/2011/07/05, http://www.pharmac.govt.nz/2011/01.

Ivermectin Ivermectin is an anthelmintic and is currently available on the Discretionary Community Supply (DCS) for filaricides, cutaneous larva migrans (creeping eruption) and strongyloidiasis. At its February 2011 meeting PTAC recommended that ivermectin be funded subject to Special Authority for the treatment of crusted scabies and for those patients for whom it is not possible to use lotions or creams. The published PTAC minutes relating to ivermectin can be found on PHARMAC’s website at: http://www.pharmac.govt.nz/2011/04/15 The Anti-Infective Subcommittee of PTAC at its 22 February 2012 meeting recommended listing ivermectin for the treatment of crusted scabies or where the patient was unable to comply with topical treatment with a high priority under the proposed Special Authority. The full minute of the Anti-Infective Subcommittee is as follows:

Members noted the PTAC minute relating to ivermectin for crusted scabies and use in institutional settings (e.g. rest homes). Members considered that the PTAC recommendation that ivermectin was no more effective than creams and lotions was appropriate. Members considered that if appropriate restrictions were not in place then institutions would use ivermectin rather than topical therapy as it was easier than applying the cream or lotion.

A514984514984T11-575

Page 4 of 5

---

Members noted that ivermectin was more expensive than topical scabies therapy. The Subcommittee noted that many community institutions had multiple general practitioners responsible for its patients and that if treatment with ivermectin was to be provided this would need to be co-ordinated. Members noted that many institutions had a charge nurse who should be able to co-ordinate care provision. The Subcommittee noted that patients with Crusted scabies (also called ‘Norwegian scabies’) are very likely to benefit from ivermectin. Members noted that crusted scabies usually occurred in the immunocompromised. Patients with crusted scabies usually had a hyperinfestation of the scabies mite. The Subcommittee considered that the following restriction may be appropriate:

1) Applying clinician has discussed the diagnosis of scabies with a Dermatologist, Infectious Disease Physician or Clinical Microbiologist; and 2) The patient is in the community; and Either a. Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or b. The community patient is physically or mentally unable to comply with the application instructions of topical therapy; or c. The patient has previously tried and failed to clear infestation using topical therapy Or 3) The Patient is a resident in an institution and a. All residents of the institution with scabies or at risk of carriage are to be treated for scabies concurrently; and either i. Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or ii. The patient is physically or mentally unable to comply with the application instructions of topical therapy; or iii. previous topical therapy has been tried and failed to clear the infestation; or Note: Ivermectin is no more effective than topical therapy for treatment of standard scabies infestation.

The proposed Special Authority follows the recommendations of the Subcommittee and includes the indications currently funded under DCS (filaricides, cutaneous larva migrans and strongyloidiasis) which would enable ivermectin to be funded for these indications without the need for a patient to be admitted as a day patient.

A514984514984T11-575

Page 5 of 5