This is the text extract for Approval of the proposal to list montelukast and ivermectin; Contact: Notifications; Posted: 2012-07-19, browse documents here.

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18 July 2012

Approval of the proposal to list montelukast and ivermectin

PHARMAC is pleased to announce the approval of a provisional agreement with Merck Sharp and Dohme (New Zealand) Limited for the funding of montelukast and ivermectin. This was the subject of a consultation letter dated 15 June 2012 (http://pharmac.govt.nz/2012/06/15). In summary, the effect of the decision is that:  Montelukast (Singulair) tablets will be funded, subject to Special Authority restrictions, for patients with pre-school wheeze, exercise-induced asthma and for patients undergoing aspirin desensitisation. Ivermectin (Stromectol) tablets will be funded, subject to Special Authority restrictions, for the treatment of scabies.

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Details of the Decision From 1 August 2012, montelukast and ivermectin will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (exmanufacturer, excluding GST):

Chemical Montelukast Montelukast Montelukast Ivermectin Presentation Tab 10 mg Tab 4 mg Tab 5 mg Tab 3 mg Brand Singulair Singulair Singulair Stromectol Pack size 28 28 28 4 Price and subsidy $18.48 $18.48 $18.48 $17.20

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The funding of montelukast will be subject to the following Special Authority restrictions:

Prescribing Guideline: Clinical evidence indicates that the effectiveness of montelukast is strongest when montelukast is used in short treatment courses. 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 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 400 µg per day beclomethasone or budesonide, or 200 µg per day fluticasone for at least one month; and

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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: Both: 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.

Initial application (aspirin desensitisation) only from a Clinical Immunologist or an Allergist. Approvals valid for one year, for applications meeting the following criteria: 1 All of the following: 1.1 Patient is undergoing aspirin desensitisation therapy under the supervision of a Clinical Immunologist or Allergist centre; and 1.2 Patient has moderate to severe aspirin-exacerbated respiratory disease or Samter’s triad; and 1.3 Nasal polyposis, confirmed radiologically or surgically; and 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.

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The funding of ivermectin will 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: Both: 1. Applying clinician has discussed the diagnosis of scabies with a Dermatologist, Infectious Disease physician or clinical microbiologist; and 2. Either 2.1. Both: 2.1.1. The patient is in the community; and 2.1.2. Any of the following: 2.1.2.1. Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or 2.1.2.2. The community patient is physically or mentally unable to comply with the application instructions of topical therapy; or 2.1.2.3. The patient has previously tried and failed to clear infestation using topical therapy; or 2.2. All of the following: 2.2.1. The Patient is a resident in an institution; and 2.2.2. All residents of the institution with scabies or at risk of carriage are to be treated for scabies concurrently; and

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2.2.3. Any of the following: 2.2.3.1. Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or 2.2.3.2. The patient is physically or mentally unable to comply with the application instructions of topical therapy; or 2.2.3.3. 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: Both: 1. Applying clinician has discussed the diagnosis of scabies with a Dermatologist, Infectious Disease Physician or Clinical Microbiologist; and 2. Either 2.1. Both: 2.1.1. The patient is in the community; and 2.1.2. Any of the following: 2.1.2.1. Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or 2.1.2.2. The community patient is physically or mentally unable to comply with the application instructions of topical therapy; or 2.1.2.3. The patient has previously tried and failed to clear infestation using topical therapy; or 2.2. All of the following 2.2.1. Patient is a resident in an institution and 2.2.2. All residents of the institution with scabies or at risk of carriage are to be treated for scabies concurrently; and 2.2.3. Any of the following: 2.2.3.1. Patient has a severe scabies hyperinfestation (Crusted/ Norwegian scabies); or 2.2.3.2. The patient is physically or mentally unable to comply with the application instructions of topical therapy; or 2.2.3.3. 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 Clinician, Clinical Microbiologist or Dermatologist. Approvals valid for one month for applications meeting the following criteria Any of the following: 1 Filaricides: or 2 Cutaneous larva migrans (creeping eruption); or 3 Strongyloidiasis Renewal (Other parasitic infections) from Infectious Disease Clinician, Clinical Microbiologist or Dermatologist. Approvals valid for one month for applications meeting the following criteria Patient has subsequent infection of either 1 Filaricides: or 2 Cutaneous larva migrans (creeping eruption); or 3 Strongyloidiasis

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For patients in age related residential care facilities, disability care facilities or penal institutions requiring ivermectin:

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Up to 100 tablets of ivermectin will be subsidised on a practitioners supply order (PSO) which must be endorsed with the name of the institution; or o A Bulk Supply Order (BSO) may be used to claim subsidies for patients requiring treatment. In both cases (PSO’s and BSO’s)a Special Authority will be required for treatment of one patient within the relevant institution the Special Authority number for that patient will need to be included in the BSO or PSO.  Singulair and Stromectol will have subsidy and delisting protection until 30 June 2014; and A confidential rebate will apply to Singulair from 1 August 2013.

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Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 29 June 2012 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, although the following issues were raised in relation to specific aspects of the proposal:

Issue Raised In general there was support for the proposals. PHARMAC Comment We appreciate this feedback.

Montelukast

A Clinical Immunologist requested that aspirin desensitisation is also funded. There was a request that the Special Authority be widened to include those patients whose asthma is refractory to inhaled corticosteroids. PHARMAC has included aspirin desensitisation. P T A C and the Respiratory Subcommittee of PTAC have considered this on several occasions. Asthma refractory to inhaled corticosteroids is not included in the current criteria for funding; however, we will continue to review the access criteria over time. PTAC considered restrictions on prescriber types who can apply for funding and recommended that any relevant practitioner is appropriate.

It was suggested that Special Authority applications for preschool wheeze are restricted to General Practitioners or Paediatricians and applications for severe asthma are restricted to Paediatricians. It was considered that prescribing decisions would be easier if the clinical thresholds for access were the same as internationally accepted evidence based guidelines. The prescribing guideline should allow daily use if it would be clinically beneficial for an individual patient.

PTAC and the Respiratory Subcommittee of PTAC have assessed montelukast a number of times and have recommended Special Authority criteria that best reflect the areas where the most clinical benefits can be gained. It was not the intention of the guideline to discourage daily use and the wording has been changed to reflect that the greatest clinical gain occurs when it is used intermittently for a period of 2 to 4 weeks.

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Issue Raised From the listed Seretide prices it was concluded that fluticasone plus montelukast is cheaper than a combination inhaler and should be able to continue to be used if the child is showing benefit.

PHARMAC Comment Montelukast is being listed for the treatment of children up to the age of five who have preschool wheeze as this is the area identified by PTAC and the Respiratory Subcommittee as showing the greatest clinical benefit. A confidential rebate applies to Seretide. We would be happy to consider a funding application for other uses of montelukast. The intention of the Special Authority is that montelukast be funded for exercise induced asthma only after other treatments have been tried. There is no requirement under the proposed Special Authority criteria that patients continue with some or all of these other treatments. Montelukast is being funded for three indications: children with preschool wheeze, patients who continue to experience frequent episodes of exercise-induced bronchoconstriction even after receiving maximal therapy and patients undergoing aspirin desensitisation therapy. Children with a poor response to ICS and LABAs are not eligible for treatment unless they meet the criteria, however we will continue to review access to this treatment over time.

Clinical guidelines recommend that if there is no improvement after a trial of inhaled corticosteroids and LABAs, then the LABA should be stopped and montelukast commenced. They do not suggest adding montelukast to LABAs as the current proposal suggests. A child who has a poor response to ICS and LABAs should be reviewed by a Paediatric specialist before commencing montelukast.

Ivermectin

Those eligible to apply for Special Authorities under the “other parasitic infections” criteria should include dermatologists, as they are the specialist m o s t li k e l y to see patients with cutaneous larva migrans It would be nice to see a strengthening of the statement: "The patient has previously tried and failed to clear infestation using topical therapy", It would be almost impossible to treat a whole ward or rest-home as they would be caught out by individual requirements. BSO is fine for hospital level care but many Age related residential care (ARRC) facilities cannot access BSO. The proposal does not allow for the treatment of staff contacts. The Special Authority has been amended to include Dermatologists.

Our clinical advice was that ivermectin is no more effective than topical therapy and clinicians would use appropriate judgment in determining failure of topical therapy. We have included a PSO provision for nonhospital level ARRC facilitates.

Staff should be able to comply with topical therapy and therefore would not require ivermectin unless they meet the special authority criteria. The length of one month for a Special Authority should allow time for the initial and repeat treatments (1 week apart). Should patients be reinfected a renewal Special Authority application should be made. There is no dose restriction proposed for ivermectin.

Would like to see the Special Authority time period extended to three months as we recognise prolonged spread, reinfection and delayed diagnosis in institutions. The dose ought not to be restricted to 4 times 3 mg tablets.

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Issue Raised Would like faster Special Authority application approvals to prevent delayed treatment or consideration of SA exemption for dermatologists.

PHARMAC Comment The current electronic Special Authority system provides a response in less than one minute. Paper based applications can take longer due to manual processing requirements.

More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

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