This is the text extract for Consultation to widen access to azithromycin for cystic fibrosis patients. Closes 15 April, browse documents here.

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27 March 2009

Proposal to widen access to azithromycin for cystic fibrosis patients. PHARMAC is proposing to apply a Special Authority to azithromycin that would widen subsidised access to include the management of cystic fibrosis. Cystic fibrosis is not an approved indication for azithromycin.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm on Wednesday 15 April 2009 to: Greg Williams Therapeutic Group Manager PHARMAC Email: greg.williams@pharmac.govt.nz Fax: 04 460 4995 Post: PO Box 10 254, Wellington 6143

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.

Details of the Proposal PHARMAC proposes to amend the listing of azithromycin in Section B of the Pharmaceutical Schedule to include a Special Authority to allow waiving of the maximum of 2 tablets per prescription rule that currently applies, for the management of cystic fibrosis. The proposed listing would be (changes in bold, deletions in strikethrough) as follows:

AZITHROMYCIN – Subsidy by endorsement a) Maximum of 2 tab per prescription b) Up to 4 tablets available on a PSO c) Subsidised only if prescribed for patients with uncomplicated urethritis or cervicitis proven or presumed to be due to Chlamydia trachomatis and their sexual contacts and prescription or PSO is endorsed accordingly. Maximum of 2 tablets per prescription can be waived by Special Authority see SA#### below SA#### Special Authority for Waiver of Rule Initial application only from a respiratory specialist or paediatrician. Approvals valid without further renewal unless notified for applications meeting the following criteria: All of the following: 1 The applicant is part of a multidisciplinary team experienced in the management of cystic fibrosis; and 2 The patient has been definitively diagnosed with cystic fibrosis; and

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The patient has chronic infection with P. aeruginosa as defined by two positive respiratory tract cultures at least three months apart; and 4 The patient has negative cultures for non-tuberculous mycobacteria; and 5 The patient has a forced expiratory volume (FEV1) of less than 80% of predicted; and 6 The patient is aware that azithromycin is being prescribed under Section 25 of the Medicines Act 1981. Note Caution is advised if using azithromycin as an antibiotic in the treatment of cystic fibrosis patients with pneumonia. Testing for non-tuberculosis mycobacteria should occur annually

Background to the proposal Azithromycin 500 mg tablets are listed in Section B of the Pharmaceutical Schedule at a price and subsidy of $9.90 per 2 tablets under a sole subsidised supply arrangement with Arrow Pharmaceuticals Limited. In 2005, PHARMAC received an application from clinicians to list azithromycin for patients with Cystic Fibrosis (CF) who also have Pseudomonas aeruginosa. This is an unregistered indication for the medication and there is a warning on the data sheet for azithromycin1 in this patient group, who also have pneumonia, as follows:

Warnings and Precautions Community-acquired pneumonia In the treatment of pneumonia, azithromycin has been shown to be safe and effective only in the treatment of community-acquired pneumonia of mild severity due to Streptococcus pneumoniae or Haemophilus influenzae in patients appropriate for outpatient oral therapy. Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for outpatient oral therapy because of moderate to severe illness or risk factors such as patients with the following conditions: · cystic fibrosis

We note that it is unusual for PHARMAC to consider funding an unapproved indication. However, in this case there are some particular issued that have led us to the preliminary view that it should be considered. PHARMAC staff have taken advice on a number of occasions from the Pharmacology and Therapeutics Advisory Committee (PTAC), the Anti-Infective Subcommittee of PTAC and the Cystic Fibrosis Advisory Panel (clinicians experienced in the care of cystic fibrosis patients). Each of these advisory committees considered matters related to the safety and efficacy of azithromycin for the management of cystic fibrosis. The Special Authority criteria proposed above were recommended by the Cystic Fibrosis Advisory Panel. The Panel recommended that patients with positive cultures for non-tuberculosis mycobacteria should not have access to azithromycin due to concerns about macrolide resistance in that patient group.

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http://www.medsafe.govt.nz/profs/datasheet/a/Arrow-Azithromycintab.htm

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In November 2007, the Anti-infective Subcommittee considered that the risk of antibiotic resistance and the possibility of excessive use of azithromcyin for a range of respiratory and other conditions were too great if no restrictions were placed on its use. Instead, the Subcommittee recommended that access to azithromycin remain restricted and access widened to azithromycin, using the Special Authority criteria recommended by the Cystic Fibrosis Advisory Panel for patients with cystic fibrosis. PTAC endorsed the Subcommittee’s recommendation in February 2008. We note that PHARMAC does not usually fund unapproved indications but are considering doing so in this case for the following reasons: · clinical advice is that this is a medically appropriate treatment; · clinicians have provided clinical data to be submitted by suppliers to request a change on the Medsafe data sheet (only the sponsor of a product can request a change to the data sheet); there are no suitable oral alternatives to this treatment; and a listing with no restrictions was considered by the Anti-Infective Subcommittee of PTAC and found to have risk associated with resistance if this occurred.

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